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Antihypertensive Therapy and BP Control
Current recommendations for blood pressure (BP) control focus on chronic management of ambulatory patients; however, treatment guidelines for hospitalized patients who have acute increases in BP or simply uncontrolled BP lack clarity regarding appropriate therapeutic options and short‐term treatment goals.[1, 2] For patients with a history of hypertension, management in the hospital setting typically involves continuation of home therapies. In the inpatient setting, uncontrolled hypertension can be categorized as hypertensive emergency, hypertensive urgency, or asymptomatic poor BP control.[3] Asymptomatic BP elevations occur when the BP is not at goal (but not inordinately high) and the patient has no signs of new or worsening end‐organ damage.[4, 5, 6]
Published data have not demonstrated that aggressive treatment of asymptomatic hypertension in the inpatient setting improves short‐ or long‐term outcomes; however, such aggressive treatment may be associated with iatrogenic adverse effects.[5, 7, 8] Despite the lack of evidence of patient benefit, there is a tendency to treat hospitalized patients with asymptomatic BP elevations aggressively by prescribing IV antihypertensive agents on an as‐needed basis.[9] Intravenous hydralazine and labetalol are frequently used, although these agents are not recommended as initial therapy in consensus recommendations for asymptomatic uncontrolled hypertension in either the inpatient or outpatient setting.[10]
We therefore undertook the present study to determine the type and frequency of ordered and administered episodic intravenous (IV) antihypertensive drug therapy, the BP thresholds triggering such administration, and subsequent in‐hospital clinical outcomes after administration of IV antihypertensive drugs. Accordingly, we evaluated a series of hospitalized patients, in noncritical care settings with no evidence of new or worsening target‐organ injury, who were treated with episodic (either as needed or 1 time only) IV antihypertensive therapy.
METHODS
This study is a retrospective review. Between November 1, 2010 and January 31, 2011 we reviewed the charts of all patients who had at least 1 dose of IV hydralazine, enalaprilat, labetalol, or metoprolol ordered, regardless of previous oral antihypertensive treatment or hypertension diagnosis. Other IV antihypertensive agents were not evaluated in this study, as they are only available in critical care units at our institution. This study took place at an 806‐bed urban hospital that utilizes 100% computer prescriber order entry and bar code technology to document medication administration. The institutional review boards of the Detroit Medical Center and Wayne State University, Detroit, Michigan approved this study.
Patient Identification
Patients were identified through a list of all 1‐time‐only and as‐needed orders for IV hydralazine, enalaprilat, labetolol, or metoprolol. The list was generated daily through the hospital electronic medical record system (Cerner Powerchart, North Kansas City, MO). Patients were excluded if they were younger than 18 or older than 89 years of age, admitted to the intensive care or coronary care unit, were receiving nothing by mouth, pregnant, received a renal transplant in the past 3 months, or if there was any clinical manifestation of new or worsening target‐organ injury consistent with the diagnosis of hypertensive emergency.
Data Collection
The following data were collected for all patients: basic demographic information including factors that have been specifically associated with differences in hypertension risk (ie, age, sex, race, weight, and renal function), antihypertensive regimen (if any) prior to admission, changes to oral antihypertensive therapy during admission, order for sodium‐restricted diet, baseline and discharge laboratory values and vital signs. In addition, the details of their antihypertensive therapy order and administration were collected, including prescriber type (attending, resident, or physician extender), service of prescriber, criteria for use, and date and time of drug administration categorized by shift (morning shift, 7 am to 3 pm; afternoon shift, 3 pm to 11 pm; and night shift, 11 pm to 7 am). To analyze the outcomes of administering episodic IV antihypertensive therapy, the following data were collected: changes in average BP within 30 minutes to 6 hours after drug administration and occurrence of antihypertensive therapy‐related adverse events, including any interventions required after administration and adjustments to oral antihypertensive therapy during admission or upon discharge. In cases where BP data were not available (either just prior to or within 6 hours following administration of an IV antihypertensive), the data were not included in the analysis. To determine whether an antihypertensive drug regimen had been intensified, a therapeutic intensity score (TIS) was calculated for the oral antihypertensive regimen on admission and again at discharge. The antihypertensive TIS was calculated by dividing the total daily dose of each antihypertensive medication by the maximum US Food and Drug Administrationapproved daily dose.[11]
Adverse Outcomes Definition
We defined an adverse outcome as a 25% decrease in systolic or diastolic BP within 6 hours and/or intervention to treat symptoms of hypotension. This definition is consistent with Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommendations to assure safety when lowering BP in the setting of hypertensive emergency.[6] Although the patients in this study were not experiencing hypertensive emergency, this definition is supported by reports of negative sequelae from overzealous lowering of BP,[12, 13, 14] and it reflects criteria used in other trials.[10] Hypotension was deemed to have occurred if any of the following were documented: as IV fluid administration; scheduled BP medication held (at either the nurses discretion or per physician order); change in level of care; change in mental status; or transient ischemic attack, stroke, or chest pain within 30 minutes to 6 hours after administration. Heart rate changes were also considered to be adverse outcomes, including tachycardia (heart rate >100 beats per minute [bpm] or increase 20 bpm from baseline) or bradycardia (heart rate <50 bpm).
Analysis
Descriptive statistics were performed for all variables. Continuous data were summarized using means and standard deviations. Categorical variables were summarized as counts and percentages. Paired t tests were used to contrast changes from baseline for continuous variables pre‐ and post‐BP, and heart rate changes were evaluated only for the first episode of IV antihypertensive drug administration in patients receiving multiple doses of antihypertensive medication to avoid the bias created by repeated or clustered measures in a given patient. 2 tests were used to test differences in categorical variables. All statistical testing was considered significant when 2‐tailed P values were <0.05. Analyses were generated using SAS software version 9.4 (SAS Institute Inc., Cary, NC).
RESULTS
Patients
During the study period, there were 6133 inpatient adult admissions. Of 495 patients who had at least 1 order for IV hydralazine, enalaprilat, labetolol, or metoprolol, 246 were included in the analysis after applying the exclusion criteria (Figure 1). Patients were divided into 2 groups. One group had an order for an IV antihypertensive that was not administered (n = 74), and the other had an order for an IV antihypertensive and received at least 1 dose (n = 172). The demographic characteristics of the 2 groups are compared in Table 1. Patients who had their chronic oral antihypertensive regimens intensified after receiving IV antihypertensive medications were more often African American, leaner, more intensively treated, and had higher baseline BP.
| Did Not Receive IV Antihypertensive (n = 74) | Did Receive IV Antihypertensive (n = 172) | P | |
|---|---|---|---|
| |||
| Age, y | 61.6 13.9 | 60.6 13.7 | |
| Male sex | 51% | 47% | |
| African American | 74% | 87% | 0.008 |
| Weight, kg | 94.6 33.2 | 88.5 27.7 | |
| Admit systolic BP | 148 23 | 163 32 | <0.0001 |
| Admit diastolic BP | 82 13 | 87 18 | 0.009 |
| Admit heart rate | 87 18 | 82 20 | 0.069 |
| Admit TIS | 0.84 0.72 | 1.08 0.88 | 0.026 |
| Baseline SCr | 1.78 2.00 | 2.74 3.30 | 0.006 |
| Baseline AST | 26.5 12.5 | 65 126.2 | 0.046 |
| Low‐sodium diet order | 65% | 83% | 0.002 |
| Ordering service | |||
| Cardiology | 14% | 19% | |
| Internal medicine | 49% | 47% | |
| Nephrology | 0% | 6% | |
| Other services | 37% | 28% | |
| Prescriber type | |||
| Resident | 30% | 49% | |
| Physician extender | 53% | 35% | |
| Attending | 17% | 16% | |
| 1‐time‐only order | 5% | 19% | |
| As‐needed order | 95% | 81% | |
Prescribing Patterns
Medical residents prescribed nearly half (49%) of the orders for episodic IV antihypertensives. Attending physicians were responsible for 16% of episodic antihypertensive orders and physician extenders (physician's assistants and nurse practitioners) for 35%. A total of 321 orders were prescribed for the 246 patients in the study. Hydralazine was the preferred antihypertensive agent (80.1%), with IV ‐blockers prescribed less frequently (labetalol 15.6% and metoprolol 4.4%). There were no orders for IV enalaprilat. BP parameters were included in 181 (56%) of the episodic IV antihypertensive orders. Of the IV antihypertensive orders containing criteria, 153 (84.5%) had systolic BP threshold for administration <180 mm Hg (Table 2).
| BP Criteria for Administration of IV Antihypertensive Contained in Order, mm Hg | Did Not Receive IV Antihypertensive, n (%), n = 71* | Did Receive IV Antihypertensive, n (%), n = 133* |
|---|---|---|
| ||
| SBP >120 | 2 (2.8) | 1 (0.7) |
| SBP >130 | 2 (2.8) | 9 (6.8) |
| SBP >140 | 2 (2.8) | 5 (3.8) |
| SBP >150 | 4 (5.6) | 8 (6) |
| SBP >160 | 27 (38) | 58 (43.7) |
| SBP >170 | 26 (36.6) | 29 (21.8) |
| SBP >180 | 8 (11.4) | 18 (13.5) |
| SBP >200 | 4 (3) | |
| DBP >100 | 1 (0.7) | |
Drug Administration and Short‐term Data
Table 2 indicates the BP criteria specified in the episodic IV antihypertensive orders. For the 74 patients who did not receive an episodic IV antihypertensive agent, despite having an order, the nurses caring for the patients determined that their BPs never met the criteria for administration of the IV antihypertensive agent. The remainder of the results apply only to the 172 patients who actually received episodic IV antihypertensive therapy. Two of these patients did not have BP data available and were not included in the short‐term BP analysis. Almost half (48%) of the patients received 1 dose of episodic IV antihypertensive, 26% received 2 doses, and 11% received 3 doses. One patient received 10 doses. Hydralazine significantly lowered BP, whereas metoprolol did not (Figure 2).
The number of IV antihypertensive doses (for which BP data are available) administered during the night shift (n = 75) was numerically higher than the morning (n = 54) and the afternoon (n = 41) shifts. The mean BPs that triggered administration of IV antihypertensives did not differ among shifts (night shift 183/93, morning shift 184/99, afternoon shift 182/97).
Changes to Oral Antihypertensive Regimen After Administration of IV Antihypertensive Drugs
After administration of an episodic IV antihypertensive, the inpatient oral medication regimen was intensified in only 89 patients (52%). The BP reduction from admission to discharge in patients who had their inpatient oral medication regimen adjusted versus those who did not have an inpatient oral regimen adjustment after receiving IV antihypertensive medication is shown in Figure 3. Patients with intensification of their oral medications had a greater reduction in systolic BP from admission to discharge, compared to patients who received episodic IV antihypertensives but had no subsequent change to their inpatient oral antihypertensive regimen (Figure 3).
Adverse Events
Fifty‐six patients (32.6%) demonstrated BP reductions of more than 25% within 6 hours of antihypertensive administration. Of these patients, 2 received IV fluids, and 6 (3.5%) had a scheduled oral BP medication held. Of the patients who received IV hydralazine, 13 (4.4%) had an increase in heart rate >20 bpm, with 7 having a heart rate >100 bpm. One patient who received labetolol experienced bradycardia. No patient required a higher level of care (transfer to an intensive care unit) because of hemodynamic instability. In addition, no patient experienced a change in mental status, transient ischemic attack, stroke, or chest pain within 30 minutes to 6 hours after administration.
DISCUSSION
The overwhelming majority of administrations of costly episodic IV antihypertensive drugs among this low‐risk population were in patients with modest BP elevations who may have merited no more, at most, than intensification of their oral antihypertensive drug regimen or observation. Such administration was infrequently followed by intensification of the oral antihypertensive drug regimen, and a significant number of patients experienced a potentially adverse clinical event. Excessive reduction of BP resulting in withholding of oral agents or administering IV fluids (as seen in 8 patients) is clinically relevant, especially in a setting where rapid lowering of BP with IV antihypertensives have no proven clinical benefit. There were differences between patients who did and did not received IV antihypertensive drug therapy, as those receiving therapy were higher‐risk patients. Of the patients initially evaluated for inclusion in this analysis, approximately half had a clear indication for IV antihypertensive therapy and were not included in this analysis. It should also be noted that one‐third of the patients included in the study did not subsequently receive an IV antihypertensive agent.
Recently updated hypertensive guidelines do not address the treatment of hypertensive urgency and emergency, whereas the JNC 7 addressed hypertensive urgency but did not provide a specific BP definition or goals because of concerns about overly aggressive management of severe asymptomatic hypertension.[2, 6] For patients with chronically elevated BP, its rapid reduction, even to levels that remain in the frankly hypertensive range, can be associated with negative clinical sequelae, attributable to decreased target organ perfusion causing clinically manifest ischemia.[3] Accordingly, there have been reports of ischemic events related to unwarranted and overzealous BP lowering.[12, 13, 14] In such patients, resistance vessel remodeling causes a rightward shift of the entire pressure/flow auto regulatory curve in critical arterial beds (eg, cerebral, coronary, and renal). Higher systemic pressure is necessary to maintain adequate perfusion in the target organ, at least over the short‐term. Thus, rapid, aggressive BP reduction can result in the aforementioned negative sequelae because remodeled resistance arterioles are not capable of vasodilating enough to ensure adequate blood flow when systemic pressure falls precipitously.
The patients in this study had no evidence of new or worsening pressure‐related end‐organ damage; therefore, there appeared to be no medical justification for emergent BP lowering via the IV route (a very small minority may have had BP high enough to have justified being diagnosed with hypertensive urgency in which fast‐acting oral therapy would be used). Despite the paucity of data to support this practice, it does, however, appear to be relatively common.[9] The high prevalence of IV hydralazine use in this inpatient study is consistent with the retrospective study reported by Weder and Erickson at the University of Michigan.[9]
Even among those with hypertensive urgencies, oral medication is the preferred route (assuming the patient can eat and swallow without difficulty and does not manifest an altered sensorium). Furthermore, the risks associated with overzealous BP lowering can be devastating. The likelihood of target‐organ ischemia (eg, angina pectoris, myocardial infarction, azotemia, stroke, transient ischemic attack) is most strongly correlated to the rapidity of the BP reduction, even to levels within the hypertensive range, in patients with persistent poor BP control.[4, 15, 16] Thus, the justification for considering a >25% drop in systolic BP within 6 hours of the administration of the IV antihypertensive agent as a potential adverse event, especially because there was only a very small immediate risk for adverse cardiovascular sequelae at the BP levels triggering administration of IV antihypertensive drug therapy.
Although we found that residents and physician assistants prescribed most IV antihypertensives, the practice of prescribing IV antihypertensive therapy appears to be common among all prescriber types. A recent survey assessing the attitudes and practices of resident physicians regarding hypertension in the inpatient setting found that 44% of respondents would treat acute asymptomatic, moderately elevated BP (182/100 mm Hg) with either an oral or intravenous agent.[17]
In addition to there being no proven clinical benefit in this setting, the use of unnecessary IV antihypertensives is associated with unnecessary risks and excess cost. Another report of IV hydralazine in asymptomatic patients found that 17 of 94 patients experienced an adverse effect after administration.[18] Not only is the drug acquisition cost for IV antihypertensives greater than their oral counterparts, often by a factor of 10 to 100, the intravenous route requires additional care to monitor their effects, adding to the human resource expense. Finally, the onset of action of intravenous agents is generally more rapid, which increases the risk of inducing hypotension and therefore target‐organ ischemia.
