Mortality Risk and Patient Experience

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The risk‐outcome‐experience triad: Mortality risk and the hospital consumer assessment of healthcare providers and systems survey

Few today deny the importance of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.[1, 2] The Centers for Medicare and Medicaid Services' (CMS) Value Based Purchasing incentive, sympathy for the ill, and relationships between the patient experience and quality of care provide sufficient justification.[3, 4] How to improve the experience scores is not well understood. The national scores have improved only modestly over the past 3 years.[5, 6]

Clinicians may not typically compartmentalize what they do to improve outcomes versus the patient experience. A possible source for new improvement strategies is to understand the types of patients in which both adverse outcomes and suboptimal experiences are likely to occur, then redesign the multidisciplinary care processes to address both concurrently.[7] Previous studies support the existence of a relationship between a higher mortality risk on admission and subsequent worse outcomes, as well as a relationship between worse outcomes and lower HCAHPS scores.[8, 9, 10, 11, 12, 13] We hypothesized the mortality risk on admission, patient experience, and outcomes might share a triad relationship (Figure 1). In this article we explore the third edge of this triangle, the association between the mortality risk on admission and the subsequent patient experience.

Figure 1
Conceptual relationships between patients' severity of illness, experience of care (Hospital Consumer Assessment of Healthcare Providers and Systems Survey), and clinical outcomes. The absence of directional arrows between apices signifies associations without implying causality. We propose the admission severity of illness triggers stratum‐based interventions designed to improve both the clinical outcomes and the experience of care.

METHODS

We studied HCAHPS from 5 midwestern US hospitals having 113, 136, 304, 443, and 537 licensed beds, affiliated with the same multistate healthcare system. HCAHPS telephone surveys were administered via a vendor to a random sample of inpatients 18 years of age or older discharged from January 1, 2012 through June 30, 2014. Per CMS guidelines, surveyed patients must have been discharged alive after a hospital stay of at least 1 night.[14] Patients ineligible to be surveyed included those discharged to skilled nursing facilities or hospice care.[14] Because not all study hospitals provided obstetrical services, we restricted the analyses to medical and surgical respondents. With the permission of the local institutional review board, subjects' survey responses were linked confidentially to their clinical data.

We focused on the 8 dimensions of the care experience used in the CMS Value Based Purchasing program: communication with doctors, communication with nurses, responsiveness of hospital staff, pain management, communication about medicines, discharge information, hospital environment, and an overall rating of the hospital.[2] Following the scoring convention for publicly reported results, we dichotomized the 4‐level Likert scales into the most favorable response possible (always) versus all other responses.[15] Similarly we dichotomized the hospital rating scale at 9 and above for the most favorable response.

Our unit of analysis was an individual hospitalization. Our primary outcome of interest was whether or not the respondent provided the most favorable response for all questions answered within a given domain. For example, for the physician communication domain, the patient must have answered always to each of the 3 questions answered within the domain. This approach is appropriate for learning which patient‐level factors influence the survey responses, but differs from that used for the publically reported domain scores for which the relative performance of hospitals is the focus.[16] For the latter, the hospital was the unit of analysis, and the domain score was basically the average of the percentages of top box scores for the questions within a domain. For example, if 90% respondents from a hospital provided a top box response for courtesy, 80% for listening, and 70% for explanation, the hospital's physician communication score would be (90 + 80 + 70)/3 = 80%.[17]

Our primary explanatory variable was a binary high versus low mortality‐risk status of the respondent on admission based on age, gender, prior hospitalizations, clinical laboratory values, and diagnoses present on admission.[12] The calculated mortality risk was then dichotomized prior to the analysis at a probability of dying equal to 0.07 or higher. This corresponded roughly to the top quintile of predicted risk found in prior studies.[12, 13] During the study period, only 2 of the hospitals had the capability of generating mortality scores in real time, so for this study the mortality risk was calculated retrospectively, using information deemed present on admission.[12]

To estimate the sample size, we assumed that the high‐risk strata contained approximately 13% of respondents, and that the true percent of top box responses from patients in the lower‐risk stratum was approximately 80% for each domain. A meaningful difference in the proportion of most favorable responses was considered as an odds ratio (OR) of 0.75 for high risk versus low risk. A significance level of P < 0.003 was set to control study‐wide type I error due to multiple comparisons. We determined that for each dimension, approximately 8583 survey responses would be required for low‐risk patients and approximately 1116 responses for high‐risk patients to achieve 80% power under these assumptions. We were able to accrue the target number of surveys for all but 3 domains (pain management, communication about medicines, and hospital environment) because of data availability, and because patients are allowed to skip questions that do not apply. Univariate relationships were examined with 2, t test, and Fisher exact tests where indicated. Generalized linear mixed regression models with a logit link were fit to determine the association between patient mortality risk and the top box experience for each of the HCAHPS domains and for the overall rating. The patient's hospital was considered a random intercept to account for the patient‐hospital hierarchy and the unmeasured hospital‐specific practices. The multivariable models controlled for gender plus the HCAHPS patient‐mix adjustment variables of age, education, self‐rated health, language spoken at home, service line, and the number of days elapsed between the date of discharge and date of the survey.[18, 19, 20, 21] In keeping with the industry analyses, a second order interaction variable was included between surgery patients and age.[19] We considered the potential collinearity between the mortality risk status, age, and patient self‐reported health. We found the variance inflation factors were small, so we drew inference from the full multivariable model.

We also performed a post hoc sensitivity analysis to determine if our conclusions were biased due to missing patient responses for the risk‐adjustment variables. Accordingly, we imputed the response level most negatively associated with most HCAHPS domains as previously reported and reran the multivariable models.[19] We did not find a meaningful change in our conclusions (see Supporting Figure 1 in the online version of this article).

RESULTS

The hospitals discharged 152,333 patients during the study period, 39,905 of whom (26.2 %) had a predicted 30‐day mortality risk greater or equal to 0.07 (Table 1). Of the 36,280 high‐risk patients discharged alive, 5901 (16.3%) died in the ensuing 30 days, and 7951 (22%) were readmitted.

Characteristics and HCAHPS Results
Characteristic Low‐Risk Stratum, No./Discharged (%) or Mean (SD) High‐Risk Stratum, No./Discharged (%) or Mean (SD) P Value*
  • NOTE: Abbreviations: HCAHPS, Hospital Consumer Assessment of Healthcare Providers and Systems Survey; SD, standard deviation. *A 2 test evaluated categorical variables, whereas a t test evaluated continuous variables. Variables evaluated as continuous. Most favorable response. Sixty‐eight records have missing gender information.

Total discharges (row percent) 112,428/152,333 (74) 39,905/152,333 (26) <0.001
Total alive discharges (row percent) 111,600/147,880 (75) 36,280/147,880 (25) <0.001
No. of respondents (row percent) 14,996/17,509 (86) 2,513/17,509 (14)
HCAHPS surveys completed 14,996/111,600 (13) 2,513/36,280 (7) < 0.001
Readmissions within 30 days (total discharges) 12,311/112,428 (11) 7,951/39,905 (20) <0.001
Readmissions within 30 days (alive discharges) 12,311/111,600 (11) 7,951/36,280 (22) <0.001
Readmissions within 30 days (respondents) 1,220/14,996 (8) 424/2,513 (17) <0.001
Mean predicted probability of 30‐day mortality (total discharges) 0.022 (0.018) 0.200 (0.151) <0.001
Mean predicted probability of 30‐day mortality (alive discharges) 0.022 (0.018) 0.187 (0.136) <0.001
Mean predicted probability of 30‐day mortality (respondents) 0.020 (0.017) 0.151 (0.098) <0.001
In‐hospital death (total discharges) 828/112,428 (0.74) 3,625/39,905 (9) <0.001
Mortality within 30 days (total discharges) 2,455/112,428 (2) 9,526/39,905 (24) <0.001
Mortality within 30 days (alive discharges) 1,627/111,600 (1.5) 5,901/36,280 (16) <0.001
Mortality within 30 days (respondents) 9/14,996 (0.06) 16/2,513 (0.64) <0.001
Female (total discharges) 62,681/112,368 (56) 21,058/39,897 (53) <0.001
Female (alive discharges) 62,216/111,540 (56) 19,164/36,272 (53) <0.001
Female (respondents) 8,684/14,996 (58) 1,318/2,513 (52) <0.001
Age (total discharges) 61.3 (16.8) 78.3 (12.5) <0.001
Age (alive discharges) 61.2 (16.8) 78.4 (12.5) <0.001
Age (respondents) 63.1 (15.2) 76.6 (11.5) <0.001
Highest education attained
8th grade or less 297/14,996 (2) 98/2,513 (4)
Some high school 1,190/14,996 (8) 267/2,513 (11)
High school grad 4,648/14,996 (31) 930/2,513 (37) <0.001
Some college 6,338/14,996 (42) 768/2,513 (31)
4‐year college grad 1,502/14,996 (10) 183/2,513 (7)
Missing response 1,021/14,996 (7) 267/2,513 (11)
Language spoken at home
English 13,763/14,996 (92) 2,208/2,513 (88)
Spanish 56/14,996 (0.37) 8/2,513 (0.32) 0.47
Chinese 153/14,996 (1) 31/2,513 (1)
Missing response 1,024/14,996 (7) 266/2,513 (11)
Self‐rated health
Excellent 1,399/14,996 (9) 114/2,513 (5)
Very good 3,916/14,996 (26) 405/2,513 (16)
Good 4,861/14,996 (32) 713/2,513 (28)
Fair 2,900/14,996 (19) 652/2,513 (26) <0.001
Poor 1,065/14,996 (7) 396/2,513 (16)
Missing response 855/14,996 (6) 233/2,513 (9)
Length of hospitalization, d (respondents) 3.5 (2.8) 4.6 (3.6) <0.001
Consulting specialties (respondents) 1.7 (1.0) 2.2 (1.3) <0.001
Service line
Surgical 6,380/14,996 (43) 346/2,513 (14) <0.001
Medical 8,616/14,996 (57) 2,167/2,513 (86)
HCAHPS
Domain 1: Communication With Doctors 9,564/14,731 (65) 1,339/2,462 (54) <0.001
Domain 2: Communication With Nurses 10,097/14,991 (67) 1,531/2,511 (61) <0.001
Domain 3: Responsiveness of Hospital Staff 7,813/12,964 (60) 1,158/2,277 (51) <0.001
Domain 4: Pain Management 6,565/10,424 (63) 786/1,328 (59) 00.007
Domain 5: Communication About Medicines 3,769/8,088 (47) 456/1,143 (40) <0.001
Domain 6: Discharge Information 11,331/14,033 (81) 1,767/2,230 (79) 0.09
Domain 7: Hospital Environment 6,981/14,687 (48) 1,093/2,451 (45) 0.007
Overall rating 10,708/14,996 (71) 1,695/2,513 (67) <0.001

The high‐risk subset was under‐represented in those who completed the HCAHPS survey with 7% (2513/36,280) completing surveys compared to 13% of low‐risk patients (14,996/111,600) (P < 0.0001). Moreover, compared to high‐risk patients who were alive at discharge but did not complete surveys, high‐risk survey respondents were less likely to die within 30 days (16/2513 = 0.64% vs 5885/33,767 = 17.4%, P < 0.0001), and less likely to be readmitted (424/2513 = 16.9% vs 7527/33,767 = 22.3%, P < 0.0001).

On average, high‐risk respondents (compared to low risk) were slightly less likely to be female (52.4% vs 57.9%), less educated (30.6% with some college vs 42.3%), less likely to have been on a surgical service (13.8% vs 42.5%), and less likely to report good or better health (49.0% vs 68.0%, all P < 0.0001). High‐risk respondents were also older (76.6 vs 63.1 years), stayed in the hospital longer (4.6 vs 3.5 days), and received care from more specialties (2.2 vs 1.7 specialties) (all P < 0.0001). High‐risk respondents experienced more 30‐day readmissions (16.9% vs 8.1%) and deaths within 30 days (0.6 % vs 0.1 %, all P < 0.0001) than their low‐risk counterparts.

High‐risk respondents were less likely to provide the most favorable response (unadjusted) for all HCAHPS domains compared to low‐risk respondents, although the difference was not significant for discharge information (Table 1, Figure 2A). The gradient between high‐risk and low‐risk patients was seen for all domains within each hospital except for pain management, hospital environment, and overall rating (Figure 3).

Figure 2
Odds ratios for a high‐risk patient reporting a top box experience (relative to a low‐risk patient) as a single explanatory variable (A) and when controlling for hospital and Hospital Consumer Assessment of Healthcare Providers and Systems Survey risk‐adjustment factors (B).
Figure 3
Unadjusted differences in the percentage of top box responses between low‐risk patients (green column) and high‐risk (red column) for each study hospital for domains 1 to 4 (A) and domains 5 to 7 and overall (B). Each green‐red dyad represents the responses within a study hospital. The general pattern is lower scores for high‐risk (red) patients across domains per hospital.

The multivariable regression models examined whether the mortality risk on admission simply represented older medical patients and/or those who considered themselves unhealthy (Figure 2B) (see Supporting Table 1 in the online version of this article). Accounting for hospital, age, gender, language, self‐reported health, educational level, service line, and days elapsed from discharge, respondents in the high‐mortality‐risk stratum were still less likely to report an always experience for doctor communication (OR: 0.85; 95% confidence interval [CI]: 0.77‐0.94) and responsiveness of hospital staff (OR: 0.77; 95% CI: 0.69‐0.85). Higher‐risk patients also tended to have less favorable experiences with nursing communication, although the CI crossed 1 (OR: 0.91; 95% CI: 0.82‐1.01). In contrast, higher‐risk patients were more likely to provide top box responses for having received discharge information (OR: 1.30; 95% CI: 1.14‐1.48). We did not find independent associations between mortality risk and the other domains when the patient risk‐adjustment factors were considered.[18, 19, 20, 21]

DISCUSSION

The high‐mortality‐risk stratum on admission contained a subset of patients who provided less favorable responses for almost all incentivized HCAHPS domains when other risk‐adjustment variables were not taken into consideration (Figure 2A). These univariate relationships weakened when we controlled for gender, the standard HCAHPS risk‐adjustment variables, and individual hospital influences (Figure 2B).[18, 19, 20, 21] After multivariable adjustment, survey respondents in the high‐risk category remained less likely to report their physicians always communicated well and to experience hospital staff responding quickly, but were more likely to report receiving discharge information. We did not find an independent association between the underlying mortality risk and the other incentivized HCAHPS domains after risk adjustment.

We are cautious with initial interpretations of our findings in light of the relatively small number of hospitals studied and the substantial survey response bias of healthier patients. Undoubtedly, the CMS exclusions of patients discharged to hospice or skilled nursing facilities provide a partial explanation for the selection bias, but the experience of those at high risk who did not complete surveys remains conjecture at this point.[14] Previous evidence suggests sicker patients and those with worse experiences are less likely to respond to the HCAHPS survey.[18, 22] On the other hand, it is possible that high‐risk nonrespondents who died could have received better communication and staff responsiveness.[23, 24] We were unable to find a previous, patient‐level study that explicitly tested the association between the admission mortality risk and the subsequent patient experience, yet our findings are consistent with a previous single‐site study of a surgical population showing lower overall ratings from patients with higher Injury Severity Scores.[25]

Our findings provide evidence of complex relationships among admission mortality risk, the 3 domains of the patient experience, and adverse outcomes, at least within the study hospitals (Figure 1). The developing field of palliative care has found very ill patients have special communication needs regarding goals of care, as well as physical symptoms, anxiety, and depression that might prompt more calls for help.[26] If these needs were more important for high‐risk compared to low‐risk patients, and were either not recognized or adequately addressed by the clinical teams at the study hospitals, then the high‐risk patients may have been less likely to perceive their physicians listened and explained things well, or that staff responded promptly to their requests for help.[27] On the other hand, the higher ratings for discharge information suggest the needs of the high‐risk patients were relatively easier to address by current practices at these hospitals. The lack of association between the mortality risk and the other HCAHPS domains may reflect the relatively stronger influence of age, gender, educational level, provider variability, and other unmeasured influences within the study sites, or that the level of patient need was similar among high‐risk and low‐risk patients within these domains.[27]

There are several possible confounders of our observed relationship between mortality risk and HCAHPS scores. The first category of confounders represents patient level variables that might impact the communication scores, some of which are part of the formula of our mortality prediction rule, for example, cognitive impairment and emergent admission.[18, 22, 27] The effect of the mortality risk could also be confounded by unmeasured patient‐level factors such as lower socioeconomic status.[28] A second category of confounders pertains to clinical outcomes and processes of care associated with serious illness irrespective of the risk of dying. More physicians involved in the care of the seriously ill (Table 1) may impact the communication scores, due to the larger opportunity for conflicting or confusing information presented to patients and their families.[29] The longer hospital stays, readmissions, and adverse events of the seriously ill may also underlie the apparent association between mortality risk and HCAHPS scores.[8, 9, 10]

Even if we do not understand precisely if and how the mortality risk might be associated with suboptimal physician communication and staff responsiveness, there may still be some value in considering how these possible relationships could be leveraged to improve patient care. We recall Berwick's insight that every system is perfectly designed to achieve the results it achieves.[7] We have previously argued for the use of mortality‐risk strata to initiate concurrent, multidisciplinary care processes to reduce adverse outcomes.[12, 13] Others have used risk‐based approaches for anticipating clinical deterioration of surgical patients, and determining the intensity of individualized case management services.[30, 31] In this framework, all patients receive a standard set of care processes, but higher‐risk patients receive additional efforts to promote better outcomes. An efficient extension of this approach is to assume patients at risk for adverse outcomes also have additional needs for communication, coordination of specialty care, and timely response to the call button. The admission mortality risk could be used as a determinant for the level of nurse staffing to reduce deaths plus shorten response time to the call button.[32, 33] Hospitalists and specialists could work together on a standard way to conference among themselves for high‐risk patients above that needed for less‐complex cases. Patients in the high‐risk strata could be screened early to see if they might benefit from the involvement of the palliative care team.[26]

Our study has limitations in addition to those already noted. First, our use of the top box as the formulation of the outcome of interest could be challenged. We chose this to be relevant to the Value‐Based Purchasing environment, but other formulations or use of other survey instruments may be needed to tease out the complex relationships we hypothesize. Next, we do not know the extent to which the patients and care processes reflected in our study represent other settings. The literature indicates some hospitals are more effective in providing care for certain subgroups of patients than for others, and that there is substantial regional variation in care intensity that is in turn associated with the patient experience.[29, 34] The mortality‐risk experience relationship for nonstudy hospitals could be weaker or stronger than what we found. Third, many hospitals may not have the capability to generate mortality scores on admission, although more hospitals may be able to do so in the future.[35] Explicit risk strata have the benefit of providing members of the multidisciplinary team with a quick preview of the clinical needs and prognoses of patients in much the way that the term baroque alerts the audience to the genre of music. Still, clinicians in any hospital could attempt to improve outcomes and experience through the use of informal risk assessment during interdisciplinary care rounds or by simply asking the team if they would be surprised if this patient died in the next year.[30, 36] Finally, we do not know if awareness of an experience risk will identify remediable practices that actually improve the experience. Clearly, future studies are needed to answer all of these concerns.

We have provided evidence that a group of patients who were at elevated risk for dying at the time of admission were more likely to have issues with physician communication and staff responsiveness than their lower‐risk counterparts. While we await future studies to confirm these findings, clinical teams can consider whether or not their patients' HCAHPS scores reflect how their system of care addresses the needs of these vulnerable people.

Acknowledgements

The authors thank Steven Lewis for assistance in the interpretation of the HCAHPS scores, Bonita Singal, MD, PhD, for initial statistical consultation, and Frank Smith, MD, for reviewing an earlier version of the manuscript. The authors acknowledge the input of the peer reviewers.

Disclosures: Dr. Cowen and Mr. Kabara had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: all authors. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: Dr. Cowen and Mr. Kabara. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Dr. Cowen and Mr. Kabara. Administrative, technical or material support: Ms. Czerwinski. Study supervision: Dr. Cowen and Ms. Czerwinski. Funding/support: internal. Conflicts of interest disclosures: no potential conflicts reported.

Disclosures

Dr. Cowen and Mr. Kabara had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: all authors. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: Dr. Cowen and Mr. Kabara. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Dr. Cowen and Mr. Kabara. Administrative, technical or material support: Ms. Czerwinski. Study supervision: Dr. Cowen and Ms. Czerwinski. Funding/support: internal. Conflicts of interest disclosures: no potential conflicts reported.

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References
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Few today deny the importance of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.[1, 2] The Centers for Medicare and Medicaid Services' (CMS) Value Based Purchasing incentive, sympathy for the ill, and relationships between the patient experience and quality of care provide sufficient justification.[3, 4] How to improve the experience scores is not well understood. The national scores have improved only modestly over the past 3 years.[5, 6]

Clinicians may not typically compartmentalize what they do to improve outcomes versus the patient experience. A possible source for new improvement strategies is to understand the types of patients in which both adverse outcomes and suboptimal experiences are likely to occur, then redesign the multidisciplinary care processes to address both concurrently.[7] Previous studies support the existence of a relationship between a higher mortality risk on admission and subsequent worse outcomes, as well as a relationship between worse outcomes and lower HCAHPS scores.[8, 9, 10, 11, 12, 13] We hypothesized the mortality risk on admission, patient experience, and outcomes might share a triad relationship (Figure 1). In this article we explore the third edge of this triangle, the association between the mortality risk on admission and the subsequent patient experience.

