Preventing VTE with Decision Support

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Improving hospital venous thromboembolism prophylaxis with electronic decision support

Over 900,000 incident and recurrent venous thromboembolism (VTE) events occur in the United States each year, resulting in nearly 300,000 fatalities.[1] VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is among the most common causes of death in the United States, with more people dying annually from VTE than motor vehicle accidents and breast cancer.[2]

Accordingly, healthcare policy makers and regulators have placed greater emphasis on VTE prevention, including use of VTE prophylaxis measures in the Centers for Medicare and Medicaid Services (CMS) value‐based purchasing (pay for performance) program and the Joint Commission's adoption of a national hospital patient safety goal related to anticoagulation therapy.[3, 4] Beginning in 2008, VTE events following hip and knee procedures were included as 1 of 10 hospital‐acquired conditions for which CMS would not pay for associated additional costs of care.[5]

A typical 300‐bed hospital can expect roughly 150 cases of hospital‐acquired VTE annually.[6] Up to 75% of these cases will occur on the medicine service, where nearly every patient has 1 or more VTE risk factor.[7] Although effective preventive modalities exist, prophylaxis rates among medical patients have been noted to be <50%.[8, 9] While quality improvement interventions have been shown to be effective in improving compliance with VTE prophylaxis, there are few studies describing effectiveness of these interventions in electronic health record (EHR) environments.[10] As EHR implementation accelerates, it will be essential to define the strengths and limitations of various decision support approaches to optimally improve patient safety.

We sought to evaluate the effectiveness and safety of a computerized decision support application, which was designed as part of a quality improvement initiative to improve rates of VTE prophylaxis rates on the medicine services at 2 hospital sites.

METHODS

Setting

The initiative was conducted at Montefiore Medical Center, an academic medical center in the Bronx, New York. This article describes results from an effort to improve inpatient VTE prophylaxis rates as part of an overall medical center initiative to improve anticoagulation management beginning in 2007. The initiative was led by an interdisciplinary committee consisting of administrators, medical and surgical physicians, nursing staff, and information technology and performance improvement personnel.

Intervention

As part of the initial quality improvement project, the group analyzed factors associated with and rates of hospital‐acquired VTE. Among the findings was a predominance of hospital‐acquired VTE cases and suboptimal rates of VTE prophylaxis on medicine services. Accordingly, the medicine service, whose discharge volume was 36,500 in 2010, was the population of focus for the improvement effort. The analysis also demonstrated a 99% agreement rate between administratively coded VTE events and VTE diagnoses verified from chart review, validating the utility of institutional administrative data for ongoing study of VTE events. As the hospital sites had computerized physician order entry, the group sought to develop an electronic clinical decision support module. The primary objective of the quality improvement effort was to increase VTE prophylaxis rates and decrease VTE incidence among medicine patients.

A range of clinical decision support approaches was explored. Based on team review, key decision support design objectives were to:

  • Minimize alert fatigue
  • Utilize existing clinical information system variables to:

     

    • Avoid de novo physician data entry solely to support the application
    • Automatically identify and exclude patients in whom pharmacologic VTE prophylaxis was contraindicated
    • Utilize the 8th edition of the American College of Chest Physicians VTE guidelines[8] as a basis for recommendations (as the study was conducted prior to the 9th edition release)

     

    The VTE decision support module was comprised of order sets with the following features:

    • Patients were identified as on the medicine service based on admitting service designation.
    • An order set was populated from this triggering mechanism offering pharmacologic VTE prophylaxis options, or alternately, options to document lack of a clinical indication for pharmacologic VTE prophylaxis, planned therapeutic anticoagulation, or contraindication to VTE prophylaxis.
    • Alternate order sets were offered with mechanical VTE prophylaxis options if the physician indicated pharmacologic VTE prophylaxis was contraindicated or if the information system identified a clinical contraindication.
    • If pharmacologic VTE prophylaxis was not prescribed, the rules logic was repeated every 5 days.

     

Analyses

The evaluation sought to assess the effectiveness and safety of the decision support module. VTE processes and outcomes for the 6‐month periods immediately before and after full scale decision support go‐live on September 9, 2009, were evaluated. This time window was chosen in relation to CMS' requirement that hospitals use present on admission codes for discharge diagnoses (including VTE) on October 1, 2007, and first implementation of a hospital‐acquired condition policy on October 1, 2008.[5] The 6‐month period prior to September 2009 was within the first calendar year where both CMS policies were in effect.

Effectiveness of the decision support module was measured by evaluating the proportion of medicine service discharges before and after module deployment who:

  • Received any VTE prophylaxis modality
  • Received a pharmacologic VTE prophylaxis modality
  • Developed a hospital‐acquired VTE

 

Successful receipt of any VTE prophylaxis modality was defined as use of compression stockings, pneumatic compression devices, or pharmacologic VTE prophylaxis modalities, including therapeutic anticoagulation (eg, mechanical heart valve). Medications counting toward the definition of pharmacologic agents included unfractionated heparin, dalteparin, warfarin, fondaparinux, lepirudin, argatroban, or bivalirudin, which are all on formulary at the medical center. Heparin used as an intravenous flush or associated with dialysis was excluded. Hospital‐acquired VTE was defined by the numerator International Classification of Diseases, 9th Revision (ICD‐9) discharge diagnosis codes for DVT or PE events as specified in the Agency for Healthcare Research and Quality (AHRQ) postoperative PE or DVT Patient Safety Indicator 12, and where the codes were not present on admission.[11]

Patient discharges excluded from analyses were those with patient age <18 years, length of stay 1 day or less, VTE diagnosis present on admission, or patient with an inferior vena cava filter during the stay. For evaluation of pharmacologic VTE prophylaxis, patients were additionally excluded if they had a platelet count <50,000/L during their stay, were a neurosurgical patient, or had a discharge diagnosis that included gastrointestinal bleeding or coagulopathy.

The safety of the decision support application was measured by assessing the proportion of medicine service discharges before and after decision support deployment who developed bleeding or thrombocytopenia. Bleeding was defined as receipt of 1 or more packed red blood cell units following administration of an anticoagulant medication at a VTE prophylaxis dosage range. Exclusion criteria for bleeding evaluation were patients aged <18 years, with length of stay 1 day or less, VTE diagnosis present on admission, platelet count <50,000/L during the stay, were a neurosurgical patient, or had diagnoses of anemia, hematologic malignancy, or inferior vena cava filter during the stay, or diagnoses of gastrointestinal bleeding, hemorrhage, or hematoma on admission.

Thrombocytopenia was defined as a >50% decrease from the initial platelet count during the hospital stay, or a decrease from an admission platelet count of >100,000/L to <100,000/L during the hospital stay. Criteria for exclusion from these analyses were age <18 years, length of stay 1 day or less, diagnosis of VTE present on admission, and vena cava filter during the stay.

A medical center comparison group was defined to contrast the magnitude of change in study end points on medicine services where the intervention was deployed with the change on other services where decision support was not used, and to distinguish potential changes observed on medicine services from secular trends. The comparison group consisted of discharges from cardiology, cardiothoracic surgery, family medicine, general surgery, surgical subspecialty, oncology, psychiatry, and rehabilitation medicine services. Newborn, neurosurgery, obstetrics, and pediatrics service discharges were excluded from the comparison group because of their being at low risk for VTE or in a high‐risk group in whom pharmacologic VTE prophylaxis was frequently contraindicated. All parameters described above were evaluated in the comparison group using inclusion and exclusion criteria similar to the intervention group. Outcomes (hospital‐acquired VTE, bleeding, thrombocytopenia) were assessed similarly across index admissions and readmissions.

The significance of change in rates of prescribing, VTE incidence, and adverse event occurrence, were tested by comparing event proportions before and after decision support module implementation in both groups. As all variables were categorical, significance was assessed using 2‐sided Pearson 2 tests at an level of 0.05. Statistical analyses were performed using SPSS software (IBM, Armonk, NY). This project was reviewed by the Albert Einstein College of Medicine/Montefiore Medical Center institutional review board (protocol number 12‐02‐058X) and deemed exempt. Design of the decision support module and definition of the implementation and evaluation plan required approximately 1 year of monthly interdisciplinary team meetings and 200 hours of programmer development time.

RESULTS

Table 1 compares the effectiveness of the decision support module intervention in medicine intervention and in nonmedicine (nonintervention) services. Among medicine service patients, any VTE prophylaxis ordering increased from 61.9% to 82.1% (P < 0.001), and pharmacologic VTE prophylaxis increased from 59.0% to 74.5% (P < 0.001). Smaller but significant increases were observed on nonmedicine services. Hospital‐acquired VTE incidence on medicine services decreased significantly, from 0.65% to 0.42% (P = 0.008) and nonsignificantly on nonmedicine services.

Rates of Any VTE Prophylaxis Ordering, Pharmacologic VTE Prophylaxis Ordering, and Hospital‐Acquired VTE, Before and After Decision Support Module Implementation in Medicine Intervention and Nonmedicine Comparison services
 Medicine ServiceNonmedicine Services
 PrePost  PrePost  
 % (n)% (n)Relative ChangeSignificance% (n)% (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Any VTE prophylaxis        
EligibleN = 15,254N = 15,065N/AN/AN = 8566N = 8162N/AN/A
Received61.9 (9443)82.1 (12,372)+32.7%P < 0.00170.5 (6040)73.6 (6010)+4.4%P < 0.001
Pharmacologic VTE prophylaxis        
EligibleN = 14,768N = 14,588N/AN/AN = 7883N = 7567N/AN/A
Received59.0 (8712)74.5 (10,869)+26.3%P < 0.00159.3 (4677)63.3 (4791)+6.7%P < 0.001
Hospital‐acquired VTE incidence        
SusceptibleN = 15,254N = 15,065N/AN/AN = 8566N = 8162N/AN/A
Developed0.65 (99)0.42 (64)34.5%P = 0.0080.82 (70)0.72 (59)11.5%P = 0.486

Table 2 shows ordering patterns for major VTE prophylaxis modalities. Among eligible medicine service patients, rates of low molecular weight heparin prophylaxis increased from 13.0% to 23.7% (P < 0.001), and of unfractionated heparin prophylaxis from 35.1% to 40.7% (P < 0.001). On nonmedicine services, there was no significant change in low molecular weight heparin use, and unfractionated heparin use increased significantly from 37.2% to 40.9% (P < 0.001). Proportions of patients receiving mechanical prophylaxis or not receiving prophylaxis decreased significantly by 37.8% on medicine services and by 9.8% on nonmedicine services Table 3 shows the safety of the decision support module. Bleeding rates increased on medicine services from 2.9% to 4.0% (P < 0.001) and on nonmedicine services from 7.7% to 8.6% (P = 0.043). Nonsignificant changes in thrombocytopenia rates were observed on both services.

Rates of Ordering of VTE Prophylaxis Modalities Included in the Medicine Service Decision Support Module in Medicine Intervention and Nonmedicine Comparison Services
 Medicine ServiceNonmedicine Services
 Pre % (n)Post % (n)Relative ChangeSignificancePre % (n)Post % (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Eligible for pharmacologic VTE prophylaxisN = 14,768N = 14,588N/A N = 7883N = 7567N/A 
Low molecular weight heparin13.0 (1922)23.7 (3463)+82.4%P < 0.00115.3 (1206)15.9 (1204)+4.0%P = 0.294
Unfractionated heparin35.1 (5181)40.7 (5936)+16.0%P < 0.00137.2 (2932)40.9 (3093)+9.9%P < 0.001
Warfarin10.8 (1594)10.0 (1461)7.2%P = 0.0296.8 (532)6.4 (483)5.4%P = 0.359
Other agent0.1 (15)0.1 (9)39.3%P = 0.2320.1 (7)0.2 (11)+63.7P = 0.303
Mechanical prophylaxis or did not receive41.0 (6056)25.5 (3719)37.8%P < 0.00140.7 (3206)36.7 (2776)9.8%P < 0.001
Rates of Bleeding and Thrombocytopenia Before and After Decision Support Module Implementation in Medicine Intervention and Nonmedicine Comparison Services
 Medicine ServiceNonmedicine Services
 Pre % (n)Post % (n)Relative ChangeSignificancePre % (n)Post % (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Bleeding        
SusceptibleN = 13,614N = 13,445N/A N = 7372N = 7061N/A 
Developed2.9 (401)4.0 (534)+34.8%P < 0.0017.7 (565)8.6 (606)+12.0%P = 0.043
Thrombocytopenia        
SusceptibleN = 15,254N = 15,065N/A N = 8566N = 8162N/A 
Developed7.4 (1123)6.9 (1047)5.6%P = 0.1648.7 (749)8.8 (716)+0.3%P = 0.948

DISCUSSION

Following implementation of a computerized decision support application to improve VTE prophylaxis on 2 hospital medicine services, we observed a significant increase in the rate of overall and pharmacologic VTE prophylaxis use and a significant decrease in the incidence of hospital‐acquired VTE. Changes were of greater magnitude and significance on medicine services where the intervention was deployed.

Rates of any VTE prophylaxis and pharmacologic VTE prophylaxis ordering on medicine services increased significantly by 32.7% and 26.3%, respectively. These rates increased on nonmedicine comparison services by a more modest 4.4% for any VTE prophylaxis and 6.7% for pharmacologic VTE prophylaxis. Although the medicine service intervention was designed to be agnostic to the type of prophylactic heparin preparation, the intervention resulted in a significant 82.4% increase in low molecular weight heparin use and a significant 16.0% increase in unfractionated heparin use. With respect to outcomes, we observed a 34.5% decrease (P < 0.001) in hospital‐acquired VTE incidence on medicine services and a nonsignificant decrease on nonmedicine services.

In assessing intervention safety, increased usage of VTE prophylaxis was not accompanied by an increase in thrombocytopenia, but was associated with an increase in bleeding from 2.9% to 4.0% (P < 0.001) on medicine services and from 7.7% to 8.6% (P = 0.043) on non‐medicine services. As our intervention was a quality improvement project, we conducted a brief post hoc analysis to evaluate the increased bleeding rate on the medicine service following intervention. A random sample of 50 records of medicine patients who had received VTE prophylaxis and had a subsequent bleeding event was reviewed. Findings are summarized in Table 4. Prophylaxis was used appropriately in 100% of cases. Bleeding episodes were minor in that no case required more than 2 U of packed red blood cells. The most common clinical scenario was a patient with baseline anemia, typically with chronic kidney disease, who had a slight decrease in hematocrit of unclear etiology requiring 1 U of blood.

Characteristics of Patient Bleeding Episodes Among Medicine Service Patients Associated With Pharmacologic VTE Prophylaxis in the Period Following Deployment of Electronic Decision Support
Characteristic% (N = 50)
  • NOTE: Abbreviations: VTE, venous thromboembolism.
  • Pharmacologic VTE prophylaxis indicated based on presence of 1 or more clinical risk factors and lack of contraindication to pharmacologic agent at time of ordering.
  • Antiplatelet agent = aspirin or clopidogrel.
Prophylaxis indication 
Pharmacologic VTE prophylaxis indicateda100.0
Clinical characteristic 
Anemia upon admission92.0
Chronic kidney disease66.0
Suspected bleeding source 
Unclear62.0
Gastrointestinal18.0
Catheter/external device site8.0
Operative6.0
Epistaxis4.0
Gynecologic2.0
Medication use 
Prophylactic agent associated with bleeding 
Unfractionated heparin66.0
Dalteparin34.0
On antiplatelet agent at time of bleedb52.0
Transfusion outcome 
Required >2 packed red blood cell units0.0

Although the intervention occurred on medicine services, favorable albeit smaller changes were observed on nonmedicine services. We expected this favorable secular trend because of VTE prophylaxis awareness efforts across the organization as a whole. There was also ongoing focus on VTE prevention and outcomes by policymakers, regulatory agencies, and professional societies during the time period of study.[3, 4, 5, 12] Public reporting of CMS inpatient surgical VTE prophylaxis measures was required throughout the study period.[13] Changes observed on medicine services occurred during a period where there were no publicly reported measures of VTE prophylaxis for inpatient medicine services.

Our study had several limitations. We derived our eligibility criteria for VTE prophylaxis based on administrative data. To address this, we incorporated accepted standardized definitions,[11] used clinical data elements in our queries beyond ICD‐9 codes (eg, platelet count), and applied pertinent exclusion criteria (eg, length of stay 1 day or less). VTE events that were present on admission were excluded from analyses. However, as these community‐acquired VTE events may be caused by inadequate VTE prophylaxis during a prior hospitalization, the overall true incidence of hospital‐acquired VTE was likely underestimated.

With respect to the hospital‐acquired VTE outcome, we did not distinguish superficial from deep VTE. A consistent AHRQ definition of 13 ICD‐9 VTE codes was used to identify clinically significant VTE events for the periods before and after the intervention. Although the present on admission code identified VTE events that were hospital acquired, 1 new acute VTE ICD‐9 code was added in October 2009, allowing for more specific coding of acute, isolated, upper extremity VTE. Accordingly, our postintervention hospital‐acquired VTE rate may have slightly underestimated the true hospital‐acquired VTE incidence by omitting some coded acute, isolated, upper extremity VTE cases (if not coded using the prior Other VTE codes). In a study in a teaching hospital setting, isolated upper extremity VTE accounted for up to 21% of all symptomatic VTE events among adults.[14]

With respect to VTE prophylaxis, the study evaluated use in a dichotomous fashion but did not assess appropriateness, or adequacy of dosing of pharmacologic agents. We did not employ the intervention in a randomized fashion on the medicine service. As our project was a quality improvement intervention, we used a concurrent control group of nonmedicine service patients to assess potential secular trend bias.

With respect to the safety of the intervention, the record review we performed supported the appropriateness of prophylaxis use following the intervention, but was not designed to establish whether the increase in prophylaxis use was the proximate cause of bleeding events observed. Similarly, as specific testing for heparin‐induced thrombocytopenia was not used, the lack of significant change in thrombocytopenia rates before and after the intervention cannot directly establish the intervention's safety. Finally, our study also included only in‐hospital end points.

The rate of VTE prophylaxis use in hospitals has been noted to be disappointing.[15] Two large multinational studies found that VTE prophylaxis rates in at‐risk hospitalized medical patients in the United States were 48% and 52%.[9, 16] Amin and colleagues found the overall rate of VTE prophylaxis among 227 US hospitals to be 62%.[17] Accordingly, our intervention, which resulted in an 82% compliance rate on a large medical service and was associated with a significantly reduced VTE incidence, appears to be highly effective. Our results are likely more favorable in that beyond length of stay criteria, we did not exclude less acutely ill medical patients from analyses.

Michota summarized quality improvement studies for VTE prevention.[10] Among 9 studies attempting to improve VTE prophylaxis, 2 used electronic decision support as a primary strategy, and only 1, by Kucher et al., used a computerized approach on a medical service.[18] This study showed significant improvement in VTE prophylaxis and incidence in patients randomized to a provider computer program. The intervention was complex, requiring specification of 8 patient‐level risk factors via a customized database, and the physician to recommend specific prophylactic regimens accordingly. Our findings, using a more basic approach, similarly support the effectiveness of using automated decision support, which can be readily modified as evidence‐based guidelines evolve.

Overall adoption of information technology systems in US hospitals is low: only 7.6% of hospitals have a basic system, and 17% have computerized physician order entry.[19] As hospitals have been financially incentivized to adopt such systems, our relatively simple intervention may prove to be readily generalizable across varied vendor systems.[20] The intervention involved order sets triggered by automated logic, corollary information, and a hard stop to prompt VTE prophylaxis. Within the context of intensified emphasis on reducing harm in the inpatient setting and various pay for performance programs, our intervention is also of importance to payers.[3, 5] Using national data in year 2000, Zhan and Miller calculated the excess charges per case associated with VTE to be $21,709.[21]

In conclusion, a relatively simple automated clinical decision support application significantly improved rates of VTE prophylaxis and was associated with significantly lower hospital‐acquired VTE incidence in hospitalized medicine patients, with a reasonable safety profile.

Acknowledgments

The authors acknowledge the roles of Gillian Wendt and Maggie Feng in data acquisition.

Disclosure: The authors declare no conflict of interest related to the research, analyses, or preparation of this manuscript. M. J. Sinnett reports receiving payment for speaking on behalf of Amgen, which was not a funder of this study. All coauthors have seen and agree with the contents of the manuscript, and all coauthors fulfill the authorship criteria specified by the Journal of Hospital Medicine. Rohit Bhalla, MD, MPH, takes responsibility for the entire manuscript. This submission is not under review by any other publication. Development of the electronic decision support application was supported in part by funding under the 2008 Cardinal Health Foundation Patient Safety Grant Program.

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References
  1. Heit JA. The epidemiology of venous thromboembolism: implications for prevention and management. Paper presented at: Surgeon General's Workshop on Deep Vein Thrombosis; May 8, 2006; Bethesda, MD. Available at: http://www.surgeongeneral.gov/topics/deepvein/workshop/agenda.html. Accessed February 17,2012.
  2. American Public Health Association White Paper. Deep‐vein thrombosis: advancing awareness to protect patient lives. Public Health Leadership Conference on Deep‐Vein Thrombosis. Washington, D.C.; February 26,2003. Available at: http://www.apha.org/NR/rdonlyres/A209F84A‐7C0E‐4761–9ECF‐61D22E1E11F7/0/DVT_ White_Paper.pdf. Accessed February 27, 2012.
  3. Department of Health and Human Services. Centers for Medicare and Medicaid Services. Medicare program: hospital inpatient value based purchasing program. Fed Regist.2011;76(88):2649026547.
  4. The Joint Commission. 2011 hospital national patient safety goals. Available at: http://www.jointcommission.org/assets/1/6/HAP_NPSG_6–10‐11.pdf. Accessed October 23,2011.
  5. US Department of Health and Human Services. Centers for Medicare and Medicaid Services. Medicare Learning Network. Hospital acquired conditions in acute inpatient prospective payment system (IPPS) hospitals. Available at: https://www.cms.gov/HospitalAcqCond/downloads/HACFactsheet.pdf. Accessed February 17,2012.
  6. Maynard G, Stein J.Preventing Hospital‐Acquired Venous Thromboembolism: A Guide For Effective Quality Improvement. Society of Hospital Medicine. AHRQ Publication No. 08–0075.Rockville, MD:Agency for Healthcare Research and Quality;2008.
  7. Francis CW. Prophylaxis for thromboembolism in hospitalized medical patients. N Engl J Med.2007;356:14381444.
  8. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence‐Based Clinical Practice Guidelines (8th Edition). Chest.2008;133;381S453S.
  9. Cohen AT, Tapson VF, Bergmann JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross‐sectional study. Lancet.2008;371(9610):387394.
  10. Michota FA. Bridging the gap between evidence and practice in venous thromboembolism prophylaxis: the quality improvement process. J Gen Intern Med.2007;22(12):17621770.
  11. Agency for Healthcare Research and Quality. PSI #12: Postoperative pulmonary embolism or deep vein thrombosis. Version 4.1.; 2009. Available at: http://www.qualityindicators.ahrq.gov/Downloads/Modules/PSI/V41/TechSpecs/PSI%2012%20Postoperative%20Pulmonary %20Embolism%20or%20Deep%20Vein%20Thrombosis.pdf. Accessed February 19,2012.
  12. Streiff MB, Haut ER. The CMS ruling on venous thromboembolism after total knee or hip arthroplasty: weighing risks and benefits. JAMA.2009;301(10):10631065.
  13. US Department of Health and Human Services. Centers for Medicare and Medicaid Services. Hospital compare. Available at: http://www.hospitalcompare.hhs.gov. Accessed October 23,2011.
  14. Mustafa S, Stein PD, Patel KC, Otten TR, Holmes R, Silbergleit A. Upper extremity deep venous thrombosis. Chest.2003;123;19531956.
  15. Fitzmaurice DA, Murray E. Thromboprophylaxis for adults in hospital: an intervention that would save many lives is still not being implemented. BMJ.2007;334:10171018.
  16. Tapson VF, Decousus H, Pini M, et al. Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients: findings from the International Medical Prevention Registry on Venous Thromboembolism. Chest.2007:132:936945.
  17. Amin A, Stemkowski S, Lin J, Yang G. Thromboprophylaxis rates in US medical centers: success or failure?J Thromb Haemost.2007;5:16101616.
  18. Kucher N, Koo S, Quiroz R, et al. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med.2005;352:969977.
  19. Jha AK, DesRoches CM, Campbell EG, et al. Use of electronic health records in U.S. hospitals. N Engl J Med.2009;360:16281638.
  20. Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med.2010;363(6):501504.
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Over 900,000 incident and recurrent venous thromboembolism (VTE) events occur in the United States each year, resulting in nearly 300,000 fatalities.[1] VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is among the most common causes of death in the United States, with more people dying annually from VTE than motor vehicle accidents and breast cancer.[2]

Accordingly, healthcare policy makers and regulators have placed greater emphasis on VTE prevention, including use of VTE prophylaxis measures in the Centers for Medicare and Medicaid Services (CMS) value‐based purchasing (pay for performance) program and the Joint Commission's adoption of a national hospital patient safety goal related to anticoagulation therapy.[3, 4] Beginning in 2008, VTE events following hip and knee procedures were included as 1 of 10 hospital‐acquired conditions for which CMS would not pay for associated additional costs of care.[5]

A typical 300‐bed hospital can expect roughly 150 cases of hospital‐acquired VTE annually.[6] Up to 75% of these cases will occur on the medicine service, where nearly every patient has 1 or more VTE risk factor.[7] Although effective preventive modalities exist, prophylaxis rates among medical patients have been noted to be <50%.[8, 9] While quality improvement interventions have been shown to be effective in improving compliance with VTE prophylaxis, there are few studies describing effectiveness of these interventions in electronic health record (EHR) environments.[10] As EHR implementation accelerates, it will be essential to define the strengths and limitations of various decision support approaches to optimally improve patient safety.

We sought to evaluate the effectiveness and safety of a computerized decision support application, which was designed as part of a quality improvement initiative to improve rates of VTE prophylaxis rates on the medicine services at 2 hospital sites.

METHODS

Setting

The initiative was conducted at Montefiore Medical Center, an academic medical center in the Bronx, New York. This article describes results from an effort to improve inpatient VTE prophylaxis rates as part of an overall medical center initiative to improve anticoagulation management beginning in 2007. The initiative was led by an interdisciplinary committee consisting of administrators, medical and surgical physicians, nursing staff, and information technology and performance improvement personnel.

Intervention

As part of the initial quality improvement project, the group analyzed factors associated with and rates of hospital‐acquired VTE. Among the findings was a predominance of hospital‐acquired VTE cases and suboptimal rates of VTE prophylaxis on medicine services. Accordingly, the medicine service, whose discharge volume was 36,500 in 2010, was the population of focus for the improvement effort. The analysis also demonstrated a 99% agreement rate between administratively coded VTE events and VTE diagnoses verified from chart review, validating the utility of institutional administrative data for ongoing study of VTE events. As the hospital sites had computerized physician order entry, the group sought to develop an electronic clinical decision support module. The primary objective of the quality improvement effort was to increase VTE prophylaxis rates and decrease VTE incidence among medicine patients.

A range of clinical decision support approaches was explored. Based on team review, key decision support design objectives were to:

  • Minimize alert fatigue
  • Utilize existing clinical information system variables to:

     

    • Avoid de novo physician data entry solely to support the application
    • Automatically identify and exclude patients in whom pharmacologic VTE prophylaxis was contraindicated
    • Utilize the 8th edition of the American College of Chest Physicians VTE guidelines[8] as a basis for recommendations (as the study was conducted prior to the 9th edition release)

     

    The VTE decision support module was comprised of order sets with the following features:

    • Patients were identified as on the medicine service based on admitting service designation.
    • An order set was populated from this triggering mechanism offering pharmacologic VTE prophylaxis options, or alternately, options to document lack of a clinical indication for pharmacologic VTE prophylaxis, planned therapeutic anticoagulation, or contraindication to VTE prophylaxis.
    • Alternate order sets were offered with mechanical VTE prophylaxis options if the physician indicated pharmacologic VTE prophylaxis was contraindicated or if the information system identified a clinical contraindication.
    • If pharmacologic VTE prophylaxis was not prescribed, the rules logic was repeated every 5 days.

     

Analyses

The evaluation sought to assess the effectiveness and safety of the decision support module. VTE processes and outcomes for the 6‐month periods immediately before and after full scale decision support go‐live on September 9, 2009, were evaluated. This time window was chosen in relation to CMS' requirement that hospitals use present on admission codes for discharge diagnoses (including VTE) on October 1, 2007, and first implementation of a hospital‐acquired condition policy on October 1, 2008.[5] The 6‐month period prior to September 2009 was within the first calendar year where both CMS policies were in effect.

Effectiveness of the decision support module was measured by evaluating the proportion of medicine service discharges before and after module deployment who:

  • Received any VTE prophylaxis modality
  • Received a pharmacologic VTE prophylaxis modality
  • Developed a hospital‐acquired VTE

 

Successful receipt of any VTE prophylaxis modality was defined as use of compression stockings, pneumatic compression devices, or pharmacologic VTE prophylaxis modalities, including therapeutic anticoagulation (eg, mechanical heart valve). Medications counting toward the definition of pharmacologic agents included unfractionated heparin, dalteparin, warfarin, fondaparinux, lepirudin, argatroban, or bivalirudin, which are all on formulary at the medical center. Heparin used as an intravenous flush or associated with dialysis was excluded. Hospital‐acquired VTE was defined by the numerator International Classification of Diseases, 9th Revision (ICD‐9) discharge diagnosis codes for DVT or PE events as specified in the Agency for Healthcare Research and Quality (AHRQ) postoperative PE or DVT Patient Safety Indicator 12, and where the codes were not present on admission.[11]

Patient discharges excluded from analyses were those with patient age <18 years, length of stay 1 day or less, VTE diagnosis present on admission, or patient with an inferior vena cava filter during the stay. For evaluation of pharmacologic VTE prophylaxis, patients were additionally excluded if they had a platelet count <50,000/L during their stay, were a neurosurgical patient, or had a discharge diagnosis that included gastrointestinal bleeding or coagulopathy.

The safety of the decision support application was measured by assessing the proportion of medicine service discharges before and after decision support deployment who developed bleeding or thrombocytopenia. Bleeding was defined as receipt of 1 or more packed red blood cell units following administration of an anticoagulant medication at a VTE prophylaxis dosage range. Exclusion criteria for bleeding evaluation were patients aged <18 years, with length of stay 1 day or less, VTE diagnosis present on admission, platelet count <50,000/L during the stay, were a neurosurgical patient, or had diagnoses of anemia, hematologic malignancy, or inferior vena cava filter during the stay, or diagnoses of gastrointestinal bleeding, hemorrhage, or hematoma on admission.

Thrombocytopenia was defined as a >50% decrease from the initial platelet count during the hospital stay, or a decrease from an admission platelet count of >100,000/L to <100,000/L during the hospital stay. Criteria for exclusion from these analyses were age <18 years, length of stay 1 day or less, diagnosis of VTE present on admission, and vena cava filter during the stay.

A medical center comparison group was defined to contrast the magnitude of change in study end points on medicine services where the intervention was deployed with the change on other services where decision support was not used, and to distinguish potential changes observed on medicine services from secular trends. The comparison group consisted of discharges from cardiology, cardiothoracic surgery, family medicine, general surgery, surgical subspecialty, oncology, psychiatry, and rehabilitation medicine services. Newborn, neurosurgery, obstetrics, and pediatrics service discharges were excluded from the comparison group because of their being at low risk for VTE or in a high‐risk group in whom pharmacologic VTE prophylaxis was frequently contraindicated. All parameters described above were evaluated in the comparison group using inclusion and exclusion criteria similar to the intervention group. Outcomes (hospital‐acquired VTE, bleeding, thrombocytopenia) were assessed similarly across index admissions and readmissions.

The significance of change in rates of prescribing, VTE incidence, and adverse event occurrence, were tested by comparing event proportions before and after decision support module implementation in both groups. As all variables were categorical, significance was assessed using 2‐sided Pearson 2 tests at an level of 0.05. Statistical analyses were performed using SPSS software (IBM, Armonk, NY). This project was reviewed by the Albert Einstein College of Medicine/Montefiore Medical Center institutional review board (protocol number 12‐02‐058X) and deemed exempt. Design of the decision support module and definition of the implementation and evaluation plan required approximately 1 year of monthly interdisciplinary team meetings and 200 hours of programmer development time.

RESULTS

Table 1 compares the effectiveness of the decision support module intervention in medicine intervention and in nonmedicine (nonintervention) services. Among medicine service patients, any VTE prophylaxis ordering increased from 61.9% to 82.1% (P < 0.001), and pharmacologic VTE prophylaxis increased from 59.0% to 74.5% (P < 0.001). Smaller but significant increases were observed on nonmedicine services. Hospital‐acquired VTE incidence on medicine services decreased significantly, from 0.65% to 0.42% (P = 0.008) and nonsignificantly on nonmedicine services.

Rates of Any VTE Prophylaxis Ordering, Pharmacologic VTE Prophylaxis Ordering, and Hospital‐Acquired VTE, Before and After Decision Support Module Implementation in Medicine Intervention and Nonmedicine Comparison services
 Medicine ServiceNonmedicine Services
 PrePost  PrePost  
 % (n)% (n)Relative ChangeSignificance% (n)% (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Any VTE prophylaxis        
EligibleN = 15,254N = 15,065N/AN/AN = 8566N = 8162N/AN/A
Received61.9 (9443)82.1 (12,372)+32.7%P < 0.00170.5 (6040)73.6 (6010)+4.4%P < 0.001
Pharmacologic VTE prophylaxis        
EligibleN = 14,768N = 14,588N/AN/AN = 7883N = 7567N/AN/A
Received59.0 (8712)74.5 (10,869)+26.3%P < 0.00159.3 (4677)63.3 (4791)+6.7%P < 0.001
Hospital‐acquired VTE incidence        
SusceptibleN = 15,254N = 15,065N/AN/AN = 8566N = 8162N/AN/A
Developed0.65 (99)0.42 (64)34.5%P = 0.0080.82 (70)0.72 (59)11.5%P = 0.486

Table 2 shows ordering patterns for major VTE prophylaxis modalities. Among eligible medicine service patients, rates of low molecular weight heparin prophylaxis increased from 13.0% to 23.7% (P < 0.001), and of unfractionated heparin prophylaxis from 35.1% to 40.7% (P < 0.001). On nonmedicine services, there was no significant change in low molecular weight heparin use, and unfractionated heparin use increased significantly from 37.2% to 40.9% (P < 0.001). Proportions of patients receiving mechanical prophylaxis or not receiving prophylaxis decreased significantly by 37.8% on medicine services and by 9.8% on nonmedicine services Table 3 shows the safety of the decision support module. Bleeding rates increased on medicine services from 2.9% to 4.0% (P < 0.001) and on nonmedicine services from 7.7% to 8.6% (P = 0.043). Nonsignificant changes in thrombocytopenia rates were observed on both services.

Rates of Ordering of VTE Prophylaxis Modalities Included in the Medicine Service Decision Support Module in Medicine Intervention and Nonmedicine Comparison Services
 Medicine ServiceNonmedicine Services
 Pre % (n)Post % (n)Relative ChangeSignificancePre % (n)Post % (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Eligible for pharmacologic VTE prophylaxisN = 14,768N = 14,588N/A N = 7883N = 7567N/A 
Low molecular weight heparin13.0 (1922)23.7 (3463)+82.4%P < 0.00115.3 (1206)15.9 (1204)+4.0%P = 0.294
Unfractionated heparin35.1 (5181)40.7 (5936)+16.0%P < 0.00137.2 (2932)40.9 (3093)+9.9%P < 0.001
Warfarin10.8 (1594)10.0 (1461)7.2%P = 0.0296.8 (532)6.4 (483)5.4%P = 0.359
Other agent0.1 (15)0.1 (9)39.3%P = 0.2320.1 (7)0.2 (11)+63.7P = 0.303
Mechanical prophylaxis or did not receive41.0 (6056)25.5 (3719)37.8%P < 0.00140.7 (3206)36.7 (2776)9.8%P < 0.001
Rates of Bleeding and Thrombocytopenia Before and After Decision Support Module Implementation in Medicine Intervention and Nonmedicine Comparison Services
 Medicine ServiceNonmedicine Services
 Pre % (n)Post % (n)Relative ChangeSignificancePre % (n)Post % (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Bleeding        
SusceptibleN = 13,614N = 13,445N/A N = 7372N = 7061N/A 
Developed2.9 (401)4.0 (534)+34.8%P < 0.0017.7 (565)8.6 (606)+12.0%P = 0.043
Thrombocytopenia        
SusceptibleN = 15,254N = 15,065N/A N = 8566N = 8162N/A 
Developed7.4 (1123)6.9 (1047)5.6%P = 0.1648.7 (749)8.8 (716)+0.3%P = 0.948

DISCUSSION

Following implementation of a computerized decision support application to improve VTE prophylaxis on 2 hospital medicine services, we observed a significant increase in the rate of overall and pharmacologic VTE prophylaxis use and a significant decrease in the incidence of hospital‐acquired VTE. Changes were of greater magnitude and significance on medicine services where the intervention was deployed.

Rates of any VTE prophylaxis and pharmacologic VTE prophylaxis ordering on medicine services increased significantly by 32.7% and 26.3%, respectively. These rates increased on nonmedicine comparison services by a more modest 4.4% for any VTE prophylaxis and 6.7% for pharmacologic VTE prophylaxis. Although the medicine service intervention was designed to be agnostic to the type of prophylactic heparin preparation, the intervention resulted in a significant 82.4% increase in low molecular weight heparin use and a significant 16.0% increase in unfractionated heparin use. With respect to outcomes, we observed a 34.5% decrease (P < 0.001) in hospital‐acquired VTE incidence on medicine services and a nonsignificant decrease on nonmedicine services.

In assessing intervention safety, increased usage of VTE prophylaxis was not accompanied by an increase in thrombocytopenia, but was associated with an increase in bleeding from 2.9% to 4.0% (P < 0.001) on medicine services and from 7.7% to 8.6% (P = 0.043) on non‐medicine services. As our intervention was a quality improvement project, we conducted a brief post hoc analysis to evaluate the increased bleeding rate on the medicine service following intervention. A random sample of 50 records of medicine patients who had received VTE prophylaxis and had a subsequent bleeding event was reviewed. Findings are summarized in Table 4. Prophylaxis was used appropriately in 100% of cases. Bleeding episodes were minor in that no case required more than 2 U of packed red blood cells. The most common clinical scenario was a patient with baseline anemia, typically with chronic kidney disease, who had a slight decrease in hematocrit of unclear etiology requiring 1 U of blood.

Characteristics of Patient Bleeding Episodes Among Medicine Service Patients Associated With Pharmacologic VTE Prophylaxis in the Period Following Deployment of Electronic Decision Support
Characteristic% (N = 50)
  • NOTE: Abbreviations: VTE, venous thromboembolism.
  • Pharmacologic VTE prophylaxis indicated based on presence of 1 or more clinical risk factors and lack of contraindication to pharmacologic agent at time of ordering.
  • Antiplatelet agent = aspirin or clopidogrel.
Prophylaxis indication 
Pharmacologic VTE prophylaxis indicateda100.0
Clinical characteristic 
Anemia upon admission92.0
Chronic kidney disease66.0
Suspected bleeding source 
Unclear62.0
Gastrointestinal18.0
Catheter/external device site8.0
Operative6.0
Epistaxis4.0
Gynecologic2.0
Medication use 
Prophylactic agent associated with bleeding 
Unfractionated heparin66.0
Dalteparin34.0
On antiplatelet agent at time of bleedb52.0
Transfusion outcome 
Required >2 packed red blood cell units0.0

Although the intervention occurred on medicine services, favorable albeit smaller changes were observed on nonmedicine services. We expected this favorable secular trend because of VTE prophylaxis awareness efforts across the organization as a whole. There was also ongoing focus on VTE prevention and outcomes by policymakers, regulatory agencies, and professional societies during the time period of study.[3, 4, 5, 12] Public reporting of CMS inpatient surgical VTE prophylaxis measures was required throughout the study period.[13] Changes observed on medicine services occurred during a period where there were no publicly reported measures of VTE prophylaxis for inpatient medicine services.

Our study had several limitations. We derived our eligibility criteria for VTE prophylaxis based on administrative data. To address this, we incorporated accepted standardized definitions,[11] used clinical data elements in our queries beyond ICD‐9 codes (eg, platelet count), and applied pertinent exclusion criteria (eg, length of stay 1 day or less). VTE events that were present on admission were excluded from analyses. However, as these community‐acquired VTE events may be caused by inadequate VTE prophylaxis during a prior hospitalization, the overall true incidence of hospital‐acquired VTE was likely underestimated.

With respect to the hospital‐acquired VTE outcome, we did not distinguish superficial from deep VTE. A consistent AHRQ definition of 13 ICD‐9 VTE codes was used to identify clinically significant VTE events for the periods before and after the intervention. Although the present on admission code identified VTE events that were hospital acquired, 1 new acute VTE ICD‐9 code was added in October 2009, allowing for more specific coding of acute, isolated, upper extremity VTE. Accordingly, our postintervention hospital‐acquired VTE rate may have slightly underestimated the true hospital‐acquired VTE incidence by omitting some coded acute, isolated, upper extremity VTE cases (if not coded using the prior Other VTE codes). In a study in a teaching hospital setting, isolated upper extremity VTE accounted for up to 21% of all symptomatic VTE events among adults.[14]

With respect to VTE prophylaxis, the study evaluated use in a dichotomous fashion but did not assess appropriateness, or adequacy of dosing of pharmacologic agents. We did not employ the intervention in a randomized fashion on the medicine service. As our project was a quality improvement intervention, we used a concurrent control group of nonmedicine service patients to assess potential secular trend bias.

With respect to the safety of the intervention, the record review we performed supported the appropriateness of prophylaxis use following the intervention, but was not designed to establish whether the increase in prophylaxis use was the proximate cause of bleeding events observed. Similarly, as specific testing for heparin‐induced thrombocytopenia was not used, the lack of significant change in thrombocytopenia rates before and after the intervention cannot directly establish the intervention's safety. Finally, our study also included only in‐hospital end points.

The rate of VTE prophylaxis use in hospitals has been noted to be disappointing.[15] Two large multinational studies found that VTE prophylaxis rates in at‐risk hospitalized medical patients in the United States were 48% and 52%.[9, 16] Amin and colleagues found the overall rate of VTE prophylaxis among 227 US hospitals to be 62%.[17] Accordingly, our intervention, which resulted in an 82% compliance rate on a large medical service and was associated with a significantly reduced VTE incidence, appears to be highly effective. Our results are likely more favorable in that beyond length of stay criteria, we did not exclude less acutely ill medical patients from analyses.

Michota summarized quality improvement studies for VTE prevention.[10] Among 9 studies attempting to improve VTE prophylaxis, 2 used electronic decision support as a primary strategy, and only 1, by Kucher et al., used a computerized approach on a medical service.[18] This study showed significant improvement in VTE prophylaxis and incidence in patients randomized to a provider computer program. The intervention was complex, requiring specification of 8 patient‐level risk factors via a customized database, and the physician to recommend specific prophylactic regimens accordingly. Our findings, using a more basic approach, similarly support the effectiveness of using automated decision support, which can be readily modified as evidence‐based guidelines evolve.

Overall adoption of information technology systems in US hospitals is low: only 7.6% of hospitals have a basic system, and 17% have computerized physician order entry.[19] As hospitals have been financially incentivized to adopt such systems, our relatively simple intervention may prove to be readily generalizable across varied vendor systems.[20] The intervention involved order sets triggered by automated logic, corollary information, and a hard stop to prompt VTE prophylaxis. Within the context of intensified emphasis on reducing harm in the inpatient setting and various pay for performance programs, our intervention is also of importance to payers.[3, 5] Using national data in year 2000, Zhan and Miller calculated the excess charges per case associated with VTE to be $21,709.[21]

In conclusion, a relatively simple automated clinical decision support application significantly improved rates of VTE prophylaxis and was associated with significantly lower hospital‐acquired VTE incidence in hospitalized medicine patients, with a reasonable safety profile.

Acknowledgments

The authors acknowledge the roles of Gillian Wendt and Maggie Feng in data acquisition.

Disclosure: The authors declare no conflict of interest related to the research, analyses, or preparation of this manuscript. M. J. Sinnett reports receiving payment for speaking on behalf of Amgen, which was not a funder of this study. All coauthors have seen and agree with the contents of the manuscript, and all coauthors fulfill the authorship criteria specified by the Journal of Hospital Medicine. Rohit Bhalla, MD, MPH, takes responsibility for the entire manuscript. This submission is not under review by any other publication. Development of the electronic decision support application was supported in part by funding under the 2008 Cardinal Health Foundation Patient Safety Grant Program.

Over 900,000 incident and recurrent venous thromboembolism (VTE) events occur in the United States each year, resulting in nearly 300,000 fatalities.[1] VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is among the most common causes of death in the United States, with more people dying annually from VTE than motor vehicle accidents and breast cancer.[2]

Accordingly, healthcare policy makers and regulators have placed greater emphasis on VTE prevention, including use of VTE prophylaxis measures in the Centers for Medicare and Medicaid Services (CMS) value‐based purchasing (pay for performance) program and the Joint Commission's adoption of a national hospital patient safety goal related to anticoagulation therapy.[3, 4] Beginning in 2008, VTE events following hip and knee procedures were included as 1 of 10 hospital‐acquired conditions for which CMS would not pay for associated additional costs of care.[5]

A typical 300‐bed hospital can expect roughly 150 cases of hospital‐acquired VTE annually.[6] Up to 75% of these cases will occur on the medicine service, where nearly every patient has 1 or more VTE risk factor.[7] Although effective preventive modalities exist, prophylaxis rates among medical patients have been noted to be <50%.[8, 9] While quality improvement interventions have been shown to be effective in improving compliance with VTE prophylaxis, there are few studies describing effectiveness of these interventions in electronic health record (EHR) environments.[10] As EHR implementation accelerates, it will be essential to define the strengths and limitations of various decision support approaches to optimally improve patient safety.

We sought to evaluate the effectiveness and safety of a computerized decision support application, which was designed as part of a quality improvement initiative to improve rates of VTE prophylaxis rates on the medicine services at 2 hospital sites.

METHODS

Setting

The initiative was conducted at Montefiore Medical Center, an academic medical center in the Bronx, New York. This article describes results from an effort to improve inpatient VTE prophylaxis rates as part of an overall medical center initiative to improve anticoagulation management beginning in 2007. The initiative was led by an interdisciplinary committee consisting of administrators, medical and surgical physicians, nursing staff, and information technology and performance improvement personnel.

Intervention

As part of the initial quality improvement project, the group analyzed factors associated with and rates of hospital‐acquired VTE. Among the findings was a predominance of hospital‐acquired VTE cases and suboptimal rates of VTE prophylaxis on medicine services. Accordingly, the medicine service, whose discharge volume was 36,500 in 2010, was the population of focus for the improvement effort. The analysis also demonstrated a 99% agreement rate between administratively coded VTE events and VTE diagnoses verified from chart review, validating the utility of institutional administrative data for ongoing study of VTE events. As the hospital sites had computerized physician order entry, the group sought to develop an electronic clinical decision support module. The primary objective of the quality improvement effort was to increase VTE prophylaxis rates and decrease VTE incidence among medicine patients.

A range of clinical decision support approaches was explored. Based on team review, key decision support design objectives were to:

  • Minimize alert fatigue
  • Utilize existing clinical information system variables to:

     

    • Avoid de novo physician data entry solely to support the application
    • Automatically identify and exclude patients in whom pharmacologic VTE prophylaxis was contraindicated
    • Utilize the 8th edition of the American College of Chest Physicians VTE guidelines[8] as a basis for recommendations (as the study was conducted prior to the 9th edition release)

     

    The VTE decision support module was comprised of order sets with the following features:

    • Patients were identified as on the medicine service based on admitting service designation.
    • An order set was populated from this triggering mechanism offering pharmacologic VTE prophylaxis options, or alternately, options to document lack of a clinical indication for pharmacologic VTE prophylaxis, planned therapeutic anticoagulation, or contraindication to VTE prophylaxis.
    • Alternate order sets were offered with mechanical VTE prophylaxis options if the physician indicated pharmacologic VTE prophylaxis was contraindicated or if the information system identified a clinical contraindication.
    • If pharmacologic VTE prophylaxis was not prescribed, the rules logic was repeated every 5 days.

     

Analyses

The evaluation sought to assess the effectiveness and safety of the decision support module. VTE processes and outcomes for the 6‐month periods immediately before and after full scale decision support go‐live on September 9, 2009, were evaluated. This time window was chosen in relation to CMS' requirement that hospitals use present on admission codes for discharge diagnoses (including VTE) on October 1, 2007, and first implementation of a hospital‐acquired condition policy on October 1, 2008.[5] The 6‐month period prior to September 2009 was within the first calendar year where both CMS policies were in effect.

Effectiveness of the decision support module was measured by evaluating the proportion of medicine service discharges before and after module deployment who:

  • Received any VTE prophylaxis modality
  • Received a pharmacologic VTE prophylaxis modality
  • Developed a hospital‐acquired VTE

 

Successful receipt of any VTE prophylaxis modality was defined as use of compression stockings, pneumatic compression devices, or pharmacologic VTE prophylaxis modalities, including therapeutic anticoagulation (eg, mechanical heart valve). Medications counting toward the definition of pharmacologic agents included unfractionated heparin, dalteparin, warfarin, fondaparinux, lepirudin, argatroban, or bivalirudin, which are all on formulary at the medical center. Heparin used as an intravenous flush or associated with dialysis was excluded. Hospital‐acquired VTE was defined by the numerator International Classification of Diseases, 9th Revision (ICD‐9) discharge diagnosis codes for DVT or PE events as specified in the Agency for Healthcare Research and Quality (AHRQ) postoperative PE or DVT Patient Safety Indicator 12, and where the codes were not present on admission.[11]

Patient discharges excluded from analyses were those with patient age <18 years, length of stay 1 day or less, VTE diagnosis present on admission, or patient with an inferior vena cava filter during the stay. For evaluation of pharmacologic VTE prophylaxis, patients were additionally excluded if they had a platelet count <50,000/L during their stay, were a neurosurgical patient, or had a discharge diagnosis that included gastrointestinal bleeding or coagulopathy.

The safety of the decision support application was measured by assessing the proportion of medicine service discharges before and after decision support deployment who developed bleeding or thrombocytopenia. Bleeding was defined as receipt of 1 or more packed red blood cell units following administration of an anticoagulant medication at a VTE prophylaxis dosage range. Exclusion criteria for bleeding evaluation were patients aged <18 years, with length of stay 1 day or less, VTE diagnosis present on admission, platelet count <50,000/L during the stay, were a neurosurgical patient, or had diagnoses of anemia, hematologic malignancy, or inferior vena cava filter during the stay, or diagnoses of gastrointestinal bleeding, hemorrhage, or hematoma on admission.

Thrombocytopenia was defined as a >50% decrease from the initial platelet count during the hospital stay, or a decrease from an admission platelet count of >100,000/L to <100,000/L during the hospital stay. Criteria for exclusion from these analyses were age <18 years, length of stay 1 day or less, diagnosis of VTE present on admission, and vena cava filter during the stay.

A medical center comparison group was defined to contrast the magnitude of change in study end points on medicine services where the intervention was deployed with the change on other services where decision support was not used, and to distinguish potential changes observed on medicine services from secular trends. The comparison group consisted of discharges from cardiology, cardiothoracic surgery, family medicine, general surgery, surgical subspecialty, oncology, psychiatry, and rehabilitation medicine services. Newborn, neurosurgery, obstetrics, and pediatrics service discharges were excluded from the comparison group because of their being at low risk for VTE or in a high‐risk group in whom pharmacologic VTE prophylaxis was frequently contraindicated. All parameters described above were evaluated in the comparison group using inclusion and exclusion criteria similar to the intervention group. Outcomes (hospital‐acquired VTE, bleeding, thrombocytopenia) were assessed similarly across index admissions and readmissions.

The significance of change in rates of prescribing, VTE incidence, and adverse event occurrence, were tested by comparing event proportions before and after decision support module implementation in both groups. As all variables were categorical, significance was assessed using 2‐sided Pearson 2 tests at an level of 0.05. Statistical analyses were performed using SPSS software (IBM, Armonk, NY). This project was reviewed by the Albert Einstein College of Medicine/Montefiore Medical Center institutional review board (protocol number 12‐02‐058X) and deemed exempt. Design of the decision support module and definition of the implementation and evaluation plan required approximately 1 year of monthly interdisciplinary team meetings and 200 hours of programmer development time.

RESULTS

Table 1 compares the effectiveness of the decision support module intervention in medicine intervention and in nonmedicine (nonintervention) services. Among medicine service patients, any VTE prophylaxis ordering increased from 61.9% to 82.1% (P < 0.001), and pharmacologic VTE prophylaxis increased from 59.0% to 74.5% (P < 0.001). Smaller but significant increases were observed on nonmedicine services. Hospital‐acquired VTE incidence on medicine services decreased significantly, from 0.65% to 0.42% (P = 0.008) and nonsignificantly on nonmedicine services.

Rates of Any VTE Prophylaxis Ordering, Pharmacologic VTE Prophylaxis Ordering, and Hospital‐Acquired VTE, Before and After Decision Support Module Implementation in Medicine Intervention and Nonmedicine Comparison services
 Medicine ServiceNonmedicine Services
 PrePost  PrePost  
 % (n)% (n)Relative ChangeSignificance% (n)% (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Any VTE prophylaxis        
EligibleN = 15,254N = 15,065N/AN/AN = 8566N = 8162N/AN/A
Received61.9 (9443)82.1 (12,372)+32.7%P < 0.00170.5 (6040)73.6 (6010)+4.4%P < 0.001
Pharmacologic VTE prophylaxis        
EligibleN = 14,768N = 14,588N/AN/AN = 7883N = 7567N/AN/A
Received59.0 (8712)74.5 (10,869)+26.3%P < 0.00159.3 (4677)63.3 (4791)+6.7%P < 0.001
Hospital‐acquired VTE incidence        
SusceptibleN = 15,254N = 15,065N/AN/AN = 8566N = 8162N/AN/A
Developed0.65 (99)0.42 (64)34.5%P = 0.0080.82 (70)0.72 (59)11.5%P = 0.486

Table 2 shows ordering patterns for major VTE prophylaxis modalities. Among eligible medicine service patients, rates of low molecular weight heparin prophylaxis increased from 13.0% to 23.7% (P < 0.001), and of unfractionated heparin prophylaxis from 35.1% to 40.7% (P < 0.001). On nonmedicine services, there was no significant change in low molecular weight heparin use, and unfractionated heparin use increased significantly from 37.2% to 40.9% (P < 0.001). Proportions of patients receiving mechanical prophylaxis or not receiving prophylaxis decreased significantly by 37.8% on medicine services and by 9.8% on nonmedicine services Table 3 shows the safety of the decision support module. Bleeding rates increased on medicine services from 2.9% to 4.0% (P < 0.001) and on nonmedicine services from 7.7% to 8.6% (P = 0.043). Nonsignificant changes in thrombocytopenia rates were observed on both services.

Rates of Ordering of VTE Prophylaxis Modalities Included in the Medicine Service Decision Support Module in Medicine Intervention and Nonmedicine Comparison Services
 Medicine ServiceNonmedicine Services
 Pre % (n)Post % (n)Relative ChangeSignificancePre % (n)Post % (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Eligible for pharmacologic VTE prophylaxisN = 14,768N = 14,588N/A N = 7883N = 7567N/A 
Low molecular weight heparin13.0 (1922)23.7 (3463)+82.4%P < 0.00115.3 (1206)15.9 (1204)+4.0%P = 0.294
Unfractionated heparin35.1 (5181)40.7 (5936)+16.0%P < 0.00137.2 (2932)40.9 (3093)+9.9%P < 0.001
Warfarin10.8 (1594)10.0 (1461)7.2%P = 0.0296.8 (532)6.4 (483)5.4%P = 0.359
Other agent0.1 (15)0.1 (9)39.3%P = 0.2320.1 (7)0.2 (11)+63.7P = 0.303
Mechanical prophylaxis or did not receive41.0 (6056)25.5 (3719)37.8%P < 0.00140.7 (3206)36.7 (2776)9.8%P < 0.001
Rates of Bleeding and Thrombocytopenia Before and After Decision Support Module Implementation in Medicine Intervention and Nonmedicine Comparison Services
 Medicine ServiceNonmedicine Services
 Pre % (n)Post % (n)Relative ChangeSignificancePre % (n)Post % (n)Relative ChangeSignificance
  • NOTE: Abbreviations: N/A, not applicable; Post, after decision support module implementation; Pre, before decision support module implementation; VTE, venous thromboembolism.
Bleeding        
SusceptibleN = 13,614N = 13,445N/A N = 7372N = 7061N/A 
Developed2.9 (401)4.0 (534)+34.8%P < 0.0017.7 (565)8.6 (606)+12.0%P = 0.043
Thrombocytopenia        
SusceptibleN = 15,254N = 15,065N/A N = 8566N = 8162N/A 
Developed7.4 (1123)6.9 (1047)5.6%P = 0.1648.7 (749)8.8 (716)+0.3%P = 0.948

DISCUSSION

Following implementation of a computerized decision support application to improve VTE prophylaxis on 2 hospital medicine services, we observed a significant increase in the rate of overall and pharmacologic VTE prophylaxis use and a significant decrease in the incidence of hospital‐acquired VTE. Changes were of greater magnitude and significance on medicine services where the intervention was deployed.

Rates of any VTE prophylaxis and pharmacologic VTE prophylaxis ordering on medicine services increased significantly by 32.7% and 26.3%, respectively. These rates increased on nonmedicine comparison services by a more modest 4.4% for any VTE prophylaxis and 6.7% for pharmacologic VTE prophylaxis. Although the medicine service intervention was designed to be agnostic to the type of prophylactic heparin preparation, the intervention resulted in a significant 82.4% increase in low molecular weight heparin use and a significant 16.0% increase in unfractionated heparin use. With respect to outcomes, we observed a 34.5% decrease (P < 0.001) in hospital‐acquired VTE incidence on medicine services and a nonsignificant decrease on nonmedicine services.

In assessing intervention safety, increased usage of VTE prophylaxis was not accompanied by an increase in thrombocytopenia, but was associated with an increase in bleeding from 2.9% to 4.0% (P < 0.001) on medicine services and from 7.7% to 8.6% (P = 0.043) on non‐medicine services. As our intervention was a quality improvement project, we conducted a brief post hoc analysis to evaluate the increased bleeding rate on the medicine service following intervention. A random sample of 50 records of medicine patients who had received VTE prophylaxis and had a subsequent bleeding event was reviewed. Findings are summarized in Table 4. Prophylaxis was used appropriately in 100% of cases. Bleeding episodes were minor in that no case required more than 2 U of packed red blood cells. The most common clinical scenario was a patient with baseline anemia, typically with chronic kidney disease, who had a slight decrease in hematocrit of unclear etiology requiring 1 U of blood.

Characteristics of Patient Bleeding Episodes Among Medicine Service Patients Associated With Pharmacologic VTE Prophylaxis in the Period Following Deployment of Electronic Decision Support
Characteristic% (N = 50)
  • NOTE: Abbreviations: VTE, venous thromboembolism.
  • Pharmacologic VTE prophylaxis indicated based on presence of 1 or more clinical risk factors and lack of contraindication to pharmacologic agent at time of ordering.
  • Antiplatelet agent = aspirin or clopidogrel.
Prophylaxis indication 
Pharmacologic VTE prophylaxis indicateda100.0
Clinical characteristic 
Anemia upon admission92.0
Chronic kidney disease66.0
Suspected bleeding source 
Unclear62.0
Gastrointestinal18.0
Catheter/external device site8.0
Operative6.0
Epistaxis4.0
Gynecologic2.0
Medication use 
Prophylactic agent associated with bleeding 
Unfractionated heparin66.0
Dalteparin34.0
On antiplatelet agent at time of bleedb52.0
Transfusion outcome 
Required >2 packed red blood cell units0.0

Although the intervention occurred on medicine services, favorable albeit smaller changes were observed on nonmedicine services. We expected this favorable secular trend because of VTE prophylaxis awareness efforts across the organization as a whole. There was also ongoing focus on VTE prevention and outcomes by policymakers, regulatory agencies, and professional societies during the time period of study.[3, 4, 5, 12] Public reporting of CMS inpatient surgical VTE prophylaxis measures was required throughout the study period.[13] Changes observed on medicine services occurred during a period where there were no publicly reported measures of VTE prophylaxis for inpatient medicine services.

Our study had several limitations. We derived our eligibility criteria for VTE prophylaxis based on administrative data. To address this, we incorporated accepted standardized definitions,[11] used clinical data elements in our queries beyond ICD‐9 codes (eg, platelet count), and applied pertinent exclusion criteria (eg, length of stay 1 day or less). VTE events that were present on admission were excluded from analyses. However, as these community‐acquired VTE events may be caused by inadequate VTE prophylaxis during a prior hospitalization, the overall true incidence of hospital‐acquired VTE was likely underestimated.

With respect to the hospital‐acquired VTE outcome, we did not distinguish superficial from deep VTE. A consistent AHRQ definition of 13 ICD‐9 VTE codes was used to identify clinically significant VTE events for the periods before and after the intervention. Although the present on admission code identified VTE events that were hospital acquired, 1 new acute VTE ICD‐9 code was added in October 2009, allowing for more specific coding of acute, isolated, upper extremity VTE. Accordingly, our postintervention hospital‐acquired VTE rate may have slightly underestimated the true hospital‐acquired VTE incidence by omitting some coded acute, isolated, upper extremity VTE cases (if not coded using the prior Other VTE codes). In a study in a teaching hospital setting, isolated upper extremity VTE accounted for up to 21% of all symptomatic VTE events among adults.[14]

With respect to VTE prophylaxis, the study evaluated use in a dichotomous fashion but did not assess appropriateness, or adequacy of dosing of pharmacologic agents. We did not employ the intervention in a randomized fashion on the medicine service. As our project was a quality improvement intervention, we used a concurrent control group of nonmedicine service patients to assess potential secular trend bias.

With respect to the safety of the intervention, the record review we performed supported the appropriateness of prophylaxis use following the intervention, but was not designed to establish whether the increase in prophylaxis use was the proximate cause of bleeding events observed. Similarly, as specific testing for heparin‐induced thrombocytopenia was not used, the lack of significant change in thrombocytopenia rates before and after the intervention cannot directly establish the intervention's safety. Finally, our study also included only in‐hospital end points.

The rate of VTE prophylaxis use in hospitals has been noted to be disappointing.[15] Two large multinational studies found that VTE prophylaxis rates in at‐risk hospitalized medical patients in the United States were 48% and 52%.[9, 16] Amin and colleagues found the overall rate of VTE prophylaxis among 227 US hospitals to be 62%.[17] Accordingly, our intervention, which resulted in an 82% compliance rate on a large medical service and was associated with a significantly reduced VTE incidence, appears to be highly effective. Our results are likely more favorable in that beyond length of stay criteria, we did not exclude less acutely ill medical patients from analyses.

Michota summarized quality improvement studies for VTE prevention.[10] Among 9 studies attempting to improve VTE prophylaxis, 2 used electronic decision support as a primary strategy, and only 1, by Kucher et al., used a computerized approach on a medical service.[18] This study showed significant improvement in VTE prophylaxis and incidence in patients randomized to a provider computer program. The intervention was complex, requiring specification of 8 patient‐level risk factors via a customized database, and the physician to recommend specific prophylactic regimens accordingly. Our findings, using a more basic approach, similarly support the effectiveness of using automated decision support, which can be readily modified as evidence‐based guidelines evolve.

Overall adoption of information technology systems in US hospitals is low: only 7.6% of hospitals have a basic system, and 17% have computerized physician order entry.[19] As hospitals have been financially incentivized to adopt such systems, our relatively simple intervention may prove to be readily generalizable across varied vendor systems.[20] The intervention involved order sets triggered by automated logic, corollary information, and a hard stop to prompt VTE prophylaxis. Within the context of intensified emphasis on reducing harm in the inpatient setting and various pay for performance programs, our intervention is also of importance to payers.[3, 5] Using national data in year 2000, Zhan and Miller calculated the excess charges per case associated with VTE to be $21,709.[21]

In conclusion, a relatively simple automated clinical decision support application significantly improved rates of VTE prophylaxis and was associated with significantly lower hospital‐acquired VTE incidence in hospitalized medicine patients, with a reasonable safety profile.

Acknowledgments

The authors acknowledge the roles of Gillian Wendt and Maggie Feng in data acquisition.

Disclosure: The authors declare no conflict of interest related to the research, analyses, or preparation of this manuscript. M. J. Sinnett reports receiving payment for speaking on behalf of Amgen, which was not a funder of this study. All coauthors have seen and agree with the contents of the manuscript, and all coauthors fulfill the authorship criteria specified by the Journal of Hospital Medicine. Rohit Bhalla, MD, MPH, takes responsibility for the entire manuscript. This submission is not under review by any other publication. Development of the electronic decision support application was supported in part by funding under the 2008 Cardinal Health Foundation Patient Safety Grant Program.