This study does, however, have limitations. This is a single‐center study, so the findings may not be generalizable to different hospital settings. The findings of this study depend on the accuracy and completeness of the medical record as recorded during routine clinical care; therefore, errors and omissions of data input and documentation may affect the quality of the data. Omissions and errors in the medication history can affect inpatient management as well as appropriateness of discharge medications. BP values before and after administration of an IV antihypertensive were not always available, limiting some of the short‐term outcomes data that were available. The impact of acuity of illness and concomitant disease states of patients were not assessed, which could also affect outcomes. The outcomes measured in this investigation were all short‐term outcomes and did not include important clinical outcomes (long‐term BP control, rehospitalization rates, or patient morbidity or mortality).
We speculate that the practice of episodic IV antihypertensive therapy has developed out of convenience for the practitioner and is likely commonplace across the country.[17] Healthcare systems should examine practices locally and address them as appropriate. To assist in promoting evidence‐based practice that is safe, prudent, and clinically appropriate, we propose that national BP organizations and consensus development groups consider placing priority on developing recommendations for inpatient hypertension treatment algorithms beyond those for hypertensive emergencies. In many cases, adjustments to a patient's oral regimen or observation of the patient are the only interventions that are needed. In addition, appropriate coordination of ambulatory follow‐up care upon discharge is prudent. Finally, individual healthcare systems might need to identify formal programs to modify institutional behavior of both medical and nursing staff to eliminate or limit this practice that is not supported by clinical evidence and potentially places the patient at risk.
CONCLUSIONS
Our study found that the practice of prescribing episodic IV antihypertensive agents at our institution occurred across all prescriber types. Hydralazine was the most frequently ordered agent. The majority of orders containing systolic BP criteria for administration of an episodic IV antihypertensive agent were well below the BP level associated with immediate or near‐immediate cardiovascular risk. Administration of episodic IV antihypertensive agents, without subsequent intensification of the patient's chronic oral antihypertensive regimen was nearly as likely to occur as subsequent intensification of the oral regimen in our study. The absence of evidence‐based guidelines, combined with the results of this evaluation, provide a rationale for implementing hospital‐ and health systembased policies limiting the use of episodic IV antihypertensive agents in asymptomatic patients with uncontrolled BP in noncritical care settings in the absence of new or worsening target‐organ injury.
Disclosure: Nothing to report.
- , , , et al. Treatment of hypertension in the prevention and management of ischemic heart disease: a scientific statement from the American Heart Association Council for High Blood Pressure Research and the Councils on Clinical Cardiology and Epidemiology and Prevention. Circulation. 2007;115(21):2761–2788.
- , , , et al. 2014 evidence‐based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507–520.
- , . Hypertensive crises: challenges and management. Chest. 2007;131(6):1949–1962.
- , . Severely increased blood pressure in the emergency department. Ann Emerg Med. 2003;41(4):513–529.
- , , , , ; American College of Emergency Physicians Clinical Policies Subcommittee on Asymptomatic Hypertension in the ED. Clinical policy: critical issues in the evaluation and management of adult patients with asymptomatic hypertension in the emergency department. Ann Emerg Med.2006;47(3):237–249.
- , , , et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19):2560–2572.
- , . Best Evidence on management of asymptomatic hypertension in ED patients. J Emerg Nurs. 2011;37(2):174–178.
- , , , et al. A novel pathway for the management of hypertension for hospitalized patients. Crit Pathw Cardiol. 2007;6(4):150–160.
- , . Treatment of hypertension in the inpatient setting: use of intravenous labetalol and hydralazine. J Clin Hypertens (Greenwich). 2010;12(1):29–33.
- , , , et al. Patterns of antihypertensive treatment in patients with acute severe hypertension from a nonneurologic cause: Studying the Treatment of Acute Hypertension (STAT) registry. Pharmacotherapy. 2010;30(11):1087–1096.
- , , , , . Does earlier attainment of blood pressure goal translate into fewer cardiovascular events? Curr Hypertens Rep. 2008;10(5):398–404.
- . Symptomatic hypotension induced by nifedipine in the acute treatment of severe hypertension. Arch Intern Med. 1987;147(3):556–558.
- , , . Rapid reduction of severe asymptomatic hypertension. A prospective, controlled trial. Arch Intern Med. 1989;149(10):2186–2189.
- , , . Nifedipine‐associated myocardial ischemia or infarction in the treatment of hypertensive urgencies. Ann Intern Med. 1987;107(2):185–186.
- , , , , . Stroke precipitated by moderate blood pressure reduction. J Emerg Med. 2000;9(4):339–346.
- , , , . Adverse events associated with aggressive treatment of increased blood pressure. Int J Clin Prac. 2004;58(5):517–519.
- , , , et al. Attitudes and practices of resident physicians regarding hypertension in the inpatient setting. J Clin Hypertens. 2010;12(9):698–705.
- , , , . Intravenous hydralazine for blood pressure management in the hospitalized patient: its use is often unjustified. J Am Soc Hypertens. 2011;5(6):473–477.
Current recommendations for blood pressure (BP) control focus on chronic management of ambulatory patients; however, treatment guidelines for hospitalized patients who have acute increases in BP or simply uncontrolled BP lack clarity regarding appropriate therapeutic options and short‐term treatment goals.[1, 2] For patients with a history of hypertension, management in the hospital setting typically involves continuation of home therapies. In the inpatient setting, uncontrolled hypertension can be categorized as hypertensive emergency, hypertensive urgency, or asymptomatic poor BP control.[3] Asymptomatic BP elevations occur when the BP is not at goal (but not inordinately high) and the patient has no signs of new or worsening end‐organ damage.[4, 5, 6]
Published data have not demonstrated that aggressive treatment of asymptomatic hypertension in the inpatient setting improves short‐ or long‐term outcomes; however, such aggressive treatment may be associated with iatrogenic adverse effects.[5, 7, 8] Despite the lack of evidence of patient benefit, there is a tendency to treat hospitalized patients with asymptomatic BP elevations aggressively by prescribing IV antihypertensive agents on an as‐needed basis.[9] Intravenous hydralazine and labetalol are frequently used, although these agents are not recommended as initial therapy in consensus recommendations for asymptomatic uncontrolled hypertension in either the inpatient or outpatient setting.[10]
We therefore undertook the present study to determine the type and frequency of ordered and administered episodic intravenous (IV) antihypertensive drug therapy, the BP thresholds triggering such administration, and subsequent in‐hospital clinical outcomes after administration of IV antihypertensive drugs. Accordingly, we evaluated a series of hospitalized patients, in noncritical care settings with no evidence of new or worsening target‐organ injury, who were treated with episodic (either as needed or 1 time only) IV antihypertensive therapy.
METHODS
This study is a retrospective review. Between November 1, 2010 and January 31, 2011 we reviewed the charts of all patients who had at least 1 dose of IV hydralazine, enalaprilat, labetalol, or metoprolol ordered, regardless of previous oral antihypertensive treatment or hypertension diagnosis. Other IV antihypertensive agents were not evaluated in this study, as they are only available in critical care units at our institution. This study took place at an 806‐bed urban hospital that utilizes 100% computer prescriber order entry and bar code technology to document medication administration. The institutional review boards of the Detroit Medical Center and Wayne State University, Detroit, Michigan approved this study.
Patient Identification
Patients were identified through a list of all 1‐time‐only and as‐needed orders for IV hydralazine, enalaprilat, labetolol, or metoprolol. The list was generated daily through the hospital electronic medical record system (Cerner Powerchart, North Kansas City, MO). Patients were excluded if they were younger than 18 or older than 89 years of age, admitted to the intensive care or coronary care unit, were receiving nothing by mouth, pregnant, received a renal transplant in the past 3 months, or if there was any clinical manifestation of new or worsening target‐organ injury consistent with the diagnosis of hypertensive emergency.
Data Collection
The following data were collected for all patients: basic demographic information including factors that have been specifically associated with differences in hypertension risk (ie, age, sex, race, weight, and renal function), antihypertensive regimen (if any) prior to admission, changes to oral antihypertensive therapy during admission, order for sodium‐restricted diet, baseline and discharge laboratory values and vital signs. In addition, the details of their antihypertensive therapy order and administration were collected, including prescriber type (attending, resident, or physician extender), service of prescriber, criteria for use, and date and time of drug administration categorized by shift (morning shift, 7 am to 3 pm; afternoon shift, 3 pm to 11 pm; and night shift, 11 pm to 7 am). To analyze the outcomes of administering episodic IV antihypertensive therapy, the following data were collected: changes in average BP within 30 minutes to 6 hours after drug administration and occurrence of antihypertensive therapy‐related adverse events, including any interventions required after administration and adjustments to oral antihypertensive therapy during admission or upon discharge. In cases where BP data were not available (either just prior to or within 6 hours following administration of an IV antihypertensive), the data were not included in the analysis. To determine whether an antihypertensive drug regimen had been intensified, a therapeutic intensity score (TIS) was calculated for the oral antihypertensive regimen on admission and again at discharge. The antihypertensive TIS was calculated by dividing the total daily dose of each antihypertensive medication by the maximum US Food and Drug Administrationapproved daily dose.[11]
Adverse Outcomes Definition
We defined an adverse outcome as a 25% decrease in systolic or diastolic BP within 6 hours and/or intervention to treat symptoms of hypotension. This definition is consistent with Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommendations to assure safety when lowering BP in the setting of hypertensive emergency.[6] Although the patients in this study were not experiencing hypertensive emergency, this definition is supported by reports of negative sequelae from overzealous lowering of BP,[12, 13, 14] and it reflects criteria used in other trials.[10] Hypotension was deemed to have occurred if any of the following were documented: as IV fluid administration; scheduled BP medication held (at either the nurses discretion or per physician order); change in level of care; change in mental status; or transient ischemic attack, stroke, or chest pain within 30 minutes to 6 hours after administration. Heart rate changes were also considered to be adverse outcomes, including tachycardia (heart rate >100 beats per minute [bpm] or increase 20 bpm from baseline) or bradycardia (heart rate <50 bpm).
Analysis
Descriptive statistics were performed for all variables. Continuous data were summarized using means and standard deviations. Categorical variables were summarized as counts and percentages. Paired t tests were used to contrast changes from baseline for continuous variables pre‐ and post‐BP, and heart rate changes were evaluated only for the first episode of IV antihypertensive drug administration in patients receiving multiple doses of antihypertensive medication to avoid the bias created by repeated or clustered measures in a given patient. 2 tests were used to test differences in categorical variables. All statistical testing was considered significant when 2‐tailed P values were <0.05. Analyses were generated using SAS software version 9.4 (SAS Institute Inc., Cary, NC).
RESULTS
Patients
During the study period, there were 6133 inpatient adult admissions. Of 495 patients who had at least 1 order for IV hydralazine, enalaprilat, labetolol, or metoprolol, 246 were included in the analysis after applying the exclusion criteria (Figure 1). Patients were divided into 2 groups. One group had an order for an IV antihypertensive that was not administered (n = 74), and the other had an order for an IV antihypertensive and received at least 1 dose (n = 172). The demographic characteristics of the 2 groups are compared in Table 1. Patients who had their chronic oral antihypertensive regimens intensified after receiving IV antihypertensive medications were more often African American, leaner, more intensively treated, and had higher baseline BP.
| Did Not Receive IV Antihypertensive (n = 74) | Did Receive IV Antihypertensive (n = 172) | P | |
|---|---|---|---|
| |||
| Age, y | 61.6 13.9 | 60.6 13.7 | |
| Male sex | 51% | 47% | |
| African American | 74% | 87% | 0.008 |
| Weight, kg | 94.6 33.2 | 88.5 27.7 | |
| Admit systolic BP | 148 23 | 163 32 | <0.0001 |
| Admit diastolic BP | 82 13 | 87 18 | 0.009 |
| Admit heart rate | 87 18 | 82 20 | 0.069 |
| Admit TIS | 0.84 0.72 | 1.08 0.88 | 0.026 |
| Baseline SCr | 1.78 2.00 | 2.74 3.30 | 0.006 |
| Baseline AST | 26.5 12.5 | 65 126.2 | 0.046 |
| Low‐sodium diet order | 65% | 83% | 0.002 |
| Ordering service | |||
| Cardiology | 14% | 19% | |
| Internal medicine | 49% | 47% | |
| Nephrology | 0% | 6% | |
| Other services | 37% | 28% | |
| Prescriber type | |||
| Resident | 30% | 49% | |
| Physician extender | 53% | 35% | |
| Attending | 17% | 16% | |
| 1‐time‐only order | 5% | 19% | |
| As‐needed order | 95% | 81% | |
Prescribing Patterns
Medical residents prescribed nearly half (49%) of the orders for episodic IV antihypertensives. Attending physicians were responsible for 16% of episodic antihypertensive orders and physician extenders (physician's assistants and nurse practitioners) for 35%. A total of 321 orders were prescribed for the 246 patients in the study. Hydralazine was the preferred antihypertensive agent (80.1%), with IV ‐blockers prescribed less frequently (labetalol 15.6% and metoprolol 4.4%). There were no orders for IV enalaprilat. BP parameters were included in 181 (56%) of the episodic IV antihypertensive orders. Of the IV antihypertensive orders containing criteria, 153 (84.5%) had systolic BP threshold for administration <180 mm Hg (Table 2).
| BP Criteria for Administration of IV Antihypertensive Contained in Order, mm Hg | Did Not Receive IV Antihypertensive, n (%), n = 71* | Did Receive IV Antihypertensive, n (%), n = 133* |
|---|---|---|
| ||
| SBP >120 | 2 (2.8) | 1 (0.7) |
| SBP >130 | 2 (2.8) | 9 (6.8) |
| SBP >140 | 2 (2.8) | 5 (3.8) |
| SBP >150 | 4 (5.6) | 8 (6) |
| SBP >160 | 27 (38) | 58 (43.7) |
| SBP >170 | 26 (36.6) | 29 (21.8) |
| SBP >180 | 8 (11.4) | 18 (13.5) |
| SBP >200 | 4 (3) | |
| DBP >100 | 1 (0.7) | |
Drug Administration and Short‐term Data
Table 2 indicates the BP criteria specified in the episodic IV antihypertensive orders. For the 74 patients who did not receive an episodic IV antihypertensive agent, despite having an order, the nurses caring for the patients determined that their BPs never met the criteria for administration of the IV antihypertensive agent. The remainder of the results apply only to the 172 patients who actually received episodic IV antihypertensive therapy. Two of these patients did not have BP data available and were not included in the short‐term BP analysis. Almost half (48%) of the patients received 1 dose of episodic IV antihypertensive, 26% received 2 doses, and 11% received 3 doses. One patient received 10 doses. Hydralazine significantly lowered BP, whereas metoprolol did not (Figure 2).