Figure 1
Conceptual relationships between patients' severity of illness, experience of care (Hospital Consumer Assessment of Healthcare Providers and Systems Survey), and clinical outcomes. The absence of directional arrows between apices signifies associations without implying causality. We propose the admission severity of illness triggers stratum‐based interventions designed to improve both the clinical outcomes and the experience of care.

METHODS

We studied HCAHPS from 5 midwestern US hospitals having 113, 136, 304, 443, and 537 licensed beds, affiliated with the same multistate healthcare system. HCAHPS telephone surveys were administered via a vendor to a random sample of inpatients 18 years of age or older discharged from January 1, 2012 through June 30, 2014. Per CMS guidelines, surveyed patients must have been discharged alive after a hospital stay of at least 1 night.[14] Patients ineligible to be surveyed included those discharged to skilled nursing facilities or hospice care.[14] Because not all study hospitals provided obstetrical services, we restricted the analyses to medical and surgical respondents. With the permission of the local institutional review board, subjects' survey responses were linked confidentially to their clinical data.

We focused on the 8 dimensions of the care experience used in the CMS Value Based Purchasing program: communication with doctors, communication with nurses, responsiveness of hospital staff, pain management, communication about medicines, discharge information, hospital environment, and an overall rating of the hospital.[2] Following the scoring convention for publicly reported results, we dichotomized the 4‐level Likert scales into the most favorable response possible (always) versus all other responses.[15] Similarly we dichotomized the hospital rating scale at 9 and above for the most favorable response.

Our unit of analysis was an individual hospitalization. Our primary outcome of interest was whether or not the respondent provided the most favorable response for all questions answered within a given domain. For example, for the physician communication domain, the patient must have answered always to each of the 3 questions answered within the domain. This approach is appropriate for learning which patient‐level factors influence the survey responses, but differs from that used for the publically reported domain scores for which the relative performance of hospitals is the focus.[16] For the latter, the hospital was the unit of analysis, and the domain score was basically the average of the percentages of top box scores for the questions within a domain. For example, if 90% respondents from a hospital provided a top box response for courtesy, 80% for listening, and 70% for explanation, the hospital's physician communication score would be (90 + 80 + 70)/3 = 80%.[17]

Our primary explanatory variable was a binary high versus low mortality‐risk status of the respondent on admission based on age, gender, prior hospitalizations, clinical laboratory values, and diagnoses present on admission.[12] The calculated mortality risk was then dichotomized prior to the analysis at a probability of dying equal to 0.07 or higher. This corresponded roughly to the top quintile of predicted risk found in prior studies.[12, 13] During the study period, only 2 of the hospitals had the capability of generating mortality scores in real time, so for this study the mortality risk was calculated retrospectively, using information deemed present on admission.[12]

To estimate the sample size, we assumed that the high‐risk strata contained approximately 13% of respondents, and that the true percent of top box responses from patients in the lower‐risk stratum was approximately 80% for each domain. A meaningful difference in the proportion of most favorable responses was considered as an odds ratio (OR) of 0.75 for high risk versus low risk. A significance level of P < 0.003 was set to control study‐wide type I error due to multiple comparisons. We determined that for each dimension, approximately 8583 survey responses would be required for low‐risk patients and approximately 1116 responses for high‐risk patients to achieve 80% power under these assumptions. We were able to accrue the target number of surveys for all but 3 domains (pain management, communication about medicines, and hospital environment) because of data availability, and because patients are allowed to skip questions that do not apply. Univariate relationships were examined with 2, t test, and Fisher exact tests where indicated. Generalized linear mixed regression models with a logit link were fit to determine the association between patient mortality risk and the top box experience for each of the HCAHPS domains and for the overall rating. The patient's hospital was considered a random intercept to account for the patient‐hospital hierarchy and the unmeasured hospital‐specific practices. The multivariable models controlled for gender plus the HCAHPS patient‐mix adjustment variables of age, education, self‐rated health, language spoken at home, service line, and the number of days elapsed between the date of discharge and date of the survey.[18, 19, 20, 21] In keeping with the industry analyses, a second order interaction variable was included between surgery patients and age.[19] We considered the potential collinearity between the mortality risk status, age, and patient self‐reported health. We found the variance inflation factors were small, so we drew inference from the full multivariable model.

We also performed a post hoc sensitivity analysis to determine if our conclusions were biased due to missing patient responses for the risk‐adjustment variables. Accordingly, we imputed the response level most negatively associated with most HCAHPS domains as previously reported and reran the multivariable models.[19] We did not find a meaningful change in our conclusions (see Supporting Figure 1 in the online version of this article).

RESULTS

The hospitals discharged 152,333 patients during the study period, 39,905 of whom (26.2 %) had a predicted 30‐day mortality risk greater or equal to 0.07 (Table 1). Of the 36,280 high‐risk patients discharged alive, 5901 (16.3%) died in the ensuing 30 days, and 7951 (22%) were readmitted.

Characteristics and HCAHPS Results
Characteristic Low‐Risk Stratum, No./Discharged (%) or Mean (SD) High‐Risk Stratum, No./Discharged (%) or Mean (SD) P Value*
  • NOTE: Abbreviations: HCAHPS, Hospital Consumer Assessment of Healthcare Providers and Systems Survey; SD, standard deviation. *A 2 test evaluated categorical variables, whereas a t test evaluated continuous variables. Variables evaluated as continuous. Most favorable response. Sixty‐eight records have missing gender information.

Total discharges (row percent) 112,428/152,333 (74) 39,905/152,333 (26) <0.001
Total alive discharges (row percent) 111,600/147,880 (75) 36,280/147,880 (25) <0.001
No. of respondents (row percent) 14,996/17,509 (86) 2,513/17,509 (14)
HCAHPS surveys completed 14,996/111,600 (13) 2,513/36,280 (7) < 0.001
Readmissions within 30 days (total discharges) 12,311/112,428 (11) 7,951/39,905 (20) <0.001
Readmissions within 30 days (alive discharges) 12,311/111,600 (11) 7,951/36,280 (22) <0.001
Readmissions within 30 days (respondents) 1,220/14,996 (8) 424/2,513 (17) <0.001
Mean predicted probability of 30‐day mortality (total discharges) 0.022 (0.018) 0.200 (0.151) <0.001
Mean predicted probability of 30‐day mortality (alive discharges) 0.022 (0.018) 0.187 (0.136) <0.001
Mean predicted probability of 30‐day mortality (respondents) 0.020 (0.017) 0.151 (0.098) <0.001
In‐hospital death (total discharges) 828/112,428 (0.74) 3,625/39,905 (9) <0.001
Mortality within 30 days (total discharges) 2,455/112,428 (2) 9,526/39,905 (24) <0.001
Mortality within 30 days (alive discharges) 1,627/111,600 (1.5) 5,901/36,280 (16) <0.001
Mortality within 30 days (respondents) 9/14,996 (0.06) 16/2,513 (0.64) <0.001
Female (total discharges) 62,681/112,368 (56) 21,058/39,897 (53) <0.001
Female (alive discharges) 62,216/111,540 (56) 19,164/36,272 (53) <0.001
Female (respondents) 8,684/14,996 (58) 1,318/2,513 (52) <0.001
Age (total discharges) 61.3 (16.8) 78.3 (12.5) <0.001
Age (alive discharges) 61.2 (16.8) 78.4 (12.5) <0.001
Age (respondents) 63.1 (15.2) 76.6 (11.5) <0.001
Highest education attained
8th grade or less 297/14,996 (2) 98/2,513 (4)
Some high school 1,190/14,996 (8) 267/2,513 (11)
High school grad 4,648/14,996 (31) 930/2,513 (37) <0.001
Some college 6,338/14,996 (42) 768/2,513 (31)
4‐year college grad 1,502/14,996 (10) 183/2,513 (7)
Missing response 1,021/14,996 (7) 267/2,513 (11)
Language spoken at home
English 13,763/14,996 (92) 2,208/2,513 (88)
Spanish 56/14,996 (0.37) 8/2,513 (0.32) 0.47
Chinese 153/14,996 (1) 31/2,513 (1)
Missing response 1,024/14,996 (7) 266/2,513 (11)
Self‐rated health
Excellent 1,399/14,996 (9) 114/2,513 (5)
Very good 3,916/14,996 (26) 405/2,513 (16)
Good 4,861/14,996 (32) 713/2,513 (28)
Fair 2,900/14,996 (19) 652/2,513 (26) <0.001
Poor 1,065/14,996 (7) 396/2,513 (16)
Missing response 855/14,996 (6) 233/2,513 (9)
Length of hospitalization, d (respondents) 3.5 (2.8) 4.6 (3.6) <0.001
Consulting specialties (respondents) 1.7 (1.0) 2.2 (1.3) <0.001
Service line
Surgical 6,380/14,996 (43) 346/2,513 (14) <0.001
Medical 8,616/14,996 (57) 2,167/2,513 (86)
HCAHPS
Domain 1: Communication With Doctors 9,564/14,731 (65) 1,339/2,462 (54) <0.001
Domain 2: Communication With Nurses 10,097/14,991 (67) 1,531/2,511 (61) <0.001
Domain 3: Responsiveness of Hospital Staff 7,813/12,964 (60) 1,158/2,277 (51) <0.001
Domain 4: Pain Management 6,565/10,424 (63) 786/1,328 (59) 00.007
Domain 5: Communication About Medicines 3,769/8,088 (47) 456/1,143 (40) <0.001
Domain 6: Discharge Information 11,331/14,033 (81) 1,767/2,230 (79) 0.09
Domain 7: Hospital Environment 6,981/14,687 (48) 1,093/2,451 (45) 0.007
Overall rating 10,708/14,996 (71) 1,695/2,513 (67) <0.001

The high‐risk subset was under‐represented in those who completed the HCAHPS survey with 7% (2513/36,280) completing surveys compared to 13% of low‐risk patients (14,996/111,600) (P < 0.0001). Moreover, compared to high‐risk patients who were alive at discharge but did not complete surveys, high‐risk survey respondents were less likely to die within 30 days (16/2513 = 0.64% vs 5885/33,767 = 17.4%, P < 0.0001), and less likely to be readmitted (424/2513 = 16.9% vs 7527/33,767 = 22.3%, P < 0.0001).

On average, high‐risk respondents (compared to low risk) were slightly less likely to be female (52.4% vs 57.9%), less educated (30.6% with some college vs 42.3%), less likely to have been on a surgical service (13.8% vs 42.5%), and less likely to report good or better health (49.0% vs 68.0%, all P < 0.0001). High‐risk respondents were also older (76.6 vs 63.1 years), stayed in the hospital longer (4.6 vs 3.5 days), and received care from more specialties (2.2 vs 1.7 specialties) (all P < 0.0001). High‐risk respondents experienced more 30‐day readmissions (16.9% vs 8.1%) and deaths within 30 days (0.6 % vs 0.1 %, all P < 0.0001) than their low‐risk counterparts.

High‐risk respondents were less likely to provide the most favorable response (unadjusted) for all HCAHPS domains compared to low‐risk respondents, although the difference was not significant for discharge information (Table 1, Figure 2A). The gradient between high‐risk and low‐risk patients was seen for all domains within each hospital except for pain management, hospital environment, and overall rating (Figure 3).

Figure 2
Odds ratios for a high‐risk patient reporting a top box experience (relative to a low‐risk patient) as a single explanatory variable (A) and when controlling for hospital and Hospital Consumer Assessment of Healthcare Providers and Systems Survey risk‐adjustment factors (B).
Figure 3
Unadjusted differences in the percentage of top box responses between low‐risk patients (green column) and high‐risk (red column) for each study hospital for domains 1 to 4 (A) and domains 5 to 7 and overall (B). Each green‐red dyad represents the responses within a study hospital. The general pattern is lower scores for high‐risk (red) patients across domains per hospital.

The multivariable regression models examined whether the mortality risk on admission simply represented older medical patients and/or those who considered themselves unhealthy (Figure 2B) (see Supporting Table 1 in the online version of this article). Accounting for hospital, age, gender, language, self‐reported health, educational level, service line, and days elapsed from discharge, respondents in the high‐mortality‐risk stratum were still less likely to report an always experience for doctor communication (OR: 0.85; 95% confidence interval [CI]: 0.77‐0.94) and responsiveness of hospital staff (OR: 0.77; 95% CI: 0.69‐0.85). Higher‐risk patients also tended to have less favorable experiences with nursing communication, although the CI crossed 1 (OR: 0.91; 95% CI: 0.82‐1.01). In contrast, higher‐risk patients were more likely to provide top box responses for having received discharge information (OR: 1.30; 95% CI: 1.14‐1.48). We did not find independent associations between mortality risk and the other domains when the patient risk‐adjustment factors were considered.[18, 19, 20, 21]

DISCUSSION

The high‐mortality‐risk stratum on admission contained a subset of patients who provided less favorable responses for almost all incentivized HCAHPS domains when other risk‐adjustment variables were not taken into consideration (Figure 2A). These univariate relationships weakened when we controlled for gender, the standard HCAHPS risk‐adjustment variables, and individual hospital influences (Figure 2B).[18, 19, 20, 21] After multivariable adjustment, survey respondents in the high‐risk category remained less likely to report their physicians always communicated well and to experience hospital staff responding quickly, but were more likely to report receiving discharge information. We did not find an independent association between the underlying mortality risk and the other incentivized HCAHPS domains after risk adjustment.

We are cautious with initial interpretations of our findings in light of the relatively small number of hospitals studied and the substantial survey response bias of healthier patients. Undoubtedly, the CMS exclusions of patients discharged to hospice or skilled nursing facilities provide a partial explanation for the selection bias, but the experience of those at high risk who did not complete surveys remains conjecture at this point.[14] Previous evidence suggests sicker patients and those with worse experiences are less likely to respond to the HCAHPS survey.[18, 22] On the other hand, it is possible that high‐risk nonrespondents who died could have received better communication and staff responsiveness.[23, 24] We were unable to find a previous, patient‐level study that explicitly tested the association between the admission mortality risk and the subsequent patient experience, yet our findings are consistent with a previous single‐site study of a surgical population showing lower overall ratings from patients with higher Injury Severity Scores.[25]

Our findings provide evidence of complex relationships among admission mortality risk, the 3 domains of the patient experience, and adverse outcomes, at least within the study hospitals (Figure 1). The developing field of palliative care has found very ill patients have special communication needs regarding goals of care, as well as physical symptoms, anxiety, and depression that might prompt more calls for help.[26] If these needs were more important for high‐risk compared to low‐risk patients, and were either not recognized or adequately addressed by the clinical teams at the study hospitals, then the high‐risk patients may have been less likely to perceive their physicians listened and explained things well, or that staff responded promptly to their requests for help.[27] On the other hand, the higher ratings for discharge information suggest the needs of the high‐risk patients were relatively easier to address by current practices at these hospitals. The lack of association between the mortality risk and the other HCAHPS domains may reflect the relatively stronger influence of age, gender, educational level, provider variability, and other unmeasured influences within the study sites, or that the level of patient need was similar among high‐risk and low‐risk patients within these domains.[27]

There are several possible confounders of our observed relationship between mortality risk and HCAHPS scores. The first category of confounders represents patient level variables that might impact the communication scores, some of which are part of the formula of our mortality prediction rule, for example, cognitive impairment and emergent admission.[18, 22, 27] The effect of the mortality risk could also be confounded by unmeasured patient‐level factors such as lower socioeconomic status.[28] A second category of confounders pertains to clinical outcomes and processes of care associated with serious illness irrespective of the risk of dying. More physicians involved in the care of the seriously ill (Table 1) may impact the communication scores, due to the larger opportunity for conflicting or confusing information presented to patients and their families.[29] The longer hospital stays, readmissions, and adverse events of the seriously ill may also underlie the apparent association between mortality risk and HCAHPS scores.[8, 9, 10]

Even if we do not understand precisely if and how the mortality risk might be associated with suboptimal physician communication and staff responsiveness, there may still be some value in considering how these possible relationships could be leveraged to improve patient care. We recall Berwick's insight that every system is perfectly designed to achieve the results it achieves.[7] We have previously argued for the use of mortality‐risk strata to initiate concurrent, multidisciplinary care processes to reduce adverse outcomes.[12, 13] Others have used risk‐based approaches for anticipating clinical deterioration of surgical patients, and determining the intensity of individualized case management services.[30, 31] In this framework, all patients receive a standard set of care processes, but higher‐risk patients receive additional efforts to promote better outcomes. An efficient extension of this approach is to assume patients at risk for adverse outcomes also have additional needs for communication, coordination of specialty care, and timely response to the call button. The admission mortality risk could be used as a determinant for the level of nurse staffing to reduce deaths plus shorten response time to the call button.[32, 33] Hospitalists and specialists could work together on a standard way to conference among themselves for high‐risk patients above that needed for less‐complex cases. Patients in the high‐risk strata could be screened early to see if they might benefit from the involvement of the palliative care team.[26]

Our study has limitations in addition to those already noted. First, our use of the top box as the formulation of the outcome of interest could be challenged. We chose this to be relevant to the Value‐Based Purchasing environment, but other formulations or use of other survey instruments may be needed to tease out the complex relationships we hypothesize. Next, we do not know the extent to which the patients and care processes reflected in our study represent other settings. The literature indicates some hospitals are more effective in providing care for certain subgroups of patients than for others, and that there is substantial regional variation in care intensity that is in turn associated with the patient experience.[29, 34] The mortality‐risk experience relationship for nonstudy hospitals could be weaker or stronger than what we found. Third, many hospitals may not have the capability to generate mortality scores on admission, although more hospitals may be able to do so in the future.[35] Explicit risk strata have the benefit of providing members of the multidisciplinary team with a quick preview of the clinical needs and prognoses of patients in much the way that the term baroque alerts the audience to the genre of music. Still, clinicians in any hospital could attempt to improve outcomes and experience through the use of informal risk assessment during interdisciplinary care rounds or by simply asking the team if they would be surprised if this patient died in the next year.[30, 36] Finally, we do not know if awareness of an experience risk will identify remediable practices that actually improve the experience. Clearly, future studies are needed to answer all of these concerns.

We have provided evidence that a group of patients who were at elevated risk for dying at the time of admission were more likely to have issues with physician communication and staff responsiveness than their lower‐risk counterparts. While we await future studies to confirm these findings, clinical teams can consider whether or not their patients' HCAHPS scores reflect how their system of care addresses the needs of these vulnerable people.

Acknowledgements

The authors thank Steven Lewis for assistance in the interpretation of the HCAHPS scores, Bonita Singal, MD, PhD, for initial statistical consultation, and Frank Smith, MD, for reviewing an earlier version of the manuscript. The authors acknowledge the input of the peer reviewers.

Disclosures: Dr. Cowen and Mr. Kabara had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: all authors. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: Dr. Cowen and Mr. Kabara. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Dr. Cowen and Mr. Kabara. Administrative, technical or material support: Ms. Czerwinski. Study supervision: Dr. Cowen and Ms. Czerwinski. Funding/support: internal. Conflicts of interest disclosures: no potential conflicts reported.

Disclosures

Dr. Cowen and Mr. Kabara had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: all authors. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: Dr. Cowen and Mr. Kabara. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Dr. Cowen and Mr. Kabara. Administrative, technical or material support: Ms. Czerwinski. Study supervision: Dr. Cowen and Ms. Czerwinski. Funding/support: internal. Conflicts of interest disclosures: no potential conflicts reported.

Few today deny the importance of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.[1, 2] The Centers for Medicare and Medicaid Services' (CMS) Value Based Purchasing incentive, sympathy for the ill, and relationships between the patient experience and quality of care provide sufficient justification.[3, 4] How to improve the experience scores is not well understood. The national scores have improved only modestly over the past 3 years.[5, 6]

Clinicians may not typically compartmentalize what they do to improve outcomes versus the patient experience. A possible source for new improvement strategies is to understand the types of patients in which both adverse outcomes and suboptimal experiences are likely to occur, then redesign the multidisciplinary care processes to address both concurrently.[7] Previous studies support the existence of a relationship between a higher mortality risk on admission and subsequent worse outcomes, as well as a relationship between worse outcomes and lower HCAHPS scores.[8, 9, 10, 11, 12, 13] We hypothesized the mortality risk on admission, patient experience, and outcomes might share a triad relationship (Figure 1). In this article we explore the third edge of this triangle, the association between the mortality risk on admission and the subsequent patient experience.

Figure 1
Conceptual relationships between patients' severity of illness, experience of care (Hospital Consumer Assessment of Healthcare Providers and Systems Survey), and clinical outcomes. The absence of directional arrows between apices signifies associations without implying causality. We propose the admission severity of illness triggers stratum‐based interventions designed to improve both the clinical outcomes and the experience of care.

METHODS

We studied HCAHPS from 5 midwestern US hospitals having 113, 136, 304, 443, and 537 licensed beds, affiliated with the same multistate healthcare system. HCAHPS telephone surveys were administered via a vendor to a random sample of inpatients 18 years of age or older discharged from January 1, 2012 through June 30, 2014. Per CMS guidelines, surveyed patients must have been discharged alive after a hospital stay of at least 1 night.[14] Patients ineligible to be surveyed included those discharged to skilled nursing facilities or hospice care.[14] Because not all study hospitals provided obstetrical services, we restricted the analyses to medical and surgical respondents. With the permission of the local institutional review board, subjects' survey responses were linked confidentially to their clinical data.