References
  1. Heit JA. The epidemiology of venous thromboembolism: implications for prevention and management. Paper presented at: Surgeon General's Workshop on Deep Vein Thrombosis; May 8, 2006; Bethesda, MD. Available at: http://www.surgeongeneral.gov/topics/deepvein/workshop/agenda.html. Accessed February 17,2012.
  2. American Public Health Association White Paper. Deep‐vein thrombosis: advancing awareness to protect patient lives. Public Health Leadership Conference on Deep‐Vein Thrombosis. Washington, D.C.; February 26,2003. Available at: http://www.apha.org/NR/rdonlyres/A209F84A‐7C0E‐4761–9ECF‐61D22E1E11F7/0/DVT_ White_Paper.pdf. Accessed February 27, 2012.
  3. Department of Health and Human Services. Centers for Medicare and Medicaid Services. Medicare program: hospital inpatient value based purchasing program. Fed Regist.2011;76(88):2649026547.
  4. The Joint Commission. 2011 hospital national patient safety goals. Available at: http://www.jointcommission.org/assets/1/6/HAP_NPSG_6–10‐11.pdf. Accessed October 23,2011.
  5. US Department of Health and Human Services. Centers for Medicare and Medicaid Services. Medicare Learning Network. Hospital acquired conditions in acute inpatient prospective payment system (IPPS) hospitals. Available at: https://www.cms.gov/HospitalAcqCond/downloads/HACFactsheet.pdf. Accessed February 17,2012.
  6. Maynard G, Stein J.Preventing Hospital‐Acquired Venous Thromboembolism: A Guide For Effective Quality Improvement. Society of Hospital Medicine. AHRQ Publication No. 08–0075.Rockville, MD:Agency for Healthcare Research and Quality;2008.
  7. Francis CW. Prophylaxis for thromboembolism in hospitalized medical patients. N Engl J Med.2007;356:14381444.
  8. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence‐Based Clinical Practice Guidelines (8th Edition). Chest.2008;133;381S453S.
  9. Cohen AT, Tapson VF, Bergmann JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross‐sectional study. Lancet.2008;371(9610):387394.
  10. Michota FA. Bridging the gap between evidence and practice in venous thromboembolism prophylaxis: the quality improvement process. J Gen Intern Med.2007;22(12):17621770.
  11. Agency for Healthcare Research and Quality. PSI #12: Postoperative pulmonary embolism or deep vein thrombosis. Version 4.1.; 2009. Available at: http://www.qualityindicators.ahrq.gov/Downloads/Modules/PSI/V41/TechSpecs/PSI%2012%20Postoperative%20Pulmonary %20Embolism%20or%20Deep%20Vein%20Thrombosis.pdf. Accessed February 19,2012.
  12. Streiff MB, Haut ER. The CMS ruling on venous thromboembolism after total knee or hip arthroplasty: weighing risks and benefits. JAMA.2009;301(10):10631065.
  13. US Department of Health and Human Services. Centers for Medicare and Medicaid Services. Hospital compare. Available at: http://www.hospitalcompare.hhs.gov. Accessed October 23,2011.
  14. Mustafa S, Stein PD, Patel KC, Otten TR, Holmes R, Silbergleit A. Upper extremity deep venous thrombosis. Chest.2003;123;19531956.
  15. Fitzmaurice DA, Murray E. Thromboprophylaxis for adults in hospital: an intervention that would save many lives is still not being implemented. BMJ.2007;334:10171018.
  16. Tapson VF, Decousus H, Pini M, et al. Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients: findings from the International Medical Prevention Registry on Venous Thromboembolism. Chest.2007:132:936945.
  17. Amin A, Stemkowski S, Lin J, Yang G. Thromboprophylaxis rates in US medical centers: success or failure?J Thromb Haemost.2007;5:16101616.
  18. Kucher N, Koo S, Quiroz R, et al. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med.2005;352:969977.
  19. Jha AK, DesRoches CM, Campbell EG, et al. Use of electronic health records in U.S. hospitals. N Engl J Med.2009;360:16281638.
  20. Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med.2010;363(6):501504.
  21. Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA.2003;290(14):18681874.
References
  1. Heit JA. The epidemiology of venous thromboembolism: implications for prevention and management. Paper presented at: Surgeon General's Workshop on Deep Vein Thrombosis; May 8, 2006; Bethesda, MD. Available at: http://www.surgeongeneral.gov/topics/deepvein/workshop/agenda.html. Accessed February 17,2012.
  2. American Public Health Association White Paper. Deep‐vein thrombosis: advancing awareness to protect patient lives. Public Health Leadership Conference on Deep‐Vein Thrombosis. Washington, D.C.; February 26,2003. Available at: http://www.apha.org/NR/rdonlyres/A209F84A‐7C0E‐4761–9ECF‐61D22E1E11F7/0/DVT_ White_Paper.pdf. Accessed February 27, 2012.
  3. Department of Health and Human Services. Centers for Medicare and Medicaid Services. Medicare program: hospital inpatient value based purchasing program. Fed Regist.2011;76(88):2649026547.
  4. The Joint Commission. 2011 hospital national patient safety goals. Available at: http://www.jointcommission.org/assets/1/6/HAP_NPSG_6–10‐11.pdf. Accessed October 23,2011.
  5. US Department of Health and Human Services. Centers for Medicare and Medicaid Services. Medicare Learning Network. Hospital acquired conditions in acute inpatient prospective payment system (IPPS) hospitals. Available at: https://www.cms.gov/HospitalAcqCond/downloads/HACFactsheet.pdf. Accessed February 17,2012.
  6. Maynard G, Stein J.Preventing Hospital‐Acquired Venous Thromboembolism: A Guide For Effective Quality Improvement. Society of Hospital Medicine. AHRQ Publication No. 08–0075.Rockville, MD:Agency for Healthcare Research and Quality;2008.
  7. Francis CW. Prophylaxis for thromboembolism in hospitalized medical patients. N Engl J Med.2007;356:14381444.
  8. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence‐Based Clinical Practice Guidelines (8th Edition). Chest.2008;133;381S453S.
  9. Cohen AT, Tapson VF, Bergmann JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross‐sectional study. Lancet.2008;371(9610):387394.
  10. Michota FA. Bridging the gap between evidence and practice in venous thromboembolism prophylaxis: the quality improvement process. J Gen Intern Med.2007;22(12):17621770.
  11. Agency for Healthcare Research and Quality. PSI #12: Postoperative pulmonary embolism or deep vein thrombosis. Version 4.1.; 2009. Available at: http://www.qualityindicators.ahrq.gov/Downloads/Modules/PSI/V41/TechSpecs/PSI%2012%20Postoperative%20Pulmonary %20Embolism%20or%20Deep%20Vein%20Thrombosis.pdf. Accessed February 19,2012.
  12. Streiff MB, Haut ER. The CMS ruling on venous thromboembolism after total knee or hip arthroplasty: weighing risks and benefits. JAMA.2009;301(10):10631065.
  13. US Department of Health and Human Services. Centers for Medicare and Medicaid Services. Hospital compare. Available at: http://www.hospitalcompare.hhs.gov. Accessed October 23,2011.
  14. Mustafa S, Stein PD, Patel KC, Otten TR, Holmes R, Silbergleit A. Upper extremity deep venous thrombosis. Chest.2003;123;19531956.
  15. Fitzmaurice DA, Murray E. Thromboprophylaxis for adults in hospital: an intervention that would save many lives is still not being implemented. BMJ.2007;334:10171018.
  16. Tapson VF, Decousus H, Pini M, et al. Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients: findings from the International Medical Prevention Registry on Venous Thromboembolism. Chest.2007:132:936945.
  17. Amin A, Stemkowski S, Lin J, Yang G. Thromboprophylaxis rates in US medical centers: success or failure?J Thromb Haemost.2007;5:16101616.
  18. Kucher N, Koo S, Quiroz R, et al. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med.2005;352:969977.
  19. Jha AK, DesRoches CM, Campbell EG, et al. Use of electronic health records in U.S. hospitals. N Engl J Med.2009;360:16281638.
  20. Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med.2010;363(6):501504.
  21. Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA.2003;290(14):18681874.
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Address for correspondence and reprint requests: Rohit Bhalla, MD, MPH, Stamford Hospital, 30 Shelburne Rd., PO Box 9317, Stamford, CT 06904‐9317; Telephone: 203‐276‐2525; Fax: 203‐276‐7223. E‐mail: [email protected]
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Steroids in Pneumonia

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Adjuvant steroid therapy in community‐acquired pneumonia: A systematic review and meta‐analysis

Community‐acquired pneumonia (CAP) is the most common lower respiratory tract infection in adults and a leading cause of infection‐related deaths in the United States.[1] According to a survey, pneumonia was the most common reason for hospital admissions through the emergency department in 2003.[2] CAP is associated with significant morbidity and mortality among those sick enough to require hospitalization. In a prospective study, hospital mortality rates ranged from 5% to 18% and length of stay from 9 to 23 days depending on patient location (intensive care unit [ICU] vs elsewhere) and severity of illness.[3]

Empirical evidence suggests that host inflammatory response contributes significantly to lung injury in pneumonia.[4] Studies have demonstrated reduction in the host inflammatory response as well as in mortality among animals with bacterial pneumonia when exposed to glucocorticoids.[5, 6] Furthermore, the efficacy of adjunctive steroid therapy in severe pneumonia caused by Pneumocystis jirovecii[7] and in pneumococcal meningitis[8, 9] is already established. However, due to equivocal, and at times conflicting, human clinical trial data on the impact of steroid therapy in CAP, the 2007 consensus guidelines (jointly published by the Infectious Diseases Society of America and American Thoracic Society) do not provide recommendations for or against use of steroids in CAP, except in the setting of hypotension secondary to adrenal insufficiency.[10]

In their meta‐analysis, Chen et al. analyzed data from 6 randomized clinical trials (RCTs) published between 1972 and 2007 (including 2 on pediatric patients) and concluded that adding steroids to current standard of care was not beneficial.[11] Earlier, Lamontagne et al.'s meta‐analysis included RCTs on hospitalized CAP patients as well as those on patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) from any cause.[12] They concluded that low‐dose corticosteroid therapy reduced all‐cause in‐hospital mortality in this mixed patient population (relative risk [RR]: 0.68 [95% confidence interval (CI): 0.49 to 0.96]). Recently, data from a number of additional RCTs have become available.[13, 14, 15, 16, 17] Therefore, an updated review of RCTs evaluating the role of adjunctive steroid therapy among adults hospitalized with CAP was warranted.

MATERIALS AND METHODS

We conducted this systematic review and meta‐analysis in accordance with the recommendations published in the Cochrane Handbook for Systematic Reviews of Interventions[18] and reported our findings according to the Preferred Reporting Items for Systematic Reviews and Meta‐analyses guidelines.[19] The overall quality of evidence was judged using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.[20]

Data Sources and Search Strategies

A comprehensive search of several databases including PubMed, Ovid MEDLINE In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus was conducted. The time range for search started from each database's earliest inclusive dates up to July 2011. An experienced institutional librarian assisted with the design and conduct of our literature search. Controlled vocabulary, supplemented with keywords, was used to search for the topic: steroid therapy for community‐acquired pneumonia. We consulted expert colleagues to ensure the inclusion of all eligible reports and also checked the bibliographies of previously published systematic reviews.[12, 21]

Eligibility Criteria

Studies deemed eligible for inclusion were RCTs that met the following patients, intervention, control, outcomes (PICO) criteria: P, adults hospitalized with CAP; I, administration of systemic corticosteroids plus standard treatment; C, standard treatment without corticosteroids; O, primary outcome: hospital mortality; secondary outcomes, length of hospital stay, length of ICU stay and duration of mechanical ventilation. Under the P criterion we included RCTs that defined CAP as a lung infection (based on a reasonable combination of history, physical examination, imaging, and/or other investigative data, such as per the American Thoracic Society definition)[22] of presumed or proven bacterial etiology, in a patient who was not immunocompromised and had no exposure to a healthcare facility in the past 90 days.

Study Selection and Quality Assessment

Two reviewers independently performed study selection, data extraction, and quality assessment. Data were abstracted using standardized data collection instruments. Kappa statistic was calculated to assess the reviewers' level of agreement.

We perused full texts of all articles whose abstracts met selection criteria, performing an appraisal of their quality using the Cochrane risk‐of‐bias tool.[23] We also reviewed the baseline characteristics of patients in each study cohort.

Analysis

We estimated RR and weighted mean differences along with the respective 95% confidence intervals by pooling data using a random effects model.[24] Study heterogeneity was assessed using the I2 statistic, which estimates the percentage of variation that is not attributable to chance.[25] We performed a priori subgroup analyses based on the location (ICU vs non‐ICU) and mean age group of study participants (based on a cutoff of 50 years). A significant (P < 0.05) test of interaction would provide an explanation for any heterogeneity.[26] We also performed an a priori sensitivity analysis excluding any studies published before the year 2000 to exclude the impact of changing standards of care for inpatient management of CAP over time.

The original investigators were not contacted for purposes of obtaining raw data.

RESULTS

Eight RCTs, comprising 1119 subjects, were eventually chosen.[14]. Seven shortlisted studies were excluded due to methodological limitations, failure to fully meet PICO criteria, or gross insufficiency of descriptive data on subjects or methodology.[18, 31, 32, 33, 34, 35, 36] Figure 1 illustrates the study selection process.

Figure 1
The study selection process.

Table 1 summarizes the baseline characteristics of patient populations from each study. Mean ages in 7 RCTs were between 60 years and 80 years. In Marik et al., the mean age of the intervention group was 31.7 years, whereas that of the control group was 40.6 years (P value not reported).[30] Three RCTs included ICU patients only,[17, 28, 30] whereas 4 only included general medical ward patients.[14, 15, 29, 31] Disease severity scores at admission were similar between the 2 groups in all RCTs except Sabry and Omar,[17] which was the only clinical trial to use a chest radiograph score. Only Sabry and Omar,[17] and Mikami et al.[29] excluded chronic obstructive pulmonary disease patients. Where possible, the serum C‐reactive protein (CRP) value on day one was subtracted from that on day eight to generate a one week delta CRP.

Baseline Characteristics of Studies Included for Analysis
Author, YearNumber of PatientsGender: Males (% Age)Age (y)Steroids Used (Daily Dose and Duration)COPD (% of Total)Diabetes (% of Total)Mean PaO2/FiO2 RatioSeverity Score (Score: Mean)Patients Already in ICU (% of Total)One‐week Delta CRP (mg/dL)
TotalSteroidControlSteroidControlSteroidControl SteroidControlSteroidControlSteroidControlSteroidControlSteroidControlSteroidControl
  • NOTE: Abbreviations: APACHE, Acute Physiology and Chronic Health Evaluation; COPD, chronic obstructive pulmonary disease; CRP, C‐reactive protein; ICU, intensive care unit; IV, intravenous; NA, not applicable; PO, orally; PSI = Pneumonia Severity Index; SAPS, Simplified Acute Physiology Score.
  • The difference between steroid and control groups was statistically significant (P<0.05)
McHardy 1972[31]126408645506259Prednisolone 20 mg, 7 d4035Not reportedNot reportedNot reported00N/AN/A
Marik 1993[30]301416Not reported3241Hydrocortisone 10 mg/kg 1Not reportedNot reported213214APACHE II100100N/AN/A
 1114 
Confalonieri 2005[28]46232374656067Hydrocortisone 200 mg bolus, then 10 mg/h, 7 dNot reportedNot reported141a178aAPACHE II10010037a+5a
 1718 
Mikami 2007[29]31151673.3757668Prednisolone 40 mg IV, 3 d00Not reportedPaO2 (FiO2 not reported)PSI00N/AN/A
 61649586 
Snijders 2010[16]21310410952.963.36364Prednisolone 40 mg IV/PO, 7 d18221011Not reportedPSI class V (% of total)14.46.4N/AN/A
 1316 
Fernandez‐Serrano 2011[15]45232269.663.66661Methylprednisone 200 mg IV; then 20 mg/6 h, 3 d; then 20 mg/12 h, 3 d; then 20 mg/d, 3 d179918200257SAPS classes IV + V (% of total)00N/AN/A
 6554 
Meijvis 2011[14]30415115357566563Dexamethasone 5 mg/d, 4 d1391514Not reportedPSI class V (% of total)00N/AN/A
 1714 
Sabry 2011[17]80404030286263Hydrocortisone 200 mg IV, then 12.5 mg/h, 7 d00Not reported338a243aChest radiograph score10010038a23a
 1a3a 

The mean ICU length of stay was 12.7 days for the steroid group and 12.3 days for the control group. The mean hospital lengths of stay were 10.2 days and 13.6 days, respectively. Quality of the studies was moderate (see Supporting Information, Appendix I, in the online version of this article). Kappa score was >0.90.

Meta‐analysis

Figure 2 illustrates the results of our meta‐analyses. Although adjunctive steroid therapy had no effect on hospital mortality or ICU length of stay, it was associated with reduced hospital length of stay (RR: 1.21 days [95% CI: 2.12 to 0.29]). Of note, Mikami et al.[29] did not report mortality in their article, whereas in McHardy and Schonell,[31] using the factorial design, each of the 2 treatment groups were further subdivided into those patients who received 1 g of ampicillin and those who received 2 g of ampicillin (Figure 2A).

Figure 2
(A) Meta‐analysis of the dichotomous outcomes. (B) Meta‐analysis of the continuous outcomes. Abbreviations: ARDS, acute respiratory distress syndrome; CI, confidence interval; CXR, chest radiograph; ICU, intensive care unit; RR, relative risk.

Analysis of other outcomes was limited by the fact that data were pooled from only a few studies. These included the need for and duration of mechanical ventilation, development of new ARDS and ICU admission rate, neither of which was associated with steroid therapy. However, steroid use was associated with lower incidence of delayed shock (ie, shock occurring after enrollment (RR: 0.12 [95% CI: 0.03 to 0.41]) and lower incidence of persistent chest x‐ray abnormalities at 1 week (RR: 0.13 [95% CI: 0.06 to 0.27]).

Subgroup and Sensitivity Analyses

Heterogeneity (I2 statistic) was <50% for all outcomes except ICU length of stay (74%). There were no significant interactions to suggest a subgroup effect based on older vs younger or ICU vs non‐ICU based patients (Table 2). In a priori sensitivity analysis that excluded McHardy and Schonell (published in 1972) and Marik et al. (published in 1993),[30] the results were not different from the main analysis.

Subgroup Analyses
 No. of StudiesEffect SizeLLULP for Interaction (Difference Between Subgroups)
  • NOTE: Abbreviations: ICU, intensive care unit; LOS, length of stay; LL, Lower Limit; UL, Upper Limit.
Mortality
ICU30.270.080.830.06
Non‐ICU40.960.452.05
Older70.750.401.380.56
Young10.380.043.26
Need for mechanical ventilation
ICU10.570.122.660.39
Non‐ICU10.140.012.51
Older10.140.012.510.39
Younger10.570.122.66
LOS
ICU18.0016.410.410.11
Non‐ICU31.141.970.31
ICU LOS
ICU23.9111.443.620.45
Non‐ICU20.818.9810.60
Older32.269.955.430.65
Younger10.303.913.31

Quality of Evidence

Using the GRADE framework, the overall quality of evidence (confidence in the estimates) was judged to be moderate with the following main limitations: 1) methodological limitations among included studies (prognostic imbalance), 2) imprecision (small number of events and wide confidence intervals), and 3) inconsistency in the outcome ICU length of stay (as reflected by the I2 statistic).

Other Reported Outcomes

Four studies[15, 16, 29, 31] provided descriptive details of microbiologic data, whereas 1 study[16] provided analytical data on microbiology. In the latter, patients with Streptococcus pneumoniae infection (identified variably by sputum, pleural fluid, urine, or blood samples), had lower clinical cure rates in the steroid group at day 30 (P = 0.01) and higher numbers of late failures (defined as recurrence of signs and symptoms of pneumonia, P = 0.02).

Three[28, 30, 31] studies did not provide data on glycemic trends, whereas Fernandez‐Serrano et al., Mikami et al., and Snijders et al. reported that rates of hyperglycemia were not different across the 2 groups.[15, 16, 29] Meijvis et al.[14] reported more frequent hyperglycemia in the steroid group (44% vs 23%, P < 0.001) but no difference in the need for glucose‐lowering treatment (5% vs 3%, P = 0.57). Sabry and Omar[17] reported a higher incidence of hyperglycemia in the steroid group (no numerical data reported). Snijders et al.,[16] Meijvis et al.,[14] and Sabry and Omar[17] reported that the rates of super‐infection were not different between the 2 groups. No other adverse effects were consistently reported.

DISCUSSION

In this meta‐analysis of 8 RCTs, we found no significant association between steroid therapy and our primary outcome of interest (hospital mortality). However, length of hospital stay was shorter in the steroid group. These findings were not altered in various sensitivity and subgroup analyses. Although adverse effects of steroid therapy were not consistently reported, most of the RCTs reported that hyperglycemia was either no more common in the steroid group or did not require additional treatment.

Previous meta‐analyses have also concluded that adding corticosteroids to conventional therapy does not impact mortality among adults hospitalized with CAP.[12, 22] This may or may not be a consequence of inadequate statistical power. Although Lamontagne et al.[13] reported that low‐dose corticosteroid therapy (2 mg/kg/day or less of methylprednisolone or equivalent) was associated with reduced hospital mortality (RR: 0.68 [95% CI: 0.49 to 0.96]), this result was obtained by pooling data from 5 RCTs on adults hospitalized with CAP and 4 on adults with ALI/ARDS from any cause. In a subgroup analysis of RCTs conducted only on CAP patients, no impact on mortality was found. Of note, all RCTs involving CAP patients had used low‐dose steroids; the 3 RCTs using high‐dose steroids were carried out on ALI/ARDS patients.[36, 37, 38] Similarly, all RCTs in our meta‐analysis were also characterized by steroid doses under 2 mg/kg/day of methylprednisolone or equivalent.

Our study is the first to demonstrate decreased length of hospital stay in this patient population. Importantly, each of the 5 studies that reported this outcome (including 3 relatively recent RCTs) showed the same trend. However, it is not inconceivable that steroid use led to a quicker decline in cytokine levels resulting in an earlier resolution of fever and hence earlier discharge without a faster cure per se. The two studies whose data permitted calculation of delta CRP also demonstrated a faster CRP decline in the steroid group (Table 1).

Our analysis also suggested reduced incidence of delayed shock. However, these data were pooled from only 2 RCTs,[17, 28] and each of them used hydrocortisone, whose direct mineralocorticoid effect is an obvious confounder. Similarly, according to data pooled from 2 RCTs, steroid use was associated with fewer cases of persistent chest x‐ray abnormalities by day 8. Of note, although calculation of the I2 statistic was not possible because of too few studies, visual inspection of the forest plots suggested low levels of heterogeneity.

It is plausible that the impact of adjunctive steroids in CAP may vary based on the causative pathogen. This pathogen‐specific association has been observed in patients with bacterial meningitis, where most of the benefit is seemingly limited to pneumococcal meningitis.[9, 10] Unfortunately, as demonstrated by Snijders et al.,[16] establishing microbiologic etiology in CAP can be difficult, and most patients are treated empirically.

Our analysis showed no difference in duration of ventilation among patients who required ventilatory support on admission. However, only 2 studies reported this outcome.[17, 28] Second, in Confalonieri et al.,[28] the steroid group had a more severe baseline inflammatory response as illustrated by higher serum CRP levels (P = 0.04). Moreover, while mechanical ventilation was defined as either invasive or noninvasive ventilation, the steroid group had a higher number of patients who required noninvasive ventilation (P = 0.03), thus introducing selection bias. This study had additional areas of concern too, including a mortality of 0 among its 46 ICU patients, in contrast to established mortality rates of up to around 20%.[4] Unlike this study, Sabry and Omar[17] reported that none of their patients was on noninvasive ventilation. It may be pertinent to compare our findings with those of Steinberg et al.,[40] who studied patients with ARDS (pneumonia being the most common cause) who received methylprednisolone. This group had an early increase in ventilator‐free days, but that effect became less pronounced (though still significant) when the study end point was prolonged from 30 to 90 days.[41]

The 2 studies that were published before 2000 (McHardy and Schonell,[31] and Marik et al.[30]) were excluded in our a priori sensitivity analysis. A number of considerations led to this decision. First, standards of care for inpatient management of pneumoniaincluding pharmacologic therapies and ventilation strategieshave changed considerably over time. For instance, newer generation macrolides became available for clinical use in the early 1990s and meropenem in 1996.[41] Therefore, it would be hard to assume constancy of effect from that time period. Furthermore, the study by McHardy and Schonell[31] suffered from significant differences in the baseline characteristics of its 2 arms. There was incomplete randomization; patients with diabetes were excluded from only the steroid arm. Another issue with Marik et al.[30] was the considerably younger age of participants compared to other studies (Table 1).

Limitations

In spite of our relatively stringent selection criteria and a number of subgroup and sensitivity analyses, the overall quality of evidence was only moderate (Table 2). Key issues with the findings reported by Confalonieri et al.,[28] McHardy and Schonell,[31] and Marik et al.[30] were discussed earlier. Baseline severity of illness, patient comorbidities, and length of follow‐up were variable both within and across various studies. Another major limitation was that the intervention of interest (ie, steroid therapy) was not uniformly applied as the regimens varied considerably even though all regimens fit the designation of low‐dose steroids as previously noted (Table 1).

In conclusion, although evidence suggests that adjunctive steroid therapy is associated with reduced hospital length of stay, the data are not strong enough to recommend routine use of steroids among all adults hospitalized with CAP. However, considering that there was no increase in mortality or hospital length of stay with steroid use, it is reasonable to continue steroids if warranted for treatment of underlying comorbid conditions.

Due to the aforementioned limitations in RCTs published to date, we believe that additional studies that are more robustly designed and sufficiently powered to detect differences in key outcomes (including mortality) are warranted. Investigators should ensure appropriate randomization of groups, taking into account severity of illness, comorbid conditions and prior use of steroid therapy. Standardizing the intervention (including dose and duration of steroid therapy and time to first antibiotic dose) would be essential. Concurrent measurement of inflammatory markers such as delta CRP would be useful too. Finally, accurate measurement of all secondary outcomes of interest, including adverse effects and duration of both invasive and noninvasive mechanical ventilation, would be important to accurately study the benefit of steroids among the most likely beneficiaries: those patients who are the sickest.

Acknowledgments

The authors gratefully acknowledge the assistance of Dr. Jon Ebbert (Department of Medicine, Mayo Clinic, Rochester, MN) with proofreading the manuscript and providing thoughtful editorial suggestions.

Disclosures

The authors report no conflicts of interest.

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References
  1. Centers for Disease Control and Prevention 2008. CDC/NCHS, National Vital Statistics System. Leading causes of Death. Available at: http://www.cdc.gov/nchs/nvss/mortality_tables.htm. Accessed August 14,2011.
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  7. Briel M, Bucher HC, Boscacci R, Furrer H. Adjunctive corticosteroids for Pneumocystis jiroveci pneumonia in patients with HIV‐infection. Cochrane Database Syst Rev. 2006;(3):CD006150.
  8. gans J, de beek D. Dexamethasone in adults with bacterial meningitis. N Engl J Med. 2002;347(20):15491556.
  9. de beek D, gans J, Mcintyre P, Prasad K. Steroids in adults with acute bacterial meningitis: a systematic review. Lancet Infect Dis. 2004;4(3):139143.
  10. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community‐acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27S72.
  11. Chen Y, Li K, Pu H, Wu T. Corticosteroids for pneumonia. Cochrane Database Syst Rev. 2011;(3):CD007720.
  12. Lamontagne F, Briel M, Guyatt GH, Cook DJ, Bhatnagar N, Meade M. Corticosteroid therapy for acute lung injury, acute respiratory distress syndrome, and severe pneumonia: a meta‐analysis of randomized controlled trials. J Crit Care. 2010;25(3):420435.
  13. Meijvis SC, Hardeman H, Remmelts HH, et al. Dexamethasone and length of hospital stay in patients with community‐acquired pneumonia: a randomised, double‐blind, placebo‐controlled trial. Lancet. 2011;377(9782):20232030.
  14. Fernandez‐Serrano S, Dorca J, Garcia‐Vidal C, et al. Effect of corticosteroids on the clinical course of community‐acquired pneumonia: a randomized controlled trial. Crit Care. 2011;15(2):R96.
  15. Snijders D, Daniels JM, Graaff CS, et al. Efficacy of corticosteroids in community‐acquired pneumonia: a randomized double‐blinded clinical trial. Am J Respir Crit Care Med. 2010;181:975978.
  16. Sabry NA, Omar E. Corticosteroids and ICU course of community acquired pneumonia in Egyptian settings. Pharmacol Pharm. 2011;2(2):7381.
  17. Nawab QU, Golden E, Confalonieri M, Umberger R, Meduri GU. Corticosteroid treatment in severe community‐acquired pneumonia: duration of treatment affects control of systemic inflammation and clinical improvement. Intensive Care Med. 2011;37(9):15531554.
  18. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. West Sussex, UK:Wiley‐Blackwell;2008.
  19. Moher D, Liberati A, Tetzlaff J, Altman DG;PRISMA Group. Preferred reporting items for systematic reviews and meta‐analyses: the PRISMA statement. J Clin Epidemiol. 2009;62:10061012.
  20. Balshem H, Helfand M, Schunemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401406.
  21. Salluh JI, Povoa P, Soares M, Castro‐Faria‐Neto HC, Bozza FA, Bozza PT. The role of corticosteroids in severe community‐acquired pneumonia: a systematic review. Crit Care. 2008;12(3):R76.
  22. Ewig S, Ruiz M, Mensa J, et al. Severe community‐acquired pneumonia: assessment of severity criteria. Am J Respir Crit Care Med. 1998;158(4):11021108.
  23. Higgins JPT, Altman DG.Assessing risk of bias in included studies. In: Higgins JPT, Green S eds. Cochrane Handbook for Systematic Reviews of Interventions. Chichester, UK:John Wiley 2009.
  24. Dersimonian R, Laird N. Meta‐analysis in clinical trials. Control Clin Trials. 1986;7(3):177188.
  25. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ. 2003;327(7414):557560.
  26. Altman DG, Bland JM. Interaction revisited: the difference between two estimates. BMJ. 2003;326(7382):219.
  27. Confalonieri M, Urbino R, Potena A, et al. Hydrocortisone infusion for severe community‐acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med. 2005;171(3):242248.
  28. Mikami K, Suzuki M, Kitagawa H, Kawakami M, Hirota N, Yamaguchi H. Efficacy of corticosteroids in the treatment of community‐acquired pneumonia requiring hospitalisation. Lung. 2007;185(5):249255.
  29. Marik P, Kraus P, Sribante J, Havlik I, Lipman J, Johnson DW. Hydrocortisone and tumour necrosis factor in severe community acquired pneumonia. A randomised controlled study. Chest. 1993;104(2):389392.
  30. McHardy VU, Schonell ME. Ampicillin dosage and use of prednisolone in treatment of pneumonia: co‐operative controlled trial. Br Med J. 1972;4:569573.
  31. Salluh JI, Soares M, Coelho LM, et al. Impact of systemic corticosteroids on the clinical course and outcomes of patients with severe community‐acquired pneumonia: a cohort study. J Crit Care. 2011;26(2):193200.
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Community‐acquired pneumonia (CAP) is the most common lower respiratory tract infection in adults and a leading cause of infection‐related deaths in the United States.[1] According to a survey, pneumonia was the most common reason for hospital admissions through the emergency department in 2003.[2] CAP is associated with significant morbidity and mortality among those sick enough to require hospitalization. In a prospective study, hospital mortality rates ranged from 5% to 18% and length of stay from 9 to 23 days depending on patient location (intensive care unit [ICU] vs elsewhere) and severity of illness.[3]

Empirical evidence suggests that host inflammatory response contributes significantly to lung injury in pneumonia.[4] Studies have demonstrated reduction in the host inflammatory response as well as in mortality among animals with bacterial pneumonia when exposed to glucocorticoids.[5, 6] Furthermore, the efficacy of adjunctive steroid therapy in severe pneumonia caused by Pneumocystis jirovecii[7] and in pneumococcal meningitis[8, 9] is already established. However, due to equivocal, and at times conflicting, human clinical trial data on the impact of steroid therapy in CAP, the 2007 consensus guidelines (jointly published by the Infectious Diseases Society of America and American Thoracic Society) do not provide recommendations for or against use of steroids in CAP, except in the setting of hypotension secondary to adrenal insufficiency.[10]

In their meta‐analysis, Chen et al. analyzed data from 6 randomized clinical trials (RCTs) published between 1972 and 2007 (including 2 on pediatric patients) and concluded that adding steroids to current standard of care was not beneficial.[11] Earlier, Lamontagne et al.'s meta‐analysis included RCTs on hospitalized CAP patients as well as those on patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) from any cause.[12] They concluded that low‐dose corticosteroid therapy reduced all‐cause in‐hospital mortality in this mixed patient population (relative risk [RR]: 0.68 [95% confidence interval (CI): 0.49 to 0.96]). Recently, data from a number of additional RCTs have become available.[13, 14, 15, 16, 17] Therefore, an updated review of RCTs evaluating the role of adjunctive steroid therapy among adults hospitalized with CAP was warranted.

MATERIALS AND METHODS

We conducted this systematic review and meta‐analysis in accordance with the recommendations published in the Cochrane Handbook for Systematic Reviews of Interventions[18] and reported our findings according to the Preferred Reporting Items for Systematic Reviews and Meta‐analyses guidelines.[19] The overall quality of evidence was judged using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.[20]

Data Sources and Search Strategies

A comprehensive search of several databases including PubMed, Ovid MEDLINE In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus was conducted. The time range for search started from each database's earliest inclusive dates up to July 2011. An experienced institutional librarian assisted with the design and conduct of our literature search. Controlled vocabulary, supplemented with keywords, was used to search for the topic: steroid therapy for community‐acquired pneumonia. We consulted expert colleagues to ensure the inclusion of all eligible reports and also checked the bibliographies of previously published systematic reviews.[12, 21]

Eligibility Criteria

Studies deemed eligible for inclusion were RCTs that met the following patients, intervention, control, outcomes (PICO) criteria: P, adults hospitalized with CAP; I, administration of systemic corticosteroids plus standard treatment; C, standard treatment without corticosteroids; O, primary outcome: hospital mortality; secondary outcomes, length of hospital stay, length of ICU stay and duration of mechanical ventilation. Under the P criterion we included RCTs that defined CAP as a lung infection (based on a reasonable combination of history, physical examination, imaging, and/or other investigative data, such as per the American Thoracic Society definition)[22] of presumed or proven bacterial etiology, in a patient who was not immunocompromised and had no exposure to a healthcare facility in the past 90 days.

Study Selection and Quality Assessment

Two reviewers independently performed study selection, data extraction, and quality assessment. Data were abstracted using standardized data collection instruments. Kappa statistic was calculated to assess the reviewers' level of agreement.

We perused full texts of all articles whose abstracts met selection criteria, performing an appraisal of their quality using the Cochrane risk‐of‐bias tool.[23] We also reviewed the baseline characteristics of patients in each study cohort.

Analysis

We estimated RR and weighted mean differences along with the respective 95% confidence intervals by pooling data using a random effects model.[24] Study heterogeneity was assessed using the I2 statistic, which estimates the percentage of variation that is not attributable to chance.[25] We performed a priori subgroup analyses based on the location (ICU vs non‐ICU) and mean age group of study participants (based on a cutoff of 50 years). A significant (P < 0.05) test of interaction would provide an explanation for any heterogeneity.[26] We also performed an a priori sensitivity analysis excluding any studies published before the year 2000 to exclude the impact of changing standards of care for inpatient management of CAP over time.

The original investigators were not contacted for purposes of obtaining raw data.

RESULTS

Eight RCTs, comprising 1119 subjects, were eventually chosen.[14]. Seven shortlisted studies were excluded due to methodological limitations, failure to fully meet PICO criteria, or gross insufficiency of descriptive data on subjects or methodology.[18, 31, 32, 33, 34, 35, 36] Figure 1 illustrates the study selection process.

Figure 1
The study selection process.

Table 1 summarizes the baseline characteristics of patient populations from each study. Mean ages in 7 RCTs were between 60 years and 80 years. In Marik et al., the mean age of the intervention group was 31.7 years, whereas that of the control group was 40.6 years (P value not reported).[30] Three RCTs included ICU patients only,[17, 28, 30] whereas 4 only included general medical ward patients.[14, 15, 29, 31] Disease severity scores at admission were similar between the 2 groups in all RCTs except Sabry and Omar,[17] which was the only clinical trial to use a chest radiograph score. Only Sabry and Omar,[17] and Mikami et al.[29] excluded chronic obstructive pulmonary disease patients. Where possible, the serum C‐reactive protein (CRP) value on day one was subtracted from that on day eight to generate a one week delta CRP.

Baseline Characteristics of Studies Included for Analysis
Author, YearNumber of PatientsGender: Males (% Age)Age (y)Steroids Used (Daily Dose and Duration)COPD (% of Total)Diabetes (% of Total)Mean PaO2/FiO2 RatioSeverity Score (Score: Mean)Patients Already in ICU (% of Total)One‐week Delta CRP (mg/dL)
TotalSteroidControlSteroidControlSteroidControl SteroidControlSteroidControlSteroidControlSteroidControlSteroidControlSteroidControl
  • NOTE: Abbreviations: APACHE, Acute Physiology and Chronic Health Evaluation; COPD, chronic obstructive pulmonary disease; CRP, C‐reactive protein; ICU, intensive care unit; IV, intravenous; NA, not applicable; PO, orally; PSI = Pneumonia Severity Index; SAPS, Simplified Acute Physiology Score.
  • The difference between steroid and control groups was statistically significant (P<0.05)
McHardy 1972[31]126408645506259Prednisolone 20 mg, 7 d4035Not reportedNot reportedNot reported00N/AN/A
Marik 1993[30]301416Not reported3241Hydrocortisone 10 mg/kg 1Not reportedNot reported213214APACHE II100100N/AN/A
 1114 
Confalonieri 2005[28]46232374656067Hydrocortisone 200 mg bolus, then 10 mg/h, 7 dNot reportedNot reported141a178aAPACHE II10010037a+5a
 1718 
Mikami 2007[29]31151673.3757668Prednisolone 40 mg IV, 3 d00Not reportedPaO2 (FiO2 not reported)PSI00N/AN/A
 61649586 
Snijders 2010[16]21310410952.963.36364Prednisolone 40 mg IV/PO, 7 d18221011Not reportedPSI class V (% of total)14.46.4N/AN/A
 1316 
Fernandez‐Serrano 2011[15]45232269.663.66661Methylprednisone 200 mg IV; then 20 mg/6 h, 3 d; then 20 mg/12 h, 3 d; then 20 mg/d, 3 d179918200257SAPS classes IV + V (% of total)00N/AN/A
 6554 
Meijvis 2011[14]30415115357566563Dexamethasone 5 mg/d, 4 d1391514Not reportedPSI class V (% of total)00N/AN/A
 1714 
Sabry 2011[17]80404030286263Hydrocortisone 200 mg IV, then 12.5 mg/h, 7 d00Not reported338a243aChest radiograph score10010038a23a
 1a3a 

The mean ICU length of stay was 12.7 days for the steroid group and 12.3 days for the control group. The mean hospital lengths of stay were 10.2 days and 13.6 days, respectively. Quality of the studies was moderate (see Supporting Information, Appendix I, in the online version of this article). Kappa score was >0.90.

Meta‐analysis

Figure 2 illustrates the results of our meta‐analyses. Although adjunctive steroid therapy had no effect on hospital mortality or ICU length of stay, it was associated with reduced hospital length of stay (RR: 1.21 days [95% CI: 2.12 to 0.29]). Of note, Mikami et al.[29] did not report mortality in their article, whereas in McHardy and Schonell,[31] using the factorial design, each of the 2 treatment groups were further subdivided into those patients who received 1 g of ampicillin and those who received 2 g of ampicillin (Figure 2A).

Figure 2
(A) Meta‐analysis of the dichotomous outcomes. (B) Meta‐analysis of the continuous outcomes. Abbreviations: ARDS, acute respiratory distress syndrome; CI, confidence interval; CXR, chest radiograph; ICU, intensive care unit; RR, relative risk.

Analysis of other outcomes was limited by the fact that data were pooled from only a few studies. These included the need for and duration of mechanical ventilation, development of new ARDS and ICU admission rate, neither of which was associated with steroid therapy. However, steroid use was associated with lower incidence of delayed shock (ie, shock occurring after enrollment (RR: 0.12 [95% CI: 0.03 to 0.41]) and lower incidence of persistent chest x‐ray abnormalities at 1 week (RR: 0.13 [95% CI: 0.06 to 0.27]).

Subgroup and Sensitivity Analyses

Heterogeneity (I2 statistic) was <50% for all outcomes except ICU length of stay (74%). There were no significant interactions to suggest a subgroup effect based on older vs younger or ICU vs non‐ICU based patients (Table 2). In a priori sensitivity analysis that excluded McHardy and Schonell (published in 1972) and Marik et al. (published in 1993),[30] the results were not different from the main analysis.

Subgroup Analyses
 No. of StudiesEffect SizeLLULP for Interaction (Difference Between Subgroups)
  • NOTE: Abbreviations: ICU, intensive care unit; LOS, length of stay; LL, Lower Limit; UL, Upper Limit.
Mortality
ICU30.270.080.830.06
Non‐ICU40.960.452.05
Older70.750.401.380.56
Young10.380.043.26
Need for mechanical ventilation
ICU10.570.122.660.39
Non‐ICU10.140.012.51
Older10.140.012.510.39
Younger10.570.122.66
LOS
ICU18.0016.410.410.11
Non‐ICU31.141.970.31
ICU LOS
ICU23.9111.443.620.45
Non‐ICU20.818.9810.60
Older32.269.955.430.65
Younger10.303.913.31

Quality of Evidence

Using the GRADE framework, the overall quality of evidence (confidence in the estimates) was judged to be moderate with the following main limitations: 1) methodological limitations among included studies (prognostic imbalance), 2) imprecision (small number of events and wide confidence intervals), and 3) inconsistency in the outcome ICU length of stay (as reflected by the I2 statistic).

Other Reported Outcomes

Four studies[15, 16, 29, 31] provided descriptive details of microbiologic data, whereas 1 study[16] provided analytical data on microbiology. In the latter, patients with Streptococcus pneumoniae infection (identified variably by sputum, pleural fluid, urine, or blood samples), had lower clinical cure rates in the steroid group at day 30 (P = 0.01) and higher numbers of late failures (defined as recurrence of signs and symptoms of pneumonia, P = 0.02).

Three[28, 30, 31] studies did not provide data on glycemic trends, whereas Fernandez‐Serrano et al., Mikami et al., and Snijders et al. reported that rates of hyperglycemia were not different across the 2 groups.[15, 16, 29] Meijvis et al.[14] reported more frequent hyperglycemia in the steroid group (44% vs 23%, P < 0.001) but no difference in the need for glucose‐lowering treatment (5% vs 3%, P = 0.57). Sabry and Omar[17] reported a higher incidence of hyperglycemia in the steroid group (no numerical data reported). Snijders et al.,[16] Meijvis et al.,[14] and Sabry and Omar[17] reported that the rates of super‐infection were not different between the 2 groups. No other adverse effects were consistently reported.

DISCUSSION

In this meta‐analysis of 8 RCTs, we found no significant association between steroid therapy and our primary outcome of interest (hospital mortality). However, length of hospital stay was shorter in the steroid group. These findings were not altered in various sensitivity and subgroup analyses. Although adverse effects of steroid therapy were not consistently reported, most of the RCTs reported that hyperglycemia was either no more common in the steroid group or did not require additional treatment.

Previous meta‐analyses have also concluded that adding corticosteroids to conventional therapy does not impact mortality among adults hospitalized with CAP.[12, 22] This may or may not be a consequence of inadequate statistical power. Although Lamontagne et al.[13] reported that low‐dose corticosteroid therapy (2 mg/kg/day or less of methylprednisolone or equivalent) was associated with reduced hospital mortality (RR: 0.68 [95% CI: 0.49 to 0.96]), this result was obtained by pooling data from 5 RCTs on adults hospitalized with CAP and 4 on adults with ALI/ARDS from any cause. In a subgroup analysis of RCTs conducted only on CAP patients, no impact on mortality was found. Of note, all RCTs involving CAP patients had used low‐dose steroids; the 3 RCTs using high‐dose steroids were carried out on ALI/ARDS patients.[36, 37, 38] Similarly, all RCTs in our meta‐analysis were also characterized by steroid doses under 2 mg/kg/day of methylprednisolone or equivalent.

Our study is the first to demonstrate decreased length of hospital stay in this patient population. Importantly, each of the 5 studies that reported this outcome (including 3 relatively recent RCTs) showed the same trend. However, it is not inconceivable that steroid use led to a quicker decline in cytokine levels resulting in an earlier resolution of fever and hence earlier discharge without a faster cure per se. The two studies whose data permitted calculation of delta CRP also demonstrated a faster CRP decline in the steroid group (Table 1).

Our analysis also suggested reduced incidence of delayed shock. However, these data were pooled from only 2 RCTs,[17, 28] and each of them used hydrocortisone, whose direct mineralocorticoid effect is an obvious confounder. Similarly, according to data pooled from 2 RCTs, steroid use was associated with fewer cases of persistent chest x‐ray abnormalities by day 8. Of note, although calculation of the I2 statistic was not possible because of too few studies, visual inspection of the forest plots suggested low levels of heterogeneity.

It is plausible that the impact of adjunctive steroids in CAP may vary based on the causative pathogen. This pathogen‐specific association has been observed in patients with bacterial meningitis, where most of the benefit is seemingly limited to pneumococcal meningitis.[9, 10] Unfortunately, as demonstrated by Snijders et al.,[16] establishing microbiologic etiology in CAP can be difficult, and most patients are treated empirically.

Our analysis showed no difference in duration of ventilation among patients who required ventilatory support on admission. However, only 2 studies reported this outcome.[17, 28] Second, in Confalonieri et al.,[28] the steroid group had a more severe baseline inflammatory response as illustrated by higher serum CRP levels (P = 0.04). Moreover, while mechanical ventilation was defined as either invasive or noninvasive ventilation, the steroid group had a higher number of patients who required noninvasive ventilation (P = 0.03), thus introducing selection bias. This study had additional areas of concern too, including a mortality of 0 among its 46 ICU patients, in contrast to established mortality rates of up to around 20%.[4] Unlike this study, Sabry and Omar[17] reported that none of their patients was on noninvasive ventilation. It may be pertinent to compare our findings with those of Steinberg et al.,[40] who studied patients with ARDS (pneumonia being the most common cause) who received methylprednisolone. This group had an early increase in ventilator‐free days, but that effect became less pronounced (though still significant) when the study end point was prolonged from 30 to 90 days.[41]

The 2 studies that were published before 2000 (McHardy and Schonell,[31] and Marik et al.[30]) were excluded in our a priori sensitivity analysis. A number of considerations led to this decision. First, standards of care for inpatient management of pneumoniaincluding pharmacologic therapies and ventilation strategieshave changed considerably over time. For instance, newer generation macrolides became available for clinical use in the early 1990s and meropenem in 1996.[41] Therefore, it would be hard to assume constancy of effect from that time period. Furthermore, the study by McHardy and Schonell[31] suffered from significant differences in the baseline characteristics of its 2 arms. There was incomplete randomization; patients with diabetes were excluded from only the steroid arm. Another issue with Marik et al.[30] was the considerably younger age of participants compared to other studies (Table 1).

Limitations

In spite of our relatively stringent selection criteria and a number of subgroup and sensitivity analyses, the overall quality of evidence was only moderate (Table 2). Key issues with the findings reported by Confalonieri et al.,[28] McHardy and Schonell,[31] and Marik et al.[30] were discussed earlier. Baseline severity of illness, patient comorbidities, and length of follow‐up were variable both within and across various studies. Another major limitation was that the intervention of interest (ie, steroid therapy) was not uniformly applied as the regimens varied considerably even though all regimens fit the designation of low‐dose steroids as previously noted (Table 1).

In conclusion, although evidence suggests that adjunctive steroid therapy is associated with reduced hospital length of stay, the data are not strong enough to recommend routine use of steroids among all adults hospitalized with CAP. However, considering that there was no increase in mortality or hospital length of stay with steroid use, it is reasonable to continue steroids if warranted for treatment of underlying comorbid conditions.

Due to the aforementioned limitations in RCTs published to date, we believe that additional studies that are more robustly designed and sufficiently powered to detect differences in key outcomes (including mortality) are warranted. Investigators should ensure appropriate randomization of groups, taking into account severity of illness, comorbid conditions and prior use of steroid therapy. Standardizing the intervention (including dose and duration of steroid therapy and time to first antibiotic dose) would be essential. Concurrent measurement of inflammatory markers such as delta CRP would be useful too. Finally, accurate measurement of all secondary outcomes of interest, including adverse effects and duration of both invasive and noninvasive mechanical ventilation, would be important to accurately study the benefit of steroids among the most likely beneficiaries: those patients who are the sickest.

Acknowledgments

The authors gratefully acknowledge the assistance of Dr. Jon Ebbert (Department of Medicine, Mayo Clinic, Rochester, MN) with proofreading the manuscript and providing thoughtful editorial suggestions.

Disclosures

The authors report no conflicts of interest.

Community‐acquired pneumonia (CAP) is the most common lower respiratory tract infection in adults and a leading cause of infection‐related deaths in the United States.[1] According to a survey, pneumonia was the most common reason for hospital admissions through the emergency department in 2003.[2] CAP is associated with significant morbidity and mortality among those sick enough to require hospitalization. In a prospective study, hospital mortality rates ranged from 5% to 18% and length of stay from 9 to 23 days depending on patient location (intensive care unit [ICU] vs elsewhere) and severity of illness.[3]

Empirical evidence suggests that host inflammatory response contributes significantly to lung injury in pneumonia.[4] Studies have demonstrated reduction in the host inflammatory response as well as in mortality among animals with bacterial pneumonia when exposed to glucocorticoids.[5, 6] Furthermore, the efficacy of adjunctive steroid therapy in severe pneumonia caused by Pneumocystis jirovecii[7] and in pneumococcal meningitis[8, 9] is already established. However, due to equivocal, and at times conflicting, human clinical trial data on the impact of steroid therapy in CAP, the 2007 consensus guidelines (jointly published by the Infectious Diseases Society of America and American Thoracic Society) do not provide recommendations for or against use of steroids in CAP, except in the setting of hypotension secondary to adrenal insufficiency.[10]

In their meta‐analysis, Chen et al. analyzed data from 6 randomized clinical trials (RCTs) published between 1972 and 2007 (including 2 on pediatric patients) and concluded that adding steroids to current standard of care was not beneficial.[11] Earlier, Lamontagne et al.'s meta‐analysis included RCTs on hospitalized CAP patients as well as those on patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) from any cause.[12] They concluded that low‐dose corticosteroid therapy reduced all‐cause in‐hospital mortality in this mixed patient population (relative risk [RR]: 0.68 [95% confidence interval (CI): 0.49 to 0.96]). Recently, data from a number of additional RCTs have become available.[13, 14, 15, 16, 17] Therefore, an updated review of RCTs evaluating the role of adjunctive steroid therapy among adults hospitalized with CAP was warranted.

MATERIALS AND METHODS

We conducted this systematic review and meta‐analysis in accordance with the recommendations published in the Cochrane Handbook for Systematic Reviews of Interventions[18] and reported our findings according to the Preferred Reporting Items for Systematic Reviews and Meta‐analyses guidelines.[19] The overall quality of evidence was judged using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.[20]

Data Sources and Search Strategies

A comprehensive search of several databases including PubMed, Ovid MEDLINE In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus was conducted. The time range for search started from each database's earliest inclusive dates up to July 2011. An experienced institutional librarian assisted with the design and conduct of our literature search. Controlled vocabulary, supplemented with keywords, was used to search for the topic: steroid therapy for community‐acquired pneumonia. We consulted expert colleagues to ensure the inclusion of all eligible reports and also checked the bibliographies of previously published systematic reviews.[12, 21]

Eligibility Criteria

Studies deemed eligible for inclusion were RCTs that met the following patients, intervention, control, outcomes (PICO) criteria: P, adults hospitalized with CAP; I, administration of systemic corticosteroids plus standard treatment; C, standard treatment without corticosteroids; O, primary outcome: hospital mortality; secondary outcomes, length of hospital stay, length of ICU stay and duration of mechanical ventilation. Under the P criterion we included RCTs that defined CAP as a lung infection (based on a reasonable combination of history, physical examination, imaging, and/or other investigative data, such as per the American Thoracic Society definition)[22] of presumed or proven bacterial etiology, in a patient who was not immunocompromised and had no exposure to a healthcare facility in the past 90 days.

Study Selection and Quality Assessment

Two reviewers independently performed study selection, data extraction, and quality assessment. Data were abstracted using standardized data collection instruments. Kappa statistic was calculated to assess the reviewers' level of agreement.

We perused full texts of all articles whose abstracts met selection criteria, performing an appraisal of their quality using the Cochrane risk‐of‐bias tool.[23] We also reviewed the baseline characteristics of patients in each study cohort.

Analysis

We estimated RR and weighted mean differences along with the respective 95% confidence intervals by pooling data using a random effects model.[24] Study heterogeneity was assessed using the I2 statistic, which estimates the percentage of variation that is not attributable to chance.[25] We performed a priori subgroup analyses based on the location (ICU vs non‐ICU) and mean age group of study participants (based on a cutoff of 50 years). A significant (P < 0.05) test of interaction would provide an explanation for any heterogeneity.[26] We also performed an a priori sensitivity analysis excluding any studies published before the year 2000 to exclude the impact of changing standards of care for inpatient management of CAP over time.

The original investigators were not contacted for purposes of obtaining raw data.

RESULTS

Eight RCTs, comprising 1119 subjects, were eventually chosen.[14]. Seven shortlisted studies were excluded due to methodological limitations, failure to fully meet PICO criteria, or gross insufficiency of descriptive data on subjects or methodology.[18, 31, 32, 33, 34, 35, 36] Figure 1 illustrates the study selection process.

Figure 1
The study selection process.

Table 1 summarizes the baseline characteristics of patient populations from each study. Mean ages in 7 RCTs were between 60 years and 80 years. In Marik et al., the mean age of the intervention group was 31.7 years, whereas that of the control group was 40.6 years (P value not reported).[30] Three RCTs included ICU patients only,[17, 28, 30] whereas 4 only included general medical ward patients.[14, 15, 29, 31] Disease severity scores at admission were similar between the 2 groups in all RCTs except Sabry and Omar,[17] which was the only clinical trial to use a chest radiograph score. Only Sabry and Omar,[17] and Mikami et al.[29] excluded chronic obstructive pulmonary disease patients. Where possible, the serum C‐reactive protein (CRP) value on day one was subtracted from that on day eight to generate a one week delta CRP.

Baseline Characteristics of Studies Included for Analysis
Author, YearNumber of PatientsGender: Males (% Age)Age (y)Steroids Used (Daily Dose and Duration)COPD (% of Total)Diabetes (% of Total)Mean PaO2/FiO2 RatioSeverity Score (Score: Mean)Patients Already in ICU (% of Total)One‐week Delta CRP (mg/dL)
TotalSteroidControlSteroidControlSteroidControl SteroidControlSteroidControlSteroidControlSteroidControlSteroidControlSteroidControl
  • NOTE: Abbreviations: APACHE, Acute Physiology and Chronic Health Evaluation; COPD, chronic obstructive pulmonary disease; CRP, C‐reactive protein; ICU, intensive care unit; IV, intravenous; NA, not applicable; PO, orally; PSI = Pneumonia Severity Index; SAPS, Simplified Acute Physiology Score.
  • The difference between steroid and control groups was statistically significant (P<0.05)
McHardy 1972[31]126408645506259Prednisolone 20 mg, 7 d4035Not reportedNot reportedNot reported00N/AN/A
Marik 1993[30]301416Not reported3241Hydrocortisone 10 mg/kg 1Not reportedNot reported213214APACHE II100100N/AN/A
 1114 
Confalonieri 2005[28]46232374656067Hydrocortisone 200 mg bolus, then 10 mg/h, 7 dNot reportedNot reported141a178aAPACHE II10010037a+5a
 1718 
Mikami 2007[29]31151673.3757668Prednisolone 40 mg IV, 3 d00Not reportedPaO2 (FiO2 not reported)PSI00N/AN/A
 61649586 
Snijders 2010[16]21310410952.963.36364Prednisolone 40 mg IV/PO, 7 d18221011Not reportedPSI class V (% of total)14.46.4N/AN/A
 1316 
Fernandez‐Serrano 2011[15]45232269.663.66661Methylprednisone 200 mg IV; then 20 mg/6 h, 3 d; then 20 mg/12 h, 3 d; then 20 mg/d, 3 d179918200257SAPS classes IV + V (% of total)00N/AN/A
 6554 
Meijvis 2011[14]30415115357566563Dexamethasone 5 mg/d, 4 d1391514Not reportedPSI class V (% of total)00N/AN/A
 1714 
Sabry 2011[17]80404030286263Hydrocortisone 200 mg IV, then 12.5 mg/h, 7 d00Not reported338a243aChest radiograph score10010038a23a
 1a3a 

The mean ICU length of stay was 12.7 days for the steroid group and 12.3 days for the control group. The mean hospital lengths of stay were 10.2 days and 13.6 days, respectively. Quality of the studies was moderate (see Supporting Information, Appendix I, in the online version of this article). Kappa score was >0.90.

Meta‐analysis

Figure 2 illustrates the results of our meta‐analyses. Although adjunctive steroid therapy had no effect on hospital mortality or ICU length of stay, it was associated with reduced hospital length of stay (RR: 1.21 days [95% CI: 2.12 to 0.29]). Of note, Mikami et al.[29] did not report mortality in their article, whereas in McHardy and Schonell,[31] using the factorial design, each of the 2 treatment groups were further subdivided into those patients who received 1 g of ampicillin and those who received 2 g of ampicillin (Figure 2A).

Figure 2
(A) Meta‐analysis of the dichotomous outcomes. (B) Meta‐analysis of the continuous outcomes. Abbreviations: ARDS, acute respiratory distress syndrome; CI, confidence interval; CXR, chest radiograph; ICU, intensive care unit; RR, relative risk.

Analysis of other outcomes was limited by the fact that data were pooled from only a few studies. These included the need for and duration of mechanical ventilation, development of new ARDS and ICU admission rate, neither of which was associated with steroid therapy. However, steroid use was associated with lower incidence of delayed shock (ie, shock occurring after enrollment (RR: 0.12 [95% CI: 0.03 to 0.41]) and lower incidence of persistent chest x‐ray abnormalities at 1 week (RR: 0.13 [95% CI: 0.06 to 0.27]).

Subgroup and Sensitivity Analyses

Heterogeneity (I2 statistic) was <50% for all outcomes except ICU length of stay (74%). There were no significant interactions to suggest a subgroup effect based on older vs younger or ICU vs non‐ICU based patients (Table 2). In a priori sensitivity analysis that excluded McHardy and Schonell (published in 1972) and Marik et al. (published in 1993),[30] the results were not different from the main analysis.

Subgroup Analyses
 No. of StudiesEffect SizeLLULP for Interaction (Difference Between Subgroups)
  • NOTE: Abbreviations: ICU, intensive care unit; LOS, length of stay; LL, Lower Limit; UL, Upper Limit.
Mortality
ICU30.270.080.830.06
Non‐ICU40.960.452.05
Older70.750.401.380.56
Young10.380.043.26
Need for mechanical ventilation
ICU10.570.122.660.39
Non‐ICU10.140.012.51
Older10.140.012.510.39
Younger10.570.122.66
LOS
ICU18.0016.410.410.11
Non‐ICU31.141.970.31
ICU LOS
ICU23.9111.443.620.45
Non‐ICU20.818.9810.60
Older32.269.955.430.65
Younger10.303.913.31

Quality of Evidence

Using the GRADE framework, the overall quality of evidence (confidence in the estimates) was judged to be moderate with the following main limitations: 1) methodological limitations among included studies (prognostic imbalance), 2) imprecision (small number of events and wide confidence intervals), and 3) inconsistency in the outcome ICU length of stay (as reflected by the I2 statistic).

Other Reported Outcomes

Four studies[15, 16, 29, 31] provided descriptive details of microbiologic data, whereas 1 study[16] provided analytical data on microbiology. In the latter, patients with Streptococcus pneumoniae infection (identified variably by sputum, pleural fluid, urine, or blood samples), had lower clinical cure rates in the steroid group at day 30 (P = 0.01) and higher numbers of late failures (defined as recurrence of signs and symptoms of pneumonia, P = 0.02).

Three[28, 30, 31] studies did not provide data on glycemic trends, whereas Fernandez‐Serrano et al., Mikami et al., and Snijders et al. reported that rates of hyperglycemia were not different across the 2 groups.[15, 16, 29] Meijvis et al.[14] reported more frequent hyperglycemia in the steroid group (44% vs 23%, P < 0.001) but no difference in the need for glucose‐lowering treatment (5% vs 3%, P = 0.57). Sabry and Omar[17] reported a higher incidence of hyperglycemia in the steroid group (no numerical data reported). Snijders et al.,[16] Meijvis et al.,[14] and Sabry and Omar[17] reported that the rates of super‐infection were not different between the 2 groups. No other adverse effects were consistently reported.

DISCUSSION

In this meta‐analysis of 8 RCTs, we found no significant association between steroid therapy and our primary outcome of interest (hospital mortality). However, length of hospital stay was shorter in the steroid group. These findings were not altered in various sensitivity and subgroup analyses. Although adverse effects of steroid therapy were not consistently reported, most of the RCTs reported that hyperglycemia was either no more common in the steroid group or did not require additional treatment.

Previous meta‐analyses have also concluded that adding corticosteroids to conventional therapy does not impact mortality among adults hospitalized with CAP.[12, 22] This may or may not be a consequence of inadequate statistical power. Although Lamontagne et al.[13] reported that low‐dose corticosteroid therapy (2 mg/kg/day or less of methylprednisolone or equivalent) was associated with reduced hospital mortality (RR: 0.68 [95% CI: 0.49 to 0.96]), this result was obtained by pooling data from 5 RCTs on adults hospitalized with CAP and 4 on adults with ALI/ARDS from any cause. In a subgroup analysis of RCTs conducted only on CAP patients, no impact on mortality was found. Of note, all RCTs involving CAP patients had used low‐dose steroids; the 3 RCTs using high‐dose steroids were carried out on ALI/ARDS patients.[36, 37, 38] Similarly, all RCTs in our meta‐analysis were also characterized by steroid doses under 2 mg/kg/day of methylprednisolone or equivalent.

Our study is the first to demonstrate decreased length of hospital stay in this patient population. Importantly, each of the 5 studies that reported this outcome (including 3 relatively recent RCTs) showed the same trend. However, it is not inconceivable that steroid use led to a quicker decline in cytokine levels resulting in an earlier resolution of fever and hence earlier discharge without a faster cure per se. The two studies whose data permitted calculation of delta CRP also demonstrated a faster CRP decline in the steroid group (Table 1).

Our analysis also suggested reduced incidence of delayed shock. However, these data were pooled from only 2 RCTs,[17, 28] and each of them used hydrocortisone, whose direct mineralocorticoid effect is an obvious confounder. Similarly, according to data pooled from 2 RCTs, steroid use was associated with fewer cases of persistent chest x‐ray abnormalities by day 8. Of note, although calculation of the I2 statistic was not possible because of too few studies, visual inspection of the forest plots suggested low levels of heterogeneity.

It is plausible that the impact of adjunctive steroids in CAP may vary based on the causative pathogen. This pathogen‐specific association has been observed in patients with bacterial meningitis, where most of the benefit is seemingly limited to pneumococcal meningitis.[9, 10] Unfortunately, as demonstrated by Snijders et al.,[16] establishing microbiologic etiology in CAP can be difficult, and most patients are treated empirically.

Our analysis showed no difference in duration of ventilation among patients who required ventilatory support on admission. However, only 2 studies reported this outcome.[17, 28] Second, in Confalonieri et al.,[28] the steroid group had a more severe baseline inflammatory response as illustrated by higher serum CRP levels (P = 0.04). Moreover, while mechanical ventilation was defined as either invasive or noninvasive ventilation, the steroid group had a higher number of patients who required noninvasive ventilation (P = 0.03), thus introducing selection bias. This study had additional areas of concern too, including a mortality of 0 among its 46 ICU patients, in contrast to established mortality rates of up to around 20%.[4] Unlike this study, Sabry and Omar[17] reported that none of their patients was on noninvasive ventilation. It may be pertinent to compare our findings with those of Steinberg et al.,[40] who studied patients with ARDS (pneumonia being the most common cause) who received methylprednisolone. This group had an early increase in ventilator‐free days, but that effect became less pronounced (though still significant) when the study end point was prolonged from 30 to 90 days.[41]

The 2 studies that were published before 2000 (McHardy and Schonell,[31] and Marik et al.[30]) were excluded in our a priori sensitivity analysis. A number of considerations led to this decision. First, standards of care for inpatient management of pneumoniaincluding pharmacologic therapies and ventilation strategieshave changed considerably over time. For instance, newer generation macrolides became available for clinical use in the early 1990s and meropenem in 1996.[41] Therefore, it would be hard to assume constancy of effect from that time period. Furthermore, the study by McHardy and Schonell[31] suffered from significant differences in the baseline characteristics of its 2 arms. There was incomplete randomization; patients with diabetes were excluded from only the steroid arm. Another issue with Marik et al.[30] was the considerably younger age of participants compared to other studies (Table 1).

Limitations

In spite of our relatively stringent selection criteria and a number of subgroup and sensitivity analyses, the overall quality of evidence was only moderate (Table 2). Key issues with the findings reported by Confalonieri et al.,[28] McHardy and Schonell,[31] and Marik et al.[30] were discussed earlier. Baseline severity of illness, patient comorbidities, and length of follow‐up were variable both within and across various studies. Another major limitation was that the intervention of interest (ie, steroid therapy) was not uniformly applied as the regimens varied considerably even though all regimens fit the designation of low‐dose steroids as previously noted (Table 1).

In conclusion, although evidence suggests that adjunctive steroid therapy is associated with reduced hospital length of stay, the data are not strong enough to recommend routine use of steroids among all adults hospitalized with CAP. However, considering that there was no increase in mortality or hospital length of stay with steroid use, it is reasonable to continue steroids if warranted for treatment of underlying comorbid conditions.

Due to the aforementioned limitations in RCTs published to date, we believe that additional studies that are more robustly designed and sufficiently powered to detect differences in key outcomes (including mortality) are warranted. Investigators should ensure appropriate randomization of groups, taking into account severity of illness, comorbid conditions and prior use of steroid therapy. Standardizing the intervention (including dose and duration of steroid therapy and time to first antibiotic dose) would be essential. Concurrent measurement of inflammatory markers such as delta CRP would be useful too. Finally, accurate measurement of all secondary outcomes of interest, including adverse effects and duration of both invasive and noninvasive mechanical ventilation, would be important to accurately study the benefit of steroids among the most likely beneficiaries: those patients who are the sickest.

Acknowledgments

The authors gratefully acknowledge the assistance of Dr. Jon Ebbert (Department of Medicine, Mayo Clinic, Rochester, MN) with proofreading the manuscript and providing thoughtful editorial suggestions.

Disclosures

The authors report no conflicts of interest.