The number of IV antihypertensive doses (for which BP data are available) administered during the night shift (n = 75) was numerically higher than the morning (n = 54) and the afternoon (n = 41) shifts. The mean BPs that triggered administration of IV antihypertensives did not differ among shifts (night shift 183/93, morning shift 184/99, afternoon shift 182/97).
Changes to Oral Antihypertensive Regimen After Administration of IV Antihypertensive Drugs
After administration of an episodic IV antihypertensive, the inpatient oral medication regimen was intensified in only 89 patients (52%). The BP reduction from admission to discharge in patients who had their inpatient oral medication regimen adjusted versus those who did not have an inpatient oral regimen adjustment after receiving IV antihypertensive medication is shown in Figure 3. Patients with intensification of their oral medications had a greater reduction in systolic BP from admission to discharge, compared to patients who received episodic IV antihypertensives but had no subsequent change to their inpatient oral antihypertensive regimen (Figure 3).
Adverse Events
Fifty‐six patients (32.6%) demonstrated BP reductions of more than 25% within 6 hours of antihypertensive administration. Of these patients, 2 received IV fluids, and 6 (3.5%) had a scheduled oral BP medication held. Of the patients who received IV hydralazine, 13 (4.4%) had an increase in heart rate >20 bpm, with 7 having a heart rate >100 bpm. One patient who received labetolol experienced bradycardia. No patient required a higher level of care (transfer to an intensive care unit) because of hemodynamic instability. In addition, no patient experienced a change in mental status, transient ischemic attack, stroke, or chest pain within 30 minutes to 6 hours after administration.
DISCUSSION
The overwhelming majority of administrations of costly episodic IV antihypertensive drugs among this low‐risk population were in patients with modest BP elevations who may have merited no more, at most, than intensification of their oral antihypertensive drug regimen or observation. Such administration was infrequently followed by intensification of the oral antihypertensive drug regimen, and a significant number of patients experienced a potentially adverse clinical event. Excessive reduction of BP resulting in withholding of oral agents or administering IV fluids (as seen in 8 patients) is clinically relevant, especially in a setting where rapid lowering of BP with IV antihypertensives have no proven clinical benefit. There were differences between patients who did and did not received IV antihypertensive drug therapy, as those receiving therapy were higher‐risk patients. Of the patients initially evaluated for inclusion in this analysis, approximately half had a clear indication for IV antihypertensive therapy and were not included in this analysis. It should also be noted that one‐third of the patients included in the study did not subsequently receive an IV antihypertensive agent.
Recently updated hypertensive guidelines do not address the treatment of hypertensive urgency and emergency, whereas the JNC 7 addressed hypertensive urgency but did not provide a specific BP definition or goals because of concerns about overly aggressive management of severe asymptomatic hypertension.[2, 6] For patients with chronically elevated BP, its rapid reduction, even to levels that remain in the frankly hypertensive range, can be associated with negative clinical sequelae, attributable to decreased target organ perfusion causing clinically manifest ischemia.[3] Accordingly, there have been reports of ischemic events related to unwarranted and overzealous BP lowering.[12, 13, 14] In such patients, resistance vessel remodeling causes a rightward shift of the entire pressure/flow auto regulatory curve in critical arterial beds (eg, cerebral, coronary, and renal). Higher systemic pressure is necessary to maintain adequate perfusion in the target organ, at least over the short‐term. Thus, rapid, aggressive BP reduction can result in the aforementioned negative sequelae because remodeled resistance arterioles are not capable of vasodilating enough to ensure adequate blood flow when systemic pressure falls precipitously.
The patients in this study had no evidence of new or worsening pressure‐related end‐organ damage; therefore, there appeared to be no medical justification for emergent BP lowering via the IV route (a very small minority may have had BP high enough to have justified being diagnosed with hypertensive urgency in which fast‐acting oral therapy would be used). Despite the paucity of data to support this practice, it does, however, appear to be relatively common.[9] The high prevalence of IV hydralazine use in this inpatient study is consistent with the retrospective study reported by Weder and Erickson at the University of Michigan.[9]
Even among those with hypertensive urgencies, oral medication is the preferred route (assuming the patient can eat and swallow without difficulty and does not manifest an altered sensorium). Furthermore, the risks associated with overzealous BP lowering can be devastating. The likelihood of target‐organ ischemia (eg, angina pectoris, myocardial infarction, azotemia, stroke, transient ischemic attack) is most strongly correlated to the rapidity of the BP reduction, even to levels within the hypertensive range, in patients with persistent poor BP control.[4, 15, 16] Thus, the justification for considering a >25% drop in systolic BP within 6 hours of the administration of the IV antihypertensive agent as a potential adverse event, especially because there was only a very small immediate risk for adverse cardiovascular sequelae at the BP levels triggering administration of IV antihypertensive drug therapy.
Although we found that residents and physician assistants prescribed most IV antihypertensives, the practice of prescribing IV antihypertensive therapy appears to be common among all prescriber types. A recent survey assessing the attitudes and practices of resident physicians regarding hypertension in the inpatient setting found that 44% of respondents would treat acute asymptomatic, moderately elevated BP (182/100 mm Hg) with either an oral or intravenous agent.[17]
In addition to there being no proven clinical benefit in this setting, the use of unnecessary IV antihypertensives is associated with unnecessary risks and excess cost. Another report of IV hydralazine in asymptomatic patients found that 17 of 94 patients experienced an adverse effect after administration.[18] Not only is the drug acquisition cost for IV antihypertensives greater than their oral counterparts, often by a factor of 10 to 100, the intravenous route requires additional care to monitor their effects, adding to the human resource expense. Finally, the onset of action of intravenous agents is generally more rapid, which increases the risk of inducing hypotension and therefore target‐organ ischemia.
This study does, however, have limitations. This is a single‐center study, so the findings may not be generalizable to different hospital settings. The findings of this study depend on the accuracy and completeness of the medical record as recorded during routine clinical care; therefore, errors and omissions of data input and documentation may affect the quality of the data. Omissions and errors in the medication history can affect inpatient management as well as appropriateness of discharge medications. BP values before and after administration of an IV antihypertensive were not always available, limiting some of the short‐term outcomes data that were available. The impact of acuity of illness and concomitant disease states of patients were not assessed, which could also affect outcomes. The outcomes measured in this investigation were all short‐term outcomes and did not include important clinical outcomes (long‐term BP control, rehospitalization rates, or patient morbidity or mortality).
We speculate that the practice of episodic IV antihypertensive therapy has developed out of convenience for the practitioner and is likely commonplace across the country.[17] Healthcare systems should examine practices locally and address them as appropriate. To assist in promoting evidence‐based practice that is safe, prudent, and clinically appropriate, we propose that national BP organizations and consensus development groups consider placing priority on developing recommendations for inpatient hypertension treatment algorithms beyond those for hypertensive emergencies. In many cases, adjustments to a patient's oral regimen or observation of the patient are the only interventions that are needed. In addition, appropriate coordination of ambulatory follow‐up care upon discharge is prudent. Finally, individual healthcare systems might need to identify formal programs to modify institutional behavior of both medical and nursing staff to eliminate or limit this practice that is not supported by clinical evidence and potentially places the patient at risk.
CONCLUSIONS
Our study found that the practice of prescribing episodic IV antihypertensive agents at our institution occurred across all prescriber types. Hydralazine was the most frequently ordered agent. The majority of orders containing systolic BP criteria for administration of an episodic IV antihypertensive agent were well below the BP level associated with immediate or near‐immediate cardiovascular risk. Administration of episodic IV antihypertensive agents, without subsequent intensification of the patient's chronic oral antihypertensive regimen was nearly as likely to occur as subsequent intensification of the oral regimen in our study. The absence of evidence‐based guidelines, combined with the results of this evaluation, provide a rationale for implementing hospital‐ and health systembased policies limiting the use of episodic IV antihypertensive agents in asymptomatic patients with uncontrolled BP in noncritical care settings in the absence of new or worsening target‐organ injury.
Disclosure: Nothing to report.
Current recommendations for blood pressure (BP) control focus on chronic management of ambulatory patients; however, treatment guidelines for hospitalized patients who have acute increases in BP or simply uncontrolled BP lack clarity regarding appropriate therapeutic options and short‐term treatment goals.[1, 2] For patients with a history of hypertension, management in the hospital setting typically involves continuation of home therapies. In the inpatient setting, uncontrolled hypertension can be categorized as hypertensive emergency, hypertensive urgency, or asymptomatic poor BP control.[3] Asymptomatic BP elevations occur when the BP is not at goal (but not inordinately high) and the patient has no signs of new or worsening end‐organ damage.[4, 5, 6]
Published data have not demonstrated that aggressive treatment of asymptomatic hypertension in the inpatient setting improves short‐ or long‐term outcomes; however, such aggressive treatment may be associated with iatrogenic adverse effects.[5, 7, 8] Despite the lack of evidence of patient benefit, there is a tendency to treat hospitalized patients with asymptomatic BP elevations aggressively by prescribing IV antihypertensive agents on an as‐needed basis.[9] Intravenous hydralazine and labetalol are frequently used, although these agents are not recommended as initial therapy in consensus recommendations for asymptomatic uncontrolled hypertension in either the inpatient or outpatient setting.[10]
We therefore undertook the present study to determine the type and frequency of ordered and administered episodic intravenous (IV) antihypertensive drug therapy, the BP thresholds triggering such administration, and subsequent in‐hospital clinical outcomes after administration of IV antihypertensive drugs. Accordingly, we evaluated a series of hospitalized patients, in noncritical care settings with no evidence of new or worsening target‐organ injury, who were treated with episodic (either as needed or 1 time only) IV antihypertensive therapy.
METHODS
This study is a retrospective review. Between November 1, 2010 and January 31, 2011 we reviewed the charts of all patients who had at least 1 dose of IV hydralazine, enalaprilat, labetalol, or metoprolol ordered, regardless of previous oral antihypertensive treatment or hypertension diagnosis. Other IV antihypertensive agents were not evaluated in this study, as they are only available in critical care units at our institution. This study took place at an 806‐bed urban hospital that utilizes 100% computer prescriber order entry and bar code technology to document medication administration. The institutional review boards of the Detroit Medical Center and Wayne State University, Detroit, Michigan approved this study.
Patient Identification
Patients were identified through a list of all 1‐time‐only and as‐needed orders for IV hydralazine, enalaprilat, labetolol, or metoprolol. The list was generated daily through the hospital electronic medical record system (Cerner Powerchart, North Kansas City, MO). Patients were excluded if they were younger than 18 or older than 89 years of age, admitted to the intensive care or coronary care unit, were receiving nothing by mouth, pregnant, received a renal transplant in the past 3 months, or if there was any clinical manifestation of new or worsening target‐organ injury consistent with the diagnosis of hypertensive emergency.
Data Collection
The following data were collected for all patients: basic demographic information including factors that have been specifically associated with differences in hypertension risk (ie, age, sex, race, weight, and renal function), antihypertensive regimen (if any) prior to admission, changes to oral antihypertensive therapy during admission, order for sodium‐restricted diet, baseline and discharge laboratory values and vital signs. In addition, the details of their antihypertensive therapy order and administration were collected, including prescriber type (attending, resident, or physician extender), service of prescriber, criteria for use, and date and time of drug administration categorized by shift (morning shift, 7 am to 3 pm; afternoon shift, 3 pm to 11 pm; and night shift, 11 pm to 7 am). To analyze the outcomes of administering episodic IV antihypertensive therapy, the following data were collected: changes in average BP within 30 minutes to 6 hours after drug administration and occurrence of antihypertensive therapy‐related adverse events, including any interventions required after administration and adjustments to oral antihypertensive therapy during admission or upon discharge. In cases where BP data were not available (either just prior to or within 6 hours following administration of an IV antihypertensive), the data were not included in the analysis. To determine whether an antihypertensive drug regimen had been intensified, a therapeutic intensity score (TIS) was calculated for the oral antihypertensive regimen on admission and again at discharge. The antihypertensive TIS was calculated by dividing the total daily dose of each antihypertensive medication by the maximum US Food and Drug Administrationapproved daily dose.[11]
Adverse Outcomes Definition
We defined an adverse outcome as a 25% decrease in systolic or diastolic BP within 6 hours and/or intervention to treat symptoms of hypotension. This definition is consistent with Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommendations to assure safety when lowering BP in the setting of hypertensive emergency.[6] Although the patients in this study were not experiencing hypertensive emergency, this definition is supported by reports of negative sequelae from overzealous lowering of BP,[12, 13, 14] and it reflects criteria used in other trials.[10] Hypotension was deemed to have occurred if any of the following were documented: as IV fluid administration; scheduled BP medication held (at either the nurses discretion or per physician order); change in level of care; change in mental status; or transient ischemic attack, stroke, or chest pain within 30 minutes to 6 hours after administration. Heart rate changes were also considered to be adverse outcomes, including tachycardia (heart rate >100 beats per minute [bpm] or increase 20 bpm from baseline) or bradycardia (heart rate <50 bpm).
Analysis
Descriptive statistics were performed for all variables. Continuous data were summarized using means and standard deviations. Categorical variables were summarized as counts and percentages. Paired t tests were used to contrast changes from baseline for continuous variables pre‐ and post‐BP, and heart rate changes were evaluated only for the first episode of IV antihypertensive drug administration in patients receiving multiple doses of antihypertensive medication to avoid the bias created by repeated or clustered measures in a given patient. 2 tests were used to test differences in categorical variables. All statistical testing was considered significant when 2‐tailed P values were <0.05. Analyses were generated using SAS software version 9.4 (SAS Institute Inc., Cary, NC).