We focused on the 8 dimensions of the care experience used in the CMS Value Based Purchasing program: communication with doctors, communication with nurses, responsiveness of hospital staff, pain management, communication about medicines, discharge information, hospital environment, and an overall rating of the hospital.[2] Following the scoring convention for publicly reported results, we dichotomized the 4‐level Likert scales into the most favorable response possible (always) versus all other responses.[15] Similarly we dichotomized the hospital rating scale at 9 and above for the most favorable response.

Our unit of analysis was an individual hospitalization. Our primary outcome of interest was whether or not the respondent provided the most favorable response for all questions answered within a given domain. For example, for the physician communication domain, the patient must have answered always to each of the 3 questions answered within the domain. This approach is appropriate for learning which patient‐level factors influence the survey responses, but differs from that used for the publically reported domain scores for which the relative performance of hospitals is the focus.[16] For the latter, the hospital was the unit of analysis, and the domain score was basically the average of the percentages of top box scores for the questions within a domain. For example, if 90% respondents from a hospital provided a top box response for courtesy, 80% for listening, and 70% for explanation, the hospital's physician communication score would be (90 + 80 + 70)/3 = 80%.[17]

Our primary explanatory variable was a binary high versus low mortality‐risk status of the respondent on admission based on age, gender, prior hospitalizations, clinical laboratory values, and diagnoses present on admission.[12] The calculated mortality risk was then dichotomized prior to the analysis at a probability of dying equal to 0.07 or higher. This corresponded roughly to the top quintile of predicted risk found in prior studies.[12, 13] During the study period, only 2 of the hospitals had the capability of generating mortality scores in real time, so for this study the mortality risk was calculated retrospectively, using information deemed present on admission.[12]

To estimate the sample size, we assumed that the high‐risk strata contained approximately 13% of respondents, and that the true percent of top box responses from patients in the lower‐risk stratum was approximately 80% for each domain. A meaningful difference in the proportion of most favorable responses was considered as an odds ratio (OR) of 0.75 for high risk versus low risk. A significance level of P < 0.003 was set to control study‐wide type I error due to multiple comparisons. We determined that for each dimension, approximately 8583 survey responses would be required for low‐risk patients and approximately 1116 responses for high‐risk patients to achieve 80% power under these assumptions. We were able to accrue the target number of surveys for all but 3 domains (pain management, communication about medicines, and hospital environment) because of data availability, and because patients are allowed to skip questions that do not apply. Univariate relationships were examined with 2, t test, and Fisher exact tests where indicated. Generalized linear mixed regression models with a logit link were fit to determine the association between patient mortality risk and the top box experience for each of the HCAHPS domains and for the overall rating. The patient's hospital was considered a random intercept to account for the patient‐hospital hierarchy and the unmeasured hospital‐specific practices. The multivariable models controlled for gender plus the HCAHPS patient‐mix adjustment variables of age, education, self‐rated health, language spoken at home, service line, and the number of days elapsed between the date of discharge and date of the survey.[18, 19, 20, 21] In keeping with the industry analyses, a second order interaction variable was included between surgery patients and age.[19] We considered the potential collinearity between the mortality risk status, age, and patient self‐reported health. We found the variance inflation factors were small, so we drew inference from the full multivariable model.

We also performed a post hoc sensitivity analysis to determine if our conclusions were biased due to missing patient responses for the risk‐adjustment variables. Accordingly, we imputed the response level most negatively associated with most HCAHPS domains as previously reported and reran the multivariable models.[19] We did not find a meaningful change in our conclusions (see Supporting Figure 1 in the online version of this article).

RESULTS

The hospitals discharged 152,333 patients during the study period, 39,905 of whom (26.2 %) had a predicted 30‐day mortality risk greater or equal to 0.07 (Table 1). Of the 36,280 high‐risk patients discharged alive, 5901 (16.3%) died in the ensuing 30 days, and 7951 (22%) were readmitted.

Characteristics and HCAHPS Results
Characteristic Low‐Risk Stratum, No./Discharged (%) or Mean (SD) High‐Risk Stratum, No./Discharged (%) or Mean (SD) P Value*
  • NOTE: Abbreviations: HCAHPS, Hospital Consumer Assessment of Healthcare Providers and Systems Survey; SD, standard deviation. *A 2 test evaluated categorical variables, whereas a t test evaluated continuous variables. Variables evaluated as continuous. Most favorable response. Sixty‐eight records have missing gender information.

Total discharges (row percent) 112,428/152,333 (74) 39,905/152,333 (26) <0.001
Total alive discharges (row percent) 111,600/147,880 (75) 36,280/147,880 (25) <0.001
No. of respondents (row percent) 14,996/17,509 (86) 2,513/17,509 (14)
HCAHPS surveys completed 14,996/111,600 (13) 2,513/36,280 (7) < 0.001
Readmissions within 30 days (total discharges) 12,311/112,428 (11) 7,951/39,905 (20) <0.001
Readmissions within 30 days (alive discharges) 12,311/111,600 (11) 7,951/36,280 (22) <0.001
Readmissions within 30 days (respondents) 1,220/14,996 (8) 424/2,513 (17) <0.001
Mean predicted probability of 30‐day mortality (total discharges) 0.022 (0.018) 0.200 (0.151) <0.001
Mean predicted probability of 30‐day mortality (alive discharges) 0.022 (0.018) 0.187 (0.136) <0.001
Mean predicted probability of 30‐day mortality (respondents) 0.020 (0.017) 0.151 (0.098) <0.001
In‐hospital death (total discharges) 828/112,428 (0.74) 3,625/39,905 (9) <0.001
Mortality within 30 days (total discharges) 2,455/112,428 (2) 9,526/39,905 (24) <0.001
Mortality within 30 days (alive discharges) 1,627/111,600 (1.5) 5,901/36,280 (16) <0.001
Mortality within 30 days (respondents) 9/14,996 (0.06) 16/2,513 (0.64) <0.001
Female (total discharges) 62,681/112,368 (56) 21,058/39,897 (53) <0.001
Female (alive discharges) 62,216/111,540 (56) 19,164/36,272 (53) <0.001
Female (respondents) 8,684/14,996 (58) 1,318/2,513 (52) <0.001
Age (total discharges) 61.3 (16.8) 78.3 (12.5) <0.001
Age (alive discharges) 61.2 (16.8) 78.4 (12.5) <0.001
Age (respondents) 63.1 (15.2) 76.6 (11.5) <0.001
Highest education attained
8th grade or less 297/14,996 (2) 98/2,513 (4)
Some high school 1,190/14,996 (8) 267/2,513 (11)
High school grad 4,648/14,996 (31) 930/2,513 (37) <0.001
Some college 6,338/14,996 (42) 768/2,513 (31)
4‐year college grad 1,502/14,996 (10) 183/2,513 (7)
Missing response 1,021/14,996 (7) 267/2,513 (11)
Language spoken at home
English 13,763/14,996 (92) 2,208/2,513 (88)
Spanish 56/14,996 (0.37) 8/2,513 (0.32) 0.47
Chinese 153/14,996 (1) 31/2,513 (1)
Missing response 1,024/14,996 (7) 266/2,513 (11)
Self‐rated health
Excellent 1,399/14,996 (9) 114/2,513 (5)
Very good 3,916/14,996 (26) 405/2,513 (16)
Good 4,861/14,996 (32) 713/2,513 (28)
Fair 2,900/14,996 (19) 652/2,513 (26) <0.001
Poor 1,065/14,996 (7) 396/2,513 (16)
Missing response 855/14,996 (6) 233/2,513 (9)
Length of hospitalization, d (respondents) 3.5 (2.8) 4.6 (3.6) <0.001
Consulting specialties (respondents) 1.7 (1.0) 2.2 (1.3) <0.001
Service line
Surgical 6,380/14,996 (43) 346/2,513 (14) <0.001
Medical 8,616/14,996 (57) 2,167/2,513 (86)
HCAHPS
Domain 1: Communication With Doctors 9,564/14,731 (65) 1,339/2,462 (54) <0.001
Domain 2: Communication With Nurses 10,097/14,991 (67) 1,531/2,511 (61) <0.001
Domain 3: Responsiveness of Hospital Staff 7,813/12,964 (60) 1,158/2,277 (51) <0.001
Domain 4: Pain Management 6,565/10,424 (63) 786/1,328 (59) 00.007
Domain 5: Communication About Medicines 3,769/8,088 (47) 456/1,143 (40) <0.001
Domain 6: Discharge Information 11,331/14,033 (81) 1,767/2,230 (79) 0.09
Domain 7: Hospital Environment 6,981/14,687 (48) 1,093/2,451 (45) 0.007
Overall rating 10,708/14,996 (71) 1,695/2,513 (67) <0.001

The high‐risk subset was under‐represented in those who completed the HCAHPS survey with 7% (2513/36,280) completing surveys compared to 13% of low‐risk patients (14,996/111,600) (P < 0.0001). Moreover, compared to high‐risk patients who were alive at discharge but did not complete surveys, high‐risk survey respondents were less likely to die within 30 days (16/2513 = 0.64% vs 5885/33,767 = 17.4%, P < 0.0001), and less likely to be readmitted (424/2513 = 16.9% vs 7527/33,767 = 22.3%, P < 0.0001).

On average, high‐risk respondents (compared to low risk) were slightly less likely to be female (52.4% vs 57.9%), less educated (30.6% with some college vs 42.3%), less likely to have been on a surgical service (13.8% vs 42.5%), and less likely to report good or better health (49.0% vs 68.0%, all P < 0.0001). High‐risk respondents were also older (76.6 vs 63.1 years), stayed in the hospital longer (4.6 vs 3.5 days), and received care from more specialties (2.2 vs 1.7 specialties) (all P < 0.0001). High‐risk respondents experienced more 30‐day readmissions (16.9% vs 8.1%) and deaths within 30 days (0.6 % vs 0.1 %, all P < 0.0001) than their low‐risk counterparts.

High‐risk respondents were less likely to provide the most favorable response (unadjusted) for all HCAHPS domains compared to low‐risk respondents, although the difference was not significant for discharge information (Table 1, Figure 2A). The gradient between high‐risk and low‐risk patients was seen for all domains within each hospital except for pain management, hospital environment, and overall rating (Figure 3).

Figure 2
Odds ratios for a high‐risk patient reporting a top box experience (relative to a low‐risk patient) as a single explanatory variable (A) and when controlling for hospital and Hospital Consumer Assessment of Healthcare Providers and Systems Survey risk‐adjustment factors (B).
Figure 3
Unadjusted differences in the percentage of top box responses between low‐risk patients (green column) and high‐risk (red column) for each study hospital for domains 1 to 4 (A) and domains 5 to 7 and overall (B). Each green‐red dyad represents the responses within a study hospital. The general pattern is lower scores for high‐risk (red) patients across domains per hospital.

The multivariable regression models examined whether the mortality risk on admission simply represented older medical patients and/or those who considered themselves unhealthy (Figure 2B) (see Supporting Table 1 in the online version of this article). Accounting for hospital, age, gender, language, self‐reported health, educational level, service line, and days elapsed from discharge, respondents in the high‐mortality‐risk stratum were still less likely to report an always experience for doctor communication (OR: 0.85; 95% confidence interval [CI]: 0.77‐0.94) and responsiveness of hospital staff (OR: 0.77; 95% CI: 0.69‐0.85). Higher‐risk patients also tended to have less favorable experiences with nursing communication, although the CI crossed 1 (OR: 0.91; 95% CI: 0.82‐1.01). In contrast, higher‐risk patients were more likely to provide top box responses for having received discharge information (OR: 1.30; 95% CI: 1.14‐1.48). We did not find independent associations between mortality risk and the other domains when the patient risk‐adjustment factors were considered.[18, 19, 20, 21]

DISCUSSION

The high‐mortality‐risk stratum on admission contained a subset of patients who provided less favorable responses for almost all incentivized HCAHPS domains when other risk‐adjustment variables were not taken into consideration (Figure 2A). These univariate relationships weakened when we controlled for gender, the standard HCAHPS risk‐adjustment variables, and individual hospital influences (Figure 2B).[18, 19, 20, 21] After multivariable adjustment, survey respondents in the high‐risk category remained less likely to report their physicians always communicated well and to experience hospital staff responding quickly, but were more likely to report receiving discharge information. We did not find an independent association between the underlying mortality risk and the other incentivized HCAHPS domains after risk adjustment.

We are cautious with initial interpretations of our findings in light of the relatively small number of hospitals studied and the substantial survey response bias of healthier patients. Undoubtedly, the CMS exclusions of patients discharged to hospice or skilled nursing facilities provide a partial explanation for the selection bias, but the experience of those at high risk who did not complete surveys remains conjecture at this point.[14] Previous evidence suggests sicker patients and those with worse experiences are less likely to respond to the HCAHPS survey.[18, 22] On the other hand, it is possible that high‐risk nonrespondents who died could have received better communication and staff responsiveness.[23, 24] We were unable to find a previous, patient‐level study that explicitly tested the association between the admission mortality risk and the subsequent patient experience, yet our findings are consistent with a previous single‐site study of a surgical population showing lower overall ratings from patients with higher Injury Severity Scores.[25]

Our findings provide evidence of complex relationships among admission mortality risk, the 3 domains of the patient experience, and adverse outcomes, at least within the study hospitals (Figure 1). The developing field of palliative care has found very ill patients have special communication needs regarding goals of care, as well as physical symptoms, anxiety, and depression that might prompt more calls for help.[26] If these needs were more important for high‐risk compared to low‐risk patients, and were either not recognized or adequately addressed by the clinical teams at the study hospitals, then the high‐risk patients may have been less likely to perceive their physicians listened and explained things well, or that staff responded promptly to their requests for help.[27] On the other hand, the higher ratings for discharge information suggest the needs of the high‐risk patients were relatively easier to address by current practices at these hospitals. The lack of association between the mortality risk and the other HCAHPS domains may reflect the relatively stronger influence of age, gender, educational level, provider variability, and other unmeasured influences within the study sites, or that the level of patient need was similar among high‐risk and low‐risk patients within these domains.[27]

There are several possible confounders of our observed relationship between mortality risk and HCAHPS scores. The first category of confounders represents patient level variables that might impact the communication scores, some of which are part of the formula of our mortality prediction rule, for example, cognitive impairment and emergent admission.[18, 22, 27] The effect of the mortality risk could also be confounded by unmeasured patient‐level factors such as lower socioeconomic status.[28] A second category of confounders pertains to clinical outcomes and processes of care associated with serious illness irrespective of the risk of dying. More physicians involved in the care of the seriously ill (Table 1) may impact the communication scores, due to the larger opportunity for conflicting or confusing information presented to patients and their families.[29] The longer hospital stays, readmissions, and adverse events of the seriously ill may also underlie the apparent association between mortality risk and HCAHPS scores.[8, 9, 10]

Even if we do not understand precisely if and how the mortality risk might be associated with suboptimal physician communication and staff responsiveness, there may still be some value in considering how these possible relationships could be leveraged to improve patient care. We recall Berwick's insight that every system is perfectly designed to achieve the results it achieves.[7] We have previously argued for the use of mortality‐risk strata to initiate concurrent, multidisciplinary care processes to reduce adverse outcomes.[12, 13] Others have used risk‐based approaches for anticipating clinical deterioration of surgical patients, and determining the intensity of individualized case management services.[30, 31] In this framework, all patients receive a standard set of care processes, but higher‐risk patients receive additional efforts to promote better outcomes. An efficient extension of this approach is to assume patients at risk for adverse outcomes also have additional needs for communication, coordination of specialty care, and timely response to the call button. The admission mortality risk could be used as a determinant for the level of nurse staffing to reduce deaths plus shorten response time to the call button.[32, 33] Hospitalists and specialists could work together on a standard way to conference among themselves for high‐risk patients above that needed for less‐complex cases. Patients in the high‐risk strata could be screened early to see if they might benefit from the involvement of the palliative care team.[26]

Our study has limitations in addition to those already noted. First, our use of the top box as the formulation of the outcome of interest could be challenged. We chose this to be relevant to the Value‐Based Purchasing environment, but other formulations or use of other survey instruments may be needed to tease out the complex relationships we hypothesize. Next, we do not know the extent to which the patients and care processes reflected in our study represent other settings. The literature indicates some hospitals are more effective in providing care for certain subgroups of patients than for others, and that there is substantial regional variation in care intensity that is in turn associated with the patient experience.[29, 34] The mortality‐risk experience relationship for nonstudy hospitals could be weaker or stronger than what we found. Third, many hospitals may not have the capability to generate mortality scores on admission, although more hospitals may be able to do so in the future.[35] Explicit risk strata have the benefit of providing members of the multidisciplinary team with a quick preview of the clinical needs and prognoses of patients in much the way that the term baroque alerts the audience to the genre of music. Still, clinicians in any hospital could attempt to improve outcomes and experience through the use of informal risk assessment during interdisciplinary care rounds or by simply asking the team if they would be surprised if this patient died in the next year.[30, 36] Finally, we do not know if awareness of an experience risk will identify remediable practices that actually improve the experience. Clearly, future studies are needed to answer all of these concerns.

We have provided evidence that a group of patients who were at elevated risk for dying at the time of admission were more likely to have issues with physician communication and staff responsiveness than their lower‐risk counterparts. While we await future studies to confirm these findings, clinical teams can consider whether or not their patients' HCAHPS scores reflect how their system of care addresses the needs of these vulnerable people.

Acknowledgements

The authors thank Steven Lewis for assistance in the interpretation of the HCAHPS scores, Bonita Singal, MD, PhD, for initial statistical consultation, and Frank Smith, MD, for reviewing an earlier version of the manuscript. The authors acknowledge the input of the peer reviewers.

Disclosures: Dr. Cowen and Mr. Kabara had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: all authors. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: Dr. Cowen and Mr. Kabara. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Dr. Cowen and Mr. Kabara. Administrative, technical or material support: Ms. Czerwinski. Study supervision: Dr. Cowen and Ms. Czerwinski. Funding/support: internal. Conflicts of interest disclosures: no potential conflicts reported.

Disclosures

Dr. Cowen and Mr. Kabara had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: all authors. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: Dr. Cowen and Mr. Kabara. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Dr. Cowen and Mr. Kabara. Administrative, technical or material support: Ms. Czerwinski. Study supervision: Dr. Cowen and Ms. Czerwinski. Funding/support: internal. Conflicts of interest disclosures: no potential conflicts reported.