References
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  14. Fernandez‐Serrano S, Dorca J, Garcia‐Vidal C, et al. Effect of corticosteroids on the clinical course of community‐acquired pneumonia: a randomized controlled trial. Crit Care. 2011;15(2):R96.
  15. Snijders D, Daniels JM, Graaff CS, et al. Efficacy of corticosteroids in community‐acquired pneumonia: a randomized double‐blinded clinical trial. Am J Respir Crit Care Med. 2010;181:975978.
  16. Sabry NA, Omar E. Corticosteroids and ICU course of community acquired pneumonia in Egyptian settings. Pharmacol Pharm. 2011;2(2):7381.
  17. Nawab QU, Golden E, Confalonieri M, Umberger R, Meduri GU. Corticosteroid treatment in severe community‐acquired pneumonia: duration of treatment affects control of systemic inflammation and clinical improvement. Intensive Care Med. 2011;37(9):15531554.
  18. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. West Sussex, UK:Wiley‐Blackwell;2008.
  19. Moher D, Liberati A, Tetzlaff J, Altman DG;PRISMA Group. Preferred reporting items for systematic reviews and meta‐analyses: the PRISMA statement. J Clin Epidemiol. 2009;62:10061012.
  20. Balshem H, Helfand M, Schunemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401406.
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  23. Higgins JPT, Altman DG.Assessing risk of bias in included studies. In: Higgins JPT, Green S eds. Cochrane Handbook for Systematic Reviews of Interventions. Chichester, UK:John Wiley 2009.
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References
  1. Centers for Disease Control and Prevention 2008. CDC/NCHS, National Vital Statistics System. Leading causes of Death. Available at: http://www.cdc.gov/nchs/nvss/mortality_tables.htm. Accessed August 14,2011.
  2. Elixhauser A, Owens P. Reasons for being admitted to the hospital through the emergency department, 2003. HCUP Statistical Brief #2. February 2006. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.hcup‐us.ahrq.gov/reports/statbriefs/sb2.pdf. Accessed August 14,2011.
  3. Lee JS, Primack BA, Mor MK, et al. Processes of care and outcomes for community‐acquired pneumonia. Am J Med. 2011;124(12):1175.e917.
  4. Bergeron Y, Ouellet N, Deslauriers AM, Simard M, Olivier M, Bergeron MG. Cytokine kinetics and other host factors in response to pneumococcal pulmonary infection in mice. Infect Immun. 1998;66(3):912922.
  5. Sibila O, Luna CM, Agusti C, et al. Effects of glucocorticoids in ventilated piglets with severe pneumonia. Eur Respir J. 2008;32(4):10371046.
  6. Li Y, Cui X, Li X, et al. Risk of death does not alter the efficacy of hydrocortisone therapy in a mouse E. coli pneumonia model: risk and corticosteroids in sepsis. Intensive Care Med. 2008;34(3):568577.
  7. Briel M, Bucher HC, Boscacci R, Furrer H. Adjunctive corticosteroids for Pneumocystis jiroveci pneumonia in patients with HIV‐infection. Cochrane Database Syst Rev. 2006;(3):CD006150.
  8. gans J, de beek D. Dexamethasone in adults with bacterial meningitis. N Engl J Med. 2002;347(20):15491556.
  9. de beek D, gans J, Mcintyre P, Prasad K. Steroids in adults with acute bacterial meningitis: a systematic review. Lancet Infect Dis. 2004;4(3):139143.
  10. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community‐acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27S72.
  11. Chen Y, Li K, Pu H, Wu T. Corticosteroids for pneumonia. Cochrane Database Syst Rev. 2011;(3):CD007720.
  12. Lamontagne F, Briel M, Guyatt GH, Cook DJ, Bhatnagar N, Meade M. Corticosteroid therapy for acute lung injury, acute respiratory distress syndrome, and severe pneumonia: a meta‐analysis of randomized controlled trials. J Crit Care. 2010;25(3):420435.
  13. Meijvis SC, Hardeman H, Remmelts HH, et al. Dexamethasone and length of hospital stay in patients with community‐acquired pneumonia: a randomised, double‐blind, placebo‐controlled trial. Lancet. 2011;377(9782):20232030.
  14. Fernandez‐Serrano S, Dorca J, Garcia‐Vidal C, et al. Effect of corticosteroids on the clinical course of community‐acquired pneumonia: a randomized controlled trial. Crit Care. 2011;15(2):R96.
  15. Snijders D, Daniels JM, Graaff CS, et al. Efficacy of corticosteroids in community‐acquired pneumonia: a randomized double‐blinded clinical trial. Am J Respir Crit Care Med. 2010;181:975978.
  16. Sabry NA, Omar E. Corticosteroids and ICU course of community acquired pneumonia in Egyptian settings. Pharmacol Pharm. 2011;2(2):7381.
  17. Nawab QU, Golden E, Confalonieri M, Umberger R, Meduri GU. Corticosteroid treatment in severe community‐acquired pneumonia: duration of treatment affects control of systemic inflammation and clinical improvement. Intensive Care Med. 2011;37(9):15531554.
  18. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. West Sussex, UK:Wiley‐Blackwell;2008.
  19. Moher D, Liberati A, Tetzlaff J, Altman DG;PRISMA Group. Preferred reporting items for systematic reviews and meta‐analyses: the PRISMA statement. J Clin Epidemiol. 2009;62:10061012.
  20. Balshem H, Helfand M, Schunemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401406.
  21. Salluh JI, Povoa P, Soares M, Castro‐Faria‐Neto HC, Bozza FA, Bozza PT. The role of corticosteroids in severe community‐acquired pneumonia: a systematic review. Crit Care. 2008;12(3):R76.
  22. Ewig S, Ruiz M, Mensa J, et al. Severe community‐acquired pneumonia: assessment of severity criteria. Am J Respir Crit Care Med. 1998;158(4):11021108.
  23. Higgins JPT, Altman DG.Assessing risk of bias in included studies. In: Higgins JPT, Green S eds. Cochrane Handbook for Systematic Reviews of Interventions. Chichester, UK:John Wiley 2009.
  24. Dersimonian R, Laird N. Meta‐analysis in clinical trials. Control Clin Trials. 1986;7(3):177188.
  25. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ. 2003;327(7414):557560.
  26. Altman DG, Bland JM. Interaction revisited: the difference between two estimates. BMJ. 2003;326(7382):219.
  27. Confalonieri M, Urbino R, Potena A, et al. Hydrocortisone infusion for severe community‐acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med. 2005;171(3):242248.
  28. Mikami K, Suzuki M, Kitagawa H, Kawakami M, Hirota N, Yamaguchi H. Efficacy of corticosteroids in the treatment of community‐acquired pneumonia requiring hospitalisation. Lung. 2007;185(5):249255.
  29. Marik P, Kraus P, Sribante J, Havlik I, Lipman J, Johnson DW. Hydrocortisone and tumour necrosis factor in severe community acquired pneumonia. A randomised controlled study. Chest. 1993;104(2):389392.
  30. McHardy VU, Schonell ME. Ampicillin dosage and use of prednisolone in treatment of pneumonia: co‐operative controlled trial. Br Med J. 1972;4:569573.
  31. Salluh JI, Soares M, Coelho LM, et al. Impact of systemic corticosteroids on the clinical course and outcomes of patients with severe community‐acquired pneumonia: a cohort study. J Crit Care. 2011;26(2):193200.
  32. Hedlund JU, Ortqvist AB, Kalin ME, Granath F. Factors of importance for the long term prognosis after hospital treated pneumonia. Thorax. 1993;48(8):785789.
  33. Mortensen EM, Kapoor WN, Chang CC, Fine MJ. Assessment of mortality after long‐term follow‐up of patients with community‐acquired pneumonia. Clin Infect Dis. 2003;37(12):16171624.
  34. Woodhead M, Welch CA, Harrison DA, Bellingan G, Ayres JG. Community‐acquired pneumonia on the intensive care unit: secondary analysis of 17,869 cases in the ICNARC Case Mix Programme Database. Crit Care. 2006;10(suppl 2):S1.
  35. Garcia‐Vidal C, Calbo E, Pascual V, Ferrer C, Quintana S, Garau J. Effects of systemic steroids in patients with severe community‐acquired pneumonia. Eur Respir J. 2007;30(5):951956.
  36. Chon GR, Lim CM, Koh Y, Hong SB. Analysis of systemic corticosteroid usage and survival in patients requiring mechanical ventilation for severe community‐acquired pneumonia. J Infect Chemother. 2011;17(4):449455.
  37. Laggner AN, Lenz K, Base W, et al. Effect of high‐dose prednisolone on lung fluid in patients with non‐cardiogenic lung edema [in German]. Wien Klin Wochenschr. 1987;99:245249.
  38. Weigelt JA, Norcross JF, Borman KR, et al. Early steroid therapy for respiratory failure. Arch Surg. 1985;120:536540.
  39. Steinberg KP, Hudson LD, Goodman RB, et al. Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome. N Engl J Med. 2006;354(16):16711684.
  40. Bernard GR, Luce JM, Sprung CL, et al. High‐dose corticosteroids in patients with the adult respiratory distress syndrome. N Engl J Med. 1987;317:15651570.
  41. Khardori N. Antibiotics—past, present, and future. Med Clin North Am. 2006;90(6):10491076.
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Journal of Hospital Medicine - 8(2)
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Journal of Hospital Medicine - 8(2)
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Adjuvant steroid therapy in community‐acquired pneumonia: A systematic review and meta‐analysis
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Adjuvant steroid therapy in community‐acquired pneumonia: A systematic review and meta‐analysis
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Address for correspondence and reprint requests: Majid Shafiq, MD, Division of General Internal Medicine — Johns Hopkins Hospital, 600 N. Wolfe St, Nelson 215, Baltimore, MD 21287; Telephone: 443‐287‐3631; Fax: 410‐502‐0923; E-mail: [email protected]
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Moving Beyond Readmission Penalties

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Moving beyond readmission penalties: Creating an ideal process to improve transitional care

Containing the rise of healthcare costs has taken on a new sense of urgency in the wake of the recent economic recession and continued growth in the cost of healthcare. Accordingly, many stakeholders seek solutions to improve value (reducing costs while improving care)[1]; hospital readmissions, which are common and costly,[2] have emerged as a key target. The Centers for Medicare and Medicaid Services (CMS) have instituted several programs intended to reduce readmissions, including funding for community‐based, care‐transition programs; penalties for hospitals with elevated risk‐adjusted readmission rates for selected diagnoses; pioneer Accountable Care Organizations (ACOs) with incentives to reduce global costs of care; and Hospital Engagement Networks (HENs) through the Partnership for Patients.[3] A primary aim of these initiatives is to enhance the quality of care transitions as patients are discharged from the hospital.

Though the recent focus on hospital readmissions has appropriately drawn attention to transitions in care, some have expressed concerns. Among these are questions about: 1) the extent to which readmissions truly reflect the quality of hospital care[4]; 2) the preventability of readmissions[5]; 3) limitations in risk‐adjustment techniques[6]; and 4) best practices for preventing readmissions.[7] We believe these concerns stem in part from deficiencies in the state of the science of transitional care, and that future efforts in this area will be hindered without a clear vision of an ideal transition in care. We propose the key components of an ideal transition in care and discuss the implications of this concept as it pertains to hospital readmissions.

THE IDEAL TRANSITION IN CARE

We propose the key components of an ideal transition in care in Figure 1 and Table 1. Figure 1 represents 10 domains described more fully below as structural supports of the bridge patients must cross from one care environment to another during a care transition. This figure highlights key domains and suggests that lack of a domain makes the bridge weaker and more prone to gaps in care and poor outcomes. It also implies that the more components are missing, the less safe is the bridge or transition. Those domains that mainly take place prior to discharge are placed closer to the hospital side of the bridge, those that mainly take place after discharge are placed closer to the community side of the bridge, while those that take place both prior to and after discharge are in the middle. Table 1 provides descriptions of the key content for each of these domains, as well as guidance about which personnel might be involved and where in the transition process that domain should be implemented. We support these domains with supporting evidence where available.

Figure 1
Key components of an ideal transition in care; when rotated ninety degrees to the right the bridge patients must cross during a care transition is demonstrated.
Domains of an Ideal Transition in Care
Domain Who When References
  • NOTE: Clinician refers to ordering providers including physicians, physician assistants, and nurse practitioners.
  • Abbreviations: IT, information technology; PCP, primary care physician.
Discharge planning
Use a multidisciplinary team to create a discharge plan Discharging clinician Predischarge 911
Collaborate with PCP regarding discharge and follow‐up plan Care managers/discharge planners
Arrange follow‐up appointments prior to discharge Nurses
Make timely appointments for follow‐up care
Make appointments that take patient and caregiver's schedules and transportation needs into account
Complete communication of information
Includes: Discharging clinician Time of discharge 1214
Patient's full name
Age
Dates of admission and discharge
Names of responsible hospital physicians
Name of physician preparing discharge summary
Name of PCP
Main diagnosis
Other relevant diagnoses, procedures, and complications
Relevant findings at admission
Treatment and response for each active problem
Results of procedures and abnormal laboratory test results
Recommendations of any subspecialty consultants
Patient's functional status at discharge
Discharge medications
Follow‐up appointments made and those to be made
Tests to be ordered and pending tests to be followed‐up
Counseling provided to patient and caregiver, when applicable
Contingency planning
Code status
Availability, timeliness, clarity, and organization of information
Timely communication with postdischarge providers verbally (preferred) or by fax/e‐mail Discharging clinician Time of discharge 1214
Timely completion of discharge summary and reliable transmission to postdischarge providers
Availability of information in medical record
Use of a structured template with subheadings in discharge communication
Medication safety
Take an accurate preadmission medication history Clinicians Admission 1521
Reconcile preadmission medications with all ordered medications at all transfers in care, including discharge Pharmacists Throughout hospitalization
Communicate discharge medications to all outpatient providers, including all changes and rationale for those changes Nurses Time of discharge
Educating patients, promoting self‐management
Focus discharge counseling on major diagnoses, medication changes, dates of follow‐up appointments, self‐care instructions, warning signs and symptoms, and who to contact for problems Clinicians Daily 911, 2228, 30
Include caregivers as appropriate Nurses Time of discharge
Ensure staff members provide consistent messages Care managers/discharge planners Postdischarge
Provide simply written patient‐centered materials with instructions Transition coaches
Use teach‐back methods to confirm understanding
Encourage questions
Continue teaching during postdischarge follow‐up
Use transition coaches in high‐risk patients: focus on medication management, keeping a personal medical record, follow‐up appointments, and knowledge of red flags
Enlisting help of social and community supports
Assess needs and appropriately arrange for home services Clinicians Predischarge and postdischarge 29, 30
Enlist help of caregivers Nurses
Enlist help of community supports Care managers
Home health staff
Advanced care planning
Establish healthcare proxy Clinicians Predischarge and postdischarge 31, 32
Discuss goals of care Palliative care staff
Palliative care consultation (if appropriate) Social workers
Enlist hospice services (if appropriate) Nurses
Hospice workers
Coordinating care among team members
Share medical records Clinicians Predischarge and postdischarge 33
Communicate involving all team members Nurses
Optimize continuity of providers and formal handoffs of care Office personnel
IT staff
Monitoring and managing symptoms after discharge
Monitor for: Clinicians Postdischarge 1113, 28, 3436
Worsening disease control Nurses
Medication side effects, discrepancies, nonadherence Pharmacists
Therapeutic drug monitoring Care managers
Inability to manage conditions at home Visiting nurses and other home health staff
Via:
Postdischarge phone calls
Home visits
Postdischarge clinic visits
Patient hotline
Availability of inpatient providers after discharge
Follow‐up with outpatient providers
Within an appropriate time frame (eg, 7 d or sooner for high‐risk patients) Clinicians Postdischarge 3740
With appropriate providers (eg, most related to reasons for hospitalization, who manage least stable conditions, and/or PCP) Nurses Pharmacists
Utilize multidisciplinary teams as appropriate Care managers
Ensure appropriate progress along plan of care and safe transition Office personnel
Other clinical staff as appropriate

Our concept of an ideal transition in care began with work by Naylor, who described several important components of a safe transition in care, including complete communication of information, patient education, enlisting the help of social and community supports, ensuring continuity of care, and coordinating care among team members.[8] It is supplemented by the Transitions of Care Consensus Policy Statement proposed by representatives from hospital medicine, primary care, and emergency medicine, which emphasized aspects of timeliness and content of communication between providers.[9] Our present articulation of these key components includes 10 organizing domains.

The Discharge Planning domain highlights the important principle of planning ahead for hospital discharge while the patient is still being treated in the hospital, a paradigm espoused by Project RED[10] and other successful care transitions interventions.[11, 12] Collaborating with the outpatient provider and taking the patient and caregiver's preferences for appointment scheduling into account can help ensure optimal outpatient follow‐up.

Complete Communication of Information refers to the content that should be included in discharge summaries and other means of information transfer from hospital to postdischarge care. The specific content areas are based on the Society of Hospital Medicine and Society of General Internal Medicine Continuity of Care Task Force systematic review and recommendations,[13] which takes into account information requested by primary care physicians after discharge.

Availability, Timeliness, Clarity, and Organization of that information is as important as the content because postdischarge providers must be able to access and quickly understand the information they have been provided before assuming care of the patient.[14, 15]

The Medication Safety domain is of central importance because medications are responsible for most postdischarge adverse events.[16] Taking an accurate medication history,[17] reconciling changes throughout the hospitalization,[18] and communicating the reconciled medication regimen to patients and providers across transitions of care can reduce medication errors and improve patient safety.[19, 20, 21, 22]

The Patient Education and Promotion of Self‐Management domain involves teaching patients and their caregivers about the main hospital diagnoses and instructions for self‐care, including medication changes, appointments, and whom to contact if issues arise. Confirming comprehension of instructions through assessments of acute (delirium) and chronic (dementia) cognitive impairments[23, 24, 25, 26] and teach‐back from the patient (or caregiver) is an important aspect of such counseling, as is providing patients and caregivers with educational materials that are appropriate for their level of health literacy and preferred language.[14] High‐risk patients may benefit from patient coaching to improve their self‐management skills.[12] These recommendations are based on years of health literacy research,[27, 28, 29] and such elements are generally included in effective interventions (including Project RED,[10] Naylor and colleagues' Transitional Care Model,[11] and Coleman and colleagues' Care Transitions Intervention[12]).

Enlisting the help of Social and Community Supports is an important adjunct to medical care and is the rationale for the recent increase in CMS funding for community‐based, care‐transition programs. These programs are crucial for assisting patients with household activities, meals, and other necessities during the period of recovery, though they should be distinguished from care management or care coordination interventions, which have not been found to be helpful in preventing readmissions unless high touch in nature.[30, 31]

The Advanced Care Planning domain may begin in the hospital or outpatient setting, and involves establishing goals of care and healthcare proxies, as well as engaging with palliative care or hospice services if appropriate. Emerging evidence supports the intuitive conclusion that this approach prevents readmissions, particularly in patients who do not benefit from hospital readmission.[32, 33]

Attention to the Coordinating Care Among Team Members domain is needed to synchronize efforts across settings and providers. Clearly, many healthcare professionals as well as other involved parties can be involved in helping a single patient during transitions in care. It is vital that they coordinate information, assessments, and plans as a team.[34]

We recognize the domain of Monitoring and Managing Symptoms After Discharge as increasingly crucial as reflected in our growing understanding of the reasons for readmission, especially among patients with fragile conditions such as heart failure, chronic lung disease, gastrointestinal disorders, dementia,[23, 24, 25, 26] and vascular disease.[35] Monitoring for new or worsening symptoms; medication side effects, discrepancies, or nonadherence; and other self‐management challenges will allow problems to be detected and addressed early, before they result in unplanned healthcare utilization. It is noteworthy that successful interventions in this regard rely on in‐home evaluation[13, 14, 29] by nurses rather than telemonitoring, which in isolation has not been effective to date.[36, 37]

Finally, optimal Outpatient Follow‐Up with appropriate postdischarge providers is crucial for providing ideal transitions. These appointments need to be prompt[38, 39] (eg, within 7 days if not sooner for high‐risk patients) and with providers who have a longitudinal relationship to the patient, as prior work has shown increased readmissions when the provider is unfamiliar with the patient.[40] The advantages and disadvantages of hospitalist‐run postdischarge clinics as one way to increase access and expedite follow‐up are currently being explored. Although the optimal content of a postdischarge visit has not been defined, logical tasks to be completed are myriad and imply the need for checklists, adequate time, and a multidisciplinary team of providers.[41]

IMPLICATIONS OF THE IDEAL TRANSITION IN CARE

Our conceptualization of an ideal transition in care provides insight for hospital and healthcare system leadership, policymakers, researchers, clinicians, and educators seeking to improve transitions of care and reduce hospital readmissions. In the sections below, we briefly review commonly cited concerns about the recent focus on readmissions as a quality measure, illustrate how the Ideal Transition in Care addresses these concerns, and propose fruitful areas for future work.

How Does the Framework Address the Extent to Which Readmissions Reflect Hospital Quality?

One of the chief problems with readmissionrates as a hospital quality measure is that many of the factors that influence readmission may not currently be under the hospital's control. The healthcare environment to which a patient is being discharged (and was admitted from in the first place) is an important determinant of readmission.[42] In this context, it is noteworthy that successful interventions to reduce readmission are generally those that focus on outpatient follow‐up, while inpatient‐only interventions have had less success.[7] This is reflected in our framework above, informed by the literature, highlighting the importance of coordination between inpatient and outpatient providers and the importance of postdischarge care, including monitoring and managing symptoms after discharge, prompt follow‐up appointments, the continuation of patient self‐management activities, monitoring for drug‐related problems after discharge, and the effective utilization of community supports. Accountable care organizations, once established, would be responsible for several components of this environment, including the provision of prompt and effective follow‐up care.

The implication of the framework is that if a hospital does not have control over most of the factors that influence its readmission rate, it should see financial incentives to reduce readmission rates as an opportunity to invest in relationships with the outpatient environment from which their patients are admitted and to which they are discharged. One can envision hospitals growing ever‐closer relationships with their network of primary care physician groups, community agencies, and home health services, rehabilitation facilities, and nursing homes through coordinated discharge planning, medication management, patient education, shared electronic medical records, structured handoffs in care, and systems of intensive outpatient monitoring. Our proposed framework, in other words, emphasizes that hospitals cannot reduce their readmission rates by focusing on aspects of care within their walls. They must forge new and stronger relationships with their communities if they are to be successful.

How Does the Framework Help Us Understand Which Readmissions Are Preventable?

Public reporting and financial penalties are currently tied to all‐cause readmission, but preventable readmissions are a more appealing outcome to target. In one study, the ranking of hospitals by all‐cause readmission rate had very little correlation with the ranking by preventable readmission rate.[5] However, researchers have struggled to establish standardized, valid, and reliable measures for determining what proportion of readmissions are in fact preventable, with estimates ranging from 5% to 79% in the published literature.[43]

The difficulty of accurately determining preventability stems from an inadequate understanding of the roles that patient comorbidities, transitional processes of care, individual patient behaviors, and social and environmental determinants of health play in the complex process of hospital recidivism. Our proposed elements of an ideal transition in care provide a structure to frame this discussion and suggest future research opportunities to allow a more accurate and reliable understanding of the spectrum of preventability. Care system leadership can use the framework to rigorously evaluate their readmissions and determine the extent to which the transitions process approached the ideal. For example, if a readmission occurs despite care processes that addressed most of the domains with high fidelity, it becomes much less likely that the readmission was preventable. It should be noted that the converse is not always true: When a transition falls well short of the ideal, it does not always imply that provision of a more ideal transition would necessarily have prevented the readmission, but it does make it more likely.

For educators, the framework may provide insights for trainees into the complexity of the transitions process and vulnerability of patients during this time, highlighting preventable aspects of readmissions that are within the grasp of the discharging clinician or team. It highlights the importance of medication reconciliation, synchronous communication, and predischarge teaching, which are measurable and teachable skills for non‐physician providers, housestaff, and medical students. It also may allow for more structured feedback, for example, on the quality of discharge summaries produced by trainees.

How Could the Framework Improve Risk Adjustment for Between‐Hospital Comparisons?

Under the Patient Protection and Affordable Care Act (PPACA), hospitals will be compared to one another using risk‐standardized readmission rates as a way to penalize poorly performing hospitals. However, risk‐adjustment models have only modest ability to predict hospital readmission.[6] Moreover, current approaches predominantly adjust for patients' medical comorbidities (which are easily measurable), but they do not adequately take into account the growing literature on other factors that influence readmission rates, including a patient's health literacy, visual or cognitive impairment, functional status, language barriers, and community‐level factors such as social supports.[44, 45]

The Ideal Transition of Care provides a comprehensive framework of hospital discharge quality that provides additional process measures on which hospitals could be compared rather than focusing solely on (inadequately) risk‐adjusted readmission rates. Indeed, most other quality and safety measures (such as the National Quality Forum's Safe Practices[46] and The Joint Commission's National Patient Safety Goals),[47] emphasize process over outcome, in part because of issues of fairness. Process measures are less subject to differences in patient populations and also change the focus from simply reducing readmissions to improving transitional care more broadly. These process measures should be based on our framework and should attempt to capture as many dimensions of an optimal care transition as possible.

Possible examples of process measures include: the accuracy of medication reconciliation at admission and discharge; provision of prompt outpatient follow‐up; provision of adequate systems to monitor and manage symptoms after discharge; advanced care planning in appropriate patients; and the quality of discharge education, incorporating measurements of the patient's understanding and ability to self‐manage their illness. At least some of these could be used now as part of a performance measurement set that highlights opportunities for immediate system change and can serve as performance milestones.

The framework could also be used to validate risk‐adjustment techniques. After accounting for patient factors, the remaining variability in outcomes should be accounted for by processes of care that are in the transitions framework. Once these processes are accurately measured, one can determine if indeed the remaining variability is due to transitions processes, or rather unaccounted factors that are not being measured and that hospitals may have little control over. Such work can lead to iterative refinement of patient risk‐adjustment models.

What Does the Framework Imply About Best Practices for Reducing Readmission Rates?

Despite the limitations of readmission rates as a quality measure noted above, hospitals presently face potentially large financial penalties for readmissions and are allocating resources to readmission reduction efforts. However, hospitals currently may not have enough guidance to know what actions to take to reduce readmissions, and thus could be spending money inefficiently and reducing the value proposition of focusing on readmissions.

A recent systematic review of interventions hospitals could employ to reduce readmissions identified several positive studies, but also many negative studies, and there were significant barriers to understanding what works to reduce readmissions.[7] For example, most of the interventions described in both positive and negative studies were multifaceted, and the authors were unable to identify which components of the intervention were most effective. Also, while several studies have identified risk factors for readmission,[6, 48, 49] very few studies have identified which subgroups of patients benefit most from specific interventions. Few of the studies described key contextual factors that may have led to successful or failed implementation, or the fidelity with which the intervention was implemented.[50, 51, 52]

Few if any of the studies were guided by a concept of the ideal transition in care.[10] Such a framework will better guide development of multifaceted interventions and provide an improved means for interpreting the results. Clearly, rigorously conducted, multicenter studies of readmission prevention interventions are needed to move the field forward. These studies should: 1) correlate implementation of specific intervention components with reductions in readmission rates to better understand the most effective components; 2) be adequately powered to show effect modification, ie, which patients benefit most from these interventions; and 3) rigorously measure environmental context and intervention fidelity, and employ mixed methods to better understand predictors of implementation success and failure.

Our framework can be used in the design and evaluation of such interventions. For example, interventions could be designed that incorporate as many of the domains of an ideal transition as possible, in particular those that span the inpatient and outpatient settings. Processes of care metrics can be developed that measure the extent to which each domain is delivered, analogous to the way the Joint Commission might aggregate individual scores on the 10 items in Acute Myocardial Infarction Core Measure Set[53] to provide a composite of the quality of care provided to patients with this diagnosis. These can be used to correlate certain intervention components with success in reducing readmissions and also in measuring intervention fidelity.

NEXT STEPS

For hospital and healthcare system leaders, who need to take action now to avoid financial penalties, we recommend starting with proven, high‐touch interventions such as Project RED and the Care Transitions Intervention, which are durable, cost‐effective, robustly address multiple domains of the Ideal Transition in Care, and have been implemented at numerous sites.[54, 55] Each hospital or group will need to decide on a bundle of interventions and customize them based on local workflow, resources, and culture.

Risk‐stratification, to match the intensity of the intervention to the risk of readmission of the patient, will undoubtedly be a key component for the efficient use of resources. We anticipate future research will allow risk stratification to be a robust part of any implementation plan. However, as noted above, current risk prediction models are imperfect,[6] and more work is needed to determine which patients benefit most from which interventions. Few if any studies have described interventions tailored to risk for this reason.

Based on our ideal transition in care, our collective experience, and published evidence,[7, 10, 11, 12] potential elements to start with include: early discharge planning; medication reconciliation[56]; patient/caregiver education using health literacy principles, cognitive assessments, and teach‐back to confirm understanding; synchronous communication (eg, by phone) between inpatient and postdischarge providers; follow‐up phone calls to patients within 72 hours of discharge; 24/7 availability of a responsible inpatient provider to address questions and problems (both from the patient/caregiver and from postdischarge providers); and prompt appointments for patients discharged home. High‐risk patients will likely require additional interventions, including in‐home assessments, disease‐monitoring programs, and/or patient coaching. Lastly, patients with certain conditions prone to readmission (such as heart failure and chronic obstructive pulmonary disease) may benefit from disease‐specific programs, including patient education, outpatient disease management, and monitoring protocols.

It is likely that the most effective interventions are those that come from combined, coordinated interventions shared between inpatient and outpatient settings, and are intensive in nature. We expect that the more domains in the framework that are addressed, the safer and more seamless transitions in care will be, with improvement in patient outcomes. To the extent that fragmentation of care has been a barrier to the implementation of these types of interventions in the past, ACOs, perhaps with imbedded Patient‐Centered Medical Homes, may be in the best position to take advantage of newly aligned financial incentives to design comprehensive transitional care. Indeed, we anticipate that Figure 1 may provide substrate for a discussion of postdischarge care and division of responsibilities between inpatient and outpatient care teams at the time of transition, so effort is not duplicated and multiple domains are addressed.

Other barriers to implementation of ideal transitions in care will continue to be an issue for most healthcare systems. Financial constraints that have been a barrier up until now will be partially overcome by penalties for high readmission rates and by ACOs, bundled payments, and alternative care contracts (ie, global payments), but the extent to which each institution feels rewarded for investing in transitional interventions will vary greatly. Healthcare leadership that sees the value of improving transitions in care will be critical to overcoming this barrier. Competing demands (such as lowering hospital length of stay and carrying out other patient care responsibilities),[57] lack of coordination and diffusion of responsibility among various clinical personnel, and lack of standards are other barriers[58] that will require clear prioritization from leadership, policy changes, team‐based care, provider education and feedback, and adequate allocation of personnel resources. In short, process redesign using continuous quality improvement efforts and effective tools will be required to maximize the possibility of success.

CONCLUSIONS

Readmissions are costly and undesirable. Intuition suggests they are a marker of poor care and that hospitals should be capable of reducing them, thereby improving care and decreasing costs. In a potential future world of ACOs based on global payments, financial incentives would be aligned for each system to reduce readmissions below their current baseline, therefore obviating the need for external financial rewards and penalties. In the meantime, financial penalties do exist, and controversy exists over their fairness and likelihood of driving appropriate behavior. To address these controversies and promote better transitional care, we call for the development and use of multifaceted, collaborative transitions interventions that span settings, risk‐adjustment models that allow for fairer comparisons among hospitals, better and more widespread measurement of processes of transitional care, a better understanding of what interventions are most effective and in whom, and better guidance in how to implement these interventions. Our conceptualization of an ideal transition of care serves as a guide and provides a common vocabulary for these efforts. Such research is likely to produce the knowledge needed for healthcare systems to improve transitions in care, reduce readmissions, and reduce costs.

Disclosure

Funding for Dr Vasilevskis has been provided by the National Institutes of Health (K23AG040157) and the VA Tennessee Valley Geriatric Research, Education and Clinical Center (GRECC). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Aging, the National Institutes of Health, or the US Department of Veterans Affairs.

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  20. Mueller SK, Sponsler KC, Kripalani S, Schnipper JL. Hospital‐based medication reconciliation practices: a systematic review. Arch Intern Med. 2012;172(14):10571069.
  21. Schnipper JL, Hamann C, Ndumele CD, et al. Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster‐randomized trial. Arch Intern Med. 2009;169(8):771780.
  22. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166(5):565571.
  23. Xu H, Covinsky KE, Stallard E, Thomas J, Sands LP. Insufficient help for activity of daily living disabilities and risk of all–cause hospitalization. J Am Geriatr Soc. 2012;60(5):927933.
  24. Callahan CM, Arling G, Tu W, et al. Transitions in care for older adults with and without dementia. J Am Geriatr Soc. 2012;60(5):813820.
  25. Phelan EA, Borson S, Grothaus L, Balch S, Larson EB. Association of incident dementia with hospitalizations. JAMA. 2012;307(2):165172.
  26. Walsh EG, Wiener JM, Haber S, et al. Potentially avoidable hospitalizations of dually eligible Medicare and Medicaid beneficiaries from nursing facility and home– and community–based services waiver programs. J Am Geriatr Soc. 2012;60(5):821829.
  27. Kripalani S, Weiss BD. Teaching about health literacy and clear communication. J Gen Intern Med. 2006;21(8):888890.
  28. Peterson PN, Shetterly SM, Clarke CL, et al. Health literacy and outcomes among patients with heart failure. JAMA. 2011;305(16):16951701.
  29. Cain CH, Neuwirth E, Bellows J, Zuber C, Green J. Patient experiences of transitioning from hospital to home: an ethnographic quality improvement project. J Hosp Med. 2012;7(5):382387.
  30. Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009;301(6):603618.
  31. Peikes D, Peterson G, Brown RS, Graff S, Lynch JP. How changes in Washington University's Medicare coordinated care demonstration pilot ultimately achieved savings. Health Aff (Millwood). 2012;31(6):12161226.
  32. Pace A, Lorenzo C, Capon A, et al. Quality of care and rehospitalization rate in the last stage of disease in brain tumor patients assisted at home: a cost effectiveness study. J Palliat Med. 2012;15(2):225227.
  33. Nelson C, Chand P, Sortais J, Oloimooja J, Rembert G. Inpatient palliative care consults and the probability of hospital readmission. Perm J. 2011;15(2):4851.
  34. King HB, Battles J, Baker DP, et al. TeamSTEPPS™: team strategies and tools to enhance performance and patient safety. In: Henriksen K, Battles JB, Keyes MA, Grady ML, ed. Advances in Patient Safety: New Directions and Alternative Approaches. Vol 3: Performance and Tools. Rockville, MD:Agency for Healthcare Research and Quality; August2008.
  35. Feigenbaum P, Neuwirth E, Trowbridge L, et al. Factors contributing to all‐cause 30‐day readmissions: a structured case series across 18 hospitals. Med Care. 2012;50(7):599605.
  36. Chaudhry SI, Mattera JA, Curtis JP, et al. Telemonitoring in patients with heart failure [erratum, N Engl J Med. 2011;364(5):490]. N Engl J Med. 2010;363(24):23012309.
  37. Takahashi PY, Pecina JL, Upatising B, et al. A randomized controlled trial of telemonitoring in older adults with multiple health issues to prevent hospitalizations and emergency department visits. Arch Intern Med. 2012;172(10):773779.
  38. Hernandez AF, Greiner MA, Fonarow GC, et al. Relationship between early physician follow‐up and 30‐day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA. 2010;303(17):17161722.
  39. Misky GJ, Wald HL, Coleman EA. Post‐hospitalization transitions: examining the effects of timing of primary care provider follow‐up. J Hosp Med. 2010;5(7):392397.
  40. Weinberger M, Oddone EZ, Henderson WG. Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission. N Engl J Med. 1996;334(22):14411447.
  41. Coleman EA. The Post‐Hospital Follow‐Up Visit: A Physician Checklist to Reduce Readmissions. California Healthcare Foundation; October 2010. Available at: http://www.chcf.org/publications/2010/10/the‐post‐hospital‐follow‐up‐visit‐a‐physician‐checklist. Accessed on January 10, 2012.
  42. Joynt KE, Orav EJ, Jha AK. Thirty‐day readmission rates for Medicare beneficiaries by race and site of care. JAMA. 2011;305(7):675681.
  43. Walraven C, Bennett C, Jennings A, Austin PC, Forster AJ. Proportion of hospital readmissions deemed avoidable: a systematic review. Can Med Assoc J. 2011;183(7):E391E402.
  44. Arbaje AI, Wolff JL, Yu Q, et al. Postdischarge environmental and socioeconomic factors and the likelihood of early hospital readmission among community‐dwelling Medicare beneficiaries. Gerontologist. 2008;48(4):495504.
  45. Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97107.
  46. National Quality Forum. Safe Practices for Better Healthcare—2010 Update: A Consensus Report. Washington, DC;2010.
  47. Joint Commission on Accreditation of Healthcare Organizations. Accreditation Program: Hospital 2010 National Patient Safety Goals (NPSGs). 2010. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/. Accessed on March 20, 2012.
  48. Hasan O, Meltzer DO, Shaykevich SA, et al. Hospital readmission in general medicine patients: a prediction model. J Gen Intern Med. 2010;25(3):211219.
  49. Walraven C, Dhalla IA, Bell C, et al. Derivation and validation of an index to predict early death or unplanned readmission after discharge from hospital to the community. Can Med Assoc J. 2010;182(6):551557.
  50. Brown C, Lilford R. Evaluating service delivery interventions to enhance patient safety. BMJ. 2008;337:a2764.
  51. Shekelle PG, Pronovost PJ, Wachter RM. Assessing the Evidence for Context‐Sensitive Effectiveness and Safety of Patient Safety Practices: Developing Criteria. Rockville, MD:Agency for Healthcare Research and Quality; December2010.
  52. Shekelle PG, Pronovost PJ, Wachter RM, et al. Advancing the science of patient safety. Ann Intern Med. 2011;154(10):693696.
  53. The Joint Commission. Acute Myocardial Infarction Core Measure Set. Available at: http://www.jointcommission.org/assets/1/6/Acute%20Myocardial%20Infarction.pdf. Accessed August 20,2012.
  54. Voss R, Gardner R, Baier R, Butterfield K, Lehrman S, Gravenstein S. The care transitions intervention: translating from efficacy to effectiveness. Arch Intern Med. 2011;171(14):12321237.
  55. Project RED toolkit, AHRQ Innovations Exchange. Available at:http://www.innovations.ahrq.gov/content.aspx?id=2180. Accessed on July 2, 2012.
  56. Gillespie U, Alassaad A, Henrohn D, et al. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009;169(9):894900.
  57. Joynt KE, Jha AK. Thirty‐day readmissions—truth and consequences. N Engl J Med. 2012;366(15):13661369.
  58. Greysen SR, Schiliro D, Horwitz LI, Curry L, Bradley EH. “Out of sight, out of mind”: housestaff perceptions of quality‐limiting factors in discharge care at teaching hospitals. J Hosp Med. 2012;7(5):376381.
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Containing the rise of healthcare costs has taken on a new sense of urgency in the wake of the recent economic recession and continued growth in the cost of healthcare. Accordingly, many stakeholders seek solutions to improve value (reducing costs while improving care)[1]; hospital readmissions, which are common and costly,[2] have emerged as a key target. The Centers for Medicare and Medicaid Services (CMS) have instituted several programs intended to reduce readmissions, including funding for community‐based, care‐transition programs; penalties for hospitals with elevated risk‐adjusted readmission rates for selected diagnoses; pioneer Accountable Care Organizations (ACOs) with incentives to reduce global costs of care; and Hospital Engagement Networks (HENs) through the Partnership for Patients.[3] A primary aim of these initiatives is to enhance the quality of care transitions as patients are discharged from the hospital.

Though the recent focus on hospital readmissions has appropriately drawn attention to transitions in care, some have expressed concerns. Among these are questions about: 1) the extent to which readmissions truly reflect the quality of hospital care[4]; 2) the preventability of readmissions[5]; 3) limitations in risk‐adjustment techniques[6]; and 4) best practices for preventing readmissions.[7] We believe these concerns stem in part from deficiencies in the state of the science of transitional care, and that future efforts in this area will be hindered without a clear vision of an ideal transition in care. We propose the key components of an ideal transition in care and discuss the implications of this concept as it pertains to hospital readmissions.

THE IDEAL TRANSITION IN CARE

We propose the key components of an ideal transition in care in Figure 1 and Table 1. Figure 1 represents 10 domains described more fully below as structural supports of the bridge patients must cross from one care environment to another during a care transition. This figure highlights key domains and suggests that lack of a domain makes the bridge weaker and more prone to gaps in care and poor outcomes. It also implies that the more components are missing, the less safe is the bridge or transition. Those domains that mainly take place prior to discharge are placed closer to the hospital side of the bridge, those that mainly take place after discharge are placed closer to the community side of the bridge, while those that take place both prior to and after discharge are in the middle. Table 1 provides descriptions of the key content for each of these domains, as well as guidance about which personnel might be involved and where in the transition process that domain should be implemented. We support these domains with supporting evidence where available.

Figure 1
Key components of an ideal transition in care; when rotated ninety degrees to the right the bridge patients must cross during a care transition is demonstrated.
Domains of an Ideal Transition in Care
Domain Who When References
  • NOTE: Clinician refers to ordering providers including physicians, physician assistants, and nurse practitioners.
  • Abbreviations: IT, information technology; PCP, primary care physician.
Discharge planning
Use a multidisciplinary team to create a discharge plan Discharging clinician Predischarge 911
Collaborate with PCP regarding discharge and follow‐up plan Care managers/discharge planners
Arrange follow‐up appointments prior to discharge Nurses
Make timely appointments for follow‐up care
Make appointments that take patient and caregiver's schedules and transportation needs into account
Complete communication of information
Includes: Discharging clinician Time of discharge 1214
Patient's full name
Age
Dates of admission and discharge
Names of responsible hospital physicians
Name of physician preparing discharge summary
Name of PCP
Main diagnosis
Other relevant diagnoses, procedures, and complications
Relevant findings at admission
Treatment and response for each active problem
Results of procedures and abnormal laboratory test results
Recommendations of any subspecialty consultants
Patient's functional status at discharge
Discharge medications
Follow‐up appointments made and those to be made
Tests to be ordered and pending tests to be followed‐up
Counseling provided to patient and caregiver, when applicable
Contingency planning
Code status
Availability, timeliness, clarity, and organization of information
Timely communication with postdischarge providers verbally (preferred) or by fax/e‐mail Discharging clinician Time of discharge 1214
Timely completion of discharge summary and reliable transmission to postdischarge providers
Availability of information in medical record
Use of a structured template with subheadings in discharge communication
Medication safety
Take an accurate preadmission medication history Clinicians Admission 1521
Reconcile preadmission medications with all ordered medications at all transfers in care, including discharge Pharmacists Throughout hospitalization
Communicate discharge medications to all outpatient providers, including all changes and rationale for those changes Nurses Time of discharge
Educating patients, promoting self‐management
Focus discharge counseling on major diagnoses, medication changes, dates of follow‐up appointments, self‐care instructions, warning signs and symptoms, and who to contact for problems Clinicians Daily 911, 2228, 30
Include caregivers as appropriate Nurses Time of discharge
Ensure staff members provide consistent messages Care managers/discharge planners Postdischarge
Provide simply written patient‐centered materials with instructions Transition coaches
Use teach‐back methods to confirm understanding
Encourage questions
Continue teaching during postdischarge follow‐up
Use transition coaches in high‐risk patients: focus on medication management, keeping a personal medical record, follow‐up appointments, and knowledge of red flags
Enlisting help of social and community supports
Assess needs and appropriately arrange for home services Clinicians Predischarge and postdischarge 29, 30
Enlist help of caregivers Nurses
Enlist help of community supports Care managers
Home health staff
Advanced care planning
Establish healthcare proxy Clinicians Predischarge and postdischarge 31, 32
Discuss goals of care Palliative care staff
Palliative care consultation (if appropriate) Social workers
Enlist hospice services (if appropriate) Nurses
Hospice workers
Coordinating care among team members
Share medical records Clinicians Predischarge and postdischarge 33
Communicate involving all team members Nurses
Optimize continuity of providers and formal handoffs of care Office personnel
IT staff
Monitoring and managing symptoms after discharge
Monitor for: Clinicians Postdischarge 1113, 28, 3436
Worsening disease control Nurses
Medication side effects, discrepancies, nonadherence Pharmacists
Therapeutic drug monitoring Care managers
Inability to manage conditions at home Visiting nurses and other home health staff
Via:
Postdischarge phone calls
Home visits
Postdischarge clinic visits
Patient hotline
Availability of inpatient providers after discharge
Follow‐up with outpatient providers
Within an appropriate time frame (eg, 7 d or sooner for high‐risk patients) Clinicians Postdischarge 3740
With appropriate providers (eg, most related to reasons for hospitalization, who manage least stable conditions, and/or PCP) Nurses Pharmacists
Utilize multidisciplinary teams as appropriate Care managers
Ensure appropriate progress along plan of care and safe transition Office personnel
Other clinical staff as appropriate

Our concept of an ideal transition in care began with work by Naylor, who described several important components of a safe transition in care, including complete communication of information, patient education, enlisting the help of social and community supports, ensuring continuity of care, and coordinating care among team members.[8] It is supplemented by the Transitions of Care Consensus Policy Statement proposed by representatives from hospital medicine, primary care, and emergency medicine, which emphasized aspects of timeliness and content of communication between providers.[9] Our present articulation of these key components includes 10 organizing domains.

The Discharge Planning domain highlights the important principle of planning ahead for hospital discharge while the patient is still being treated in the hospital, a paradigm espoused by Project RED[10] and other successful care transitions interventions.[11, 12] Collaborating with the outpatient provider and taking the patient and caregiver's preferences for appointment scheduling into account can help ensure optimal outpatient follow‐up.

Complete Communication of Information refers to the content that should be included in discharge summaries and other means of information transfer from hospital to postdischarge care. The specific content areas are based on the Society of Hospital Medicine and Society of General Internal Medicine Continuity of Care Task Force systematic review and recommendations,[13] which takes into account information requested by primary care physicians after discharge.

Availability, Timeliness, Clarity, and Organization of that information is as important as the content because postdischarge providers must be able to access and quickly understand the information they have been provided before assuming care of the patient.[14, 15]

The Medication Safety domain is of central importance because medications are responsible for most postdischarge adverse events.[16] Taking an accurate medication history,[17] reconciling changes throughout the hospitalization,[18] and communicating the reconciled medication regimen to patients and providers across transitions of care can reduce medication errors and improve patient safety.[19, 20, 21, 22]

The Patient Education and Promotion of Self‐Management domain involves teaching patients and their caregivers about the main hospital diagnoses and instructions for self‐care, including medication changes, appointments, and whom to contact if issues arise. Confirming comprehension of instructions through assessments of acute (delirium) and chronic (dementia) cognitive impairments[23, 24, 25, 26] and teach‐back from the patient (or caregiver) is an important aspect of such counseling, as is providing patients and caregivers with educational materials that are appropriate for their level of health literacy and preferred language.[14] High‐risk patients may benefit from patient coaching to improve their self‐management skills.[12] These recommendations are based on years of health literacy research,[27, 28, 29] and such elements are generally included in effective interventions (including Project RED,[10] Naylor and colleagues' Transitional Care Model,[11] and Coleman and colleagues' Care Transitions Intervention[12]).

Enlisting the help of Social and Community Supports is an important adjunct to medical care and is the rationale for the recent increase in CMS funding for community‐based, care‐transition programs. These programs are crucial for assisting patients with household activities, meals, and other necessities during the period of recovery, though they should be distinguished from care management or care coordination interventions, which have not been found to be helpful in preventing readmissions unless high touch in nature.[30, 31]

The Advanced Care Planning domain may begin in the hospital or outpatient setting, and involves establishing goals of care and healthcare proxies, as well as engaging with palliative care or hospice services if appropriate. Emerging evidence supports the intuitive conclusion that this approach prevents readmissions, particularly in patients who do not benefit from hospital readmission.[32, 33]

Attention to the Coordinating Care Among Team Members domain is needed to synchronize efforts across settings and providers. Clearly, many healthcare professionals as well as other involved parties can be involved in helping a single patient during transitions in care. It is vital that they coordinate information, assessments, and plans as a team.[34]

We recognize the domain of Monitoring and Managing Symptoms After Discharge as increasingly crucial as reflected in our growing understanding of the reasons for readmission, especially among patients with fragile conditions such as heart failure, chronic lung disease, gastrointestinal disorders, dementia,[23, 24, 25, 26] and vascular disease.[35] Monitoring for new or worsening symptoms; medication side effects, discrepancies, or nonadherence; and other self‐management challenges will allow problems to be detected and addressed early, before they result in unplanned healthcare utilization. It is noteworthy that successful interventions in this regard rely on in‐home evaluation[13, 14, 29] by nurses rather than telemonitoring, which in isolation has not been effective to date.[36, 37]

Finally, optimal Outpatient Follow‐Up with appropriate postdischarge providers is crucial for providing ideal transitions. These appointments need to be prompt[38, 39] (eg, within 7 days if not sooner for high‐risk patients) and with providers who have a longitudinal relationship to the patient, as prior work has shown increased readmissions when the provider is unfamiliar with the patient.[40] The advantages and disadvantages of hospitalist‐run postdischarge clinics as one way to increase access and expedite follow‐up are currently being explored. Although the optimal content of a postdischarge visit has not been defined, logical tasks to be completed are myriad and imply the need for checklists, adequate time, and a multidisciplinary team of providers.[41]

IMPLICATIONS OF THE IDEAL TRANSITION IN CARE

Our conceptualization of an ideal transition in care provides insight for hospital and healthcare system leadership, policymakers, researchers, clinicians, and educators seeking to improve transitions of care and reduce hospital readmissions. In the sections below, we briefly review commonly cited concerns about the recent focus on readmissions as a quality measure, illustrate how the Ideal Transition in Care addresses these concerns, and propose fruitful areas for future work.

How Does the Framework Address the Extent to Which Readmissions Reflect Hospital Quality?

One of the chief problems with readmissionrates as a hospital quality measure is that many of the factors that influence readmission may not currently be under the hospital's control. The healthcare environment to which a patient is being discharged (and was admitted from in the first place) is an important determinant of readmission.[42] In this context, it is noteworthy that successful interventions to reduce readmission are generally those that focus on outpatient follow‐up, while inpatient‐only interventions have had less success.[7] This is reflected in our framework above, informed by the literature, highlighting the importance of coordination between inpatient and outpatient providers and the importance of postdischarge care, including monitoring and managing symptoms after discharge, prompt follow‐up appointments, the continuation of patient self‐management activities, monitoring for drug‐related problems after discharge, and the effective utilization of community supports. Accountable care organizations, once established, would be responsible for several components of this environment, including the provision of prompt and effective follow‐up care.

The implication of the framework is that if a hospital does not have control over most of the factors that influence its readmission rate, it should see financial incentives to reduce readmission rates as an opportunity to invest in relationships with the outpatient environment from which their patients are admitted and to which they are discharged. One can envision hospitals growing ever‐closer relationships with their network of primary care physician groups, community agencies, and home health services, rehabilitation facilities, and nursing homes through coordinated discharge planning, medication management, patient education, shared electronic medical records, structured handoffs in care, and systems of intensive outpatient monitoring. Our proposed framework, in other words, emphasizes that hospitals cannot reduce their readmission rates by focusing on aspects of care within their walls. They must forge new and stronger relationships with their communities if they are to be successful.

How Does the Framework Help Us Understand Which Readmissions Are Preventable?

Public reporting and financial penalties are currently tied to all‐cause readmission, but preventable readmissions are a more appealing outcome to target. In one study, the ranking of hospitals by all‐cause readmission rate had very little correlation with the ranking by preventable readmission rate.[5] However, researchers have struggled to establish standardized, valid, and reliable measures for determining what proportion of readmissions are in fact preventable, with estimates ranging from 5% to 79% in the published literature.[43]

The difficulty of accurately determining preventability stems from an inadequate understanding of the roles that patient comorbidities, transitional processes of care, individual patient behaviors, and social and environmental determinants of health play in the complex process of hospital recidivism. Our proposed elements of an ideal transition in care provide a structure to frame this discussion and suggest future research opportunities to allow a more accurate and reliable understanding of the spectrum of preventability. Care system leadership can use the framework to rigorously evaluate their readmissions and determine the extent to which the transitions process approached the ideal. For example, if a readmission occurs despite care processes that addressed most of the domains with high fidelity, it becomes much less likely that the readmission was preventable. It should be noted that the converse is not always true: When a transition falls well short of the ideal, it does not always imply that provision of a more ideal transition would necessarily have prevented the readmission, but it does make it more likely.

For educators, the framework may provide insights for trainees into the complexity of the transitions process and vulnerability of patients during this time, highlighting preventable aspects of readmissions that are within the grasp of the discharging clinician or team. It highlights the importance of medication reconciliation, synchronous communication, and predischarge teaching, which are measurable and teachable skills for non‐physician providers, housestaff, and medical students. It also may allow for more structured feedback, for example, on the quality of discharge summaries produced by trainees.

How Could the Framework Improve Risk Adjustment for Between‐Hospital Comparisons?

Under the Patient Protection and Affordable Care Act (PPACA), hospitals will be compared to one another using risk‐standardized readmission rates as a way to penalize poorly performing hospitals. However, risk‐adjustment models have only modest ability to predict hospital readmission.[6] Moreover, current approaches predominantly adjust for patients' medical comorbidities (which are easily measurable), but they do not adequately take into account the growing literature on other factors that influence readmission rates, including a patient's health literacy, visual or cognitive impairment, functional status, language barriers, and community‐level factors such as social supports.[44, 45]

The Ideal Transition of Care provides a comprehensive framework of hospital discharge quality that provides additional process measures on which hospitals could be compared rather than focusing solely on (inadequately) risk‐adjusted readmission rates. Indeed, most other quality and safety measures (such as the National Quality Forum's Safe Practices[46] and The Joint Commission's National Patient Safety Goals),[47] emphasize process over outcome, in part because of issues of fairness. Process measures are less subject to differences in patient populations and also change the focus from simply reducing readmissions to improving transitional care more broadly. These process measures should be based on our framework and should attempt to capture as many dimensions of an optimal care transition as possible.

Possible examples of process measures include: the accuracy of medication reconciliation at admission and discharge; provision of prompt outpatient follow‐up; provision of adequate systems to monitor and manage symptoms after discharge; advanced care planning in appropriate patients; and the quality of discharge education, incorporating measurements of the patient's understanding and ability to self‐manage their illness. At least some of these could be used now as part of a performance measurement set that highlights opportunities for immediate system change and can serve as performance milestones.

The framework could also be used to validate risk‐adjustment techniques. After accounting for patient factors, the remaining variability in outcomes should be accounted for by processes of care that are in the transitions framework. Once these processes are accurately measured, one can determine if indeed the remaining variability is due to transitions processes, or rather unaccounted factors that are not being measured and that hospitals may have little control over. Such work can lead to iterative refinement of patient risk‐adjustment models.

What Does the Framework Imply About Best Practices for Reducing Readmission Rates?

Despite the limitations of readmission rates as a quality measure noted above, hospitals presently face potentially large financial penalties for readmissions and are allocating resources to readmission reduction efforts. However, hospitals currently may not have enough guidance to know what actions to take to reduce readmissions, and thus could be spending money inefficiently and reducing the value proposition of focusing on readmissions.

A recent systematic review of interventions hospitals could employ to reduce readmissions identified several positive studies, but also many negative studies, and there were significant barriers to understanding what works to reduce readmissions.[7] For example, most of the interventions described in both positive and negative studies were multifaceted, and the authors were unable to identify which components of the intervention were most effective. Also, while several studies have identified risk factors for readmission,[6, 48, 49] very few studies have identified which subgroups of patients benefit most from specific interventions. Few of the studies described key contextual factors that may have led to successful or failed implementation, or the fidelity with which the intervention was implemented.[50, 51, 52]

Few if any of the studies were guided by a concept of the ideal transition in care.[10] Such a framework will better guide development of multifaceted interventions and provide an improved means for interpreting the results. Clearly, rigorously conducted, multicenter studies of readmission prevention interventions are needed to move the field forward. These studies should: 1) correlate implementation of specific intervention components with reductions in readmission rates to better understand the most effective components; 2) be adequately powered to show effect modification, ie, which patients benefit most from these interventions; and 3) rigorously measure environmental context and intervention fidelity, and employ mixed methods to better understand predictors of implementation success and failure.

Our framework can be used in the design and evaluation of such interventions. For example, interventions could be designed that incorporate as many of the domains of an ideal transition as possible, in particular those that span the inpatient and outpatient settings. Processes of care metrics can be developed that measure the extent to which each domain is delivered, analogous to the way the Joint Commission might aggregate individual scores on the 10 items in Acute Myocardial Infarction Core Measure Set[53] to provide a composite of the quality of care provided to patients with this diagnosis. These can be used to correlate certain intervention components with success in reducing readmissions and also in measuring intervention fidelity.

NEXT STEPS

For hospital and healthcare system leaders, who need to take action now to avoid financial penalties, we recommend starting with proven, high‐touch interventions such as Project RED and the Care Transitions Intervention, which are durable, cost‐effective, robustly address multiple domains of the Ideal Transition in Care, and have been implemented at numerous sites.[54, 55] Each hospital or group will need to decide on a bundle of interventions and customize them based on local workflow, resources, and culture.

Risk‐stratification, to match the intensity of the intervention to the risk of readmission of the patient, will undoubtedly be a key component for the efficient use of resources. We anticipate future research will allow risk stratification to be a robust part of any implementation plan. However, as noted above, current risk prediction models are imperfect,[6] and more work is needed to determine which patients benefit most from which interventions. Few if any studies have described interventions tailored to risk for this reason.

Based on our ideal transition in care, our collective experience, and published evidence,[7, 10, 11, 12] potential elements to start with include: early discharge planning; medication reconciliation[56]; patient/caregiver education using health literacy principles, cognitive assessments, and teach‐back to confirm understanding; synchronous communication (eg, by phone) between inpatient and postdischarge providers; follow‐up phone calls to patients within 72 hours of discharge; 24/7 availability of a responsible inpatient provider to address questions and problems (both from the patient/caregiver and from postdischarge providers); and prompt appointments for patients discharged home. High‐risk patients will likely require additional interventions, including in‐home assessments, disease‐monitoring programs, and/or patient coaching. Lastly, patients with certain conditions prone to readmission (such as heart failure and chronic obstructive pulmonary disease) may benefit from disease‐specific programs, including patient education, outpatient disease management, and monitoring protocols.

It is likely that the most effective interventions are those that come from combined, coordinated interventions shared between inpatient and outpatient settings, and are intensive in nature. We expect that the more domains in the framework that are addressed, the safer and more seamless transitions in care will be, with improvement in patient outcomes. To the extent that fragmentation of care has been a barrier to the implementation of these types of interventions in the past, ACOs, perhaps with imbedded Patient‐Centered Medical Homes, may be in the best position to take advantage of newly aligned financial incentives to design comprehensive transitional care. Indeed, we anticipate that Figure 1 may provide substrate for a discussion of postdischarge care and division of responsibilities between inpatient and outpatient care teams at the time of transition, so effort is not duplicated and multiple domains are addressed.

Other barriers to implementation of ideal transitions in care will continue to be an issue for most healthcare systems. Financial constraints that have been a barrier up until now will be partially overcome by penalties for high readmission rates and by ACOs, bundled payments, and alternative care contracts (ie, global payments), but the extent to which each institution feels rewarded for investing in transitional interventions will vary greatly. Healthcare leadership that sees the value of improving transitions in care will be critical to overcoming this barrier. Competing demands (such as lowering hospital length of stay and carrying out other patient care responsibilities),[57] lack of coordination and diffusion of responsibility among various clinical personnel, and lack of standards are other barriers[58] that will require clear prioritization from leadership, policy changes, team‐based care, provider education and feedback, and adequate allocation of personnel resources. In short, process redesign using continuous quality improvement efforts and effective tools will be required to maximize the possibility of success.

CONCLUSIONS

Readmissions are costly and undesirable. Intuition suggests they are a marker of poor care and that hospitals should be capable of reducing them, thereby improving care and decreasing costs. In a potential future world of ACOs based on global payments, financial incentives would be aligned for each system to reduce readmissions below their current baseline, therefore obviating the need for external financial rewards and penalties. In the meantime, financial penalties do exist, and controversy exists over their fairness and likelihood of driving appropriate behavior. To address these controversies and promote better transitional care, we call for the development and use of multifaceted, collaborative transitions interventions that span settings, risk‐adjustment models that allow for fairer comparisons among hospitals, better and more widespread measurement of processes of transitional care, a better understanding of what interventions are most effective and in whom, and better guidance in how to implement these interventions. Our conceptualization of an ideal transition of care serves as a guide and provides a common vocabulary for these efforts. Such research is likely to produce the knowledge needed for healthcare systems to improve transitions in care, reduce readmissions, and reduce costs.

Disclosure

Funding for Dr Vasilevskis has been provided by the National Institutes of Health (K23AG040157) and the VA Tennessee Valley Geriatric Research, Education and Clinical Center (GRECC). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Aging, the National Institutes of Health, or the US Department of Veterans Affairs.

Containing the rise of healthcare costs has taken on a new sense of urgency in the wake of the recent economic recession and continued growth in the cost of healthcare. Accordingly, many stakeholders seek solutions to improve value (reducing costs while improving care)[1]; hospital readmissions, which are common and costly,[2] have emerged as a key target. The Centers for Medicare and Medicaid Services (CMS) have instituted several programs intended to reduce readmissions, including funding for community‐based, care‐transition programs; penalties for hospitals with elevated risk‐adjusted readmission rates for selected diagnoses; pioneer Accountable Care Organizations (ACOs) with incentives to reduce global costs of care; and Hospital Engagement Networks (HENs) through the Partnership for Patients.[3] A primary aim of these initiatives is to enhance the quality of care transitions as patients are discharged from the hospital.

Though the recent focus on hospital readmissions has appropriately drawn attention to transitions in care, some have expressed concerns. Among these are questions about: 1) the extent to which readmissions truly reflect the quality of hospital care[4]; 2) the preventability of readmissions[5]; 3) limitations in risk‐adjustment techniques[6]; and 4) best practices for preventing readmissions.[7] We believe these concerns stem in part from deficiencies in the state of the science of transitional care, and that future efforts in this area will be hindered without a clear vision of an ideal transition in care. We propose the key components of an ideal transition in care and discuss the implications of this concept as it pertains to hospital readmissions.

THE IDEAL TRANSITION IN CARE

We propose the key components of an ideal transition in care in Figure 1 and Table 1. Figure 1 represents 10 domains described more fully below as structural supports of the bridge patients must cross from one care environment to another during a care transition. This figure highlights key domains and suggests that lack of a domain makes the bridge weaker and more prone to gaps in care and poor outcomes. It also implies that the more components are missing, the less safe is the bridge or transition. Those domains that mainly take place prior to discharge are placed closer to the hospital side of the bridge, those that mainly take place after discharge are placed closer to the community side of the bridge, while those that take place both prior to and after discharge are in the middle. Table 1 provides descriptions of the key content for each of these domains, as well as guidance about which personnel might be involved and where in the transition process that domain should be implemented. We support these domains with supporting evidence where available.

Figure 1
Key components of an ideal transition in care; when rotated ninety degrees to the right the bridge patients must cross during a care transition is demonstrated.
Domains of an Ideal Transition in Care
Domain Who When References
  • NOTE: Clinician refers to ordering providers including physicians, physician assistants, and nurse practitioners.
  • Abbreviations: IT, information technology; PCP, primary care physician.
Discharge planning
Use a multidisciplinary team to create a discharge plan Discharging clinician Predischarge 911
Collaborate with PCP regarding discharge and follow‐up plan Care managers/discharge planners
Arrange follow‐up appointments prior to discharge Nurses
Make timely appointments for follow‐up care
Make appointments that take patient and caregiver's schedules and transportation needs into account
Complete communication of information
Includes: Discharging clinician Time of discharge 1214
Patient's full name
Age
Dates of admission and discharge
Names of responsible hospital physicians
Name of physician preparing discharge summary
Name of PCP
Main diagnosis
Other relevant diagnoses, procedures, and complications
Relevant findings at admission
Treatment and response for each active problem
Results of procedures and abnormal laboratory test results
Recommendations of any subspecialty consultants
Patient's functional status at discharge
Discharge medications
Follow‐up appointments made and those to be made
Tests to be ordered and pending tests to be followed‐up
Counseling provided to patient and caregiver, when applicable
Contingency planning
Code status
Availability, timeliness, clarity, and organization of information
Timely communication with postdischarge providers verbally (preferred) or by fax/e‐mail Discharging clinician Time of discharge 1214
Timely completion of discharge summary and reliable transmission to postdischarge providers
Availability of information in medical record
Use of a structured template with subheadings in discharge communication
Medication safety
Take an accurate preadmission medication history Clinicians Admission 1521
Reconcile preadmission medications with all ordered medications at all transfers in care, including discharge Pharmacists Throughout hospitalization
Communicate discharge medications to all outpatient providers, including all changes and rationale for those changes Nurses Time of discharge
Educating patients, promoting self‐management
Focus discharge counseling on major diagnoses, medication changes, dates of follow‐up appointments, self‐care instructions, warning signs and symptoms, and who to contact for problems Clinicians Daily 911, 2228, 30
Include caregivers as appropriate Nurses Time of discharge
Ensure staff members provide consistent messages Care managers/discharge planners Postdischarge
Provide simply written patient‐centered materials with instructions Transition coaches
Use teach‐back methods to confirm understanding
Encourage questions
Continue teaching during postdischarge follow‐up
Use transition coaches in high‐risk patients: focus on medication management, keeping a personal medical record, follow‐up appointments, and knowledge of red flags
Enlisting help of social and community supports
Assess needs and appropriately arrange for home services Clinicians Predischarge and postdischarge 29, 30
Enlist help of caregivers Nurses
Enlist help of community supports Care managers
Home health staff
Advanced care planning
Establish healthcare proxy Clinicians Predischarge and postdischarge 31, 32
Discuss goals of care Palliative care staff
Palliative care consultation (if appropriate) Social workers
Enlist hospice services (if appropriate) Nurses
Hospice workers
Coordinating care among team members
Share medical records Clinicians Predischarge and postdischarge 33
Communicate involving all team members Nurses
Optimize continuity of providers and formal handoffs of care Office personnel
IT staff
Monitoring and managing symptoms after discharge
Monitor for: Clinicians Postdischarge 1113, 28, 3436
Worsening disease control Nurses
Medication side effects, discrepancies, nonadherence Pharmacists
Therapeutic drug monitoring Care managers
Inability to manage conditions at home Visiting nurses and other home health staff
Via:
Postdischarge phone calls
Home visits
Postdischarge clinic visits
Patient hotline
Availability of inpatient providers after discharge
Follow‐up with outpatient providers
Within an appropriate time frame (eg, 7 d or sooner for high‐risk patients) Clinicians Postdischarge 3740
With appropriate providers (eg, most related to reasons for hospitalization, who manage least stable conditions, and/or PCP) Nurses Pharmacists
Utilize multidisciplinary teams as appropriate Care managers
Ensure appropriate progress along plan of care and safe transition Office personnel
Other clinical staff as appropriate

Our concept of an ideal transition in care began with work by Naylor, who described several important components of a safe transition in care, including complete communication of information, patient education, enlisting the help of social and community supports, ensuring continuity of care, and coordinating care among team members.[8] It is supplemented by the Transitions of Care Consensus Policy Statement proposed by representatives from hospital medicine, primary care, and emergency medicine, which emphasized aspects of timeliness and content of communication between providers.[9] Our present articulation of these key components includes 10 organizing domains.

The Discharge Planning domain highlights the important principle of planning ahead for hospital discharge while the patient is still being treated in the hospital, a paradigm espoused by Project RED[10] and other successful care transitions interventions.[11, 12] Collaborating with the outpatient provider and taking the patient and caregiver's preferences for appointment scheduling into account can help ensure optimal outpatient follow‐up.

Complete Communication of Information refers to the content that should be included in discharge summaries and other means of information transfer from hospital to postdischarge care. The specific content areas are based on the Society of Hospital Medicine and Society of General Internal Medicine Continuity of Care Task Force systematic review and recommendations,[13] which takes into account information requested by primary care physicians after discharge.

Availability, Timeliness, Clarity, and Organization of that information is as important as the content because postdischarge providers must be able to access and quickly understand the information they have been provided before assuming care of the patient.[14, 15]

The Medication Safety domain is of central importance because medications are responsible for most postdischarge adverse events.[16] Taking an accurate medication history,[17] reconciling changes throughout the hospitalization,[18] and communicating the reconciled medication regimen to patients and providers across transitions of care can reduce medication errors and improve patient safety.[19, 20, 21, 22]

The Patient Education and Promotion of Self‐Management domain involves teaching patients and their caregivers about the main hospital diagnoses and instructions for self‐care, including medication changes, appointments, and whom to contact if issues arise. Confirming comprehension of instructions through assessments of acute (delirium) and chronic (dementia) cognitive impairments[23, 24, 25, 26] and teach‐back from the patient (or caregiver) is an important aspect of such counseling, as is providing patients and caregivers with educational materials that are appropriate for their level of health literacy and preferred language.[14] High‐risk patients may benefit from patient coaching to improve their self‐management skills.[12] These recommendations are based on years of health literacy research,[27, 28, 29] and such elements are generally included in effective interventions (including Project RED,[10] Naylor and colleagues' Transitional Care Model,[11] and Coleman and colleagues' Care Transitions Intervention[12]).

Enlisting the help of Social and Community Supports is an important adjunct to medical care and is the rationale for the recent increase in CMS funding for community‐based, care‐transition programs. These programs are crucial for assisting patients with household activities, meals, and other necessities during the period of recovery, though they should be distinguished from care management or care coordination interventions, which have not been found to be helpful in preventing readmissions unless high touch in nature.[30, 31]

The Advanced Care Planning domain may begin in the hospital or outpatient setting, and involves establishing goals of care and healthcare proxies, as well as engaging with palliative care or hospice services if appropriate. Emerging evidence supports the intuitive conclusion that this approach prevents readmissions, particularly in patients who do not benefit from hospital readmission.[32, 33]

Attention to the Coordinating Care Among Team Members domain is needed to synchronize efforts across settings and providers. Clearly, many healthcare professionals as well as other involved parties can be involved in helping a single patient during transitions in care. It is vital that they coordinate information, assessments, and plans as a team.[34]

We recognize the domain of Monitoring and Managing Symptoms After Discharge as increasingly crucial as reflected in our growing understanding of the reasons for readmission, especially among patients with fragile conditions such as heart failure, chronic lung disease, gastrointestinal disorders, dementia,[23, 24, 25, 26] and vascular disease.[35] Monitoring for new or worsening symptoms; medication side effects, discrepancies, or nonadherence; and other self‐management challenges will allow problems to be detected and addressed early, before they result in unplanned healthcare utilization. It is noteworthy that successful interventions in this regard rely on in‐home evaluation[13, 14, 29] by nurses rather than telemonitoring, which in isolation has not been effective to date.[36, 37]

Finally, optimal Outpatient Follow‐Up with appropriate postdischarge providers is crucial for providing ideal transitions. These appointments need to be prompt[38, 39] (eg, within 7 days if not sooner for high‐risk patients) and with providers who have a longitudinal relationship to the patient, as prior work has shown increased readmissions when the provider is unfamiliar with the patient.[40] The advantages and disadvantages of hospitalist‐run postdischarge clinics as one way to increase access and expedite follow‐up are currently being explored. Although the optimal content of a postdischarge visit has not been defined, logical tasks to be completed are myriad and imply the need for checklists, adequate time, and a multidisciplinary team of providers.[41]

IMPLICATIONS OF THE IDEAL TRANSITION IN CARE

Our conceptualization of an ideal transition in care provides insight for hospital and healthcare system leadership, policymakers, researchers, clinicians, and educators seeking to improve transitions of care and reduce hospital readmissions. In the sections below, we briefly review commonly cited concerns about the recent focus on readmissions as a quality measure, illustrate how the Ideal Transition in Care addresses these concerns, and propose fruitful areas for future work.

How Does the Framework Address the Extent to Which Readmissions Reflect Hospital Quality?

One of the chief problems with readmissionrates as a hospital quality measure is that many of the factors that influence readmission may not currently be under the hospital's control. The healthcare environment to which a patient is being discharged (and was admitted from in the first place) is an important determinant of readmission.[42] In this context, it is noteworthy that successful interventions to reduce readmission are generally those that focus on outpatient follow‐up, while inpatient‐only interventions have had less success.[7] This is reflected in our framework above, informed by the literature, highlighting the importance of coordination between inpatient and outpatient providers and the importance of postdischarge care, including monitoring and managing symptoms after discharge, prompt follow‐up appointments, the continuation of patient self‐management activities, monitoring for drug‐related problems after discharge, and the effective utilization of community supports. Accountable care organizations, once established, would be responsible for several components of this environment, including the provision of prompt and effective follow‐up care.

The implication of the framework is that if a hospital does not have control over most of the factors that influence its readmission rate, it should see financial incentives to reduce readmission rates as an opportunity to invest in relationships with the outpatient environment from which their patients are admitted and to which they are discharged. One can envision hospitals growing ever‐closer relationships with their network of primary care physician groups, community agencies, and home health services, rehabilitation facilities, and nursing homes through coordinated discharge planning, medication management, patient education, shared electronic medical records, structured handoffs in care, and systems of intensive outpatient monitoring. Our proposed framework, in other words, emphasizes that hospitals cannot reduce their readmission rates by focusing on aspects of care within their walls. They must forge new and stronger relationships with their communities if they are to be successful.

How Does the Framework Help Us Understand Which Readmissions Are Preventable?