RESULTS
Patients
During the study period, there were 6133 inpatient adult admissions. Of 495 patients who had at least 1 order for IV hydralazine, enalaprilat, labetolol, or metoprolol, 246 were included in the analysis after applying the exclusion criteria (Figure 1). Patients were divided into 2 groups. One group had an order for an IV antihypertensive that was not administered (n = 74), and the other had an order for an IV antihypertensive and received at least 1 dose (n = 172). The demographic characteristics of the 2 groups are compared in Table 1. Patients who had their chronic oral antihypertensive regimens intensified after receiving IV antihypertensive medications were more often African American, leaner, more intensively treated, and had higher baseline BP.
| Did Not Receive IV Antihypertensive (n = 74) | Did Receive IV Antihypertensive (n = 172) | P | |
|---|---|---|---|
| |||
| Age, y | 61.6 13.9 | 60.6 13.7 | |
| Male sex | 51% | 47% | |
| African American | 74% | 87% | 0.008 |
| Weight, kg | 94.6 33.2 | 88.5 27.7 | |
| Admit systolic BP | 148 23 | 163 32 | <0.0001 |
| Admit diastolic BP | 82 13 | 87 18 | 0.009 |
| Admit heart rate | 87 18 | 82 20 | 0.069 |
| Admit TIS | 0.84 0.72 | 1.08 0.88 | 0.026 |
| Baseline SCr | 1.78 2.00 | 2.74 3.30 | 0.006 |
| Baseline AST | 26.5 12.5 | 65 126.2 | 0.046 |
| Low‐sodium diet order | 65% | 83% | 0.002 |
| Ordering service | |||
| Cardiology | 14% | 19% | |
| Internal medicine | 49% | 47% | |
| Nephrology | 0% | 6% | |
| Other services | 37% | 28% | |
| Prescriber type | |||
| Resident | 30% | 49% | |
| Physician extender | 53% | 35% | |
| Attending | 17% | 16% | |
| 1‐time‐only order | 5% | 19% | |
| As‐needed order | 95% | 81% | |
Prescribing Patterns
Medical residents prescribed nearly half (49%) of the orders for episodic IV antihypertensives. Attending physicians were responsible for 16% of episodic antihypertensive orders and physician extenders (physician's assistants and nurse practitioners) for 35%. A total of 321 orders were prescribed for the 246 patients in the study. Hydralazine was the preferred antihypertensive agent (80.1%), with IV ‐blockers prescribed less frequently (labetalol 15.6% and metoprolol 4.4%). There were no orders for IV enalaprilat. BP parameters were included in 181 (56%) of the episodic IV antihypertensive orders. Of the IV antihypertensive orders containing criteria, 153 (84.5%) had systolic BP threshold for administration <180 mm Hg (Table 2).
| BP Criteria for Administration of IV Antihypertensive Contained in Order, mm Hg | Did Not Receive IV Antihypertensive, n (%), n = 71* | Did Receive IV Antihypertensive, n (%), n = 133* |
|---|---|---|
| ||
| SBP >120 | 2 (2.8) | 1 (0.7) |
| SBP >130 | 2 (2.8) | 9 (6.8) |
| SBP >140 | 2 (2.8) | 5 (3.8) |
| SBP >150 | 4 (5.6) | 8 (6) |
| SBP >160 | 27 (38) | 58 (43.7) |
| SBP >170 | 26 (36.6) | 29 (21.8) |
| SBP >180 | 8 (11.4) | 18 (13.5) |
| SBP >200 | 4 (3) | |
| DBP >100 | 1 (0.7) | |
Drug Administration and Short‐term Data
Table 2 indicates the BP criteria specified in the episodic IV antihypertensive orders. For the 74 patients who did not receive an episodic IV antihypertensive agent, despite having an order, the nurses caring for the patients determined that their BPs never met the criteria for administration of the IV antihypertensive agent. The remainder of the results apply only to the 172 patients who actually received episodic IV antihypertensive therapy. Two of these patients did not have BP data available and were not included in the short‐term BP analysis. Almost half (48%) of the patients received 1 dose of episodic IV antihypertensive, 26% received 2 doses, and 11% received 3 doses. One patient received 10 doses. Hydralazine significantly lowered BP, whereas metoprolol did not (Figure 2).
The number of IV antihypertensive doses (for which BP data are available) administered during the night shift (n = 75) was numerically higher than the morning (n = 54) and the afternoon (n = 41) shifts. The mean BPs that triggered administration of IV antihypertensives did not differ among shifts (night shift 183/93, morning shift 184/99, afternoon shift 182/97).
Changes to Oral Antihypertensive Regimen After Administration of IV Antihypertensive Drugs
After administration of an episodic IV antihypertensive, the inpatient oral medication regimen was intensified in only 89 patients (52%). The BP reduction from admission to discharge in patients who had their inpatient oral medication regimen adjusted versus those who did not have an inpatient oral regimen adjustment after receiving IV antihypertensive medication is shown in Figure 3. Patients with intensification of their oral medications had a greater reduction in systolic BP from admission to discharge, compared to patients who received episodic IV antihypertensives but had no subsequent change to their inpatient oral antihypertensive regimen (Figure 3).
Adverse Events
Fifty‐six patients (32.6%) demonstrated BP reductions of more than 25% within 6 hours of antihypertensive administration. Of these patients, 2 received IV fluids, and 6 (3.5%) had a scheduled oral BP medication held. Of the patients who received IV hydralazine, 13 (4.4%) had an increase in heart rate >20 bpm, with 7 having a heart rate >100 bpm. One patient who received labetolol experienced bradycardia. No patient required a higher level of care (transfer to an intensive care unit) because of hemodynamic instability. In addition, no patient experienced a change in mental status, transient ischemic attack, stroke, or chest pain within 30 minutes to 6 hours after administration.
DISCUSSION
The overwhelming majority of administrations of costly episodic IV antihypertensive drugs among this low‐risk population were in patients with modest BP elevations who may have merited no more, at most, than intensification of their oral antihypertensive drug regimen or observation. Such administration was infrequently followed by intensification of the oral antihypertensive drug regimen, and a significant number of patients experienced a potentially adverse clinical event. Excessive reduction of BP resulting in withholding of oral agents or administering IV fluids (as seen in 8 patients) is clinically relevant, especially in a setting where rapid lowering of BP with IV antihypertensives have no proven clinical benefit. There were differences between patients who did and did not received IV antihypertensive drug therapy, as those receiving therapy were higher‐risk patients. Of the patients initially evaluated for inclusion in this analysis, approximately half had a clear indication for IV antihypertensive therapy and were not included in this analysis. It should also be noted that one‐third of the patients included in the study did not subsequently receive an IV antihypertensive agent.
Recently updated hypertensive guidelines do not address the treatment of hypertensive urgency and emergency, whereas the JNC 7 addressed hypertensive urgency but did not provide a specific BP definition or goals because of concerns about overly aggressive management of severe asymptomatic hypertension.[2, 6] For patients with chronically elevated BP, its rapid reduction, even to levels that remain in the frankly hypertensive range, can be associated with negative clinical sequelae, attributable to decreased target organ perfusion causing clinically manifest ischemia.[3] Accordingly, there have been reports of ischemic events related to unwarranted and overzealous BP lowering.[12, 13, 14] In such patients, resistance vessel remodeling causes a rightward shift of the entire pressure/flow auto regulatory curve in critical arterial beds (eg, cerebral, coronary, and renal). Higher systemic pressure is necessary to maintain adequate perfusion in the target organ, at least over the short‐term. Thus, rapid, aggressive BP reduction can result in the aforementioned negative sequelae because remodeled resistance arterioles are not capable of vasodilating enough to ensure adequate blood flow when systemic pressure falls precipitously.
The patients in this study had no evidence of new or worsening pressure‐related end‐organ damage; therefore, there appeared to be no medical justification for emergent BP lowering via the IV route (a very small minority may have had BP high enough to have justified being diagnosed with hypertensive urgency in which fast‐acting oral therapy would be used). Despite the paucity of data to support this practice, it does, however, appear to be relatively common.[9] The high prevalence of IV hydralazine use in this inpatient study is consistent with the retrospective study reported by Weder and Erickson at the University of Michigan.[9]
Even among those with hypertensive urgencies, oral medication is the preferred route (assuming the patient can eat and swallow without difficulty and does not manifest an altered sensorium). Furthermore, the risks associated with overzealous BP lowering can be devastating. The likelihood of target‐organ ischemia (eg, angina pectoris, myocardial infarction, azotemia, stroke, transient ischemic attack) is most strongly correlated to the rapidity of the BP reduction, even to levels within the hypertensive range, in patients with persistent poor BP control.[4, 15, 16] Thus, the justification for considering a >25% drop in systolic BP within 6 hours of the administration of the IV antihypertensive agent as a potential adverse event, especially because there was only a very small immediate risk for adverse cardiovascular sequelae at the BP levels triggering administration of IV antihypertensive drug therapy.
Although we found that residents and physician assistants prescribed most IV antihypertensives, the practice of prescribing IV antihypertensive therapy appears to be common among all prescriber types. A recent survey assessing the attitudes and practices of resident physicians regarding hypertension in the inpatient setting found that 44% of respondents would treat acute asymptomatic, moderately elevated BP (182/100 mm Hg) with either an oral or intravenous agent.[17]
In addition to there being no proven clinical benefit in this setting, the use of unnecessary IV antihypertensives is associated with unnecessary risks and excess cost. Another report of IV hydralazine in asymptomatic patients found that 17 of 94 patients experienced an adverse effect after administration.[18] Not only is the drug acquisition cost for IV antihypertensives greater than their oral counterparts, often by a factor of 10 to 100, the intravenous route requires additional care to monitor their effects, adding to the human resource expense. Finally, the onset of action of intravenous agents is generally more rapid, which increases the risk of inducing hypotension and therefore target‐organ ischemia.
This study does, however, have limitations. This is a single‐center study, so the findings may not be generalizable to different hospital settings. The findings of this study depend on the accuracy and completeness of the medical record as recorded during routine clinical care; therefore, errors and omissions of data input and documentation may affect the quality of the data. Omissions and errors in the medication history can affect inpatient management as well as appropriateness of discharge medications. BP values before and after administration of an IV antihypertensive were not always available, limiting some of the short‐term outcomes data that were available. The impact of acuity of illness and concomitant disease states of patients were not assessed, which could also affect outcomes. The outcomes measured in this investigation were all short‐term outcomes and did not include important clinical outcomes (long‐term BP control, rehospitalization rates, or patient morbidity or mortality).
We speculate that the practice of episodic IV antihypertensive therapy has developed out of convenience for the practitioner and is likely commonplace across the country.[17] Healthcare systems should examine practices locally and address them as appropriate. To assist in promoting evidence‐based practice that is safe, prudent, and clinically appropriate, we propose that national BP organizations and consensus development groups consider placing priority on developing recommendations for inpatient hypertension treatment algorithms beyond those for hypertensive emergencies. In many cases, adjustments to a patient's oral regimen or observation of the patient are the only interventions that are needed. In addition, appropriate coordination of ambulatory follow‐up care upon discharge is prudent. Finally, individual healthcare systems might need to identify formal programs to modify institutional behavior of both medical and nursing staff to eliminate or limit this practice that is not supported by clinical evidence and potentially places the patient at risk.
CONCLUSIONS
Our study found that the practice of prescribing episodic IV antihypertensive agents at our institution occurred across all prescriber types. Hydralazine was the most frequently ordered agent. The majority of orders containing systolic BP criteria for administration of an episodic IV antihypertensive agent were well below the BP level associated with immediate or near‐immediate cardiovascular risk. Administration of episodic IV antihypertensive agents, without subsequent intensification of the patient's chronic oral antihypertensive regimen was nearly as likely to occur as subsequent intensification of the oral regimen in our study. The absence of evidence‐based guidelines, combined with the results of this evaluation, provide a rationale for implementing hospital‐ and health systembased policies limiting the use of episodic IV antihypertensive agents in asymptomatic patients with uncontrolled BP in noncritical care settings in the absence of new or worsening target‐organ injury.
Disclosure: Nothing to report.
- , , , et al. Treatment of hypertension in the prevention and management of ischemic heart disease: a scientific statement from the American Heart Association Council for High Blood Pressure Research and the Councils on Clinical Cardiology and Epidemiology and Prevention. Circulation. 2007;115(21):2761–2788.
- , , , et al. 2014 evidence‐based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507–520.
- , . Hypertensive crises: challenges and management. Chest. 2007;131(6):1949–1962.
- , . Severely increased blood pressure in the emergency department. Ann Emerg Med. 2003;41(4):513–529.
- , , , , ; American College of Emergency Physicians Clinical Policies Subcommittee on Asymptomatic Hypertension in the ED. Clinical policy: critical issues in the evaluation and management of adult patients with asymptomatic hypertension in the emergency department. Ann Emerg Med.2006;47(3):237–249.
- , , , et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19):2560–2572.
- , . Best Evidence on management of asymptomatic hypertension in ED patients. J Emerg Nurs. 2011;37(2):174–178.
- , , , et al. A novel pathway for the management of hypertension for hospitalized patients. Crit Pathw Cardiol. 2007;6(4):150–160.
- , . Treatment of hypertension in the inpatient setting: use of intravenous labetalol and hydralazine. J Clin Hypertens (Greenwich). 2010;12(1):29–33.
- , , , et al. Patterns of antihypertensive treatment in patients with acute severe hypertension from a nonneurologic cause: Studying the Treatment of Acute Hypertension (STAT) registry. Pharmacotherapy. 2010;30(11):1087–1096.
- , , , , . Does earlier attainment of blood pressure goal translate into fewer cardiovascular events? Curr Hypertens Rep. 2008;10(5):398–404.
- . Symptomatic hypotension induced by nifedipine in the acute treatment of severe hypertension. Arch Intern Med. 1987;147(3):556–558.
- , , . Rapid reduction of severe asymptomatic hypertension. A prospective, controlled trial. Arch Intern Med. 1989;149(10):2186–2189.
- , , . Nifedipine‐associated myocardial ischemia or infarction in the treatment of hypertensive urgencies. Ann Intern Med. 1987;107(2):185–186.
- , , , , . Stroke precipitated by moderate blood pressure reduction. J Emerg Med. 2000;9(4):339–346.
- , , , . Adverse events associated with aggressive treatment of increased blood pressure. Int J Clin Prac. 2004;58(5):517–519.
- , , , et al. Attitudes and practices of resident physicians regarding hypertension in the inpatient setting. J Clin Hypertens. 2010;12(9):698–705.
- , , , . Intravenous hydralazine for blood pressure management in the hospitalized patient: its use is often unjustified. J Am Soc Hypertens. 2011;5(6):473–477.
- , , , et al. Treatment of hypertension in the prevention and management of ischemic heart disease: a scientific statement from the American Heart Association Council for High Blood Pressure Research and the Councils on Clinical Cardiology and Epidemiology and Prevention. Circulation. 2007;115(21):2761–2788.
- , , , et al. 2014 evidence‐based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507–520.
- , . Hypertensive crises: challenges and management. Chest. 2007;131(6):1949–1962.
- , . Severely increased blood pressure in the emergency department. Ann Emerg Med. 2003;41(4):513–529.
- , , , , ; American College of Emergency Physicians Clinical Policies Subcommittee on Asymptomatic Hypertension in the ED. Clinical policy: critical issues in the evaluation and management of adult patients with asymptomatic hypertension in the emergency department. Ann Emerg Med.2006;47(3):237–249.
- , , , et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19):2560–2572.
- , . Best Evidence on management of asymptomatic hypertension in ED patients. J Emerg Nurs. 2011;37(2):174–178.
- , , , et al. A novel pathway for the management of hypertension for hospitalized patients. Crit Pathw Cardiol. 2007;6(4):150–160.
- , . Treatment of hypertension in the inpatient setting: use of intravenous labetalol and hydralazine. J Clin Hypertens (Greenwich). 2010;12(1):29–33.
- , , , et al. Patterns of antihypertensive treatment in patients with acute severe hypertension from a nonneurologic cause: Studying the Treatment of Acute Hypertension (STAT) registry. Pharmacotherapy. 2010;30(11):1087–1096.
- , , , , . Does earlier attainment of blood pressure goal translate into fewer cardiovascular events? Curr Hypertens Rep. 2008;10(5):398–404.
- . Symptomatic hypotension induced by nifedipine in the acute treatment of severe hypertension. Arch Intern Med. 1987;147(3):556–558.
- , , . Rapid reduction of severe asymptomatic hypertension. A prospective, controlled trial. Arch Intern Med. 1989;149(10):2186–2189.