References
  1. Goldstein E, Farquhar M, Crofton C, Darby C, Garfinkel S. Measuring hospital care from the patients' perspective: an overview of the CAHPS hospital survey development process. Health Serv Res. 2005;40 (6 part 2):19771995.
  2. Centers for Medicare 79(163):4985450449.
  3. Isaac T, Zaslavsky AM, Cleary PD, Landon BE. The relationship between patients' perception of care and measures of hospital quality and safety. Health Serv Res. 2010;45(4):10241040.
  4. Centers for Medicare 312(7031):619622.
  5. Boulding W, Glickman SW, Manary MP, Schulman KA, Staelin R. Relationship between patient satisfaction with inpatient care and hospital readmission within 30 days. Am J Manag Care. 2011;17(1):4148.
  6. Iannuzzi JC, Kahn SA, Zhang L, Gestring ML, Noyes K, Monson JRT. Getting satisfaction: drivers of surgical Hospital Consumer Assessment of Health care Providers and Systems survey scores. J Surg Res. 2015;197(1):155161.
  7. Tsai TC, Orav EJ, Jha AK. Patient satisfaction and quality of surgical care in US hospitals. Ann Surg. 2015;261(1):28.
  8. Kennedy GD, Tevis SE, Kent KC. Is there a relationship between patient satisfaction and favorable outcomes? Ann Surg. 2014;260(4):592598; discussion 598–600.
  9. Cowen ME, Strawderman RL, Czerwinski JL, Smith MJ, Halasyamani LK. Mortality predictions on admission as a context for organizing care activities. J Hosp Med. 2013;8(5):229235.
  10. Cowen ME, Czerwinski JL, Posa PJ, et al. Implementation of a mortality prediction rule for real‐time decision making: feasibility and validity. J Hosp Med. 2014;9(11):720726.
  11. Centers for Medicare 40(6 pt 2):20782095.
  12. Centers for Medicare 44(2 pt 1):501518.
  13. Patient‐mix coefficients for October 2015 (1Q14 through 4Q14 discharges) publicly reported HCAHPS Results. Available at: http://www.hcahpsonline.org/Files/October_2015_PMA_Web_Document_a.pdf. Published July 2, 2015. Accessed August 4, 2015.
  14. O'Malley AJ, Zaslavsky AM, Elliott MN, Zaborski L, Cleary PD. Case‐mix adjustment of the CAHPS hospital survey. Health Serv Res. 2005;40(6):21622181.
  15. Elliott MN, Lehrman WG, Beckett MK, et.al. Gender differences in patients' perceptions of inpatient care. Health Serv Res. 2012;47(4):14821501.
  16. Elliott MN, Edwards C, Angeles J, et al. Patterns of unit and item nonresponse in the CAHPS hospital survey. Health Serv Res. 2005;40(6 pt 2):20962119.
  17. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172(5):405411.
  18. Elliott MN, Haviland AM, Cleary PD, et al. Care experiences of managed care Medicare enrollees near the end of life. J Am Geriatr Soc. 2013;61(3):407412.
  19. Kahn SA, Iannuzzi JC, Stassen NA, Bankey PE, Gestring M. Measuring satisfaction: factors that drive hospital consumer assessment of healthcare providers and systems survey responses in a trauma and acute care surgery population. Am Surg. 2015;81(5):537543.
  20. Kelley AS, Morrison RS. Palliative care for the seriously ill. N Engl J Med. 2015;373(8):747755.
  21. Elliott MN, Kanouse DE, Edwards CA, et.al. Components of care vary in importance for overall patient‐reported experience by type of hospitalization. Med Care. 2009;47(8):842849.
  22. Stringhini S, Berkman L, Dugravot A, et al. Socioeconomic status, structural and functional measures of social support, and mortality: the British Whitehall II cohort study, 1985–2009. Am J Epidemiol. 2012;175(12):12751283.
  23. Wennberg JE, Bronner K, Skinner JS, et al. Inpatient care intensity and patients' ratings of their hospital experiences. Health Aff (Millwood). 2009;28(1):103112.
  24. Ravikumar TS, Sharma C, Marini C, et al. A validated value‐based model to improve hospital‐wide perioperative outcomes. Ann Surg. 2010;252(3):486498.
  25. Amarasingham R, Patel PC, Toto K, et al. Allocating scare resources in real‐time to reduce heart failure readmissions: a prospective, controlled study. BMJ Qual Saf. 2013;22(12):9981005.
  26. Jha AK, Orav EJ, Zheng J, Epstein AM. Patients' perception of hospital care in the United States. N Engl J Med. 2008;359(18):19211931.
  27. Needleman J, Buerhaus P, Pankratz S, Leibson CL, Stevens SR, Harris M. Nurse staffing and inpatient hospital mortality. N Engl J Med. 2011;364(11):10371045.
  28. Elliott MN, Lehrman WG, Goldstein E, et al. Do hospitals rank differently on HCAHPS for different patient subgroups? Med Care Res Rev. 2010;67(1):5673.
  29. Escobar GJ, Greene JD, Scheirer P, Gardner MN, Draper D, Kipnis P. Risk‐adjusting hospital inpatient mortality using automated inpatient, outpatient, and laboratory databases. Med Care. 2008;46(3):232239.
  30. Moss AH, Ganjoo J, Sharma S, et al. Utility of the “surprise” question to identify dialysis patients with high mortality. Clin J Am Soc Nephrol. 2008;3(5):13791384.
References
  1. Goldstein E, Farquhar M, Crofton C, Darby C, Garfinkel S. Measuring hospital care from the patients' perspective: an overview of the CAHPS hospital survey development process. Health Serv Res. 2005;40 (6 part 2):19771995.
  2. Centers for Medicare 79(163):4985450449.
  3. Isaac T, Zaslavsky AM, Cleary PD, Landon BE. The relationship between patients' perception of care and measures of hospital quality and safety. Health Serv Res. 2010;45(4):10241040.
  4. Centers for Medicare 312(7031):619622.
  5. Boulding W, Glickman SW, Manary MP, Schulman KA, Staelin R. Relationship between patient satisfaction with inpatient care and hospital readmission within 30 days. Am J Manag Care. 2011;17(1):4148.
  6. Iannuzzi JC, Kahn SA, Zhang L, Gestring ML, Noyes K, Monson JRT. Getting satisfaction: drivers of surgical Hospital Consumer Assessment of Health care Providers and Systems survey scores. J Surg Res. 2015;197(1):155161.
  7. Tsai TC, Orav EJ, Jha AK. Patient satisfaction and quality of surgical care in US hospitals. Ann Surg. 2015;261(1):28.
  8. Kennedy GD, Tevis SE, Kent KC. Is there a relationship between patient satisfaction and favorable outcomes? Ann Surg. 2014;260(4):592598; discussion 598–600.
  9. Cowen ME, Strawderman RL, Czerwinski JL, Smith MJ, Halasyamani LK. Mortality predictions on admission as a context for organizing care activities. J Hosp Med. 2013;8(5):229235.
  10. Cowen ME, Czerwinski JL, Posa PJ, et al. Implementation of a mortality prediction rule for real‐time decision making: feasibility and validity. J Hosp Med. 2014;9(11):720726.
  11. Centers for Medicare 40(6 pt 2):20782095.
  12. Centers for Medicare 44(2 pt 1):501518.
  13. Patient‐mix coefficients for October 2015 (1Q14 through 4Q14 discharges) publicly reported HCAHPS Results. Available at: http://www.hcahpsonline.org/Files/October_2015_PMA_Web_Document_a.pdf. Published July 2, 2015. Accessed August 4, 2015.
  14. O'Malley AJ, Zaslavsky AM, Elliott MN, Zaborski L, Cleary PD. Case‐mix adjustment of the CAHPS hospital survey. Health Serv Res. 2005;40(6):21622181.
  15. Elliott MN, Lehrman WG, Beckett MK, et.al. Gender differences in patients' perceptions of inpatient care. Health Serv Res. 2012;47(4):14821501.
  16. Elliott MN, Edwards C, Angeles J, et al. Patterns of unit and item nonresponse in the CAHPS hospital survey. Health Serv Res. 2005;40(6 pt 2):20962119.
  17. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172(5):405411.
  18. Elliott MN, Haviland AM, Cleary PD, et al. Care experiences of managed care Medicare enrollees near the end of life. J Am Geriatr Soc. 2013;61(3):407412.
  19. Kahn SA, Iannuzzi JC, Stassen NA, Bankey PE, Gestring M. Measuring satisfaction: factors that drive hospital consumer assessment of healthcare providers and systems survey responses in a trauma and acute care surgery population. Am Surg. 2015;81(5):537543.
  20. Kelley AS, Morrison RS. Palliative care for the seriously ill. N Engl J Med. 2015;373(8):747755.
  21. Elliott MN, Kanouse DE, Edwards CA, et.al. Components of care vary in importance for overall patient‐reported experience by type of hospitalization. Med Care. 2009;47(8):842849.
  22. Stringhini S, Berkman L, Dugravot A, et al. Socioeconomic status, structural and functional measures of social support, and mortality: the British Whitehall II cohort study, 1985–2009. Am J Epidemiol. 2012;175(12):12751283.
  23. Wennberg JE, Bronner K, Skinner JS, et al. Inpatient care intensity and patients' ratings of their hospital experiences. Health Aff (Millwood). 2009;28(1):103112.
  24. Ravikumar TS, Sharma C, Marini C, et al. A validated value‐based model to improve hospital‐wide perioperative outcomes. Ann Surg. 2010;252(3):486498.
  25. Amarasingham R, Patel PC, Toto K, et al. Allocating scare resources in real‐time to reduce heart failure readmissions: a prospective, controlled study. BMJ Qual Saf. 2013;22(12):9981005.
  26. Jha AK, Orav EJ, Zheng J, Epstein AM. Patients' perception of hospital care in the United States. N Engl J Med. 2008;359(18):19211931.
  27. Needleman J, Buerhaus P, Pankratz S, Leibson CL, Stevens SR, Harris M. Nurse staffing and inpatient hospital mortality. N Engl J Med. 2011;364(11):10371045.
  28. Elliott MN, Lehrman WG, Goldstein E, et al. Do hospitals rank differently on HCAHPS for different patient subgroups? Med Care Res Rev. 2010;67(1):5673.
  29. Escobar GJ, Greene JD, Scheirer P, Gardner MN, Draper D, Kipnis P. Risk‐adjusting hospital inpatient mortality using automated inpatient, outpatient, and laboratory databases. Med Care. 2008;46(3):232239.
  30. Moss AH, Ganjoo J, Sharma S, et al. Utility of the “surprise” question to identify dialysis patients with high mortality. Clin J Am Soc Nephrol. 2008;3(5):13791384.
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Address for correspondence and reprint requests: Mark E. Cowen, MD, Quality Institute, St. Joseph Mercy Health System, Suite 400, 3075 Clark Road, Ypsilanti, MI 48197; Telephone: 734‐712‐8776; Fax: 734‐712‐8651; E‐mail: [email protected]
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It's a matter of respect

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It's a matter of respect

Serious illnesses challenge patients, their families, clinicians, and the health systems that care for them. In this issue of the Journal of Hospital Medicine, Cowen and coauthors shed light on the experience of inpatients on medical and surgical services with a high risk of mortality on admission, as measured by Hospital Consumer Assessment of Healthcare Providers and Systems Surveys (HCAHPS).[1] In their study population, even after adjustment for some confounders, these patients tended to rate responsiveness of hospital staff and communication by doctors lower than patients with a low risk of mortality on admission.

A more generalizable frame than admission risk of mortality is to consider the patients they identified as high risk to be patients with serious illness. Using this frame will be helpful in understanding the implications of their results, but it is important to acknowledge that for several reasons, the data in this study may not represent the entire population of seriously ill patients. First, there may be patients at lower risk of mortality who would qualify as having a serious illness. Second, the study's data were from only a few hospitals in 1 healthcare system. Third, 93% of patients at high risk of mortality on admission did not return surveys. Despite these significant limitations, there are still important insights to be gleaned from their work.

Before exploring what they found, it is also important to note that it can be challenging to know what to make of HCAHPS scores. For instance, patients with higher HCAHPS scores have been found to have higher costs of care and higher mortality.[2] Satisfied patients are not clearly better off. However, what if, for purposes of learning, the scores serve as a window into the seriously ill patient's experience, helping inform an understanding of the challenges and opportunities for improvement?

One of the key findings of this study was that seriously ill patients rated responsiveness by hospital staff worse than those who were not as ill. Patients were asked 2 questions as part of the composite measure: During this hospital stay, after you pressed the call button, how often did you get help as soon as you wanted it? How often did you get help in getting to the bathroom or in using a bedpan as soon as you wanted?

It is not difficult to imagine how seriously ill patients might have more intense care needs that would result in more requests for help, nor is it difficult to imagine how some proportion of those requests might not be handled in a timely fashion. Objective research shows higher rates of call button requests have been associated with slower response times, and it appears there is a complex relationship with staffing levels and the intensity of work on the floor.[3] Certainly there may be times that patients want a quick response after pressing a call button, but do not need one, and a lot of time could be spent discussing these quandaries. However, there are also times when a patient describes having called for help, really needing it, yet no one came. At least some of the time, responsiveness is a matter of respect, especially considering the vulnerability of seriously ill patients and the issue of dignity around toileting.

Another key finding was about communication by doctors, and the questions patients answered were: During this hospital stay, how often did doctors treat you with courtesy and respect? During this hospital stay, how often did doctors listen carefully to you? During this hospital stay, how often did doctors explain things in a way you could understand?

There is a growing and important body of literature about communication with seriously ill patients.[4] Consider some of the data about patients with advanced cancer. Evidence suggests the majority of such patients want to know their prognosis, and that when it is discussed it does not worsen the patient‐physician relationship, sadness, or anxiety.[5] Despite this, among physicians who have formulated a prognosis for patients with advanced cancer, even if they were asked directly by those patients about their prognosis, 23% of the time they would communicate no prognosis. Forty percent of the time they would communicate a different prognosis than what they had formulated, with 70% of those being optimistically discrepant.[6] Although data are more limited, there is evidence that hospitalists are similarly wary to acknowledge when patients are at risk of dying.[7]

Although certainly other aspects of communication by doctors with seriously ill patients contributed to this study's findings, this issue of acknowledging and discussing the serious illness itself is important to highlight. Healthcare professionals have an ethical obligation to respect patients' autonomy by helping them make informed decisions about their care. Having these conversations can be challenging, but training programs and conversation guides are showing promise.[8] If health professionals do not try to ensure that seriously ill patients understand their diagnosis, prognosis, and full range of treatment options in patient‐centered ways, then by definition patients cannot be making informed decisions. It is a matter of respect.

This study's most important contribution is how it focuses attention on the domains of responsiveness by hospital staff and communication by doctors, encouraging a deeper dive to consider what else is known about these topics. Allowing that the lower scores from seriously ill patients might reflect more than just poor satisfaction reveals that at least some proportion of the time, these patients are experiencing disrespect. The work then becomes clear: What are the ways in which health professionals should reliably be demonstrating respect toward patients, especially those who are seriously ill? It is there, in the process of developing a reliable practice of respect, that consensus about how to improve the patient experience is most likely to be found.

Disclosure

Nothing to report.

References
  1. Cowen ME, Czerwinski J, Kabara J, Blumenthal DU, Kheder S, Simmons S. The risk‐outcome‐experience triad: mortality risk and the Hospital Consumer Assessment of Healthcare Providers and Systems Survey. J Hosp Med. 2016;11(9):628635.
  2. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172(5):405411.
  3. Tzeng H‐M, Larson JL. Exploring the relationship between patient call‐light use rate and nurse call‐light response time in acute care settings. Comput Inform Nurs. 2011;29(3):138143.
  4. Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014;174(12):19942003.
  5. Enzinger AC, Zhang B, Schrag D, Prigerson HG. Outcomes of prognostic disclosure: associations with prognostic understanding, distress, and relationship with physician among patients with advanced cancer. J Clin Oncol. 2015;33(32):38093816.
  6. Lamont EB, Christakis NA. Prognostic disclosure to patients with cancer near the end of life. Ann Intern Med. 2001;134(12):10961105.
  7. Anderson WG, Kools S, Lyndon A. Dancing around death: hospitalist‐patient communication about serious illness. Qual Health Res. 2013;23(1):313.
  8. Bernacki R, Hutchings M, Vick J, et al. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015;5(10):e009032.
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Serious illnesses challenge patients, their families, clinicians, and the health systems that care for them. In this issue of the Journal of Hospital Medicine, Cowen and coauthors shed light on the experience of inpatients on medical and surgical services with a high risk of mortality on admission, as measured by Hospital Consumer Assessment of Healthcare Providers and Systems Surveys (HCAHPS).[1] In their study population, even after adjustment for some confounders, these patients tended to rate responsiveness of hospital staff and communication by doctors lower than patients with a low risk of mortality on admission.

A more generalizable frame than admission risk of mortality is to consider the patients they identified as high risk to be patients with serious illness. Using this frame will be helpful in understanding the implications of their results, but it is important to acknowledge that for several reasons, the data in this study may not represent the entire population of seriously ill patients. First, there may be patients at lower risk of mortality who would qualify as having a serious illness. Second, the study's data were from only a few hospitals in 1 healthcare system. Third, 93% of patients at high risk of mortality on admission did not return surveys. Despite these significant limitations, there are still important insights to be gleaned from their work.

Before exploring what they found, it is also important to note that it can be challenging to know what to make of HCAHPS scores. For instance, patients with higher HCAHPS scores have been found to have higher costs of care and higher mortality.[2] Satisfied patients are not clearly better off. However, what if, for purposes of learning, the scores serve as a window into the seriously ill patient's experience, helping inform an understanding of the challenges and opportunities for improvement?

One of the key findings of this study was that seriously ill patients rated responsiveness by hospital staff worse than those who were not as ill. Patients were asked 2 questions as part of the composite measure: During this hospital stay, after you pressed the call button, how often did you get help as soon as you wanted it? How often did you get help in getting to the bathroom or in using a bedpan as soon as you wanted?

It is not difficult to imagine how seriously ill patients might have more intense care needs that would result in more requests for help, nor is it difficult to imagine how some proportion of those requests might not be handled in a timely fashion. Objective research shows higher rates of call button requests have been associated with slower response times, and it appears there is a complex relationship with staffing levels and the intensity of work on the floor.[3] Certainly there may be times that patients want a quick response after pressing a call button, but do not need one, and a lot of time could be spent discussing these quandaries. However, there are also times when a patient describes having called for help, really needing it, yet no one came. At least some of the time, responsiveness is a matter of respect, especially considering the vulnerability of seriously ill patients and the issue of dignity around toileting.

Another key finding was about communication by doctors, and the questions patients answered were: During this hospital stay, how often did doctors treat you with courtesy and respect? During this hospital stay, how often did doctors listen carefully to you? During this hospital stay, how often did doctors explain things in a way you could understand?

There is a growing and important body of literature about communication with seriously ill patients.[4] Consider some of the data about patients with advanced cancer. Evidence suggests the majority of such patients want to know their prognosis, and that when it is discussed it does not worsen the patient‐physician relationship, sadness, or anxiety.[5] Despite this, among physicians who have formulated a prognosis for patients with advanced cancer, even if they were asked directly by those patients about their prognosis, 23% of the time they would communicate no prognosis. Forty percent of the time they would communicate a different prognosis than what they had formulated, with 70% of those being optimistically discrepant.[6] Although data are more limited, there is evidence that hospitalists are similarly wary to acknowledge when patients are at risk of dying.[7]

Although certainly other aspects of communication by doctors with seriously ill patients contributed to this study's findings, this issue of acknowledging and discussing the serious illness itself is important to highlight. Healthcare professionals have an ethical obligation to respect patients' autonomy by helping them make informed decisions about their care. Having these conversations can be challenging, but training programs and conversation guides are showing promise.[8] If health professionals do not try to ensure that seriously ill patients understand their diagnosis, prognosis, and full range of treatment options in patient‐centered ways, then by definition patients cannot be making informed decisions. It is a matter of respect.

This study's most important contribution is how it focuses attention on the domains of responsiveness by hospital staff and communication by doctors, encouraging a deeper dive to consider what else is known about these topics. Allowing that the lower scores from seriously ill patients might reflect more than just poor satisfaction reveals that at least some proportion of the time, these patients are experiencing disrespect. The work then becomes clear: What are the ways in which health professionals should reliably be demonstrating respect toward patients, especially those who are seriously ill? It is there, in the process of developing a reliable practice of respect, that consensus about how to improve the patient experience is most likely to be found.

Disclosure

Nothing to report.

Serious illnesses challenge patients, their families, clinicians, and the health systems that care for them. In this issue of the Journal of Hospital Medicine, Cowen and coauthors shed light on the experience of inpatients on medical and surgical services with a high risk of mortality on admission, as measured by Hospital Consumer Assessment of Healthcare Providers and Systems Surveys (HCAHPS).[1] In their study population, even after adjustment for some confounders, these patients tended to rate responsiveness of hospital staff and communication by doctors lower than patients with a low risk of mortality on admission.

A more generalizable frame than admission risk of mortality is to consider the patients they identified as high risk to be patients with serious illness. Using this frame will be helpful in understanding the implications of their results, but it is important to acknowledge that for several reasons, the data in this study may not represent the entire population of seriously ill patients. First, there may be patients at lower risk of mortality who would qualify as having a serious illness. Second, the study's data were from only a few hospitals in 1 healthcare system. Third, 93% of patients at high risk of mortality on admission did not return surveys. Despite these significant limitations, there are still important insights to be gleaned from their work.

Before exploring what they found, it is also important to note that it can be challenging to know what to make of HCAHPS scores. For instance, patients with higher HCAHPS scores have been found to have higher costs of care and higher mortality.[2] Satisfied patients are not clearly better off. However, what if, for purposes of learning, the scores serve as a window into the seriously ill patient's experience, helping inform an understanding of the challenges and opportunities for improvement?

One of the key findings of this study was that seriously ill patients rated responsiveness by hospital staff worse than those who were not as ill. Patients were asked 2 questions as part of the composite measure: During this hospital stay, after you pressed the call button, how often did you get help as soon as you wanted it? How often did you get help in getting to the bathroom or in using a bedpan as soon as you wanted?

It is not difficult to imagine how seriously ill patients might have more intense care needs that would result in more requests for help, nor is it difficult to imagine how some proportion of those requests might not be handled in a timely fashion. Objective research shows higher rates of call button requests have been associated with slower response times, and it appears there is a complex relationship with staffing levels and the intensity of work on the floor.[3] Certainly there may be times that patients want a quick response after pressing a call button, but do not need one, and a lot of time could be spent discussing these quandaries. However, there are also times when a patient describes having called for help, really needing it, yet no one came. At least some of the time, responsiveness is a matter of respect, especially considering the vulnerability of seriously ill patients and the issue of dignity around toileting.

Another key finding was about communication by doctors, and the questions patients answered were: During this hospital stay, how often did doctors treat you with courtesy and respect? During this hospital stay, how often did doctors listen carefully to you? During this hospital stay, how often did doctors explain things in a way you could understand?

There is a growing and important body of literature about communication with seriously ill patients.[4] Consider some of the data about patients with advanced cancer. Evidence suggests the majority of such patients want to know their prognosis, and that when it is discussed it does not worsen the patient‐physician relationship, sadness, or anxiety.[5] Despite this, among physicians who have formulated a prognosis for patients with advanced cancer, even if they were asked directly by those patients about their prognosis, 23% of the time they would communicate no prognosis. Forty percent of the time they would communicate a different prognosis than what they had formulated, with 70% of those being optimistically discrepant.[6] Although data are more limited, there is evidence that hospitalists are similarly wary to acknowledge when patients are at risk of dying.[7]

Although certainly other aspects of communication by doctors with seriously ill patients contributed to this study's findings, this issue of acknowledging and discussing the serious illness itself is important to highlight. Healthcare professionals have an ethical obligation to respect patients' autonomy by helping them make informed decisions about their care. Having these conversations can be challenging, but training programs and conversation guides are showing promise.[8] If health professionals do not try to ensure that seriously ill patients understand their diagnosis, prognosis, and full range of treatment options in patient‐centered ways, then by definition patients cannot be making informed decisions. It is a matter of respect.

This study's most important contribution is how it focuses attention on the domains of responsiveness by hospital staff and communication by doctors, encouraging a deeper dive to consider what else is known about these topics. Allowing that the lower scores from seriously ill patients might reflect more than just poor satisfaction reveals that at least some proportion of the time, these patients are experiencing disrespect. The work then becomes clear: What are the ways in which health professionals should reliably be demonstrating respect toward patients, especially those who are seriously ill? It is there, in the process of developing a reliable practice of respect, that consensus about how to improve the patient experience is most likely to be found.