Public reporting and financial penalties are currently tied to all‐cause readmission, but preventable readmissions are a more appealing outcome to target. In one study, the ranking of hospitals by all‐cause readmission rate had very little correlation with the ranking by preventable readmission rate.[5] However, researchers have struggled to establish standardized, valid, and reliable measures for determining what proportion of readmissions are in fact preventable, with estimates ranging from 5% to 79% in the published literature.[43]

The difficulty of accurately determining preventability stems from an inadequate understanding of the roles that patient comorbidities, transitional processes of care, individual patient behaviors, and social and environmental determinants of health play in the complex process of hospital recidivism. Our proposed elements of an ideal transition in care provide a structure to frame this discussion and suggest future research opportunities to allow a more accurate and reliable understanding of the spectrum of preventability. Care system leadership can use the framework to rigorously evaluate their readmissions and determine the extent to which the transitions process approached the ideal. For example, if a readmission occurs despite care processes that addressed most of the domains with high fidelity, it becomes much less likely that the readmission was preventable. It should be noted that the converse is not always true: When a transition falls well short of the ideal, it does not always imply that provision of a more ideal transition would necessarily have prevented the readmission, but it does make it more likely.

For educators, the framework may provide insights for trainees into the complexity of the transitions process and vulnerability of patients during this time, highlighting preventable aspects of readmissions that are within the grasp of the discharging clinician or team. It highlights the importance of medication reconciliation, synchronous communication, and predischarge teaching, which are measurable and teachable skills for non‐physician providers, housestaff, and medical students. It also may allow for more structured feedback, for example, on the quality of discharge summaries produced by trainees.

How Could the Framework Improve Risk Adjustment for Between‐Hospital Comparisons?

Under the Patient Protection and Affordable Care Act (PPACA), hospitals will be compared to one another using risk‐standardized readmission rates as a way to penalize poorly performing hospitals. However, risk‐adjustment models have only modest ability to predict hospital readmission.[6] Moreover, current approaches predominantly adjust for patients' medical comorbidities (which are easily measurable), but they do not adequately take into account the growing literature on other factors that influence readmission rates, including a patient's health literacy, visual or cognitive impairment, functional status, language barriers, and community‐level factors such as social supports.[44, 45]

The Ideal Transition of Care provides a comprehensive framework of hospital discharge quality that provides additional process measures on which hospitals could be compared rather than focusing solely on (inadequately) risk‐adjusted readmission rates. Indeed, most other quality and safety measures (such as the National Quality Forum's Safe Practices[46] and The Joint Commission's National Patient Safety Goals),[47] emphasize process over outcome, in part because of issues of fairness. Process measures are less subject to differences in patient populations and also change the focus from simply reducing readmissions to improving transitional care more broadly. These process measures should be based on our framework and should attempt to capture as many dimensions of an optimal care transition as possible.

Possible examples of process measures include: the accuracy of medication reconciliation at admission and discharge; provision of prompt outpatient follow‐up; provision of adequate systems to monitor and manage symptoms after discharge; advanced care planning in appropriate patients; and the quality of discharge education, incorporating measurements of the patient's understanding and ability to self‐manage their illness. At least some of these could be used now as part of a performance measurement set that highlights opportunities for immediate system change and can serve as performance milestones.

The framework could also be used to validate risk‐adjustment techniques. After accounting for patient factors, the remaining variability in outcomes should be accounted for by processes of care that are in the transitions framework. Once these processes are accurately measured, one can determine if indeed the remaining variability is due to transitions processes, or rather unaccounted factors that are not being measured and that hospitals may have little control over. Such work can lead to iterative refinement of patient risk‐adjustment models.

What Does the Framework Imply About Best Practices for Reducing Readmission Rates?

Despite the limitations of readmission rates as a quality measure noted above, hospitals presently face potentially large financial penalties for readmissions and are allocating resources to readmission reduction efforts. However, hospitals currently may not have enough guidance to know what actions to take to reduce readmissions, and thus could be spending money inefficiently and reducing the value proposition of focusing on readmissions.

A recent systematic review of interventions hospitals could employ to reduce readmissions identified several positive studies, but also many negative studies, and there were significant barriers to understanding what works to reduce readmissions.[7] For example, most of the interventions described in both positive and negative studies were multifaceted, and the authors were unable to identify which components of the intervention were most effective. Also, while several studies have identified risk factors for readmission,[6, 48, 49] very few studies have identified which subgroups of patients benefit most from specific interventions. Few of the studies described key contextual factors that may have led to successful or failed implementation, or the fidelity with which the intervention was implemented.[50, 51, 52]

Few if any of the studies were guided by a concept of the ideal transition in care.[10] Such a framework will better guide development of multifaceted interventions and provide an improved means for interpreting the results. Clearly, rigorously conducted, multicenter studies of readmission prevention interventions are needed to move the field forward. These studies should: 1) correlate implementation of specific intervention components with reductions in readmission rates to better understand the most effective components; 2) be adequately powered to show effect modification, ie, which patients benefit most from these interventions; and 3) rigorously measure environmental context and intervention fidelity, and employ mixed methods to better understand predictors of implementation success and failure.

Our framework can be used in the design and evaluation of such interventions. For example, interventions could be designed that incorporate as many of the domains of an ideal transition as possible, in particular those that span the inpatient and outpatient settings. Processes of care metrics can be developed that measure the extent to which each domain is delivered, analogous to the way the Joint Commission might aggregate individual scores on the 10 items in Acute Myocardial Infarction Core Measure Set[53] to provide a composite of the quality of care provided to patients with this diagnosis. These can be used to correlate certain intervention components with success in reducing readmissions and also in measuring intervention fidelity.

NEXT STEPS

For hospital and healthcare system leaders, who need to take action now to avoid financial penalties, we recommend starting with proven, high‐touch interventions such as Project RED and the Care Transitions Intervention, which are durable, cost‐effective, robustly address multiple domains of the Ideal Transition in Care, and have been implemented at numerous sites.[54, 55] Each hospital or group will need to decide on a bundle of interventions and customize them based on local workflow, resources, and culture.

Risk‐stratification, to match the intensity of the intervention to the risk of readmission of the patient, will undoubtedly be a key component for the efficient use of resources. We anticipate future research will allow risk stratification to be a robust part of any implementation plan. However, as noted above, current risk prediction models are imperfect,[6] and more work is needed to determine which patients benefit most from which interventions. Few if any studies have described interventions tailored to risk for this reason.

Based on our ideal transition in care, our collective experience, and published evidence,[7, 10, 11, 12] potential elements to start with include: early discharge planning; medication reconciliation[56]; patient/caregiver education using health literacy principles, cognitive assessments, and teach‐back to confirm understanding; synchronous communication (eg, by phone) between inpatient and postdischarge providers; follow‐up phone calls to patients within 72 hours of discharge; 24/7 availability of a responsible inpatient provider to address questions and problems (both from the patient/caregiver and from postdischarge providers); and prompt appointments for patients discharged home. High‐risk patients will likely require additional interventions, including in‐home assessments, disease‐monitoring programs, and/or patient coaching. Lastly, patients with certain conditions prone to readmission (such as heart failure and chronic obstructive pulmonary disease) may benefit from disease‐specific programs, including patient education, outpatient disease management, and monitoring protocols.

It is likely that the most effective interventions are those that come from combined, coordinated interventions shared between inpatient and outpatient settings, and are intensive in nature. We expect that the more domains in the framework that are addressed, the safer and more seamless transitions in care will be, with improvement in patient outcomes. To the extent that fragmentation of care has been a barrier to the implementation of these types of interventions in the past, ACOs, perhaps with imbedded Patient‐Centered Medical Homes, may be in the best position to take advantage of newly aligned financial incentives to design comprehensive transitional care. Indeed, we anticipate that Figure 1 may provide substrate for a discussion of postdischarge care and division of responsibilities between inpatient and outpatient care teams at the time of transition, so effort is not duplicated and multiple domains are addressed.

Other barriers to implementation of ideal transitions in care will continue to be an issue for most healthcare systems. Financial constraints that have been a barrier up until now will be partially overcome by penalties for high readmission rates and by ACOs, bundled payments, and alternative care contracts (ie, global payments), but the extent to which each institution feels rewarded for investing in transitional interventions will vary greatly. Healthcare leadership that sees the value of improving transitions in care will be critical to overcoming this barrier. Competing demands (such as lowering hospital length of stay and carrying out other patient care responsibilities),[57] lack of coordination and diffusion of responsibility among various clinical personnel, and lack of standards are other barriers[58] that will require clear prioritization from leadership, policy changes, team‐based care, provider education and feedback, and adequate allocation of personnel resources. In short, process redesign using continuous quality improvement efforts and effective tools will be required to maximize the possibility of success.

CONCLUSIONS

Readmissions are costly and undesirable. Intuition suggests they are a marker of poor care and that hospitals should be capable of reducing them, thereby improving care and decreasing costs. In a potential future world of ACOs based on global payments, financial incentives would be aligned for each system to reduce readmissions below their current baseline, therefore obviating the need for external financial rewards and penalties. In the meantime, financial penalties do exist, and controversy exists over their fairness and likelihood of driving appropriate behavior. To address these controversies and promote better transitional care, we call for the development and use of multifaceted, collaborative transitions interventions that span settings, risk‐adjustment models that allow for fairer comparisons among hospitals, better and more widespread measurement of processes of transitional care, a better understanding of what interventions are most effective and in whom, and better guidance in how to implement these interventions. Our conceptualization of an ideal transition of care serves as a guide and provides a common vocabulary for these efforts. Such research is likely to produce the knowledge needed for healthcare systems to improve transitions in care, reduce readmissions, and reduce costs.

Disclosure

Funding for Dr Vasilevskis has been provided by the National Institutes of Health (K23AG040157) and the VA Tennessee Valley Geriatric Research, Education and Clinical Center (GRECC). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Aging, the National Institutes of Health, or the US Department of Veterans Affairs.

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  42. Joynt KE, Orav EJ, Jha AK. Thirty‐day readmission rates for Medicare beneficiaries by race and site of care. JAMA. 2011;305(7):675681.
  43. Walraven C, Bennett C, Jennings A, Austin PC, Forster AJ. Proportion of hospital readmissions deemed avoidable: a systematic review. Can Med Assoc J. 2011;183(7):E391E402.
  44. Arbaje AI, Wolff JL, Yu Q, et al. Postdischarge environmental and socioeconomic factors and the likelihood of early hospital readmission among community‐dwelling Medicare beneficiaries. Gerontologist. 2008;48(4):495504.
  45. Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97107.
  46. National Quality Forum. Safe Practices for Better Healthcare—2010 Update: A Consensus Report. Washington, DC;2010.
  47. Joint Commission on Accreditation of Healthcare Organizations. Accreditation Program: Hospital 2010 National Patient Safety Goals (NPSGs). 2010. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/. Accessed on March 20, 2012.
  48. Hasan O, Meltzer DO, Shaykevich SA, et al. Hospital readmission in general medicine patients: a prediction model. J Gen Intern Med. 2010;25(3):211219.
  49. Walraven C, Dhalla IA, Bell C, et al. Derivation and validation of an index to predict early death or unplanned readmission after discharge from hospital to the community. Can Med Assoc J. 2010;182(6):551557.
  50. Brown C, Lilford R. Evaluating service delivery interventions to enhance patient safety. BMJ. 2008;337:a2764.
  51. Shekelle PG, Pronovost PJ, Wachter RM. Assessing the Evidence for Context‐Sensitive Effectiveness and Safety of Patient Safety Practices: Developing Criteria. Rockville, MD:Agency for Healthcare Research and Quality; December2010.
  52. Shekelle PG, Pronovost PJ, Wachter RM, et al. Advancing the science of patient safety. Ann Intern Med. 2011;154(10):693696.
  53. The Joint Commission. Acute Myocardial Infarction Core Measure Set. Available at: http://www.jointcommission.org/assets/1/6/Acute%20Myocardial%20Infarction.pdf. Accessed August 20,2012.
  54. Voss R, Gardner R, Baier R, Butterfield K, Lehrman S, Gravenstein S. The care transitions intervention: translating from efficacy to effectiveness. Arch Intern Med. 2011;171(14):12321237.
  55. Project RED toolkit, AHRQ Innovations Exchange. Available at:http://www.innovations.ahrq.gov/content.aspx?id=2180. Accessed on July 2, 2012.
  56. Gillespie U, Alassaad A, Henrohn D, et al. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009;169(9):894900.
  57. Joynt KE, Jha AK. Thirty‐day readmissions—truth and consequences. N Engl J Med. 2012;366(15):13661369.
  58. Greysen SR, Schiliro D, Horwitz LI, Curry L, Bradley EH. “Out of sight, out of mind”: housestaff perceptions of quality‐limiting factors in discharge care at teaching hospitals. J Hosp Med. 2012;7(5):376381.
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  20. Mueller SK, Sponsler KC, Kripalani S, Schnipper JL. Hospital‐based medication reconciliation practices: a systematic review. Arch Intern Med. 2012;172(14):10571069.
  21. Schnipper JL, Hamann C, Ndumele CD, et al. Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster‐randomized trial. Arch Intern Med. 2009;169(8):771780.
  22. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166(5):565571.
  23. Xu H, Covinsky KE, Stallard E, Thomas J, Sands LP. Insufficient help for activity of daily living disabilities and risk of all–cause hospitalization. J Am Geriatr Soc. 2012;60(5):927933.
  24. Callahan CM, Arling G, Tu W, et al. Transitions in care for older adults with and without dementia. J Am Geriatr Soc. 2012;60(5):813820.
  25. Phelan EA, Borson S, Grothaus L, Balch S, Larson EB. Association of incident dementia with hospitalizations. JAMA. 2012;307(2):165172.
  26. Walsh EG, Wiener JM, Haber S, et al. Potentially avoidable hospitalizations of dually eligible Medicare and Medicaid beneficiaries from nursing facility and home– and community–based services waiver programs. J Am Geriatr Soc. 2012;60(5):821829.
  27. Kripalani S, Weiss BD. Teaching about health literacy and clear communication. J Gen Intern Med. 2006;21(8):888890.
  28. Peterson PN, Shetterly SM, Clarke CL, et al. Health literacy and outcomes among patients with heart failure. JAMA. 2011;305(16):16951701.
  29. Cain CH, Neuwirth E, Bellows J, Zuber C, Green J. Patient experiences of transitioning from hospital to home: an ethnographic quality improvement project. J Hosp Med. 2012;7(5):382387.
  30. Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009;301(6):603618.
  31. Peikes D, Peterson G, Brown RS, Graff S, Lynch JP. How changes in Washington University's Medicare coordinated care demonstration pilot ultimately achieved savings. Health Aff (Millwood). 2012;31(6):12161226.
  32. Pace A, Lorenzo C, Capon A, et al. Quality of care and rehospitalization rate in the last stage of disease in brain tumor patients assisted at home: a cost effectiveness study. J Palliat Med. 2012;15(2):225227.
  33. Nelson C, Chand P, Sortais J, Oloimooja J, Rembert G. Inpatient palliative care consults and the probability of hospital readmission. Perm J. 2011;15(2):4851.
  34. King HB, Battles J, Baker DP, et al. TeamSTEPPS™: team strategies and tools to enhance performance and patient safety. In: Henriksen K, Battles JB, Keyes MA, Grady ML, ed. Advances in Patient Safety: New Directions and Alternative Approaches. Vol 3: Performance and Tools. Rockville, MD:Agency for Healthcare Research and Quality; August2008.
  35. Feigenbaum P, Neuwirth E, Trowbridge L, et al. Factors contributing to all‐cause 30‐day readmissions: a structured case series across 18 hospitals. Med Care. 2012;50(7):599605.
  36. Chaudhry SI, Mattera JA, Curtis JP, et al. Telemonitoring in patients with heart failure [erratum, N Engl J Med. 2011;364(5):490]. N Engl J Med. 2010;363(24):23012309.
  37. Takahashi PY, Pecina JL, Upatising B, et al. A randomized controlled trial of telemonitoring in older adults with multiple health issues to prevent hospitalizations and emergency department visits. Arch Intern Med. 2012;172(10):773779.
  38. Hernandez AF, Greiner MA, Fonarow GC, et al. Relationship between early physician follow‐up and 30‐day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA. 2010;303(17):17161722.
  39. Misky GJ, Wald HL, Coleman EA. Post‐hospitalization transitions: examining the effects of timing of primary care provider follow‐up. J Hosp Med. 2010;5(7):392397.
  40. Weinberger M, Oddone EZ, Henderson WG. Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission. N Engl J Med. 1996;334(22):14411447.
  41. Coleman EA. The Post‐Hospital Follow‐Up Visit: A Physician Checklist to Reduce Readmissions. California Healthcare Foundation; October 2010. Available at: http://www.chcf.org/publications/2010/10/the‐post‐hospital‐follow‐up‐visit‐a‐physician‐checklist. Accessed on January 10, 2012.
  42. Joynt KE, Orav EJ, Jha AK. Thirty‐day readmission rates for Medicare beneficiaries by race and site of care. JAMA. 2011;305(7):675681.
  43. Walraven C, Bennett C, Jennings A, Austin PC, Forster AJ. Proportion of hospital readmissions deemed avoidable: a systematic review. Can Med Assoc J. 2011;183(7):E391E402.
  44. Arbaje AI, Wolff JL, Yu Q, et al. Postdischarge environmental and socioeconomic factors and the likelihood of early hospital readmission among community‐dwelling Medicare beneficiaries. Gerontologist. 2008;48(4):495504.
  45. Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97107.
  46. National Quality Forum. Safe Practices for Better Healthcare—2010 Update: A Consensus Report. Washington, DC;2010.
  47. Joint Commission on Accreditation of Healthcare Organizations. Accreditation Program: Hospital 2010 National Patient Safety Goals (NPSGs). 2010. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/. Accessed on March 20, 2012.
  48. Hasan O, Meltzer DO, Shaykevich SA, et al. Hospital readmission in general medicine patients: a prediction model. J Gen Intern Med. 2010;25(3):211219.
  49. Walraven C, Dhalla IA, Bell C, et al. Derivation and validation of an index to predict early death or unplanned readmission after discharge from hospital to the community. Can Med Assoc J. 2010;182(6):551557.
  50. Brown C, Lilford R. Evaluating service delivery interventions to enhance patient safety. BMJ. 2008;337:a2764.
  51. Shekelle PG, Pronovost PJ, Wachter RM. Assessing the Evidence for Context‐Sensitive Effectiveness and Safety of Patient Safety Practices: Developing Criteria. Rockville, MD:Agency for Healthcare Research and Quality; December2010.
  52. Shekelle PG, Pronovost PJ, Wachter RM, et al. Advancing the science of patient safety. Ann Intern Med. 2011;154(10):693696.
  53. The Joint Commission. Acute Myocardial Infarction Core Measure Set. Available at: http://www.jointcommission.org/assets/1/6/Acute%20Myocardial%20Infarction.pdf. Accessed August 20,2012.
  54. Voss R, Gardner R, Baier R, Butterfield K, Lehrman S, Gravenstein S. The care transitions intervention: translating from efficacy to effectiveness. Arch Intern Med. 2011;171(14):12321237.
  55. Project RED toolkit, AHRQ Innovations Exchange. Available at:http://www.innovations.ahrq.gov/content.aspx?id=2180. Accessed on July 2, 2012.
  56. Gillespie U, Alassaad A, Henrohn D, et al. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009;169(9):894900.
  57. Joynt KE, Jha AK. Thirty‐day readmissions—truth and consequences. N Engl J Med. 2012;366(15):13661369.
  58. Greysen SR, Schiliro D, Horwitz LI, Curry L, Bradley EH. “Out of sight, out of mind”: housestaff perceptions of quality‐limiting factors in discharge care at teaching hospitals. J Hosp Med. 2012;7(5):376381.
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Patients with Aspiration Pneumonia

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Mortality, morbidity, and disease severity of patients with aspiration pneumonia

Pneumonia is a common clinical syndrome with well‐described epidemiology and microbiology. Aspiration pneumonia comprises 5% to 15% of patients with pneumonia,[1] but is less well‐characterized despite being a major syndrome of pneumonia in the elderly.[2, 3] Difficulties in studying aspiration pneumonia include the lack of a sensitive and specific marker for aspiration, the overlap between aspiration pneumonia and other forms of pneumonia, and the lack of differentiation between aspiration pneumonia and aspiration pneumonitis by many clinicians.[4, 5, 6] Aspiration pneumonia, which develops after the aspiration of oropharyngeal contents, differs from aspiration pneumonitis, wherein inhalation of gastric contents causes inflammation without the subsequent development of bacterial infection.[7, 8]

A number of validated mortality prediction models exist for community‐acquired pneumonia (CAP), using a variety of clinical predictors. One clinical prediction rule endorsed by the British Thoracic Society is the CURB‐65, which assigns a score for Confusion, Uremia >19 mg/dL, Respiratory rate >= 30 breaths/min, Blood Pressure < 90 mmHg systolic or < 60 mmHg diastolic, and age 65). We favor eCURB, a version of the CURB‐65 model that uses continuously weighted variables to more accurately predict mortality, validated in CAP populations.[9] Most studies validating pneumonia severity scoring systems excluded aspiration pneumonia from their study population.[10, 11, 12] Severity scoring systems for CAP may not accurately predict disease severity patients with aspiration pneumonia.

The aims of our study were to: (1) identify a population of patients with aspiration pneumonia; (2) compare characteristics and outcomes in patients with community‐acquired aspiration pneumonia to those with CAP; and (3) study the performance of eCURB and CURB‐65 in predicting mortality for patients with community‐acquired aspiration pneumonia.

PATIENTS AND METHODS

Study Design and Setting

The study was performed at LDS Hospital, a university‐affiliated community teaching hospital in Salt Lake City, Utah, with 520 beds. In retrospective analysis of data from the electronic medical records, we identified all patients older than 18 years who were evaluated in the emergency department at LDS Hospital or admitted patients from other sources (direct admission, transfer from another hospital) from 1996 to 2006 with International Statistical Classification of Disease and Health Related Problems, 9th Revision (ICD‐9) codes specific for aspiration pneumonia and pneumonitis (507.x). The treating physicians were mostly hospitalists and intensivists. Two physicians (M.L. and N.D.) manually reviewed the electronic medical records, including the emergency room physician's notes, the admission histories and physicals, the discharge summaries, and radiographic reports of the patients identified in the query. Consensus regarding the diagnosis of aspiration pneumonia was achieved in all patients reviewed using criteria listed in Table 1. This study was approved by the LDS Hospital institutional review board, and permission was granted to use the Utah Population Database for determining mortality (#1008505), with a waiver of informed consent. For the contemporaneous group of CAP patients, we used a previously described population identified using ICD‐9 codes 481.x to 487.x, captured from the same hospital during the same period.[13]

Inclusion and Exclusion Criteria for the Study
Inclusion CriteriaExclusion Criteria
  • NOTE: Abbreviations: AIDS, acquired immune deficiency syndrome.
1. Age 18 years1. Absence of radiographic evidence of pneumonia within 48 hours after evaluation
2. Either admitted to hospital or evaluated in emergency department2. Previous episode of aspiration pneumonia within 12 months
3. 507.x code as primary diagnosis3. Initial admission date >48 hours before transfer to LDS Hospital
4. 507.x code as secondary diagnosis with a primary diagnosis of pneumonia, respiratory failure, or septicemia4. AIDS 5. Receipt of antiretroviral therapy 6. History of solid organ transplant
5. Treating physician indicated a diagnosis of aspiration pneumonia in the history and physical and/or discharge summary7. Hematologic malignancy 8. Witnessed isolated aspiration event within 24 hours prior to evaluation 9. Drug overdose, cardiopulmonary arrest, or seizure prior to hospital admission 10. Laryngoscopic or bronchoscopic evidence of food material in airway

Inclusion and Exclusion Criteria

Inclusion and exclusion criteria are listed in Table 1. To exclude patients with recurrent pneumonia, we included only the first episode of pneumonia in a given 12‐month period. LDS Hospital frequently receives patients transferred from surrounding emergency departments and intensive care units. We excluded patients who were transferred >48 hours from their initial emergency department admission and therefore were late in their disease course. Exclusion criteria 8 to 10 were used to exclude patients with clinical presentations more consistent with aspiration pneumonitis. We also excluded immunocompromised patients (criteria 4 to 7).

Healthcare‐associated aspiration pneumonia was defined as receipt of chronic hemodialysis, residence in a nursing facility, or hospitalization within any Intermountain Healthcare‐affiliated hospital within the past 90 days.[14] The remaining patients were defined as community‐acquired aspiration pneumonia.

Measurements

The first vital signs, orientation status, and first 12 hours of routine laboratory results were extracted from the electronic medical records and used to calculate predicted mortality by eCURB and CURB‐65. We determined 30‐day mortality from the merger of the electronic medical records with vital status information from the Utah Population Database.[15] The first measured SpO2 and FiO2 were used to estimate the PaO2/FiO2 ratio, using the Severinghaus calculation[16] if no arterial blood gas was available. Presence of American Thoracic Society/Infectious Diseases Society of America (IDSA/ATS) 2007 minor criteria for severe community‐acquired pneumonia (SCAP)[17] were obtained from baseline patient characteristics (Table 2). A Charlson comorbidity index was calculated from ICD‐9 codes using published methodology.[18, 19] Presence of an abnormal swallow was defined as dysphagia or aspiration on modified barium swallow study, fiberoptic endoscopic evaluation, or clinical determination by a speech language pathologist during the index hospitalization. We also looked for causative pathogens, defined by a positive pneumococcus or legionella urinary antigen, or a positive culture from blood, bronchoalveolar lavage, pleural fluid, or tracheal aspirate, collected within 24 hours of admission. Antibiotics administered within the first 24 hours of admission were classified into 4 broad groups based on local physician prescribing patterns. Clindamycin and metronidazole were considered anaerobic‐specific antibiotics. Vancomycin or linezolid were considered methicillin‐resistant Staphylococcus aureus (MRSA) antibiotics. Broad‐spectrum antibiotics included any of the following: carbapenems, aztreonam, piperacillin/tazobactam, ticarcillin/clavulanate, cefepime, and ceftazidime. Macrolides, respiratory fluoroquinolones, and third‐generation cephalosporins were considered standard‐care antibiotics.

Minor Criteria for Severe Community‐Acquired Pneumonia, From the Infectious Disease Society of America/American Thoracic Society 2007 Criteria
Respiratory rate 30 breaths/minute
PaO2/FiO2 250
Multilobar infiltrates
Confusion/disorientation
Uremia (blood urea nitrogen 20 mg/dL)
Leukopenia (white blood cell count <4000 cells/mm3)
Thrombocytopenia (platelet count <100,000 cells/mm3)
Hypothermia (core temperature 36C)
Hypotension requiring aggressive fluid resuscitation

Statistical Analysis

We compared baseline patient characteristics and clinical outcomes using the Fisher exact test to compare proportions of categorical variables, and Mann‐Whitney U test or Student t test to compare central tendencies of continuous variables, as dictated by the normality of the data. Receiver operating characteristic curves calculated the ability of eCURB and CURB‐65 to predict 30‐day mortality prediction in patients with community‐acquired aspiration pneumonia and CAP, as well as the ability of IDSA/ATS minor criteria for SCAP to predict admission to the intensive care unit (ICU). We performed multivariate logistic regression to predict 30‐day mortality in patients with community‐acquired aspiration pneumonia and CAP, using stepwise backward elimination. Confounders were included if they were significant at a 0.05 level or if they altered the coefficient of the main variable by more than 10%. For logistic models, we evaluated goodness of fit with the Hosmer‐Lemeshow technique; comparisons of area under the curve (AUC) among models were made using the technique of DeLong.[20] Two‐tailed P values of 0.05 were considered statistically significant. Stata version 12 (StataCorp, College Station, TX) was used for all analyses.

RESULTS

Our initial query identified 1165 patients. Physician review of the medical records resulted in 628 patients, 118 of whom were classified as healthcare‐associated aspiration pneumonia (Figure 1, Table 3). Of all aspiration pneumonia patients, 80% were seen in the emergency department, 12.5% were directly admitted from the community, and 7.5% were transferred from another healthcare facility. Almost all patients seen in the emergency department (99.0%) were admitted to the hospital, with median length of hospitalization 6.7 days among survivors.

Figure 1
Inclusion and exclusion criteria. Abbreviations: HIV/AIDS, human immunodeficiency virus/acquired immune deficiency syndrome; ICD‐9, International Classification of Diseases, 9th Revision.
Patient Characteristics of Aspiration Pneumonia, Subdivided by Presence of Healthcare Association
 Aspiration Pneumonia (N = 628)Community‐Acquired Aspiration Pneumonia (N = 510)Healthcare Associated Aspiration Pneumonia (N=118)P Value
  • NOTE: All continuous or ordinal data are median values followed by interquartile ranges, unless otherwise specified. Significance testing between community‐acquired aspiration pneumonia and healthcare‐associated aspiration pneumonia was calculated with Fisher exact or Wilcoxon tests, where appropriate. Abbreviations: AUC, area under the curve; DNR/DNI, Do not resuscitate/do not intubate; ED, emergency department; LOS, length of stay; MRSA, methicillin‐resistant Staphylococcus aureus; SCAP, severe community‐acquired pneumonia. *SCAP described in the 2007 Infectious Diseases Society of America/American Thoracic Society guidelines (Table 2).
Age (range), y77 (6585)77 (6485)80 (6786)0.42
Female, %49.850.248.30.76
30‐day mortality, %21.0%19.0%29.7%0.02
CURB‐65 score2 (13)2 (13)2 (13)0.0012
Confusion13.9%12.7%18.6%0.10
Blood urea nitrogen (mg/dL)22 (1634)21 (1532)30 (2047)<0.0001
Respiratory rate (breaths/min)20 (1826)20 (1824)21 (1828)0.30
Systolic blood pressure (mm Hg)128 (110149)129 (110150)127 (105146)0.28
eCURB 30‐day mortality estimate (median, %)5.6 (2.414.2)5.2 (2.212.4)8.9 (4.222.5)<0.0001
eCURB 30‐day mortality estimate (mean, %)10.6 12.29.7 11.514.614.1<0.0001
Hospital admission (of ED visits), %99.098.81000.59
Hospital LOS, d6.7 (4.111.1)6.5 (4.011.0)7.8 (5.412.3)0.05
ICU admission, %37.937.141.50.21
ICU LOS, d3.5 (1.98.8)3.1 (1.87.6)5.6 (3.810.8)0.02
Mean ventilator‐free days (of ICU patients, out of 30 days)25.28.325.97.722.710.00.01
Receipt of mechanical ventilation, %18.617.224.60.09
Duration of ventilation, d2.8 (0.96.5)3.1 (1.06.6)1.9 (0.86.3)0.05
Receipt of vasopressor, %1.81.43.40.13
Charlson comorbidity index4 (26)3 (26)4 (36)0.0024
Cerebrovascular disease, %33.932.440.70.11
Chronic pulmonary disease, %51.051.847.50.42
Congestive heart failure, %52.450.062.70.01
Connective tissue disease, %8.48.86.80.58
Dementia, %14.212.023.70.0019
Hemiplegia/paraplegia9.48.015.20.02
Myocardial infarction, %21.017.829.70.02
Peripheral vascular disease, %17.716.323.70.06
Peptic ulcer disease, %18.819.216.90.70
Diabetes without complications, %10.79.216.90.02
Diabetes with complications, %31.530.436.40.23
Mild liver disease, %8.68.011.00.28
Moderate or severe liver disease, %1.81.62.50.44
Malignant solid tumor, %16.617.313.60.41
Metastatic cancer, %5.45.74.20.66
Renal disease, %14.74.218.60.19
3 or more minor SCAP criteria, %*24.723.131.40.08
PaO2/FiO2 ratio221 (161280)226 (169280)181 (133245)0.0004
Multilobar disease, %46.343.253.90.11
Presence of an effusion, %23.119.731.90.03
Swallow impairment (of tested survivors), %34.134.134.10.22
Presence of a DNR/DNI order, %26.423.738.10.0024
Mortality of patients with DNR/DNI order, %39.138.840.01.00
Receipt of broad‐spectrum antibiotic, %35.432.547.50.0028
Receipt of MRSA antibiotic, %7.55.715.30.0014
Receipt of anaerobe antibiotic, %28.727.633.10.26

Observed mortality was 21.0%. eCURB significantly underestimated mortality in this group, predicting a mortality rate of 10.6%. When classifying patients by the 2007 IDSA/ATS guidelines, 24.7% of the patients had 3 or more minor criteria for SCAP.[17] The PaO2/FiO2 ratio was obtained in 99.7% of patients. The median PaO2/FiO2 ratio observed in this population was 221 mm Hg (equivalent to 260 mm Hg at sea level barometric pressure, adjusted for our altitude of 1400 meters), near the threshold sea level definition (250 mm Hg) for SCAP.[13, 17] Admission to the ICU was common, as were admission orders for do not resuscitate (DNR) or do not intubate (DNI). Patients with healthcare‐associated aspiration pneumonia had a higher comorbidity index and had a higher mortality rate than patients with community‐acquired aspiration pneumonia, although we found no significant difference in the rate of hospital or ICU admission or the receipt of critical care therapies. Inpatient assessment of dysphagia and aspiration was conducted in 177 patients. Abnormal swallow was noted in 96% of those tested.

We found several differences between patients with community‐acquired aspiration pneumonia and 2584 patients with CAP identified during the same time period[13] (Table 4). Patients with community‐acquired aspiration pneumonia were older, more likely to have multilobar disease or effusion on imaging, and had greater disease severity. They also had a higher frequency of ICU and hospital admission, IDSA/ATS minor criteria for SCAP, and higher Charlson comorbidity indices. Patients with community‐acquired aspiration pneumonia were more likely to receive mechanical ventilation than CAP patients, although there was no difference in 30‐day mortality among intubated patients or a difference in ventilator‐free days.

Comparison of Community‐Acquired Aspiration Pneumonia and Typical Community‐Acquired Pneumonia
 Community‐Acquired Aspiration Pneumonia (N = 510)Community‐ Acquired Pneumonia (N = 2584)P Value
  • NOTE: All dichotomous data are proportions. All continuous or ordinal data are median values followed by interquartile ranges, unless otherwise specified. Significance testing was calculated with Fisher exact or Wilcoxon tests, where appropriate. Abbreviations: AUC, area under the curve; CURB‐65, a clinical prediction rule based on Confusion, Uremia, Respiratory rate, Blood Pressure, and age > 65; DNR/DNI, do not resuscitate/do not intubate; eCURB, a version of the CURB‐65 mode that uses continuously weighted variables; ED, emergency department; ICU, intensive care unit; LOS, length of stay; MRSA, methicillin‐resistant Staphylococcus aureus; SCAP, severe community‐acquired pneumonia *SCAP described in the 2007 Infectious Diseases Society of America/American Thoracic Society guidelines.
Age (range), y77 (6485)59 (4176)<0.0001
Female, %50.249.50.81
30‐day mortality, %19.04.2<0.0001
CURB‐65 score2 (13)1 (02)<0.0001
Confusion, %12.75.1<0.0001
Blood urea nitrogen21 (1532)16 (1124)<0.0001
Respiratory rate20 (1824)20 (1824)<0.0001
Systolic blood pressure129 (110150)130 (112146)0.67
eCURB 30‐day mortality estimate, median, %5.2 (2.212.4)1.7 (0.94.3)<0.0001
eCURB 30‐day mortality estimate, mean, %9.7 11.54.4 7.5<0.0001
AUC of eCURB versus mortality0.71 (0.660.75)0.86 (0.830.90)<0.0001
Excluding DNR/DNI patients0.69 (0.650.74)0.87 (0.830.90)0.0001
AUC of CURB‐65 versus mortality0.66 (0.620.69)0.81 (0.780.85)<0.0001
Excluding DNR/DNI patients0.65 (0.600.70)0.81 (0.760.85)0.0003
Hospital admission (of ED visits), %98.857.8<0.0001
Hospital LOS, d6.5 (4.011.0)3.3 (2.25.2)<0.0001
ICU admission, %37.114.2<0.0001
ICU LOS, d3.1 (1.87.6)2.5 (1.17.7)0.01
Mean ventilator‐free days (of ICU patients, out of 30 days)25.9 7.725 90.75
Receipt of mechanical ventilation, %17.27.8<0.0001
Duration of ventilation, d3.1 (1.06.6)3.5 (1.57.2)0.09
Receipt of vasopressor, %1.43.30.02
Charlson comorbidity index3 (26)1 (03)<0.0001
Cerebrovascular disease, %32.410.0<0.0001
Chronic pulmonary disease, %51.842.5<0.0001
Congestive heart failure, %50.022.1<0.0001
Connective tissue disease, %8.85.60.0084
Dementia, %12.02.8<0.0001
Hemiplegia/paraplegia, %8.02.7<0.0001
Myocardial infarction, %17.810.8<0.0001
Peripheral vascular disease, %16.37.4<0.0001
Peptic ulcer disease, %19.27.6<0.0001
Diabetes without complications, %9.224.7<0.0001
Diabetes with complications, %30.45.1<0.0001
Mild liver disease, %8.06.20.14
Moderate or severe liver disease, %1.60.80.13
Malignant solid tumor, %17.8.9<0.0001
Metastatic cancer, %5.71.3<0.0001
Renal disease, %4.25.6<0.0001
3 or more minor SCAP criteria, %*24.719.10.01
PaO2/FiO2 ratio226 (169280)260 (148338)0.0004
Multilobar disease, %43.237.20.0012
Presence of an effusion, %19.718.3<0.0001
Presence of a DNR/DNI order, %23.79.7<0.0001
Mortality of patients with DNR/DNI order, %38.812.4<0.0001
Receipt of broad‐spectrum antibiotic, %32.58.4<0.0001
Receipt of MRSA antibiotic, %5.72.2<0.0001
Receipt of anaerobe antibiotic, %27.63.1<0.0001

Thirty‐day mortality for patients with community‐acquired aspiration pneumonia was significantly higher than in CAP patients. Patients with community‐acquired aspiration pneumonia also had higher eCURB and CURB‐65 scores. However, eCURB was a poor predictor of 30‐day mortality, with an AUC of 0.71, compared to 0.86 calculated for the CAP population (Figure 2). CURB‐65 performed similarly: AUC was 0.66 vs 0.81. The presence of a DNR/DNI order was twice as prevalent in the community‐acquired aspiration pneumonia population vs the CAP population; those patients with a DNR/DNI order were 3 times as likely to die. Excluding patients with a DNR/DNI order did not improve performance of eCURB or CURB‐65 (Table 4). The presence of IDSA/ATS minor criteria for SCAP was not predictive of triage to the ICU in the group of patients with community‐acquired aspiration pneumonia (AUC: 0.51), compared with CAP patients (AUC: 0.88, P < 0.01 for comparison, Figure 3). This finding persisted in the subset of patients without a DNR/DNI order (AUC: 0.52 in community‐acquired aspiration pneumonia vs 0.88 in CAP, P < 0.01).

Figure 2
Receiver operating characteristic curve, comparing the eCURB score against 30‐day mortality in patients with typical community‐acquired pneumonia and in patients with community‐acquired aspiration pneumonia. The eCURB score is an electronic version of the CURB‐65 model, validated in the community‐acquired pneumonia population, that uses continuously weighted variables to more accurately predict mortality.These curves statistically differ, P < 0.0001. Abbreviations: AUC, area under the curve; CAP, community‐acquired pneumonia.
Figure 3
Receiver operating characteristic curve, comparing the Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) minor criteria for severe community‐acquired pneumonia against intensive care unit (ICU) admission in patients with typical community‐acquired pneumonia (CAP) and in patients with community‐acquired aspiration pneumonia. These curves statistically differ, P < 0.0001. Abbreviations: AUC: area under the curve.

Our regression model of mortality incorporated gender, presence of effusion or multilobar pneumonia, presence of a DNR/DNI order, and all the components of the CURB‐65, IDSA/ATS minor criteria for SCAP, and Charlson comorbidity index. The regression model demonstrated that even after adjustment for age, comorbidities, disease severity, and presence of a DNR/DNI order, the presence of aspiration pneumonia was associated with higher mortality than CAP (odds ratio [OR]: 3.46, P < 0.001, Table 5). In this model, systolic blood pressure did not predict mortality, and diabetes with complications was associated with decreased mortality.

Final Logistic Regression Model Predicting 30‐Day Mortality in Patients With Community‐Acquired Pneumonia and Community‐Acquired Aspiration Pneumonia
 Odds RatioP Value
  • NOTE: Initial model also included gender, presence of multilobar pneumonia, and all components of the CURB (Confusion, Uremia, Respiratory Rate, Blood Pressure) score and Charlson comorbidity index, and minor criteria for severe community‐acquired pneumonia. Area under the curve of the final model = 0.87. Odds ratios are followed by 95% confidence intervals in parentheses. Exclusion of DNR/DNI status did not significantly alter the regression model. Abbreviations: DNR/DNI, do not resuscitate/do not intubate.
Presence of aspiration pneumonia3.46 (2.115.67)<0.001
Age, y1.03 (1.011.04)<0.001
Confusion3.14 (1.955.05)<0.001
Blood urea nitrogen, mg/dL1.03 (1.021.04)<0.001
Respiratory rate, breaths/minute1.03 (1.001.06)0.04
PaO2/FiO2 ratio, per 1 mm Hg0.99 (0.991.00)<0.001
Moderate or severe liver disease9.21 (3.1626.86)<0.001
Paraplegia/hemiplegia2.43 (1.135.27)0.02
Diabetes with complications0.42 (0.200.87)0.02
Leukocytosis4.47 (2.278.82)<0.001
DNR/DNI1.75 (1.112.75)0.02

Microbiological Findings

Blood cultures were performed at admission in 67.4% of aspiration‐pneumonia patients, and a tracheal aspirate in half (50.7%) of intubated patients with aspiration pneumonia. Organisms were recovered in 90 patients (14.3%), although 41 of those patients had tracheal aspirates of organisms commonly thought to be nonpathogenic (nonpneumococcal alpha‐hemolytic streptococcus, nonhemolytic streptococcus, diphtheroids, micrococci, coagulase negative staphylococccus). Tracheal aspirate was the most common method of recovering an organism (7.8% of patients), followed by blood culture (4.3%). Bronchoalveolar lavage, urinary antigen, and pleural fluid culture were less common (1.3%, 1.1%, 0.3%, respectively). The microbiologic results were grouped into: Staphylococcus aureus, Streptococcus pneumoniae, enteric bacilli, Haemophilus species, Neisseria species, Moraxella catarrhalis, and Pseudomonas aeruginosa (Figure 4). Comparing healthcare‐associated with community‐acquired aspiration pneumonia, healthcare‐associated patients were more likely to have a confirmed infection with MRSA (4.2% vs 1.4%, P = 0.06) and enteric bacteria (5.1% vs 1.6%, P = 0.03). There were no other statistically significant differences in microbiologic recovery between the 2 groups. Antibiotics targeting anaerobic pathogens were administered in 28.7% of patients with aspiration pneumonia, with no correlation to the presence of healthcare‐associated risks. Healthcare‐associated patients were more likely to receive broad‐spectrum antibiotics (47.5% vs 32.5%, P < 0.01) and MRSA coverage (15.3% vs 5.7%, P < 0.01) than patients with community‐acquired aspiration pneumonia.

Figure 4
Distribution of bacterial organism recovered from 628 patients with aspiration pneumonia. Percentages are expressed as a fraction of 628 patients. Note that the total exceeds 100% due to polymicrobial infection. Viral, fungal, and acid fast bacilli cultures were not routinely obtained and not included in this graphic. Other = Bacillus cereus (1), Serratia marcescens (1), Nocardia species (1), Acinetobacter bauminii (1), Capnocytophaga (1), Eikenella corrodens (1), Proteus (1), Saccharomyces cerevisiae (1). Abbreviations: M. catarrhalis, Moraxella catarrhalis; MRSA, methicillin‐resistant Staphylococcus aureus; MSSA, methicillin‐sensitive Staphylococcus aureus; S. pneumoniae, Streptococcus pneumoniae.

DISCUSSION

Our study identifies a larger cohort of patients with aspiration pneumonia than previous studies.[21, 22, 23, 24, 25] Patients with community‐acquired aspiration pneumonia are older and more likely to die than CAP patients. They are more likely to be admitted to the hospital or ICU. Thirty‐day mortality in this patient population was significantly underestimated by CURB‐65 and eCURB, models developed and validated in CAP populations.[9, 26] This finding supports a prior study.[27] It appears that a traditional prognostic model assessing mortality risk in the CAP patient does not apply to the aspiration‐pneumonia patient. One reason for eCURB and CURB‐65s poor utility in community‐acquired aspiration pneumonia may be their reliance on objective clinical features rather than comorbidities, which may influence mortality to a greater degree in aspiration pneumonia.

This study has several limitations. There is no gold standard for the definition of aspiration pneumonia, and it is difficult to distinguish aspiration pneumonia from typical pneumonia. It is plausible that older patients with greater comorbidities are being designated as aspiration pneumonia. If this is the case, then aspiration pneumonia merely represents the end of the pneumonia spectrum with highest mortality risk, and it is no surprise that these patients fare poorly.

It appears that the hospitalist or emergency department physician implicitly appreciates that aspiration pneumonia has a higher mortality risk than predicted by traditional severity assessment. With such high mortality and morbidity, a patient presenting to the emergency room with aspiration pneumonia is almost always admitted to the hospital. Further work in this area should investigate other factors to improve prognostic modeling in patients with aspiration pneumonia, although the utility of such a model may be limited to determining ICU admission. Our data indicate that IDSA/ATS minor criteria for SCAP are not useful in predicting admission to the ICU in patients with aspiration pneumonia.

In this study, a DNR/DNI order was twice as common in the community‐acquired aspiration pneumonia population than the CAP population. However, patients with community‐acquired aspiration pneumonia and a DNR/DNI order were more than 3 times more likely to die than patients with CAP and a DNR/DNI order. Our regression model suggested that the presence of a DNR/DNI order was an independent predictor of mortality (OR: 1.75, P < 0.001). Although a DNR/DNI order may correlate with the withholding or withdrawal of medical therapy, it is also a surrogate for increased age or comorbidities.[28] In our study, however, the increased prevalence of DNR/DNI orders did not explain the poor mortality prediction of the eCURB or CURB‐65, as exclusion of those patients did not significantly alter the AUCs in either the aspiration group or the CAP group.

Controversy exists regarding treatment of aspiration pneumonia. Historically, some have advocated for treatment of aspiration pneumonia with a regimen designed to cover anaerobic bacteria.[29] This recommendation was based on early microbiologic studies that obtained the samples late in the course of illness, or other studies where the sample was obtained transtracheally, where oropharyngeal flora may contaminate the sample.[30, 31, 32] Our clinically obtained microbiologic recovery of organisms was similar to the flora recovered in more recent CAP studies, in respect to both the incidence of pathogen recovery and the relative frequencies of recovered organisms.[33, 34] Our data do not support inferences regarding the prevalence of anaerobic infections, as the recovery of anaerobic organisms was limited to blood and pleural fluid cultures in this study, rather than techniques used in research settings that might have greater yield. As expected, patients with healthcare‐associated risk factors trended toward increased incidence of MRSA. Given the similarity of the organisms recovered to those recovered in CAP,[35] this study supports IDSA/ATS recommendations that antibiotic therapy in aspiration pneumonia be similar to that of higher‐risk CAP, with the addition of vancomycin or linezolid for MRSA coverage in patients with risk factors for healthcare‐associated pneumonia.[17]

Our study is limited by its single‐center retrospective design. However, beginning in 1995, the LDS Hospital emergency department initiated a standardized pneumonia therapy protocol and deployed electronic medical records, which prospectively recorded a wide array of clinical, therapeutic, and biometric data. Most data elements used in this analysis were routinely charted for clinical purposes in real time. Although the eCURB, CURB‐65, and some comorbidities could be extracted electronically for each patient, it was not possible to calculate the pneumonia severity index score due to our inability to rigorously identify the necessary comorbid illness elements. Other comorbidities, not present in our model, may have been identified by the physician who makes a diagnosis of aspiration pneumonia. Our identification of swallow impairment is also methodologically limited. The decision to obtain a swallow study was clinical, usually occurring upon convalescence. Therefore, it is not possible to distinguish between antecedent oropharyngeal dysfunction and post‐critical illness dysfunction.

Our definition of aspiration pneumonia required the treating physician to diagnose and code the patient as having aspiration pneumonia, followed by excluding patients more likely to have aspiration pneumonitis. Although we relied on ICD‐9 codes to initially identify aspiration pneumonia, all patients in our database were confirmed by physician chart review. Our incidence of community‐acquired aspiration pneumonia is congruent with other studies using different methodologies.[1, 36, 37] Unfortunately, there is no standard and widely accepted definition for separating aspiration pneumonia from usual CAP. A younger and healthier patient who has developed pneumonia subsequent to aspiration may be more likely to be diagnosed with CAP, resulting in selection bias for older patients with greater comorbidities.

CONCLUSION

Patients diagnosed with aspiration pneumonia are older, have more comorbid conditions, and demonstrate greater disease severity and higher 30‐day mortality than CAP patients. Mortality prediction using CURB‐65 and eCURB in this population was poor, possibly due to a greater effect of comorbidities on mortality. The pneumonia severity index, which incorporates patient comorbidities, might perform better than the eCURB or CURB‐65, and should be studied in aspiration pneumonia populations where comorbid illness information is prospectively collected. Further areas of study include creating an improved mortality prediction model for aspiration pneumonia that incorporates comorbid conditions, DNR/DNI status, and disease severity.

Acknowledgments

The authors acknowledge Al Jephson for database support, Yao Li for statistical analysis, and Anita Austin for help reviewing the medical records. Dr. Lanspa had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Disclosure

Preliminary versions of this work were presented as posters at the American Thoracic Society Meeting, Denver, Colorado, May 17, 2011. This study was supported by grants from the Intermountain Research and Medical Foundation. Dr. Brown is supported by a career development award from National Institute of General Medical Sciences (K23GM094465). Dr. Dean served on an advisory board for Merck, has been a paid consultant for Cerexa, and has received an investigator‐initiated competitive grant from Pfizer for development of an electronic pneumonia decision support tool. All other authors report no relevant financial disclosures.

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References
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Pneumonia is a common clinical syndrome with well‐described epidemiology and microbiology. Aspiration pneumonia comprises 5% to 15% of patients with pneumonia,[1] but is less well‐characterized despite being a major syndrome of pneumonia in the elderly.[2, 3] Difficulties in studying aspiration pneumonia include the lack of a sensitive and specific marker for aspiration, the overlap between aspiration pneumonia and other forms of pneumonia, and the lack of differentiation between aspiration pneumonia and aspiration pneumonitis by many clinicians.[4, 5, 6] Aspiration pneumonia, which develops after the aspiration of oropharyngeal contents, differs from aspiration pneumonitis, wherein inhalation of gastric contents causes inflammation without the subsequent development of bacterial infection.[7, 8]

A number of validated mortality prediction models exist for community‐acquired pneumonia (CAP), using a variety of clinical predictors. One clinical prediction rule endorsed by the British Thoracic Society is the CURB‐65, which assigns a score for Confusion, Uremia >19 mg/dL, Respiratory rate >= 30 breaths/min, Blood Pressure < 90 mmHg systolic or < 60 mmHg diastolic, and age 65). We favor eCURB, a version of the CURB‐65 model that uses continuously weighted variables to more accurately predict mortality, validated in CAP populations.[9] Most studies validating pneumonia severity scoring systems excluded aspiration pneumonia from their study population.[10, 11, 12] Severity scoring systems for CAP may not accurately predict disease severity patients with aspiration pneumonia.

The aims of our study were to: (1) identify a population of patients with aspiration pneumonia; (2) compare characteristics and outcomes in patients with community‐acquired aspiration pneumonia to those with CAP; and (3) study the performance of eCURB and CURB‐65 in predicting mortality for patients with community‐acquired aspiration pneumonia.

PATIENTS AND METHODS

Study Design and Setting

The study was performed at LDS Hospital, a university‐affiliated community teaching hospital in Salt Lake City, Utah, with 520 beds. In retrospective analysis of data from the electronic medical records, we identified all patients older than 18 years who were evaluated in the emergency department at LDS Hospital or admitted patients from other sources (direct admission, transfer from another hospital) from 1996 to 2006 with International Statistical Classification of Disease and Health Related Problems, 9th Revision (ICD‐9) codes specific for aspiration pneumonia and pneumonitis (507.x). The treating physicians were mostly hospitalists and intensivists. Two physicians (M.L. and N.D.) manually reviewed the electronic medical records, including the emergency room physician's notes, the admission histories and physicals, the discharge summaries, and radiographic reports of the patients identified in the query. Consensus regarding the diagnosis of aspiration pneumonia was achieved in all patients reviewed using criteria listed in Table 1. This study was approved by the LDS Hospital institutional review board, and permission was granted to use the Utah Population Database for determining mortality (#1008505), with a waiver of informed consent. For the contemporaneous group of CAP patients, we used a previously described population identified using ICD‐9 codes 481.x to 487.x, captured from the same hospital during the same period.[13]

Inclusion and Exclusion Criteria for the Study
Inclusion CriteriaExclusion Criteria
  • NOTE: Abbreviations: AIDS, acquired immune deficiency syndrome.
1. Age 18 years1. Absence of radiographic evidence of pneumonia within 48 hours after evaluation
2. Either admitted to hospital or evaluated in emergency department2. Previous episode of aspiration pneumonia within 12 months
3. 507.x code as primary diagnosis3. Initial admission date >48 hours before transfer to LDS Hospital
4. 507.x code as secondary diagnosis with a primary diagnosis of pneumonia, respiratory failure, or septicemia4. AIDS 5. Receipt of antiretroviral therapy 6. History of solid organ transplant
5. Treating physician indicated a diagnosis of aspiration pneumonia in the history and physical and/or discharge summary7. Hematologic malignancy 8. Witnessed isolated aspiration event within 24 hours prior to evaluation 9. Drug overdose, cardiopulmonary arrest, or seizure prior to hospital admission 10. Laryngoscopic or bronchoscopic evidence of food material in airway

Inclusion and Exclusion Criteria

Inclusion and exclusion criteria are listed in Table 1. To exclude patients with recurrent pneumonia, we included only the first episode of pneumonia in a given 12‐month period. LDS Hospital frequently receives patients transferred from surrounding emergency departments and intensive care units. We excluded patients who were transferred >48 hours from their initial emergency department admission and therefore were late in their disease course. Exclusion criteria 8 to 10 were used to exclude patients with clinical presentations more consistent with aspiration pneumonitis. We also excluded immunocompromised patients (criteria 4 to 7).

Healthcare‐associated aspiration pneumonia was defined as receipt of chronic hemodialysis, residence in a nursing facility, or hospitalization within any Intermountain Healthcare‐affiliated hospital within the past 90 days.[14] The remaining patients were defined as community‐acquired aspiration pneumonia.

Measurements

The first vital signs, orientation status, and first 12 hours of routine laboratory results were extracted from the electronic medical records and used to calculate predicted mortality by eCURB and CURB‐65. We determined 30‐day mortality from the merger of the electronic medical records with vital status information from the Utah Population Database.[15] The first measured SpO2 and FiO2 were used to estimate the PaO2/FiO2 ratio, using the Severinghaus calculation[16] if no arterial blood gas was available. Presence of American Thoracic Society/Infectious Diseases Society of America (IDSA/ATS) 2007 minor criteria for severe community‐acquired pneumonia (SCAP)[17] were obtained from baseline patient characteristics (Table 2). A Charlson comorbidity index was calculated from ICD‐9 codes using published methodology.[18, 19] Presence of an abnormal swallow was defined as dysphagia or aspiration on modified barium swallow study, fiberoptic endoscopic evaluation, or clinical determination by a speech language pathologist during the index hospitalization. We also looked for causative pathogens, defined by a positive pneumococcus or legionella urinary antigen, or a positive culture from blood, bronchoalveolar lavage, pleural fluid, or tracheal aspirate, collected within 24 hours of admission. Antibiotics administered within the first 24 hours of admission were classified into 4 broad groups based on local physician prescribing patterns. Clindamycin and metronidazole were considered anaerobic‐specific antibiotics. Vancomycin or linezolid were considered methicillin‐resistant Staphylococcus aureus (MRSA) antibiotics. Broad‐spectrum antibiotics included any of the following: carbapenems, aztreonam, piperacillin/tazobactam, ticarcillin/clavulanate, cefepime, and ceftazidime. Macrolides, respiratory fluoroquinolones, and third‐generation cephalosporins were considered standard‐care antibiotics.

Minor Criteria for Severe Community‐Acquired Pneumonia, From the Infectious Disease Society of America/American Thoracic Society 2007 Criteria
Respiratory rate 30 breaths/minute
PaO2/FiO2 250
Multilobar infiltrates
Confusion/disorientation
Uremia (blood urea nitrogen 20 mg/dL)
Leukopenia (white blood cell count <4000 cells/mm3)
Thrombocytopenia (platelet count <100,000 cells/mm3)
Hypothermia (core temperature 36C)
Hypotension requiring aggressive fluid resuscitation

Statistical Analysis

We compared baseline patient characteristics and clinical outcomes using the Fisher exact test to compare proportions of categorical variables, and Mann‐Whitney U test or Student t test to compare central tendencies of continuous variables, as dictated by the normality of the data. Receiver operating characteristic curves calculated the ability of eCURB and CURB‐65 to predict 30‐day mortality prediction in patients with community‐acquired aspiration pneumonia and CAP, as well as the ability of IDSA/ATS minor criteria for SCAP to predict admission to the intensive care unit (ICU). We performed multivariate logistic regression to predict 30‐day mortality in patients with community‐acquired aspiration pneumonia and CAP, using stepwise backward elimination. Confounders were included if they were significant at a 0.05 level or if they altered the coefficient of the main variable by more than 10%. For logistic models, we evaluated goodness of fit with the Hosmer‐Lemeshow technique; comparisons of area under the curve (AUC) among models were made using the technique of DeLong.[20] Two‐tailed P values of 0.05 were considered statistically significant. Stata version 12 (StataCorp, College Station, TX) was used for all analyses.

RESULTS

Our initial query identified 1165 patients. Physician review of the medical records resulted in 628 patients, 118 of whom were classified as healthcare‐associated aspiration pneumonia (Figure 1, Table 3). Of all aspiration pneumonia patients, 80% were seen in the emergency department, 12.5% were directly admitted from the community, and 7.5% were transferred from another healthcare facility. Almost all patients seen in the emergency department (99.0%) were admitted to the hospital, with median length of hospitalization 6.7 days among survivors.

Figure 1
Inclusion and exclusion criteria. Abbreviations: HIV/AIDS, human immunodeficiency virus/acquired immune deficiency syndrome; ICD‐9, International Classification of Diseases, 9th Revision.
Patient Characteristics of Aspiration Pneumonia, Subdivided by Presence of Healthcare Association
 Aspiration Pneumonia (N = 628)Community‐Acquired Aspiration Pneumonia (N = 510)Healthcare Associated Aspiration Pneumonia (N=118)P Value
  • NOTE: All continuous or ordinal data are median values followed by interquartile ranges, unless otherwise specified. Significance testing between community‐acquired aspiration pneumonia and healthcare‐associated aspiration pneumonia was calculated with Fisher exact or Wilcoxon tests, where appropriate. Abbreviations: AUC, area under the curve; DNR/DNI, Do not resuscitate/do not intubate; ED, emergency department; LOS, length of stay; MRSA, methicillin‐resistant Staphylococcus aureus; SCAP, severe community‐acquired pneumonia. *SCAP described in the 2007 Infectious Diseases Society of America/American Thoracic Society guidelines (Table 2).
Age (range), y77 (6585)77 (6485)80 (6786)0.42
Female, %49.850.248.30.76
30‐day mortality, %21.0%19.0%29.7%0.02
CURB‐65 score2 (13)2 (13)2 (13)0.0012
Confusion13.9%12.7%18.6%0.10
Blood urea nitrogen (mg/dL)22 (1634)21 (1532)30 (2047)<0.0001
Respiratory rate (breaths/min)20 (1826)20 (1824)21 (1828)0.30
Systolic blood pressure (mm Hg)128 (110149)129 (110150)127 (105146)0.28
eCURB 30‐day mortality estimate (median, %)5.6 (2.414.2)5.2 (2.212.4)8.9 (4.222.5)<0.0001
eCURB 30‐day mortality estimate (mean, %)10.6 12.29.7 11.514.614.1<0.0001
Hospital admission (of ED visits), %99.098.81000.59
Hospital LOS, d6.7 (4.111.1)6.5 (4.011.0)7.8 (5.412.3)0.05
ICU admission, %37.937.141.50.21
ICU LOS, d3.5 (1.98.8)3.1 (1.87.6)5.6 (3.810.8)0.02
Mean ventilator‐free days (of ICU patients, out of 30 days)25.28.325.97.722.710.00.01
Receipt of mechanical ventilation, %18.617.224.60.09
Duration of ventilation, d2.8 (0.96.5)3.1 (1.06.6)1.9 (0.86.3)0.05
Receipt of vasopressor, %1.81.43.40.13
Charlson comorbidity index4 (26)3 (26)4 (36)0.0024
Cerebrovascular disease, %33.932.440.70.11
Chronic pulmonary disease, %51.051.847.50.42
Congestive heart failure, %52.450.062.70.01
Connective tissue disease, %8.48.86.80.58
Dementia, %14.212.023.70.0019
Hemiplegia/paraplegia9.48.015.20.02
Myocardial infarction, %21.017.829.70.02
Peripheral vascular disease, %17.716.323.70.06
Peptic ulcer disease, %18.819.216.90.70
Diabetes without complications, %10.79.216.90.02
Diabetes with complications, %31.530.436.40.23
Mild liver disease, %8.68.011.00.28
Moderate or severe liver disease, %1.81.62.50.44
Malignant solid tumor, %16.617.313.60.41
Metastatic cancer, %5.45.74.20.66
Renal disease, %14.74.218.60.19
3 or more minor SCAP criteria, %*24.723.131.40.08
PaO2/FiO2 ratio221 (161280)226 (169280)181 (133245)0.0004
Multilobar disease, %46.343.253.90.11
Presence of an effusion, %23.119.731.90.03
Swallow impairment (of tested survivors), %34.134.134.10.22
Presence of a DNR/DNI order, %26.423.738.10.0024
Mortality of patients with DNR/DNI order, %39.138.840.01.00
Receipt of broad‐spectrum antibiotic, %35.432.547.50.0028
Receipt of MRSA antibiotic, %7.55.715.30.0014
Receipt of anaerobe antibiotic, %28.727.633.10.26

Observed mortality was 21.0%. eCURB significantly underestimated mortality in this group, predicting a mortality rate of 10.6%. When classifying patients by the 2007 IDSA/ATS guidelines, 24.7% of the patients had 3 or more minor criteria for SCAP.[17] The PaO2/FiO2 ratio was obtained in 99.7% of patients. The median PaO2/FiO2 ratio observed in this population was 221 mm Hg (equivalent to 260 mm Hg at sea level barometric pressure, adjusted for our altitude of 1400 meters), near the threshold sea level definition (250 mm Hg) for SCAP.[13, 17] Admission to the ICU was common, as were admission orders for do not resuscitate (DNR) or do not intubate (DNI). Patients with healthcare‐associated aspiration pneumonia had a higher comorbidity index and had a higher mortality rate than patients with community‐acquired aspiration pneumonia, although we found no significant difference in the rate of hospital or ICU admission or the receipt of critical care therapies. Inpatient assessment of dysphagia and aspiration was conducted in 177 patients. Abnormal swallow was noted in 96% of those tested.

We found several differences between patients with community‐acquired aspiration pneumonia and 2584 patients with CAP identified during the same time period[13] (Table 4). Patients with community‐acquired aspiration pneumonia were older, more likely to have multilobar disease or effusion on imaging, and had greater disease severity. They also had a higher frequency of ICU and hospital admission, IDSA/ATS minor criteria for SCAP, and higher Charlson comorbidity indices. Patients with community‐acquired aspiration pneumonia were more likely to receive mechanical ventilation than CAP patients, although there was no difference in 30‐day mortality among intubated patients or a difference in ventilator‐free days.

Comparison of Community‐Acquired Aspiration Pneumonia and Typical Community‐Acquired Pneumonia
 Community‐Acquired Aspiration Pneumonia (N = 510)Community‐ Acquired Pneumonia (N = 2584)P Value
  • NOTE: All dichotomous data are proportions. All continuous or ordinal data are median values followed by interquartile ranges, unless otherwise specified. Significance testing was calculated with Fisher exact or Wilcoxon tests, where appropriate. Abbreviations: AUC, area under the curve; CURB‐65, a clinical prediction rule based on Confusion, Uremia, Respiratory rate, Blood Pressure, and age > 65; DNR/DNI, do not resuscitate/do not intubate; eCURB, a version of the CURB‐65 mode that uses continuously weighted variables; ED, emergency department; ICU, intensive care unit; LOS, length of stay; MRSA, methicillin‐resistant Staphylococcus aureus; SCAP, severe community‐acquired pneumonia *SCAP described in the 2007 Infectious Diseases Society of America/American Thoracic Society guidelines.
Age (range), y77 (6485)59 (4176)<0.0001
Female, %50.249.50.81
30‐day mortality, %19.04.2<0.0001
CURB‐65 score2 (13)1 (02)<0.0001
Confusion, %12.75.1<0.0001
Blood urea nitrogen21 (1532)16 (1124)<0.0001
Respiratory rate20 (1824)20 (1824)<0.0001
Systolic blood pressure129 (110150)130 (112146)0.67
eCURB 30‐day mortality estimate, median, %5.2 (2.212.4)1.7 (0.94.3)<0.0001
eCURB 30‐day mortality estimate, mean, %9.7 11.54.4 7.5<0.0001
AUC of eCURB versus mortality0.71 (0.660.75)0.86 (0.830.90)<0.0001
Excluding DNR/DNI patients0.69 (0.650.74)0.87 (0.830.90)0.0001
AUC of CURB‐65 versus mortality0.66 (0.620.69)0.81 (0.780.85)<0.0001
Excluding DNR/DNI patients0.65 (0.600.70)0.81 (0.760.85)0.0003
Hospital admission (of ED visits), %98.857.8<0.0001
Hospital LOS, d6.5 (4.011.0)3.3 (2.25.2)<0.0001
ICU admission, %37.114.2<0.0001
ICU LOS, d3.1 (1.87.6)2.5 (1.17.7)0.01
Mean ventilator‐free days (of ICU patients, out of 30 days)25.9 7.725 90.75
Receipt of mechanical ventilation, %17.27.8<0.0001
Duration of ventilation, d3.1 (1.06.6)3.5 (1.57.2)0.09
Receipt of vasopressor, %1.43.30.02
Charlson comorbidity index3 (26)1 (03)<0.0001
Cerebrovascular disease, %32.410.0<0.0001
Chronic pulmonary disease, %51.842.5<0.0001
Congestive heart failure, %50.022.1<0.0001
Connective tissue disease, %8.85.60.0084
Dementia, %12.02.8<0.0001
Hemiplegia/paraplegia, %8.02.7<0.0001
Myocardial infarction, %17.810.8<0.0001
Peripheral vascular disease, %16.37.4<0.0001
Peptic ulcer disease, %19.27.6<0.0001
Diabetes without complications, %9.224.7<0.0001
Diabetes with complications, %30.45.1<0.0001
Mild liver disease, %8.06.20.14
Moderate or severe liver disease, %1.60.80.13
Malignant solid tumor, %17.8.9<0.0001
Metastatic cancer, %5.71.3<0.0001
Renal disease, %4.25.6<0.0001
3 or more minor SCAP criteria, %*24.719.10.01
PaO2/FiO2 ratio226 (169280)260 (148338)0.0004
Multilobar disease, %43.237.20.0012
Presence of an effusion, %19.718.3<0.0001
Presence of a DNR/DNI order, %23.79.7<0.0001
Mortality of patients with DNR/DNI order, %38.812.4<0.0001
Receipt of broad‐spectrum antibiotic, %32.58.4<0.0001
Receipt of MRSA antibiotic, %5.72.2<0.0001
Receipt of anaerobe antibiotic, %27.63.1<0.0001

Thirty‐day mortality for patients with community‐acquired aspiration pneumonia was significantly higher than in CAP patients. Patients with community‐acquired aspiration pneumonia also had higher eCURB and CURB‐65 scores. However, eCURB was a poor predictor of 30‐day mortality, with an AUC of 0.71, compared to 0.86 calculated for the CAP population (Figure 2). CURB‐65 performed similarly: AUC was 0.66 vs 0.81. The presence of a DNR/DNI order was twice as prevalent in the community‐acquired aspiration pneumonia population vs the CAP population; those patients with a DNR/DNI order were 3 times as likely to die. Excluding patients with a DNR/DNI order did not improve performance of eCURB or CURB‐65 (Table 4). The presence of IDSA/ATS minor criteria for SCAP was not predictive of triage to the ICU in the group of patients with community‐acquired aspiration pneumonia (AUC: 0.51), compared with CAP patients (AUC: 0.88, P < 0.01 for comparison, Figure 3). This finding persisted in the subset of patients without a DNR/DNI order (AUC: 0.52 in community‐acquired aspiration pneumonia vs 0.88 in CAP, P < 0.01).