- , , . Nifedipine‐associated myocardial ischemia or infarction in the treatment of hypertensive urgencies. Ann Intern Med. 1987;107(2):185–186.
- , , , , . Stroke precipitated by moderate blood pressure reduction. J Emerg Med. 2000;9(4):339–346.
- , , , . Adverse events associated with aggressive treatment of increased blood pressure. Int J Clin Prac. 2004;58(5):517–519.
- , , , et al. Attitudes and practices of resident physicians regarding hypertension in the inpatient setting. J Clin Hypertens. 2010;12(9):698–705.
- , , , . Intravenous hydralazine for blood pressure management in the hospitalized patient: its use is often unjustified. J Am Soc Hypertens. 2011;5(6):473–477.
© 2015 Society of Hospital Medicine
Appropriateness of Antibiotics for UTIs
After pneumonia, urinary tract infection (UTI) is the second most commonly diagnosed infection leading to hospitalization.[1] However, a large proportion of those admitted with a diagnosis of UTI do not meet diagnostic criteria and receive inappropriate antibiotic therapy.[2, 3] Because antibiotic treatment often begins in the emergency department (ED), we conducted a study to determine the rate of initiation of inappropriate antibiotic treatment for UTIs in the ED and the rate of continuation of inappropriate antibiotics after admission to the hospital.
METHODS
We retrospectively identified all patients admitted from the ED of Johns Hopkins Bayview Medical Center, a tertiary, acute care hospital during 4 nonconsecutive weeks in the winter of 2012 to 2013. We reviewed ED and hospital records of all patients with positive urinalyses who initiated antibiotic treatment in the ED for a diagnosis of UTI. A positive urinalysis was defined as the presence of more than 5 leukocytes per high‐power field, leukocyte esterase, or nitrites. In the ED, approximately two‐thirds of urinalyses were ordered via order sets, and the majority of patients were evaluated by nurse practitioners and physician assistants.
In the absence of specific guidelines for the treatment of UTIs in the ED, criteria for this study were based on the Centers for Disease Control and Prevention (CDC) surveillance definitions,[4] the Infectious Diseases Society of America guidelines for asymptomatic bacteriuria,[5] and the Society for Healthcare Epidemiology of America (SHEA) criteria for diagnosing and treating UTIs in long‐term care facilities.[6, 7] We defined initiation of antibiotic treatment in the ED for a potential UTI as appropriate only if the patient had a positive urinalysis and 1 or more of the following: (1) fever (temperature >38C), (2) a urinary symptom or sign (urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), (3) an indication for treating asymptomatic bacteriuria (pregnancy or a planned invasive urologic procedure), or (4) altered mental status in the presence of a chronic urinary catheter.[6, 7] Continuation of antibiotics was considered inappropriate if 1 or more doses were given after admission to patients who did not meet the above criteria for appropriate initiation of antibiotics (regardless of urine culture results). For patients who met the above criteria, continuation was considered inappropriate if the urine culture grew no organisms or only grew nonpathogenic urogenital flora and the patient received antibiotics for 3 or more days.
Urine culture results were reported as positive if >104 organisms per milliliter grew on semiquantitative culture. The following were considered potential uropathogens: enteric gram‐negative rods (GNRs), nonlactose fermenting GNRs, Corynebacterium urealyticum, yeast, group B streptococci, Enterococcus spp., Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus lugdunensis, and Aerococcus urinae. More than 2 potential uropathogens were reported as mixed fecal flora. The following were considered to be nonpathogenic urogenital flora: coagulase‐negative staphylococci not designated as potential uropathogens, Lactobacillus spp, urease‐negative Corynebacterium, viridans group streptococci, and Gardnerella vaginalis. Specimens with mixed fecal flora and specimens with 1 to 2 uropathogens were grouped together as containing a potential uropathogen. Cultures that grew no organisms or only nonpathogenic urogenital flora were labeled as containing no uropathogen.
RESULTS
Of 1163 patients admitted to the hospital from the ED, 138 began antibiotic therapy for either a presumed UTI (94 patients) or another infection (44) (Figure 1). Non‐UTI infections included pneumonia (23), skin and soft tissue infection (9), intra‐abdominal infection (8), and other (4).
For the 94 patients treated for a UTI in the ED, the mean age was 67 years, and 77% were women. Ten had a chronic urinary catheter, and 13 came from a long‐term care facility. Eighty of these patients continued antibiotics after admission.
According to study criteria, 55 of the 94 patients (59%) who initiated treatment for a UTI in the ED had no indication to do so. These 55 patients had a variety of admitting diagnoses other than UTI (Table 1); 25% were admitted with altered mental status. Forty‐four of these 55 (80%) continued antibiotics (inappropriately) after admission, including 11 patients whose urine cultures grew no uropathogens.
| Admission Diagnosis | No. of Patients With Diagnosis (%) | Mean Age, y | No. of Women (%) | No. of Patients Continuing Antibiotics After Admission (%) |
|---|---|---|---|---|
| ||||
| Altered mental status* | 14 (25) | 76 | 11 (79) | 14 (100) |
| Syncope or near syncope | 7 (13) | 72 | 6 (86) | 5 (71) |
| Other neurologic conditions | 6 (11) | 64 | 5 (83) | 6 (100) |
| Mechanical falls | 6 (11) | 85 | 5 (83) | 4 (67) |
| Gastrointestinal conditions | 8 (15) | 53 | 6 (75) | 3 (38) |
| Psychiatric conditions | 3 (5) | 32 | 4 (100) | 4 (100) |
| Other | 11 (20) | 72 | 9 (79) | 9 (79) |
| All patients | 55 (100) | 69 | 46 (84) | 45 (82) |
Of the 39 patients with an indication to initiate treatment for a possible UTI, 13 had urine cultures (taken before antibiotics were administered) that grew no uropathogens, yet 10 of these patients continued antibiotics inappropriately after admission (Figure 1).
In summary, initiation of antibiotics in the ED was inappropriate for 55 of 94 patients (59% [95% confidence interval {CI}, 48%‐69%]), and continuation after admission was inappropriate for 54 of 80 patients (68% [95% CI, 57%‐78%]).
DISCUSSION
According to study criteria, the majority of patients treated for a UTI in the ED before admission initiated antibiotic treatment inappropriately in the ED and continued antibiotics inappropriately after admission. Our findings suggest several points where intervention could interrupt this chain of events.
Reducing the number of urinalyses ordered in the ED could reduce inappropriate treatment.[8] In this study, 43% of patients admitted from the ED had urinalyses, many obtained via order sets before evaluation by a clinician. Although triage order sets improve ED throughput,[9] they also produce extraneous results that may lead to unnecessary interventions. We suggest removing urinalyses from order sets for conditions for which a UTI is unlikely to contribute.
In this study altered mental status was a common diagnosis among patients categorized as receiving inappropriate antibiotics in the ED. All patients with altered mental status continued antibiotic treatment after admission. According to the study definition (and CDC and SHEA criteria[4, 6, 7]), bacteriuria and altered mental status without additional criteria (urinary symptoms or signs, fever, or an indwelling urinary catheter) are insufficient for the diagnosis of a symptomatic UTI. Since the study was conducted, the CDC surveillance definition for UTIs in long‐term care has been updated and now includes the new onset of confusion in catheterized individuals only if leukocytosis is also present.[10] Because patients at the greatest risk of developing altered mental statusthe frail elderlyalso have high rates of asymptomatic bacteriuria (up to 40%50% in nursing home residents[5]), the 2 conditions co‐occur frequently by chance alone. Although it is common to attribute altered mental status in a patient with pyuria or bacteriuria to a UTI, there are no convincing data to support a causal relationship for patients who are otherwise asymptomatic.[11] An alternative approach for stable patients is careful observation while withholding antibiotics and looking for other causes of altered mental status.[11]
Inappropriate treatment may also stem from misunderstanding the significance of asymptomatic pyuria and bacteriuria, common findings in certain populations. The only evidence‐based indications for treatment of asymptomatic bacteriuria are pregnancy and planned invasive urinary tract procedures.[5] For several other populations, strong randomized trials show no benefit.[5]
Obtaining a good specimen for urinalysis and culture is often problematic. In this study, 37 of 88 cultures (42%) grew mixed fecal or nonpathogenic urogenital flora and appeared to be contaminated. Reporting techniques can be influential.[12] Microbiology reports could state that mixed urogenital flora and mixed fecal flora often represent contamination.
Human factors may also contribute to the inappropriate continuation of antibiotic therapy started in the ED. Hospital providers may not question a diagnosis made by another provider, especially if no alternative diagnosis emerges. Coincidental improvement with antimicrobial treatment may be mistaken as evidence of efficacy. Clinicians may be reluctant to tell a patient or family that the initial diagnosis and treatment plan were incorrect.
This study has several limitations. First, this review was retrospective. Omission of undocumented symptoms could lead to an overestimation of inappropriate antibiotic treatment. Alternatively, several factors could lead to an underestimation: patients treated for a UTI in the ED were identified only among those with positive urinalyses; cultures with mixed fecal flora were accepted as containing a potential uropathogen in spite of the high likelihood of contamination. Also, the study definition of appropriate antibiotic treatment was less stringent than guidelines on which it was based. The generalizability is limited by the single‐center design, and results may not apply to centers with different staffing in their EDs or less utilization of order sets. Finally, the study definition was derived from guidelines that were not developed specifically for use in the ED.
In conclusion, we found a high rate of inappropriate antibiotic administration for UTIs that began in the ED and continued after admission. Overall, providers in the ED should aim not to detect or treat asymptomatic pyuria, and clinicians in the hospital should reevaluate the need for antibiotic treatment started in the ED. Specific guidelines should be developed and validated to direct diagnosis and treatment of UTIs in the ED and hospital.
Disclosures: The information in this article was presented in part at the Society of Hospital Medicine annual meeting on March 2427, 2014. No financial support was provided, and no conflicts of interest exist for any author.
- , , , , , . Infectious disease hospitalizations in the United States. Clin Infect Dis. 2009;49:1025–1035.
- , . Reducing antibiotic overuse: a call for a national performance measure for not treating asymptomatic bacteriuria. Clin Infect Dis. 2007;45:1335–1337.
- , , , , . Importance of urinary tract infection to antibiotic use among hospitalized patients. Infect Control Hosp Epidemiol. 2009;30:193–195.
- Centers for Disease Control and Prevention. CDC/NHSN surveillance definition of healthcare‐associated infection and criteria for specific types of infections in the acute care setting. 2013. Available at: http://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf. Accessed August 2014.
- , , , et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40(5):643–654.
- , , , et al. Development of minimum criteria for the initiation of antibiotics in residents of long‐term–care facilities: results of a consensus conference. Infect Control Hosp Epidemiol. 2001;22:120–124.
- , , , et al. Effect of a multifaceted intervention on number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes: cluster randomised controlled trial. BMJ. 2005;331(7518):669.
- , , . Urinalysis orders among patients admitted to the general medicine service. JAMA Intern Med. 2015;175(10):1711–1713.
- , , , , . The effect of triage diagnostic standing orders on emergency department treatment time. Ann Emerg Med. 2011;57:89–99.
- Centers for Disease Control and Prevention. Urinary tract infection (UTI) event for long‐term care facilities. Available at: http://www.cdc.gov/nhsn/PDFs/LTC/LTCF‐UTI‐protocol_FINAL_8‐24‐2012.pdf. Accessed September 2015.
- , , , . Bacteriuria in patients who become delirious. Am J Med. 2014;127:255–257.
- , , , et al. Reducing antimicrobial therapy for asymptomatic bacteriuria among noncatheterized inpatients: a proof‐of‐concept study. Clin Infect Dis. 2014;58:980–983.
After pneumonia, urinary tract infection (UTI) is the second most commonly diagnosed infection leading to hospitalization.[1] However, a large proportion of those admitted with a diagnosis of UTI do not meet diagnostic criteria and receive inappropriate antibiotic therapy.[2, 3] Because antibiotic treatment often begins in the emergency department (ED), we conducted a study to determine the rate of initiation of inappropriate antibiotic treatment for UTIs in the ED and the rate of continuation of inappropriate antibiotics after admission to the hospital.
METHODS
We retrospectively identified all patients admitted from the ED of Johns Hopkins Bayview Medical Center, a tertiary, acute care hospital during 4 nonconsecutive weeks in the winter of 2012 to 2013. We reviewed ED and hospital records of all patients with positive urinalyses who initiated antibiotic treatment in the ED for a diagnosis of UTI. A positive urinalysis was defined as the presence of more than 5 leukocytes per high‐power field, leukocyte esterase, or nitrites. In the ED, approximately two‐thirds of urinalyses were ordered via order sets, and the majority of patients were evaluated by nurse practitioners and physician assistants.
In the absence of specific guidelines for the treatment of UTIs in the ED, criteria for this study were based on the Centers for Disease Control and Prevention (CDC) surveillance definitions,[4] the Infectious Diseases Society of America guidelines for asymptomatic bacteriuria,[5] and the Society for Healthcare Epidemiology of America (SHEA) criteria for diagnosing and treating UTIs in long‐term care facilities.[6, 7] We defined initiation of antibiotic treatment in the ED for a potential UTI as appropriate only if the patient had a positive urinalysis and 1 or more of the following: (1) fever (temperature >38C), (2) a urinary symptom or sign (urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), (3) an indication for treating asymptomatic bacteriuria (pregnancy or a planned invasive urologic procedure), or (4) altered mental status in the presence of a chronic urinary catheter.[6, 7] Continuation of antibiotics was considered inappropriate if 1 or more doses were given after admission to patients who did not meet the above criteria for appropriate initiation of antibiotics (regardless of urine culture results). For patients who met the above criteria, continuation was considered inappropriate if the urine culture grew no organisms or only grew nonpathogenic urogenital flora and the patient received antibiotics for 3 or more days.
Urine culture results were reported as positive if >104 organisms per milliliter grew on semiquantitative culture. The following were considered potential uropathogens: enteric gram‐negative rods (GNRs), nonlactose fermenting GNRs, Corynebacterium urealyticum, yeast, group B streptococci, Enterococcus spp., Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus lugdunensis, and Aerococcus urinae. More than 2 potential uropathogens were reported as mixed fecal flora. The following were considered to be nonpathogenic urogenital flora: coagulase‐negative staphylococci not designated as potential uropathogens, Lactobacillus spp, urease‐negative Corynebacterium, viridans group streptococci, and Gardnerella vaginalis. Specimens with mixed fecal flora and specimens with 1 to 2 uropathogens were grouped together as containing a potential uropathogen. Cultures that grew no organisms or only nonpathogenic urogenital flora were labeled as containing no uropathogen.
RESULTS
Of 1163 patients admitted to the hospital from the ED, 138 began antibiotic therapy for either a presumed UTI (94 patients) or another infection (44) (Figure 1). Non‐UTI infections included pneumonia (23), skin and soft tissue infection (9), intra‐abdominal infection (8), and other (4).
For the 94 patients treated for a UTI in the ED, the mean age was 67 years, and 77% were women. Ten had a chronic urinary catheter, and 13 came from a long‐term care facility. Eighty of these patients continued antibiotics after admission.