Disclosure

Nothing to report.

References
  1. Cowen ME, Czerwinski J, Kabara J, Blumenthal DU, Kheder S, Simmons S. The risk‐outcome‐experience triad: mortality risk and the Hospital Consumer Assessment of Healthcare Providers and Systems Survey. J Hosp Med. 2016;11(9):628635.
  2. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172(5):405411.
  3. Tzeng H‐M, Larson JL. Exploring the relationship between patient call‐light use rate and nurse call‐light response time in acute care settings. Comput Inform Nurs. 2011;29(3):138143.
  4. Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014;174(12):19942003.
  5. Enzinger AC, Zhang B, Schrag D, Prigerson HG. Outcomes of prognostic disclosure: associations with prognostic understanding, distress, and relationship with physician among patients with advanced cancer. J Clin Oncol. 2015;33(32):38093816.
  6. Lamont EB, Christakis NA. Prognostic disclosure to patients with cancer near the end of life. Ann Intern Med. 2001;134(12):10961105.
  7. Anderson WG, Kools S, Lyndon A. Dancing around death: hospitalist‐patient communication about serious illness. Qual Health Res. 2013;23(1):313.
  8. Bernacki R, Hutchings M, Vick J, et al. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015;5(10):e009032.
References
  1. Cowen ME, Czerwinski J, Kabara J, Blumenthal DU, Kheder S, Simmons S. The risk‐outcome‐experience triad: mortality risk and the Hospital Consumer Assessment of Healthcare Providers and Systems Survey. J Hosp Med. 2016;11(9):628635.
  2. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172(5):405411.
  3. Tzeng H‐M, Larson JL. Exploring the relationship between patient call‐light use rate and nurse call‐light response time in acute care settings. Comput Inform Nurs. 2011;29(3):138143.
  4. Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014;174(12):19942003.
  5. Enzinger AC, Zhang B, Schrag D, Prigerson HG. Outcomes of prognostic disclosure: associations with prognostic understanding, distress, and relationship with physician among patients with advanced cancer. J Clin Oncol. 2015;33(32):38093816.
  6. Lamont EB, Christakis NA. Prognostic disclosure to patients with cancer near the end of life. Ann Intern Med. 2001;134(12):10961105.
  7. Anderson WG, Kools S, Lyndon A. Dancing around death: hospitalist‐patient communication about serious illness. Qual Health Res. 2013;23(1):313.
  8. Bernacki R, Hutchings M, Vick J, et al. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015;5(10):e009032.
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It's a matter of respect
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Shellfish Allergies and CT Scans

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Avoiding contrast‐enhanced computed tomography scans in patients with shellfish allergies

The Things We Do for No Reason (TWDFNR) series reviews practices which have become common parts of hospital care but which may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent black and white conclusions or clinical practice standards, but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion. https://www.choosingwisely.org/

A 55‐year‐old patient with a history of chronic obstructive pulmonary disease and diabetes mellitus presented to the emergency room with acute shortness of breath and right leg swelling that began 1 week after lumbar disk surgery. The emergency department team decides against ordering a chest CT scan with contrast to evaluate for a possible pulmonary embolism after noting that the patient's allergies include shellfish, which cause urticaria and facial edema. A ventilation‐perfusion scan reveals heterogeneous perfusion defects consistent with an intermediate probability (20%80%) for pulmonary embolism. The treating physicians consider starting the patient on a steroid regimen to prepare him for a CT scan with IV contrast, while presumptively anticoagulating the patient for 24 hours in order for the steroids to provide maximal protective effect before obtaining the scan. Should a history of shellfish allergy affect decision making regarding whether to administer IV contrast?

WHY YOU MIGHT THINK ASKING ABOUT SHELLFISH ALLERGIES BEFORE PERFORMING CONTRAST‐ENHANCED CT SCANS IS HELPFUL

Fish and shellfish contain iodine, and allergic reactions to seafood are quite common, with a prevalence ranging anywhere between 2% and 6% of the population.[1] As a result, patients with suspected shellfish allergies are often told by providers that they are allergic to iodine. In 1 study, nearly 92% of patients presenting to a pediatrics clinic with a suspected seafood or shellfish allergy cited iodine as the culprit.[2] As contrast‐enhanced CT scans utilize a variety of iodine‐based agents, patients are often told to avoid CT scans with iodinated contrast agents or receive corticosteroid/antihistamine premedications prior to undergoing CT scans to mitigate potentially life‐threatening allergic reactions. A survey of radiologists and interventional cardiologists revealed that 65.3% and 88.9%, respectively, asked about seafood or shellfish allergies prior to administering contrast enhanced CT scans, and 34.7% and 50.0%, respectively, stated that they would withhold contrast media or recommend premedication with corticosteroid/antihistamines for patients with seafood or shellfish allergy.[2]

WHY ASKING ABOUT SHELLFISH ALLERGIES BEFORE IV CONTRAST CT SCANS DOES NOT REDUCE THE RISK OF CONTRAST REACTIONS

What Causes Allergic‐Like Reactions to Fish and Shellfish?

Allergic reactions are inappropriate or exaggerated immune response (hypersensitivity reaction). Four types of hypersensitivity reactions have been described (type IIV)[3]; allergic reactions mediated by immunoglobulin E (IgE) represent type I hypersensitivity reactions.

Although fish and shellfish contain iodine, so too do a wide variety of commonly consumed foods (eg, yogurt, milk, bread). In addition, our bodies contain and require sufficient quantities of iodine for basic functions, making immune reactions to such an essential ingredient of life unlikely. Instead, fish and shellfish contain proteins (parvalbumin and tropomyosins, respectively), which act as the major allergens, not iodine.[4]

What Causes Reactions to IV Contrast Media?

Around the world, tens of millions of injections occur every year for contrast‐enhanced scans.[5] Reactions to IV contrast media are not uncommon, occurring anywhere between 0.6% and 17% of the time, with severe reactions occurring between 0.02% and 0.5% of the time.[6] Higher reaction rates were associated with the use of higher‐osmolarity contrast agents. A review of research studies found a lower rate of reactions to IV contrast in eras in which low‐osmolarity agents were exclusively used (0.2% after 1991) versus eras in which high‐osmolarity agents were exclusively used (7.0% between 1985 and 1986).[7]

Reactions to contrast include allergic‐like reactions as well as a variety of other reactions (eg, arrhythmias, vasovagal reactions, flushing), which are thought to be related to the dose and concentration of contrast media.[8]

Allergic‐like, or anaphylactoid, reactions related to contrast are largely thought to have a fundamentally different molecular mechanism than true classic allergic reactions. Anaphylactoid reactions are caused by direct release of histamine into the bloodstream in response to interacting with chemicals. These reactions are not related to or mediated by IgE antibodies and do not require prior exposure.

True classic allergic reactions, on the other hand, are mediated by IgE antibodies in which initial exposure to an allergen (antigen) is followed by subsequent exposure and production of IgE antibodies.[9] The allergenIgE antibody complex causes the degranulation of mast cells and basophils, leading to the release of histamines.

Reactions to IV contrast are likely related to some component of the contrast media instead of the iodine itself. It is thought that the majority of these reactions are anaphylactoid reactions instead of true classic allergic reactions, given that IgE antibodies are not consistently elevated in patients who exhibit these reactions.[8] Nevertheless, the symptoms of these 2 types of reactions (anaphylactoid and allergic reactions) are similar and require comparable treatment to prevent life‐threatening anaphylaxis.

What Are the Major Risk Factors for Allergic‐Like Contrast Reactions?

Previous studies on risk factors for allergic‐like contrast reactions suggest that the strongest predictor of future contrast reactions is a history of prior contrast reaction (5‐fold higher risk), with an estimated 10% to 35% recurrence risk of contrast reactions.[8] Patients with a history of atopy, asthma, and food allergies (including seafood) are at approximately 2 to 3 times greater risk of contrast reactions.[9]

Do Shellfish Allergies Place Patients at Higher Risk for Contrast Reactions Than Other Allergies?

In 1 of the few studies evaluating seafood allergies specifically, Witten et al. compared the frequency of contrast reactions in patients with histories of seafood allergy, food allergy, asthma, hay fever, hives, and contrast medium.[10] Using their results, we compared the frequency of reactions in patients with histories of seafood allergy (6.3%, 4/64) to patients with any other type of allergy or atopic state (9.2%, 212/2304) and found no statistically significant differences (P = 0.418). Similarly, Shehadi evaluated seafood as well as asthma, hay fever, common medications (eg, penicillin, aspirin, morphine), and others.[11] A reanalysis of the results found no statistically significant differences comparing the frequencies of contrast reactions in patients with seafood allergy (15.0%) compared with other allergens (eggs, milk and chocolate, 14.6%; general allergies, 13.1%; fruit allergies, 12.9%; asthma, 11.2%; P values ranging between 0.2 and 0.6).[6] Overall, the results suggest that patients with seafood allergy are at no higher risk for having a contrast reaction compared with patients with other food allergies or other forms of atopy.

Additionally, seafood and other food allergies should be distinguished from food intolerances in which the ingestion of histamine‐rich materials in conjunction with histamine inhibitors (drugs or alcohol) leads to symptoms that can mimic allergic‐like reactions (urticaria, pruritus, diarrhea, asthma).[12]

What Do the Guidelines Recommend?

For patients who require IV contrast media for CT scans, the American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering lowiso‐osmolar radiocontrast media or pretreating with corticosteroids and antihistamines for patients with a history of seafood allergy.[13] The American College of Radiology recommends pretreatment with corticosteroids only for those patients who have previously experienced moderate to severe reactions to IV contrast.[8]

WHAT YOU SHOULD DO INSTEAD: ASK ABOUT PRIOR CONTRAST REACTIONS BEFORE ADMINISTERING CONTRAST

When a patient presents for a contrast‐enhanced CT scan, patients should be asked if they have experienced reactions to contrast and the severity and type of the associated reactions. Providers and support staff should not ask specifically about shellfish allergies, as they have not been found to be associated with an elevated risk of contrast reactions compared with other allergens. Although all allergies seem to increase the likelihood of having a reaction to contrast, only a history of previous contrast reactions will prompt a change in management. Asking specifically about seafood allergies before performing an IV contrast CT scan is a Thing We Do for No Reason.

RECOMMENDATIONS

 

  1. Before performing contrast‐enhanced CT scans, patients should be asked if they have experienced reactions to IV contrast. There is no reason for providers and support staff to specifically inquire about seafood allergies.
  2. Patients with seafood and other food allergies do not require premedication prior to CT scans. Seafood and other food allergies do not represent contraindications to obtaining contrast‐enhanced CT scans and should not prompt a change in management.

 

Disclosures

The authors do not have any relevant financial disclosures to report.

Do you think this is a low‐value practice? Is this truly a Thing We Do for No Reason? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking It on Facebook. We invite you to propose ideas for other Things We Do for No Reason topics by emailing [email protected]

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The Things We Do for No Reason (TWDFNR) series reviews practices which have become common parts of hospital care but which may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent black and white conclusions or clinical practice standards, but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion. https://www.choosingwisely.org/

A 55‐year‐old patient with a history of chronic obstructive pulmonary disease and diabetes mellitus presented to the emergency room with acute shortness of breath and right leg swelling that began 1 week after lumbar disk surgery. The emergency department team decides against ordering a chest CT scan with contrast to evaluate for a possible pulmonary embolism after noting that the patient's allergies include shellfish, which cause urticaria and facial edema. A ventilation‐perfusion scan reveals heterogeneous perfusion defects consistent with an intermediate probability (20%80%) for pulmonary embolism. The treating physicians consider starting the patient on a steroid regimen to prepare him for a CT scan with IV contrast, while presumptively anticoagulating the patient for 24 hours in order for the steroids to provide maximal protective effect before obtaining the scan. Should a history of shellfish allergy affect decision making regarding whether to administer IV contrast?

WHY YOU MIGHT THINK ASKING ABOUT SHELLFISH ALLERGIES BEFORE PERFORMING CONTRAST‐ENHANCED CT SCANS IS HELPFUL

Fish and shellfish contain iodine, and allergic reactions to seafood are quite common, with a prevalence ranging anywhere between 2% and 6% of the population.[1] As a result, patients with suspected shellfish allergies are often told by providers that they are allergic to iodine. In 1 study, nearly 92% of patients presenting to a pediatrics clinic with a suspected seafood or shellfish allergy cited iodine as the culprit.[2] As contrast‐enhanced CT scans utilize a variety of iodine‐based agents, patients are often told to avoid CT scans with iodinated contrast agents or receive corticosteroid/antihistamine premedications prior to undergoing CT scans to mitigate potentially life‐threatening allergic reactions. A survey of radiologists and interventional cardiologists revealed that 65.3% and 88.9%, respectively, asked about seafood or shellfish allergies prior to administering contrast enhanced CT scans, and 34.7% and 50.0%, respectively, stated that they would withhold contrast media or recommend premedication with corticosteroid/antihistamines for patients with seafood or shellfish allergy.[2]

WHY ASKING ABOUT SHELLFISH ALLERGIES BEFORE IV CONTRAST CT SCANS DOES NOT REDUCE THE RISK OF CONTRAST REACTIONS

What Causes Allergic‐Like Reactions to Fish and Shellfish?

Allergic reactions are inappropriate or exaggerated immune response (hypersensitivity reaction). Four types of hypersensitivity reactions have been described (type IIV)[3]; allergic reactions mediated by immunoglobulin E (IgE) represent type I hypersensitivity reactions.

Although fish and shellfish contain iodine, so too do a wide variety of commonly consumed foods (eg, yogurt, milk, bread). In addition, our bodies contain and require sufficient quantities of iodine for basic functions, making immune reactions to such an essential ingredient of life unlikely. Instead, fish and shellfish contain proteins (parvalbumin and tropomyosins, respectively), which act as the major allergens, not iodine.[4]

What Causes Reactions to IV Contrast Media?

Around the world, tens of millions of injections occur every year for contrast‐enhanced scans.[5] Reactions to IV contrast media are not uncommon, occurring anywhere between 0.6% and 17% of the time, with severe reactions occurring between 0.02% and 0.5% of the time.[6] Higher reaction rates were associated with the use of higher‐osmolarity contrast agents. A review of research studies found a lower rate of reactions to IV contrast in eras in which low‐osmolarity agents were exclusively used (0.2% after 1991) versus eras in which high‐osmolarity agents were exclusively used (7.0% between 1985 and 1986).[7]

Reactions to contrast include allergic‐like reactions as well as a variety of other reactions (eg, arrhythmias, vasovagal reactions, flushing), which are thought to be related to the dose and concentration of contrast media.[8]

Allergic‐like, or anaphylactoid, reactions related to contrast are largely thought to have a fundamentally different molecular mechanism than true classic allergic reactions. Anaphylactoid reactions are caused by direct release of histamine into the bloodstream in response to interacting with chemicals. These reactions are not related to or mediated by IgE antibodies and do not require prior exposure.

True classic allergic reactions, on the other hand, are mediated by IgE antibodies in which initial exposure to an allergen (antigen) is followed by subsequent exposure and production of IgE antibodies.[9] The allergenIgE antibody complex causes the degranulation of mast cells and basophils, leading to the release of histamines.

Reactions to IV contrast are likely related to some component of the contrast media instead of the iodine itself. It is thought that the majority of these reactions are anaphylactoid reactions instead of true classic allergic reactions, given that IgE antibodies are not consistently elevated in patients who exhibit these reactions.[8] Nevertheless, the symptoms of these 2 types of reactions (anaphylactoid and allergic reactions) are similar and require comparable treatment to prevent life‐threatening anaphylaxis.

What Are the Major Risk Factors for Allergic‐Like Contrast Reactions?

Previous studies on risk factors for allergic‐like contrast reactions suggest that the strongest predictor of future contrast reactions is a history of prior contrast reaction (5‐fold higher risk), with an estimated 10% to 35% recurrence risk of contrast reactions.[8] Patients with a history of atopy, asthma, and food allergies (including seafood) are at approximately 2 to 3 times greater risk of contrast reactions.[9]

Do Shellfish Allergies Place Patients at Higher Risk for Contrast Reactions Than Other Allergies?

In 1 of the few studies evaluating seafood allergies specifically, Witten et al. compared the frequency of contrast reactions in patients with histories of seafood allergy, food allergy, asthma, hay fever, hives, and contrast medium.[10] Using their results, we compared the frequency of reactions in patients with histories of seafood allergy (6.3%, 4/64) to patients with any other type of allergy or atopic state (9.2%, 212/2304) and found no statistically significant differences (P = 0.418). Similarly, Shehadi evaluated seafood as well as asthma, hay fever, common medications (eg, penicillin, aspirin, morphine), and others.[11] A reanalysis of the results found no statistically significant differences comparing the frequencies of contrast reactions in patients with seafood allergy (15.0%) compared with other allergens (eggs, milk and chocolate, 14.6%; general allergies, 13.1%; fruit allergies, 12.9%; asthma, 11.2%; P values ranging between 0.2 and 0.6).[6] Overall, the results suggest that patients with seafood allergy are at no higher risk for having a contrast reaction compared with patients with other food allergies or other forms of atopy.

Additionally, seafood and other food allergies should be distinguished from food intolerances in which the ingestion of histamine‐rich materials in conjunction with histamine inhibitors (drugs or alcohol) leads to symptoms that can mimic allergic‐like reactions (urticaria, pruritus, diarrhea, asthma).[12]

What Do the Guidelines Recommend?

For patients who require IV contrast media for CT scans, the American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering lowiso‐osmolar radiocontrast media or pretreating with corticosteroids and antihistamines for patients with a history of seafood allergy.[13] The American College of Radiology recommends pretreatment with corticosteroids only for those patients who have previously experienced moderate to severe reactions to IV contrast.[8]

WHAT YOU SHOULD DO INSTEAD: ASK ABOUT PRIOR CONTRAST REACTIONS BEFORE ADMINISTERING CONTRAST

When a patient presents for a contrast‐enhanced CT scan, patients should be asked if they have experienced reactions to contrast and the severity and type of the associated reactions. Providers and support staff should not ask specifically about shellfish allergies, as they have not been found to be associated with an elevated risk of contrast reactions compared with other allergens. Although all allergies seem to increase the likelihood of having a reaction to contrast, only a history of previous contrast reactions will prompt a change in management. Asking specifically about seafood allergies before performing an IV contrast CT scan is a Thing We Do for No Reason.

RECOMMENDATIONS

 

  1. Before performing contrast‐enhanced CT scans, patients should be asked if they have experienced reactions to IV contrast. There is no reason for providers and support staff to specifically inquire about seafood allergies.
  2. Patients with seafood and other food allergies do not require premedication prior to CT scans. Seafood and other food allergies do not represent contraindications to obtaining contrast‐enhanced CT scans and should not prompt a change in management.

 

Disclosures

The authors do not have any relevant financial disclosures to report.

Do you think this is a low‐value practice? Is this truly a Thing We Do for No Reason? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking It on Facebook. We invite you to propose ideas for other Things We Do for No Reason topics by emailing [email protected]

The Things We Do for No Reason (TWDFNR) series reviews practices which have become common parts of hospital care but which may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent black and white conclusions or clinical practice standards, but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion. https://www.choosingwisely.org/

A 55‐year‐old patient with a history of chronic obstructive pulmonary disease and diabetes mellitus presented to the emergency room with acute shortness of breath and right leg swelling that began 1 week after lumbar disk surgery. The emergency department team decides against ordering a chest CT scan with contrast to evaluate for a possible pulmonary embolism after noting that the patient's allergies include shellfish, which cause urticaria and facial edema. A ventilation‐perfusion scan reveals heterogeneous perfusion defects consistent with an intermediate probability (20%80%) for pulmonary embolism. The treating physicians consider starting the patient on a steroid regimen to prepare him for a CT scan with IV contrast, while presumptively anticoagulating the patient for 24 hours in order for the steroids to provide maximal protective effect before obtaining the scan. Should a history of shellfish allergy affect decision making regarding whether to administer IV contrast?

WHY YOU MIGHT THINK ASKING ABOUT SHELLFISH ALLERGIES BEFORE PERFORMING CONTRAST‐ENHANCED CT SCANS IS HELPFUL

Fish and shellfish contain iodine, and allergic reactions to seafood are quite common, with a prevalence ranging anywhere between 2% and 6% of the population.[1] As a result, patients with suspected shellfish allergies are often told by providers that they are allergic to iodine. In 1 study, nearly 92% of patients presenting to a pediatrics clinic with a suspected seafood or shellfish allergy cited iodine as the culprit.[2] As contrast‐enhanced CT scans utilize a variety of iodine‐based agents, patients are often told to avoid CT scans with iodinated contrast agents or receive corticosteroid/antihistamine premedications prior to undergoing CT scans to mitigate potentially life‐threatening allergic reactions. A survey of radiologists and interventional cardiologists revealed that 65.3% and 88.9%, respectively, asked about seafood or shellfish allergies prior to administering contrast enhanced CT scans, and 34.7% and 50.0%, respectively, stated that they would withhold contrast media or recommend premedication with corticosteroid/antihistamines for patients with seafood or shellfish allergy.[2]

WHY ASKING ABOUT SHELLFISH ALLERGIES BEFORE IV CONTRAST CT SCANS DOES NOT REDUCE THE RISK OF CONTRAST REACTIONS

What Causes Allergic‐Like Reactions to Fish and Shellfish?