Figure 2
Receiver operating characteristic curve, comparing the eCURB score against 30‐day mortality in patients with typical community‐acquired pneumonia and in patients with community‐acquired aspiration pneumonia. The eCURB score is an electronic version of the CURB‐65 model, validated in the community‐acquired pneumonia population, that uses continuously weighted variables to more accurately predict mortality.These curves statistically differ, P < 0.0001. Abbreviations: AUC, area under the curve; CAP, community‐acquired pneumonia.
Figure 3
Receiver operating characteristic curve, comparing the Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) minor criteria for severe community‐acquired pneumonia against intensive care unit (ICU) admission in patients with typical community‐acquired pneumonia (CAP) and in patients with community‐acquired aspiration pneumonia. These curves statistically differ, P < 0.0001. Abbreviations: AUC: area under the curve.

Our regression model of mortality incorporated gender, presence of effusion or multilobar pneumonia, presence of a DNR/DNI order, and all the components of the CURB‐65, IDSA/ATS minor criteria for SCAP, and Charlson comorbidity index. The regression model demonstrated that even after adjustment for age, comorbidities, disease severity, and presence of a DNR/DNI order, the presence of aspiration pneumonia was associated with higher mortality than CAP (odds ratio [OR]: 3.46, P < 0.001, Table 5). In this model, systolic blood pressure did not predict mortality, and diabetes with complications was associated with decreased mortality.

Final Logistic Regression Model Predicting 30‐Day Mortality in Patients With Community‐Acquired Pneumonia and Community‐Acquired Aspiration Pneumonia
 Odds RatioP Value
  • NOTE: Initial model also included gender, presence of multilobar pneumonia, and all components of the CURB (Confusion, Uremia, Respiratory Rate, Blood Pressure) score and Charlson comorbidity index, and minor criteria for severe community‐acquired pneumonia. Area under the curve of the final model = 0.87. Odds ratios are followed by 95% confidence intervals in parentheses. Exclusion of DNR/DNI status did not significantly alter the regression model. Abbreviations: DNR/DNI, do not resuscitate/do not intubate.
Presence of aspiration pneumonia3.46 (2.115.67)<0.001
Age, y1.03 (1.011.04)<0.001
Confusion3.14 (1.955.05)<0.001
Blood urea nitrogen, mg/dL1.03 (1.021.04)<0.001
Respiratory rate, breaths/minute1.03 (1.001.06)0.04
PaO2/FiO2 ratio, per 1 mm Hg0.99 (0.991.00)<0.001
Moderate or severe liver disease9.21 (3.1626.86)<0.001
Paraplegia/hemiplegia2.43 (1.135.27)0.02
Diabetes with complications0.42 (0.200.87)0.02
Leukocytosis4.47 (2.278.82)<0.001
DNR/DNI1.75 (1.112.75)0.02

Microbiological Findings

Blood cultures were performed at admission in 67.4% of aspiration‐pneumonia patients, and a tracheal aspirate in half (50.7%) of intubated patients with aspiration pneumonia. Organisms were recovered in 90 patients (14.3%), although 41 of those patients had tracheal aspirates of organisms commonly thought to be nonpathogenic (nonpneumococcal alpha‐hemolytic streptococcus, nonhemolytic streptococcus, diphtheroids, micrococci, coagulase negative staphylococccus). Tracheal aspirate was the most common method of recovering an organism (7.8% of patients), followed by blood culture (4.3%). Bronchoalveolar lavage, urinary antigen, and pleural fluid culture were less common (1.3%, 1.1%, 0.3%, respectively). The microbiologic results were grouped into: Staphylococcus aureus, Streptococcus pneumoniae, enteric bacilli, Haemophilus species, Neisseria species, Moraxella catarrhalis, and Pseudomonas aeruginosa (Figure 4). Comparing healthcare‐associated with community‐acquired aspiration pneumonia, healthcare‐associated patients were more likely to have a confirmed infection with MRSA (4.2% vs 1.4%, P = 0.06) and enteric bacteria (5.1% vs 1.6%, P = 0.03). There were no other statistically significant differences in microbiologic recovery between the 2 groups. Antibiotics targeting anaerobic pathogens were administered in 28.7% of patients with aspiration pneumonia, with no correlation to the presence of healthcare‐associated risks. Healthcare‐associated patients were more likely to receive broad‐spectrum antibiotics (47.5% vs 32.5%, P < 0.01) and MRSA coverage (15.3% vs 5.7%, P < 0.01) than patients with community‐acquired aspiration pneumonia.

Figure 4
Distribution of bacterial organism recovered from 628 patients with aspiration pneumonia. Percentages are expressed as a fraction of 628 patients. Note that the total exceeds 100% due to polymicrobial infection. Viral, fungal, and acid fast bacilli cultures were not routinely obtained and not included in this graphic. Other = Bacillus cereus (1), Serratia marcescens (1), Nocardia species (1), Acinetobacter bauminii (1), Capnocytophaga (1), Eikenella corrodens (1), Proteus (1), Saccharomyces cerevisiae (1). Abbreviations: M. catarrhalis, Moraxella catarrhalis; MRSA, methicillin‐resistant Staphylococcus aureus; MSSA, methicillin‐sensitive Staphylococcus aureus; S. pneumoniae, Streptococcus pneumoniae.

DISCUSSION

Our study identifies a larger cohort of patients with aspiration pneumonia than previous studies.[21, 22, 23, 24, 25] Patients with community‐acquired aspiration pneumonia are older and more likely to die than CAP patients. They are more likely to be admitted to the hospital or ICU. Thirty‐day mortality in this patient population was significantly underestimated by CURB‐65 and eCURB, models developed and validated in CAP populations.[9, 26] This finding supports a prior study.[27] It appears that a traditional prognostic model assessing mortality risk in the CAP patient does not apply to the aspiration‐pneumonia patient. One reason for eCURB and CURB‐65s poor utility in community‐acquired aspiration pneumonia may be their reliance on objective clinical features rather than comorbidities, which may influence mortality to a greater degree in aspiration pneumonia.

This study has several limitations. There is no gold standard for the definition of aspiration pneumonia, and it is difficult to distinguish aspiration pneumonia from typical pneumonia. It is plausible that older patients with greater comorbidities are being designated as aspiration pneumonia. If this is the case, then aspiration pneumonia merely represents the end of the pneumonia spectrum with highest mortality risk, and it is no surprise that these patients fare poorly.

It appears that the hospitalist or emergency department physician implicitly appreciates that aspiration pneumonia has a higher mortality risk than predicted by traditional severity assessment. With such high mortality and morbidity, a patient presenting to the emergency room with aspiration pneumonia is almost always admitted to the hospital. Further work in this area should investigate other factors to improve prognostic modeling in patients with aspiration pneumonia, although the utility of such a model may be limited to determining ICU admission. Our data indicate that IDSA/ATS minor criteria for SCAP are not useful in predicting admission to the ICU in patients with aspiration pneumonia.

In this study, a DNR/DNI order was twice as common in the community‐acquired aspiration pneumonia population than the CAP population. However, patients with community‐acquired aspiration pneumonia and a DNR/DNI order were more than 3 times more likely to die than patients with CAP and a DNR/DNI order. Our regression model suggested that the presence of a DNR/DNI order was an independent predictor of mortality (OR: 1.75, P < 0.001). Although a DNR/DNI order may correlate with the withholding or withdrawal of medical therapy, it is also a surrogate for increased age or comorbidities.[28] In our study, however, the increased prevalence of DNR/DNI orders did not explain the poor mortality prediction of the eCURB or CURB‐65, as exclusion of those patients did not significantly alter the AUCs in either the aspiration group or the CAP group.

Controversy exists regarding treatment of aspiration pneumonia. Historically, some have advocated for treatment of aspiration pneumonia with a regimen designed to cover anaerobic bacteria.[29] This recommendation was based on early microbiologic studies that obtained the samples late in the course of illness, or other studies where the sample was obtained transtracheally, where oropharyngeal flora may contaminate the sample.[30, 31, 32] Our clinically obtained microbiologic recovery of organisms was similar to the flora recovered in more recent CAP studies, in respect to both the incidence of pathogen recovery and the relative frequencies of recovered organisms.[33, 34] Our data do not support inferences regarding the prevalence of anaerobic infections, as the recovery of anaerobic organisms was limited to blood and pleural fluid cultures in this study, rather than techniques used in research settings that might have greater yield. As expected, patients with healthcare‐associated risk factors trended toward increased incidence of MRSA. Given the similarity of the organisms recovered to those recovered in CAP,[35] this study supports IDSA/ATS recommendations that antibiotic therapy in aspiration pneumonia be similar to that of higher‐risk CAP, with the addition of vancomycin or linezolid for MRSA coverage in patients with risk factors for healthcare‐associated pneumonia.[17]

Our study is limited by its single‐center retrospective design. However, beginning in 1995, the LDS Hospital emergency department initiated a standardized pneumonia therapy protocol and deployed electronic medical records, which prospectively recorded a wide array of clinical, therapeutic, and biometric data. Most data elements used in this analysis were routinely charted for clinical purposes in real time. Although the eCURB, CURB‐65, and some comorbidities could be extracted electronically for each patient, it was not possible to calculate the pneumonia severity index score due to our inability to rigorously identify the necessary comorbid illness elements. Other comorbidities, not present in our model, may have been identified by the physician who makes a diagnosis of aspiration pneumonia. Our identification of swallow impairment is also methodologically limited. The decision to obtain a swallow study was clinical, usually occurring upon convalescence. Therefore, it is not possible to distinguish between antecedent oropharyngeal dysfunction and post‐critical illness dysfunction.

Our definition of aspiration pneumonia required the treating physician to diagnose and code the patient as having aspiration pneumonia, followed by excluding patients more likely to have aspiration pneumonitis. Although we relied on ICD‐9 codes to initially identify aspiration pneumonia, all patients in our database were confirmed by physician chart review. Our incidence of community‐acquired aspiration pneumonia is congruent with other studies using different methodologies.[1, 36, 37] Unfortunately, there is no standard and widely accepted definition for separating aspiration pneumonia from usual CAP. A younger and healthier patient who has developed pneumonia subsequent to aspiration may be more likely to be diagnosed with CAP, resulting in selection bias for older patients with greater comorbidities.

CONCLUSION

Patients diagnosed with aspiration pneumonia are older, have more comorbid conditions, and demonstrate greater disease severity and higher 30‐day mortality than CAP patients. Mortality prediction using CURB‐65 and eCURB in this population was poor, possibly due to a greater effect of comorbidities on mortality. The pneumonia severity index, which incorporates patient comorbidities, might perform better than the eCURB or CURB‐65, and should be studied in aspiration pneumonia populations where comorbid illness information is prospectively collected. Further areas of study include creating an improved mortality prediction model for aspiration pneumonia that incorporates comorbid conditions, DNR/DNI status, and disease severity.

Acknowledgments

The authors acknowledge Al Jephson for database support, Yao Li for statistical analysis, and Anita Austin for help reviewing the medical records. Dr. Lanspa had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Disclosure

Preliminary versions of this work were presented as posters at the American Thoracic Society Meeting, Denver, Colorado, May 17, 2011. This study was supported by grants from the Intermountain Research and Medical Foundation. Dr. Brown is supported by a career development award from National Institute of General Medical Sciences (K23GM094465). Dr. Dean served on an advisory board for Merck, has been a paid consultant for Cerexa, and has received an investigator‐initiated competitive grant from Pfizer for development of an electronic pneumonia decision support tool. All other authors report no relevant financial disclosures.

Pneumonia is a common clinical syndrome with well‐described epidemiology and microbiology. Aspiration pneumonia comprises 5% to 15% of patients with pneumonia,[1] but is less well‐characterized despite being a major syndrome of pneumonia in the elderly.[2, 3] Difficulties in studying aspiration pneumonia include the lack of a sensitive and specific marker for aspiration, the overlap between aspiration pneumonia and other forms of pneumonia, and the lack of differentiation between aspiration pneumonia and aspiration pneumonitis by many clinicians.[4, 5, 6] Aspiration pneumonia, which develops after the aspiration of oropharyngeal contents, differs from aspiration pneumonitis, wherein inhalation of gastric contents causes inflammation without the subsequent development of bacterial infection.[7, 8]

A number of validated mortality prediction models exist for community‐acquired pneumonia (CAP), using a variety of clinical predictors. One clinical prediction rule endorsed by the British Thoracic Society is the CURB‐65, which assigns a score for Confusion, Uremia >19 mg/dL, Respiratory rate >= 30 breaths/min, Blood Pressure < 90 mmHg systolic or < 60 mmHg diastolic, and age 65). We favor eCURB, a version of the CURB‐65 model that uses continuously weighted variables to more accurately predict mortality, validated in CAP populations.[9] Most studies validating pneumonia severity scoring systems excluded aspiration pneumonia from their study population.[10, 11, 12] Severity scoring systems for CAP may not accurately predict disease severity patients with aspiration pneumonia.

The aims of our study were to: (1) identify a population of patients with aspiration pneumonia; (2) compare characteristics and outcomes in patients with community‐acquired aspiration pneumonia to those with CAP; and (3) study the performance of eCURB and CURB‐65 in predicting mortality for patients with community‐acquired aspiration pneumonia.

PATIENTS AND METHODS

Study Design and Setting

The study was performed at LDS Hospital, a university‐affiliated community teaching hospital in Salt Lake City, Utah, with 520 beds. In retrospective analysis of data from the electronic medical records, we identified all patients older than 18 years who were evaluated in the emergency department at LDS Hospital or admitted patients from other sources (direct admission, transfer from another hospital) from 1996 to 2006 with International Statistical Classification of Disease and Health Related Problems, 9th Revision (ICD‐9) codes specific for aspiration pneumonia and pneumonitis (507.x). The treating physicians were mostly hospitalists and intensivists. Two physicians (M.L. and N.D.) manually reviewed the electronic medical records, including the emergency room physician's notes, the admission histories and physicals, the discharge summaries, and radiographic reports of the patients identified in the query. Consensus regarding the diagnosis of aspiration pneumonia was achieved in all patients reviewed using criteria listed in Table 1. This study was approved by the LDS Hospital institutional review board, and permission was granted to use the Utah Population Database for determining mortality (#1008505), with a waiver of informed consent. For the contemporaneous group of CAP patients, we used a previously described population identified using ICD‐9 codes 481.x to 487.x, captured from the same hospital during the same period.[13]

Inclusion and Exclusion Criteria for the Study
Inclusion CriteriaExclusion Criteria
  • NOTE: Abbreviations: AIDS, acquired immune deficiency syndrome.
1. Age 18 years1. Absence of radiographic evidence of pneumonia within 48 hours after evaluation
2. Either admitted to hospital or evaluated in emergency department2. Previous episode of aspiration pneumonia within 12 months
3. 507.x code as primary diagnosis3. Initial admission date >48 hours before transfer to LDS Hospital
4. 507.x code as secondary diagnosis with a primary diagnosis of pneumonia, respiratory failure, or septicemia4. AIDS 5. Receipt of antiretroviral therapy 6. History of solid organ transplant
5. Treating physician indicated a diagnosis of aspiration pneumonia in the history and physical and/or discharge summary7. Hematologic malignancy 8. Witnessed isolated aspiration event within 24 hours prior to evaluation 9. Drug overdose, cardiopulmonary arrest, or seizure prior to hospital admission 10. Laryngoscopic or bronchoscopic evidence of food material in airway

Inclusion and Exclusion Criteria

Inclusion and exclusion criteria are listed in Table 1. To exclude patients with recurrent pneumonia, we included only the first episode of pneumonia in a given 12‐month period. LDS Hospital frequently receives patients transferred from surrounding emergency departments and intensive care units. We excluded patients who were transferred >48 hours from their initial emergency department admission and therefore were late in their disease course. Exclusion criteria 8 to 10 were used to exclude patients with clinical presentations more consistent with aspiration pneumonitis. We also excluded immunocompromised patients (criteria 4 to 7).

Healthcare‐associated aspiration pneumonia was defined as receipt of chronic hemodialysis, residence in a nursing facility, or hospitalization within any Intermountain Healthcare‐affiliated hospital within the past 90 days.[14] The remaining patients were defined as community‐acquired aspiration pneumonia.

Measurements

The first vital signs, orientation status, and first 12 hours of routine laboratory results were extracted from the electronic medical records and used to calculate predicted mortality by eCURB and CURB‐65. We determined 30‐day mortality from the merger of the electronic medical records with vital status information from the Utah Population Database.[15] The first measured SpO2 and FiO2 were used to estimate the PaO2/FiO2 ratio, using the Severinghaus calculation[16] if no arterial blood gas was available. Presence of American Thoracic Society/Infectious Diseases Society of America (IDSA/ATS) 2007 minor criteria for severe community‐acquired pneumonia (SCAP)[17] were obtained from baseline patient characteristics (Table 2). A Charlson comorbidity index was calculated from ICD‐9 codes using published methodology.[18, 19] Presence of an abnormal swallow was defined as dysphagia or aspiration on modified barium swallow study, fiberoptic endoscopic evaluation, or clinical determination by a speech language pathologist during the index hospitalization. We also looked for causative pathogens, defined by a positive pneumococcus or legionella urinary antigen, or a positive culture from blood, bronchoalveolar lavage, pleural fluid, or tracheal aspirate, collected within 24 hours of admission. Antibiotics administered within the first 24 hours of admission were classified into 4 broad groups based on local physician prescribing patterns. Clindamycin and metronidazole were considered anaerobic‐specific antibiotics. Vancomycin or linezolid were considered methicillin‐resistant Staphylococcus aureus (MRSA) antibiotics. Broad‐spectrum antibiotics included any of the following: carbapenems, aztreonam, piperacillin/tazobactam, ticarcillin/clavulanate, cefepime, and ceftazidime. Macrolides, respiratory fluoroquinolones, and third‐generation cephalosporins were considered standard‐care antibiotics.

Minor Criteria for Severe Community‐Acquired Pneumonia, From the Infectious Disease Society of America/American Thoracic Society 2007 Criteria
Respiratory rate 30 breaths/minute
PaO2/FiO2 250
Multilobar infiltrates
Confusion/disorientation
Uremia (blood urea nitrogen 20 mg/dL)
Leukopenia (white blood cell count <4000 cells/mm3)
Thrombocytopenia (platelet count <100,000 cells/mm3)
Hypothermia (core temperature 36C)
Hypotension requiring aggressive fluid resuscitation

Statistical Analysis

We compared baseline patient characteristics and clinical outcomes using the Fisher exact test to compare proportions of categorical variables, and Mann‐Whitney U test or Student t test to compare central tendencies of continuous variables, as dictated by the normality of the data. Receiver operating characteristic curves calculated the ability of eCURB and CURB‐65 to predict 30‐day mortality prediction in patients with community‐acquired aspiration pneumonia and CAP, as well as the ability of IDSA/ATS minor criteria for SCAP to predict admission to the intensive care unit (ICU). We performed multivariate logistic regression to predict 30‐day mortality in patients with community‐acquired aspiration pneumonia and CAP, using stepwise backward elimination. Confounders were included if they were significant at a 0.05 level or if they altered the coefficient of the main variable by more than 10%. For logistic models, we evaluated goodness of fit with the Hosmer‐Lemeshow technique; comparisons of area under the curve (AUC) among models were made using the technique of DeLong.[20] Two‐tailed P values of 0.05 were considered statistically significant. Stata version 12 (StataCorp, College Station, TX) was used for all analyses.

RESULTS

Our initial query identified 1165 patients. Physician review of the medical records resulted in 628 patients, 118 of whom were classified as healthcare‐associated aspiration pneumonia (Figure 1, Table 3). Of all aspiration pneumonia patients, 80% were seen in the emergency department, 12.5% were directly admitted from the community, and 7.5% were transferred from another healthcare facility. Almost all patients seen in the emergency department (99.0%) were admitted to the hospital, with median length of hospitalization 6.7 days among survivors.

Figure 1
Inclusion and exclusion criteria. Abbreviations: HIV/AIDS, human immunodeficiency virus/acquired immune deficiency syndrome; ICD‐9, International Classification of Diseases, 9th Revision.
Patient Characteristics of Aspiration Pneumonia, Subdivided by Presence of Healthcare Association
 Aspiration Pneumonia (N = 628)Community‐Acquired Aspiration Pneumonia (N = 510)Healthcare Associated Aspiration Pneumonia (N=118)P Value
  • NOTE: All continuous or ordinal data are median values followed by interquartile ranges, unless otherwise specified. Significance testing between community‐acquired aspiration pneumonia and healthcare‐associated aspiration pneumonia was calculated with Fisher exact or Wilcoxon tests, where appropriate. Abbreviations: AUC, area under the curve; DNR/DNI, Do not resuscitate/do not intubate; ED, emergency department; LOS, length of stay; MRSA, methicillin‐resistant Staphylococcus aureus; SCAP, severe community‐acquired pneumonia. *SCAP described in the 2007 Infectious Diseases Society of America/American Thoracic Society guidelines (Table 2).
Age (range), y77 (6585)77 (6485)80 (6786)0.42
Female, %49.850.248.30.76
30‐day mortality, %21.0%19.0%29.7%0.02
CURB‐65 score2 (13)2 (13)2 (13)0.0012
Confusion13.9%12.7%18.6%0.10
Blood urea nitrogen (mg/dL)22 (1634)21 (1532)30 (2047)<0.0001
Respiratory rate (breaths/min)20 (1826)20 (1824)21 (1828)0.30
Systolic blood pressure (mm Hg)128 (110149)129 (110150)127 (105146)0.28
eCURB 30‐day mortality estimate (median, %)5.6 (2.414.2)5.2 (2.212.4)8.9 (4.222.5)<0.0001
eCURB 30‐day mortality estimate (mean, %)10.6 12.29.7 11.514.614.1<0.0001
Hospital admission (of ED visits), %99.098.81000.59
Hospital LOS, d6.7 (4.111.1)6.5 (4.011.0)7.8 (5.412.3)0.05
ICU admission, %37.937.141.50.21
ICU LOS, d3.5 (1.98.8)3.1 (1.87.6)5.6 (3.810.8)0.02
Mean ventilator‐free days (of ICU patients, out of 30 days)25.28.325.97.722.710.00.01
Receipt of mechanical ventilation, %18.617.224.60.09
Duration of ventilation, d2.8 (0.96.5)3.1 (1.06.6)1.9 (0.86.3)0.05
Receipt of vasopressor, %1.81.43.40.13
Charlson comorbidity index4 (26)3 (26)4 (36)0.0024
Cerebrovascular disease, %33.932.440.70.11
Chronic pulmonary disease, %51.051.847.50.42
Congestive heart failure, %52.450.062.70.01
Connective tissue disease, %8.48.86.80.58
Dementia, %14.212.023.70.0019
Hemiplegia/paraplegia9.48.015.20.02
Myocardial infarction, %21.017.829.70.02
Peripheral vascular disease, %17.716.323.70.06
Peptic ulcer disease, %18.819.216.90.70
Diabetes without complications, %10.79.216.90.02
Diabetes with complications, %31.530.436.40.23
Mild liver disease, %8.68.011.00.28
Moderate or severe liver disease, %1.81.62.50.44
Malignant solid tumor, %16.617.313.60.41
Metastatic cancer, %5.45.74.20.66
Renal disease, %14.74.218.60.19
3 or more minor SCAP criteria, %*24.723.131.40.08
PaO2/FiO2 ratio221 (161280)226 (169280)181 (133245)0.0004
Multilobar disease, %46.343.253.90.11
Presence of an effusion, %23.119.731.90.03
Swallow impairment (of tested survivors), %34.134.134.10.22
Presence of a DNR/DNI order, %26.423.738.10.0024
Mortality of patients with DNR/DNI order, %39.138.840.01.00
Receipt of broad‐spectrum antibiotic, %35.432.547.50.0028
Receipt of MRSA antibiotic, %7.55.715.30.0014
Receipt of anaerobe antibiotic, %28.727.633.10.26

Observed mortality was 21.0%. eCURB significantly underestimated mortality in this group, predicting a mortality rate of 10.6%. When classifying patients by the 2007 IDSA/ATS guidelines, 24.7% of the patients had 3 or more minor criteria for SCAP.[17] The PaO2/FiO2 ratio was obtained in 99.7% of patients. The median PaO2/FiO2 ratio observed in this population was 221 mm Hg (equivalent to 260 mm Hg at sea level barometric pressure, adjusted for our altitude of 1400 meters), near the threshold sea level definition (250 mm Hg) for SCAP.[13, 17] Admission to the ICU was common, as were admission orders for do not resuscitate (DNR) or do not intubate (DNI). Patients with healthcare‐associated aspiration pneumonia had a higher comorbidity index and had a higher mortality rate than patients with community‐acquired aspiration pneumonia, although we found no significant difference in the rate of hospital or ICU admission or the receipt of critical care therapies. Inpatient assessment of dysphagia and aspiration was conducted in 177 patients. Abnormal swallow was noted in 96% of those tested.

We found several differences between patients with community‐acquired aspiration pneumonia and 2584 patients with CAP identified during the same time period[13] (Table 4). Patients with community‐acquired aspiration pneumonia were older, more likely to have multilobar disease or effusion on imaging, and had greater disease severity. They also had a higher frequency of ICU and hospital admission, IDSA/ATS minor criteria for SCAP, and higher Charlson comorbidity indices. Patients with community‐acquired aspiration pneumonia were more likely to receive mechanical ventilation than CAP patients, although there was no difference in 30‐day mortality among intubated patients or a difference in ventilator‐free days.

Comparison of Community‐Acquired Aspiration Pneumonia and Typical Community‐Acquired Pneumonia
 Community‐Acquired Aspiration Pneumonia (N = 510)Community‐ Acquired Pneumonia (N = 2584)P Value
  • NOTE: All dichotomous data are proportions. All continuous or ordinal data are median values followed by interquartile ranges, unless otherwise specified. Significance testing was calculated with Fisher exact or Wilcoxon tests, where appropriate. Abbreviations: AUC, area under the curve; CURB‐65, a clinical prediction rule based on Confusion, Uremia, Respiratory rate, Blood Pressure, and age > 65; DNR/DNI, do not resuscitate/do not intubate; eCURB, a version of the CURB‐65 mode that uses continuously weighted variables; ED, emergency department; ICU, intensive care unit; LOS, length of stay; MRSA, methicillin‐resistant Staphylococcus aureus; SCAP, severe community‐acquired pneumonia *SCAP described in the 2007 Infectious Diseases Society of America/American Thoracic Society guidelines.
Age (range), y77 (6485)59 (4176)<0.0001
Female, %50.249.50.81
30‐day mortality, %19.04.2<0.0001
CURB‐65 score2 (13)1 (02)<0.0001
Confusion, %12.75.1<0.0001
Blood urea nitrogen21 (1532)16 (1124)<0.0001
Respiratory rate20 (1824)20 (1824)<0.0001
Systolic blood pressure129 (110150)130 (112146)0.67
eCURB 30‐day mortality estimate, median, %5.2 (2.212.4)1.7 (0.94.3)<0.0001
eCURB 30‐day mortality estimate, mean, %9.7 11.54.4 7.5<0.0001
AUC of eCURB versus mortality0.71 (0.660.75)0.86 (0.830.90)<0.0001
Excluding DNR/DNI patients0.69 (0.650.74)0.87 (0.830.90)0.0001
AUC of CURB‐65 versus mortality0.66 (0.620.69)0.81 (0.780.85)<0.0001
Excluding DNR/DNI patients0.65 (0.600.70)0.81 (0.760.85)0.0003
Hospital admission (of ED visits), %98.857.8<0.0001
Hospital LOS, d6.5 (4.011.0)3.3 (2.25.2)<0.0001
ICU admission, %37.114.2<0.0001
ICU LOS, d3.1 (1.87.6)2.5 (1.17.7)0.01
Mean ventilator‐free days (of ICU patients, out of 30 days)25.9 7.725 90.75
Receipt of mechanical ventilation, %17.27.8<0.0001
Duration of ventilation, d3.1 (1.06.6)3.5 (1.57.2)0.09
Receipt of vasopressor, %1.43.30.02
Charlson comorbidity index3 (26)1 (03)<0.0001
Cerebrovascular disease, %32.410.0<0.0001
Chronic pulmonary disease, %51.842.5<0.0001
Congestive heart failure, %50.022.1<0.0001
Connective tissue disease, %8.85.60.0084
Dementia, %12.02.8<0.0001
Hemiplegia/paraplegia, %8.02.7<0.0001
Myocardial infarction, %17.810.8<0.0001
Peripheral vascular disease, %16.37.4<0.0001
Peptic ulcer disease, %19.27.6<0.0001
Diabetes without complications, %9.224.7<0.0001
Diabetes with complications, %30.45.1<0.0001
Mild liver disease, %8.06.20.14
Moderate or severe liver disease, %1.60.80.13
Malignant solid tumor, %17.8.9<0.0001
Metastatic cancer, %5.71.3<0.0001
Renal disease, %4.25.6<0.0001
3 or more minor SCAP criteria, %*24.719.10.01
PaO2/FiO2 ratio226 (169280)260 (148338)0.0004
Multilobar disease, %43.237.20.0012
Presence of an effusion, %19.718.3<0.0001
Presence of a DNR/DNI order, %23.79.7<0.0001
Mortality of patients with DNR/DNI order, %38.812.4<0.0001
Receipt of broad‐spectrum antibiotic, %32.58.4<0.0001
Receipt of MRSA antibiotic, %5.72.2<0.0001
Receipt of anaerobe antibiotic, %27.63.1<0.0001

Thirty‐day mortality for patients with community‐acquired aspiration pneumonia was significantly higher than in CAP patients. Patients with community‐acquired aspiration pneumonia also had higher eCURB and CURB‐65 scores. However, eCURB was a poor predictor of 30‐day mortality, with an AUC of 0.71, compared to 0.86 calculated for the CAP population (Figure 2). CURB‐65 performed similarly: AUC was 0.66 vs 0.81. The presence of a DNR/DNI order was twice as prevalent in the community‐acquired aspiration pneumonia population vs the CAP population; those patients with a DNR/DNI order were 3 times as likely to die. Excluding patients with a DNR/DNI order did not improve performance of eCURB or CURB‐65 (Table 4). The presence of IDSA/ATS minor criteria for SCAP was not predictive of triage to the ICU in the group of patients with community‐acquired aspiration pneumonia (AUC: 0.51), compared with CAP patients (AUC: 0.88, P < 0.01 for comparison, Figure 3). This finding persisted in the subset of patients without a DNR/DNI order (AUC: 0.52 in community‐acquired aspiration pneumonia vs 0.88 in CAP, P < 0.01).

Figure 2
Receiver operating characteristic curve, comparing the eCURB score against 30‐day mortality in patients with typical community‐acquired pneumonia and in patients with community‐acquired aspiration pneumonia. The eCURB score is an electronic version of the CURB‐65 model, validated in the community‐acquired pneumonia population, that uses continuously weighted variables to more accurately predict mortality.These curves statistically differ, P < 0.0001. Abbreviations: AUC, area under the curve; CAP, community‐acquired pneumonia.
Figure 3
Receiver operating characteristic curve, comparing the Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) minor criteria for severe community‐acquired pneumonia against intensive care unit (ICU) admission in patients with typical community‐acquired pneumonia (CAP) and in patients with community‐acquired aspiration pneumonia. These curves statistically differ, P < 0.0001. Abbreviations: AUC: area under the curve.

Our regression model of mortality incorporated gender, presence of effusion or multilobar pneumonia, presence of a DNR/DNI order, and all the components of the CURB‐65, IDSA/ATS minor criteria for SCAP, and Charlson comorbidity index. The regression model demonstrated that even after adjustment for age, comorbidities, disease severity, and presence of a DNR/DNI order, the presence of aspiration pneumonia was associated with higher mortality than CAP (odds ratio [OR]: 3.46, P < 0.001, Table 5). In this model, systolic blood pressure did not predict mortality, and diabetes with complications was associated with decreased mortality.

Final Logistic Regression Model Predicting 30‐Day Mortality in Patients With Community‐Acquired Pneumonia and Community‐Acquired Aspiration Pneumonia
 Odds RatioP Value
  • NOTE: Initial model also included gender, presence of multilobar pneumonia, and all components of the CURB (Confusion, Uremia, Respiratory Rate, Blood Pressure) score and Charlson comorbidity index, and minor criteria for severe community‐acquired pneumonia. Area under the curve of the final model = 0.87. Odds ratios are followed by 95% confidence intervals in parentheses. Exclusion of DNR/DNI status did not significantly alter the regression model. Abbreviations: DNR/DNI, do not resuscitate/do not intubate.
Presence of aspiration pneumonia3.46 (2.115.67)<0.001
Age, y1.03 (1.011.04)<0.001
Confusion3.14 (1.955.05)<0.001
Blood urea nitrogen, mg/dL1.03 (1.021.04)<0.001
Respiratory rate, breaths/minute1.03 (1.001.06)0.04
PaO2/FiO2 ratio, per 1 mm Hg0.99 (0.991.00)<0.001
Moderate or severe liver disease9.21 (3.1626.86)<0.001
Paraplegia/hemiplegia2.43 (1.135.27)0.02
Diabetes with complications0.42 (0.200.87)0.02
Leukocytosis4.47 (2.278.82)<0.001
DNR/DNI1.75 (1.112.75)0.02

Microbiological Findings

Blood cultures were performed at admission in 67.4% of aspiration‐pneumonia patients, and a tracheal aspirate in half (50.7%) of intubated patients with aspiration pneumonia. Organisms were recovered in 90 patients (14.3%), although 41 of those patients had tracheal aspirates of organisms commonly thought to be nonpathogenic (nonpneumococcal alpha‐hemolytic streptococcus, nonhemolytic streptococcus, diphtheroids, micrococci, coagulase negative staphylococccus). Tracheal aspirate was the most common method of recovering an organism (7.8% of patients), followed by blood culture (4.3%). Bronchoalveolar lavage, urinary antigen, and pleural fluid culture were less common (1.3%, 1.1%, 0.3%, respectively). The microbiologic results were grouped into: Staphylococcus aureus, Streptococcus pneumoniae, enteric bacilli, Haemophilus species, Neisseria species, Moraxella catarrhalis, and Pseudomonas aeruginosa (Figure 4). Comparing healthcare‐associated with community‐acquired aspiration pneumonia, healthcare‐associated patients were more likely to have a confirmed infection with MRSA (4.2% vs 1.4%, P = 0.06) and enteric bacteria (5.1% vs 1.6%, P = 0.03). There were no other statistically significant differences in microbiologic recovery between the 2 groups. Antibiotics targeting anaerobic pathogens were administered in 28.7% of patients with aspiration pneumonia, with no correlation to the presence of healthcare‐associated risks. Healthcare‐associated patients were more likely to receive broad‐spectrum antibiotics (47.5% vs 32.5%, P < 0.01) and MRSA coverage (15.3% vs 5.7%, P < 0.01) than patients with community‐acquired aspiration pneumonia.

Figure 4
Distribution of bacterial organism recovered from 628 patients with aspiration pneumonia. Percentages are expressed as a fraction of 628 patients. Note that the total exceeds 100% due to polymicrobial infection. Viral, fungal, and acid fast bacilli cultures were not routinely obtained and not included in this graphic. Other = Bacillus cereus (1), Serratia marcescens (1), Nocardia species (1), Acinetobacter bauminii (1), Capnocytophaga (1), Eikenella corrodens (1), Proteus (1), Saccharomyces cerevisiae (1). Abbreviations: M. catarrhalis, Moraxella catarrhalis; MRSA, methicillin‐resistant Staphylococcus aureus; MSSA, methicillin‐sensitive Staphylococcus aureus; S. pneumoniae, Streptococcus pneumoniae.

DISCUSSION

Our study identifies a larger cohort of patients with aspiration pneumonia than previous studies.[21, 22, 23, 24, 25] Patients with community‐acquired aspiration pneumonia are older and more likely to die than CAP patients. They are more likely to be admitted to the hospital or ICU. Thirty‐day mortality in this patient population was significantly underestimated by CURB‐65 and eCURB, models developed and validated in CAP populations.[9, 26] This finding supports a prior study.[27] It appears that a traditional prognostic model assessing mortality risk in the CAP patient does not apply to the aspiration‐pneumonia patient. One reason for eCURB and CURB‐65s poor utility in community‐acquired aspiration pneumonia may be their reliance on objective clinical features rather than comorbidities, which may influence mortality to a greater degree in aspiration pneumonia.

This study has several limitations. There is no gold standard for the definition of aspiration pneumonia, and it is difficult to distinguish aspiration pneumonia from typical pneumonia. It is plausible that older patients with greater comorbidities are being designated as aspiration pneumonia. If this is the case, then aspiration pneumonia merely represents the end of the pneumonia spectrum with highest mortality risk, and it is no surprise that these patients fare poorly.

It appears that the hospitalist or emergency department physician implicitly appreciates that aspiration pneumonia has a higher mortality risk than predicted by traditional severity assessment. With such high mortality and morbidity, a patient presenting to the emergency room with aspiration pneumonia is almost always admitted to the hospital. Further work in this area should investigate other factors to improve prognostic modeling in patients with aspiration pneumonia, although the utility of such a model may be limited to determining ICU admission. Our data indicate that IDSA/ATS minor criteria for SCAP are not useful in predicting admission to the ICU in patients with aspiration pneumonia.

In this study, a DNR/DNI order was twice as common in the community‐acquired aspiration pneumonia population than the CAP population. However, patients with community‐acquired aspiration pneumonia and a DNR/DNI order were more than 3 times more likely to die than patients with CAP and a DNR/DNI order. Our regression model suggested that the presence of a DNR/DNI order was an independent predictor of mortality (OR: 1.75, P < 0.001). Although a DNR/DNI order may correlate with the withholding or withdrawal of medical therapy, it is also a surrogate for increased age or comorbidities.[28] In our study, however, the increased prevalence of DNR/DNI orders did not explain the poor mortality prediction of the eCURB or CURB‐65, as exclusion of those patients did not significantly alter the AUCs in either the aspiration group or the CAP group.

Controversy exists regarding treatment of aspiration pneumonia. Historically, some have advocated for treatment of aspiration pneumonia with a regimen designed to cover anaerobic bacteria.[29] This recommendation was based on early microbiologic studies that obtained the samples late in the course of illness, or other studies where the sample was obtained transtracheally, where oropharyngeal flora may contaminate the sample.[30, 31, 32] Our clinically obtained microbiologic recovery of organisms was similar to the flora recovered in more recent CAP studies, in respect to both the incidence of pathogen recovery and the relative frequencies of recovered organisms.[33, 34] Our data do not support inferences regarding the prevalence of anaerobic infections, as the recovery of anaerobic organisms was limited to blood and pleural fluid cultures in this study, rather than techniques used in research settings that might have greater yield. As expected, patients with healthcare‐associated risk factors trended toward increased incidence of MRSA. Given the similarity of the organisms recovered to those recovered in CAP,[35] this study supports IDSA/ATS recommendations that antibiotic therapy in aspiration pneumonia be similar to that of higher‐risk CAP, with the addition of vancomycin or linezolid for MRSA coverage in patients with risk factors for healthcare‐associated pneumonia.[17]

Our study is limited by its single‐center retrospective design. However, beginning in 1995, the LDS Hospital emergency department initiated a standardized pneumonia therapy protocol and deployed electronic medical records, which prospectively recorded a wide array of clinical, therapeutic, and biometric data. Most data elements used in this analysis were routinely charted for clinical purposes in real time. Although the eCURB, CURB‐65, and some comorbidities could be extracted electronically for each patient, it was not possible to calculate the pneumonia severity index score due to our inability to rigorously identify the necessary comorbid illness elements. Other comorbidities, not present in our model, may have been identified by the physician who makes a diagnosis of aspiration pneumonia. Our identification of swallow impairment is also methodologically limited. The decision to obtain a swallow study was clinical, usually occurring upon convalescence. Therefore, it is not possible to distinguish between antecedent oropharyngeal dysfunction and post‐critical illness dysfunction.

Our definition of aspiration pneumonia required the treating physician to diagnose and code the patient as having aspiration pneumonia, followed by excluding patients more likely to have aspiration pneumonitis. Although we relied on ICD‐9 codes to initially identify aspiration pneumonia, all patients in our database were confirmed by physician chart review. Our incidence of community‐acquired aspiration pneumonia is congruent with other studies using different methodologies.[1, 36, 37] Unfortunately, there is no standard and widely accepted definition for separating aspiration pneumonia from usual CAP. A younger and healthier patient who has developed pneumonia subsequent to aspiration may be more likely to be diagnosed with CAP, resulting in selection bias for older patients with greater comorbidities.

CONCLUSION

Patients diagnosed with aspiration pneumonia are older, have more comorbid conditions, and demonstrate greater disease severity and higher 30‐day mortality than CAP patients. Mortality prediction using CURB‐65 and eCURB in this population was poor, possibly due to a greater effect of comorbidities on mortality. The pneumonia severity index, which incorporates patient comorbidities, might perform better than the eCURB or CURB‐65, and should be studied in aspiration pneumonia populations where comorbid illness information is prospectively collected. Further areas of study include creating an improved mortality prediction model for aspiration pneumonia that incorporates comorbid conditions, DNR/DNI status, and disease severity.

Acknowledgments

The authors acknowledge Al Jephson for database support, Yao Li for statistical analysis, and Anita Austin for help reviewing the medical records. Dr. Lanspa had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Disclosure

Preliminary versions of this work were presented as posters at the American Thoracic Society Meeting, Denver, Colorado, May 17, 2011. This study was supported by grants from the Intermountain Research and Medical Foundation. Dr. Brown is supported by a career development award from National Institute of General Medical Sciences (K23GM094465). Dr. Dean served on an advisory board for Merck, has been a paid consultant for Cerexa, and has received an investigator‐initiated competitive grant from Pfizer for development of an electronic pneumonia decision support tool. All other authors report no relevant financial disclosures.

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  1. Torres A, Serra‐Batlles J, Ferrer A, et al. Severe community‐acquired pneumonia. Epidemiology and prognostic factors. Am Rev Respir Dis. 1991;144(2):312318.
  2. Koivula I, Sten M, Makela PH. Risk factors for pneumonia in the elderly. Am J Med. 1994;96(4):313320.
  3. Marik PE, Kaplan D. Aspiration pneumonia and dysphagia in the elderly. Chest. 2003;124(1):328336.
  4. Mylotte JM, Goodnough S, Naughton BJ. Pneumonia versus aspiration pneumonitis in nursing home residents: diagnosis and management. J Am Geriatr Soc. 2003;51(1):1723.
  5. Marik PE. Aspiration pneumonia: mixing apples with oranges and tangerines. Crit Care Med. 2004;32(5):1236; author reply 1236–1237.
  6. Kozlow JH, Berenholtz SM, Garrett E, Dorman T, Pronovost PJ. Epidemiology and impact of aspiration pneumonia in patients undergoing surgery in Maryland, 1999–2000. Crit Care Med. 2003;31(7):19301937.
  7. Marik PE. Aspiration syndromes: aspiration pneumonia and pneumonitis. Hosp Pract (Minneap). 2010;38(1):3542.
  8. Marik PE. Aspiration pneumonitis and aspiration pneumonia. N Engl J Med. 2001;344(9):665671.
  9. Jones BE, Jones J, Bewick T, et al. CURB‐65 pneumonia severity assessment adapted for electronic decision support. Chest. 2011;140(1):156163.
  10. Lim WS, Eerden MM, Laing R, et al. Defining community acquired pneumonia severity on presentation to hospital: an international derivation and validation study. Thorax. 2003;58(5):377382.
  11. Fine MJ, Hanusa BH, Lave JR, et al. Comparison of a disease‐specific and a generic severity of illness measure for patients with community‐acquired pneumonia. J Gen Intern Med. 1995;10(7):359368.
  12. Espana PP, Capelastegui A, Gorordo I, et al. Development and validation of a clinical prediction rule for severe community‐acquired pneumonia. Am J Respir Crit Care Med. 2006;174(11):12491256.
  13. Brown SM, Jones BE, Jephson AR, Dean NC. Validation of the Infectious Disease Society of America/American Thoracic Society 2007 guidelines for severe community‐acquired pneumonia. Crit Care Med. 2009;37(12):30103016.
  14. Guidelines for the management of adults with hospital‐acquired, ventilator‐associated, and healthcare‐associated pneumonia. Am J Respir Crit Care Med. 2005;171(4):388416.
  15. Skolnick M.The Utah genealogical database: a resource for genetic epidemiology. In: Cairns JL, Skolnick M, eds. Banbury Report No 4; Cancer Incidence in Defined Populations. New York, NY:Cold Spring Harbor Laboratory;1980:285297.
  16. Severinghaus JW. Simple, accurate equations for human blood O2 dissociation computations. J Appl Physiol. 1979;46(3):599602.
  17. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community‐acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27S72.
  18. Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47(11):12451251.
  19. Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD‐9‐CM administrative databases. J Clin Epidemiol. 1992;45(6):613619.
  20. DeLong ER, DeLong DM, Clarke‐Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988;44(3):837845.
  21. Feinberg MJ, Knebl J, Tully J. Prandial aspiration and pneumonia in an elderly population followed over 3 years. Dysphagia. 1996;11(2):104109.
  22. Langmore SE, Skarupski KA, Park PS, Fries BE. Predictors of aspiration pneumonia in nursing home residents. Dysphagia. 2002;17(4):298307.
  23. Terpenning MS, Taylor GW, Lopatin DE, Kerr CK, Dominguez BL, Loesche WJ. Aspiration pneumonia: dental and oral risk factors in an older veteran population. J Am Geriatr Soc. 2001;49(5):557563.
  24. El‐Solh AA, Pietrantoni C, Bhat A, et al. Microbiology of severe aspiration pneumonia in institutionalized elderly. Am J Respir Crit Care Med. 2003;167(12):16501654.
  25. Johnson ER, McKenzie SW, Sievers A. Aspiration pneumonia in stroke. Arch Phys Med Rehabil. 1993;74(9):973976.
  26. Capelastegui A, Espana PP, Quintana JM, et al. Validation of a predictive rule for the management of community‐acquired pneumonia. Eur Respir J. 2006;27(1):151157.
  27. Heppner HJ, Sehlhoff B, Niklaus D, Pientka L, Thiem U. Pneumonia Severity Index (PSI), CURB‐65, and mortality in hospitalized elderly patients with aspiration pneumonia [in German]. Zeitschrift fur Gerontologie und Geriatrie. 2011;44(4):229234.
  28. Bedell SE, Pelle D, Maher PL, Cleary PD. Do‐not‐resuscitate orders for critically ill patients in the hospital. How are they used and what is their impact?JAMA. 1986;256(2):233237.
  29. Gilbert DN, Moellering RC, Eliopoulos GM, Chambers HF, Saag MS. The Sanford Guide to Antimicrobial Therapy: 2010.40th ed.Sperryville, VA:Antimicrobial Therapy, Inc.;2009.
  30. Bartlett JG, Gorbach SL, Finegold SM. The bacteriology of aspiration pneumonia. Am J Med. 1974;56(2):202207.
  31. Cesar L, Gonzalez C, Calia FM. Bacteriologic flora of aspiration‐induced pulmonary infections. Arch Intern Med. 1975;135(5):711714.
  32. Lorber B, Swenson RM. Bacteriology of aspiration pneumonia. A prospective study of community‐ and hospital‐acquired cases. Ann Intern Med. 1974;81(3):329331.
  33. Marik PE, Careau P. The role of anaerobes in patients with ventilator‐associated pneumonia and aspiration pneumonia: a prospective study. Chest. 1999;115(1):178183.
  34. Mier L, Dreyfuss D, Darchy B, et al. Is penicillin G an adequate initial treatment for aspiration pneumonia? A prospective evaluation using a protected specimen brush and quantitative cultures. Intensive Care Med. 1993;19(5):279284.
  35. Torres A, El‐Ebiary M, Riquelme R, Ruiz M, Celis R. Community‐acquired pneumonia in the elderly. Semin Respir Infect. 1999;14(2):173183.
  36. Marrie TJ, Durant H, Kwan C. Nursing home‐acquired pneumonia. A case‐control study. J Am Geriatr Soc. 1986;34(10):697702.
  37. Moine P, Vercken JB, Chevret S, Chastang C, Gajdos P. Severe community‐acquired pneumonia. Etiology, epidemiology, and prognosis factors. French Study Group for Community‐Acquired Pneumonia in the Intensive Care Unit. Chest. 1994;105(5):14871495.
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Address for correspondence and reprint requests: Michael J. Lanspa, MD, Intermountain Medical Center, Shock‐Trauma Intensive Care Unit, 5121 S. Cottonwood Street, Murray, UT 84107; Telephone: 801‐507‐6450; Fax: 801‐507‐4699; E-mail: [email protected]
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Impact of clinical history on chest radiograph interpretation

The inclusion of clinical information in diagnostic testing may influence the interpretation of the clinical findings. Historical and clinical findings may focus the reader's attention to the relevant details, thereby improving the accuracy of the interpretation. However, such information may cause the reader to have preconceived notions about the results, biasing the overall interpretation.

The impact of clinical information on the interpretation of radiographic studies remains an issue of debate. Previous studies have found that clinical information improves the accuracy of radiographic interpretation for a broad range of diagnoses,[1, 2, 3, 4] whereas others do not show improvement.[5, 6, 7] Additionally, clinical information may serve as a distraction that leads to more false‐positive interpretations.[8] For this reason, many radiologists prefer to review radiographs without knowledge of the clinical scenario prompting the study to avoid focusing on the expected findings and potentially missing other important abnormalities.[9]

The chest radiograph (CXR) is the most commonly used diagnostic imaging modality. Nevertheless, poor agreement exists among radiologists in the interpretation of chest radiographs for the diagnosis of pneumonia in both adults and children.[10, 11, 12, 13, 14, 15] Recent studies have found a high degree of agreement among pediatric radiologists with implementation of the World Health Organization (WHO) criteria for standardized CXR interpretation for diagnosis of bacterial pneumonia in children.[16, 17, 18] In these studies, participants were blinded to the clinical presentation. Data investigating the impact of clinical history on CXR interpretation in the pediatric population are limited.[19]

We conducted this prospective case‐based study to evaluate the impact of clinical information on the reliability of radiographic diagnosis of pneumonia among children presenting to a pediatric emergency department (ED) with clinical suspicion of pneumonia.

METHODS

Study Subjects

Six board‐certified radiologists at 2 academic children's hospitals (Children's Hospital of Philadelphia [n = 3] and Boston Children's Hospital [n = 3]) interpreted the same 110 chest radiographs (100 original and 10 duplicates) on 2 separate occasions. Clinical information was withheld during the first interpretation. The inter‐ and inter‐rater reliability for the interpretation of these 110 radiographs without clinical information have been previously reported.[18] After a period of 6 months, the radiologists reviewed the radiographs with access to clinical information provided by the physician ordering the CXR. This clinical information included age, sex, clinical indication for obtaining the radiograph, relevant history, and physical examination findings. The radiologists did not have access to the patients' medical records. The radiologists varied with respect to the number of years practicing pediatric radiology (median, 8 years; range, 336 years).

Radiographs were selected from children who presented to the ED at Boston Children's Hospital with concern of pneumonia. We selected radiographs with a spectrum of respiratory disease processes encountered in a pediatric population. The final radiographs included 50 radiographs with a final reading in the medical record without suspicion for pneumonia and 50 radiographs with suspicion of pneumonia. In the latter group, 25 radiographs had a final reading suggestive of an alveolar infiltrate, and 25 radiographs had a final reading suggestive of an interstitial infiltrate. Ten duplicate radiographs were included.

Radiograph Interpretation

The radiologists interpreted both anterior‐posterior and lateral views for each subject. Digital Imaging and Communications in Medicine images were downloaded from a registry at Boston Children's Hospital, and were copied to DVDs that were provided to each radiologist. Standardized radiographic imaging software (eFilm Lite; Merge Healthcare, Chicago, Illinois) was used by each radiologist.

Each radiologist completed a study questionnaire for each radiograph (see Supporting Information, Appendix 1, in the online version of this article). The questionnaire utilized radiographic descriptors of primary endpoint pneumonia described by the WHO to standardize the radiographic diagnosis of pneumonia.[20, 21] No additional training was provided to the radiologists. The main outcome of interest was the presence or absence of an infiltrate. Among radiographs in which an infiltrate was identified, radiologists selected whether there was an alveolar infiltrate, interstitial infiltrate, or both. Alveolar infiltrate and interstitial infiltrate are defined on the study questionnaire (Appendix 1). A radiograph classified as having either an alveolar infiltrate or interstitial infiltrate (not atelectasis) was considered to have any infiltrate. Additional findings including air bronchograms, hilar adenopathy, pleural effusion, and location of abnormalities were also recorded.

Statistical Analysis

Inter‐rater reliability was assessed using the kappa statistic to determine the overall agreement among the 6 radiologists for each outcome (eg, presence or absence of alveolar infiltrate). The kappa statistic for more than 2 raters utilizes an analysis of variance approach.[22] To calculate 95% confidence intervals (CI) for kappa statistics with more than 2 raters, we employed a bootstrapping method with 1000 replications of samples equal in size to the study sample. Intra‐rater reliability was evaluated by examining the agreement within each radiologist upon review of 10 duplicate radiographs. We used the following benchmarks to classify the strength of agreement: poor (<0.0), slight (00.20), fair (0.210.40), moderate (0.410.60), substantial (0.610.80), almost perfect (0.811.0).[23] Negative kappa values represent agreement less than would be predicted by chance alone.[24, 25] To calculate the kappa, a value must be recorded in 3 of 4 of the following categories: negative to positive, positive to negative, concordant negative, and concordant positive reporting of pneumonia. If raters did not fulfill 3 categories, the kappa could not be calculated.

The inter‐rater concordance for identification of an alveolar infiltrate was calculated for each radiologist by comparing their reporting of alveolar infiltrate with and without clinical history for each of the 100 radiographs. Radiographs that were identified by an individual rater as no alveolar infiltrate when read without clinical history, but those subsequently identified as alveolar infiltrate with clinical history were categorized as negative to positive reporting of pneumonia with clinical history. Those that were identified as alveolar infiltrate but subsequently identified as no alveolar infiltrate were categorized as positive to negative reporting of pneumonia with clinical history. Those radiographs in which there was no change in identification of alveolar infiltrate with clinical information were categorized as concordant reporting of pneumonia.

The study was approved by the institutional review boards at both children's hospitals.

RESULTS

Patient Sample

The radiographs were from patients ranging in age from 1 week to 19 years (median, 3.5 years; interquartile range, 1.66.0 years). Fifty (50%) patients were male.

Inter‐rater Reliability

The kappa coefficients of inter‐rater reliability between the radiologists across the 6 clinical measures of interest with and without access to clinical history are plotted in Figure 1. Reliability improved from fair (k = 0.32, 95% CI: 0.24 to 0.42) to moderate (k = 0.53, 95% CI: 0.43 to 0.64) for identification of air bronchograms with the addition of clinical history. Although there was an increase in kappa values for identification of any infiltrate, alveolar infiltrate, interstitial infiltrate, and pleural effusion, and a decrease in the kappa value for identification of hilar adenopathy with the addition of clinical information, there was substantial overlap of the 95% CIs, suggesting that inclusion of clinical history did not result in a statistically significant change in the reliability of these findings.

Figure 1
Inter‐rater reliability of radiologists (n = 6) evaluating chest radiographs with and without access to clinical history data in children presenting to the emergency department with suspected pneumonia (n = 100).

Intra‐rater Reliability

The estimates of inter‐rater reliability for the interpretation of the 10 duplicate images with and without clinical history are shown in Table 1. The inter‐rater reliability in the identification of alveolar infiltrate remained substantial to almost perfect for each rater with and without access to clinical history. Rater 1 had a decrease in inter‐rater reliability from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.21, 95% CI: 0.43 to 0.85) in the identification of interstitial infiltrate with the addition of clinical history. This rater also had a decrease in agreement from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.4, 95% CI: 0.16 to 0.96) in the identification of any infiltrate.

Intra‐rater Reliability of Radiologists With and Without Access to Clinical History While Evaluating Chest Radiographs (n = 10) for Pneumonia in Children
 Phase 1No Clinical HistoryPhase 2Access to Clinical History
Kappa95% Confidence IntervalKappa95% Confidence Interval
  • NOTE: Abbreviations: N/A, not applicable.
  • Too few categories of agreement to calculate kappa. Both responses are negative for all 10 paired radiographs; kappa cannot be calculated.
Any infiltrate    
Rater 11.001.00 to 1.000.400.16 to 0.96
Rater 20.600.10 to 1.000.580.07 to 1.00
Rater 30.800.44 to 1.000.800.44 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 5N/Aa 0.110.36 to 0.14
Rater 61.001.00 to 1.001.001.00 to 1.00
Alveolar infiltrate    
Rater 11.001.00 to 1.001.001.00 to 1.00
Rater 21.001.00 to 1.001.001.00 to 1.00
Rater 31.001.00 to 1.001.001.00 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 50.780.39 to 1.001.001.00 to 1.00
Rater 60.740.27 to 1.000.780.39 to 1.00
Interstitial infiltrate    
Rater 11.001.00 to 1.000.210.43 to 0.85
Rater 20.210.43 to 0.850.110.36 to 0.14
Rater 30.740.27 to 1.000.780.39 to 1.00
Rater 4N/A N/A 
Rater 50.580.07 to 1.000.520.05 to 1.00
Rater 60.620.5 to 1.00N/Aa 

Intra‐rater Concordance

The inter‐rater concordance of the radiologists for the identification of alveolar infiltrate during the interpretation of the 100 chest radiographs with and without access to clinical history is shown in Figure 2. The availability of clinical information impacted physicians differently in the evaluation of alveolar infiltrates. Raters 1, 4, and 6 appeared more likely to identify an alveolar infiltrate with access to the clinical information, whereas raters 3 and 5 appeared less likely to identify an alveolar infiltrate. Of the 100 films that were interpreted with and without clinical information, the mean number of discordant interpretations per rater was 10, with values ranging from 6 to 19 for the individual raters. Radiographs in which more than 3 raters changed their interpretation regarding the presence of an alveolar infiltrate are shown in Figure 3. For Figure 3D, 4 radiologists changed their interpretation from no alveolar infiltrate to alveolar infiltrate, and 1 radiologist changed from alveolar infiltrate to no alveolar infiltrate with the addition of clinical history.

Figure 2
Intra‐rater concordance of radiologists before and after access to clinical history while evaluating chest radiographs (n = 100) for alveolar infiltrate in children.
Figure 3
Chest radiographs of children in which 3 or more radiologists changed their interpretation in regard to the presence or absence of an alveolar infiltrate with the addition of clinical information. (A, B, and C) Three of 6 radiologists changed their interpretation. (D) Five of 6 radiologists changed their interpretation. (A) Female, 2 years old. (B) Male, 9 months old. (C) Male, 3 years old. (D) Male, 3 years old. The clinical history provided for (D) read as follows: “3‐year‐old male with cough and difficulty breathing. Rales at left base.”

Comment

We investigated the impact of the availability of clinical information on the reliability of chest radiographic interpretation in the diagnosis of pneumonia. There was improved inter‐rater reliability in the identification of air bronchograms with the addition of clinical information; however, clinical history did not have a substantial impact on the inter‐rater reliability of other findings. The addition of clinical information did not alter the inter‐rater reliability in the identification of alveolar infiltrate. Clinical history affected individual raters differently in their interpretation of alveolar infiltrate, with 3 raters more likely to identify an alveolar infiltrate and 2 raters less likely to identify an alveolar infiltrate.

Most studies addressing the impact of clinical history on radiographic interpretation evaluated accuracy. In many of these studies, accuracy was defined as the raters' agreement with the final interpretation of each film as documented in the medical record or their agreement with the interpretation of the radiologists selecting the cases.[1, 2, 3, 5, 6, 7] Given the known inter‐rater variability in radiographic interpretation,[10, 11, 12, 13, 14, 15] accuracy of a radiologist's interpretation cannot be appropriately assessed through agreement with their peers. Because a true measure of accuracy in the radiographic diagnosis of pneumonia can only be determined through invasive testing, such as lung biopsy, reliability serves as a more appropriate measure of performance. Inclusion of clinical information in chest radiograph interpretation has been shown to improve reliability in the radiographic diagnosis of a broad range of conditions.[15]

The primary outcome in this study was the identification of an infiltrate. Previous studies have noted consistent identification of the radiographic features that are most suggestive of bacterial pneumonia, such as alveolar infiltrate, and less consistent identification of other radiographic findings, including interstitial infiltrate.[18, 26, 27] Among the radiologists in this study, the addition of clinical information did not have a meaningful impact on the reliability of either of these findings, as there was substantial inter‐rater agreement for the identification of alveolar infiltrate and only slight agreement for the identification of interstitial infiltrate, both with and without clinical history. Additionally, inter‐rater reliability for the identification of alveolar infiltrate remained substantial to almost perfect for all 6 raters with the addition of clinical information.

Clinical information impacted the raters differently in their pattern of alveolar infiltrate identification, suggesting that radiologists may differ in their approach to incorporating clinical history in the interpretation of chest radiographs. The inclusion of clinical information may impact a radiologist's perception, leading to improved identification of abnormalities; however, it may also guide their decision making about the relevance of previously identified abnormalities.[28] Some radiologists may use clinical information to support or suggest possible radiographic findings, whereas others may use the information to challenge potential findings. This study did not address the manner in which the individual raters utilized the clinical history. There were also several radiographs in which the clinical information resulted in a change in the identification of an alveolar infiltrate by 3 or more raters, with as many as 5 of 6 raters changing their interpretation for 1 particular radiograph. These changes in identification of an infiltrate suggest that unidentified aspects of a history may be likely to influence a rater's interpretation of a radiograph. Nevertheless, these changes did not result in improved reliability and it is not possible to determine if these changes resulted in improved accuracy in interpretation.

This study had several limitations. First, radiographs were purposefully selected to encompass a broad spectrum of radiographic findings. Thus, the prevalence of pneumonia and other abnormal findings was artificially higher than typically observed among a cohort of children for whom pneumonia is considered. Second, the radiologists recruited for this study all practice in an academic children's hospital setting. These factors may limit the generalizability of our findings. However, we would expect these results to be generalizable to pediatric radiologists from other academic institutions. Third, this study does not meet the criteria of a balanced study design as defined by Loy and Irwig.[19] A study was characterized as balanced if half of the radiographs were read with and half without clinical information in each of the 2 reading sessions. The proposed benefit of such a design is to control for possible changes in ability or reporting practices of the raters that may have occurred between study periods. The use of a standardized reporting tool likely minimized changes in reporting practices. Also, it is unlikely that the ability or reporting practices of an experienced radiologist would change over the study period. Fourth, the radiologists interpreted the films outside of their standard workflow and utilized a standardized reporting tool that focused on the presence or absence of pneumonia indicators. These factors may have increased the radiologists' suspicion for pneumonia even in the absence of clinical information. This may have biased the results toward finding no difference in the identification of pneumonia with the addition of detailed clinical history. Thus, the inclusion of clinical information in radiograph interpretation in clinical practice may have greater impact on the identification of these pneumonia indicators than was found in this study.[29] Finally, reliability does not imply accuracy, and it is unknown if changes in the identification of pneumonia indicators led to more accurate interpretation with respect to the clinical or pathologic diagnosis of pneumonia.

In conclusion, we observed high intra‐ and inter‐rater reliability among radiologists in the identification of an alveolar infiltrate, the radiographic finding most suggestive of bacterial pneumonia.[16, 17, 18, 30] The addition of clinical information did not have a substantial impact on the reliability of its identification.

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References
  1. Berbaum KS, Franken EA, Dorfman DD, et al. Tentative diagnoses facilitate the detection of diverse lesions in chest radiographs. Invest Radiol. 1986;21(7):532539.
  2. Berbaum KS, Franken EA, Dorfman DD, Barloon TJ. Influence of clinical history upon detection of nodules and other lesions. Invest Radiol. 1988;23(1):4855.
  3. Berbaum KS, Franken EA, Dorfman DD, Lueben KR. Influence of clinical history on perception of abnormalities in pediatric radiographs. Acad Radiol. 1994;1(3):217223.
  4. Song KS, Song HH, Park SH, et al. Impact of clinical history on film interpretation. Yonsei Med J. 1992;33(2):168172.
  5. Cooperstein LA, Good BC, Eelkema EA, et al. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1990;25(6):670674.
  6. Good BC, Cooperstein LA, DeMarino GB, et al. Does knowledge of the clinical history affect the accuracy of chest radiograph interpretation?AJR Am J Roentgenol. 1990;154(4):709712.
  7. Quekel LG, Goei R, Kessels AG, Engelshoven JM. Detection of lung cancer on the chest radiograph: impact of previous films, clinical information, double reading, and dual reading. J Clin Epidemiol. 2001;54(11):11461150.
  8. Eldevik OP, Dugstad G, Orrison WW, Haughton VM. The effect of clinical bias on the interpretation of myelography and spinal computed tomography. Radiology. 1982;145(1):8589.
  9. Griscom NT. A suggestion: look at the images first, before you read the history. Radiology. 2002;223(1):910.
  10. Albaum MN, Hill LC, Murphy M, et al. Interobserver reliability of the chest radiograph in community‐acquired pneumonia. PORT Investigators. Chest. 1996;110(2):343350.
  11. Bloomfield FH, Teele RL, Voss M, Knight DB, Harding JE. Inter‐ and intra‐observer variability in the assessment of atelectasis and consolidation in neonatal chest radiographs. Pediatr Radiol. 1999;29(6):459462.
  12. Gatt ME, Spectre G, Paltiel O, Hiller N, Stalnikowicz R. Chest radiographs in the emergency department: is the radiologist really necessary?Postgrad Med J. 2003;79(930):214217.
  13. Hopstaken RM, Witbraad T, Engelshoven JM, Dinant GJ. Inter‐observer variation in the interpretation of chest radiographs for pneumonia in community‐acquired lower respiratory tract infections. Clin Radiol. 2004;59(8):743752.
  14. Novack V, Avnon LS, Smolyakov A, Barnea R, Jotkowitz A, Schlaeffer F. Disagreement in the interpretation of chest radiographs among specialists and clinical outcomes of patients hospitalized with suspected pneumonia. Eur J Intern Med. 2006;17(1):4347.
  15. Tudor GR, Finlay D, Taub N. An assessment of inter‐observer agreement and accuracy when reporting plain radiographs. Clin Radiol. 1997;52(3):235238.
  16. Shimol BS, Dagan R, Givon‐Lavi N, et al. Evaluation of the World Health Organization criteria for chest radiographs for pneumonia diagnosis in children. Eur J Pediatr. 2011;171(2):369374.
  17. Cherian T, Mulholland EK, Carlin JB, et al. Standardized interpretation of paediatric chest radiographs for the diagnosis of pneumonia in epidemiological studies. Bull World Health Organ. 2005;83(5):353359.
  18. Neuman MI, Lee EY, Bixby S, et al. Variability in the interpretation of chest radiographs for the diagnosis of pneumonia in children. J Hosp Med. 2012;7(4):294298.
  19. Loy CT, Irwig L. Accuracy of diagnostic tests read with and without clinical information: a systematic review. JAMA. 2004;292(13):16021609.
  20. Standardization of interpretation of chest radiographs for the diagnosis of pneumonia in children. In:World Health Organization: Pneumonia Vaccine Trial Investigators' Group.Geneva: Department of Vaccine and Biologics;2001.
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  24. Juurlink DN, Detsky AS. Kappa statistic. CMAJ. 2005;173(1):16.
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The inclusion of clinical information in diagnostic testing may influence the interpretation of the clinical findings. Historical and clinical findings may focus the reader's attention to the relevant details, thereby improving the accuracy of the interpretation. However, such information may cause the reader to have preconceived notions about the results, biasing the overall interpretation.

The impact of clinical information on the interpretation of radiographic studies remains an issue of debate. Previous studies have found that clinical information improves the accuracy of radiographic interpretation for a broad range of diagnoses,[1, 2, 3, 4] whereas others do not show improvement.[5, 6, 7] Additionally, clinical information may serve as a distraction that leads to more false‐positive interpretations.[8] For this reason, many radiologists prefer to review radiographs without knowledge of the clinical scenario prompting the study to avoid focusing on the expected findings and potentially missing other important abnormalities.[9]

The chest radiograph (CXR) is the most commonly used diagnostic imaging modality. Nevertheless, poor agreement exists among radiologists in the interpretation of chest radiographs for the diagnosis of pneumonia in both adults and children.[10, 11, 12, 13, 14, 15] Recent studies have found a high degree of agreement among pediatric radiologists with implementation of the World Health Organization (WHO) criteria for standardized CXR interpretation for diagnosis of bacterial pneumonia in children.[16, 17, 18] In these studies, participants were blinded to the clinical presentation. Data investigating the impact of clinical history on CXR interpretation in the pediatric population are limited.[19]

We conducted this prospective case‐based study to evaluate the impact of clinical information on the reliability of radiographic diagnosis of pneumonia among children presenting to a pediatric emergency department (ED) with clinical suspicion of pneumonia.