According to study criteria, 55 of the 94 patients (59%) who initiated treatment for a UTI in the ED had no indication to do so. These 55 patients had a variety of admitting diagnoses other than UTI (Table 1); 25% were admitted with altered mental status. Forty‐four of these 55 (80%) continued antibiotics (inappropriately) after admission, including 11 patients whose urine cultures grew no uropathogens.
| Admission Diagnosis | No. of Patients With Diagnosis (%) | Mean Age, y | No. of Women (%) | No. of Patients Continuing Antibiotics After Admission (%) |
|---|---|---|---|---|
| ||||
| Altered mental status* | 14 (25) | 76 | 11 (79) | 14 (100) |
| Syncope or near syncope | 7 (13) | 72 | 6 (86) | 5 (71) |
| Other neurologic conditions | 6 (11) | 64 | 5 (83) | 6 (100) |
| Mechanical falls | 6 (11) | 85 | 5 (83) | 4 (67) |
| Gastrointestinal conditions | 8 (15) | 53 | 6 (75) | 3 (38) |
| Psychiatric conditions | 3 (5) | 32 | 4 (100) | 4 (100) |
| Other | 11 (20) | 72 | 9 (79) | 9 (79) |
| All patients | 55 (100) | 69 | 46 (84) | 45 (82) |
Of the 39 patients with an indication to initiate treatment for a possible UTI, 13 had urine cultures (taken before antibiotics were administered) that grew no uropathogens, yet 10 of these patients continued antibiotics inappropriately after admission (Figure 1).
In summary, initiation of antibiotics in the ED was inappropriate for 55 of 94 patients (59% [95% confidence interval {CI}, 48%‐69%]), and continuation after admission was inappropriate for 54 of 80 patients (68% [95% CI, 57%‐78%]).
DISCUSSION
According to study criteria, the majority of patients treated for a UTI in the ED before admission initiated antibiotic treatment inappropriately in the ED and continued antibiotics inappropriately after admission. Our findings suggest several points where intervention could interrupt this chain of events.
Reducing the number of urinalyses ordered in the ED could reduce inappropriate treatment.[8] In this study, 43% of patients admitted from the ED had urinalyses, many obtained via order sets before evaluation by a clinician. Although triage order sets improve ED throughput,[9] they also produce extraneous results that may lead to unnecessary interventions. We suggest removing urinalyses from order sets for conditions for which a UTI is unlikely to contribute.
In this study altered mental status was a common diagnosis among patients categorized as receiving inappropriate antibiotics in the ED. All patients with altered mental status continued antibiotic treatment after admission. According to the study definition (and CDC and SHEA criteria[4, 6, 7]), bacteriuria and altered mental status without additional criteria (urinary symptoms or signs, fever, or an indwelling urinary catheter) are insufficient for the diagnosis of a symptomatic UTI. Since the study was conducted, the CDC surveillance definition for UTIs in long‐term care has been updated and now includes the new onset of confusion in catheterized individuals only if leukocytosis is also present.[10] Because patients at the greatest risk of developing altered mental statusthe frail elderlyalso have high rates of asymptomatic bacteriuria (up to 40%50% in nursing home residents[5]), the 2 conditions co‐occur frequently by chance alone. Although it is common to attribute altered mental status in a patient with pyuria or bacteriuria to a UTI, there are no convincing data to support a causal relationship for patients who are otherwise asymptomatic.[11] An alternative approach for stable patients is careful observation while withholding antibiotics and looking for other causes of altered mental status.[11]
Inappropriate treatment may also stem from misunderstanding the significance of asymptomatic pyuria and bacteriuria, common findings in certain populations. The only evidence‐based indications for treatment of asymptomatic bacteriuria are pregnancy and planned invasive urinary tract procedures.[5] For several other populations, strong randomized trials show no benefit.[5]
Obtaining a good specimen for urinalysis and culture is often problematic. In this study, 37 of 88 cultures (42%) grew mixed fecal or nonpathogenic urogenital flora and appeared to be contaminated. Reporting techniques can be influential.[12] Microbiology reports could state that mixed urogenital flora and mixed fecal flora often represent contamination.
Human factors may also contribute to the inappropriate continuation of antibiotic therapy started in the ED. Hospital providers may not question a diagnosis made by another provider, especially if no alternative diagnosis emerges. Coincidental improvement with antimicrobial treatment may be mistaken as evidence of efficacy. Clinicians may be reluctant to tell a patient or family that the initial diagnosis and treatment plan were incorrect.
This study has several limitations. First, this review was retrospective. Omission of undocumented symptoms could lead to an overestimation of inappropriate antibiotic treatment. Alternatively, several factors could lead to an underestimation: patients treated for a UTI in the ED were identified only among those with positive urinalyses; cultures with mixed fecal flora were accepted as containing a potential uropathogen in spite of the high likelihood of contamination. Also, the study definition of appropriate antibiotic treatment was less stringent than guidelines on which it was based. The generalizability is limited by the single‐center design, and results may not apply to centers with different staffing in their EDs or less utilization of order sets. Finally, the study definition was derived from guidelines that were not developed specifically for use in the ED.
In conclusion, we found a high rate of inappropriate antibiotic administration for UTIs that began in the ED and continued after admission. Overall, providers in the ED should aim not to detect or treat asymptomatic pyuria, and clinicians in the hospital should reevaluate the need for antibiotic treatment started in the ED. Specific guidelines should be developed and validated to direct diagnosis and treatment of UTIs in the ED and hospital.
Disclosures: The information in this article was presented in part at the Society of Hospital Medicine annual meeting on March 2427, 2014. No financial support was provided, and no conflicts of interest exist for any author.
After pneumonia, urinary tract infection (UTI) is the second most commonly diagnosed infection leading to hospitalization.[1] However, a large proportion of those admitted with a diagnosis of UTI do not meet diagnostic criteria and receive inappropriate antibiotic therapy.[2, 3] Because antibiotic treatment often begins in the emergency department (ED), we conducted a study to determine the rate of initiation of inappropriate antibiotic treatment for UTIs in the ED and the rate of continuation of inappropriate antibiotics after admission to the hospital.
METHODS
We retrospectively identified all patients admitted from the ED of Johns Hopkins Bayview Medical Center, a tertiary, acute care hospital during 4 nonconsecutive weeks in the winter of 2012 to 2013. We reviewed ED and hospital records of all patients with positive urinalyses who initiated antibiotic treatment in the ED for a diagnosis of UTI. A positive urinalysis was defined as the presence of more than 5 leukocytes per high‐power field, leukocyte esterase, or nitrites. In the ED, approximately two‐thirds of urinalyses were ordered via order sets, and the majority of patients were evaluated by nurse practitioners and physician assistants.
In the absence of specific guidelines for the treatment of UTIs in the ED, criteria for this study were based on the Centers for Disease Control and Prevention (CDC) surveillance definitions,[4] the Infectious Diseases Society of America guidelines for asymptomatic bacteriuria,[5] and the Society for Healthcare Epidemiology of America (SHEA) criteria for diagnosing and treating UTIs in long‐term care facilities.[6, 7] We defined initiation of antibiotic treatment in the ED for a potential UTI as appropriate only if the patient had a positive urinalysis and 1 or more of the following: (1) fever (temperature >38C), (2) a urinary symptom or sign (urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), (3) an indication for treating asymptomatic bacteriuria (pregnancy or a planned invasive urologic procedure), or (4) altered mental status in the presence of a chronic urinary catheter.[6, 7] Continuation of antibiotics was considered inappropriate if 1 or more doses were given after admission to patients who did not meet the above criteria for appropriate initiation of antibiotics (regardless of urine culture results). For patients who met the above criteria, continuation was considered inappropriate if the urine culture grew no organisms or only grew nonpathogenic urogenital flora and the patient received antibiotics for 3 or more days.
Urine culture results were reported as positive if >104 organisms per milliliter grew on semiquantitative culture. The following were considered potential uropathogens: enteric gram‐negative rods (GNRs), nonlactose fermenting GNRs, Corynebacterium urealyticum, yeast, group B streptococci, Enterococcus spp., Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus lugdunensis, and Aerococcus urinae. More than 2 potential uropathogens were reported as mixed fecal flora. The following were considered to be nonpathogenic urogenital flora: coagulase‐negative staphylococci not designated as potential uropathogens, Lactobacillus spp, urease‐negative Corynebacterium, viridans group streptococci, and Gardnerella vaginalis. Specimens with mixed fecal flora and specimens with 1 to 2 uropathogens were grouped together as containing a potential uropathogen. Cultures that grew no organisms or only nonpathogenic urogenital flora were labeled as containing no uropathogen.
RESULTS
Of 1163 patients admitted to the hospital from the ED, 138 began antibiotic therapy for either a presumed UTI (94 patients) or another infection (44) (Figure 1). Non‐UTI infections included pneumonia (23), skin and soft tissue infection (9), intra‐abdominal infection (8), and other (4).
For the 94 patients treated for a UTI in the ED, the mean age was 67 years, and 77% were women. Ten had a chronic urinary catheter, and 13 came from a long‐term care facility. Eighty of these patients continued antibiotics after admission.
According to study criteria, 55 of the 94 patients (59%) who initiated treatment for a UTI in the ED had no indication to do so. These 55 patients had a variety of admitting diagnoses other than UTI (Table 1); 25% were admitted with altered mental status. Forty‐four of these 55 (80%) continued antibiotics (inappropriately) after admission, including 11 patients whose urine cultures grew no uropathogens.
| Admission Diagnosis | No. of Patients With Diagnosis (%) | Mean Age, y | No. of Women (%) | No. of Patients Continuing Antibiotics After Admission (%) |
|---|---|---|---|---|
| ||||
| Altered mental status* | 14 (25) | 76 | 11 (79) | 14 (100) |
| Syncope or near syncope | 7 (13) | 72 | 6 (86) | 5 (71) |
| Other neurologic conditions | 6 (11) | 64 | 5 (83) | 6 (100) |
| Mechanical falls | 6 (11) | 85 | 5 (83) | 4 (67) |
| Gastrointestinal conditions | 8 (15) | 53 | 6 (75) | 3 (38) |
| Psychiatric conditions | 3 (5) | 32 | 4 (100) | 4 (100) |
| Other | 11 (20) | 72 | 9 (79) | 9 (79) |
| All patients | 55 (100) | 69 | 46 (84) | 45 (82) |
Of the 39 patients with an indication to initiate treatment for a possible UTI, 13 had urine cultures (taken before antibiotics were administered) that grew no uropathogens, yet 10 of these patients continued antibiotics inappropriately after admission (Figure 1).
In summary, initiation of antibiotics in the ED was inappropriate for 55 of 94 patients (59% [95% confidence interval {CI}, 48%‐69%]), and continuation after admission was inappropriate for 54 of 80 patients (68% [95% CI, 57%‐78%]).
DISCUSSION
According to study criteria, the majority of patients treated for a UTI in the ED before admission initiated antibiotic treatment inappropriately in the ED and continued antibiotics inappropriately after admission. Our findings suggest several points where intervention could interrupt this chain of events.
Reducing the number of urinalyses ordered in the ED could reduce inappropriate treatment.[8] In this study, 43% of patients admitted from the ED had urinalyses, many obtained via order sets before evaluation by a clinician. Although triage order sets improve ED throughput,[9] they also produce extraneous results that may lead to unnecessary interventions. We suggest removing urinalyses from order sets for conditions for which a UTI is unlikely to contribute.
In this study altered mental status was a common diagnosis among patients categorized as receiving inappropriate antibiotics in the ED. All patients with altered mental status continued antibiotic treatment after admission. According to the study definition (and CDC and SHEA criteria[4, 6, 7]), bacteriuria and altered mental status without additional criteria (urinary symptoms or signs, fever, or an indwelling urinary catheter) are insufficient for the diagnosis of a symptomatic UTI. Since the study was conducted, the CDC surveillance definition for UTIs in long‐term care has been updated and now includes the new onset of confusion in catheterized individuals only if leukocytosis is also present.[10] Because patients at the greatest risk of developing altered mental statusthe frail elderlyalso have high rates of asymptomatic bacteriuria (up to 40%50% in nursing home residents[5]), the 2 conditions co‐occur frequently by chance alone. Although it is common to attribute altered mental status in a patient with pyuria or bacteriuria to a UTI, there are no convincing data to support a causal relationship for patients who are otherwise asymptomatic.[11] An alternative approach for stable patients is careful observation while withholding antibiotics and looking for other causes of altered mental status.[11]
Inappropriate treatment may also stem from misunderstanding the significance of asymptomatic pyuria and bacteriuria, common findings in certain populations. The only evidence‐based indications for treatment of asymptomatic bacteriuria are pregnancy and planned invasive urinary tract procedures.[5] For several other populations, strong randomized trials show no benefit.[5]
Obtaining a good specimen for urinalysis and culture is often problematic. In this study, 37 of 88 cultures (42%) grew mixed fecal or nonpathogenic urogenital flora and appeared to be contaminated. Reporting techniques can be influential.[12] Microbiology reports could state that mixed urogenital flora and mixed fecal flora often represent contamination.
Human factors may also contribute to the inappropriate continuation of antibiotic therapy started in the ED. Hospital providers may not question a diagnosis made by another provider, especially if no alternative diagnosis emerges. Coincidental improvement with antimicrobial treatment may be mistaken as evidence of efficacy. Clinicians may be reluctant to tell a patient or family that the initial diagnosis and treatment plan were incorrect.
This study has several limitations. First, this review was retrospective. Omission of undocumented symptoms could lead to an overestimation of inappropriate antibiotic treatment. Alternatively, several factors could lead to an underestimation: patients treated for a UTI in the ED were identified only among those with positive urinalyses; cultures with mixed fecal flora were accepted as containing a potential uropathogen in spite of the high likelihood of contamination. Also, the study definition of appropriate antibiotic treatment was less stringent than guidelines on which it was based. The generalizability is limited by the single‐center design, and results may not apply to centers with different staffing in their EDs or less utilization of order sets. Finally, the study definition was derived from guidelines that were not developed specifically for use in the ED.
In conclusion, we found a high rate of inappropriate antibiotic administration for UTIs that began in the ED and continued after admission. Overall, providers in the ED should aim not to detect or treat asymptomatic pyuria, and clinicians in the hospital should reevaluate the need for antibiotic treatment started in the ED. Specific guidelines should be developed and validated to direct diagnosis and treatment of UTIs in the ED and hospital.
Disclosures: The information in this article was presented in part at the Society of Hospital Medicine annual meeting on March 2427, 2014. No financial support was provided, and no conflicts of interest exist for any author.
- , , , , , . Infectious disease hospitalizations in the United States. Clin Infect Dis. 2009;49:1025–1035.
- , . Reducing antibiotic overuse: a call for a national performance measure for not treating asymptomatic bacteriuria. Clin Infect Dis. 2007;45:1335–1337.
- , , , , . Importance of urinary tract infection to antibiotic use among hospitalized patients. Infect Control Hosp Epidemiol. 2009;30:193–195.
- Centers for Disease Control and Prevention. CDC/NHSN surveillance definition of healthcare‐associated infection and criteria for specific types of infections in the acute care setting. 2013. Available at: http://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf. Accessed August 2014.