Allergic reactions are inappropriate or exaggerated immune response (hypersensitivity reaction). Four types of hypersensitivity reactions have been described (type IIV)[3]; allergic reactions mediated by immunoglobulin E (IgE) represent type I hypersensitivity reactions.

Although fish and shellfish contain iodine, so too do a wide variety of commonly consumed foods (eg, yogurt, milk, bread). In addition, our bodies contain and require sufficient quantities of iodine for basic functions, making immune reactions to such an essential ingredient of life unlikely. Instead, fish and shellfish contain proteins (parvalbumin and tropomyosins, respectively), which act as the major allergens, not iodine.[4]

What Causes Reactions to IV Contrast Media?

Around the world, tens of millions of injections occur every year for contrast‐enhanced scans.[5] Reactions to IV contrast media are not uncommon, occurring anywhere between 0.6% and 17% of the time, with severe reactions occurring between 0.02% and 0.5% of the time.[6] Higher reaction rates were associated with the use of higher‐osmolarity contrast agents. A review of research studies found a lower rate of reactions to IV contrast in eras in which low‐osmolarity agents were exclusively used (0.2% after 1991) versus eras in which high‐osmolarity agents were exclusively used (7.0% between 1985 and 1986).[7]

Reactions to contrast include allergic‐like reactions as well as a variety of other reactions (eg, arrhythmias, vasovagal reactions, flushing), which are thought to be related to the dose and concentration of contrast media.[8]

Allergic‐like, or anaphylactoid, reactions related to contrast are largely thought to have a fundamentally different molecular mechanism than true classic allergic reactions. Anaphylactoid reactions are caused by direct release of histamine into the bloodstream in response to interacting with chemicals. These reactions are not related to or mediated by IgE antibodies and do not require prior exposure.

True classic allergic reactions, on the other hand, are mediated by IgE antibodies in which initial exposure to an allergen (antigen) is followed by subsequent exposure and production of IgE antibodies.[9] The allergenIgE antibody complex causes the degranulation of mast cells and basophils, leading to the release of histamines.

Reactions to IV contrast are likely related to some component of the contrast media instead of the iodine itself. It is thought that the majority of these reactions are anaphylactoid reactions instead of true classic allergic reactions, given that IgE antibodies are not consistently elevated in patients who exhibit these reactions.[8] Nevertheless, the symptoms of these 2 types of reactions (anaphylactoid and allergic reactions) are similar and require comparable treatment to prevent life‐threatening anaphylaxis.

What Are the Major Risk Factors for Allergic‐Like Contrast Reactions?

Previous studies on risk factors for allergic‐like contrast reactions suggest that the strongest predictor of future contrast reactions is a history of prior contrast reaction (5‐fold higher risk), with an estimated 10% to 35% recurrence risk of contrast reactions.[8] Patients with a history of atopy, asthma, and food allergies (including seafood) are at approximately 2 to 3 times greater risk of contrast reactions.[9]

Do Shellfish Allergies Place Patients at Higher Risk for Contrast Reactions Than Other Allergies?

In 1 of the few studies evaluating seafood allergies specifically, Witten et al. compared the frequency of contrast reactions in patients with histories of seafood allergy, food allergy, asthma, hay fever, hives, and contrast medium.[10] Using their results, we compared the frequency of reactions in patients with histories of seafood allergy (6.3%, 4/64) to patients with any other type of allergy or atopic state (9.2%, 212/2304) and found no statistically significant differences (P = 0.418). Similarly, Shehadi evaluated seafood as well as asthma, hay fever, common medications (eg, penicillin, aspirin, morphine), and others.[11] A reanalysis of the results found no statistically significant differences comparing the frequencies of contrast reactions in patients with seafood allergy (15.0%) compared with other allergens (eggs, milk and chocolate, 14.6%; general allergies, 13.1%; fruit allergies, 12.9%; asthma, 11.2%; P values ranging between 0.2 and 0.6).[6] Overall, the results suggest that patients with seafood allergy are at no higher risk for having a contrast reaction compared with patients with other food allergies or other forms of atopy.

Additionally, seafood and other food allergies should be distinguished from food intolerances in which the ingestion of histamine‐rich materials in conjunction with histamine inhibitors (drugs or alcohol) leads to symptoms that can mimic allergic‐like reactions (urticaria, pruritus, diarrhea, asthma).[12]

What Do the Guidelines Recommend?

For patients who require IV contrast media for CT scans, the American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering lowiso‐osmolar radiocontrast media or pretreating with corticosteroids and antihistamines for patients with a history of seafood allergy.[13] The American College of Radiology recommends pretreatment with corticosteroids only for those patients who have previously experienced moderate to severe reactions to IV contrast.[8]

WHAT YOU SHOULD DO INSTEAD: ASK ABOUT PRIOR CONTRAST REACTIONS BEFORE ADMINISTERING CONTRAST

When a patient presents for a contrast‐enhanced CT scan, patients should be asked if they have experienced reactions to contrast and the severity and type of the associated reactions. Providers and support staff should not ask specifically about shellfish allergies, as they have not been found to be associated with an elevated risk of contrast reactions compared with other allergens. Although all allergies seem to increase the likelihood of having a reaction to contrast, only a history of previous contrast reactions will prompt a change in management. Asking specifically about seafood allergies before performing an IV contrast CT scan is a Thing We Do for No Reason.

RECOMMENDATIONS

 

  1. Before performing contrast‐enhanced CT scans, patients should be asked if they have experienced reactions to IV contrast. There is no reason for providers and support staff to specifically inquire about seafood allergies.
  2. Patients with seafood and other food allergies do not require premedication prior to CT scans. Seafood and other food allergies do not represent contraindications to obtaining contrast‐enhanced CT scans and should not prompt a change in management.

 

Disclosures

The authors do not have any relevant financial disclosures to report.

Do you think this is a low‐value practice? Is this truly a Thing We Do for No Reason? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking It on Facebook. We invite you to propose ideas for other Things We Do for No Reason topics by emailing [email protected]

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Journal of Hospital Medicine - 11(6)
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Journal of Hospital Medicine - 11(6)
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Avoiding contrast‐enhanced computed tomography scans in patients with shellfish allergies
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Address for correspondence and reprint requests: Anand Narayan, MD, Department of Radiology, Johns Hopkins University School of Medicine, 600 N. Wolfe St., Baltimore, MD 21287; Telephone: 410‐955‐6500; Fax: 410‐550‐1183; E‐mail: [email protected]
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Early results positive for treating high-grade gliomas with virus-based therapy

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Early results positive for treating high-grade gliomas with virus-based therapy

An investigational virus-based therapy was safely given to patients with high-grade or recurrent gliomas in a phase I study, improving survival for some, investigators report.

Dr. Timothy Cloughesy

In the phase I trial of Toca 511 (vocimagene amiretrorepvec) in combination with surgical resection, median overall survival was 13.6 months (95% confidence interval, 10.8-20.0) among all evaluable patients with high-grade glioblastoma (n = 43) and 14.4 months (95% CI, 11.3-32.3) for patients with first or second recurrence (n = 32), Dr. Timothy Cloughesy of the University of California, Los Angeles, and his associates reported (Sci Transl Med. 2016;8:1-11).

Investigators compared their data to those of external controls with glioblastoma at first and second recurrence treated with lomustine and saw an almost twofold improvement in overall survival (13.6 months vs. 7.1 months (hazard ratio, 0.45; P = .003).

Toca 511 dispatches a virus to rapidly dividing cancer cells, then delivers a gene encoding an enzyme that converts a nontoxic prodrug, Toca FC (extended-release 5-fluorocytosine), into its active form, 5-fluorouracil.

C. Bickel / Science Translational Medicine (2016)
A virus infects the tumor and delivers an enzyme, which activates a chemotherapeutic prodrug.

There were no treatment-related deaths, and there were fewer grade 3 adverse events, compared with the external lomustine control group.

“Recurrent HGG [high-grade glioblastoma] is associated with dismal clinical outcomes, and patients are in need of safe and more efficacious therapy. The nonlytic RRV [retroviral replicating vector] Toca 511 and an extended-release 5-FC [5-fluorocytosine] have the potential to fill this medical need,” the researchers said.

A randomized phase II/III trial in patients with recurrent glioblastoma and anaplastic astrocytoma is underway, they said.

This study was supported by the Accelerate Brain Cancer Cure Foundation, the National Brain Tumor Society, the American Brain Tumor Association, the Musela Foundation, Voices Against Brain Cancer, and the National Institute of Neurological Disorders and Stroke. Thirteen investigators reported serving in advisory roles, having ownership or stock interest in, or receiving financial compensation from multiple companies.

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On Twitter @JessCraig_OP

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An investigational virus-based therapy was safely given to patients with high-grade or recurrent gliomas in a phase I study, improving survival for some, investigators report.

Dr. Timothy Cloughesy

In the phase I trial of Toca 511 (vocimagene amiretrorepvec) in combination with surgical resection, median overall survival was 13.6 months (95% confidence interval, 10.8-20.0) among all evaluable patients with high-grade glioblastoma (n = 43) and 14.4 months (95% CI, 11.3-32.3) for patients with first or second recurrence (n = 32), Dr. Timothy Cloughesy of the University of California, Los Angeles, and his associates reported (Sci Transl Med. 2016;8:1-11).

Investigators compared their data to those of external controls with glioblastoma at first and second recurrence treated with lomustine and saw an almost twofold improvement in overall survival (13.6 months vs. 7.1 months (hazard ratio, 0.45; P = .003).

Toca 511 dispatches a virus to rapidly dividing cancer cells, then delivers a gene encoding an enzyme that converts a nontoxic prodrug, Toca FC (extended-release 5-fluorocytosine), into its active form, 5-fluorouracil.

C. Bickel / Science Translational Medicine (2016)
A virus infects the tumor and delivers an enzyme, which activates a chemotherapeutic prodrug.

There were no treatment-related deaths, and there were fewer grade 3 adverse events, compared with the external lomustine control group.

“Recurrent HGG [high-grade glioblastoma] is associated with dismal clinical outcomes, and patients are in need of safe and more efficacious therapy. The nonlytic RRV [retroviral replicating vector] Toca 511 and an extended-release 5-FC [5-fluorocytosine] have the potential to fill this medical need,” the researchers said.

A randomized phase II/III trial in patients with recurrent glioblastoma and anaplastic astrocytoma is underway, they said.

This study was supported by the Accelerate Brain Cancer Cure Foundation, the National Brain Tumor Society, the American Brain Tumor Association, the Musela Foundation, Voices Against Brain Cancer, and the National Institute of Neurological Disorders and Stroke. Thirteen investigators reported serving in advisory roles, having ownership or stock interest in, or receiving financial compensation from multiple companies.

[email protected]

On Twitter @JessCraig_OP

An investigational virus-based therapy was safely given to patients with high-grade or recurrent gliomas in a phase I study, improving survival for some, investigators report.

Dr. Timothy Cloughesy

In the phase I trial of Toca 511 (vocimagene amiretrorepvec) in combination with surgical resection, median overall survival was 13.6 months (95% confidence interval, 10.8-20.0) among all evaluable patients with high-grade glioblastoma (n = 43) and 14.4 months (95% CI, 11.3-32.3) for patients with first or second recurrence (n = 32), Dr. Timothy Cloughesy of the University of California, Los Angeles, and his associates reported (Sci Transl Med. 2016;8:1-11).

Investigators compared their data to those of external controls with glioblastoma at first and second recurrence treated with lomustine and saw an almost twofold improvement in overall survival (13.6 months vs. 7.1 months (hazard ratio, 0.45; P = .003).

Toca 511 dispatches a virus to rapidly dividing cancer cells, then delivers a gene encoding an enzyme that converts a nontoxic prodrug, Toca FC (extended-release 5-fluorocytosine), into its active form, 5-fluorouracil.

C. Bickel / Science Translational Medicine (2016)
A virus infects the tumor and delivers an enzyme, which activates a chemotherapeutic prodrug.

There were no treatment-related deaths, and there were fewer grade 3 adverse events, compared with the external lomustine control group.

“Recurrent HGG [high-grade glioblastoma] is associated with dismal clinical outcomes, and patients are in need of safe and more efficacious therapy. The nonlytic RRV [retroviral replicating vector] Toca 511 and an extended-release 5-FC [5-fluorocytosine] have the potential to fill this medical need,” the researchers said.

A randomized phase II/III trial in patients with recurrent glioblastoma and anaplastic astrocytoma is underway, they said.

This study was supported by the Accelerate Brain Cancer Cure Foundation, the National Brain Tumor Society, the American Brain Tumor Association, the Musela Foundation, Voices Against Brain Cancer, and the National Institute of Neurological Disorders and Stroke. Thirteen investigators reported serving in advisory roles, having ownership or stock interest in, or receiving financial compensation from multiple companies.

[email protected]

On Twitter @JessCraig_OP

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Early results positive for treating high-grade gliomas with virus-based therapy
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Early results positive for treating high-grade gliomas with virus-based therapy
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FROM SCIENCE TRANSLATIONAL MEDICINE

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Key clinical point: A phase I trial indicates that Toca 511 is safe and shows activity in treating patients with high-grade or recurrent glioblastoma.

Major finding: Median overall survival was 13.6 months (95% CI, 10.8-20.0) for patients with high-grade glioblastoma (n = 43), almost twice as long as that of similar patients from a separate trial treated with standard therapy (hazard ratio, 0.45; P = .003).

Data source: A phase I trial of 45 patients with glioblastoma, compared with an external control group.

Disclosures: This study was supported by the Accelerate Brain Cancer Cure Foundation, the National Brain Tumor Society, the American Brain Tumor Association, the Musela Foundation, Voices Against Brain Cancer, and the National Institute of Neurological Disorders and Stroke. Thirteen investigators reported serving in advisory roles, having ownership or stock interest in, or receiving financial compensation from multiple companies.

Esophageal perforation severity scoring system reliably stratifies patients

Prospective study needed before recommendations made
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Esophageal perforation severity scoring system reliably stratifies patients

The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.

Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.

The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).

Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).

Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.

Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).

Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.

They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.

They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.

“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.

The authors reported having no disclosures.

A webcast of the AATS Annual Meeting presentation of this paper is available.

[email protected]

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Body

Dr. Mara B. Antonoff

Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.

The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.

Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.

Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).

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Body

Dr. Mara B. Antonoff

Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.

The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.

Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.

Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).

Body

Dr. Mara B. Antonoff

Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.

The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.

Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.

Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).

Title
Prospective study needed before recommendations made
Prospective study needed before recommendations made

The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.

Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.

The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).

Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).

Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.

Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).

Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.

They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.

They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.

“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.

The authors reported having no disclosures.

A webcast of the AATS Annual Meeting presentation of this paper is available.

[email protected]

The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.

Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.

The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).

Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).

Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.

Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).

Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.

They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.

They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.

“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.

The authors reported having no disclosures.

A webcast of the AATS Annual Meeting presentation of this paper is available.

[email protected]

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Esophageal perforation severity scoring system reliably stratifies patients
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Esophageal perforation severity scoring system reliably stratifies patients
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Key clinical point: Scoring system reliably stratifies patients into low-, intermediate-, and high-risk groups.

Major finding: Patients with a high perforation severity score were 3.37 times more likely to have operative management, compared with low-scoring patients.

Data source: A retrospective study was performed on 288 patients with esophageal perforation at 11 centers since 1990.

Disclosures: The authors presented no relevant disclosures.

Midlife interventions help preserve later cognitive function

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Midlife interventions help preserve later cognitive function

Midlife interventions including physical activity, hypertension control, and maintaining healthy HDL cholesterol may ward off later cognitive decline, reported Cassandra Szoeke, Ph.D., of the Centre for Medical Research at the University of Melbourne, and her colleagues.

©Jana Blašková/ thinkstockphotos.com

In a study of 387 patients from the Women’s Healthy Ageing Project, investigators collected neuropsychiatric assessments, clinical data, and biomarkers at baseline, with at least three follow-up visits and one cognitive reassessment over 20 years. Dr. Szoeke and her colleagues used mixed linear models to analyze the significance of risk factors on verbal memory. The mean age of participants was 49.6 years.

Results showed that cumulative mid- to late-life physical activity had the strongest effect on better verbal memory later in life, the authors said in the report. The next most likely contributors were the negative effect of cumulative hypertension and the beneficial effect of HDL cholesterol.

The findings indicate that “physical activity, hypertension control, and achieving optimal levels of HDL cholesterol will help maintain later-life verbal memory skills,” Dr. Szoeke and her colleagues wrote.

Read the full report in the American Journal of Geriatric Psychiatry: http://www.ajgponline.org/article/S1064-7481%2816%2930113-0/fulltext

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Midlife interventions including physical activity, hypertension control, and maintaining healthy HDL cholesterol may ward off later cognitive decline, reported Cassandra Szoeke, Ph.D., of the Centre for Medical Research at the University of Melbourne, and her colleagues.

©Jana Blašková/ thinkstockphotos.com

In a study of 387 patients from the Women’s Healthy Ageing Project, investigators collected neuropsychiatric assessments, clinical data, and biomarkers at baseline, with at least three follow-up visits and one cognitive reassessment over 20 years. Dr. Szoeke and her colleagues used mixed linear models to analyze the significance of risk factors on verbal memory. The mean age of participants was 49.6 years.

Results showed that cumulative mid- to late-life physical activity had the strongest effect on better verbal memory later in life, the authors said in the report. The next most likely contributors were the negative effect of cumulative hypertension and the beneficial effect of HDL cholesterol.

The findings indicate that “physical activity, hypertension control, and achieving optimal levels of HDL cholesterol will help maintain later-life verbal memory skills,” Dr. Szoeke and her colleagues wrote.

Read the full report in the American Journal of Geriatric Psychiatry: http://www.ajgponline.org/article/S1064-7481%2816%2930113-0/fulltext

[email protected]

Midlife interventions including physical activity, hypertension control, and maintaining healthy HDL cholesterol may ward off later cognitive decline, reported Cassandra Szoeke, Ph.D., of the Centre for Medical Research at the University of Melbourne, and her colleagues.

©Jana Blašková/ thinkstockphotos.com

In a study of 387 patients from the Women’s Healthy Ageing Project, investigators collected neuropsychiatric assessments, clinical data, and biomarkers at baseline, with at least three follow-up visits and one cognitive reassessment over 20 years. Dr. Szoeke and her colleagues used mixed linear models to analyze the significance of risk factors on verbal memory. The mean age of participants was 49.6 years.

Results showed that cumulative mid- to late-life physical activity had the strongest effect on better verbal memory later in life, the authors said in the report. The next most likely contributors were the negative effect of cumulative hypertension and the beneficial effect of HDL cholesterol.

The findings indicate that “physical activity, hypertension control, and achieving optimal levels of HDL cholesterol will help maintain later-life verbal memory skills,” Dr. Szoeke and her colleagues wrote.

Read the full report in the American Journal of Geriatric Psychiatry: http://www.ajgponline.org/article/S1064-7481%2816%2930113-0/fulltext

[email protected]

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Midlife interventions help preserve later cognitive function
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Disappointing results for GI bleed prevention in high-risk aspirin users

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Disappointing results for GI bleed prevention in high-risk aspirin users

SAN DIEGO – Neither a proton pump inhibitor nor an H2 antagonist is an optimal choice for users of low-dose aspirin with previously confirmed ulcer bleeding, according to data from a 12-month randomized trial.

“This is one of the largest clinical trials focusing on aspirin users with a history of ulcer bleeding. Previous trials of aspirin users were mostly endoscopic trials. The important message here is that – while PPI may be useful as gastroprotection for patients with a history of ulcer bleed – it seems that neither treatment is sufficiently protective,” Dr. Francis Chan said at the annual Digestive Disease Week.

Findings from earlier research by the same investigators showed that cotreatment with aspirin and a PPI seemed to be effective as secondary prevention for aspirin-induced ulcer bleeding. He noted that PPIs have a warning for high-risk aspirin users, so alternatives are being sought.

In the present randomized trial, even with PPI prophylaxis, 7.9% of these high-risk aspirin users developed recurrent bleed or endoscopic ulcers versus 12.4% of the group treated with an H2 antagonist, a nonsignificant difference.

Dr. Francis Chan

The prospective, randomized double-blind trial randomized 270 patients in a 1:1 ratio to 1 year of treatment with either 20 mg rabeprazole (a PPI) once daily or 40 mg of the H2 antagonist famotidine once daily. All patients’ ulcers had healed, and all tested negative for Helicobacter pylori prior to randomization. Study participants were taking 80 mg of aspirin daily.

Patients were followed for 12 months. Endoscopy was repeated if there was suspicion of recurrent bleed or they reached 12 months of treatment.

The primary endpoint was a composite of upper gastrointestinal bleed or recurrent ulcer. Secondary endpoints included a composite of recurrent bleed, ulcers visible on endoscopy, and early withdrawal due to severe dyspepsia; lower GI bleeding; and cardiothrombotic events.

Study participants had a mean age of 73 years. At baseline, all patients were negative for H. pylori and hepatitis B virus infection. Both treatment arms were comparable for indication for aspirin. A history of coronary disease was noted in 37% of the PPI group and 40.2% of the H2 antagonist group. A history of cerebrovascular disease was present in 35.5% and 37.1%, respectively.

The source of previous bleeding was comparable in the two groups.

In an intent-to-treat analysis that included all patients who took at least one dose of study medication as well as those who underwent endoscopy at 12 months, 24 cases of suspected bleeding were found: 14 in the PPI group (1 confirmed) and 10 in the H2 antagonist group (4 confirmed). The rate of recurrent bleeding was 5.1% for the PPI and 8.1% for the H2 antagonist.