METHODS

Study Subjects

Six board‐certified radiologists at 2 academic children's hospitals (Children's Hospital of Philadelphia [n = 3] and Boston Children's Hospital [n = 3]) interpreted the same 110 chest radiographs (100 original and 10 duplicates) on 2 separate occasions. Clinical information was withheld during the first interpretation. The inter‐ and inter‐rater reliability for the interpretation of these 110 radiographs without clinical information have been previously reported.[18] After a period of 6 months, the radiologists reviewed the radiographs with access to clinical information provided by the physician ordering the CXR. This clinical information included age, sex, clinical indication for obtaining the radiograph, relevant history, and physical examination findings. The radiologists did not have access to the patients' medical records. The radiologists varied with respect to the number of years practicing pediatric radiology (median, 8 years; range, 336 years).

Radiographs were selected from children who presented to the ED at Boston Children's Hospital with concern of pneumonia. We selected radiographs with a spectrum of respiratory disease processes encountered in a pediatric population. The final radiographs included 50 radiographs with a final reading in the medical record without suspicion for pneumonia and 50 radiographs with suspicion of pneumonia. In the latter group, 25 radiographs had a final reading suggestive of an alveolar infiltrate, and 25 radiographs had a final reading suggestive of an interstitial infiltrate. Ten duplicate radiographs were included.

Radiograph Interpretation

The radiologists interpreted both anterior‐posterior and lateral views for each subject. Digital Imaging and Communications in Medicine images were downloaded from a registry at Boston Children's Hospital, and were copied to DVDs that were provided to each radiologist. Standardized radiographic imaging software (eFilm Lite; Merge Healthcare, Chicago, Illinois) was used by each radiologist.

Each radiologist completed a study questionnaire for each radiograph (see Supporting Information, Appendix 1, in the online version of this article). The questionnaire utilized radiographic descriptors of primary endpoint pneumonia described by the WHO to standardize the radiographic diagnosis of pneumonia.[20, 21] No additional training was provided to the radiologists. The main outcome of interest was the presence or absence of an infiltrate. Among radiographs in which an infiltrate was identified, radiologists selected whether there was an alveolar infiltrate, interstitial infiltrate, or both. Alveolar infiltrate and interstitial infiltrate are defined on the study questionnaire (Appendix 1). A radiograph classified as having either an alveolar infiltrate or interstitial infiltrate (not atelectasis) was considered to have any infiltrate. Additional findings including air bronchograms, hilar adenopathy, pleural effusion, and location of abnormalities were also recorded.

Statistical Analysis

Inter‐rater reliability was assessed using the kappa statistic to determine the overall agreement among the 6 radiologists for each outcome (eg, presence or absence of alveolar infiltrate). The kappa statistic for more than 2 raters utilizes an analysis of variance approach.[22] To calculate 95% confidence intervals (CI) for kappa statistics with more than 2 raters, we employed a bootstrapping method with 1000 replications of samples equal in size to the study sample. Intra‐rater reliability was evaluated by examining the agreement within each radiologist upon review of 10 duplicate radiographs. We used the following benchmarks to classify the strength of agreement: poor (<0.0), slight (00.20), fair (0.210.40), moderate (0.410.60), substantial (0.610.80), almost perfect (0.811.0).[23] Negative kappa values represent agreement less than would be predicted by chance alone.[24, 25] To calculate the kappa, a value must be recorded in 3 of 4 of the following categories: negative to positive, positive to negative, concordant negative, and concordant positive reporting of pneumonia. If raters did not fulfill 3 categories, the kappa could not be calculated.

The inter‐rater concordance for identification of an alveolar infiltrate was calculated for each radiologist by comparing their reporting of alveolar infiltrate with and without clinical history for each of the 100 radiographs. Radiographs that were identified by an individual rater as no alveolar infiltrate when read without clinical history, but those subsequently identified as alveolar infiltrate with clinical history were categorized as negative to positive reporting of pneumonia with clinical history. Those that were identified as alveolar infiltrate but subsequently identified as no alveolar infiltrate were categorized as positive to negative reporting of pneumonia with clinical history. Those radiographs in which there was no change in identification of alveolar infiltrate with clinical information were categorized as concordant reporting of pneumonia.

The study was approved by the institutional review boards at both children's hospitals.

RESULTS

Patient Sample

The radiographs were from patients ranging in age from 1 week to 19 years (median, 3.5 years; interquartile range, 1.66.0 years). Fifty (50%) patients were male.

Inter‐rater Reliability

The kappa coefficients of inter‐rater reliability between the radiologists across the 6 clinical measures of interest with and without access to clinical history are plotted in Figure 1. Reliability improved from fair (k = 0.32, 95% CI: 0.24 to 0.42) to moderate (k = 0.53, 95% CI: 0.43 to 0.64) for identification of air bronchograms with the addition of clinical history. Although there was an increase in kappa values for identification of any infiltrate, alveolar infiltrate, interstitial infiltrate, and pleural effusion, and a decrease in the kappa value for identification of hilar adenopathy with the addition of clinical information, there was substantial overlap of the 95% CIs, suggesting that inclusion of clinical history did not result in a statistically significant change in the reliability of these findings.

Figure 1
Inter‐rater reliability of radiologists (n = 6) evaluating chest radiographs with and without access to clinical history data in children presenting to the emergency department with suspected pneumonia (n = 100).

Intra‐rater Reliability

The estimates of inter‐rater reliability for the interpretation of the 10 duplicate images with and without clinical history are shown in Table 1. The inter‐rater reliability in the identification of alveolar infiltrate remained substantial to almost perfect for each rater with and without access to clinical history. Rater 1 had a decrease in inter‐rater reliability from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.21, 95% CI: 0.43 to 0.85) in the identification of interstitial infiltrate with the addition of clinical history. This rater also had a decrease in agreement from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.4, 95% CI: 0.16 to 0.96) in the identification of any infiltrate.

Intra‐rater Reliability of Radiologists With and Without Access to Clinical History While Evaluating Chest Radiographs (n = 10) for Pneumonia in Children
 Phase 1No Clinical HistoryPhase 2Access to Clinical History
Kappa95% Confidence IntervalKappa95% Confidence Interval
  • NOTE: Abbreviations: N/A, not applicable.
  • Too few categories of agreement to calculate kappa. Both responses are negative for all 10 paired radiographs; kappa cannot be calculated.
Any infiltrate    
Rater 11.001.00 to 1.000.400.16 to 0.96
Rater 20.600.10 to 1.000.580.07 to 1.00
Rater 30.800.44 to 1.000.800.44 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 5N/Aa 0.110.36 to 0.14
Rater 61.001.00 to 1.001.001.00 to 1.00
Alveolar infiltrate    
Rater 11.001.00 to 1.001.001.00 to 1.00
Rater 21.001.00 to 1.001.001.00 to 1.00
Rater 31.001.00 to 1.001.001.00 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 50.780.39 to 1.001.001.00 to 1.00
Rater 60.740.27 to 1.000.780.39 to 1.00
Interstitial infiltrate    
Rater 11.001.00 to 1.000.210.43 to 0.85
Rater 20.210.43 to 0.850.110.36 to 0.14
Rater 30.740.27 to 1.000.780.39 to 1.00
Rater 4N/A N/A 
Rater 50.580.07 to 1.000.520.05 to 1.00
Rater 60.620.5 to 1.00N/Aa 

Intra‐rater Concordance

The inter‐rater concordance of the radiologists for the identification of alveolar infiltrate during the interpretation of the 100 chest radiographs with and without access to clinical history is shown in Figure 2. The availability of clinical information impacted physicians differently in the evaluation of alveolar infiltrates. Raters 1, 4, and 6 appeared more likely to identify an alveolar infiltrate with access to the clinical information, whereas raters 3 and 5 appeared less likely to identify an alveolar infiltrate. Of the 100 films that were interpreted with and without clinical information, the mean number of discordant interpretations per rater was 10, with values ranging from 6 to 19 for the individual raters. Radiographs in which more than 3 raters changed their interpretation regarding the presence of an alveolar infiltrate are shown in Figure 3. For Figure 3D, 4 radiologists changed their interpretation from no alveolar infiltrate to alveolar infiltrate, and 1 radiologist changed from alveolar infiltrate to no alveolar infiltrate with the addition of clinical history.

Figure 2
Intra‐rater concordance of radiologists before and after access to clinical history while evaluating chest radiographs (n = 100) for alveolar infiltrate in children.
Figure 3
Chest radiographs of children in which 3 or more radiologists changed their interpretation in regard to the presence or absence of an alveolar infiltrate with the addition of clinical information. (A, B, and C) Three of 6 radiologists changed their interpretation. (D) Five of 6 radiologists changed their interpretation. (A) Female, 2 years old. (B) Male, 9 months old. (C) Male, 3 years old. (D) Male, 3 years old. The clinical history provided for (D) read as follows: “3‐year‐old male with cough and difficulty breathing. Rales at left base.”

Comment

We investigated the impact of the availability of clinical information on the reliability of chest radiographic interpretation in the diagnosis of pneumonia. There was improved inter‐rater reliability in the identification of air bronchograms with the addition of clinical information; however, clinical history did not have a substantial impact on the inter‐rater reliability of other findings. The addition of clinical information did not alter the inter‐rater reliability in the identification of alveolar infiltrate. Clinical history affected individual raters differently in their interpretation of alveolar infiltrate, with 3 raters more likely to identify an alveolar infiltrate and 2 raters less likely to identify an alveolar infiltrate.

Most studies addressing the impact of clinical history on radiographic interpretation evaluated accuracy. In many of these studies, accuracy was defined as the raters' agreement with the final interpretation of each film as documented in the medical record or their agreement with the interpretation of the radiologists selecting the cases.[1, 2, 3, 5, 6, 7] Given the known inter‐rater variability in radiographic interpretation,[10, 11, 12, 13, 14, 15] accuracy of a radiologist's interpretation cannot be appropriately assessed through agreement with their peers. Because a true measure of accuracy in the radiographic diagnosis of pneumonia can only be determined through invasive testing, such as lung biopsy, reliability serves as a more appropriate measure of performance. Inclusion of clinical information in chest radiograph interpretation has been shown to improve reliability in the radiographic diagnosis of a broad range of conditions.[15]

The primary outcome in this study was the identification of an infiltrate. Previous studies have noted consistent identification of the radiographic features that are most suggestive of bacterial pneumonia, such as alveolar infiltrate, and less consistent identification of other radiographic findings, including interstitial infiltrate.[18, 26, 27] Among the radiologists in this study, the addition of clinical information did not have a meaningful impact on the reliability of either of these findings, as there was substantial inter‐rater agreement for the identification of alveolar infiltrate and only slight agreement for the identification of interstitial infiltrate, both with and without clinical history. Additionally, inter‐rater reliability for the identification of alveolar infiltrate remained substantial to almost perfect for all 6 raters with the addition of clinical information.

Clinical information impacted the raters differently in their pattern of alveolar infiltrate identification, suggesting that radiologists may differ in their approach to incorporating clinical history in the interpretation of chest radiographs. The inclusion of clinical information may impact a radiologist's perception, leading to improved identification of abnormalities; however, it may also guide their decision making about the relevance of previously identified abnormalities.[28] Some radiologists may use clinical information to support or suggest possible radiographic findings, whereas others may use the information to challenge potential findings. This study did not address the manner in which the individual raters utilized the clinical history. There were also several radiographs in which the clinical information resulted in a change in the identification of an alveolar infiltrate by 3 or more raters, with as many as 5 of 6 raters changing their interpretation for 1 particular radiograph. These changes in identification of an infiltrate suggest that unidentified aspects of a history may be likely to influence a rater's interpretation of a radiograph. Nevertheless, these changes did not result in improved reliability and it is not possible to determine if these changes resulted in improved accuracy in interpretation.

This study had several limitations. First, radiographs were purposefully selected to encompass a broad spectrum of radiographic findings. Thus, the prevalence of pneumonia and other abnormal findings was artificially higher than typically observed among a cohort of children for whom pneumonia is considered. Second, the radiologists recruited for this study all practice in an academic children's hospital setting. These factors may limit the generalizability of our findings. However, we would expect these results to be generalizable to pediatric radiologists from other academic institutions. Third, this study does not meet the criteria of a balanced study design as defined by Loy and Irwig.[19] A study was characterized as balanced if half of the radiographs were read with and half without clinical information in each of the 2 reading sessions. The proposed benefit of such a design is to control for possible changes in ability or reporting practices of the raters that may have occurred between study periods. The use of a standardized reporting tool likely minimized changes in reporting practices. Also, it is unlikely that the ability or reporting practices of an experienced radiologist would change over the study period. Fourth, the radiologists interpreted the films outside of their standard workflow and utilized a standardized reporting tool that focused on the presence or absence of pneumonia indicators. These factors may have increased the radiologists' suspicion for pneumonia even in the absence of clinical information. This may have biased the results toward finding no difference in the identification of pneumonia with the addition of detailed clinical history. Thus, the inclusion of clinical information in radiograph interpretation in clinical practice may have greater impact on the identification of these pneumonia indicators than was found in this study.[29] Finally, reliability does not imply accuracy, and it is unknown if changes in the identification of pneumonia indicators led to more accurate interpretation with respect to the clinical or pathologic diagnosis of pneumonia.

In conclusion, we observed high intra‐ and inter‐rater reliability among radiologists in the identification of an alveolar infiltrate, the radiographic finding most suggestive of bacterial pneumonia.[16, 17, 18, 30] The addition of clinical information did not have a substantial impact on the reliability of its identification.

The inclusion of clinical information in diagnostic testing may influence the interpretation of the clinical findings. Historical and clinical findings may focus the reader's attention to the relevant details, thereby improving the accuracy of the interpretation. However, such information may cause the reader to have preconceived notions about the results, biasing the overall interpretation.

The impact of clinical information on the interpretation of radiographic studies remains an issue of debate. Previous studies have found that clinical information improves the accuracy of radiographic interpretation for a broad range of diagnoses,[1, 2, 3, 4] whereas others do not show improvement.[5, 6, 7] Additionally, clinical information may serve as a distraction that leads to more false‐positive interpretations.[8] For this reason, many radiologists prefer to review radiographs without knowledge of the clinical scenario prompting the study to avoid focusing on the expected findings and potentially missing other important abnormalities.[9]

The chest radiograph (CXR) is the most commonly used diagnostic imaging modality. Nevertheless, poor agreement exists among radiologists in the interpretation of chest radiographs for the diagnosis of pneumonia in both adults and children.[10, 11, 12, 13, 14, 15] Recent studies have found a high degree of agreement among pediatric radiologists with implementation of the World Health Organization (WHO) criteria for standardized CXR interpretation for diagnosis of bacterial pneumonia in children.[16, 17, 18] In these studies, participants were blinded to the clinical presentation. Data investigating the impact of clinical history on CXR interpretation in the pediatric population are limited.[19]

We conducted this prospective case‐based study to evaluate the impact of clinical information on the reliability of radiographic diagnosis of pneumonia among children presenting to a pediatric emergency department (ED) with clinical suspicion of pneumonia.

METHODS

Study Subjects

Six board‐certified radiologists at 2 academic children's hospitals (Children's Hospital of Philadelphia [n = 3] and Boston Children's Hospital [n = 3]) interpreted the same 110 chest radiographs (100 original and 10 duplicates) on 2 separate occasions. Clinical information was withheld during the first interpretation. The inter‐ and inter‐rater reliability for the interpretation of these 110 radiographs without clinical information have been previously reported.[18] After a period of 6 months, the radiologists reviewed the radiographs with access to clinical information provided by the physician ordering the CXR. This clinical information included age, sex, clinical indication for obtaining the radiograph, relevant history, and physical examination findings. The radiologists did not have access to the patients' medical records. The radiologists varied with respect to the number of years practicing pediatric radiology (median, 8 years; range, 336 years).

Radiographs were selected from children who presented to the ED at Boston Children's Hospital with concern of pneumonia. We selected radiographs with a spectrum of respiratory disease processes encountered in a pediatric population. The final radiographs included 50 radiographs with a final reading in the medical record without suspicion for pneumonia and 50 radiographs with suspicion of pneumonia. In the latter group, 25 radiographs had a final reading suggestive of an alveolar infiltrate, and 25 radiographs had a final reading suggestive of an interstitial infiltrate. Ten duplicate radiographs were included.

Radiograph Interpretation

The radiologists interpreted both anterior‐posterior and lateral views for each subject. Digital Imaging and Communications in Medicine images were downloaded from a registry at Boston Children's Hospital, and were copied to DVDs that were provided to each radiologist. Standardized radiographic imaging software (eFilm Lite; Merge Healthcare, Chicago, Illinois) was used by each radiologist.

Each radiologist completed a study questionnaire for each radiograph (see Supporting Information, Appendix 1, in the online version of this article). The questionnaire utilized radiographic descriptors of primary endpoint pneumonia described by the WHO to standardize the radiographic diagnosis of pneumonia.[20, 21] No additional training was provided to the radiologists. The main outcome of interest was the presence or absence of an infiltrate. Among radiographs in which an infiltrate was identified, radiologists selected whether there was an alveolar infiltrate, interstitial infiltrate, or both. Alveolar infiltrate and interstitial infiltrate are defined on the study questionnaire (Appendix 1). A radiograph classified as having either an alveolar infiltrate or interstitial infiltrate (not atelectasis) was considered to have any infiltrate. Additional findings including air bronchograms, hilar adenopathy, pleural effusion, and location of abnormalities were also recorded.

Statistical Analysis

Inter‐rater reliability was assessed using the kappa statistic to determine the overall agreement among the 6 radiologists for each outcome (eg, presence or absence of alveolar infiltrate). The kappa statistic for more than 2 raters utilizes an analysis of variance approach.[22] To calculate 95% confidence intervals (CI) for kappa statistics with more than 2 raters, we employed a bootstrapping method with 1000 replications of samples equal in size to the study sample. Intra‐rater reliability was evaluated by examining the agreement within each radiologist upon review of 10 duplicate radiographs. We used the following benchmarks to classify the strength of agreement: poor (<0.0), slight (00.20), fair (0.210.40), moderate (0.410.60), substantial (0.610.80), almost perfect (0.811.0).[23] Negative kappa values represent agreement less than would be predicted by chance alone.[24, 25] To calculate the kappa, a value must be recorded in 3 of 4 of the following categories: negative to positive, positive to negative, concordant negative, and concordant positive reporting of pneumonia. If raters did not fulfill 3 categories, the kappa could not be calculated.

The inter‐rater concordance for identification of an alveolar infiltrate was calculated for each radiologist by comparing their reporting of alveolar infiltrate with and without clinical history for each of the 100 radiographs. Radiographs that were identified by an individual rater as no alveolar infiltrate when read without clinical history, but those subsequently identified as alveolar infiltrate with clinical history were categorized as negative to positive reporting of pneumonia with clinical history. Those that were identified as alveolar infiltrate but subsequently identified as no alveolar infiltrate were categorized as positive to negative reporting of pneumonia with clinical history. Those radiographs in which there was no change in identification of alveolar infiltrate with clinical information were categorized as concordant reporting of pneumonia.

The study was approved by the institutional review boards at both children's hospitals.

RESULTS

Patient Sample

The radiographs were from patients ranging in age from 1 week to 19 years (median, 3.5 years; interquartile range, 1.66.0 years). Fifty (50%) patients were male.

Inter‐rater Reliability

The kappa coefficients of inter‐rater reliability between the radiologists across the 6 clinical measures of interest with and without access to clinical history are plotted in Figure 1. Reliability improved from fair (k = 0.32, 95% CI: 0.24 to 0.42) to moderate (k = 0.53, 95% CI: 0.43 to 0.64) for identification of air bronchograms with the addition of clinical history. Although there was an increase in kappa values for identification of any infiltrate, alveolar infiltrate, interstitial infiltrate, and pleural effusion, and a decrease in the kappa value for identification of hilar adenopathy with the addition of clinical information, there was substantial overlap of the 95% CIs, suggesting that inclusion of clinical history did not result in a statistically significant change in the reliability of these findings.

Figure 1
Inter‐rater reliability of radiologists (n = 6) evaluating chest radiographs with and without access to clinical history data in children presenting to the emergency department with suspected pneumonia (n = 100).

Intra‐rater Reliability

The estimates of inter‐rater reliability for the interpretation of the 10 duplicate images with and without clinical history are shown in Table 1. The inter‐rater reliability in the identification of alveolar infiltrate remained substantial to almost perfect for each rater with and without access to clinical history. Rater 1 had a decrease in inter‐rater reliability from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.21, 95% CI: 0.43 to 0.85) in the identification of interstitial infiltrate with the addition of clinical history. This rater also had a decrease in agreement from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.4, 95% CI: 0.16 to 0.96) in the identification of any infiltrate.

Intra‐rater Reliability of Radiologists With and Without Access to Clinical History While Evaluating Chest Radiographs (n = 10) for Pneumonia in Children
 Phase 1No Clinical HistoryPhase 2Access to Clinical History
Kappa95% Confidence IntervalKappa95% Confidence Interval
  • NOTE: Abbreviations: N/A, not applicable.
  • Too few categories of agreement to calculate kappa. Both responses are negative for all 10 paired radiographs; kappa cannot be calculated.
Any infiltrate    
Rater 11.001.00 to 1.000.400.16 to 0.96
Rater 20.600.10 to 1.000.580.07 to 1.00
Rater 30.800.44 to 1.000.800.44 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 5N/Aa 0.110.36 to 0.14
Rater 61.001.00 to 1.001.001.00 to 1.00
Alveolar infiltrate    
Rater 11.001.00 to 1.001.001.00 to 1.00
Rater 21.001.00 to 1.001.001.00 to 1.00
Rater 31.001.00 to 1.001.001.00 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 50.780.39 to 1.001.001.00 to 1.00
Rater 60.740.27 to 1.000.780.39 to 1.00
Interstitial infiltrate    
Rater 11.001.00 to 1.000.210.43 to 0.85
Rater 20.210.43 to 0.850.110.36 to 0.14
Rater 30.740.27 to 1.000.780.39 to 1.00
Rater 4N/A N/A 
Rater 50.580.07 to 1.000.520.05 to 1.00
Rater 60.620.5 to 1.00N/Aa 

Intra‐rater Concordance

The inter‐rater concordance of the radiologists for the identification of alveolar infiltrate during the interpretation of the 100 chest radiographs with and without access to clinical history is shown in Figure 2. The availability of clinical information impacted physicians differently in the evaluation of alveolar infiltrates. Raters 1, 4, and 6 appeared more likely to identify an alveolar infiltrate with access to the clinical information, whereas raters 3 and 5 appeared less likely to identify an alveolar infiltrate. Of the 100 films that were interpreted with and without clinical information, the mean number of discordant interpretations per rater was 10, with values ranging from 6 to 19 for the individual raters. Radiographs in which more than 3 raters changed their interpretation regarding the presence of an alveolar infiltrate are shown in Figure 3. For Figure 3D, 4 radiologists changed their interpretation from no alveolar infiltrate to alveolar infiltrate, and 1 radiologist changed from alveolar infiltrate to no alveolar infiltrate with the addition of clinical history.

Figure 2
Intra‐rater concordance of radiologists before and after access to clinical history while evaluating chest radiographs (n = 100) for alveolar infiltrate in children.
Figure 3
Chest radiographs of children in which 3 or more radiologists changed their interpretation in regard to the presence or absence of an alveolar infiltrate with the addition of clinical information. (A, B, and C) Three of 6 radiologists changed their interpretation. (D) Five of 6 radiologists changed their interpretation. (A) Female, 2 years old. (B) Male, 9 months old. (C) Male, 3 years old. (D) Male, 3 years old. The clinical history provided for (D) read as follows: “3‐year‐old male with cough and difficulty breathing. Rales at left base.”

Comment

We investigated the impact of the availability of clinical information on the reliability of chest radiographic interpretation in the diagnosis of pneumonia. There was improved inter‐rater reliability in the identification of air bronchograms with the addition of clinical information; however, clinical history did not have a substantial impact on the inter‐rater reliability of other findings. The addition of clinical information did not alter the inter‐rater reliability in the identification of alveolar infiltrate. Clinical history affected individual raters differently in their interpretation of alveolar infiltrate, with 3 raters more likely to identify an alveolar infiltrate and 2 raters less likely to identify an alveolar infiltrate.

Most studies addressing the impact of clinical history on radiographic interpretation evaluated accuracy. In many of these studies, accuracy was defined as the raters' agreement with the final interpretation of each film as documented in the medical record or their agreement with the interpretation of the radiologists selecting the cases.[1, 2, 3, 5, 6, 7] Given the known inter‐rater variability in radiographic interpretation,[10, 11, 12, 13, 14, 15] accuracy of a radiologist's interpretation cannot be appropriately assessed through agreement with their peers. Because a true measure of accuracy in the radiographic diagnosis of pneumonia can only be determined through invasive testing, such as lung biopsy, reliability serves as a more appropriate measure of performance. Inclusion of clinical information in chest radiograph interpretation has been shown to improve reliability in the radiographic diagnosis of a broad range of conditions.[15]

The primary outcome in this study was the identification of an infiltrate. Previous studies have noted consistent identification of the radiographic features that are most suggestive of bacterial pneumonia, such as alveolar infiltrate, and less consistent identification of other radiographic findings, including interstitial infiltrate.[18, 26, 27] Among the radiologists in this study, the addition of clinical information did not have a meaningful impact on the reliability of either of these findings, as there was substantial inter‐rater agreement for the identification of alveolar infiltrate and only slight agreement for the identification of interstitial infiltrate, both with and without clinical history. Additionally, inter‐rater reliability for the identification of alveolar infiltrate remained substantial to almost perfect for all 6 raters with the addition of clinical information.

Clinical information impacted the raters differently in their pattern of alveolar infiltrate identification, suggesting that radiologists may differ in their approach to incorporating clinical history in the interpretation of chest radiographs. The inclusion of clinical information may impact a radiologist's perception, leading to improved identification of abnormalities; however, it may also guide their decision making about the relevance of previously identified abnormalities.[28] Some radiologists may use clinical information to support or suggest possible radiographic findings, whereas others may use the information to challenge potential findings. This study did not address the manner in which the individual raters utilized the clinical history. There were also several radiographs in which the clinical information resulted in a change in the identification of an alveolar infiltrate by 3 or more raters, with as many as 5 of 6 raters changing their interpretation for 1 particular radiograph. These changes in identification of an infiltrate suggest that unidentified aspects of a history may be likely to influence a rater's interpretation of a radiograph. Nevertheless, these changes did not result in improved reliability and it is not possible to determine if these changes resulted in improved accuracy in interpretation.

This study had several limitations. First, radiographs were purposefully selected to encompass a broad spectrum of radiographic findings. Thus, the prevalence of pneumonia and other abnormal findings was artificially higher than typically observed among a cohort of children for whom pneumonia is considered. Second, the radiologists recruited for this study all practice in an academic children's hospital setting. These factors may limit the generalizability of our findings. However, we would expect these results to be generalizable to pediatric radiologists from other academic institutions. Third, this study does not meet the criteria of a balanced study design as defined by Loy and Irwig.[19] A study was characterized as balanced if half of the radiographs were read with and half without clinical information in each of the 2 reading sessions. The proposed benefit of such a design is to control for possible changes in ability or reporting practices of the raters that may have occurred between study periods. The use of a standardized reporting tool likely minimized changes in reporting practices. Also, it is unlikely that the ability or reporting practices of an experienced radiologist would change over the study period. Fourth, the radiologists interpreted the films outside of their standard workflow and utilized a standardized reporting tool that focused on the presence or absence of pneumonia indicators. These factors may have increased the radiologists' suspicion for pneumonia even in the absence of clinical information. This may have biased the results toward finding no difference in the identification of pneumonia with the addition of detailed clinical history. Thus, the inclusion of clinical information in radiograph interpretation in clinical practice may have greater impact on the identification of these pneumonia indicators than was found in this study.[29] Finally, reliability does not imply accuracy, and it is unknown if changes in the identification of pneumonia indicators led to more accurate interpretation with respect to the clinical or pathologic diagnosis of pneumonia.

In conclusion, we observed high intra‐ and inter‐rater reliability among radiologists in the identification of an alveolar infiltrate, the radiographic finding most suggestive of bacterial pneumonia.[16, 17, 18, 30] The addition of clinical information did not have a substantial impact on the reliability of its identification.

References
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  15. Tudor GR, Finlay D, Taub N. An assessment of inter‐observer agreement and accuracy when reporting plain radiographs. Clin Radiol. 1997;52(3):235238.
  16. Shimol BS, Dagan R, Givon‐Lavi N, et al. Evaluation of the World Health Organization criteria for chest radiographs for pneumonia diagnosis in children. Eur J Pediatr. 2011;171(2):369374.
  17. Cherian T, Mulholland EK, Carlin JB, et al. Standardized interpretation of paediatric chest radiographs for the diagnosis of pneumonia in epidemiological studies. Bull World Health Organ. 2005;83(5):353359.
  18. Neuman MI, Lee EY, Bixby S, et al. Variability in the interpretation of chest radiographs for the diagnosis of pneumonia in children. J Hosp Med. 2012;7(4):294298.
  19. Loy CT, Irwig L. Accuracy of diagnostic tests read with and without clinical information: a systematic review. JAMA. 2004;292(13):16021609.
  20. Standardization of interpretation of chest radiographs for the diagnosis of pneumonia in children. In:World Health Organization: Pneumonia Vaccine Trial Investigators' Group.Geneva: Department of Vaccine and Biologics;2001.
  21. Hansen J, Black S, Shinefield H, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than 5 years of age for prevention of pneumonia: updated analysis using World Health Organization standardized interpretation of chest radiographs. Pediatr Infect Dis J. 2006;25(9):779781.
  22. Landis JR, Koch GG. A one‐way components of variance model for categorical data. Biometrics. 1977;33:671679.
  23. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159174.
  24. Juurlink DN, Detsky AS. Kappa statistic. CMAJ. 2005;173(1):16.
  25. Kramer MS, Feinstein AR. Clinical biostatistics. LIV. The biostatistics of concordance. Clin Pharmacol Ther. 1981;29(1):111123.
  26. Bartlett JG, Dowell SF, Mandell LA, File TM, Musher DM, Fine MJ. Practice guidelines for the management of community‐acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000;31(2):347382.
  27. Niederman MS, Mandell LA, Anzueto A, et al. Guidelines for the management of adults with community‐acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001;163(7):17301754.
  28. Berbaum KS, Franken EA. Commentary does clinical history affect perception?Acad Radiol. 2006;13(3):402403.
  29. Berbaum KS, Franken EA. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1991;26(5):512514.
  30. Korppi M, Kiekara O, Heiskanen‐Kosma T, Soimakallio S. Comparison of radiological findings and microbial aetiology of childhood pneumonia. Acta Paediatr. 1993;82(4):360363.
References
  1. Berbaum KS, Franken EA, Dorfman DD, et al. Tentative diagnoses facilitate the detection of diverse lesions in chest radiographs. Invest Radiol. 1986;21(7):532539.
  2. Berbaum KS, Franken EA, Dorfman DD, Barloon TJ. Influence of clinical history upon detection of nodules and other lesions. Invest Radiol. 1988;23(1):4855.
  3. Berbaum KS, Franken EA, Dorfman DD, Lueben KR. Influence of clinical history on perception of abnormalities in pediatric radiographs. Acad Radiol. 1994;1(3):217223.
  4. Song KS, Song HH, Park SH, et al. Impact of clinical history on film interpretation. Yonsei Med J. 1992;33(2):168172.
  5. Cooperstein LA, Good BC, Eelkema EA, et al. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1990;25(6):670674.
  6. Good BC, Cooperstein LA, DeMarino GB, et al. Does knowledge of the clinical history affect the accuracy of chest radiograph interpretation?AJR Am J Roentgenol. 1990;154(4):709712.
  7. Quekel LG, Goei R, Kessels AG, Engelshoven JM. Detection of lung cancer on the chest radiograph: impact of previous films, clinical information, double reading, and dual reading. J Clin Epidemiol. 2001;54(11):11461150.
  8. Eldevik OP, Dugstad G, Orrison WW, Haughton VM. The effect of clinical bias on the interpretation of myelography and spinal computed tomography. Radiology. 1982;145(1):8589.
  9. Griscom NT. A suggestion: look at the images first, before you read the history. Radiology. 2002;223(1):910.
  10. Albaum MN, Hill LC, Murphy M, et al. Interobserver reliability of the chest radiograph in community‐acquired pneumonia. PORT Investigators. Chest. 1996;110(2):343350.
  11. Bloomfield FH, Teele RL, Voss M, Knight DB, Harding JE. Inter‐ and intra‐observer variability in the assessment of atelectasis and consolidation in neonatal chest radiographs. Pediatr Radiol. 1999;29(6):459462.
  12. Gatt ME, Spectre G, Paltiel O, Hiller N, Stalnikowicz R. Chest radiographs in the emergency department: is the radiologist really necessary?Postgrad Med J. 2003;79(930):214217.
  13. Hopstaken RM, Witbraad T, Engelshoven JM, Dinant GJ. Inter‐observer variation in the interpretation of chest radiographs for pneumonia in community‐acquired lower respiratory tract infections. Clin Radiol. 2004;59(8):743752.
  14. Novack V, Avnon LS, Smolyakov A, Barnea R, Jotkowitz A, Schlaeffer F. Disagreement in the interpretation of chest radiographs among specialists and clinical outcomes of patients hospitalized with suspected pneumonia. Eur J Intern Med. 2006;17(1):4347.
  15. Tudor GR, Finlay D, Taub N. An assessment of inter‐observer agreement and accuracy when reporting plain radiographs. Clin Radiol. 1997;52(3):235238.
  16. Shimol BS, Dagan R, Givon‐Lavi N, et al. Evaluation of the World Health Organization criteria for chest radiographs for pneumonia diagnosis in children. Eur J Pediatr. 2011;171(2):369374.
  17. Cherian T, Mulholland EK, Carlin JB, et al. Standardized interpretation of paediatric chest radiographs for the diagnosis of pneumonia in epidemiological studies. Bull World Health Organ. 2005;83(5):353359.
  18. Neuman MI, Lee EY, Bixby S, et al. Variability in the interpretation of chest radiographs for the diagnosis of pneumonia in children. J Hosp Med. 2012;7(4):294298.
  19. Loy CT, Irwig L. Accuracy of diagnostic tests read with and without clinical information: a systematic review. JAMA. 2004;292(13):16021609.
  20. Standardization of interpretation of chest radiographs for the diagnosis of pneumonia in children. In:World Health Organization: Pneumonia Vaccine Trial Investigators' Group.Geneva: Department of Vaccine and Biologics;2001.
  21. Hansen J, Black S, Shinefield H, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than 5 years of age for prevention of pneumonia: updated analysis using World Health Organization standardized interpretation of chest radiographs. Pediatr Infect Dis J. 2006;25(9):779781.
  22. Landis JR, Koch GG. A one‐way components of variance model for categorical data. Biometrics. 1977;33:671679.
  23. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159174.
  24. Juurlink DN, Detsky AS. Kappa statistic. CMAJ. 2005;173(1):16.
  25. Kramer MS, Feinstein AR. Clinical biostatistics. LIV. The biostatistics of concordance. Clin Pharmacol Ther. 1981;29(1):111123.
  26. Bartlett JG, Dowell SF, Mandell LA, File TM, Musher DM, Fine MJ. Practice guidelines for the management of community‐acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000;31(2):347382.
  27. Niederman MS, Mandell LA, Anzueto A, et al. Guidelines for the management of adults with community‐acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001;163(7):17301754.
  28. Berbaum KS, Franken EA. Commentary does clinical history affect perception?Acad Radiol. 2006;13(3):402403.
  29. Berbaum KS, Franken EA. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1991;26(5):512514.
  30. Korppi M, Kiekara O, Heiskanen‐Kosma T, Soimakallio S. Comparison of radiological findings and microbial aetiology of childhood pneumonia. Acta Paediatr. 1993;82(4):360363.
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Address for correspondence and reprint requests: Samir S. Shah, MD, 3333 Burnet Avenue, ML 9016, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229. E-mail: [email protected]
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Pay-for-Performance Challenged as Best Model for Healthcare

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Pushing healthcare toward pay-for-performance models that provide financial rewards for patient outcomes might not be the best direction for healthcare, according to an article published by a duo of doctors and a behavioral economist.

“Will Pay for Performance Backfire? Insights from Behavioral Economics” posted at Healthaffairs.org, questions the validity of paying for outcomes, particularly as there is no evidence yet that the model improves patient outcomes.

“You’re not actually paying for quality,” says David Himmelstein, MD, a professor at City University of New York School of Public Health at Hunter College, New York. “What you’re paying for is some very gameable measurement that doctors will find a way to cheat.”

The blog post notes that monetary rewards can actually undermine motivation for tasks that are intrinsically interesting or rewarding, a phenomenon known as “motivational crowd-out.” Dr. Himmelstein says it could focus attention on coding, rather than patients, or encourage providers to avoid noncompliant patients who will make their measured performances look bad.

“Injecting different monetary incentives into healthcare can certainly change it,” according to the article, “but not necessarily in the ways that policy makers would plan, much less hope for.”

Dr. Himmelstein says that without evidence for, or against, pay for performance, it’s difficult to say whether it will improve outcomes over the long term. Given the government push toward pay-for-performance programs—such as value-based purchasing (VBP)—he suggests physicians prepare themselves to comply. Accordingly, SHM supports policies that link "quality measurement to performance-based payment” and has created a toolkit to help hospitalists prepare for VBP, one of the most targeted pay-for-performance programs.

Even as HM moves toward adopting pay for performance as a mantra, Dr. Himmelstein believes hospitalists are in a good position to lead discussions on whether pay for performance is the only way to move forward.

“It can feel like a fait d’accompli, but things can change, and they can change rapidly,” Dr. Himmelstein adds. “The first step is to have real discussions about it. Up to now, much of the medical literature is saying, ‘It’s not working. We must have the wrong incentives.’ What if there are no right incentives?”

 

Visit our website for more information about pay-for-performance programs.

 

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Pushing healthcare toward pay-for-performance models that provide financial rewards for patient outcomes might not be the best direction for healthcare, according to an article published by a duo of doctors and a behavioral economist.

“Will Pay for Performance Backfire? Insights from Behavioral Economics” posted at Healthaffairs.org, questions the validity of paying for outcomes, particularly as there is no evidence yet that the model improves patient outcomes.

“You’re not actually paying for quality,” says David Himmelstein, MD, a professor at City University of New York School of Public Health at Hunter College, New York. “What you’re paying for is some very gameable measurement that doctors will find a way to cheat.”

The blog post notes that monetary rewards can actually undermine motivation for tasks that are intrinsically interesting or rewarding, a phenomenon known as “motivational crowd-out.” Dr. Himmelstein says it could focus attention on coding, rather than patients, or encourage providers to avoid noncompliant patients who will make their measured performances look bad.

“Injecting different monetary incentives into healthcare can certainly change it,” according to the article, “but not necessarily in the ways that policy makers would plan, much less hope for.”

Dr. Himmelstein says that without evidence for, or against, pay for performance, it’s difficult to say whether it will improve outcomes over the long term. Given the government push toward pay-for-performance programs—such as value-based purchasing (VBP)—he suggests physicians prepare themselves to comply. Accordingly, SHM supports policies that link "quality measurement to performance-based payment” and has created a toolkit to help hospitalists prepare for VBP, one of the most targeted pay-for-performance programs.

Even as HM moves toward adopting pay for performance as a mantra, Dr. Himmelstein believes hospitalists are in a good position to lead discussions on whether pay for performance is the only way to move forward.

“It can feel like a fait d’accompli, but things can change, and they can change rapidly,” Dr. Himmelstein adds. “The first step is to have real discussions about it. Up to now, much of the medical literature is saying, ‘It’s not working. We must have the wrong incentives.’ What if there are no right incentives?”

 

Visit our website for more information about pay-for-performance programs.

 

Pushing healthcare toward pay-for-performance models that provide financial rewards for patient outcomes might not be the best direction for healthcare, according to an article published by a duo of doctors and a behavioral economist.

“Will Pay for Performance Backfire? Insights from Behavioral Economics” posted at Healthaffairs.org, questions the validity of paying for outcomes, particularly as there is no evidence yet that the model improves patient outcomes.

“You’re not actually paying for quality,” says David Himmelstein, MD, a professor at City University of New York School of Public Health at Hunter College, New York. “What you’re paying for is some very gameable measurement that doctors will find a way to cheat.”

The blog post notes that monetary rewards can actually undermine motivation for tasks that are intrinsically interesting or rewarding, a phenomenon known as “motivational crowd-out.” Dr. Himmelstein says it could focus attention on coding, rather than patients, or encourage providers to avoid noncompliant patients who will make their measured performances look bad.

“Injecting different monetary incentives into healthcare can certainly change it,” according to the article, “but not necessarily in the ways that policy makers would plan, much less hope for.”

Dr. Himmelstein says that without evidence for, or against, pay for performance, it’s difficult to say whether it will improve outcomes over the long term. Given the government push toward pay-for-performance programs—such as value-based purchasing (VBP)—he suggests physicians prepare themselves to comply. Accordingly, SHM supports policies that link "quality measurement to performance-based payment” and has created a toolkit to help hospitalists prepare for VBP, one of the most targeted pay-for-performance programs.

Even as HM moves toward adopting pay for performance as a mantra, Dr. Himmelstein believes hospitalists are in a good position to lead discussions on whether pay for performance is the only way to move forward.

“It can feel like a fait d’accompli, but things can change, and they can change rapidly,” Dr. Himmelstein adds. “The first step is to have real discussions about it. Up to now, much of the medical literature is saying, ‘It’s not working. We must have the wrong incentives.’ What if there are no right incentives?”

 

Visit our website for more information about pay-for-performance programs.

 

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Not Sexy Enough

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The annual meeting of the American College of Rheumatology has just ended. As usual, it was frenetic. So many lectures to choose from, so little time (and, as I age, energy) to get to them all.

The meeting is a great opportunity for the motivated rheumatologist if you know how to use it to your advantage – and that’s a skill that’s learned over a few years of attendance. Apart from catching up with old mentors and friends, you can catch up on the latest and greatest in basic science research. You can find out how experts manage difficult cases. There are sessions on how to manage your practice more efficiently. There are thousands of posters from all over the world to peruse.

Year after year there are several sessions on the autoimmune diseases, covering everything from basic science to bench and clinical research to clinical practice. An ever-growing pool of information about the genetic and molecular bases of disease has led to a rapid expansion of treatment targets – primarily for rheumatoid arthritis but extending to other autoimmune diseases as well.

But there are certain bread-and-butter illnesses that are not as sexy and, as such, do not get as much airtime.

This year, for example, there was only one clinical session on gout, and it was held in one of the smaller rooms. Slated for the same time slot were "Dermatology Topics for Rheumatologists" and "Preclinical Autoimmunity – Potential for Prevention," both much sexier-sounding and held in much larger venues. If my small cohort of friends and colleagues is a microcosm of the attendee population, it made complete sense to do this because I was the only one out of six who was interested in gout.

I understand that "Dermatology Topics for Rheumatologists" – by far the most popular in my small cohort – is indeed interesting, but I do not think it provides terribly useful information. No offense to the ACR or to my friends who picked this topic, but while you may see an interesting rash here and there and maybe remember seeing a similar picture from a lecture that you attended somewhere, I contend that it is more valuable for a clinician to be able to treat challenging gout cases, to learn more postmarketing information about pegloticase, and to understand what asymptomatic hyperuricemia might potentially indicate.

And what of osteoarthritis? There was a popular lecture on back pain, though I heard it was not very good. OA has become one of my biggest frustrations. It is never easy to tell patients that there is not much that can be done for their condition. Thankfully there was a basic science lecture on OA. Hopefully, this means more funding for more research, and ultimately perhaps a disease-modifier as well.

I appreciate that there was a session on paraneoplastic syndromes, one on polymyalgia rheumatica, and one on osteoporosis. I see more of these conditions in my practice than I do systemic lupus erythematosus, scleroderma, or vasculitis.

Without a doubt, ours is a wonderful field to be in. Our diseases have historically been very challenging to define, let alone treat. I feel lucky to be a rheumatologist at such a heady time, when it is now possible to go into drug-free remission if you have rheumatoid arthritis. We understand mechanisms of autoimmune disease better and are making great strides in therapeutics.

But there are other diseases that have been largely ignored, for reasons that are not entirely clear to me (perhaps the unfettered profit motivation that I talked about a few columns ago?), and I think it is about time we had a more equitable distribution of resources for research. Glamorous zebras aside, I will be grateful for the day that I can tell my patients: "yes, there is a nonsurgical option for your osteoarthritis, and no, it is not an antidepressant."

Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her at [email protected].

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The annual meeting of the American College of Rheumatology has just ended. As usual, it was frenetic. So many lectures to choose from, so little time (and, as I age, energy) to get to them all.

The meeting is a great opportunity for the motivated rheumatologist if you know how to use it to your advantage – and that’s a skill that’s learned over a few years of attendance. Apart from catching up with old mentors and friends, you can catch up on the latest and greatest in basic science research. You can find out how experts manage difficult cases. There are sessions on how to manage your practice more efficiently. There are thousands of posters from all over the world to peruse.

Year after year there are several sessions on the autoimmune diseases, covering everything from basic science to bench and clinical research to clinical practice. An ever-growing pool of information about the genetic and molecular bases of disease has led to a rapid expansion of treatment targets – primarily for rheumatoid arthritis but extending to other autoimmune diseases as well.

But there are certain bread-and-butter illnesses that are not as sexy and, as such, do not get as much airtime.

This year, for example, there was only one clinical session on gout, and it was held in one of the smaller rooms. Slated for the same time slot were "Dermatology Topics for Rheumatologists" and "Preclinical Autoimmunity – Potential for Prevention," both much sexier-sounding and held in much larger venues. If my small cohort of friends and colleagues is a microcosm of the attendee population, it made complete sense to do this because I was the only one out of six who was interested in gout.

I understand that "Dermatology Topics for Rheumatologists" – by far the most popular in my small cohort – is indeed interesting, but I do not think it provides terribly useful information. No offense to the ACR or to my friends who picked this topic, but while you may see an interesting rash here and there and maybe remember seeing a similar picture from a lecture that you attended somewhere, I contend that it is more valuable for a clinician to be able to treat challenging gout cases, to learn more postmarketing information about pegloticase, and to understand what asymptomatic hyperuricemia might potentially indicate.

And what of osteoarthritis? There was a popular lecture on back pain, though I heard it was not very good. OA has become one of my biggest frustrations. It is never easy to tell patients that there is not much that can be done for their condition. Thankfully there was a basic science lecture on OA. Hopefully, this means more funding for more research, and ultimately perhaps a disease-modifier as well.

I appreciate that there was a session on paraneoplastic syndromes, one on polymyalgia rheumatica, and one on osteoporosis. I see more of these conditions in my practice than I do systemic lupus erythematosus, scleroderma, or vasculitis.

Without a doubt, ours is a wonderful field to be in. Our diseases have historically been very challenging to define, let alone treat. I feel lucky to be a rheumatologist at such a heady time, when it is now possible to go into drug-free remission if you have rheumatoid arthritis. We understand mechanisms of autoimmune disease better and are making great strides in therapeutics.

But there are other diseases that have been largely ignored, for reasons that are not entirely clear to me (perhaps the unfettered profit motivation that I talked about a few columns ago?), and I think it is about time we had a more equitable distribution of resources for research. Glamorous zebras aside, I will be grateful for the day that I can tell my patients: "yes, there is a nonsurgical option for your osteoarthritis, and no, it is not an antidepressant."

Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her at [email protected].

The annual meeting of the American College of Rheumatology has just ended. As usual, it was frenetic. So many lectures to choose from, so little time (and, as I age, energy) to get to them all.

The meeting is a great opportunity for the motivated rheumatologist if you know how to use it to your advantage – and that’s a skill that’s learned over a few years of attendance. Apart from catching up with old mentors and friends, you can catch up on the latest and greatest in basic science research. You can find out how experts manage difficult cases. There are sessions on how to manage your practice more efficiently. There are thousands of posters from all over the world to peruse.

Year after year there are several sessions on the autoimmune diseases, covering everything from basic science to bench and clinical research to clinical practice. An ever-growing pool of information about the genetic and molecular bases of disease has led to a rapid expansion of treatment targets – primarily for rheumatoid arthritis but extending to other autoimmune diseases as well.

But there are certain bread-and-butter illnesses that are not as sexy and, as such, do not get as much airtime.

This year, for example, there was only one clinical session on gout, and it was held in one of the smaller rooms. Slated for the same time slot were "Dermatology Topics for Rheumatologists" and "Preclinical Autoimmunity – Potential for Prevention," both much sexier-sounding and held in much larger venues. If my small cohort of friends and colleagues is a microcosm of the attendee population, it made complete sense to do this because I was the only one out of six who was interested in gout.

I understand that "Dermatology Topics for Rheumatologists" – by far the most popular in my small cohort – is indeed interesting, but I do not think it provides terribly useful information. No offense to the ACR or to my friends who picked this topic, but while you may see an interesting rash here and there and maybe remember seeing a similar picture from a lecture that you attended somewhere, I contend that it is more valuable for a clinician to be able to treat challenging gout cases, to learn more postmarketing information about pegloticase, and to understand what asymptomatic hyperuricemia might potentially indicate.

And what of osteoarthritis? There was a popular lecture on back pain, though I heard it was not very good. OA has become one of my biggest frustrations. It is never easy to tell patients that there is not much that can be done for their condition. Thankfully there was a basic science lecture on OA. Hopefully, this means more funding for more research, and ultimately perhaps a disease-modifier as well.

I appreciate that there was a session on paraneoplastic syndromes, one on polymyalgia rheumatica, and one on osteoporosis. I see more of these conditions in my practice than I do systemic lupus erythematosus, scleroderma, or vasculitis.

Without a doubt, ours is a wonderful field to be in. Our diseases have historically been very challenging to define, let alone treat. I feel lucky to be a rheumatologist at such a heady time, when it is now possible to go into drug-free remission if you have rheumatoid arthritis. We understand mechanisms of autoimmune disease better and are making great strides in therapeutics.

But there are other diseases that have been largely ignored, for reasons that are not entirely clear to me (perhaps the unfettered profit motivation that I talked about a few columns ago?), and I think it is about time we had a more equitable distribution of resources for research. Glamorous zebras aside, I will be grateful for the day that I can tell my patients: "yes, there is a nonsurgical option for your osteoarthritis, and no, it is not an antidepressant."

Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her at [email protected].

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Triple Therapy Boosts HCV Response After Transplant

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BOSTON  – Liver transplant recipients with hepatitis C virus infection who underwent triple-drug therapy achieved a high extended rapid virologic response rate but often contended with treatment complications in a retrospective multicenter cohort study.

The extended rapid virologic response (eRVR) rate seen in 57% of patients was "encouraging, given a very difficult-to-cure population," Dr. James R. Burton, Jr., said at the annual meeting of the American Association for the Study of Liver Diseases. He noted, however, that it’s not clear if the encouraging eRVR rate will predict sustained virologic response (SVR) as it does in non-liver transplant patients.

Dr. James R. Burton, Jr.

The use of peginteferon plus ribavirin in liver transplant recipients with hepatitis C virus infection has an SVR of only 30%. While triple therapy with peginterferon, ribavirin, and a protease inhibitor (boceprevir or telaprevir) has significantly improved rates of SVR in patients infected with genotype 1 hepatitis C virus, its safety and efficacy in liver transplant recipients is unknown, said Dr. Burton, medical director of liver transplantation at the University of Colorado Hospital, Aurora.

With 101 patients, the five-center study is the largest involving triple therapy in liver transplant recipients with hepatitis C virus infection.

Telaprevir was the protease inhibitor used most often in patients (90% vs. 10% with boceprevir). Nearly all patients (96%) had a lead-in treatment phase with peginterferon plus ribavirin. A minority of patients (14%) had an extended lead-in phase of at least 90 days (median of 189 days) and were excluded from efficacy, but not safety, analyses. The other patients had a lead-in lasting a median of 29 days. The patients with a long lead-in phase had a median of 398 total treatment days, compared with a median of 154 days for those with a shorter lead-in time.

The efficacy study population involved genotype 1–infected patients (54% genotype 1a, 39% 1b, and 7% mixed) from five medical centers. Most patients were men (76%); they had a median age of 58 years and a median duration of 54 months from their liver transplant to starting a protease inhibitor. An unfavorable IL28B genotype was found in 69% of 45 patients tested. In the 60% of patients who had undergone previous antiviral therapy, 29% had a partial response. On liver biopsy, another 47% of patients had either bridging fibrosis or cirrhosis.

The immunosuppressive agents used by the patients included cyclosporine (66%) and tacrolimus (23%). A small percentage did not receive a calcineurin inhibitor or rapamycin. Another 27% were taking corticosteroids, and 72% were taking mycophenolate mofetil or mycophenolic acid.

On treatment, the percentage of patients who had an HCV RNA level less than the limit of detection increased from 55% at 4 weeks to 63% at 8 weeks. At 12 weeks the percentage was 71%. An eRVR, defined as negative HCV RNA tests at 4 and 12 weeks, occurred in 57%. An eRVR occurred significantly more often among patients who had at least a 1 log drop in HCV RNA levels during the lead-in phase than did those with less than a 1 log drop (76% vs. 35%).

Overall, 12% of patients experienced virologic breakthrough, and treatment was stopped. This occurred more often among those with a long lead-in vs. those with a short lead-in (21% vs. 10%, respectively). Another 14% discontinued treatment early because of an adverse event; discontinuations occurred more often among patients with a long lead-in (40% vs. 11%).

Protease inhibitors are known to inhibit the metabolism of calcineurin inhibitors, which was reflected in the study by the need to reduce the median daily doses of cyclosporine (from 200 mg to 50 mg) and tacrolimus (from 1.0 mg to 0.06 mg) after protease inhibitor therapy began.

Many patients (49%) required blood transfusions during triple therapy. During the first 16 weeks of therapy, these patients used a median of 2.5 units. The majority of patients (86%) used growth factors, including granulocyte-colony stimulating factor in 44% and erythropoietin in 79%. Medication dose reductions were most frequent for ribavirin (in 78%). A total of 7% were hospitalized for anemia, Dr. Burton said.

Renal insufficiency, defined as an increase in creatinine of greater than 0.5 mg/dL from baseline, developed in 32%. Of two rejection episodes in the study, one involved a patient coming off a protease inhibitor.

Dr. Burton suggested that future studies should focus on identifying predictors for nonresponse to avoid unnecessary treatment and associated toxicities such as complications of anemia and adverse events related to significant protease inhibitor–calcineurin inhibitor interactions, such as worsening renal function and graft rejection when transitioning off a protease inhibitor.

 

 

Dr. Burton disclosed that he is an investigator in a clinical trial sponsored by Vertex Pharmaceuticals, which makes telaprevir.☐

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BOSTON  – Liver transplant recipients with hepatitis C virus infection who underwent triple-drug therapy achieved a high extended rapid virologic response rate but often contended with treatment complications in a retrospective multicenter cohort study.

The extended rapid virologic response (eRVR) rate seen in 57% of patients was "encouraging, given a very difficult-to-cure population," Dr. James R. Burton, Jr., said at the annual meeting of the American Association for the Study of Liver Diseases. He noted, however, that it’s not clear if the encouraging eRVR rate will predict sustained virologic response (SVR) as it does in non-liver transplant patients.

Dr. James R. Burton, Jr.

The use of peginteferon plus ribavirin in liver transplant recipients with hepatitis C virus infection has an SVR of only 30%. While triple therapy with peginterferon, ribavirin, and a protease inhibitor (boceprevir or telaprevir) has significantly improved rates of SVR in patients infected with genotype 1 hepatitis C virus, its safety and efficacy in liver transplant recipients is unknown, said Dr. Burton, medical director of liver transplantation at the University of Colorado Hospital, Aurora.

With 101 patients, the five-center study is the largest involving triple therapy in liver transplant recipients with hepatitis C virus infection.

Telaprevir was the protease inhibitor used most often in patients (90% vs. 10% with boceprevir). Nearly all patients (96%) had a lead-in treatment phase with peginterferon plus ribavirin. A minority of patients (14%) had an extended lead-in phase of at least 90 days (median of 189 days) and were excluded from efficacy, but not safety, analyses. The other patients had a lead-in lasting a median of 29 days. The patients with a long lead-in phase had a median of 398 total treatment days, compared with a median of 154 days for those with a shorter lead-in time.

The efficacy study population involved genotype 1–infected patients (54% genotype 1a, 39% 1b, and 7% mixed) from five medical centers. Most patients were men (76%); they had a median age of 58 years and a median duration of 54 months from their liver transplant to starting a protease inhibitor. An unfavorable IL28B genotype was found in 69% of 45 patients tested. In the 60% of patients who had undergone previous antiviral therapy, 29% had a partial response. On liver biopsy, another 47% of patients had either bridging fibrosis or cirrhosis.

The immunosuppressive agents used by the patients included cyclosporine (66%) and tacrolimus (23%). A small percentage did not receive a calcineurin inhibitor or rapamycin. Another 27% were taking corticosteroids, and 72% were taking mycophenolate mofetil or mycophenolic acid.

On treatment, the percentage of patients who had an HCV RNA level less than the limit of detection increased from 55% at 4 weeks to 63% at 8 weeks. At 12 weeks the percentage was 71%. An eRVR, defined as negative HCV RNA tests at 4 and 12 weeks, occurred in 57%. An eRVR occurred significantly more often among patients who had at least a 1 log drop in HCV RNA levels during the lead-in phase than did those with less than a 1 log drop (76% vs. 35%).

Overall, 12% of patients experienced virologic breakthrough, and treatment was stopped. This occurred more often among those with a long lead-in vs. those with a short lead-in (21% vs. 10%, respectively). Another 14% discontinued treatment early because of an adverse event; discontinuations occurred more often among patients with a long lead-in (40% vs. 11%).

Protease inhibitors are known to inhibit the metabolism of calcineurin inhibitors, which was reflected in the study by the need to reduce the median daily doses of cyclosporine (from 200 mg to 50 mg) and tacrolimus (from 1.0 mg to 0.06 mg) after protease inhibitor therapy began.

Many patients (49%) required blood transfusions during triple therapy. During the first 16 weeks of therapy, these patients used a median of 2.5 units. The majority of patients (86%) used growth factors, including granulocyte-colony stimulating factor in 44% and erythropoietin in 79%. Medication dose reductions were most frequent for ribavirin (in 78%). A total of 7% were hospitalized for anemia, Dr. Burton said.

Renal insufficiency, defined as an increase in creatinine of greater than 0.5 mg/dL from baseline, developed in 32%. Of two rejection episodes in the study, one involved a patient coming off a protease inhibitor.

Dr. Burton suggested that future studies should focus on identifying predictors for nonresponse to avoid unnecessary treatment and associated toxicities such as complications of anemia and adverse events related to significant protease inhibitor–calcineurin inhibitor interactions, such as worsening renal function and graft rejection when transitioning off a protease inhibitor.

 

 

Dr. Burton disclosed that he is an investigator in a clinical trial sponsored by Vertex Pharmaceuticals, which makes telaprevir.☐

BOSTON  – Liver transplant recipients with hepatitis C virus infection who underwent triple-drug therapy achieved a high extended rapid virologic response rate but often contended with treatment complications in a retrospective multicenter cohort study.

The extended rapid virologic response (eRVR) rate seen in 57% of patients was "encouraging, given a very difficult-to-cure population," Dr. James R. Burton, Jr., said at the annual meeting of the American Association for the Study of Liver Diseases. He noted, however, that it’s not clear if the encouraging eRVR rate will predict sustained virologic response (SVR) as it does in non-liver transplant patients.

Dr. James R. Burton, Jr.

The use of peginteferon plus ribavirin in liver transplant recipients with hepatitis C virus infection has an SVR of only 30%. While triple therapy with peginterferon, ribavirin, and a protease inhibitor (boceprevir or telaprevir) has significantly improved rates of SVR in patients infected with genotype 1 hepatitis C virus, its safety and efficacy in liver transplant recipients is unknown, said Dr. Burton, medical director of liver transplantation at the University of Colorado Hospital, Aurora.

With 101 patients, the five-center study is the largest involving triple therapy in liver transplant recipients with hepatitis C virus infection.

Telaprevir was the protease inhibitor used most often in patients (90% vs. 10% with boceprevir). Nearly all patients (96%) had a lead-in treatment phase with peginterferon plus ribavirin. A minority of patients (14%) had an extended lead-in phase of at least 90 days (median of 189 days) and were excluded from efficacy, but not safety, analyses. The other patients had a lead-in lasting a median of 29 days. The patients with a long lead-in phase had a median of 398 total treatment days, compared with a median of 154 days for those with a shorter lead-in time.

The efficacy study population involved genotype 1–infected patients (54% genotype 1a, 39% 1b, and 7% mixed) from five medical centers. Most patients were men (76%); they had a median age of 58 years and a median duration of 54 months from their liver transplant to starting a protease inhibitor. An unfavorable IL28B genotype was found in 69% of 45 patients tested. In the 60% of patients who had undergone previous antiviral therapy, 29% had a partial response. On liver biopsy, another 47% of patients had either bridging fibrosis or cirrhosis.

The immunosuppressive agents used by the patients included cyclosporine (66%) and tacrolimus (23%). A small percentage did not receive a calcineurin inhibitor or rapamycin. Another 27% were taking corticosteroids, and 72% were taking mycophenolate mofetil or mycophenolic acid.

On treatment, the percentage of patients who had an HCV RNA level less than the limit of detection increased from 55% at 4 weeks to 63% at 8 weeks. At 12 weeks the percentage was 71%. An eRVR, defined as negative HCV RNA tests at 4 and 12 weeks, occurred in 57%. An eRVR occurred significantly more often among patients who had at least a 1 log drop in HCV RNA levels during the lead-in phase than did those with less than a 1 log drop (76% vs. 35%).

Overall, 12% of patients experienced virologic breakthrough, and treatment was stopped. This occurred more often among those with a long lead-in vs. those with a short lead-in (21% vs. 10%, respectively). Another 14% discontinued treatment early because of an adverse event; discontinuations occurred more often among patients with a long lead-in (40% vs. 11%).

Protease inhibitors are known to inhibit the metabolism of calcineurin inhibitors, which was reflected in the study by the need to reduce the median daily doses of cyclosporine (from 200 mg to 50 mg) and tacrolimus (from 1.0 mg to 0.06 mg) after protease inhibitor therapy began.

Many patients (49%) required blood transfusions during triple therapy. During the first 16 weeks of therapy, these patients used a median of 2.5 units. The majority of patients (86%) used growth factors, including granulocyte-colony stimulating factor in 44% and erythropoietin in 79%. Medication dose reductions were most frequent for ribavirin (in 78%). A total of 7% were hospitalized for anemia, Dr. Burton said.

Renal insufficiency, defined as an increase in creatinine of greater than 0.5 mg/dL from baseline, developed in 32%. Of two rejection episodes in the study, one involved a patient coming off a protease inhibitor.

Dr. Burton suggested that future studies should focus on identifying predictors for nonresponse to avoid unnecessary treatment and associated toxicities such as complications of anemia and adverse events related to significant protease inhibitor–calcineurin inhibitor interactions, such as worsening renal function and graft rejection when transitioning off a protease inhibitor.

 

 

Dr. Burton disclosed that he is an investigator in a clinical trial sponsored by Vertex Pharmaceuticals, which makes telaprevir.☐

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Triple Therapy Boosts HCV Response After Transplant
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Triple Therapy Boosts HCV Response After Transplant
Legacy Keywords
Liver transplant, hepatitis C virus, hvc, extended rapid virologic response (eRVR), Dr. James R. Burton, Jr., American Association for the Study of Liver Diseases, sustained virologic response (SVR), peginteferon, ribavirin, protease inhibitor, boceprevir, telaprevir
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Liver transplant, hepatitis C virus, hvc, extended rapid virologic response (eRVR), Dr. James R. Burton, Jr., American Association for the Study of Liver Diseases, sustained virologic response (SVR), peginteferon, ribavirin, protease inhibitor, boceprevir, telaprevir
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AT THE ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES

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Major Finding: An extended rapid virologic response occurred significantly more often among patients who had at least a 1 log drop in HCV RNA levels during the lead-in phase than did those with less than a 1 log drop (76% vs. 35%)

Data Source: This was a multicenter retrospective cohort study of triple therapy for hepatitis C virus infection in 101 patients with post liver transplant.

Disclosures: Dr. Burton disclosed that he is an investigator in a clinical trial sponsored by Vertex Pharmaceuticals, which makes telaprevir.

End‐of‐Life Discussions

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Opportunity lost: End‐of‐life discussions in cancer patients who die in the hospital

Most patients prefer to die at home, pain free and without the use of life‐sustaining treatments[1, 2] yet the majority of patients with serious illness die in the hospital.[3, 4, 5] When hospitalized patient die, the care is frequently focused on life‐sustaining treatments[6]; pain, dyspnea, and agitation levels are higher when compared with patients who die in non‐hospital settings.[7, 8, 9] End‐of‐life discussions and their products (ie, advanced directives) can clarify treatment options with patients and family,[10] and help ensure that patients receive care consistent with their beliefs.[11, 12, 13] End‐of‐life discussions are associated with a decrease use of life‐sustaining treatments, improved quality of life, and reduced costs of care.[14, 15] For the majority of patients dying of cancer, the first end‐of‐life discussion takes place in the hospital setting.[16]

Conducting end‐of‐life conversations in the hospital setting can be challenging. Patients are acutely ill and nearly 40% are incapable of making their own medical decisions.[17] In order to participate in an end‐of‐life discussion, a physician must determine that a patient meets the 4 criteria of decisional capacity as outlined by Appelbaum and Grisso:[18] Does the patient (1) communicate a clear and consistent choice; (2) understand the relevant information surrounding that decision; (3) appreciate the consequences of that decision; and (4) communicate reasoning for that decision?[19] In practice, however, clinicians inaccurately assign capacity up to 25% of the time.[17] When a physician determines, accurately or inaccurately, that the patient does not meet this standard for decisional capacity, discussions must be held instead with a surrogate decision‐maker. Surrogate decision‐making can make communication with the physician more difficult,[20] delay important medical decisions,[21] and be stressful on the decision‐maker.[22] To our knowledge, no studies have examined patient and surrogate participation in end‐of‐life discussions at the time of terminal hospitalization and its association with end‐of‐life treatments received.

Our goals were to examine physician assessment of decisional capacity and the prevalence of end‐of‐life discussions during the terminal hospitalization of patients with advanced cancer. Our research questions were: (1) What proportion of patients were assessed to have decisional capacity by the clinical team at the time of their terminal hospital admission? (2) What proportion of these patients had a documented discussion about end‐of‐life care with the clinical team, and for what proportion was the conversation held instead by the patient's surrogate decision‐maker because the patient was considered to have lost decisional capacity? (3) Was patient participation in a discussion about end‐of‐life care associated with life‐sustaining and palliative treatments received?

METHODS

Design

This is a retrospective cohort study of consecutive adult patients with advanced cancer who died at the University of Michigan Hospital, Ann Arbor, MI, from January 1, 2004 through December 31, 2007. This study was exempted from review by the University of Michigan (UM) Institutional Review Board because decedent data were used.

Sample

The UM Cancer Registry is a database of all cancer patients treated at the UM Comprehensive Cancer Center. We used the Registry to identify patients who met the following criteria: (1) age 18 years at time of cancer diagnosis; (2) estimated probability of 5‐year survival 20% at time of diagnosis, as predicted by the SEER Cancer Statistics Review[23]; (3) the entirety of cancer treatment was received at University of Michigan Health System (UMHS); and (4) the patient died while admitted to the University Hospital between January 1, 2004 and December 31, 2007.

UMHS is a healthcare system and academic medical center consisting of hospitals, health centers, and clinics, including the University of Michigan Hospital and Comprehensive Cancer Center. Over 4000 cancer patients are admitted to University Hospital and 80,000 outpatient visits occur to the Cancer Center every year. It serves as a major cancer referral center for the patients of Michigan and the greater Midwest. The University of Michigan implemented a palliative care consult service that was started in 2005, during the time period of our study.