- , , , et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40(5):643–654.
- , , , et al. Development of minimum criteria for the initiation of antibiotics in residents of long‐term–care facilities: results of a consensus conference. Infect Control Hosp Epidemiol. 2001;22:120–124.
- , , , et al. Effect of a multifaceted intervention on number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes: cluster randomised controlled trial. BMJ. 2005;331(7518):669.
- , , . Urinalysis orders among patients admitted to the general medicine service. JAMA Intern Med. 2015;175(10):1711–1713.
- , , , , . The effect of triage diagnostic standing orders on emergency department treatment time. Ann Emerg Med. 2011;57:89–99.
- Centers for Disease Control and Prevention. Urinary tract infection (UTI) event for long‐term care facilities. Available at: http://www.cdc.gov/nhsn/PDFs/LTC/LTCF‐UTI‐protocol_FINAL_8‐24‐2012.pdf. Accessed September 2015.
- , , , . Bacteriuria in patients who become delirious. Am J Med. 2014;127:255–257.
- , , , et al. Reducing antimicrobial therapy for asymptomatic bacteriuria among noncatheterized inpatients: a proof‐of‐concept study. Clin Infect Dis. 2014;58:980–983.
- , , , , , . Infectious disease hospitalizations in the United States. Clin Infect Dis. 2009;49:1025–1035.
- , . Reducing antibiotic overuse: a call for a national performance measure for not treating asymptomatic bacteriuria. Clin Infect Dis. 2007;45:1335–1337.
- , , , , . Importance of urinary tract infection to antibiotic use among hospitalized patients. Infect Control Hosp Epidemiol. 2009;30:193–195.
- Centers for Disease Control and Prevention. CDC/NHSN surveillance definition of healthcare‐associated infection and criteria for specific types of infections in the acute care setting. 2013. Available at: http://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf. Accessed August 2014.
- , , , et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40(5):643–654.
- , , , et al. Development of minimum criteria for the initiation of antibiotics in residents of long‐term–care facilities: results of a consensus conference. Infect Control Hosp Epidemiol. 2001;22:120–124.
- , , , et al. Effect of a multifaceted intervention on number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes: cluster randomised controlled trial. BMJ. 2005;331(7518):669.
- , , . Urinalysis orders among patients admitted to the general medicine service. JAMA Intern Med. 2015;175(10):1711–1713.
- , , , , . The effect of triage diagnostic standing orders on emergency department treatment time. Ann Emerg Med. 2011;57:89–99.
- Centers for Disease Control and Prevention. Urinary tract infection (UTI) event for long‐term care facilities. Available at: http://www.cdc.gov/nhsn/PDFs/LTC/LTCF‐UTI‐protocol_FINAL_8‐24‐2012.pdf. Accessed September 2015.
- , , , . Bacteriuria in patients who become delirious. Am J Med. 2014;127:255–257.
- , , , et al. Reducing antimicrobial therapy for asymptomatic bacteriuria among noncatheterized inpatients: a proof‐of‐concept study. Clin Infect Dis. 2014;58:980–983.
© 2015 Society of Hospital Medicine
EHR use and patient satisfaction: What we learned
ABSTRACT
Purpose Few studies have quantitatively examined the degree to which the use of the computer affects patients’ satisfaction with the clinician and the quality of the visit. We conducted a study to examine this association.
Methods Twenty-three clinicians (21 internal medicine physicians, 2 nurse practitioners) were recruited from 4 Veteran Affairs Medical Center (VAMC) clinics located in San Diego, Calif. Five to 6 patients for most clinicians (one patient each for 2 of the clinicians) were recruited to participate in a study of patient-physician communication. The clinicians’ computer use and the patient-clinician interactions in the exam room were captured in real time via video recordings of the interactions and the computer screen, and through the use of the Morae usability testing software system, which recorded clinician clicks and scrolls on the computer. After the visit, patients were asked to complete a satisfaction survey.
Results The final sample consisted of 126 consultations. Total patient satisfaction (beta=0.014; P=.027) and patient satisfaction with patient-centered communication (beta=0.02; P=.02) were significantly associated with higher clinician “gaze time” at the patient. A higher percentage of gaze time during a visit (controlling for the length of the visit) was significantly associated with greater satisfaction with patient-centered communication (beta=0.628; P=.033).
Conclusions Higher clinician gaze time at the patient predicted greater patient satisfaction. This suggests that clinicians would be well served to refine their multitasking skills so that they communicate in a patient-centered manner while performing necessary computer-related tasks. These findings also have important implications for clinical training with respect to using an electronic health record (EHR) system in ways that do not impede the one-on-one conversation between clinician and patient.
Primary care physicians’ use of electronic health record (EHR) systems has markedly increased in recent years. For example, a 2008 study of more than 1000 randomly selected practicing physicians in Massachusetts found that 33% utilized an EHR.1 Many physicians believe that EHR systems are beneficial to patient care,2 and several studies have supported this perception, showing clear benefits of EHR use. A study of one component of EHR systems—computerized physician order entry (CPOE)—found that CPOEs resulted in a >50% decrease in serious medication errors.3 Other errors have declined with the use of EHR systems, as well; Virapongse et al1 found a trend towards fewer paid malpractice claims against physicians who used an EHR compared to those physicians using paper charting.
EHR systems may also improve efficiency. In a study of a health maintenance organization (HMO) model, initiating an EHR system improved efficiency by decreasing office visits.4 Widespread adoption of EHR systems could save an estimated $81 billion annually through reductions in errors and adverse events, and improved preventive care and chronic disease management.5 In a survey of approximately 300 patients who had been evaluated at a family medicine clinic for hypertension, high blood pressure without hypertension, or hyperlipidemia, 75% indicated that they felt EHRs had a positive impact on their care.6
However, some clinicians are concerned about the possible negative impact of EHR systems on health care. One major concern is that EHR systems might increase physician workload7 and the amount of time spent using a computer during patient visits. A study that examined physician EHR use found that while time spent on certain tasks, such as prescription writing and lab ordering, was reduced, there was an overall increase in time spent on computer tasks related to charting, preventive care, and chronic disease management.8 Baron et al9 also found an increase in time spent using the EHR during each clinic session in one private practice setting.
Physicians are also concerned that EHR systems might interfere with the patient-physician interaction (eg, maintaining eye contact, paying attention to patients’ concerns) by directing the physician’s attention away from the patient and toward the computer.10 In one study, this concern increased after physicians started utilizing a new EHR system.11 Although a survey of inpatients indicated that residents engaged in greater patient-physician communication after an EHR was implemented,12 a separate study conducted in an outpatient setting found physicians spent less time looking at patients after converting from a paper-based system to an EHR system.13
Very few studies have quantitatively examined the association of patient satisfaction with clinician EHR usage. The goal of this study was to examine the correlation of patient satisfaction with actual EHR usage in an ambulatory setting. The data reported in this paper are part of a larger study aimed at understanding EHR use in a VAMC.
METHODS
Study design and sample
The study participants were clinicians in 4 VAMC community clinics located in San Diego, Calif. Twenty-three clinicians (21 general internal medicine physicians and 2 nurse practitioners) were enrolled in the study. Most clinicians identified 5 to 6 patients from their practices to participate in the study (2 participants identified only one patient each). All patients were visiting their clinician for either an acute visit or a follow-up visit.
Although there were slight variations in clinic room size and shape, all rooms were equipped with a compact desk against a wall, a rolling desk chair, a desktop computer with keyboard and mouse, and a second, fixed chair placed diagonal to the physician’s chair. Two rooms had dual monitors. There was a standard examination table in all examination rooms.
The clinicians’ computer use and the patient-clinician interactions in the exam room were captured in real time via video recordings of the interactions and the computer screen. A usability testing software system (Morae) was used to record clinicians’ computer activities, including mouse clicks and scrolls on the computer. The Computerized Patient Records System (CPRS) was the EHR used by all clinicians in this study.
At the end of the visit, patients were asked to complete a satisfaction survey with questions in 3 domains: the physician’s engagement in patient-centered communication, the physician’s clinical skills, and the physician’s interpersonal skills.
Data analysis
Descriptive statistics were used to document patient characteristics, the clinicians’ EHR usage (total number of mouse clicks and scrolls during the visit) and interaction with the patient (gaze time at EHR vs at patient and companion), and to summarize patient satisfaction with the visit. To account for clinician cluster effect, a linear mixed effects model was used to assess the associations between patient satisfaction with the clinician and 2 variables: the amount of clinician time spent viewing or using the computer and the clinician time spent interacting with the patient.
We also assessed the above associations by controlling for visit length. Visit lengths not significant at P<.10 were reported as unadjusted analyses.
All analyses were performed using R statistical software, with a P value of <.05 interpreted as statistically significant.
RESULTS
Satisfaction surveys and video and Morae data were collected for 126 individual patient office visits to the 23 participating physicians and nurses. A majority of the patients who participated in the study were older (mean: 60.5 years; standard deviation [SD]=13.4 years), male as expected in a VA setting (96.8%), Caucasian (65.1%), and had at least some college education (81.7%, TABLE 1).
Patients rated their satisfaction in 3 domains—patient-centered communication, physician clinical skills, and physician interpersonal skills—using a 1 to 5 scale (1=least satisfied, 5=most satisfied). Patients in this study were highly satisfied with their physician or nurse in all 3 domains and overall (TABLE 2), with an average satisfaction score of 4.52 ± 0.51 for patient-centered communication, 4.71 ± 0.56 for physician clinical skills, 4.86 ± 0.32 for physician interpersonal skills, and 4.64 ± 0.38 for total satisfaction.
The physicians and nurses used their EHR system extensively during the visits as delineated by the number of clicks and scrolls on the computer. The average number of clicks and scrolls was 192, with a maximum of 685 clicks and scrolls during one visit. The average visit lasted 30.7 minutes, and on average the clinician spent 12.7 minutes (SD: 8.22 minutes), or an average of about 39.4% of total visit time, viewing or working on the EHR; an average of 10.8 minutes (SD: 5.63 minutes), or an average of about 36.3% of total visit time, was spent interacting with the patient (TABLE 3).
Without adjusting for visit length, patient satisfaction with the clinicians’ patientcentered communication (beta=0.02; P=.02) and total satisfaction (beta=0.014; P=.027) were significantly associated with clinicians’ gaze time at the patient; more clinician gaze time at the patient resulted in greater patient satisfaction (TABLE 4). Adding visit length to the above models had no significant effect (P>.10); therefore, we did not include it in the models.
Patient satisfaction with clinicians’ interpersonal skills was positively associated with gaze time at the patient (beta=0.013, P =.017) without adjusting for visit length. Since the normal assumption of residuals was not plausible based on a normal probability plot, we also assessed the association by dichotomizing the score (5=very satisfied vs <5=not very satisfied) and this significance disappeared. This association was not significant while controlling for visit length.
The percentage of gaze time at the patient (the fraction of patient gaze time over the entire visit) was not significantly associated with patient-centered communication (beta=0.483, P=.12, TABLE 4) when not adjusted for visit length. After adjusting for visit length (P=.052), the association became significant (beta=0.628, P=.033); thus, the higher percentage of time the clinician spent interacting with the patient, the more satisfied the patient was.
DISCUSSION
In this study, patients were highly satisfied with their clinicians despite often high usage of the EHR. Gadd and Penrod11 reported that patients perceived no impact on communication or eye contact with the clinician despite the initiation of an EHR system in 6 large academic medical practices. Another study demonstrated no significant differences in patient satisfaction with their physicians when comparing patients whose physicians used a paper charting system with those who used an EHR system.14
The fact that patients demonstrated high levels of satisfaction with patient-clinician communication even for clinicians with high EHR usage is somewhat surprising. However, Hsu et al15 found patients’ satisfaction with their clinicians’ communication about medical issues and familiarity with them increased 7 months after implementing an EHR system. In a different study that analyzed videotaped interactions between patients and 5 physicians, the patients found it disturbing not knowing what their doctor was doing when he or she worked on the computer, and preferred being able to see the computer screen.16 This study suggests that it’s advisable for clinicians to describe what they are doing when they use the computer, so that patients better understand how this time spent inputting data actually benefits them.
EHRs can be time-consuming. Physicians and nurses in our study interacted with the EHR a great deal during the office visit, as evidenced by the large average number of clicks and scrolls. This finding confirms clinicians’ perceptions of the amount of work the EHR system requires. For example, in a semi-structured interview of physicians regarding their use of a VA EHR system,10 one respondent noted that the reminders in the EHR required hundreds of clicks.
In our study, the average number of clicks and scrolls during the visit was 192, with some clinicians registering hundreds more. In fact, concerns about the time involved in the use of the EHR and about the adequacy of data collection may lead some clinicians who currently don’t have an EHR system to be reluctant to integrate one into their practices.17
Makoul et al18 found that compared with physicians who used a paper chart, physicians who used an EHR system were more active in clarifying information from the patient and encouraging patient questions during visits, although the study found a trend toward less active roles in more patient-centered communication when using an EHR system. This latter finding is similar to the concerns raised in our study.
Clinical and communication skills are factors, too. One study found that compared to patients who were cared for by more experienced physicians, patients seen by residents using EHRs were more likely to feel that the physician spent less time talking with them and examining them; they were also more likely to report that the visit felt less personal.19 Another study found that clinicians with poor baseline communication skills had more difficulties interacting with patients when an EHR system was introduced than those who had better baseline communication skills.20
Training needed to improve communication during EHR use. Research has shown that when used properly and thoughtfully, EHR use can result in greater patient engagement.21 But, as noted above, there are challenges, suggesting a need for training clinicians to more successfully use an EHR system while simultaneously communicating with their patients.
Study limitations. This study was conducted at a single site, using a single EHR system deployed in the VA clinics. We cannot generalize our findings to other sites or types of clinic systems. Other EHR systems may have different functionalities, which may affect the time required to provide the same type of medical care.
In addition, the study involved only 23 physicians and nurses in a single health system. Other clinicians may have patterns different from those we studied, although a wide range of patterns was seen among the participants, as demonstrated by the large variation in the number of clicks and scrolls. Another limitation is that study patients were not randomly selected, but rather referred by the provider, and the visits were not blinded to either the provider or patient. This may cause some selection bias.
In this study of VA clinicians’ EHR use, patients expressed satisfaction with the clinicians’ clinical skills and patient-centered communication when the clinician spent more time and a greater percentage of the visit engaging the patient. EHR systems need to be designed in a clinician-friendly manner that allows for increased time during the interaction for face-to-face communication between the clinician and the patient, and to ease the workload of EHR documentation. In the meantime, clinicians should be trained in how to expedite their use of the EHR during the clinical visit as well as outside of the exam room in order to improve their patients’ satisfaction.
CORRESPONDENCE
Neil J. Farber, MD, University of California, San Diego, 8939 Villa La Jolla Drive, La Jolla, CA 92037; [email protected].
1. Virapongse A, Bates DW, Shi P, et al. Electronic health records and malpractice claims in office practice. Arch Intern Med. 2008;168:2362-2367.
2. DesRoches CM, Campbell EG, Rao SR, et al. Electronic health records in ambulatory care—a national survey of physicians. N Engl J Med. 2008;359:50-60.