Lower GI bleeding was reported in 11 patients (8.9%) on the PPI and 6 patients (5%) on the H2 antagonist.

Cardiothrombotic events were reported in five patients: two on the PPI (1.6%) and three on the H2 antagonist (2.5%) .

“We didn’t see any trends for cardiovascular bleeding in either group,” Dr. Chan noted.

An audience member asked what the best way is to treat these patients, given that neither drug provided adequate protection against upper GI bleeding.

“The answer is, I don’t know. We need more study of high-risk patients, and we should study a combination of PPI plus misoprostol. In the absence of larger studies, I currently treat my patients with PPI plus low-dose misoprostol,” he said.

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SAN DIEGO – Neither a proton pump inhibitor nor an H2 antagonist is an optimal choice for users of low-dose aspirin with previously confirmed ulcer bleeding, according to data from a 12-month randomized trial.

“This is one of the largest clinical trials focusing on aspirin users with a history of ulcer bleeding. Previous trials of aspirin users were mostly endoscopic trials. The important message here is that – while PPI may be useful as gastroprotection for patients with a history of ulcer bleed – it seems that neither treatment is sufficiently protective,” Dr. Francis Chan said at the annual Digestive Disease Week.

Findings from earlier research by the same investigators showed that cotreatment with aspirin and a PPI seemed to be effective as secondary prevention for aspirin-induced ulcer bleeding. He noted that PPIs have a warning for high-risk aspirin users, so alternatives are being sought.

In the present randomized trial, even with PPI prophylaxis, 7.9% of these high-risk aspirin users developed recurrent bleed or endoscopic ulcers versus 12.4% of the group treated with an H2 antagonist, a nonsignificant difference.

Dr. Francis Chan

The prospective, randomized double-blind trial randomized 270 patients in a 1:1 ratio to 1 year of treatment with either 20 mg rabeprazole (a PPI) once daily or 40 mg of the H2 antagonist famotidine once daily. All patients’ ulcers had healed, and all tested negative for Helicobacter pylori prior to randomization. Study participants were taking 80 mg of aspirin daily.

Patients were followed for 12 months. Endoscopy was repeated if there was suspicion of recurrent bleed or they reached 12 months of treatment.

The primary endpoint was a composite of upper gastrointestinal bleed or recurrent ulcer. Secondary endpoints included a composite of recurrent bleed, ulcers visible on endoscopy, and early withdrawal due to severe dyspepsia; lower GI bleeding; and cardiothrombotic events.

Study participants had a mean age of 73 years. At baseline, all patients were negative for H. pylori and hepatitis B virus infection. Both treatment arms were comparable for indication for aspirin. A history of coronary disease was noted in 37% of the PPI group and 40.2% of the H2 antagonist group. A history of cerebrovascular disease was present in 35.5% and 37.1%, respectively.

The source of previous bleeding was comparable in the two groups.

In an intent-to-treat analysis that included all patients who took at least one dose of study medication as well as those who underwent endoscopy at 12 months, 24 cases of suspected bleeding were found: 14 in the PPI group (1 confirmed) and 10 in the H2 antagonist group (4 confirmed). The rate of recurrent bleeding was 5.1% for the PPI and 8.1% for the H2 antagonist.

Lower GI bleeding was reported in 11 patients (8.9%) on the PPI and 6 patients (5%) on the H2 antagonist.

Cardiothrombotic events were reported in five patients: two on the PPI (1.6%) and three on the H2 antagonist (2.5%) .

“We didn’t see any trends for cardiovascular bleeding in either group,” Dr. Chan noted.

An audience member asked what the best way is to treat these patients, given that neither drug provided adequate protection against upper GI bleeding.

“The answer is, I don’t know. We need more study of high-risk patients, and we should study a combination of PPI plus misoprostol. In the absence of larger studies, I currently treat my patients with PPI plus low-dose misoprostol,” he said.

SAN DIEGO – Neither a proton pump inhibitor nor an H2 antagonist is an optimal choice for users of low-dose aspirin with previously confirmed ulcer bleeding, according to data from a 12-month randomized trial.

“This is one of the largest clinical trials focusing on aspirin users with a history of ulcer bleeding. Previous trials of aspirin users were mostly endoscopic trials. The important message here is that – while PPI may be useful as gastroprotection for patients with a history of ulcer bleed – it seems that neither treatment is sufficiently protective,” Dr. Francis Chan said at the annual Digestive Disease Week.

Findings from earlier research by the same investigators showed that cotreatment with aspirin and a PPI seemed to be effective as secondary prevention for aspirin-induced ulcer bleeding. He noted that PPIs have a warning for high-risk aspirin users, so alternatives are being sought.

In the present randomized trial, even with PPI prophylaxis, 7.9% of these high-risk aspirin users developed recurrent bleed or endoscopic ulcers versus 12.4% of the group treated with an H2 antagonist, a nonsignificant difference.

Dr. Francis Chan

The prospective, randomized double-blind trial randomized 270 patients in a 1:1 ratio to 1 year of treatment with either 20 mg rabeprazole (a PPI) once daily or 40 mg of the H2 antagonist famotidine once daily. All patients’ ulcers had healed, and all tested negative for Helicobacter pylori prior to randomization. Study participants were taking 80 mg of aspirin daily.

Patients were followed for 12 months. Endoscopy was repeated if there was suspicion of recurrent bleed or they reached 12 months of treatment.

The primary endpoint was a composite of upper gastrointestinal bleed or recurrent ulcer. Secondary endpoints included a composite of recurrent bleed, ulcers visible on endoscopy, and early withdrawal due to severe dyspepsia; lower GI bleeding; and cardiothrombotic events.

Study participants had a mean age of 73 years. At baseline, all patients were negative for H. pylori and hepatitis B virus infection. Both treatment arms were comparable for indication for aspirin. A history of coronary disease was noted in 37% of the PPI group and 40.2% of the H2 antagonist group. A history of cerebrovascular disease was present in 35.5% and 37.1%, respectively.

The source of previous bleeding was comparable in the two groups.

In an intent-to-treat analysis that included all patients who took at least one dose of study medication as well as those who underwent endoscopy at 12 months, 24 cases of suspected bleeding were found: 14 in the PPI group (1 confirmed) and 10 in the H2 antagonist group (4 confirmed). The rate of recurrent bleeding was 5.1% for the PPI and 8.1% for the H2 antagonist.

Lower GI bleeding was reported in 11 patients (8.9%) on the PPI and 6 patients (5%) on the H2 antagonist.

Cardiothrombotic events were reported in five patients: two on the PPI (1.6%) and three on the H2 antagonist (2.5%) .

“We didn’t see any trends for cardiovascular bleeding in either group,” Dr. Chan noted.

An audience member asked what the best way is to treat these patients, given that neither drug provided adequate protection against upper GI bleeding.

“The answer is, I don’t know. We need more study of high-risk patients, and we should study a combination of PPI plus misoprostol. In the absence of larger studies, I currently treat my patients with PPI plus low-dose misoprostol,” he said.

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Key clinical point: Neither a PPI nor an H2 antagonist provided sufficient gastroprotection in high-risk aspirin users.

Major finding: The rate of recurrent bleeding or endoscopic ulcers was 7.9% with a PPI versus 12.4% with an H2 antagonist.

Data source: A randomized, controlled trial of 270 patients with a previous history of ulcers.

Disclosures: Dr. Chan has received financial support from Pfizer and Eisai.

Atopic Dermatitis in Children

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Pulmonary function testing adds little to STS risk scores

Data needed to support definitions
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Pulmonary function testing adds little to STS risk scores

Routine preoperative pulmonary function tests appear to have only limited utility in predicting outcomes in patients undergoing cardiothoracic surgery when the Society of Thoracic Surgeons risk score is available, according to the results of a retrospective study.

Dr. Alexander Ivanov of New York Methodist Hospital, Brooklyn, and his colleagues conducted a database analysis of 1,685 patients undergoing index cardiac surgery at New York Methodist Hospital between April 2004 and January 2014. They used the STS risk model version 2.73 to estimate postoperative risk of respiratory failure (defined as the need for mechanical ventilation greater than or equal to 72 hours, or reintubation), prolonged postoperative length of stay (defined as greater than 14 days), and 30-day all cause mortality in these patients, according to their report in The Journal of Thoracic and Cardiovascular Surgery (2016;151:1183-9).

They plotted the receiver operating characteristics curve for the STS score for each of these adverse events and compared the resulting area under the curve (AUC) with the AUC after adding pulmonary function testing parameters and COPD classifications.

A total of 1,412 patients had a calculated STS score, of which 751 underwent pulmonary function testing (53%). In general, patients who had pulmonary function testing were older and had higher rates of comorbidities and more complex cardiothoracic surgery compared with their counterparts, according to Dr. Ivanov. These patients also had significantly elevated STS risk for prolonged ventilation (12.4% vs. 10.3%), prolonged postoperative length of stay (8.9% vs. 7.2%), and 30-day mortality (2.7% vs. 2.2%).

The decision to perform pulmonary testing was left to the treating physician. Of those patients tested, 652 had bedside spirometry and 99 had formal laboratory testing. Forced expiratory volume in 1 second (FEV1) and forced volume vital capacity (FVC) values were determined by taking the best of three trials. COPD was diagnosed in cases of an FEV1/FVC ratio of less than 70%.

Among these patients, 4.5% developed postoperative respiratory failure, and there was no statistically significant difference in the respiratory failure rate between patients with and without pulmonary function testing. In addition, there was no significant difference in 30-day mortality between these patients (1.9% vs. 2.1%). However, a total of 6.9% had a prolonged postoperative length of stay, with a significantly higher rate in the patients with pulmonary function testing than without (8.8% vs. 4.7%).

Dr. Ivanov and his colleagues found that the AUC of the STS score was 0.65 (95% confidence interval [CI], 0.55-0.74)for respiratory failure, 0.67 (95% CI, 0.6-0.74) for prolonged postoperative length of stay, and 0.74 (95% CI, 0.6-0.87) for 30-day mortality. Even though the STS score based upon clinical definitions of lung disease afforded only modest discriminatory ability for the three studied outcomes, they found that there was no significant added benefit to the predictive ability of these STS scores obtained by incorporating any of the pulmonary function testing parameters or COPD classifications studied.

“A possible physiological explanation for these findings may be that the examined pulmonary function testing variables do not depend solely on pulmonary parameters such as airway diameter, degree of obstruction, or lung elasticity, but rather on a patient’s effort and muscle “strength,” characteristics that are already well captured and accounted for in the current STS model,” the researchers stated.

“The STS score calculated with clinical information on lung disease status offers modest discriminatory ability for respiratory failure, prolonged postoperative length of stay, and 30-day mortality after CT surgery, which cannot be improved by adding PFT parameters or PFT-derived COPD categorization,” they wrote. “Therefore, routine preoperative PFTs may have only limited clinical utility in patients undergoing CT surgery when the STS score is readily available. Further prospective studies will be helpful in confirming these conclusions,” Dr. Ivanov and his colleagues noted.

The authors reported that they had nothing to disclose.

[email protected]

References

Body

Chronic lung disease is one of the risk factors included in the STS model for mortality, renal failure, prolonged ventilation, sternal wound infection, reoperation, and length of hospital stay. Mild, moderate, and severe CLD increases the odds ratio for those complications. A total of 20% of almost 1 million patients used in developing the current STS risk model had CLD.

Dr. Juan A. Crestanello

The authors found that none of the pulmonary function testing parameters added to the predictive ability of the STS risk model for operative mortality, prolonged ventilation, or prolonged length of hospital stay. Because CLD is 1 of 40 preoperative and operative variables used in the STS risk model, an improvement in discrimination of only 1 of 40 variables is very unlikely to improve the overall model.

One may be tempted to conclude that it is not worth performing pulmonary function testing before cardiac surgery. However, remember once again the importance of precise and accurate data to support risk stratification. In science, behind each word resides a precise definition; without a pulmonary function test, we cannot define chronic lung disease severity.

Dr. Juan A. Crestanello is in the division of cardiac surgery, Wexner Medical Center, Ohio State University, Columbus. His remarks are from an invited commentary (J Thorac Cardiovasc Surg. 2016;151:1189-90).

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Chronic lung disease is one of the risk factors included in the STS model for mortality, renal failure, prolonged ventilation, sternal wound infection, reoperation, and length of hospital stay. Mild, moderate, and severe CLD increases the odds ratio for those complications. A total of 20% of almost 1 million patients used in developing the current STS risk model had CLD.

Dr. Juan A. Crestanello

The authors found that none of the pulmonary function testing parameters added to the predictive ability of the STS risk model for operative mortality, prolonged ventilation, or prolonged length of hospital stay. Because CLD is 1 of 40 preoperative and operative variables used in the STS risk model, an improvement in discrimination of only 1 of 40 variables is very unlikely to improve the overall model.

One may be tempted to conclude that it is not worth performing pulmonary function testing before cardiac surgery. However, remember once again the importance of precise and accurate data to support risk stratification. In science, behind each word resides a precise definition; without a pulmonary function test, we cannot define chronic lung disease severity.

Dr. Juan A. Crestanello is in the division of cardiac surgery, Wexner Medical Center, Ohio State University, Columbus. His remarks are from an invited commentary (J Thorac Cardiovasc Surg. 2016;151:1189-90).

Body

Chronic lung disease is one of the risk factors included in the STS model for mortality, renal failure, prolonged ventilation, sternal wound infection, reoperation, and length of hospital stay. Mild, moderate, and severe CLD increases the odds ratio for those complications. A total of 20% of almost 1 million patients used in developing the current STS risk model had CLD.

Dr. Juan A. Crestanello

The authors found that none of the pulmonary function testing parameters added to the predictive ability of the STS risk model for operative mortality, prolonged ventilation, or prolonged length of hospital stay. Because CLD is 1 of 40 preoperative and operative variables used in the STS risk model, an improvement in discrimination of only 1 of 40 variables is very unlikely to improve the overall model.

One may be tempted to conclude that it is not worth performing pulmonary function testing before cardiac surgery. However, remember once again the importance of precise and accurate data to support risk stratification. In science, behind each word resides a precise definition; without a pulmonary function test, we cannot define chronic lung disease severity.

Dr. Juan A. Crestanello is in the division of cardiac surgery, Wexner Medical Center, Ohio State University, Columbus. His remarks are from an invited commentary (J Thorac Cardiovasc Surg. 2016;151:1189-90).

Title
Data needed to support definitions
Data needed to support definitions

Routine preoperative pulmonary function tests appear to have only limited utility in predicting outcomes in patients undergoing cardiothoracic surgery when the Society of Thoracic Surgeons risk score is available, according to the results of a retrospective study.

Dr. Alexander Ivanov of New York Methodist Hospital, Brooklyn, and his colleagues conducted a database analysis of 1,685 patients undergoing index cardiac surgery at New York Methodist Hospital between April 2004 and January 2014. They used the STS risk model version 2.73 to estimate postoperative risk of respiratory failure (defined as the need for mechanical ventilation greater than or equal to 72 hours, or reintubation), prolonged postoperative length of stay (defined as greater than 14 days), and 30-day all cause mortality in these patients, according to their report in The Journal of Thoracic and Cardiovascular Surgery (2016;151:1183-9).

They plotted the receiver operating characteristics curve for the STS score for each of these adverse events and compared the resulting area under the curve (AUC) with the AUC after adding pulmonary function testing parameters and COPD classifications.

A total of 1,412 patients had a calculated STS score, of which 751 underwent pulmonary function testing (53%). In general, patients who had pulmonary function testing were older and had higher rates of comorbidities and more complex cardiothoracic surgery compared with their counterparts, according to Dr. Ivanov. These patients also had significantly elevated STS risk for prolonged ventilation (12.4% vs. 10.3%), prolonged postoperative length of stay (8.9% vs. 7.2%), and 30-day mortality (2.7% vs. 2.2%).

The decision to perform pulmonary testing was left to the treating physician. Of those patients tested, 652 had bedside spirometry and 99 had formal laboratory testing. Forced expiratory volume in 1 second (FEV1) and forced volume vital capacity (FVC) values were determined by taking the best of three trials. COPD was diagnosed in cases of an FEV1/FVC ratio of less than 70%.

Among these patients, 4.5% developed postoperative respiratory failure, and there was no statistically significant difference in the respiratory failure rate between patients with and without pulmonary function testing. In addition, there was no significant difference in 30-day mortality between these patients (1.9% vs. 2.1%). However, a total of 6.9% had a prolonged postoperative length of stay, with a significantly higher rate in the patients with pulmonary function testing than without (8.8% vs. 4.7%).

Dr. Ivanov and his colleagues found that the AUC of the STS score was 0.65 (95% confidence interval [CI], 0.55-0.74)for respiratory failure, 0.67 (95% CI, 0.6-0.74) for prolonged postoperative length of stay, and 0.74 (95% CI, 0.6-0.87) for 30-day mortality. Even though the STS score based upon clinical definitions of lung disease afforded only modest discriminatory ability for the three studied outcomes, they found that there was no significant added benefit to the predictive ability of these STS scores obtained by incorporating any of the pulmonary function testing parameters or COPD classifications studied.

“A possible physiological explanation for these findings may be that the examined pulmonary function testing variables do not depend solely on pulmonary parameters such as airway diameter, degree of obstruction, or lung elasticity, but rather on a patient’s effort and muscle “strength,” characteristics that are already well captured and accounted for in the current STS model,” the researchers stated.

“The STS score calculated with clinical information on lung disease status offers modest discriminatory ability for respiratory failure, prolonged postoperative length of stay, and 30-day mortality after CT surgery, which cannot be improved by adding PFT parameters or PFT-derived COPD categorization,” they wrote. “Therefore, routine preoperative PFTs may have only limited clinical utility in patients undergoing CT surgery when the STS score is readily available. Further prospective studies will be helpful in confirming these conclusions,” Dr. Ivanov and his colleagues noted.

The authors reported that they had nothing to disclose.

[email protected]

Routine preoperative pulmonary function tests appear to have only limited utility in predicting outcomes in patients undergoing cardiothoracic surgery when the Society of Thoracic Surgeons risk score is available, according to the results of a retrospective study.

Dr. Alexander Ivanov of New York Methodist Hospital, Brooklyn, and his colleagues conducted a database analysis of 1,685 patients undergoing index cardiac surgery at New York Methodist Hospital between April 2004 and January 2014. They used the STS risk model version 2.73 to estimate postoperative risk of respiratory failure (defined as the need for mechanical ventilation greater than or equal to 72 hours, or reintubation), prolonged postoperative length of stay (defined as greater than 14 days), and 30-day all cause mortality in these patients, according to their report in The Journal of Thoracic and Cardiovascular Surgery (2016;151:1183-9).

They plotted the receiver operating characteristics curve for the STS score for each of these adverse events and compared the resulting area under the curve (AUC) with the AUC after adding pulmonary function testing parameters and COPD classifications.

A total of 1,412 patients had a calculated STS score, of which 751 underwent pulmonary function testing (53%). In general, patients who had pulmonary function testing were older and had higher rates of comorbidities and more complex cardiothoracic surgery compared with their counterparts, according to Dr. Ivanov. These patients also had significantly elevated STS risk for prolonged ventilation (12.4% vs. 10.3%), prolonged postoperative length of stay (8.9% vs. 7.2%), and 30-day mortality (2.7% vs. 2.2%).

The decision to perform pulmonary testing was left to the treating physician. Of those patients tested, 652 had bedside spirometry and 99 had formal laboratory testing. Forced expiratory volume in 1 second (FEV1) and forced volume vital capacity (FVC) values were determined by taking the best of three trials. COPD was diagnosed in cases of an FEV1/FVC ratio of less than 70%.

Among these patients, 4.5% developed postoperative respiratory failure, and there was no statistically significant difference in the respiratory failure rate between patients with and without pulmonary function testing. In addition, there was no significant difference in 30-day mortality between these patients (1.9% vs. 2.1%). However, a total of 6.9% had a prolonged postoperative length of stay, with a significantly higher rate in the patients with pulmonary function testing than without (8.8% vs. 4.7%).

Dr. Ivanov and his colleagues found that the AUC of the STS score was 0.65 (95% confidence interval [CI], 0.55-0.74)for respiratory failure, 0.67 (95% CI, 0.6-0.74) for prolonged postoperative length of stay, and 0.74 (95% CI, 0.6-0.87) for 30-day mortality. Even though the STS score based upon clinical definitions of lung disease afforded only modest discriminatory ability for the three studied outcomes, they found that there was no significant added benefit to the predictive ability of these STS scores obtained by incorporating any of the pulmonary function testing parameters or COPD classifications studied.

“A possible physiological explanation for these findings may be that the examined pulmonary function testing variables do not depend solely on pulmonary parameters such as airway diameter, degree of obstruction, or lung elasticity, but rather on a patient’s effort and muscle “strength,” characteristics that are already well captured and accounted for in the current STS model,” the researchers stated.

“The STS score calculated with clinical information on lung disease status offers modest discriminatory ability for respiratory failure, prolonged postoperative length of stay, and 30-day mortality after CT surgery, which cannot be improved by adding PFT parameters or PFT-derived COPD categorization,” they wrote. “Therefore, routine preoperative PFTs may have only limited clinical utility in patients undergoing CT surgery when the STS score is readily available. Further prospective studies will be helpful in confirming these conclusions,” Dr. Ivanov and his colleagues noted.

The authors reported that they had nothing to disclose.

[email protected]

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Pulmonary function testing adds little to STS risk scores
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FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY

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Inside the Article

Vitals

Key clinical point: Additional pulmonary function testing adds little predictive value to STS risk scoring when available.