Data Collection

Data were abstracted by review of the medical record by an internist (M.Z.) using a comprehensive chart abstraction instrument based on a previously validated tool.[24] Demographic data abstracted from the medical record included age, religious affiliation, race, ethnicity, and marital status. The original abstraction tool, which included 83 items, was reduced to include 47 items focusing on information related to advanced care planning, hospital course, and end‐of‐life discussions. Specific items included: reasons for admission, primary hospital service, occurrence and timing of end‐of‐life decision‐making, whether patient or family preferences were elicited through an end‐of‐life discussion, clinician's assessment of patient's decisional capacity at time of admission and end‐of‐life conversations, whether a comfort care plan was made, and whether palliative morphine was used.

The chart abstraction tool was pilot tested on the medical records of 10 patients, who were not included in the study, and refined to improve completeness of data collection. A copy of the abstraction tool is available upon request.

Definition of Key Variables

Decisional Capacity Assessment

Decisional capacity assessment is a reflection of the clinical team's assessment of the patient's decisional capacity on admission, and was determined through examination of the medical record in the first 24 hours of admission. Positive decision‐making capacity assessment was assumed if the clinician assessment of decisional capacity was documented in the mental status exam, or if the clinician documented conversations between clinician and patient in the history that suggested intact decision‐making capacity (ie, clinician documented terms such as patient stated or patient described and then described a coherent or sensible statement which implied patient capacity and intact mental status), or if the clinician's documentation of the assessment and plan stated or suggested decisions were being made by the patient. Other supportive information from the record was used to corroborate the evidence used to determine the clinician's assessment of the patient's decisional capacity, including whether the patient signed consent forms.

End‐of‐Life Discussions

The presence of an end‐of‐life discussion was presumed when the clinician documented a discussion with the patient, discussion with family, or family meeting concerning treatment preferences, or when the clinician quoted the patient's preferences in a fashion that documents a face‐to‐face discussion or directly described the elicitation of preferences from the patient or family.

Living Will

A living will was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed a living will.

Health Care Proxy

Health Care Proxy or Durable Power of Attorney for Healthcare was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed such a document.

Do Not Resuscitate (DNR) on Admission

DNR status was identified as present if the patient had documents with established DNR orders, or if a physician explicitly documented code status as DNR in the admission note or other documents placed in the record within the first 24 hours of admission.

Intensive Care Unit (ICU)Treatment

Patients were defined as having received ICU treatment if they were admitted directly or subsequently transferred to the ICU during the hospital course.

Comfort Care

Comfort care was defined as present only if the phrases comfort care, palliative care, or supportive care, were documented.

Palliative Opioid Therapy

Treatments with morphine or other opioids were recorded as palliative only if it was explicitly stated that these medications were used in the context of palliative or end‐of‐life care.

Data Analysis

We report the proportion of patients who were documented to lack decisional capacity at the time of hospital admission. We compared patient characteristics for those with and without documentation of decisional capacity on admission, and patients with decisional capacity on admission who did and did not participate in discussions about end‐of‐life care using chi‐square tests for categorical data, t tests for normally distributed continuous variables, and MannWhitney U tests for non‐normally distributed continuous variables. We examined whether documentation of a discussion about end‐of‐life care was associated with life‐sustaining and palliative treatments received using chi‐square for categorical treatments, and MannWhitney U tests for days from admission to initiation of comfort care. We used P < 0.05 to signify statistical significance.

RESULTS

Characteristics of Population and Decisional Capacity on Admission

The characteristics of the 145 patients who met entry criteria are summarized in Table 1. The most common types of cancers were lung cancer and leukemia/lymphoma. Of the 145 patients, the medical team's assessment of the patient's decisional capacity on admission could be established for 142 patients. As documented within the first 24 hours of admission, 27 patients (19%) were considered not to have decisional capacity, and 115 patients (79%) were considered to have decisional capacity. Both of these groups had similar age and gender distributions. There were no significant differences in the distribution of cancer type between those with and without decisional capacity. In both groups, the majority of the cancer diagnoses were made prior to admission. There was no difference in DNR orders established prior to or on admission between the groups (Table 1).

Characteristics of Patients With and Without Documented Decision‐Making Capacity
 Decision‐Making Capacity on Admissiona 
No (N = 27)Yes (N = 115) 
N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Decisional capacity as assessed and documented by the clinician; clinicians assessment of decisional capacity could not be determined in 3 patients.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age >6515 (55.6)60 (52.2)0.75
Gender (male)14 (51.9)68 (59.1)0.46
Cancer type
Lung12 (44.4)42 (36.5)0.67
Bone marrow5 (18.5)35 (30.4)
Liver3 (11.1)6 (5.2)
Pancreas3 (11.1)7 (6.10)
Esophagus1 (3.7)8 (7.0)
Colon1 (3.7)6 (5.2)
Otherb2 (7.4)11 (9.6)
Prior to admission
Cancer diagnosis known23 (85.2)91 (79.1)0.48
Living will completed6 (22.2)26 (22.60.97
Health care proxy established3 (11.1)26 (22.6)0.18
DNR established8 (29.6)27 (23.5)0.79

End‐of‐Life Discussion in Patients With Decisional Capacity on Admission

Of the 115 patients assessed to have intact decisional capacity on admission, 56 (48.7%) participated in an end‐of‐life discussion with the medical team during their terminal hospitalization. For the remaining 59 patients who did not participate in an end‐of‐life discussion during the terminal hospital course, 46 (40.0%) had documentation suggesting they lost decisional capacity prior to a conversation and that the end‐of‐life discussions were held instead with the patient's surrogate decision‐maker, and 13 (11.3%) had no evidence of any end‐of‐life discussion (with the patient or surrogate).

When comparing those patients who participated in an end‐of‐life discussion with those patients whose surrogate participated in the discussion, there were no significant differences in gender and age distributions (Table 2). There was a significant difference in the type of cancers between the 2 groups. Among patients who participated in their end‐of‐life discussions, bone marrow cancer was proportionately more prevalent (17.9% vs 2.2%; P <0.01) and lung cancer was less prevalent (16.1% vs 41.3%; P <0.01), when compared to those who required surrogate participation. Timing of cancer diagnosis and prevalence of advance directives were similar between the 2 groups. The proportion of patients who had an established DNR order prior to admission was higher among those who did participate in end‐of‐life discussions when compared to those who had surrogate participation in these discussions (30.4% vs 17.4%; P < 0.04).

Among Patients With Documented Decision‐Making Capacity on Admission, the Characteristics of Patients by Status of Their Participation in End‐of‐Life Discussions
Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
 N =13N = 102 
 End‐of‐Life discussion not documentedEnd‐of‐Life discussion with surrogate (N = 46)End‐of‐Life discussion with patient (N = 56) 
 N (%)N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age 659 (69.2)18 (39.1)27 (48.2)0.36
Gender (male)10 (76.9)27 (60.0)31 (55.4)0.64
Cancer type    
Lung3 (23.1)19 (41.3)9 (16.1) 
Bone marrow7 (53.9)1 (2.2)10 (17.9) 
Liver1 (7.7)3 (6.5)2 (3.6) 
Pancreas1 (7.7)2 (4.4)4 (7.1)<0.01
Esophagus06 (13.0)2 (3.6) 
Colon1 (7.7)1 (2.2)3 (5.4) 
Othera01 (2.2)10 (17.9) 
Prior to Admission
Cancer diagnosis known10 (76.9)37 (80.4)43 (76.8)0.66
Living will completed4 (30.8)10 (21.7)12 (21.4)0.97
Health care proxy established    
 3 (23.1)13 (28.3)10 (17.9)0.21
DNR established2 (15.4)8 (17.4)17 (30.4)0.04

Life‐Prolonging and Palliative Care Treatments Received and Participation in End‐of‐Life Discussions

Life‐prolonging treatments were more likely to be used for patients whose end‐of‐life discussions were held by patient's surrogate decision‐maker, in comparison to those patients who participated in the discussions themselves. Patients who had conversations held by surrogates were more likely to receive ventilator support (56.5% vs 23.2%, P < 0.01), chemotherapy (39.1% vs 5.4%, P < 0.01), artificial nutrition or hydration (45.7% vs 25.0%, P = 0.03), and antibiotics (97.8% vs 78.6%, P < 0.01), when compared to patients who participated in their own end‐of‐life discussion. Intensive care treatment rates also differed significantly between the 2 groups; 56.5% of those who did not participate in end‐of‐life discussions, and only 23.2% of those patients who did participate, were admitted or transferred to the intensive care unit (P < 0.01). There was no significant difference in the proportion of patients who received cardiopulmonary resuscitation (CPR) (15.2% vs 7.1%, P = 0.56) (Table 3). Patients who lost decisional capacity and required a surrogate decision‐maker to participate in their end‐of‐life discussions had longer length of stay (15.8 vs 10.3 days, P = 0.03) and length of time to end‐of‐life discussions (14.0 vs 6.1 days, P < 0.01) (Table 3).

Patient or Surrogate Participation in End‐of‐Life Discussions, Treatments Received, and Timing of Advanced Care Planning Among Patients With Documented Decision‐Making Capacity on Admission
 Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
End‐of‐Life Discussion With Surrogate (N =46)End‐of‐Life Discussion With Patient (N = 56) 
 N (%)N (%)P Value
  • Abbreviations: CI, confidence interval; ICU, intensive care unit. *P value is for comparison of end‐of‐life discussion with surrogate vs end‐of‐life discussion with patient.
Life‐Prolonging Treatment   
Ventilatory support26 (56.5)13 (23.2)<0.01
Chemotherapy18 (39.1)3 (5.4)<0.01
Artificial nutrition or hydration21 (45.7)14 (25.0)0.03
Antibiotics45 (97.8)44 (78.6)<0.01
Cardiopulmonary resuscitation7 (15.2)4 (7.1)0.19
ICU treatment (admit or transfer)26 (56.5)13 (23.2)<0.01
Palliative Treatments   
Comfort care39 (84.8)45 (80.4)0.56
Palliative morphine drip24 (52.2)33 (57.1)0.62
 Mean (95% CI) [Range]Mean (95% CI) [Range] 
Timing of Advanced Care Planning   
Length of hospitalization15.8 d (11.420.2) [157]10.3 d (146) [146]0.03
Time to end‐of‐life discussion14.0 d (9.918.1) [055]6.1 d (3.88.4) [046]<0.01
Time to comfort care23.5 d (4.342.8) [1374]9.2 d (6.312.1) [046]0.12

A comparison of the proportion of patients receiving palliative treatments, such as palliative comfort care orders and morphine infusions, revealed no significant differences between those with and without a discussion about end‐of‐life care (Table 3). Furthermore, while the time interval from hospital admission to initiation of comfort care was shorter for those who did participate in end‐of‐life discussions compared with those had surrogate participation (9.3 vs 23.5 days, P = 0.13 for equality), this difference was not statistically significant (Table 3).

Since a higher proportion of those who participated in end‐of‐life discussions during the hospitalization were admitted with a DNR order established prior to or on admission, we also examined the use of life‐prolonging treatments in the subgroup of patients who did not have a DNR order prior to admission. The difference in life‐prolonging treatments between those who did and did not participate in end‐of‐life discussions was preserved among those patients who did not have DNR status on admission (data not shown).

DISCUSSION

In this retrospective study of 145 terminal cancer patients who died in the hospital, we found that half of the patients had documentation suggesting that they lost decisional capacity during hospitalization and did not participate in end‐of‐life discussion with their healthcare providers. Among cancer patients in our study, 19% were determined not to have decisional capacity on admission, and another 32% were determined to lose decisional capacity during the hospital course. When patients did participate in documented discussions about end‐of‐life care, they were less likely to receive intensive life‐sustaining treatments, less likely to be admitted or transferred to the ICU, and more likely to avoid prolonged hospitalization. The finding that the majority of cancer patients are assessed to have intact decisional capacity upon admission to their terminal hospitalization, but less than half of them participate in their own end‐of‐life conversation, suggests that there is an important lost opportunity to provide quality advanced care planning to hospitalized patients.

Advanced care planning is the act of defining a competent patient's wishes regarding their future healthcare in the event of loss of decisional capacity. For many of the patients who were determined to lose decisional capacity during their hospitalization in our study, a surrogate decision‐maker was involved in a subsequent end‐of‐life discussion. This represents a missed opportunity in 2 ways. First, because surrogates may incorrectly predict patients' end‐of‐life treatment preferences in approximately one‐third of the cases,[25] patients may receive care that is inconsistent with their beliefs. Second, reliance on surrogate decision‐making may result in a greater burden on family members. Surrogate decision‐making places a large burden on surrogates, and can lead to emotional and psychological stress that can last well beyond the death of the loved one.[16, 26]

Our results reinforce the growing body of evidence suggesting that communication with the dying patient, both before and during the terminal hospitalization, promotes end‐of‐life care that involves less invasive life‐prolonging treatments,[10, 11, 12, 13, 14, 15] which is a consistently stated goal of most patients at the end of life.[1, 2] Our findings are consistent with a recent randomized trial of hospitalized patients over the age of 80 which showed that advance care planning discussions were associated with decreased use of intensive life‐sustaining treatments, increased patient and family satisfaction with care, as well as decreased psychological symptoms among family members.[27] In addition, studies examining patients with advanced cancer have shown that discussions about end‐of‐life care in the outpatient setting resulted in less intensive life‐sustaining treatments.[14, 15] Nearly 20% of our cohort was determined by the clinical team to lack decisional capacity at the time of their terminal hospitalization, highlighting the importance of end‐of‐life discussion prior to hospitalization. Our results also extend these recent findings to the inpatient setting. Seventy‐nine percent of patients in our study were determined to have decisional capacity at the time of their terminal hospitalization, and end‐of‐life discussion conducted with these patients was associated with decreased use of life‐sustaining treatments.

Seriously ill patients, particularly in hospital settings, have high symptom burden and subsequent poor quality of life.[6] These patients and families often report inadequate pain and symptom relief.[8, 28, 29] It is therefore reassuring that we found no difference in the proportion of patients who received comfort care and palliative morphine infusions according to whether they or a surrogate participated in the end‐of‐life discussions. In fact, the majority of patients were made DNR and received some form of comfort measure prior to death, although these comfort measures were frequently initiated only hours prior to death.

While our findings are consistent with research that has demonstrated that end‐of‐life discussions with patients are associated with a decrease in life‐prolonging treatments, it is important to note that our observational study cannot establish a causal relationship between the end‐of‐life discussion and the subsequent use of life‐sustaining treatments. It is possible that patients who have discussions about end‐of‐life care inherently prefer to have less intensive life‐sustaining treatment at the end of life. Physicians may be more apt to engage in these types of discussions with patients who express interest in limited intervention. Interestingly, patients with a DNR order at the time of admission were more likely to participate in end‐of‐life care with their provider during their terminal hospitalization, which supports this alternate explanation. However, when we excluded all patients with a DNR on admission, our findings persisted. Regardless of the explanation for the association between end‐of‐life discussions and life‐sustaining treatments, our study identifies a cohort of hospitalized patients who could benefit from improved end‐of‐life communication, and a clinical setting where opportunities remain to improve the quality of advanced care planning.

Discussions about end‐of‐life care with patients result in earlier transition to care focused on palliation.[14] Although we examined the timing to initiation of comfort care between those who participated and those who did not participate in end‐of‐life discussions, we were not able to demonstrate a statistically significant difference. However, our cohort may not be suitable for an examination of this type of intervention, as early discussions about end‐of‐life care may have lead to early referral to hospice, and therefore death outside the hospital setting, making the patients ineligible for our study.

There are several additional limitations to our study. First, our study is subject to the potential biases inherent in retrospective chart review. For example, since we identified patients who died in the hospital, our study does not generalize to patients with advanced cancer who survive the hospitalization or who were discharged to die at home.[30] Furthermore, our use of the medical record to assess documentation of communication about end‐of‐life care and decisional capacity relies on the accuracy of clinician documentation. There may have been communication about end‐of‐life care that was not documented in the medical record, resulting in underestimation of the effects of end‐of‐life discussions. In clinical practice, the assessment of decisional capacity can be challenging.[19, 31, 32] Although clinicians are often accurate in identifying patients with capacity, in nearly one‐quarter of all assessments, they mistakenly assign capacity to patients who lack decision‐making capacity.[17] In our study, we examine clinician assessment of the patient's decisional capacity, but cannot assess either the accuracy of their clinical assessment or the accuracy of their documentation of this assessment. A second limitation is that the chart abstraction was conducted by a single reviewer without inter‐rater assessment, although the abstraction tool was modified from a well‐established tool.[24] A third limitation is that all of the patients were from a single academic center and the results may not generalize to other regions. Fourth, we did not assess for the potential effect of individual clinicians. Since most patients were cared for by multiple physicians, our study is not capable of assessing a clinician‐level effect. Finally, our study was not able to address whether the care received by patients was in accord with their informed preferences.

We have shown that opportunities exist for advanced care planning at the time of the terminal hospitalization of patients with advanced cancer. The majority of these patients have documentation of decisional capacity at the time of admission, suggesting that opportunities exist to conduct end‐of‐life discussion while the patient retains decisional capacity. Furthermore, we found that patients who participate in these discussions about end‐of‐life care with their clinicians have an associated decrease in the use of life‐sustaining treatments, which is consistent with prior studies.[11, 13, 14, 15, 27] Improving communication about end‐of‐life care for patients hospitalized with advanced cancer may represent an important opportunity to improve the concordance between patients' wishes for care at the end‐of‐life and the care that these patients actually receive. Such communication may also decrease the burden on family members who are frequently asked to play the role of surrogate decision‐maker without an opportunity to discuss these issues with the patient.

Acknowledgments

The authors acknowledge Melissa Braxton for her assistance with the preparation of this manuscript.

Disclosures: A portion of this data was presented at the annual meeting of the Society of Hospital Medicine, 2011, in Grapevine, TX. This work was supported by the National Cancer Institute at the National Institutes of Health (KO5 CA 104699 to J.G.E.) and the National Heart, Lung, and Blood Institute (K24HL68593 to J.R.C.). Dr Silveira's salary was supported by core funds from the Ann Arbor VA HSRD Center of Excellence. The authors have no relevant financial interest in the subject matter contained within this manuscript.

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References
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  2. Teno JM, Weitzen S, Fennell ML, Mor V. Dying trajectory in the last year of life: does cancer trajectory fit other diseases?J Palliat Med. 2001;4(4):457464.
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Most patients prefer to die at home, pain free and without the use of life‐sustaining treatments[1, 2] yet the majority of patients with serious illness die in the hospital.[3, 4, 5] When hospitalized patient die, the care is frequently focused on life‐sustaining treatments[6]; pain, dyspnea, and agitation levels are higher when compared with patients who die in non‐hospital settings.[7, 8, 9] End‐of‐life discussions and their products (ie, advanced directives) can clarify treatment options with patients and family,[10] and help ensure that patients receive care consistent with their beliefs.[11, 12, 13] End‐of‐life discussions are associated with a decrease use of life‐sustaining treatments, improved quality of life, and reduced costs of care.[14, 15] For the majority of patients dying of cancer, the first end‐of‐life discussion takes place in the hospital setting.[16]

Conducting end‐of‐life conversations in the hospital setting can be challenging. Patients are acutely ill and nearly 40% are incapable of making their own medical decisions.[17] In order to participate in an end‐of‐life discussion, a physician must determine that a patient meets the 4 criteria of decisional capacity as outlined by Appelbaum and Grisso:[18] Does the patient (1) communicate a clear and consistent choice; (2) understand the relevant information surrounding that decision; (3) appreciate the consequences of that decision; and (4) communicate reasoning for that decision?[19] In practice, however, clinicians inaccurately assign capacity up to 25% of the time.[17] When a physician determines, accurately or inaccurately, that the patient does not meet this standard for decisional capacity, discussions must be held instead with a surrogate decision‐maker. Surrogate decision‐making can make communication with the physician more difficult,[20] delay important medical decisions,[21] and be stressful on the decision‐maker.[22] To our knowledge, no studies have examined patient and surrogate participation in end‐of‐life discussions at the time of terminal hospitalization and its association with end‐of‐life treatments received.

Our goals were to examine physician assessment of decisional capacity and the prevalence of end‐of‐life discussions during the terminal hospitalization of patients with advanced cancer. Our research questions were: (1) What proportion of patients were assessed to have decisional capacity by the clinical team at the time of their terminal hospital admission? (2) What proportion of these patients had a documented discussion about end‐of‐life care with the clinical team, and for what proportion was the conversation held instead by the patient's surrogate decision‐maker because the patient was considered to have lost decisional capacity? (3) Was patient participation in a discussion about end‐of‐life care associated with life‐sustaining and palliative treatments received?

METHODS

Design

This is a retrospective cohort study of consecutive adult patients with advanced cancer who died at the University of Michigan Hospital, Ann Arbor, MI, from January 1, 2004 through December 31, 2007. This study was exempted from review by the University of Michigan (UM) Institutional Review Board because decedent data were used.

Sample

The UM Cancer Registry is a database of all cancer patients treated at the UM Comprehensive Cancer Center. We used the Registry to identify patients who met the following criteria: (1) age 18 years at time of cancer diagnosis; (2) estimated probability of 5‐year survival 20% at time of diagnosis, as predicted by the SEER Cancer Statistics Review[23]; (3) the entirety of cancer treatment was received at University of Michigan Health System (UMHS); and (4) the patient died while admitted to the University Hospital between January 1, 2004 and December 31, 2007.

UMHS is a healthcare system and academic medical center consisting of hospitals, health centers, and clinics, including the University of Michigan Hospital and Comprehensive Cancer Center. Over 4000 cancer patients are admitted to University Hospital and 80,000 outpatient visits occur to the Cancer Center every year. It serves as a major cancer referral center for the patients of Michigan and the greater Midwest. The University of Michigan implemented a palliative care consult service that was started in 2005, during the time period of our study.

Data Collection

Data were abstracted by review of the medical record by an internist (M.Z.) using a comprehensive chart abstraction instrument based on a previously validated tool.[24] Demographic data abstracted from the medical record included age, religious affiliation, race, ethnicity, and marital status. The original abstraction tool, which included 83 items, was reduced to include 47 items focusing on information related to advanced care planning, hospital course, and end‐of‐life discussions. Specific items included: reasons for admission, primary hospital service, occurrence and timing of end‐of‐life decision‐making, whether patient or family preferences were elicited through an end‐of‐life discussion, clinician's assessment of patient's decisional capacity at time of admission and end‐of‐life conversations, whether a comfort care plan was made, and whether palliative morphine was used.

The chart abstraction tool was pilot tested on the medical records of 10 patients, who were not included in the study, and refined to improve completeness of data collection. A copy of the abstraction tool is available upon request.

Definition of Key Variables

Decisional Capacity Assessment

Decisional capacity assessment is a reflection of the clinical team's assessment of the patient's decisional capacity on admission, and was determined through examination of the medical record in the first 24 hours of admission. Positive decision‐making capacity assessment was assumed if the clinician assessment of decisional capacity was documented in the mental status exam, or if the clinician documented conversations between clinician and patient in the history that suggested intact decision‐making capacity (ie, clinician documented terms such as patient stated or patient described and then described a coherent or sensible statement which implied patient capacity and intact mental status), or if the clinician's documentation of the assessment and plan stated or suggested decisions were being made by the patient. Other supportive information from the record was used to corroborate the evidence used to determine the clinician's assessment of the patient's decisional capacity, including whether the patient signed consent forms.

End‐of‐Life Discussions

The presence of an end‐of‐life discussion was presumed when the clinician documented a discussion with the patient, discussion with family, or family meeting concerning treatment preferences, or when the clinician quoted the patient's preferences in a fashion that documents a face‐to‐face discussion or directly described the elicitation of preferences from the patient or family.

Living Will

A living will was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed a living will.

Health Care Proxy

Health Care Proxy or Durable Power of Attorney for Healthcare was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed such a document.

Do Not Resuscitate (DNR) on Admission

DNR status was identified as present if the patient had documents with established DNR orders, or if a physician explicitly documented code status as DNR in the admission note or other documents placed in the record within the first 24 hours of admission.

Intensive Care Unit (ICU)Treatment

Patients were defined as having received ICU treatment if they were admitted directly or subsequently transferred to the ICU during the hospital course.

Comfort Care

Comfort care was defined as present only if the phrases comfort care, palliative care, or supportive care, were documented.

Palliative Opioid Therapy

Treatments with morphine or other opioids were recorded as palliative only if it was explicitly stated that these medications were used in the context of palliative or end‐of‐life care.

Data Analysis

We report the proportion of patients who were documented to lack decisional capacity at the time of hospital admission. We compared patient characteristics for those with and without documentation of decisional capacity on admission, and patients with decisional capacity on admission who did and did not participate in discussions about end‐of‐life care using chi‐square tests for categorical data, t tests for normally distributed continuous variables, and MannWhitney U tests for non‐normally distributed continuous variables. We examined whether documentation of a discussion about end‐of‐life care was associated with life‐sustaining and palliative treatments received using chi‐square for categorical treatments, and MannWhitney U tests for days from admission to initiation of comfort care. We used P < 0.05 to signify statistical significance.

RESULTS

Characteristics of Population and Decisional Capacity on Admission

The characteristics of the 145 patients who met entry criteria are summarized in Table 1. The most common types of cancers were lung cancer and leukemia/lymphoma. Of the 145 patients, the medical team's assessment of the patient's decisional capacity on admission could be established for 142 patients. As documented within the first 24 hours of admission, 27 patients (19%) were considered not to have decisional capacity, and 115 patients (79%) were considered to have decisional capacity. Both of these groups had similar age and gender distributions. There were no significant differences in the distribution of cancer type between those with and without decisional capacity. In both groups, the majority of the cancer diagnoses were made prior to admission. There was no difference in DNR orders established prior to or on admission between the groups (Table 1).

Characteristics of Patients With and Without Documented Decision‐Making Capacity
 Decision‐Making Capacity on Admissiona 
No (N = 27)Yes (N = 115) 
N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Decisional capacity as assessed and documented by the clinician; clinicians assessment of decisional capacity could not be determined in 3 patients.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age >6515 (55.6)60 (52.2)0.75
Gender (male)14 (51.9)68 (59.1)0.46
Cancer type
Lung12 (44.4)42 (36.5)0.67
Bone marrow5 (18.5)35 (30.4)
Liver3 (11.1)6 (5.2)
Pancreas3 (11.1)7 (6.10)
Esophagus1 (3.7)8 (7.0)
Colon1 (3.7)6 (5.2)
Otherb2 (7.4)11 (9.6)
Prior to admission
Cancer diagnosis known23 (85.2)91 (79.1)0.48
Living will completed6 (22.2)26 (22.60.97
Health care proxy established3 (11.1)26 (22.6)0.18
DNR established8 (29.6)27 (23.5)0.79

End‐of‐Life Discussion in Patients With Decisional Capacity on Admission

Of the 115 patients assessed to have intact decisional capacity on admission, 56 (48.7%) participated in an end‐of‐life discussion with the medical team during their terminal hospitalization. For the remaining 59 patients who did not participate in an end‐of‐life discussion during the terminal hospital course, 46 (40.0%) had documentation suggesting they lost decisional capacity prior to a conversation and that the end‐of‐life discussions were held instead with the patient's surrogate decision‐maker, and 13 (11.3%) had no evidence of any end‐of‐life discussion (with the patient or surrogate).

When comparing those patients who participated in an end‐of‐life discussion with those patients whose surrogate participated in the discussion, there were no significant differences in gender and age distributions (Table 2). There was a significant difference in the type of cancers between the 2 groups. Among patients who participated in their end‐of‐life discussions, bone marrow cancer was proportionately more prevalent (17.9% vs 2.2%; P <0.01) and lung cancer was less prevalent (16.1% vs 41.3%; P <0.01), when compared to those who required surrogate participation. Timing of cancer diagnosis and prevalence of advance directives were similar between the 2 groups. The proportion of patients who had an established DNR order prior to admission was higher among those who did participate in end‐of‐life discussions when compared to those who had surrogate participation in these discussions (30.4% vs 17.4%; P < 0.04).

Among Patients With Documented Decision‐Making Capacity on Admission, the Characteristics of Patients by Status of Their Participation in End‐of‐Life Discussions
Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
 N =13N = 102 
 End‐of‐Life discussion not documentedEnd‐of‐Life discussion with surrogate (N = 46)End‐of‐Life discussion with patient (N = 56) 
 N (%)N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age 659 (69.2)18 (39.1)27 (48.2)0.36
Gender (male)10 (76.9)27 (60.0)31 (55.4)0.64
Cancer type    
Lung3 (23.1)19 (41.3)9 (16.1) 
Bone marrow7 (53.9)1 (2.2)10 (17.9) 
Liver1 (7.7)3 (6.5)2 (3.6) 
Pancreas1 (7.7)2 (4.4)4 (7.1)<0.01
Esophagus06 (13.0)2 (3.6) 
Colon1 (7.7)1 (2.2)3 (5.4) 
Othera01 (2.2)10 (17.9) 
Prior to Admission
Cancer diagnosis known10 (76.9)37 (80.4)43 (76.8)0.66
Living will completed4 (30.8)10 (21.7)12 (21.4)0.97
Health care proxy established    
 3 (23.1)13 (28.3)10 (17.9)0.21
DNR established2 (15.4)8 (17.4)17 (30.4)0.04

Life‐Prolonging and Palliative Care Treatments Received and Participation in End‐of‐Life Discussions

Life‐prolonging treatments were more likely to be used for patients whose end‐of‐life discussions were held by patient's surrogate decision‐maker, in comparison to those patients who participated in the discussions themselves. Patients who had conversations held by surrogates were more likely to receive ventilator support (56.5% vs 23.2%, P < 0.01), chemotherapy (39.1% vs 5.4%, P < 0.01), artificial nutrition or hydration (45.7% vs 25.0%, P = 0.03), and antibiotics (97.8% vs 78.6%, P < 0.01), when compared to patients who participated in their own end‐of‐life discussion. Intensive care treatment rates also differed significantly between the 2 groups; 56.5% of those who did not participate in end‐of‐life discussions, and only 23.2% of those patients who did participate, were admitted or transferred to the intensive care unit (P < 0.01). There was no significant difference in the proportion of patients who received cardiopulmonary resuscitation (CPR) (15.2% vs 7.1%, P = 0.56) (Table 3). Patients who lost decisional capacity and required a surrogate decision‐maker to participate in their end‐of‐life discussions had longer length of stay (15.8 vs 10.3 days, P = 0.03) and length of time to end‐of‐life discussions (14.0 vs 6.1 days, P < 0.01) (Table 3).

Patient or Surrogate Participation in End‐of‐Life Discussions, Treatments Received, and Timing of Advanced Care Planning Among Patients With Documented Decision‐Making Capacity on Admission
 Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
End‐of‐Life Discussion With Surrogate (N =46)End‐of‐Life Discussion With Patient (N = 56) 
 N (%)N (%)P Value
  • Abbreviations: CI, confidence interval; ICU, intensive care unit. *P value is for comparison of end‐of‐life discussion with surrogate vs end‐of‐life discussion with patient.
Life‐Prolonging Treatment   
Ventilatory support26 (56.5)13 (23.2)<0.01
Chemotherapy18 (39.1)3 (5.4)<0.01
Artificial nutrition or hydration21 (45.7)14 (25.0)0.03
Antibiotics45 (97.8)44 (78.6)<0.01
Cardiopulmonary resuscitation7 (15.2)4 (7.1)0.19
ICU treatment (admit or transfer)26 (56.5)13 (23.2)<0.01
Palliative Treatments   
Comfort care39 (84.8)45 (80.4)0.56
Palliative morphine drip24 (52.2)33 (57.1)0.62
 Mean (95% CI) [Range]Mean (95% CI) [Range] 
Timing of Advanced Care Planning   
Length of hospitalization15.8 d (11.420.2) [157]10.3 d (146) [146]0.03
Time to end‐of‐life discussion14.0 d (9.918.1) [055]6.1 d (3.88.4) [046]<0.01
Time to comfort care23.5 d (4.342.8) [1374]9.2 d (6.312.1) [046]0.12

A comparison of the proportion of patients receiving palliative treatments, such as palliative comfort care orders and morphine infusions, revealed no significant differences between those with and without a discussion about end‐of‐life care (Table 3). Furthermore, while the time interval from hospital admission to initiation of comfort care was shorter for those who did participate in end‐of‐life discussions compared with those had surrogate participation (9.3 vs 23.5 days, P = 0.13 for equality), this difference was not statistically significant (Table 3).

Since a higher proportion of those who participated in end‐of‐life discussions during the hospitalization were admitted with a DNR order established prior to or on admission, we also examined the use of life‐prolonging treatments in the subgroup of patients who did not have a DNR order prior to admission. The difference in life‐prolonging treatments between those who did and did not participate in end‐of‐life discussions was preserved among those patients who did not have DNR status on admission (data not shown).

DISCUSSION

In this retrospective study of 145 terminal cancer patients who died in the hospital, we found that half of the patients had documentation suggesting that they lost decisional capacity during hospitalization and did not participate in end‐of‐life discussion with their healthcare providers. Among cancer patients in our study, 19% were determined not to have decisional capacity on admission, and another 32% were determined to lose decisional capacity during the hospital course. When patients did participate in documented discussions about end‐of‐life care, they were less likely to receive intensive life‐sustaining treatments, less likely to be admitted or transferred to the ICU, and more likely to avoid prolonged hospitalization. The finding that the majority of cancer patients are assessed to have intact decisional capacity upon admission to their terminal hospitalization, but less than half of them participate in their own end‐of‐life conversation, suggests that there is an important lost opportunity to provide quality advanced care planning to hospitalized patients.

Advanced care planning is the act of defining a competent patient's wishes regarding their future healthcare in the event of loss of decisional capacity. For many of the patients who were determined to lose decisional capacity during their hospitalization in our study, a surrogate decision‐maker was involved in a subsequent end‐of‐life discussion. This represents a missed opportunity in 2 ways. First, because surrogates may incorrectly predict patients' end‐of‐life treatment preferences in approximately one‐third of the cases,[25] patients may receive care that is inconsistent with their beliefs. Second, reliance on surrogate decision‐making may result in a greater burden on family members. Surrogate decision‐making places a large burden on surrogates, and can lead to emotional and psychological stress that can last well beyond the death of the loved one.[16, 26]

Our results reinforce the growing body of evidence suggesting that communication with the dying patient, both before and during the terminal hospitalization, promotes end‐of‐life care that involves less invasive life‐prolonging treatments,[10, 11, 12, 13, 14, 15] which is a consistently stated goal of most patients at the end of life.[1, 2] Our findings are consistent with a recent randomized trial of hospitalized patients over the age of 80 which showed that advance care planning discussions were associated with decreased use of intensive life‐sustaining treatments, increased patient and family satisfaction with care, as well as decreased psychological symptoms among family members.[27] In addition, studies examining patients with advanced cancer have shown that discussions about end‐of‐life care in the outpatient setting resulted in less intensive life‐sustaining treatments.[14, 15] Nearly 20% of our cohort was determined by the clinical team to lack decisional capacity at the time of their terminal hospitalization, highlighting the importance of end‐of‐life discussion prior to hospitalization. Our results also extend these recent findings to the inpatient setting. Seventy‐nine percent of patients in our study were determined to have decisional capacity at the time of their terminal hospitalization, and end‐of‐life discussion conducted with these patients was associated with decreased use of life‐sustaining treatments.

Seriously ill patients, particularly in hospital settings, have high symptom burden and subsequent poor quality of life.[6] These patients and families often report inadequate pain and symptom relief.[8, 28, 29] It is therefore reassuring that we found no difference in the proportion of patients who received comfort care and palliative morphine infusions according to whether they or a surrogate participated in the end‐of‐life discussions. In fact, the majority of patients were made DNR and received some form of comfort measure prior to death, although these comfort measures were frequently initiated only hours prior to death.

While our findings are consistent with research that has demonstrated that end‐of‐life discussions with patients are associated with a decrease in life‐prolonging treatments, it is important to note that our observational study cannot establish a causal relationship between the end‐of‐life discussion and the subsequent use of life‐sustaining treatments. It is possible that patients who have discussions about end‐of‐life care inherently prefer to have less intensive life‐sustaining treatment at the end of life. Physicians may be more apt to engage in these types of discussions with patients who express interest in limited intervention. Interestingly, patients with a DNR order at the time of admission were more likely to participate in end‐of‐life care with their provider during their terminal hospitalization, which supports this alternate explanation. However, when we excluded all patients with a DNR on admission, our findings persisted. Regardless of the explanation for the association between end‐of‐life discussions and life‐sustaining treatments, our study identifies a cohort of hospitalized patients who could benefit from improved end‐of‐life communication, and a clinical setting where opportunities remain to improve the quality of advanced care planning.

Discussions about end‐of‐life care with patients result in earlier transition to care focused on palliation.[14] Although we examined the timing to initiation of comfort care between those who participated and those who did not participate in end‐of‐life discussions, we were not able to demonstrate a statistically significant difference. However, our cohort may not be suitable for an examination of this type of intervention, as early discussions about end‐of‐life care may have lead to early referral to hospice, and therefore death outside the hospital setting, making the patients ineligible for our study.

There are several additional limitations to our study. First, our study is subject to the potential biases inherent in retrospective chart review. For example, since we identified patients who died in the hospital, our study does not generalize to patients with advanced cancer who survive the hospitalization or who were discharged to die at home.[30] Furthermore, our use of the medical record to assess documentation of communication about end‐of‐life care and decisional capacity relies on the accuracy of clinician documentation. There may have been communication about end‐of‐life care that was not documented in the medical record, resulting in underestimation of the effects of end‐of‐life discussions. In clinical practice, the assessment of decisional capacity can be challenging.[19, 31, 32] Although clinicians are often accurate in identifying patients with capacity, in nearly one‐quarter of all assessments, they mistakenly assign capacity to patients who lack decision‐making capacity.[17] In our study, we examine clinician assessment of the patient's decisional capacity, but cannot assess either the accuracy of their clinical assessment or the accuracy of their documentation of this assessment. A second limitation is that the chart abstraction was conducted by a single reviewer without inter‐rater assessment, although the abstraction tool was modified from a well‐established tool.[24] A third limitation is that all of the patients were from a single academic center and the results may not generalize to other regions. Fourth, we did not assess for the potential effect of individual clinicians. Since most patients were cared for by multiple physicians, our study is not capable of assessing a clinician‐level effect. Finally, our study was not able to address whether the care received by patients was in accord with their informed preferences.

We have shown that opportunities exist for advanced care planning at the time of the terminal hospitalization of patients with advanced cancer. The majority of these patients have documentation of decisional capacity at the time of admission, suggesting that opportunities exist to conduct end‐of‐life discussion while the patient retains decisional capacity. Furthermore, we found that patients who participate in these discussions about end‐of‐life care with their clinicians have an associated decrease in the use of life‐sustaining treatments, which is consistent with prior studies.[11, 13, 14, 15, 27] Improving communication about end‐of‐life care for patients hospitalized with advanced cancer may represent an important opportunity to improve the concordance between patients' wishes for care at the end‐of‐life and the care that these patients actually receive. Such communication may also decrease the burden on family members who are frequently asked to play the role of surrogate decision‐maker without an opportunity to discuss these issues with the patient.

Acknowledgments

The authors acknowledge Melissa Braxton for her assistance with the preparation of this manuscript.

Disclosures: A portion of this data was presented at the annual meeting of the Society of Hospital Medicine, 2011, in Grapevine, TX. This work was supported by the National Cancer Institute at the National Institutes of Health (KO5 CA 104699 to J.G.E.) and the National Heart, Lung, and Blood Institute (K24HL68593 to J.R.C.). Dr Silveira's salary was supported by core funds from the Ann Arbor VA HSRD Center of Excellence. The authors have no relevant financial interest in the subject matter contained within this manuscript.

Most patients prefer to die at home, pain free and without the use of life‐sustaining treatments[1, 2] yet the majority of patients with serious illness die in the hospital.[3, 4, 5] When hospitalized patient die, the care is frequently focused on life‐sustaining treatments[6]; pain, dyspnea, and agitation levels are higher when compared with patients who die in non‐hospital settings.[7, 8, 9] End‐of‐life discussions and their products (ie, advanced directives) can clarify treatment options with patients and family,[10] and help ensure that patients receive care consistent with their beliefs.[11, 12, 13] End‐of‐life discussions are associated with a decrease use of life‐sustaining treatments, improved quality of life, and reduced costs of care.[14, 15] For the majority of patients dying of cancer, the first end‐of‐life discussion takes place in the hospital setting.[16]

Conducting end‐of‐life conversations in the hospital setting can be challenging. Patients are acutely ill and nearly 40% are incapable of making their own medical decisions.[17] In order to participate in an end‐of‐life discussion, a physician must determine that a patient meets the 4 criteria of decisional capacity as outlined by Appelbaum and Grisso:[18] Does the patient (1) communicate a clear and consistent choice; (2) understand the relevant information surrounding that decision; (3) appreciate the consequences of that decision; and (4) communicate reasoning for that decision?[19] In practice, however, clinicians inaccurately assign capacity up to 25% of the time.[17] When a physician determines, accurately or inaccurately, that the patient does not meet this standard for decisional capacity, discussions must be held instead with a surrogate decision‐maker. Surrogate decision‐making can make communication with the physician more difficult,[20] delay important medical decisions,[21] and be stressful on the decision‐maker.[22] To our knowledge, no studies have examined patient and surrogate participation in end‐of‐life discussions at the time of terminal hospitalization and its association with end‐of‐life treatments received.

Our goals were to examine physician assessment of decisional capacity and the prevalence of end‐of‐life discussions during the terminal hospitalization of patients with advanced cancer. Our research questions were: (1) What proportion of patients were assessed to have decisional capacity by the clinical team at the time of their terminal hospital admission? (2) What proportion of these patients had a documented discussion about end‐of‐life care with the clinical team, and for what proportion was the conversation held instead by the patient's surrogate decision‐maker because the patient was considered to have lost decisional capacity? (3) Was patient participation in a discussion about end‐of‐life care associated with life‐sustaining and palliative treatments received?

METHODS

Design

This is a retrospective cohort study of consecutive adult patients with advanced cancer who died at the University of Michigan Hospital, Ann Arbor, MI, from January 1, 2004 through December 31, 2007. This study was exempted from review by the University of Michigan (UM) Institutional Review Board because decedent data were used.

Sample

The UM Cancer Registry is a database of all cancer patients treated at the UM Comprehensive Cancer Center. We used the Registry to identify patients who met the following criteria: (1) age 18 years at time of cancer diagnosis; (2) estimated probability of 5‐year survival 20% at time of diagnosis, as predicted by the SEER Cancer Statistics Review[23]; (3) the entirety of cancer treatment was received at University of Michigan Health System (UMHS); and (4) the patient died while admitted to the University Hospital between January 1, 2004 and December 31, 2007.

UMHS is a healthcare system and academic medical center consisting of hospitals, health centers, and clinics, including the University of Michigan Hospital and Comprehensive Cancer Center. Over 4000 cancer patients are admitted to University Hospital and 80,000 outpatient visits occur to the Cancer Center every year. It serves as a major cancer referral center for the patients of Michigan and the greater Midwest. The University of Michigan implemented a palliative care consult service that was started in 2005, during the time period of our study.

Data Collection

Data were abstracted by review of the medical record by an internist (M.Z.) using a comprehensive chart abstraction instrument based on a previously validated tool.[24] Demographic data abstracted from the medical record included age, religious affiliation, race, ethnicity, and marital status. The original abstraction tool, which included 83 items, was reduced to include 47 items focusing on information related to advanced care planning, hospital course, and end‐of‐life discussions. Specific items included: reasons for admission, primary hospital service, occurrence and timing of end‐of‐life decision‐making, whether patient or family preferences were elicited through an end‐of‐life discussion, clinician's assessment of patient's decisional capacity at time of admission and end‐of‐life conversations, whether a comfort care plan was made, and whether palliative morphine was used.

The chart abstraction tool was pilot tested on the medical records of 10 patients, who were not included in the study, and refined to improve completeness of data collection. A copy of the abstraction tool is available upon request.

Definition of Key Variables

Decisional Capacity Assessment

Decisional capacity assessment is a reflection of the clinical team's assessment of the patient's decisional capacity on admission, and was determined through examination of the medical record in the first 24 hours of admission. Positive decision‐making capacity assessment was assumed if the clinician assessment of decisional capacity was documented in the mental status exam, or if the clinician documented conversations between clinician and patient in the history that suggested intact decision‐making capacity (ie, clinician documented terms such as patient stated or patient described and then described a coherent or sensible statement which implied patient capacity and intact mental status), or if the clinician's documentation of the assessment and plan stated or suggested decisions were being made by the patient. Other supportive information from the record was used to corroborate the evidence used to determine the clinician's assessment of the patient's decisional capacity, including whether the patient signed consent forms.

End‐of‐Life Discussions

The presence of an end‐of‐life discussion was presumed when the clinician documented a discussion with the patient, discussion with family, or family meeting concerning treatment preferences, or when the clinician quoted the patient's preferences in a fashion that documents a face‐to‐face discussion or directly described the elicitation of preferences from the patient or family.

Living Will

A living will was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed a living will.

Health Care Proxy

Health Care Proxy or Durable Power of Attorney for Healthcare was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed such a document.

Do Not Resuscitate (DNR) on Admission

DNR status was identified as present if the patient had documents with established DNR orders, or if a physician explicitly documented code status as DNR in the admission note or other documents placed in the record within the first 24 hours of admission.

Intensive Care Unit (ICU)Treatment

Patients were defined as having received ICU treatment if they were admitted directly or subsequently transferred to the ICU during the hospital course.

Comfort Care

Comfort care was defined as present only if the phrases comfort care, palliative care, or supportive care, were documented.

Palliative Opioid Therapy

Treatments with morphine or other opioids were recorded as palliative only if it was explicitly stated that these medications were used in the context of palliative or end‐of‐life care.

Data Analysis

We report the proportion of patients who were documented to lack decisional capacity at the time of hospital admission. We compared patient characteristics for those with and without documentation of decisional capacity on admission, and patients with decisional capacity on admission who did and did not participate in discussions about end‐of‐life care using chi‐square tests for categorical data, t tests for normally distributed continuous variables, and MannWhitney U tests for non‐normally distributed continuous variables. We examined whether documentation of a discussion about end‐of‐life care was associated with life‐sustaining and palliative treatments received using chi‐square for categorical treatments, and MannWhitney U tests for days from admission to initiation of comfort care. We used P < 0.05 to signify statistical significance.

RESULTS

Characteristics of Population and Decisional Capacity on Admission

The characteristics of the 145 patients who met entry criteria are summarized in Table 1. The most common types of cancers were lung cancer and leukemia/lymphoma. Of the 145 patients, the medical team's assessment of the patient's decisional capacity on admission could be established for 142 patients. As documented within the first 24 hours of admission, 27 patients (19%) were considered not to have decisional capacity, and 115 patients (79%) were considered to have decisional capacity. Both of these groups had similar age and gender distributions. There were no significant differences in the distribution of cancer type between those with and without decisional capacity. In both groups, the majority of the cancer diagnoses were made prior to admission. There was no difference in DNR orders established prior to or on admission between the groups (Table 1).

Characteristics of Patients With and Without Documented Decision‐Making Capacity
 Decision‐Making Capacity on Admissiona 
No (N = 27)Yes (N = 115) 
N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Decisional capacity as assessed and documented by the clinician; clinicians assessment of decisional capacity could not be determined in 3 patients.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age >6515 (55.6)60 (52.2)0.75
Gender (male)14 (51.9)68 (59.1)0.46
Cancer type
Lung12 (44.4)42 (36.5)0.67
Bone marrow5 (18.5)35 (30.4)
Liver3 (11.1)6 (5.2)
Pancreas3 (11.1)7 (6.10)
Esophagus1 (3.7)8 (7.0)
Colon1 (3.7)6 (5.2)
Otherb2 (7.4)11 (9.6)
Prior to admission
Cancer diagnosis known23 (85.2)91 (79.1)0.48
Living will completed6 (22.2)26 (22.60.97
Health care proxy established3 (11.1)26 (22.6)0.18
DNR established8 (29.6)27 (23.5)0.79

End‐of‐Life Discussion in Patients With Decisional Capacity on Admission

Of the 115 patients assessed to have intact decisional capacity on admission, 56 (48.7%) participated in an end‐of‐life discussion with the medical team during their terminal hospitalization. For the remaining 59 patients who did not participate in an end‐of‐life discussion during the terminal hospital course, 46 (40.0%) had documentation suggesting they lost decisional capacity prior to a conversation and that the end‐of‐life discussions were held instead with the patient's surrogate decision‐maker, and 13 (11.3%) had no evidence of any end‐of‐life discussion (with the patient or surrogate).

When comparing those patients who participated in an end‐of‐life discussion with those patients whose surrogate participated in the discussion, there were no significant differences in gender and age distributions (Table 2). There was a significant difference in the type of cancers between the 2 groups. Among patients who participated in their end‐of‐life discussions, bone marrow cancer was proportionately more prevalent (17.9% vs 2.2%; P <0.01) and lung cancer was less prevalent (16.1% vs 41.3%; P <0.01), when compared to those who required surrogate participation. Timing of cancer diagnosis and prevalence of advance directives were similar between the 2 groups. The proportion of patients who had an established DNR order prior to admission was higher among those who did participate in end‐of‐life discussions when compared to those who had surrogate participation in these discussions (30.4% vs 17.4%; P < 0.04).

Among Patients With Documented Decision‐Making Capacity on Admission, the Characteristics of Patients by Status of Their Participation in End‐of‐Life Discussions
Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
 N =13N = 102 
 End‐of‐Life discussion not documentedEnd‐of‐Life discussion with surrogate (N = 46)End‐of‐Life discussion with patient (N = 56) 
 N (%)N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age 659 (69.2)18 (39.1)27 (48.2)0.36
Gender (male)10 (76.9)27 (60.0)31 (55.4)0.64
Cancer type    
Lung3 (23.1)19 (41.3)9 (16.1) 
Bone marrow7 (53.9)1 (2.2)10 (17.9) 
Liver1 (7.7)3 (6.5)2 (3.6) 
Pancreas1 (7.7)2 (4.4)4 (7.1)<0.01
Esophagus06 (13.0)2 (3.6) 
Colon1 (7.7)1 (2.2)3 (5.4) 
Othera01 (2.2)10 (17.9) 
Prior to Admission
Cancer diagnosis known10 (76.9)37 (80.4)43 (76.8)0.66
Living will completed4 (30.8)10 (21.7)12 (21.4)0.97
Health care proxy established    
 3 (23.1)13 (28.3)10 (17.9)0.21
DNR established2 (15.4)8 (17.4)17 (30.4)0.04

Life‐Prolonging and Palliative Care Treatments Received and Participation in End‐of‐Life Discussions

Life‐prolonging treatments were more likely to be used for patients whose end‐of‐life discussions were held by patient's surrogate decision‐maker, in comparison to those patients who participated in the discussions themselves. Patients who had conversations held by surrogates were more likely to receive ventilator support (56.5% vs 23.2%, P < 0.01), chemotherapy (39.1% vs 5.4%, P < 0.01), artificial nutrition or hydration (45.7% vs 25.0%, P = 0.03), and antibiotics (97.8% vs 78.6%, P < 0.01), when compared to patients who participated in their own end‐of‐life discussion. Intensive care treatment rates also differed significantly between the 2 groups; 56.5% of those who did not participate in end‐of‐life discussions, and only 23.2% of those patients who did participate, were admitted or transferred to the intensive care unit (P < 0.01). There was no significant difference in the proportion of patients who received cardiopulmonary resuscitation (CPR) (15.2% vs 7.1%, P = 0.56) (Table 3). Patients who lost decisional capacity and required a surrogate decision‐maker to participate in their end‐of‐life discussions had longer length of stay (15.8 vs 10.3 days, P = 0.03) and length of time to end‐of‐life discussions (14.0 vs 6.1 days, P < 0.01) (Table 3).

Patient or Surrogate Participation in End‐of‐Life Discussions, Treatments Received, and Timing of Advanced Care Planning Among Patients With Documented Decision‐Making Capacity on Admission
 Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
End‐of‐Life Discussion With Surrogate (N =46)End‐of‐Life Discussion With Patient (N = 56) 
 N (%)N (%)P Value
  • Abbreviations: CI, confidence interval; ICU, intensive care unit. *P value is for comparison of end‐of‐life discussion with surrogate vs end‐of‐life discussion with patient.
Life‐Prolonging Treatment   
Ventilatory support26 (56.5)13 (23.2)<0.01
Chemotherapy18 (39.1)3 (5.4)<0.01
Artificial nutrition or hydration21 (45.7)14 (25.0)0.03
Antibiotics45 (97.8)44 (78.6)<0.01
Cardiopulmonary resuscitation7 (15.2)4 (7.1)0.19
ICU treatment (admit or transfer)26 (56.5)13 (23.2)<0.01
Palliative Treatments   
Comfort care39 (84.8)45 (80.4)0.56
Palliative morphine drip24 (52.2)33 (57.1)0.62
 Mean (95% CI) [Range]Mean (95% CI) [Range] 
Timing of Advanced Care Planning   
Length of hospitalization15.8 d (11.420.2) [157]10.3 d (146) [146]0.03
Time to end‐of‐life discussion14.0 d (9.918.1) [055]6.1 d (3.88.4) [046]<0.01
Time to comfort care23.5 d (4.342.8) [1374]9.2 d (6.312.1) [046]0.12

A comparison of the proportion of patients receiving palliative treatments, such as palliative comfort care orders and morphine infusions, revealed no significant differences between those with and without a discussion about end‐of‐life care (Table 3). Furthermore, while the time interval from hospital admission to initiation of comfort care was shorter for those who did participate in end‐of‐life discussions compared with those had surrogate participation (9.3 vs 23.5 days, P = 0.13 for equality), this difference was not statistically significant (Table 3).

Since a higher proportion of those who participated in end‐of‐life discussions during the hospitalization were admitted with a DNR order established prior to or on admission, we also examined the use of life‐prolonging treatments in the subgroup of patients who did not have a DNR order prior to admission. The difference in life‐prolonging treatments between those who did and did not participate in end‐of‐life discussions was preserved among those patients who did not have DNR status on admission (data not shown).

DISCUSSION

In this retrospective study of 145 terminal cancer patients who died in the hospital, we found that half of the patients had documentation suggesting that they lost decisional capacity during hospitalization and did not participate in end‐of‐life discussion with their healthcare providers. Among cancer patients in our study, 19% were determined not to have decisional capacity on admission, and another 32% were determined to lose decisional capacity during the hospital course. When patients did participate in documented discussions about end‐of‐life care, they were less likely to receive intensive life‐sustaining treatments, less likely to be admitted or transferred to the ICU, and more likely to avoid prolonged hospitalization. The finding that the majority of cancer patients are assessed to have intact decisional capacity upon admission to their terminal hospitalization, but less than half of them participate in their own end‐of‐life conversation, suggests that there is an important lost opportunity to provide quality advanced care planning to hospitalized patients.

Advanced care planning is the act of defining a competent patient's wishes regarding their future healthcare in the event of loss of decisional capacity. For many of the patients who were determined to lose decisional capacity during their hospitalization in our study, a surrogate decision‐maker was involved in a subsequent end‐of‐life discussion. This represents a missed opportunity in 2 ways. First, because surrogates may incorrectly predict patients' end‐of‐life treatment preferences in approximately one‐third of the cases,[25] patients may receive care that is inconsistent with their beliefs. Second, reliance on surrogate decision‐making may result in a greater burden on family members. Surrogate decision‐making places a large burden on surrogates, and can lead to emotional and psychological stress that can last well beyond the death of the loved one.[16, 26]

Our results reinforce the growing body of evidence suggesting that communication with the dying patient, both before and during the terminal hospitalization, promotes end‐of‐life care that involves less invasive life‐prolonging treatments,[10, 11, 12, 13, 14, 15] which is a consistently stated goal of most patients at the end of life.[1, 2] Our findings are consistent with a recent randomized trial of hospitalized patients over the age of 80 which showed that advance care planning discussions were associated with decreased use of intensive life‐sustaining treatments, increased patient and family satisfaction with care, as well as decreased psychological symptoms among family members.[27] In addition, studies examining patients with advanced cancer have shown that discussions about end‐of‐life care in the outpatient setting resulted in less intensive life‐sustaining treatments.[14, 15] Nearly 20% of our cohort was determined by the clinical team to lack decisional capacity at the time of their terminal hospitalization, highlighting the importance of end‐of‐life discussion prior to hospitalization. Our results also extend these recent findings to the inpatient setting. Seventy‐nine percent of patients in our study were determined to have decisional capacity at the time of their terminal hospitalization, and end‐of‐life discussion conducted with these patients was associated with decreased use of life‐sustaining treatments.

Seriously ill patients, particularly in hospital settings, have high symptom burden and subsequent poor quality of life.[6] These patients and families often report inadequate pain and symptom relief.[8, 28, 29] It is therefore reassuring that we found no difference in the proportion of patients who received comfort care and palliative morphine infusions according to whether they or a surrogate participated in the end‐of‐life discussions. In fact, the majority of patients were made DNR and received some form of comfort measure prior to death, although these comfort measures were frequently initiated only hours prior to death.

While our findings are consistent with research that has demonstrated that end‐of‐life discussions with patients are associated with a decrease in life‐prolonging treatments, it is important to note that our observational study cannot establish a causal relationship between the end‐of‐life discussion and the subsequent use of life‐sustaining treatments. It is possible that patients who have discussions about end‐of‐life care inherently prefer to have less intensive life‐sustaining treatment at the end of life. Physicians may be more apt to engage in these types of discussions with patients who express interest in limited intervention. Interestingly, patients with a DNR order at the time of admission were more likely to participate in end‐of‐life care with their provider during their terminal hospitalization, which supports this alternate explanation. However, when we excluded all patients with a DNR on admission, our findings persisted. Regardless of the explanation for the association between end‐of‐life discussions and life‐sustaining treatments, our study identifies a cohort of hospitalized patients who could benefit from improved end‐of‐life communication, and a clinical setting where opportunities remain to improve the quality of advanced care planning.

Discussions about end‐of‐life care with patients result in earlier transition to care focused on palliation.[14] Although we examined the timing to initiation of comfort care between those who participated and those who did not participate in end‐of‐life discussions, we were not able to demonstrate a statistically significant difference. However, our cohort may not be suitable for an examination of this type of intervention, as early discussions about end‐of‐life care may have lead to early referral to hospice, and therefore death outside the hospital setting, making the patients ineligible for our study.

There are several additional limitations to our study. First, our study is subject to the potential biases inherent in retrospective chart review. For example, since we identified patients who died in the hospital, our study does not generalize to patients with advanced cancer who survive the hospitalization or who were discharged to die at home.[30] Furthermore, our use of the medical record to assess documentation of communication about end‐of‐life care and decisional capacity relies on the accuracy of clinician documentation. There may have been communication about end‐of‐life care that was not documented in the medical record, resulting in underestimation of the effects of end‐of‐life discussions. In clinical practice, the assessment of decisional capacity can be challenging.[19, 31, 32] Although clinicians are often accurate in identifying patients with capacity, in nearly one‐quarter of all assessments, they mistakenly assign capacity to patients who lack decision‐making capacity.[17] In our study, we examine clinician assessment of the patient's decisional capacity, but cannot assess either the accuracy of their clinical assessment or the accuracy of their documentation of this assessment. A second limitation is that the chart abstraction was conducted by a single reviewer without inter‐rater assessment, although the abstraction tool was modified from a well‐established tool.[24] A third limitation is that all of the patients were from a single academic center and the results may not generalize to other regions. Fourth, we did not assess for the potential effect of individual clinicians. Since most patients were cared for by multiple physicians, our study is not capable of assessing a clinician‐level effect. Finally, our study was not able to address whether the care received by patients was in accord with their informed preferences.

We have shown that opportunities exist for advanced care planning at the time of the terminal hospitalization of patients with advanced cancer. The majority of these patients have documentation of decisional capacity at the time of admission, suggesting that opportunities exist to conduct end‐of‐life discussion while the patient retains decisional capacity. Furthermore, we found that patients who participate in these discussions about end‐of‐life care with their clinicians have an associated decrease in the use of life‐sustaining treatments, which is consistent with prior studies.[11, 13, 14, 15, 27] Improving communication about end‐of‐life care for patients hospitalized with advanced cancer may represent an important opportunity to improve the concordance between patients' wishes for care at the end‐of‐life and the care that these patients actually receive. Such communication may also decrease the burden on family members who are frequently asked to play the role of surrogate decision‐maker without an opportunity to discuss these issues with the patient.

Acknowledgments

The authors acknowledge Melissa Braxton for her assistance with the preparation of this manuscript.

Disclosures: A portion of this data was presented at the annual meeting of the Society of Hospital Medicine, 2011, in Grapevine, TX. This work was supported by the National Cancer Institute at the National Institutes of Health (KO5 CA 104699 to J.G.E.) and the National Heart, Lung, and Blood Institute (K24HL68593 to J.R.C.). Dr Silveira's salary was supported by core funds from the Ann Arbor VA HSRD Center of Excellence. The authors have no relevant financial interest in the subject matter contained within this manuscript.

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  19. Torke AM, Siegler M, Abalos A, Moloney RM, Alexander GC. Physicians' experience with surrogate decision making for hospitalized adults. J Gen Intern Med. 2009;24(9):10231028.
  20. Handy CM, Sulmasy DP, Merkel CK, Ury WA. The surrogate's experience in authorizing a do not resuscitate order. Palliat Support Care. 2008;6(1):1319.
  21. Ries LAG, Melbert D, Krapcho M, et al. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review 1975–2004. Bethesda, MD:National Cancer Institute. Based on November 2006 SEER data submission, posted to the SEER Web site,2007. Available at: http://seer.cancer.gov/csr/1975_2004/. Accessed on November 1, 2007.
  22. Fins JJ, Miller FG, Acres CA, Bacchetta MD, Huzzard LL, Rapkin BD. End‐of‐life decision‐making in the hospital: current practice and future prospects. J Pain Symptom Manage. 1999;17(1):615.
  23. Shalowitz DI, Garrett‐Mayer E, Wendler D. The accuracy of surrogate decision makers: a systematic review. Arch Intern Med. 2006;166(5):493497.
  24. Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011;154(5):336346.
  25. Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010;340:c1345.
  26. Claessens MT, Lynn J, Zhong Z, et al. Dying with lung cancer or chronic obstructive pulmonary disease: insights from SUPPORT. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. J Am Geriatr Soc. 2000;48(5 suppl):S146S153.
  27. Somogyi‐Zalud E, Zhong Z, Hamel MB, Lynn J. The use of life‐sustaining treatments in hospitalized persons aged 80 and older. J Am Geriatr Soc. 2002;50(5):930934.
  28. Bach PB, Schrag D, Begg CB. Resurrecting treatment histories of dead patients: a study design that should be laid to rest. JAMA. 2004;292(22):27652770.
  29. Etchells E, Darzins P, Silberfeld M, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999;14(1):2734.
  30. Grisso T, Appelbaum PS, Hill‐Fotouhi C. The MacCAT‐T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997;48(11):14151419.
References
  1. Bruera E, Willey JS, Palmer JL, Rosales M. Treatment decisions for breast carcinoma: patient preferences and physician perceptions. Cancer. 2002;94(7):20762080.
  2. Teno JM, Weitzen S, Fennell ML, Mor V. Dying trajectory in the last year of life: does cancer trajectory fit other diseases?J Palliat Med. 2001;4(4):457464.
  3. Goodman DC, Etsy AR, Fisher ES, Chang C‐H. Trends and Variation in End‐of‐Life Care for Medicare Beneficiaries with Severe Chronic Illness.The Dartmouth Institute for Health Policy 32(3):638643.
  4. Desbiens NA, Mueller‐Rizner N, Connors AF, Wenger NS, Lynn J. The symptom burden of seriously ill hospitalized patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcome and Risks of Treatment. J Pain Symptom Manage. 1999;17(4):248255.
  5. Tolle SW, Tilden VP, Hickman SE, Rosenfeld AG. Family reports of pain in dying hospitalized patients: a structured telephone survey. West J Med. 2000;172(6):374377.
  6. Lynn J, Teno JM, Phillips RS, et al. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997;126(2):97106.
  7. Goodlin SJ, Winzelberg GS, Teno JM, Whedon M, Lynn J. Death in the hospital. Arch Intern Med. 1998;158(14):15701572.
  8. Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End‐of‐life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010;28(7):12031208.
  9. Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010;362(13):12111218.
  10. Teno JM, Clarridge BR, Casey V, et al. Family perspectives on end‐of‐life care at the last place of care. JAMA. 2004;291(1):8893.
  11. Teno JM, Gruneir A, Schwartz Z, Nanda A, Wetle T. Association between advance directives and quality of end‐of‐life care: a national study. J Am Geriatr Soc. 2007;55(2):189194.
  12. Wright AA, Zhang B, Ray A, et al. Associations between end‐of‐life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008;300(14):16651673.
  13. Zhang B, Wright AA, Huskamp HA, et al. Health care costs in the last week of life: associations with end‐of‐life conversations. Arch Intern Med. 2009;169(5):480488.
  14. Mack JW, Cronin A, Taback N, et al. End‐of‐life care discussions among patients with advanced cancer: a cohort study. Ann Intern Med. 2012;156(3):204210.
  15. Raymont V, Bingley W, Buchanan A, et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: cross‐sectional study. Lancet. 2004;364(9443):14211427.
  16. Applebaum P, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 1998;319:16351638.
  17. Appelbaum PS. Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med. 2007;357(18):18341840.
  18. Torke AM, Alexander GC, Lantos J, Siegler M. The physician‐surrogate relationship. Arch Intern Med. 2007;167(11):11171121.
  19. Torke AM, Siegler M, Abalos A, Moloney RM, Alexander GC. Physicians' experience with surrogate decision making for hospitalized adults. J Gen Intern Med. 2009;24(9):10231028.
  20. Handy CM, Sulmasy DP, Merkel CK, Ury WA. The surrogate's experience in authorizing a do not resuscitate order. Palliat Support Care. 2008;6(1):1319.
  21. Ries LAG, Melbert D, Krapcho M, et al. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review 1975–2004. Bethesda, MD:National Cancer Institute. Based on November 2006 SEER data submission, posted to the SEER Web site,2007. Available at: http://seer.cancer.gov/csr/1975_2004/. Accessed on November 1, 2007.
  22. Fins JJ, Miller FG, Acres CA, Bacchetta MD, Huzzard LL, Rapkin BD. End‐of‐life decision‐making in the hospital: current practice and future prospects. J Pain Symptom Manage. 1999;17(1):615.
  23. Shalowitz DI, Garrett‐Mayer E, Wendler D. The accuracy of surrogate decision makers: a systematic review. Arch Intern Med. 2006;166(5):493497.
  24. Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011;154(5):336346.
  25. Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010;340:c1345.
  26. Claessens MT, Lynn J, Zhong Z, et al. Dying with lung cancer or chronic obstructive pulmonary disease: insights from SUPPORT. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. J Am Geriatr Soc. 2000;48(5 suppl):S146S153.
  27. Somogyi‐Zalud E, Zhong Z, Hamel MB, Lynn J. The use of life‐sustaining treatments in hospitalized persons aged 80 and older. J Am Geriatr Soc. 2002;50(5):930934.
  28. Bach PB, Schrag D, Begg CB. Resurrecting treatment histories of dead patients: a study design that should be laid to rest. JAMA. 2004;292(22):27652770.
  29. Etchells E, Darzins P, Silberfeld M, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999;14(1):2734.
  30. Grisso T, Appelbaum PS, Hill‐Fotouhi C. The MacCAT‐T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997;48(11):14151419.
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Journal of Hospital Medicine - 8(6)
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Journal of Hospital Medicine - 8(6)
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Opportunity lost: End‐of‐life discussions in cancer patients who die in the hospital
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Opportunity lost: End‐of‐life discussions in cancer patients who die in the hospital
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Address for correspondence and reprint requests: Mark C. Zaros, Harborview Medical Center, Mailbox 359780, 325 Ninth Ave, Seattle, WA 98104‐2499. Telephone: 206‐744‐2054; Fax: 206‐744‐6063; E-mail: [email protected]
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Hospitalist‐Job Fit

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Person‐job fit: An exploratory cross‐sectional analysis of hospitalists

Person‐organization fit concerns the conditions and consequences of compatibility between people and the organizations for which they work.[1] Studies of other industries have demonstrated that person‐organization fit informs the way individuals join, perform in, and are retained by organizations.[2] Person‐job fit is a closely related subordinate concept that concerns the alignment of workers and their job in as much as workers have needs that their job supplies, or conversely, jobs have requirements that certain workers' abilities can help meet.[3] Explorations of job fit in physicians and their work have recently emerged in a few investigations published in medical journals.[4, 5, 6, 7, 8] Further expanding the understanding of fit between physicians and their employment is important, because the decline of solo practices and recent emphasis on team‐based care have led to a growing number of US physicians working in organizations.[9]

The movement of physicians into employed situations may continue if certain types of Accountable Care Organizations take root.[10] And physicians may be primed to join employer organizations based on current career priorities of individuals in American society. Surveys of medical residents entering the workforce reveal more physicians preferring the security of being employees than starting their own practices.[11] Given these trends, job fit will inform our understanding of how personal and job characteristics facilitate recruitment, performance, satisfaction, and longevity of physician employees.

BACKGROUND

Virtually all hospitalists work in organizationshospitalsand are employees of hospitals, medical schools, physician group practices, or management companies, and therefore invariably function within organizational structures and systems.[7] In spite of their rapid growth in numbers, many employers have faced difficulties recruiting and retaining enough hospitalists to fill their staffing needs. Consequently, the US hospitalist workforce today is characterized by high salaries, work load, and attrition rates.[12]

In this evolving unsaturated market, the attraction‐selection‐attrition framework[13] provides a theoretical construct that predicts that hospitalists and their employers would seek congruence of goals and values early in their relationship through a process of trial and error. This framework assumes that early interactions between workers and organizations serve as opportunities for them to understand if job fit is poor and dissociate or remain affiliated as long as job fit is mutually acceptable. Therefore, job switching on average is expected to increase job fit because workers and organizations gain a better understanding of their own goals and values and choose more wisely the next time.

Other theoretical frameworks, such as the job characteristic model,[14] suggest that over time as workers stay at the same job, they continue to maintain and improve job fit through various workplace‐ or self‐modification strategies. For example, seniority status may have privileges (eg, less undesirable call), or workers may create privileged niches through the acquisition of new skills and abilities over time. Hospitalists' tendency to diversify their work‐related activities by incorporating administrative and teaching responsibilities[15] may thus contribute to improving job fit. Additionally, as a measure of complementarity among people who work together, job fit may be influenced by the quality of relationships among hospitalists and their coworkers through their reorientation to the prevailing organizational climate[16, 17] and increasing socialization.[18] Finally, given that experiential learning is known to contribute to better hospitalist work performance,[19] job fit may affect productivity and clinical outcomes vis‐‐vis quality of work life.

To test the validity of these assumptions in a sample of hospitalists, we critically appraised the following 4 hypotheses:

  • Hypothesis 1 (H1): Job attrition and reselection improves job fit among hospitalists entering the job market.
  • Hypothesis 2 (H2): Better job fit is achieved through hospitalists engaging a variety of personal skills and abilities.
  • Hypothesis 3 (H3): Job fit increases with hospitalists' job duration together with socialization and internalization of organizational values.
  • Hypothesis 4 (H4): Job fit is correlated with hospitalists' quality of work life.

 

METHODS

Analysis was performed on data from the 2009 to 2010 Hospital Medicine Physician Worklife Survey. The sample frame included nonmembers and members of Society of Hospital Medicine (SHM). Details about sampling strategy, data collection, and data quality are available in previous publications.[7, 20] The 118‐item survey instrument, including 9 demographic items and 24 practice and job characteristic items, was administered by mail. Examples of information solicited through these items included respondents' practice model, the number of hospitalist jobs they have held, and the specific kinds of clinical and nonclinical activities they performed as part of their current job.

We used a reliable but broad and generic measure of self‐perceived person‐job fit.[21] The survey items of the 5‐point Likert‐type scale anchored between strongly disagree and strongly agree were: I feel that my work utilizes my full abilities, I feel competent and fully able to handle my job, my job gives me the chance to do the things I feel I do best, I feel that my job and I are well‐matched, I feel I have adequate preparation for the job I now hold. The quality of hospitalists' relationships with physician colleagues, staff, and patients as well as job satisfaction was measured using scales adapted from the Physician Worklife Study.[22] Organizational climate was measured using an adapted scale from the Minimizing Error, Maximizing Outcome study incorporating 3 items from the cohesiveness subscale, 4 items from the organizational trust subscale, and 1 item from the quality emphasis subscale that were most pertinent to hospitalists' relationship with their organizations.[23] Intent to leave practice or reduce work hours was measured using 5 items from the Multi‐Center Hospitalist Survey Project.[24] Frequency of participation in suboptimal patient care was measured by adapting 3 items from the suboptimal reported practice subscale and 2 items from the suboptimal patient care subscale developed by Shanafelt et al.[25] Stress and job burnout were assessed using validated measures.[26, 27] Detailed descriptions of the response rate calculation and imputation of missing item data are available in previous publications.[7, 20]

Mean, variance, range, and skew were used to characterize the responses to the job fit survey scale. A table of respondent characteristics was constructed. A visual representation of job fit by individual hospitalist year in current practice was created, first, by plotting a locally weighted scatterplot smoothing curve to examine the shape of the general relationship, and second, by fitting a similarly contoured functional polynomial curve with 95% confidence intervals (CI) to a plot of the mean and interquartile range of job fit for each year in current practice. Spearman partial correlations were calculated for job fit and each of the 5 items addressing likelihood of leaving practice or reducing workload adjusted for gender to control for the higher proportion of women who plan to work part time. Median (interquartile range) job fit was calculated for categories defined by the number of job changes and compared with the reference category (no job change) using the nonparametric rank sum test for comparing non‐normally distributed data. Multivariate logistic regression models were used to calculate the odds ratio (OR) of participating in each of several clinical and nonclinical hospitalist activities between respondents whose job fit score was optimal (5 on a 5‐point scale) and less than optimal controlling for covariates that influence the likelihood of participating in these activities (years in current practice, practice model, and specialty training). A Spearman correlation matrix was created to assess interscale correlations among organizational parameters (years in current practice, job fit, organizational climate, and relationship with colleagues, staff, and patients). Finally, a separate Spearman correlation matrix was created to assess the interscale correlations among individual worker parameters (job fit, suboptimal patient care, job burnout, stress, and job satisfaction). Statistical significance was defined as P value <0.05, and all analyses were performed on Stata 11.0 (StataCorp, College Station, TX). The Northwestern University institutional review board approved this study.

RESULTS

Respondents included 816 hospitalists belonging to around 700 unique organizations. The adjusted response rate from the stratified sample was 26%. Respondents and nonrespondents were similar with regard to geographic region and model of practice, but respondents were more likely to be members of the SHM than nonrespondents. Panel A of Table 1 shows the demographic characteristics of the respondents. The mean age was 44.3 years, and about one‐third were women. The average hospitalist had about 7 years of experience in the specialty and about 5 years with their current hospitalist job. The majority were trained in internal medicine or one of its subspecialties, whereas pediatricians, family physicians, and physicians with other training made up the remainder.

Characteristics of Respondent Hospitalists
 Panel APanel B
 TotalAssimilation Period HospitalistsAdvancement Period Hospitalists
  • NOTE: Abbreviations: SD, standard deviation.
Total, n816103713
Female, n (%)284 (35)37 (36)247 (35)
Age, mean (SD)44.3 (9.0)41.9 (9.3)44.7 (8.9)
Years postresidency experience as hospitalist, mean (SD)6.9 (4.5)4.3 (3.1)7.2 (4.6)
Years in current practice, mean (SD)5.1 (3.9)0.9 (0.3)6.7 (3.8)
Specialty training, n (%)   
Internal medicine555 (68)75 (73)480 (67)
Pediatrics117 (14)8 (8)109 (15.3)
Family medicine49 (6)7 (7)42 (6)
Other95 (11)13 (13)82 (12)

Job fit was highly skewed toward optimum fit, with a mean of 4.3 on a scale of 1 to 5, with a narrow standard deviation of 0.7. The poorest job fit was reported by 0.3%, whereas optimal fit was reported by 21% of respondents. Job fit plotted against years in current practice had a logarithmic appearance typical of learning curves (Figure 1). An inflection point was visualized at around 2 years. For the purposes of this article, we refer to hospitalists' experience in the first 2 years of a job as an assimilation period, which is marked by a steep increase in job fit early when rapid learning or attrition took place. The years beyond the inflection point are characterized as an advancement period, when a more attenuated rise in job fit was experienced with time. The Spearman correlation between job fit and years in practice during the advancement period was 0.145 (n = 678, P < 0.001). Panel B of Table 1 displays the characteristics of respondents separately for the assimilation and advancement cohorts. Assimilation hospitalists in our sample had a mean age of 41.9 years and mean on‐the‐job experience of 4.3 years, reflecting that many hospitalists in the first 2 years of a job have made at least 1 job change in the past.

Figure 1
Graph of hospitalist‐job fit (minimum 1, maximum 5) by years of completed practice in current hospitalist job.

To show the effects of attrition and reselection, we first evaluated the proposition that hospitalists experience attrition (ie, intend to leave their jobs) in response to poor fit. Table 2 shows the correlations between job fit and the self‐reported intent to leave practice or reduce workload separately for the assimilation and advancement periods. For hospitalists in the assimilation period, job fit was negatively correlated with intent to leave current practice within 2 years and to leave hospital medicine within 5 years (P = 0.010 and 0.043, respectively). Hospitalists with <2 years in their current job, therefore, tended to consider attrition but not workload reduction to deal with poor job fit. On the other hand, hospitalists in the advancement period considered both attrition and workload reduction strategies in response to poor fit (all P < 0.001).

Spearman Correlations Between Hospitalist‐Job Fit (1 Worst Fit, 5 Best Fit) and Intent to Leave or Reduce Workload (1 Not Likely at All, 4 Very Likely) Adjusted for Gender
 Assimilation Period HospitalistsAdvancement Period Hospitalists
RhoP ValueRhoP Value
Likelihood that a hospitalist will:    
Leave current practice within 2 years0.2530.0100.367<0.001
Decrease total work hours within 5 years0.0600.5480.179<0.001
Decrease clinical work hours within 5 years0.0720.4690.144<0.001
Leave hospital medicine within 5 years0.2000.0430.231<0.001
Leave direct patient care within 5 years0.0400.6910.212<0.001

In Table 3, we further compared the median job fit across categories for the number of job switches. The median job fit during the assimilation period of hospitalists who had made 1 job change was slightly but statistically higher than the job fit of their counterparts who never left their first job (4.4 vs 4.0, P = 0.046). This suggests that job switching by hospitalists early in their jobs is associated with improved job fit (H1). However, the fit during the assimilation period of hospitalists who switched jobs twice or more was statistically no different from the fit of those in their first jobs, suggesting that the effect of the attrition‐reselection strategy is weak or inconsistent. The job fit for advancement period hospitalists was also different across the job change and no‐change categories. However, in the case of hospitalists later in their jobs, the median job fit was slightly but statistically lower among those who made job changes, revealing the potential drop in job fit that occurs when a hospitalist already established in his or her job starts over again in a new setting.

Relative Job Fit During the Assimilation and Advancement Periods Comparing Hospitalists Who Made Job Changes to Those Who Did Not
 nAge, Mean (95% CI), yHospitalist‐Job Fit, Median (IQR)P Valuea
  • NOTE: Abbreviations: CI, confidence interval; IQR, interquartile range.
  • Indicates P value of the deviation from the hospitalist‐job fit reference value
  • Eight item nonrespondents.
  • Forty‐one item nonrespondents.
Assimilation period hospitalistsb
No job change2942.3 (37.347.3)4.0 (3.84.4)Reference
1 job change3940.3 (38.142.5)4.4 (4.04.8)0.046
2 or more job changes2743.8 (41.046.6)4.4 (3.84.8)0.153
Advancement period hospitalistsc
No job change39044.5 (43.645.5)4.6 (4.05.0)Reference
1 job change18345.0 (43.746.3)4.2 (4.04.8)0.002
2 or more job changes9944.9 (43.146.6)4.2 (3.84.8)0.002

We hypothesized that hospitalists who achieved high job fit within a particular job were more likely to have engaged in activities that utilize a wider spectrum of their abilities. As shown in Table 4, hospitalists in the highest quartile of job fit were associated with a general trend toward higher odds of participating in a variety of common clinical and nonclinical hospitalist activities, but only the odds ratio associated with teaching achieved statistical significance (OR: 1.53, 95% CI: 1.01‐2.31) (H2).

Odds Ratio of Indicating Participation in Various Clinical and Nonclinical Activities Between the Highest Quartile and the Lower 3 Quartiles of Hospitalist‐Job Fit Adjusted for Years in Current Practice, Practice Model, and Specialty Training
 Participation, n/N (%)Odds Ratio (95% CI)P Value
  • NOTE: Abbreviations: CI, confidence interval.
Administrative or committee work704/816 (86)0.73 (0.431.26)0.262
Quality improvement or patient safety initiatives678/816 (83)1.13 (0.642.00)0.680
Information technology design or implementation379/816 (46)1.18 (0.801.73)0.408
Any of the above leadership activities758/816 (93)1.31 (0.563.05)0.535
Teaching442/816 (54)1.53 (1.012.31)0.046
Research120/816 (15)1.07 (0.601.92)0.816
Any of the above academic activities457/816 (56)1.50 (0.992.27)0.057
Code team or rapid response team437/816 (54)1.13 (0.771.68)0.533
Intensive care unit254/816 (31)0.84 (0.531.35)0.469
Skilled nursing facility or long‐term acute care facility126/816 (15)1.06 (0.621.81)0.835
Outpatient general medical practice44/816 (5)1.75 (0.813.80)0.157
Any of the above clinical activities681/816 (79)1.02 (0.601.76)0.930

Socialization with peers and the gradual sharing of values within organizations are hypothesized mechanisms for increasing job fit with time. We found that the number of years in current practice was positively correlated with job fit (Spearman coefficient R = 0.149, P < 0.001), organizational climate (R = 0.128, P < 0.001), and relationship with nonphysician staff (R = 0.102, P < 0.01). The association between years in practice and relationship with physician colleagues were weaker (R = 0.079, P < 0.05). Consistent with the episodic nature of patients' encounters with hospitalists, the measure of patient relationships was not significantly associated with length of time in job. In addition, we found substantial correlations among job fit, organizational climate, and all the relational measures (all R > 0.280, P < 0.001), indicating that hospitalists increasingly share the values of their organizations over time (H3).

Finally, we also hypothesized that poor job fit is associated with poor performance and quality of work life. Strong correlations with job fit were noted for stress (R = 0.307, P < 0.001), job burnout (R = 0.360, P < 0.001), and job satisfaction (R = 0.570, P < 0.001). Job fit (R = 0.147, P < 0.001), job burnout (R = 0.236, P < 0.001), stress (R = 0.305, P < 0.001), and job satisfaction (R = 0.224, P < 0.001) were all significantly correlated with the frequency of participating in suboptimal care (H4).

DISCUSSION

In this exploratory analysis, we validated in the hospitalist workforce several assumptions about person‐job fit that have been observed in workers of other industries. We observed attrition‐reselection (ie, job switching) as a strategy used by physicians to achieve better fit early in their job tenure, whereas job modification appeared to be more effective than attrition‐reselection among physicians already established in their jobs. We provided weak but plausible evidence that physicians with optimal job fit had a tendency to participate in activities (eg, teaching) that engage a wider set of interests and abilities. We also demonstrated the growth in hospitalists sharing the values of their organization through the time‐dependent associations among organizational climate, relational measures, and job fit. Finally, we found that physicians with suboptimal job fit were more likely to report poor performance in their work compared to those indicating optimal fit.

Our previous analysis of data from the Hospital Medicine Physician Worklife Survey exposed the widely variable work characteristics of hospitalist jobs in the US market and the equally variable preferences and priorities of individual hospitalists in selecting their work setting.[7] The implication of our present study is that hospitalists achieve the high levels of observed job fit using various strategies that aid their alignment with their employment. One of these strategies involves time, but physician longevity in practice may be both a determinant and product of good job fit. Although early job attrition may be necessary for fitting the right hospitalists to the right jobs, employers may appreciate the importance of retaining experienced hospitalists not only for cost and performance considerations but also for the growth of social capital in organizations consisting of enduring individuals. As our data suggest that hospitalists grow with their jobs, physicians may experience better fit with jobs that flexibly couple their work demands with benefits that address their individual work‐life needs over time. Another implication of this study is that job fit is a useful and predictive measure of job selection, performance, and retention. In light of studies that expose the limitations of job satisfaction as a measure influenced more by workers' dispositional affect (ie, their temperament and outlook) than their compatibility with their jobs,[28] job fit may add a functional dimension to traditional employee feedback measures.

There are limitations to this analysis. The most notable is the low survey response rate. Two reasons contributed to the fairly low rate of return. First, the original sampling frame included many outdated addresses and names of individuals who did not meet inclusion criteria. Although all sampled individuals who would have been excluded from the study could not be identified, we calculated our response rate without accounting for the proportion of potential ineligibles in the denominator population [Response Rate 2 (RR2) according to standards of the American Association of Public Opinion Research].[29] Second, the response rates of physician surveys have seen a steady decline over the years.[30] Respondents to our survey may be older and more experienced than US hospitalists in general. Although concerns about bias from under‐reporting cannot be fully addressed, we believe that the study sample is adequate for this preliminary study intended to translate the evidence of observed phenomena from the nonphysician to the physician workforces. The suboptimal response characteristics (high skew and low variability) of the generic person‐job fit survey scale used in this study indicate that a reliable survey instrument specifically designed to measure physician‐job fit need to be constructed de novo and validated for any future study. Although we performed simple analyses to support our assertions, few of our subanalyses may be underpowered, contributing to overinterpretation of the data. Additional empirical work is also necessary to assess the generalizability of this study's claims in other medical and surgical specialties. Such studies would also allow measurement of the sensitivity and specificity of physicians' self‐identification of poor job fit. Finally, additional investigations of this time‐dependent construct are more appropriately performed using a longitudinal study design to overcome the limitations inherent in this cross‐sectional analysis. Our conclusions about the time‐dependent features of job fit may be explained by other characteristics such as generational and cultural differences among hospitalists with varying experience.

As the US healthcare system reorganizes to bolster accountability,[31] we anticipate increasing interdependence between physicians and their employer organizations. Ultimately, the desired accountability in healthcare is likely to be obtained if physicians function not only as passive and interchangeable employees but as active stakeholders in the achievement of each organization's goals. A methodology for assessing the alignment of physicians and their jobs will continue to be important along the way.

Disclosure

Nothing to report.

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  9. Okie S. The evolving primary care physician. N Engl J Med. 2012;366(20):18491853.
  10. Kocher R, Sahni NR. Hospitals' race to employ physicians—the logic behind a money‐losing proposition. N Engl J Med. 2011;364(19):17901793.
  11. 2011 Survey of Final‐Year Medical Residents. Irving, TX:Merritt Hawkins;2011.
  12. State of Hospital Medicine: 2010 Report Based on 2009 Data. Englewood, CO:Society of Hospital Medicine and the Medical Group Management Association;2010.
  13. Schneider B, Goldstein HW, Smith DB. The ASA framework: an update. Personnel Psychol. 1995;48(4):747773.
  14. Hackman JR, Oldham GR. Work Redesign. Reading. MA:Addison‐Wesley;1980.
  15. Sehgal NL, Wachter RM. The expanding role of hospitalists in the United States. Swiss Med Wkly. 2006;136(37–38):591596.
  16. Ostroff C, Kozlowski SWJ. Organizational socialization as a learning‐process—the role of information acquisition. Personnel Psychol. 1992;45(4):849874.
  17. Ostroff C, Rothausen TJ. The moderating effect of tenure in person‐environment fit: a field study in educational organizations. J Occup Organ Psych. 1997;70:173188.
  18. Chatman JA. Matching people and organizations—selection and socialization in public accounting firms. Admin Sci Quart. 1991;36(3):459484.
  19. Meltzer D, Manning WG, Morrison J, et al. Effects of physician experience on costs and outcomes on an academic general medicine service: results of a trial of hospitalists. Ann Intern Med. 2002;137(11):866874.
  20. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):2836.
  21. Xie JL. Karasek's model in the People's Republic of China: effects of job demands, control, and individual differences. Acad Manage J. 1996;39(6):15941618.
  22. Konrad TR, Williams ES, Linzer M, et al. Measuring physician job satisfaction in a changing workplace and a challenging environment. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999;37(11):11741182.
  23. Linzer M, Manwell LB, Mundt M, et al. Organizational climate, stress, and error in primary care: The MEMO Study. Adv Patient Saf. 2005;1:6577.
  24. Meltzer DO, Arora V, Zhang JX, et al. Effects of inpatient experience on outcomes and costs in a multicenter trial of academic hospitalists. J Gen Intern Med. 2005;20(suppl 1):141142.
  25. Shanafelt TD, Bradley KA, Wipf JE, Back AL. Burnout and self‐reported patient care in an internal medicine residency program. Ann Intern Med. 2002;136(5):358367.
  26. Yang CL, Carayon P. Effect of job demands and social support on worker stress—a study of VDT users. Behav Inform Technol. 1995;14(1):3240.
  27. Rohland BM, Kruse GR, Rohrer JE. Validation of a single‐item measure of burnout against the Maslach Burnout Inventory among physicians. Stress Health. 2004;20(2):7579.
  28. Dormann C, Zapf D. Job satisfaction: a meta‐analysis of stabilities. J Organ Behav. 2001;22(5):483504.
  29. The American Association for Public Opinion Research. Standard definitions: final dispositions of case codes and outcome rates for surveys.7th ed. Available at: http://www.aapor.org/Standard_Definitions2.htm. Accessed May 2,2012.
  30. Cull WL, O'Connor KG, Sharp S, Tang SFS. Response rates and response bias for 50 surveys of pediatricians. Health Serv Res. 2005;40(1):213226.
  31. Fisher ES, Shortell SM. Accountable care organizations: accountable for what, to whom, and how. JAMA. 2010;304(15):17156.
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Person‐organization fit concerns the conditions and consequences of compatibility between people and the organizations for which they work.[1] Studies of other industries have demonstrated that person‐organization fit informs the way individuals join, perform in, and are retained by organizations.[2] Person‐job fit is a closely related subordinate concept that concerns the alignment of workers and their job in as much as workers have needs that their job supplies, or conversely, jobs have requirements that certain workers' abilities can help meet.[3] Explorations of job fit in physicians and their work have recently emerged in a few investigations published in medical journals.[4, 5, 6, 7, 8] Further expanding the understanding of fit between physicians and their employment is important, because the decline of solo practices and recent emphasis on team‐based care have led to a growing number of US physicians working in organizations.[9]

The movement of physicians into employed situations may continue if certain types of Accountable Care Organizations take root.[10] And physicians may be primed to join employer organizations based on current career priorities of individuals in American society. Surveys of medical residents entering the workforce reveal more physicians preferring the security of being employees than starting their own practices.[11] Given these trends, job fit will inform our understanding of how personal and job characteristics facilitate recruitment, performance, satisfaction, and longevity of physician employees.

BACKGROUND

Virtually all hospitalists work in organizationshospitalsand are employees of hospitals, medical schools, physician group practices, or management companies, and therefore invariably function within organizational structures and systems.[7] In spite of their rapid growth in numbers, many employers have faced difficulties recruiting and retaining enough hospitalists to fill their staffing needs. Consequently, the US hospitalist workforce today is characterized by high salaries, work load, and attrition rates.[12]

In this evolving unsaturated market, the attraction‐selection‐attrition framework[13] provides a theoretical construct that predicts that hospitalists and their employers would seek congruence of goals and values early in their relationship through a process of trial and error. This framework assumes that early interactions between workers and organizations serve as opportunities for them to understand if job fit is poor and dissociate or remain affiliated as long as job fit is mutually acceptable. Therefore, job switching on average is expected to increase job fit because workers and organizations gain a better understanding of their own goals and values and choose more wisely the next time.

Other theoretical frameworks, such as the job characteristic model,[14] suggest that over time as workers stay at the same job, they continue to maintain and improve job fit through various workplace‐ or self‐modification strategies. For example, seniority status may have privileges (eg, less undesirable call), or workers may create privileged niches through the acquisition of new skills and abilities over time. Hospitalists' tendency to diversify their work‐related activities by incorporating administrative and teaching responsibilities[15] may thus contribute to improving job fit. Additionally, as a measure of complementarity among people who work together, job fit may be influenced by the quality of relationships among hospitalists and their coworkers through their reorientation to the prevailing organizational climate[16, 17] and increasing socialization.[18] Finally, given that experiential learning is known to contribute to better hospitalist work performance,[19] job fit may affect productivity and clinical outcomes vis‐‐vis quality of work life.

To test the validity of these assumptions in a sample of hospitalists, we critically appraised the following 4 hypotheses:

  • Hypothesis 1 (H1): Job attrition and reselection improves job fit among hospitalists entering the job market.
  • Hypothesis 2 (H2): Better job fit is achieved through hospitalists engaging a variety of personal skills and abilities.
  • Hypothesis 3 (H3): Job fit increases with hospitalists' job duration together with socialization and internalization of organizational values.
  • Hypothesis 4 (H4): Job fit is correlated with hospitalists' quality of work life.

 

METHODS

Analysis was performed on data from the 2009 to 2010 Hospital Medicine Physician Worklife Survey. The sample frame included nonmembers and members of Society of Hospital Medicine (SHM). Details about sampling strategy, data collection, and data quality are available in previous publications.[7, 20] The 118‐item survey instrument, including 9 demographic items and 24 practice and job characteristic items, was administered by mail. Examples of information solicited through these items included respondents' practice model, the number of hospitalist jobs they have held, and the specific kinds of clinical and nonclinical activities they performed as part of their current job.

We used a reliable but broad and generic measure of self‐perceived person‐job fit.[21] The survey items of the 5‐point Likert‐type scale anchored between strongly disagree and strongly agree were: I feel that my work utilizes my full abilities, I feel competent and fully able to handle my job, my job gives me the chance to do the things I feel I do best, I feel that my job and I are well‐matched, I feel I have adequate preparation for the job I now hold. The quality of hospitalists' relationships with physician colleagues, staff, and patients as well as job satisfaction was measured using scales adapted from the Physician Worklife Study.[22] Organizational climate was measured using an adapted scale from the Minimizing Error, Maximizing Outcome study incorporating 3 items from the cohesiveness subscale, 4 items from the organizational trust subscale, and 1 item from the quality emphasis subscale that were most pertinent to hospitalists' relationship with their organizations.[23] Intent to leave practice or reduce work hours was measured using 5 items from the Multi‐Center Hospitalist Survey Project.[24] Frequency of participation in suboptimal patient care was measured by adapting 3 items from the suboptimal reported practice subscale and 2 items from the suboptimal patient care subscale developed by Shanafelt et al.[25] Stress and job burnout were assessed using validated measures.[26, 27] Detailed descriptions of the response rate calculation and imputation of missing item data are available in previous publications.[7, 20]

Mean, variance, range, and skew were used to characterize the responses to the job fit survey scale. A table of respondent characteristics was constructed. A visual representation of job fit by individual hospitalist year in current practice was created, first, by plotting a locally weighted scatterplot smoothing curve to examine the shape of the general relationship, and second, by fitting a similarly contoured functional polynomial curve with 95% confidence intervals (CI) to a plot of the mean and interquartile range of job fit for each year in current practice. Spearman partial correlations were calculated for job fit and each of the 5 items addressing likelihood of leaving practice or reducing workload adjusted for gender to control for the higher proportion of women who plan to work part time. Median (interquartile range) job fit was calculated for categories defined by the number of job changes and compared with the reference category (no job change) using the nonparametric rank sum test for comparing non‐normally distributed data. Multivariate logistic regression models were used to calculate the odds ratio (OR) of participating in each of several clinical and nonclinical hospitalist activities between respondents whose job fit score was optimal (5 on a 5‐point scale) and less than optimal controlling for covariates that influence the likelihood of participating in these activities (years in current practice, practice model, and specialty training). A Spearman correlation matrix was created to assess interscale correlations among organizational parameters (years in current practice, job fit, organizational climate, and relationship with colleagues, staff, and patients). Finally, a separate Spearman correlation matrix was created to assess the interscale correlations among individual worker parameters (job fit, suboptimal patient care, job burnout, stress, and job satisfaction). Statistical significance was defined as P value <0.05, and all analyses were performed on Stata 11.0 (StataCorp, College Station, TX). The Northwestern University institutional review board approved this study.

RESULTS

Respondents included 816 hospitalists belonging to around 700 unique organizations. The adjusted response rate from the stratified sample was 26%. Respondents and nonrespondents were similar with regard to geographic region and model of practice, but respondents were more likely to be members of the SHM than nonrespondents. Panel A of Table 1 shows the demographic characteristics of the respondents. The mean age was 44.3 years, and about one‐third were women. The average hospitalist had about 7 years of experience in the specialty and about 5 years with their current hospitalist job. The majority were trained in internal medicine or one of its subspecialties, whereas pediatricians, family physicians, and physicians with other training made up the remainder.

Characteristics of Respondent Hospitalists
 Panel APanel B
 TotalAssimilation Period HospitalistsAdvancement Period Hospitalists
  • NOTE: Abbreviations: SD, standard deviation.
Total, n816103713
Female, n (%)284 (35)37 (36)247 (35)
Age, mean (SD)44.3 (9.0)41.9 (9.3)44.7 (8.9)
Years postresidency experience as hospitalist, mean (SD)6.9 (4.5)4.3 (3.1)7.2 (4.6)
Years in current practice, mean (SD)5.1 (3.9)0.9 (0.3)6.7 (3.8)
Specialty training, n (%)   
Internal medicine555 (68)75 (73)480 (67)
Pediatrics117 (14)8 (8)109 (15.3)
Family medicine49 (6)7 (7)42 (6)
Other95 (11)13 (13)82 (12)

Job fit was highly skewed toward optimum fit, with a mean of 4.3 on a scale of 1 to 5, with a narrow standard deviation of 0.7. The poorest job fit was reported by 0.3%, whereas optimal fit was reported by 21% of respondents. Job fit plotted against years in current practice had a logarithmic appearance typical of learning curves (Figure 1). An inflection point was visualized at around 2 years. For the purposes of this article, we refer to hospitalists' experience in the first 2 years of a job as an assimilation period, which is marked by a steep increase in job fit early when rapid learning or attrition took place. The years beyond the inflection point are characterized as an advancement period, when a more attenuated rise in job fit was experienced with time. The Spearman correlation between job fit and years in practice during the advancement period was 0.145 (n = 678, P < 0.001). Panel B of Table 1 displays the characteristics of respondents separately for the assimilation and advancement cohorts. Assimilation hospitalists in our sample had a mean age of 41.9 years and mean on‐the‐job experience of 4.3 years, reflecting that many hospitalists in the first 2 years of a job have made at least 1 job change in the past.

Figure 1
Graph of hospitalist‐job fit (minimum 1, maximum 5) by years of completed practice in current hospitalist job.

To show the effects of attrition and reselection, we first evaluated the proposition that hospitalists experience attrition (ie, intend to leave their jobs) in response to poor fit. Table 2 shows the correlations between job fit and the self‐reported intent to leave practice or reduce workload separately for the assimilation and advancement periods. For hospitalists in the assimilation period, job fit was negatively correlated with intent to leave current practice within 2 years and to leave hospital medicine within 5 years (P = 0.010 and 0.043, respectively). Hospitalists with <2 years in their current job, therefore, tended to consider attrition but not workload reduction to deal with poor job fit. On the other hand, hospitalists in the advancement period considered both attrition and workload reduction strategies in response to poor fit (all P < 0.001).

Spearman Correlations Between Hospitalist‐Job Fit (1 Worst Fit, 5 Best Fit) and Intent to Leave or Reduce Workload (1 Not Likely at All, 4 Very Likely) Adjusted for Gender
 Assimilation Period HospitalistsAdvancement Period Hospitalists
RhoP ValueRhoP Value
Likelihood that a hospitalist will:    
Leave current practice within 2 years0.2530.0100.367<0.001
Decrease total work hours within 5 years0.0600.5480.179<0.001
Decrease clinical work hours within 5 years0.0720.4690.144<0.001
Leave hospital medicine within 5 years0.2000.0430.231<0.001
Leave direct patient care within 5 years0.0400.6910.212<0.001

In Table 3, we further compared the median job fit across categories for the number of job switches. The median job fit during the assimilation period of hospitalists who had made 1 job change was slightly but statistically higher than the job fit of their counterparts who never left their first job (4.4 vs 4.0, P = 0.046). This suggests that job switching by hospitalists early in their jobs is associated with improved job fit (H1). However, the fit during the assimilation period of hospitalists who switched jobs twice or more was statistically no different from the fit of those in their first jobs, suggesting that the effect of the attrition‐reselection strategy is weak or inconsistent. The job fit for advancement period hospitalists was also different across the job change and no‐change categories. However, in the case of hospitalists later in their jobs, the median job fit was slightly but statistically lower among those who made job changes, revealing the potential drop in job fit that occurs when a hospitalist already established in his or her job starts over again in a new setting.

Relative Job Fit During the Assimilation and Advancement Periods Comparing Hospitalists Who Made Job Changes to Those Who Did Not
 nAge, Mean (95% CI), yHospitalist‐Job Fit, Median (IQR)P Valuea
  • NOTE: Abbreviations: CI, confidence interval; IQR, interquartile range.
  • Indicates P value of the deviation from the hospitalist‐job fit reference value
  • Eight item nonrespondents.
  • Forty‐one item nonrespondents.
Assimilation period hospitalistsb
No job change2942.3 (37.347.3)4.0 (3.84.4)Reference
1 job change3940.3 (38.142.5)4.4 (4.04.8)0.046
2 or more job changes2743.8 (41.046.6)4.4 (3.84.8)0.153
Advancement period hospitalistsc
No job change39044.5 (43.645.5)4.6 (4.05.0)Reference
1 job change18345.0 (43.746.3)4.2 (4.04.8)0.002
2 or more job changes9944.9 (43.146.6)4.2 (3.84.8)0.002

We hypothesized that hospitalists who achieved high job fit within a particular job were more likely to have engaged in activities that utilize a wider spectrum of their abilities. As shown in Table 4, hospitalists in the highest quartile of job fit were associated with a general trend toward higher odds of participating in a variety of common clinical and nonclinical hospitalist activities, but only the odds ratio associated with teaching achieved statistical significance (OR: 1.53, 95% CI: 1.01‐2.31) (H2).

Odds Ratio of Indicating Participation in Various Clinical and Nonclinical Activities Between the Highest Quartile and the Lower 3 Quartiles of Hospitalist‐Job Fit Adjusted for Years in Current Practice, Practice Model, and Specialty Training
 Participation, n/N (%)Odds Ratio (95% CI)P Value
  • NOTE: Abbreviations: CI, confidence interval.
Administrative or committee work704/816 (86)0.73 (0.431.26)0.262
Quality improvement or patient safety initiatives678/816 (83)1.13 (0.642.00)0.680
Information technology design or implementation379/816 (46)1.18 (0.801.73)0.408
Any of the above leadership activities758/816 (93)1.31 (0.563.05)0.535
Teaching442/816 (54)1.53 (1.012.31)0.046
Research120/816 (15)1.07 (0.601.92)0.816
Any of the above academic activities457/816 (56)1.50 (0.992.27)0.057
Code team or rapid response team437/816 (54)1.13 (0.771.68)0.533
Intensive care unit254/816 (31)0.84 (0.531.35)0.469
Skilled nursing facility or long‐term acute care facility126/816 (15)1.06 (0.621.81)0.835
Outpatient general medical practice44/816 (5)1.75 (0.813.80)0.157
Any of the above clinical activities681/816 (79)1.02 (0.601.76)0.930

Socialization with peers and the gradual sharing of values within organizations are hypothesized mechanisms for increasing job fit with time. We found that the number of years in current practice was positively correlated with job fit (Spearman coefficient R = 0.149, P < 0.001), organizational climate (R = 0.128, P < 0.001), and relationship with nonphysician staff (R = 0.102, P < 0.01). The association between years in practice and relationship with physician colleagues were weaker (R = 0.079, P < 0.05). Consistent with the episodic nature of patients' encounters with hospitalists, the measure of patient relationships was not significantly associated with length of time in job. In addition, we found substantial correlations among job fit, organizational climate, and all the relational measures (all R > 0.280, P < 0.001), indicating that hospitalists increasingly share the values of their organizations over time (H3).

Finally, we also hypothesized that poor job fit is associated with poor performance and quality of work life. Strong correlations with job fit were noted for stress (R = 0.307, P < 0.001), job burnout (R = 0.360, P < 0.001), and job satisfaction (R = 0.570, P < 0.001). Job fit (R = 0.147, P < 0.001), job burnout (R = 0.236, P < 0.001), stress (R = 0.305, P < 0.001), and job satisfaction (R = 0.224, P < 0.001) were all significantly correlated with the frequency of participating in suboptimal care (H4).

DISCUSSION

In this exploratory analysis, we validated in the hospitalist workforce several assumptions about person‐job fit that have been observed in workers of other industries. We observed attrition‐reselection (ie, job switching) as a strategy used by physicians to achieve better fit early in their job tenure, whereas job modification appeared to be more effective than attrition‐reselection among physicians already established in their jobs. We provided weak but plausible evidence that physicians with optimal job fit had a tendency to participate in activities (eg, teaching) that engage a wider set of interests and abilities. We also demonstrated the growth in hospitalists sharing the values of their organization through the time‐dependent associations among organizational climate, relational measures, and job fit. Finally, we found that physicians with suboptimal job fit were more likely to report poor performance in their work compared to those indicating optimal fit.

Our previous analysis of data from the Hospital Medicine Physician Worklife Survey exposed the widely variable work characteristics of hospitalist jobs in the US market and the equally variable preferences and priorities of individual hospitalists in selecting their work setting.[7] The implication of our present study is that hospitalists achieve the high levels of observed job fit using various strategies that aid their alignment with their employment. One of these strategies involves time, but physician longevity in practice may be both a determinant and product of good job fit. Although early job attrition may be necessary for fitting the right hospitalists to the right jobs, employers may appreciate the importance of retaining experienced hospitalists not only for cost and performance considerations but also for the growth of social capital in organizations consisting of enduring individuals. As our data suggest that hospitalists grow with their jobs, physicians may experience better fit with jobs that flexibly couple their work demands with benefits that address their individual work‐life needs over time. Another implication of this study is that job fit is a useful and predictive measure of job selection, performance, and retention. In light of studies that expose the limitations of job satisfaction as a measure influenced more by workers' dispositional affect (ie, their temperament and outlook) than their compatibility with their jobs,[28] job fit may add a functional dimension to traditional employee feedback measures.

There are limitations to this analysis. The most notable is the low survey response rate. Two reasons contributed to the fairly low rate of return. First, the original sampling frame included many outdated addresses and names of individuals who did not meet inclusion criteria. Although all sampled individuals who would have been excluded from the study could not be identified, we calculated our response rate without accounting for the proportion of potential ineligibles in the denominator population [Response Rate 2 (RR2) according to standards of the American Association of Public Opinion Research].[29] Second, the response rates of physician surveys have seen a steady decline over the years.[30] Respondents to our survey may be older and more experienced than US hospitalists in general. Although concerns about bias from under‐reporting cannot be fully addressed, we believe that the study sample is adequate for this preliminary study intended to translate the evidence of observed phenomena from the nonphysician to the physician workforces. The suboptimal response characteristics (high skew and low variability) of the generic person‐job fit survey scale used in this study indicate that a reliable survey instrument specifically designed to measure physician‐job fit need to be constructed de novo and validated for any future study. Although we performed simple analyses to support our assertions, few of our subanalyses may be underpowered, contributing to overinterpretation of the data. Additional empirical work is also necessary to assess the generalizability of this study's claims in other medical and surgical specialties. Such studies would also allow measurement of the sensitivity and specificity of physicians' self‐identification of poor job fit. Finally, additional investigations of this time‐dependent construct are more appropriately performed using a longitudinal study design to overcome the limitations inherent in this cross‐sectional analysis. Our conclusions about the time‐dependent features of job fit may be explained by other characteristics such as generational and cultural differences among hospitalists with varying experience.

As the US healthcare system reorganizes to bolster accountability,[31] we anticipate increasing interdependence between physicians and their employer organizations. Ultimately, the desired accountability in healthcare is likely to be obtained if physicians function not only as passive and interchangeable employees but as active stakeholders in the achievement of each organization's goals. A methodology for assessing the alignment of physicians and their jobs will continue to be important along the way.

Disclosure

Nothing to report.

Person‐organization fit concerns the conditions and consequences of compatibility between people and the organizations for which they work.[1] Studies of other industries have demonstrated that person‐organization fit informs the way individuals join, perform in, and are retained by organizations.[2] Person‐job fit is a closely related subordinate concept that concerns the alignment of workers and their job in as much as workers have needs that their job supplies, or conversely, jobs have requirements that certain workers' abilities can help meet.[3] Explorations of job fit in physicians and their work have recently emerged in a few investigations published in medical journals.[4, 5, 6, 7, 8] Further expanding the understanding of fit between physicians and their employment is important, because the decline of solo practices and recent emphasis on team‐based care have led to a growing number of US physicians working in organizations.[9]

The movement of physicians into employed situations may continue if certain types of Accountable Care Organizations take root.[10] And physicians may be primed to join employer organizations based on current career priorities of individuals in American society. Surveys of medical residents entering the workforce reveal more physicians preferring the security of being employees than starting their own practices.[11] Given these trends, job fit will inform our understanding of how personal and job characteristics facilitate recruitment, performance, satisfaction, and longevity of physician employees.

BACKGROUND

Virtually all hospitalists work in organizationshospitalsand are employees of hospitals, medical schools, physician group practices, or management companies, and therefore invariably function within organizational structures and systems.[7] In spite of their rapid growth in numbers, many employers have faced difficulties recruiting and retaining enough hospitalists to fill their staffing needs. Consequently, the US hospitalist workforce today is characterized by high salaries, work load, and attrition rates.[12]

In this evolving unsaturated market, the attraction‐selection‐attrition framework[13] provides a theoretical construct that predicts that hospitalists and their employers would seek congruence of goals and values early in their relationship through a process of trial and error. This framework assumes that early interactions between workers and organizations serve as opportunities for them to understand if job fit is poor and dissociate or remain affiliated as long as job fit is mutually acceptable. Therefore, job switching on average is expected to increase job fit because workers and organizations gain a better understanding of their own goals and values and choose more wisely the next time.

Other theoretical frameworks, such as the job characteristic model,[14] suggest that over time as workers stay at the same job, they continue to maintain and improve job fit through various workplace‐ or self‐modification strategies. For example, seniority status may have privileges (eg, less undesirable call), or workers may create privileged niches through the acquisition of new skills and abilities over time. Hospitalists' tendency to diversify their work‐related activities by incorporating administrative and teaching responsibilities[15] may thus contribute to improving job fit. Additionally, as a measure of complementarity among people who work together, job fit may be influenced by the quality of relationships among hospitalists and their coworkers through their reorientation to the prevailing organizational climate[16, 17] and increasing socialization.[18] Finally, given that experiential learning is known to contribute to better hospitalist work performance,[19] job fit may affect productivity and clinical outcomes vis‐‐vis quality of work life.

To test the validity of these assumptions in a sample of hospitalists, we critically appraised the following 4 hypotheses:

  • Hypothesis 1 (H1): Job attrition and reselection improves job fit among hospitalists entering the job market.
  • Hypothesis 2 (H2): Better job fit is achieved through hospitalists engaging a variety of personal skills and abilities.
  • Hypothesis 3 (H3): Job fit increases with hospitalists' job duration together with socialization and internalization of organizational values.
  • Hypothesis 4 (H4): Job fit is correlated with hospitalists' quality of work life.

 

METHODS

Analysis was performed on data from the 2009 to 2010 Hospital Medicine Physician Worklife Survey. The sample frame included nonmembers and members of Society of Hospital Medicine (SHM). Details about sampling strategy, data collection, and data quality are available in previous publications.[7, 20] The 118‐item survey instrument, including 9 demographic items and 24 practice and job characteristic items, was administered by mail. Examples of information solicited through these items included respondents' practice model, the number of hospitalist jobs they have held, and the specific kinds of clinical and nonclinical activities they performed as part of their current job.

We used a reliable but broad and generic measure of self‐perceived person‐job fit.[21] The survey items of the 5‐point Likert‐type scale anchored between strongly disagree and strongly agree were: I feel that my work utilizes my full abilities, I feel competent and fully able to handle my job, my job gives me the chance to do the things I feel I do best, I feel that my job and I are well‐matched, I feel I have adequate preparation for the job I now hold. The quality of hospitalists' relationships with physician colleagues, staff, and patients as well as job satisfaction was measured using scales adapted from the Physician Worklife Study.[22] Organizational climate was measured using an adapted scale from the Minimizing Error, Maximizing Outcome study incorporating 3 items from the cohesiveness subscale, 4 items from the organizational trust subscale, and 1 item from the quality emphasis subscale that were most pertinent to hospitalists' relationship with their organizations.[23] Intent to leave practice or reduce work hours was measured using 5 items from the Multi‐Center Hospitalist Survey Project.[24] Frequency of participation in suboptimal patient care was measured by adapting 3 items from the suboptimal reported practice subscale and 2 items from the suboptimal patient care subscale developed by Shanafelt et al.[25] Stress and job burnout were assessed using validated measures.[26, 27] Detailed descriptions of the response rate calculation and imputation of missing item data are available in previous publications.[7, 20]

Mean, variance, range, and skew were used to characterize the responses to the job fit survey scale. A table of respondent characteristics was constructed. A visual representation of job fit by individual hospitalist year in current practice was created, first, by plotting a locally weighted scatterplot smoothing curve to examine the shape of the general relationship, and second, by fitting a similarly contoured functional polynomial curve with 95% confidence intervals (CI) to a plot of the mean and interquartile range of job fit for each year in current practice. Spearman partial correlations were calculated for job fit and each of the 5 items addressing likelihood of leaving practice or reducing workload adjusted for gender to control for the higher proportion of women who plan to work part time. Median (interquartile range) job fit was calculated for categories defined by the number of job changes and compared with the reference category (no job change) using the nonparametric rank sum test for comparing non‐normally distributed data. Multivariate logistic regression models were used to calculate the odds ratio (OR) of participating in each of several clinical and nonclinical hospitalist activities between respondents whose job fit score was optimal (5 on a 5‐point scale) and less than optimal controlling for covariates that influence the likelihood of participating in these activities (years in current practice, practice model, and specialty training). A Spearman correlation matrix was created to assess interscale correlations among organizational parameters (years in current practice, job fit, organizational climate, and relationship with colleagues, staff, and patients). Finally, a separate Spearman correlation matrix was created to assess the interscale correlations among individual worker parameters (job fit, suboptimal patient care, job burnout, stress, and job satisfaction). Statistical significance was defined as P value <0.05, and all analyses were performed on Stata 11.0 (StataCorp, College Station, TX). The Northwestern University institutional review board approved this study.

RESULTS

Respondents included 816 hospitalists belonging to around 700 unique organizations. The adjusted response rate from the stratified sample was 26%. Respondents and nonrespondents were similar with regard to geographic region and model of practice, but respondents were more likely to be members of the SHM than nonrespondents. Panel A of Table 1 shows the demographic characteristics of the respondents. The mean age was 44.3 years, and about one‐third were women. The average hospitalist had about 7 years of experience in the specialty and about 5 years with their current hospitalist job. The majority were trained in internal medicine or one of its subspecialties, whereas pediatricians, family physicians, and physicians with other training made up the remainder.

Characteristics of Respondent Hospitalists
 Panel APanel B
 TotalAssimilation Period HospitalistsAdvancement Period Hospitalists
  • NOTE: Abbreviations: SD, standard deviation.
Total, n816103713
Female, n (%)284 (35)37 (36)247 (35)
Age, mean (SD)44.3 (9.0)41.9 (9.3)44.7 (8.9)
Years postresidency experience as hospitalist, mean (SD)6.9 (4.5)4.3 (3.1)7.2 (4.6)
Years in current practice, mean (SD)5.1 (3.9)0.9 (0.3)6.7 (3.8)
Specialty training, n (%)   
Internal medicine555 (68)75 (73)480 (67)
Pediatrics117 (14)8 (8)109 (15.3)
Family medicine49 (6)7 (7)42 (6)
Other95 (11)13 (13)82 (12)

Job fit was highly skewed toward optimum fit, with a mean of 4.3 on a scale of 1 to 5, with a narrow standard deviation of 0.7. The poorest job fit was reported by 0.3%, whereas optimal fit was reported by 21% of respondents. Job fit plotted against years in current practice had a logarithmic appearance typical of learning curves (Figure 1). An inflection point was visualized at around 2 years. For the purposes of this article, we refer to hospitalists' experience in the first 2 years of a job as an assimilation period, which is marked by a steep increase in job fit early when rapid learning or attrition took place. The years beyond the inflection point are characterized as an advancement period, when a more attenuated rise in job fit was experienced with time. The Spearman correlation between job fit and years in practice during the advancement period was 0.145 (n = 678, P < 0.001). Panel B of Table 1 displays the characteristics of respondents separately for the assimilation and advancement cohorts. Assimilation hospitalists in our sample had a mean age of 41.9 years and mean on‐the‐job experience of 4.3 years, reflecting that many hospitalists in the first 2 years of a job have made at least 1 job change in the past.

Figure 1
Graph of hospitalist‐job fit (minimum 1, maximum 5) by years of completed practice in current hospitalist job.

To show the effects of attrition and reselection, we first evaluated the proposition that hospitalists experience attrition (ie, intend to leave their jobs) in response to poor fit. Table 2 shows the correlations between job fit and the self‐reported intent to leave practice or reduce workload separately for the assimilation and advancement periods. For hospitalists in the assimilation period, job fit was negatively correlated with intent to leave current practice within 2 years and to leave hospital medicine within 5 years (P = 0.010 and 0.043, respectively). Hospitalists with <2 years in their current job, therefore, tended to consider attrition but not workload reduction to deal with poor job fit. On the other hand, hospitalists in the advancement period considered both attrition and workload reduction strategies in response to poor fit (all P < 0.001).

Spearman Correlations Between Hospitalist‐Job Fit (1 Worst Fit, 5 Best Fit) and Intent to Leave or Reduce Workload (1 Not Likely at All, 4 Very Likely) Adjusted for Gender
 Assimilation Period HospitalistsAdvancement Period Hospitalists
RhoP ValueRhoP Value
Likelihood that a hospitalist will:    
Leave current practice within 2 years0.2530.0100.367<0.001
Decrease total work hours within 5 years0.0600.5480.179<0.001
Decrease clinical work hours within 5 years0.0720.4690.144<0.001
Leave hospital medicine within 5 years0.2000.0430.231<0.001
Leave direct patient care within 5 years0.0400.6910.212<0.001

In Table 3, we further compared the median job fit across categories for the number of job switches. The median job fit during the assimilation period of hospitalists who had made 1 job change was slightly but statistically higher than the job fit of their counterparts who never left their first job (4.4 vs 4.0, P = 0.046). This suggests that job switching by hospitalists early in their jobs is associated with improved job fit (H1). However, the fit during the assimilation period of hospitalists who switched jobs twice or more was statistically no different from the fit of those in their first jobs, suggesting that the effect of the attrition‐reselection strategy is weak or inconsistent. The job fit for advancement period hospitalists was also different across the job change and no‐change categories. However, in the case of hospitalists later in their jobs, the median job fit was slightly but statistically lower among those who made job changes, revealing the potential drop in job fit that occurs when a hospitalist already established in his or her job starts over again in a new setting.

Relative Job Fit During the Assimilation and Advancement Periods Comparing Hospitalists Who Made Job Changes to Those Who Did Not
 nAge, Mean (95% CI), yHospitalist‐Job Fit, Median (IQR)P Valuea
  • NOTE: Abbreviations: CI, confidence interval; IQR, interquartile range.
  • Indicates P value of the deviation from the hospitalist‐job fit reference value
  • Eight item nonrespondents.
  • Forty‐one item nonrespondents.
Assimilation period hospitalistsb
No job change2942.3 (37.347.3)4.0 (3.84.4)Reference
1 job change3940.3 (38.142.5)4.4 (4.04.8)0.046
2 or more job changes2743.8 (41.046.6)4.4 (3.84.8)0.153
Advancement period hospitalistsc
No job change39044.5 (43.645.5)4.6 (4.05.0)Reference
1 job change18345.0 (43.746.3)4.2 (4.04.8)0.002
2 or more job changes9944.9 (43.146.6)4.2 (3.84.8)0.002

We hypothesized that hospitalists who achieved high job fit within a particular job were more likely to have engaged in activities that utilize a wider spectrum of their abilities. As shown in Table 4, hospitalists in the highest quartile of job fit were associated with a general trend toward higher odds of participating in a variety of common clinical and nonclinical hospitalist activities, but only the odds ratio associated with teaching achieved statistical significance (OR: 1.53, 95% CI: 1.01‐2.31) (H2).

Odds Ratio of Indicating Participation in Various Clinical and Nonclinical Activities Between the Highest Quartile and the Lower 3 Quartiles of Hospitalist‐Job Fit Adjusted for Years in Current Practice, Practice Model, and Specialty Training
 Participation, n/N (%)Odds Ratio (95% CI)P Value
  • NOTE: Abbreviations: CI, confidence interval.
Administrative or committee work704/816 (86)0.73 (0.431.26)0.262
Quality improvement or patient safety initiatives678/816 (83)1.13 (0.642.00)0.680
Information technology design or implementation379/816 (46)1.18 (0.801.73)0.408
Any of the above leadership activities758/816 (93)1.31 (0.563.05)0.535
Teaching442/816 (54)1.53 (1.012.31)0.046
Research120/816 (15)1.07 (0.601.92)0.816
Any of the above academic activities457/816 (56)1.50 (0.992.27)0.057
Code team or rapid response team437/816 (54)1.13 (0.771.68)0.533
Intensive care unit254/816 (31)0.84 (0.531.35)0.469
Skilled nursing facility or long‐term acute care facility126/816 (15)1.06 (0.621.81)0.835
Outpatient general medical practice44/816 (5)1.75 (0.813.80)0.157
Any of the above clinical activities681/816 (79)1.02 (0.601.76)0.930

Socialization with peers and the gradual sharing of values within organizations are hypothesized mechanisms for increasing job fit with time. We found that the number of years in current practice was positively correlated with job fit (Spearman coefficient R = 0.149, P < 0.001), organizational climate (R = 0.128, P < 0.001), and relationship with nonphysician staff (R = 0.102, P < 0.01). The association between years in practice and relationship with physician colleagues were weaker (R = 0.079, P < 0.05). Consistent with the episodic nature of patients' encounters with hospitalists, the measure of patient relationships was not significantly associated with length of time in job. In addition, we found substantial correlations among job fit, organizational climate, and all the relational measures (all R > 0.280, P < 0.001), indicating that hospitalists increasingly share the values of their organizations over time (H3).

Finally, we also hypothesized that poor job fit is associated with poor performance and quality of work life. Strong correlations with job fit were noted for stress (R = 0.307, P < 0.001), job burnout (R = 0.360, P < 0.001), and job satisfaction (R = 0.570, P < 0.001). Job fit (R = 0.147, P < 0.001), job burnout (R = 0.236, P < 0.001), stress (R = 0.305, P < 0.001), and job satisfaction (R = 0.224, P < 0.001) were all significantly correlated with the frequency of participating in suboptimal care (H4).

DISCUSSION

In this exploratory analysis, we validated in the hospitalist workforce several assumptions about person‐job fit that have been observed in workers of other industries. We observed attrition‐reselection (ie, job switching) as a strategy used by physicians to achieve better fit early in their job tenure, whereas job modification appeared to be more effective than attrition‐reselection among physicians already established in their jobs. We provided weak but plausible evidence that physicians with optimal job fit had a tendency to participate in activities (eg, teaching) that engage a wider set of interests and abilities. We also demonstrated the growth in hospitalists sharing the values of their organization through the time‐dependent associations among organizational climate, relational measures, and job fit. Finally, we found that physicians with suboptimal job fit were more likely to report poor performance in their work compared to those indicating optimal fit.

Our previous analysis of data from the Hospital Medicine Physician Worklife Survey exposed the widely variable work characteristics of hospitalist jobs in the US market and the equally variable preferences and priorities of individual hospitalists in selecting their work setting.[7] The implication of our present study is that hospitalists achieve the high levels of observed job fit using various strategies that aid their alignment with their employment. One of these strategies involves time, but physician longevity in practice may be both a determinant and product of good job fit. Although early job attrition may be necessary for fitting the right hospitalists to the right jobs, employers may appreciate the importance of retaining experienced hospitalists not only for cost and performance considerations but also for the growth of social capital in organizations consisting of enduring individuals. As our data suggest that hospitalists grow with their jobs, physicians may experience better fit with jobs that flexibly couple their work demands with benefits that address their individual work‐life needs over time. Another implication of this study is that job fit is a useful and predictive measure of job selection, performance, and retention. In light of studies that expose the limitations of job satisfaction as a measure influenced more by workers' dispositional affect (ie, their temperament and outlook) than their compatibility with their jobs,[28] job fit may add a functional dimension to traditional employee feedback measures.

There are limitations to this analysis. The most notable is the low survey response rate. Two reasons contributed to the fairly low rate of return. First, the original sampling frame included many outdated addresses and names of individuals who did not meet inclusion criteria. Although all sampled individuals who would have been excluded from the study could not be identified, we calculated our response rate without accounting for the proportion of potential ineligibles in the denominator population [Response Rate 2 (RR2) according to standards of the American Association of Public Opinion Research].[29] Second, the response rates of physician surveys have seen a steady decline over the years.[30] Respondents to our survey may be older and more experienced than US hospitalists in general. Although concerns about bias from under‐reporting cannot be fully addressed, we believe that the study sample is adequate for this preliminary study intended to translate the evidence of observed phenomena from the nonphysician to the physician workforces. The suboptimal response characteristics (high skew and low variability) of the generic person‐job fit survey scale used in this study indicate that a reliable survey instrument specifically designed to measure physician‐job fit need to be constructed de novo and validated for any future study. Although we performed simple analyses to support our assertions, few of our subanalyses may be underpowered, contributing to overinterpretation of the data. Additional empirical work is also necessary to assess the generalizability of this study's claims in other medical and surgical specialties. Such studies would also allow measurement of the sensitivity and specificity of physicians' self‐identification of poor job fit. Finally, additional investigations of this time‐dependent construct are more appropriately performed using a longitudinal study design to overcome the limitations inherent in this cross‐sectional analysis. Our conclusions about the time‐dependent features of job fit may be explained by other characteristics such as generational and cultural differences among hospitalists with varying experience.

As the US healthcare system reorganizes to bolster accountability,[31] we anticipate increasing interdependence between physicians and their employer organizations. Ultimately, the desired accountability in healthcare is likely to be obtained if physicians function not only as passive and interchangeable employees but as active stakeholders in the achievement of each organization's goals. A methodology for assessing the alignment of physicians and their jobs will continue to be important along the way.

Disclosure

Nothing to report.

References
  1. Kristof AL. Person‐organization fit: an integrative review of its conceptualizations, measurement, and implications. Personnel Psychol. 1996;49:149.
  2. Kristof‐Brown AL, Zimmerman RD, Johnson EC. Consequences of individuals' fit at work: a meta‐analysis of person‐job, person‐organization, person‐group, and person‐supervisor fit. Personnel Psychol. 2005;58(2):281342.
  3. Edwards JR.Person‐job fit: a conceptual integration, literature review and methodological critique. In: Cooper CL, Robertson IT, eds. International Review of Industrial and Organizational Psychology. Vol.6. New York, NY:John Wiley 1991.
  4. Vandenberghe C. Organizational culture, person‐culture fit, and turnover: a replication in the health care industry. J Organ Behav. 1999;20(2):175184.
  5. Zazzali JL, Alexander JA, Shortell SM, Burns LR. Organizational culture and physician satisfaction with dimensions of group practice. Health Serv Res. 2007;42(3 pt 1):11501176.
  6. Shanafelt TD, West CP, Sloan JA, et al. Career fit and burnout among academic faculty. Arch Intern Med. 2009;169(10):990995.
  7. Hinami K, Whelan CT, Miller JA, Wolosin RJ, Wetterneck TB. Job characteristics, satisfaction, and burnout across hospitalist practice models. J Hosp Med. 2012;7(5):402410.
  8. Huesch MD. Provider‐hospital “fit” and patient outcomes: evidence from Massachusetts cardiac surgeons, 2002–2004. Health Serv Res. 2011;46(1 pt 1):126.
  9. Okie S. The evolving primary care physician. N Engl J Med. 2012;366(20):18491853.
  10. Kocher R, Sahni NR. Hospitals' race to employ physicians—the logic behind a money‐losing proposition. N Engl J Med. 2011;364(19):17901793.
  11. 2011 Survey of Final‐Year Medical Residents. Irving, TX:Merritt Hawkins;2011.
  12. State of Hospital Medicine: 2010 Report Based on 2009 Data. Englewood, CO:Society of Hospital Medicine and the Medical Group Management Association;2010.
  13. Schneider B, Goldstein HW, Smith DB. The ASA framework: an update. Personnel Psychol. 1995;48(4):747773.
  14. Hackman JR, Oldham GR. Work Redesign. Reading. MA:Addison‐Wesley;1980.
  15. Sehgal NL, Wachter RM. The expanding role of hospitalists in the United States. Swiss Med Wkly. 2006;136(37–38):591596.
  16. Ostroff C, Kozlowski SWJ. Organizational socialization as a learning‐process—the role of information acquisition. Personnel Psychol. 1992;45(4):849874.
  17. Ostroff C, Rothausen TJ. The moderating effect of tenure in person‐environment fit: a field study in educational organizations. J Occup Organ Psych. 1997;70:173188.
  18. Chatman JA. Matching people and organizations—selection and socialization in public accounting firms. Admin Sci Quart. 1991;36(3):459484.
  19. Meltzer D, Manning WG, Morrison J, et al. Effects of physician experience on costs and outcomes on an academic general medicine service: results of a trial of hospitalists. Ann Intern Med. 2002;137(11):866874.
  20. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):2836.
  21. Xie JL. Karasek's model in the People's Republic of China: effects of job demands, control, and individual differences. Acad Manage J. 1996;39(6):15941618.
  22. Konrad TR, Williams ES, Linzer M, et al. Measuring physician job satisfaction in a changing workplace and a challenging environment. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999;37(11):11741182.
  23. Linzer M, Manwell LB, Mundt M, et al. Organizational climate, stress, and error in primary care: The MEMO Study. Adv Patient Saf. 2005;1:6577.
  24. Meltzer DO, Arora V, Zhang JX, et al. Effects of inpatient experience on outcomes and costs in a multicenter trial of academic hospitalists. J Gen Intern Med. 2005;20(suppl 1):141142.
  25. Shanafelt TD, Bradley KA, Wipf JE, Back AL. Burnout and self‐reported patient care in an internal medicine residency program. Ann Intern Med. 2002;136(5):358367.
  26. Yang CL, Carayon P. Effect of job demands and social support on worker stress—a study of VDT users. Behav Inform Technol. 1995;14(1):3240.
  27. Rohland BM, Kruse GR, Rohrer JE. Validation of a single‐item measure of burnout against the Maslach Burnout Inventory among physicians. Stress Health. 2004;20(2):7579.
  28. Dormann C, Zapf D. Job satisfaction: a meta‐analysis of stabilities. J Organ Behav. 2001;22(5):483504.
  29. The American Association for Public Opinion Research. Standard definitions: final dispositions of case codes and outcome rates for surveys.7th ed. Available at: http://www.aapor.org/Standard_Definitions2.htm. Accessed May 2,2012.
  30. Cull WL, O'Connor KG, Sharp S, Tang SFS. Response rates and response bias for 50 surveys of pediatricians. Health Serv Res. 2005;40(1):213226.
  31. Fisher ES, Shortell SM. Accountable care organizations: accountable for what, to whom, and how. JAMA. 2010;304(15):17156.
References
  1. Kristof AL. Person‐organization fit: an integrative review of its conceptualizations, measurement, and implications. Personnel Psychol. 1996;49:149.
  2. Kristof‐Brown AL, Zimmerman RD, Johnson EC. Consequences of individuals' fit at work: a meta‐analysis of person‐job, person‐organization, person‐group, and person‐supervisor fit. Personnel Psychol. 2005;58(2):281342.
  3. Edwards JR.Person‐job fit: a conceptual integration, literature review and methodological critique. In: Cooper CL, Robertson IT, eds. International Review of Industrial and Organizational Psychology. Vol.6. New York, NY:John Wiley 1991.
  4. Vandenberghe C. Organizational culture, person‐culture fit, and turnover: a replication in the health care industry. J Organ Behav. 1999;20(2):175184.
  5. Zazzali JL, Alexander JA, Shortell SM, Burns LR. Organizational culture and physician satisfaction with dimensions of group practice. Health Serv Res. 2007;42(3 pt 1):11501176.
  6. Shanafelt TD, West CP, Sloan JA, et al. Career fit and burnout among academic faculty. Arch Intern Med. 2009;169(10):990995.
  7. Hinami K, Whelan CT, Miller JA, Wolosin RJ, Wetterneck TB. Job characteristics, satisfaction, and burnout across hospitalist practice models. J Hosp Med. 2012;7(5):402410.
  8. Huesch MD. Provider‐hospital “fit” and patient outcomes: evidence from Massachusetts cardiac surgeons, 2002–2004. Health Serv Res. 2011;46(1 pt 1):126.
  9. Okie S. The evolving primary care physician. N Engl J Med. 2012;366(20):18491853.
  10. Kocher R, Sahni NR. Hospitals' race to employ physicians—the logic behind a money‐losing proposition. N Engl J Med. 2011;364(19):17901793.
  11. 2011 Survey of Final‐Year Medical Residents. Irving, TX:Merritt Hawkins;2011.
  12. State of Hospital Medicine: 2010 Report Based on 2009 Data. Englewood, CO:Society of Hospital Medicine and the Medical Group Management Association;2010.
  13. Schneider B, Goldstein HW, Smith DB. The ASA framework: an update. Personnel Psychol. 1995;48(4):747773.
  14. Hackman JR, Oldham GR. Work Redesign. Reading. MA:Addison‐Wesley;1980.
  15. Sehgal NL, Wachter RM. The expanding role of hospitalists in the United States. Swiss Med Wkly. 2006;136(37–38):591596.
  16. Ostroff C, Kozlowski SWJ. Organizational socialization as a learning‐process—the role of information acquisition. Personnel Psychol. 1992;45(4):849874.
  17. Ostroff C, Rothausen TJ. The moderating effect of tenure in person‐environment fit: a field study in educational organizations. J Occup Organ Psych. 1997;70:173188.
  18. Chatman JA. Matching people and organizations—selection and socialization in public accounting firms. Admin Sci Quart. 1991;36(3):459484.
  19. Meltzer D, Manning WG, Morrison J, et al. Effects of physician experience on costs and outcomes on an academic general medicine service: results of a trial of hospitalists. Ann Intern Med. 2002;137(11):866874.
  20. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):2836.
  21. Xie JL. Karasek's model in the People's Republic of China: effects of job demands, control, and individual differences. Acad Manage J. 1996;39(6):15941618.
  22. Konrad TR, Williams ES, Linzer M, et al. Measuring physician job satisfaction in a changing workplace and a challenging environment. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999;37(11):11741182.
  23. Linzer M, Manwell LB, Mundt M, et al. Organizational climate, stress, and error in primary care: The MEMO Study. Adv Patient Saf. 2005;1:6577.
  24. Meltzer DO, Arora V, Zhang JX, et al. Effects of inpatient experience on outcomes and costs in a multicenter trial of academic hospitalists. J Gen Intern Med. 2005;20(suppl 1):141142.
  25. Shanafelt TD, Bradley KA, Wipf JE, Back AL. Burnout and self‐reported patient care in an internal medicine residency program. Ann Intern Med. 2002;136(5):358367.
  26. Yang CL, Carayon P. Effect of job demands and social support on worker stress—a study of VDT users. Behav Inform Technol. 1995;14(1):3240.
  27. Rohland BM, Kruse GR, Rohrer JE. Validation of a single‐item measure of burnout against the Maslach Burnout Inventory among physicians. Stress Health. 2004;20(2):7579.
  28. Dormann C, Zapf D. Job satisfaction: a meta‐analysis of stabilities. J Organ Behav. 2001;22(5):483504.
  29. The American Association for Public Opinion Research. Standard definitions: final dispositions of case codes and outcome rates for surveys.7th ed. Available at: http://www.aapor.org/Standard_Definitions2.htm. Accessed May 2,2012.
  30. Cull WL, O'Connor KG, Sharp S, Tang SFS. Response rates and response bias for 50 surveys of pediatricians. Health Serv Res. 2005;40(1):213226.
  31. Fisher ES, Shortell SM. Accountable care organizations: accountable for what, to whom, and how. JAMA. 2010;304(15):17156.
Issue
Journal of Hospital Medicine - 8(2)
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Journal of Hospital Medicine - 8(2)
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96-101
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96-101
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Person‐job fit: An exploratory cross‐sectional analysis of hospitalists
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Person‐job fit: An exploratory cross‐sectional analysis of hospitalists
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Address for correspondence and reprint requests: Keiki Hinami, MD, MS, Northwestern University Feinberg School of Medicine, 211 E. Ontario St, 7‐727, Chicago IL 60611; Telephone: 312‐926‐0050; Fax: 312‐926‐4588; E-mail: [email protected]
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