Major finding: There was no significant added benefit to the predictive ability of STS scores obtained by incorporating any of the pulmonary function testing parameters or COPD classifications studied, as determined by AUC analysis.

Data source: A retrospective, database analysis of 1,685 patients undergoing index cardiac surgery at a single center between April 2004 and January 2014.

Disclosures: The authors reported that they had no disclosures.

MS Misdiagnosis in the Era of McDonald Criteria

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MS Misdiagnosis in the Era of McDonald Criteria

VANCOUVER—The misdiagnosis of multiple sclerosis (MS) is a problem with significant consequences for patients, as well as the health care system, according to Andrew J. Solomon, MD, Assistant Professor in the Department of Neurological Sciences at the University of Vermont in Burlington. “Overreliance on MRI abnormalities in the setting of atypical syndromes and unverified prior symptoms may be a major cause of misdiagnosis,” Dr. Solomon said at the 68th Annual Meeting of the American Academy of Neurology.

Andrew J. Solomon, MD

Dr. Solomon and colleagues conducted a simple survey in 2012. They asked 122 MS specialists if they recalled seeing a patient who was incorrectly diagnosed with MS over the last year. Nearly all (95%) had evaluated such patients. As a follow-up, Dr. Solomon and colleagues designed the present study, which evaluated the characteristics of a large population of patients who had been misdiagnosed with MS. “We wanted to determine what the diagnoses were that were being mistaken for MS and what the risks were that were associated with these misdiagnoses.” Their pilot study also probed the causes of misdiagnosis, particularly relating to the current McDonald MS diagnostic criteria.

Twenty-three MS specialists from the University of Vermont, Oregon Health and Science University, Washington University, and the Mayo Clinic participated in this study. The investigators defined two categories: definite and probable misdiagnosis. Patients were identified by participating neurologists during clinical evaluations either prospectively during the 13 months of the study or shortly prior to study initiation. Patients were classified as having definite misdiagnosis when an alternative diagnosis was definitively made based on clinical, laboratory, and neuroimaging evaluation and probable misdiagnosis when an alternative diagnosis was suspected and diagnostic criteria for MS were not met.

Migraine Was Mistaken for MS

The researchers identified 110 patients who were misdiagnosed with MS; 85% were women, and the mean age was 49. About one-quarter (24%) were initially misdiagnosed by a neurologist with fellowship training or a practice focus in MS, and 32% were initially misdiagnosed by a neurologist without such training. For 42%, it was difficult to determine the level of training of the initial neurologist. Nearly half (46%) were classified as definite misdiagnosis, and 54% fell into the probable misdiagnosis category. Neurologists informed 107 (97%) of the patients that their MS diagnosis was incorrect. Almost 30% had been misdiagnosed with MS for three to nine years; 33% had been misdiagnosed for 10 years or longer.

Of the syndromes and diagnoses that were commonly mistaken for MS, the top five represented two-thirds (66%) of all the misdiagnoses that were identified. Migraine, alone or in combination with other disorders, accounted for 22%. Fibromyalgia, along with another alternative cause of MRI abnormalities, accounted for 15%. A category labeled nonspecific or nonlocalized neurologic symptoms—symptoms that were not typical of demyelinating injury or CNS injury—with an abnormal MRI accounted for 12%. Conversion or psychogenic disorder accounted for 11%, and neuromyelitis optica (NMO) spectrum disorder accounted for 6%.

Disease-modifying therapy (DMT) had been initiated in 70% of these patients. About one-third (36%) had received more than one DMT for MS, and a number had received two, three, or four therapies. Thirteen percent had been exposed to natalizumab, a number had received oral therapies for MS, and a few patients had received mitoxantrone. Nearly one-quarter (24%) at some time were on a DMT with a known risk of PML. Almost 30% had been exposed to DMT for three to nine years. Almost 30% had been on DMT for 10 years or longer.

Cerebrospinal fluid (CSF) was available for 52 patients from the time of initial diagnosis, prior to study entry. In 54%, the CSF was normal, including oligoclonal bands and normal IgG. In eight patients, the study neurologists thought that there was an erroneous interpretation of CSF, meaning, for instance, oligoclonal bands were positive in CSF as well as serum.

The study neurologists concluded that 30% of the patients experienced some morbidity as a direct result of an MS misdiagnosis. Morbidities included inadequate treatment of their correct diagnosis, exposure to DMT, and other consequences. In 72% of all patients, study neurologists identified clear evidence of an earlier missed opportunity to make the correct diagnosis.

Imaging and Misdiagnosis

In 65% of cases, study neurologists concluded that inappropriate application of MS diagnostic criteria to a neurologic symptom atypical for a demyelinating attack contributed to misdiagnosis. Inappropriate application of diagnostic criteria to a historical episode of neurologic symptoms without any corroborating objective evidence of a lesion was noted in almost half the cases.

 

 

In more than 30% of cases, an erroneous determination of juxtacortical or periventricular lesion location was thought to have contributed to misdiagnosis. In 60%, the study neurologists cited misdiagnosis related to overreliance on MRI abnormalities, meaning dissemination in time, to confirm a diagnosis of MS in a patient with nonspecific neurologic symptoms.

“We all know the differential diagnosis of MS is broad, and a number of rare disorders can mimic MS,” Dr. Solomon said. “But here it was migraine, fibromyalgia, and a number of other disorders that are quite common that mimicked MS and were mistaken for MS.” Most of these diagnoses, with the exception of NMO, lack a specific biomarker. “What this means is that the correct diagnosis in many of these cases relies on our clinical skills and critical thinking, not just MRI. The problem is not confined to nonspecialists. MS specialists can also make mistakes.”

Study neurologists reported that in almost two-thirds of cases, atypical symptoms for a demyelinating attack contributed to misdiagnosis. “Perhaps this reflects a misunderstanding of what constitutes a typical demyelinating attack and when we should rely on our diagnostic criteria alone,” Dr. Solomon said. In half, historical episodes of neurologic dysfunction, without corroborating objective findings, contributed to misdiagnosis. “This means that patients came in and they had reported historical episodes—episodes of numbness or tingling or blurry vision—where there were no objective exam findings, evoked potentials, imaging findings, to corroborate those symptoms, yet perhaps these episodes were used to meet dissemination in time.”

MRI abnormalities incorrectly attributed to MS in patients without typical demyelinating symptoms contributed to more than half of the misdiagnoses. “It is important to highlight that our MRI criteria, as part of our MS diagnostic criteria, were not developed to differentiate MS from other disorders. The MRI criteria for MS were meant to identify patients at high risk for MS after typical clinical presentations for demyelination,” Dr. Solomon said.

The Importance of Diagnostic Criteria

“Making a diagnosis of MS is challenging. It is important to acknowledge that,” Dr. Solomon said. Common diagnoses and syndromes are often mistaken for MS. But there is significant risk and morbidity associated with misdiagnosis. “The best way to prevent misdiagnosis may be strict adherence and proper use of our MS diagnostic criteria. In patients with atypical clinical presentations or in patients with nonspecific MRI abnormalities, we may need to do more. We may need to monitor longer, do more imaging, make sure we get CSF. That may prevent misdiagnosis in a number of cases.”

Dr. Solomon also stressed the need for continued vigilance for misdiagnosis in patients with an existing MS diagnosis. “We should be thinking, ‘Is this really MS?’ each time we see a new patient, rather than simply accepting that diagnosis.” And lastly, Dr. Solomon recommended that future MS diagnostic criteria should balance the benefit of prompt diagnosis and initiation of DMT versus the potential risks of misdiagnosis.

 

Glenn S. Williams

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VANCOUVER—The misdiagnosis of multiple sclerosis (MS) is a problem with significant consequences for patients, as well as the health care system, according to Andrew J. Solomon, MD, Assistant Professor in the Department of Neurological Sciences at the University of Vermont in Burlington. “Overreliance on MRI abnormalities in the setting of atypical syndromes and unverified prior symptoms may be a major cause of misdiagnosis,” Dr. Solomon said at the 68th Annual Meeting of the American Academy of Neurology.

Andrew J. Solomon, MD

Dr. Solomon and colleagues conducted a simple survey in 2012. They asked 122 MS specialists if they recalled seeing a patient who was incorrectly diagnosed with MS over the last year. Nearly all (95%) had evaluated such patients. As a follow-up, Dr. Solomon and colleagues designed the present study, which evaluated the characteristics of a large population of patients who had been misdiagnosed with MS. “We wanted to determine what the diagnoses were that were being mistaken for MS and what the risks were that were associated with these misdiagnoses.” Their pilot study also probed the causes of misdiagnosis, particularly relating to the current McDonald MS diagnostic criteria.

Twenty-three MS specialists from the University of Vermont, Oregon Health and Science University, Washington University, and the Mayo Clinic participated in this study. The investigators defined two categories: definite and probable misdiagnosis. Patients were identified by participating neurologists during clinical evaluations either prospectively during the 13 months of the study or shortly prior to study initiation. Patients were classified as having definite misdiagnosis when an alternative diagnosis was definitively made based on clinical, laboratory, and neuroimaging evaluation and probable misdiagnosis when an alternative diagnosis was suspected and diagnostic criteria for MS were not met.

Migraine Was Mistaken for MS

The researchers identified 110 patients who were misdiagnosed with MS; 85% were women, and the mean age was 49. About one-quarter (24%) were initially misdiagnosed by a neurologist with fellowship training or a practice focus in MS, and 32% were initially misdiagnosed by a neurologist without such training. For 42%, it was difficult to determine the level of training of the initial neurologist. Nearly half (46%) were classified as definite misdiagnosis, and 54% fell into the probable misdiagnosis category. Neurologists informed 107 (97%) of the patients that their MS diagnosis was incorrect. Almost 30% had been misdiagnosed with MS for three to nine years; 33% had been misdiagnosed for 10 years or longer.

Of the syndromes and diagnoses that were commonly mistaken for MS, the top five represented two-thirds (66%) of all the misdiagnoses that were identified. Migraine, alone or in combination with other disorders, accounted for 22%. Fibromyalgia, along with another alternative cause of MRI abnormalities, accounted for 15%. A category labeled nonspecific or nonlocalized neurologic symptoms—symptoms that were not typical of demyelinating injury or CNS injury—with an abnormal MRI accounted for 12%. Conversion or psychogenic disorder accounted for 11%, and neuromyelitis optica (NMO) spectrum disorder accounted for 6%.

Disease-modifying therapy (DMT) had been initiated in 70% of these patients. About one-third (36%) had received more than one DMT for MS, and a number had received two, three, or four therapies. Thirteen percent had been exposed to natalizumab, a number had received oral therapies for MS, and a few patients had received mitoxantrone. Nearly one-quarter (24%) at some time were on a DMT with a known risk of PML. Almost 30% had been exposed to DMT for three to nine years. Almost 30% had been on DMT for 10 years or longer.

Cerebrospinal fluid (CSF) was available for 52 patients from the time of initial diagnosis, prior to study entry. In 54%, the CSF was normal, including oligoclonal bands and normal IgG. In eight patients, the study neurologists thought that there was an erroneous interpretation of CSF, meaning, for instance, oligoclonal bands were positive in CSF as well as serum.

The study neurologists concluded that 30% of the patients experienced some morbidity as a direct result of an MS misdiagnosis. Morbidities included inadequate treatment of their correct diagnosis, exposure to DMT, and other consequences. In 72% of all patients, study neurologists identified clear evidence of an earlier missed opportunity to make the correct diagnosis.

Imaging and Misdiagnosis

In 65% of cases, study neurologists concluded that inappropriate application of MS diagnostic criteria to a neurologic symptom atypical for a demyelinating attack contributed to misdiagnosis. Inappropriate application of diagnostic criteria to a historical episode of neurologic symptoms without any corroborating objective evidence of a lesion was noted in almost half the cases.

 

 

In more than 30% of cases, an erroneous determination of juxtacortical or periventricular lesion location was thought to have contributed to misdiagnosis. In 60%, the study neurologists cited misdiagnosis related to overreliance on MRI abnormalities, meaning dissemination in time, to confirm a diagnosis of MS in a patient with nonspecific neurologic symptoms.

“We all know the differential diagnosis of MS is broad, and a number of rare disorders can mimic MS,” Dr. Solomon said. “But here it was migraine, fibromyalgia, and a number of other disorders that are quite common that mimicked MS and were mistaken for MS.” Most of these diagnoses, with the exception of NMO, lack a specific biomarker. “What this means is that the correct diagnosis in many of these cases relies on our clinical skills and critical thinking, not just MRI. The problem is not confined to nonspecialists. MS specialists can also make mistakes.”

Study neurologists reported that in almost two-thirds of cases, atypical symptoms for a demyelinating attack contributed to misdiagnosis. “Perhaps this reflects a misunderstanding of what constitutes a typical demyelinating attack and when we should rely on our diagnostic criteria alone,” Dr. Solomon said. In half, historical episodes of neurologic dysfunction, without corroborating objective findings, contributed to misdiagnosis. “This means that patients came in and they had reported historical episodes—episodes of numbness or tingling or blurry vision—where there were no objective exam findings, evoked potentials, imaging findings, to corroborate those symptoms, yet perhaps these episodes were used to meet dissemination in time.”

MRI abnormalities incorrectly attributed to MS in patients without typical demyelinating symptoms contributed to more than half of the misdiagnoses. “It is important to highlight that our MRI criteria, as part of our MS diagnostic criteria, were not developed to differentiate MS from other disorders. The MRI criteria for MS were meant to identify patients at high risk for MS after typical clinical presentations for demyelination,” Dr. Solomon said.

The Importance of Diagnostic Criteria

“Making a diagnosis of MS is challenging. It is important to acknowledge that,” Dr. Solomon said. Common diagnoses and syndromes are often mistaken for MS. But there is significant risk and morbidity associated with misdiagnosis. “The best way to prevent misdiagnosis may be strict adherence and proper use of our MS diagnostic criteria. In patients with atypical clinical presentations or in patients with nonspecific MRI abnormalities, we may need to do more. We may need to monitor longer, do more imaging, make sure we get CSF. That may prevent misdiagnosis in a number of cases.”

Dr. Solomon also stressed the need for continued vigilance for misdiagnosis in patients with an existing MS diagnosis. “We should be thinking, ‘Is this really MS?’ each time we see a new patient, rather than simply accepting that diagnosis.” And lastly, Dr. Solomon recommended that future MS diagnostic criteria should balance the benefit of prompt diagnosis and initiation of DMT versus the potential risks of misdiagnosis.

 

Glenn S. Williams

VANCOUVER—The misdiagnosis of multiple sclerosis (MS) is a problem with significant consequences for patients, as well as the health care system, according to Andrew J. Solomon, MD, Assistant Professor in the Department of Neurological Sciences at the University of Vermont in Burlington. “Overreliance on MRI abnormalities in the setting of atypical syndromes and unverified prior symptoms may be a major cause of misdiagnosis,” Dr. Solomon said at the 68th Annual Meeting of the American Academy of Neurology.

Andrew J. Solomon, MD

Dr. Solomon and colleagues conducted a simple survey in 2012. They asked 122 MS specialists if they recalled seeing a patient who was incorrectly diagnosed with MS over the last year. Nearly all (95%) had evaluated such patients. As a follow-up, Dr. Solomon and colleagues designed the present study, which evaluated the characteristics of a large population of patients who had been misdiagnosed with MS. “We wanted to determine what the diagnoses were that were being mistaken for MS and what the risks were that were associated with these misdiagnoses.” Their pilot study also probed the causes of misdiagnosis, particularly relating to the current McDonald MS diagnostic criteria.

Twenty-three MS specialists from the University of Vermont, Oregon Health and Science University, Washington University, and the Mayo Clinic participated in this study. The investigators defined two categories: definite and probable misdiagnosis. Patients were identified by participating neurologists during clinical evaluations either prospectively during the 13 months of the study or shortly prior to study initiation. Patients were classified as having definite misdiagnosis when an alternative diagnosis was definitively made based on clinical, laboratory, and neuroimaging evaluation and probable misdiagnosis when an alternative diagnosis was suspected and diagnostic criteria for MS were not met.

Migraine Was Mistaken for MS

The researchers identified 110 patients who were misdiagnosed with MS; 85% were women, and the mean age was 49. About one-quarter (24%) were initially misdiagnosed by a neurologist with fellowship training or a practice focus in MS, and 32% were initially misdiagnosed by a neurologist without such training. For 42%, it was difficult to determine the level of training of the initial neurologist. Nearly half (46%) were classified as definite misdiagnosis, and 54% fell into the probable misdiagnosis category. Neurologists informed 107 (97%) of the patients that their MS diagnosis was incorrect. Almost 30% had been misdiagnosed with MS for three to nine years; 33% had been misdiagnosed for 10 years or longer.

Of the syndromes and diagnoses that were commonly mistaken for MS, the top five represented two-thirds (66%) of all the misdiagnoses that were identified. Migraine, alone or in combination with other disorders, accounted for 22%. Fibromyalgia, along with another alternative cause of MRI abnormalities, accounted for 15%. A category labeled nonspecific or nonlocalized neurologic symptoms—symptoms that were not typical of demyelinating injury or CNS injury—with an abnormal MRI accounted for 12%. Conversion or psychogenic disorder accounted for 11%, and neuromyelitis optica (NMO) spectrum disorder accounted for 6%.

Disease-modifying therapy (DMT) had been initiated in 70% of these patients. About one-third (36%) had received more than one DMT for MS, and a number had received two, three, or four therapies. Thirteen percent had been exposed to natalizumab, a number had received oral therapies for MS, and a few patients had received mitoxantrone. Nearly one-quarter (24%) at some time were on a DMT with a known risk of PML. Almost 30% had been exposed to DMT for three to nine years. Almost 30% had been on DMT for 10 years or longer.

Cerebrospinal fluid (CSF) was available for 52 patients from the time of initial diagnosis, prior to study entry. In 54%, the CSF was normal, including oligoclonal bands and normal IgG. In eight patients, the study neurologists thought that there was an erroneous interpretation of CSF, meaning, for instance, oligoclonal bands were positive in CSF as well as serum.

The study neurologists concluded that 30% of the patients experienced some morbidity as a direct result of an MS misdiagnosis. Morbidities included inadequate treatment of their correct diagnosis, exposure to DMT, and other consequences. In 72% of all patients, study neurologists identified clear evidence of an earlier missed opportunity to make the correct diagnosis.

Imaging and Misdiagnosis

In 65% of cases, study neurologists concluded that inappropriate application of MS diagnostic criteria to a neurologic symptom atypical for a demyelinating attack contributed to misdiagnosis. Inappropriate application of diagnostic criteria to a historical episode of neurologic symptoms without any corroborating objective evidence of a lesion was noted in almost half the cases.

 

 

In more than 30% of cases, an erroneous determination of juxtacortical or periventricular lesion location was thought to have contributed to misdiagnosis. In 60%, the study neurologists cited misdiagnosis related to overreliance on MRI abnormalities, meaning dissemination in time, to confirm a diagnosis of MS in a patient with nonspecific neurologic symptoms.

“We all know the differential diagnosis of MS is broad, and a number of rare disorders can mimic MS,” Dr. Solomon said. “But here it was migraine, fibromyalgia, and a number of other disorders that are quite common that mimicked MS and were mistaken for MS.” Most of these diagnoses, with the exception of NMO, lack a specific biomarker. “What this means is that the correct diagnosis in many of these cases relies on our clinical skills and critical thinking, not just MRI. The problem is not confined to nonspecialists. MS specialists can also make mistakes.”

Study neurologists reported that in almost two-thirds of cases, atypical symptoms for a demyelinating attack contributed to misdiagnosis. “Perhaps this reflects a misunderstanding of what constitutes a typical demyelinating attack and when we should rely on our diagnostic criteria alone,” Dr. Solomon said. In half, historical episodes of neurologic dysfunction, without corroborating objective findings, contributed to misdiagnosis. “This means that patients came in and they had reported historical episodes—episodes of numbness or tingling or blurry vision—where there were no objective exam findings, evoked potentials, imaging findings, to corroborate those symptoms, yet perhaps these episodes were used to meet dissemination in time.”

MRI abnormalities incorrectly attributed to MS in patients without typical demyelinating symptoms contributed to more than half of the misdiagnoses. “It is important to highlight that our MRI criteria, as part of our MS diagnostic criteria, were not developed to differentiate MS from other disorders. The MRI criteria for MS were meant to identify patients at high risk for MS after typical clinical presentations for demyelination,” Dr. Solomon said.

The Importance of Diagnostic Criteria

“Making a diagnosis of MS is challenging. It is important to acknowledge that,” Dr. Solomon said. Common diagnoses and syndromes are often mistaken for MS. But there is significant risk and morbidity associated with misdiagnosis. “The best way to prevent misdiagnosis may be strict adherence and proper use of our MS diagnostic criteria. In patients with atypical clinical presentations or in patients with nonspecific MRI abnormalities, we may need to do more. We may need to monitor longer, do more imaging, make sure we get CSF. That may prevent misdiagnosis in a number of cases.”

Dr. Solomon also stressed the need for continued vigilance for misdiagnosis in patients with an existing MS diagnosis. “We should be thinking, ‘Is this really MS?’ each time we see a new patient, rather than simply accepting that diagnosis.” And lastly, Dr. Solomon recommended that future MS diagnostic criteria should balance the benefit of prompt diagnosis and initiation of DMT versus the potential risks of misdiagnosis.

 

Glenn S. Williams

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Neurology Reviews - 24(6)
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