3. Bates DW, Leape LL, Cullen DJ, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998;280:1311-1316.
4. Chen C, Garrido T, Chock D, et al. The Kaiser Permanente Electronic Health Record: transforming and streamlining modalities of care. Health Aff (Millwood). 2009;28:323-333.
5. Hillestad R, Bigelow J, Bower A, et al. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Aff (Millwood). 2005;24:1103-1117.
6. Garrison GM, Bernard ME, Rasmussen NH. 21st-century health care: the effect of computer use by physicians on patient satisfaction at a family medicine clinic. Fam Med. 2002;34:362-368.
7. Likourezos A, Chalfin DB, Murphy DG, et al. Physician and nurse satisfaction with an Electronic Medical Record system. J Emerg Med. 2004;27:419-424.
8. Howard J, Clark EC, Friedman A, et al. Electronic health record impact on work burden in small, unaffiliated, community-based primary care practices. J Gen Intern Med. 2013;28:107-113.
9. Baron RJ. What’s keeping us so busy in primary care? A snapshot from one practice. N Engl J Med. 2010;362:1632-1636.
10. Bonner LM, Simons CE, Parker LE, et al. ‘To take care of the patients’: Qualitative analysis of Veterans Health Administration personnel experiences with a clinical informatics system. Implement Sci. 2010;5:63.
11. Gadd CS, Penrod LE. Dichotomy between physicians’ and patients’ attitudes regarding EMR use during outpatient encounters. Proc AMIA Symp. 2000:275-279.
12. Migdal CW, Namavar AA, Mosley VN, et al. Impact of electronic health records on the patient experience in a hospital setting. J Hosp Med. 2014;9:627-633.
13. Asan O, D Smith P, Montague E. More screen time, less face time - implications for EHR design. J Eval Clin Pract. 2014;20:896-901.
14. Legler JD, Oates R. Patients’ reactions to physician use of a computerized medical record system during clinical encounters. J Fam Pract. 1993;37:241-244.
15. Hsu J, Huang J, Fung V, et al. Health information technology and physician-patient interactions: impact of computers on communication during outpatient primary care visits. J Am Med Inform Assoc. 2005;12:474-480.
16. Als AB. The desk-top computer as a magic box: patterns of behaviour connected with the desk-top computer; GPs’ and patients’ perceptions. Fam Pract. 1997;14:17-23.
17. Bates DW. Physicians and ambulatory electronic health records. Health Aff (Millwood). 2005;24:1180-1189.
18. Makoul G, Curry RH, Tang PC. The use of electronic medical records: communication patterns in outpatient encounters. J Am Med Inform Assoc. 2001;8:610-615.
19. Rouf E, Whittle J, Lu N, et al. Computers in the exam room: differences in physician-patient interaction may be due to physician experience. J Gen Intern Med. 2007;22:43-48.
20. Frankel R, Altschuler A, George S, et al. Effects of exam-room computing on clinician-patient communication: a longitudinal qualitative study. J Gen Intern Med. 2005;20:677-682.
21. Asan O, Young HN, Chewning B, et al. How physician electronic health record screen sharing affects patient and doctor nonverbal communication in primary care. Patient Educ Couns. 2015;98:310-316.
ABSTRACT
Purpose Few studies have quantitatively examined the degree to which the use of the computer affects patients’ satisfaction with the clinician and the quality of the visit. We conducted a study to examine this association.
Methods Twenty-three clinicians (21 internal medicine physicians, 2 nurse practitioners) were recruited from 4 Veteran Affairs Medical Center (VAMC) clinics located in San Diego, Calif. Five to 6 patients for most clinicians (one patient each for 2 of the clinicians) were recruited to participate in a study of patient-physician communication. The clinicians’ computer use and the patient-clinician interactions in the exam room were captured in real time via video recordings of the interactions and the computer screen, and through the use of the Morae usability testing software system, which recorded clinician clicks and scrolls on the computer. After the visit, patients were asked to complete a satisfaction survey.
Results The final sample consisted of 126 consultations. Total patient satisfaction (beta=0.014; P=.027) and patient satisfaction with patient-centered communication (beta=0.02; P=.02) were significantly associated with higher clinician “gaze time” at the patient. A higher percentage of gaze time during a visit (controlling for the length of the visit) was significantly associated with greater satisfaction with patient-centered communication (beta=0.628; P=.033).
Conclusions Higher clinician gaze time at the patient predicted greater patient satisfaction. This suggests that clinicians would be well served to refine their multitasking skills so that they communicate in a patient-centered manner while performing necessary computer-related tasks. These findings also have important implications for clinical training with respect to using an electronic health record (EHR) system in ways that do not impede the one-on-one conversation between clinician and patient.
Primary care physicians’ use of electronic health record (EHR) systems has markedly increased in recent years. For example, a 2008 study of more than 1000 randomly selected practicing physicians in Massachusetts found that 33% utilized an EHR.1 Many physicians believe that EHR systems are beneficial to patient care,2 and several studies have supported this perception, showing clear benefits of EHR use. A study of one component of EHR systems—computerized physician order entry (CPOE)—found that CPOEs resulted in a >50% decrease in serious medication errors.3 Other errors have declined with the use of EHR systems, as well; Virapongse et al1 found a trend towards fewer paid malpractice claims against physicians who used an EHR compared to those physicians using paper charting.
EHR systems may also improve efficiency. In a study of a health maintenance organization (HMO) model, initiating an EHR system improved efficiency by decreasing office visits.4 Widespread adoption of EHR systems could save an estimated $81 billion annually through reductions in errors and adverse events, and improved preventive care and chronic disease management.5 In a survey of approximately 300 patients who had been evaluated at a family medicine clinic for hypertension, high blood pressure without hypertension, or hyperlipidemia, 75% indicated that they felt EHRs had a positive impact on their care.6
However, some clinicians are concerned about the possible negative impact of EHR systems on health care. One major concern is that EHR systems might increase physician workload7 and the amount of time spent using a computer during patient visits. A study that examined physician EHR use found that while time spent on certain tasks, such as prescription writing and lab ordering, was reduced, there was an overall increase in time spent on computer tasks related to charting, preventive care, and chronic disease management.8 Baron et al9 also found an increase in time spent using the EHR during each clinic session in one private practice setting.
Physicians are also concerned that EHR systems might interfere with the patient-physician interaction (eg, maintaining eye contact, paying attention to patients’ concerns) by directing the physician’s attention away from the patient and toward the computer.10 In one study, this concern increased after physicians started utilizing a new EHR system.11 Although a survey of inpatients indicated that residents engaged in greater patient-physician communication after an EHR was implemented,12 a separate study conducted in an outpatient setting found physicians spent less time looking at patients after converting from a paper-based system to an EHR system.13
Very few studies have quantitatively examined the association of patient satisfaction with clinician EHR usage. The goal of this study was to examine the correlation of patient satisfaction with actual EHR usage in an ambulatory setting. The data reported in this paper are part of a larger study aimed at understanding EHR use in a VAMC.
METHODS
Study design and sample
The study participants were clinicians in 4 VAMC community clinics located in San Diego, Calif. Twenty-three clinicians (21 general internal medicine physicians and 2 nurse practitioners) were enrolled in the study. Most clinicians identified 5 to 6 patients from their practices to participate in the study (2 participants identified only one patient each). All patients were visiting their clinician for either an acute visit or a follow-up visit.
Although there were slight variations in clinic room size and shape, all rooms were equipped with a compact desk against a wall, a rolling desk chair, a desktop computer with keyboard and mouse, and a second, fixed chair placed diagonal to the physician’s chair. Two rooms had dual monitors. There was a standard examination table in all examination rooms.
The clinicians’ computer use and the patient-clinician interactions in the exam room were captured in real time via video recordings of the interactions and the computer screen. A usability testing software system (Morae) was used to record clinicians’ computer activities, including mouse clicks and scrolls on the computer. The Computerized Patient Records System (CPRS) was the EHR used by all clinicians in this study.
At the end of the visit, patients were asked to complete a satisfaction survey with questions in 3 domains: the physician’s engagement in patient-centered communication, the physician’s clinical skills, and the physician’s interpersonal skills.
Data analysis
Descriptive statistics were used to document patient characteristics, the clinicians’ EHR usage (total number of mouse clicks and scrolls during the visit) and interaction with the patient (gaze time at EHR vs at patient and companion), and to summarize patient satisfaction with the visit. To account for clinician cluster effect, a linear mixed effects model was used to assess the associations between patient satisfaction with the clinician and 2 variables: the amount of clinician time spent viewing or using the computer and the clinician time spent interacting with the patient.
We also assessed the above associations by controlling for visit length. Visit lengths not significant at P<.10 were reported as unadjusted analyses.
All analyses were performed using R statistical software, with a P value of <.05 interpreted as statistically significant.
RESULTS
Satisfaction surveys and video and Morae data were collected for 126 individual patient office visits to the 23 participating physicians and nurses. A majority of the patients who participated in the study were older (mean: 60.5 years; standard deviation [SD]=13.4 years), male as expected in a VA setting (96.8%), Caucasian (65.1%), and had at least some college education (81.7%, TABLE 1).
Patients rated their satisfaction in 3 domains—patient-centered communication, physician clinical skills, and physician interpersonal skills—using a 1 to 5 scale (1=least satisfied, 5=most satisfied). Patients in this study were highly satisfied with their physician or nurse in all 3 domains and overall (TABLE 2), with an average satisfaction score of 4.52 ± 0.51 for patient-centered communication, 4.71 ± 0.56 for physician clinical skills, 4.86 ± 0.32 for physician interpersonal skills, and 4.64 ± 0.38 for total satisfaction.
The physicians and nurses used their EHR system extensively during the visits as delineated by the number of clicks and scrolls on the computer. The average number of clicks and scrolls was 192, with a maximum of 685 clicks and scrolls during one visit. The average visit lasted 30.7 minutes, and on average the clinician spent 12.7 minutes (SD: 8.22 minutes), or an average of about 39.4% of total visit time, viewing or working on the EHR; an average of 10.8 minutes (SD: 5.63 minutes), or an average of about 36.3% of total visit time, was spent interacting with the patient (TABLE 3).
Without adjusting for visit length, patient satisfaction with the clinicians’ patientcentered communication (beta=0.02; P=.02) and total satisfaction (beta=0.014; P=.027) were significantly associated with clinicians’ gaze time at the patient; more clinician gaze time at the patient resulted in greater patient satisfaction (TABLE 4). Adding visit length to the above models had no significant effect (P>.10); therefore, we did not include it in the models.
Patient satisfaction with clinicians’ interpersonal skills was positively associated with gaze time at the patient (beta=0.013, P =.017) without adjusting for visit length. Since the normal assumption of residuals was not plausible based on a normal probability plot, we also assessed the association by dichotomizing the score (5=very satisfied vs <5=not very satisfied) and this significance disappeared. This association was not significant while controlling for visit length.
The percentage of gaze time at the patient (the fraction of patient gaze time over the entire visit) was not significantly associated with patient-centered communication (beta=0.483, P=.12, TABLE 4) when not adjusted for visit length. After adjusting for visit length (P=.052), the association became significant (beta=0.628, P=.033); thus, the higher percentage of time the clinician spent interacting with the patient, the more satisfied the patient was.
DISCUSSION
In this study, patients were highly satisfied with their clinicians despite often high usage of the EHR. Gadd and Penrod11 reported that patients perceived no impact on communication or eye contact with the clinician despite the initiation of an EHR system in 6 large academic medical practices. Another study demonstrated no significant differences in patient satisfaction with their physicians when comparing patients whose physicians used a paper charting system with those who used an EHR system.14
The fact that patients demonstrated high levels of satisfaction with patient-clinician communication even for clinicians with high EHR usage is somewhat surprising. However, Hsu et al15 found patients’ satisfaction with their clinicians’ communication about medical issues and familiarity with them increased 7 months after implementing an EHR system. In a different study that analyzed videotaped interactions between patients and 5 physicians, the patients found it disturbing not knowing what their doctor was doing when he or she worked on the computer, and preferred being able to see the computer screen.16 This study suggests that it’s advisable for clinicians to describe what they are doing when they use the computer, so that patients better understand how this time spent inputting data actually benefits them.
EHRs can be time-consuming. Physicians and nurses in our study interacted with the EHR a great deal during the office visit, as evidenced by the large average number of clicks and scrolls. This finding confirms clinicians’ perceptions of the amount of work the EHR system requires. For example, in a semi-structured interview of physicians regarding their use of a VA EHR system,10 one respondent noted that the reminders in the EHR required hundreds of clicks.
In our study, the average number of clicks and scrolls during the visit was 192, with some clinicians registering hundreds more. In fact, concerns about the time involved in the use of the EHR and about the adequacy of data collection may lead some clinicians who currently don’t have an EHR system to be reluctant to integrate one into their practices.17
Makoul et al18 found that compared with physicians who used a paper chart, physicians who used an EHR system were more active in clarifying information from the patient and encouraging patient questions during visits, although the study found a trend toward less active roles in more patient-centered communication when using an EHR system. This latter finding is similar to the concerns raised in our study.
Clinical and communication skills are factors, too. One study found that compared to patients who were cared for by more experienced physicians, patients seen by residents using EHRs were more likely to feel that the physician spent less time talking with them and examining them; they were also more likely to report that the visit felt less personal.19 Another study found that clinicians with poor baseline communication skills had more difficulties interacting with patients when an EHR system was introduced than those who had better baseline communication skills.20
Training needed to improve communication during EHR use. Research has shown that when used properly and thoughtfully, EHR use can result in greater patient engagement.21 But, as noted above, there are challenges, suggesting a need for training clinicians to more successfully use an EHR system while simultaneously communicating with their patients.
Study limitations. This study was conducted at a single site, using a single EHR system deployed in the VA clinics. We cannot generalize our findings to other sites or types of clinic systems. Other EHR systems may have different functionalities, which may affect the time required to provide the same type of medical care.
In addition, the study involved only 23 physicians and nurses in a single health system. Other clinicians may have patterns different from those we studied, although a wide range of patterns was seen among the participants, as demonstrated by the large variation in the number of clicks and scrolls. Another limitation is that study patients were not randomly selected, but rather referred by the provider, and the visits were not blinded to either the provider or patient. This may cause some selection bias.
In this study of VA clinicians’ EHR use, patients expressed satisfaction with the clinicians’ clinical skills and patient-centered communication when the clinician spent more time and a greater percentage of the visit engaging the patient. EHR systems need to be designed in a clinician-friendly manner that allows for increased time during the interaction for face-to-face communication between the clinician and the patient, and to ease the workload of EHR documentation. In the meantime, clinicians should be trained in how to expedite their use of the EHR during the clinical visit as well as outside of the exam room in order to improve their patients’ satisfaction.
CORRESPONDENCE
Neil J. Farber, MD, University of California, San Diego, 8939 Villa La Jolla Drive, La Jolla, CA 92037; [email protected].
ABSTRACT
Purpose Few studies have quantitatively examined the degree to which the use of the computer affects patients’ satisfaction with the clinician and the quality of the visit. We conducted a study to examine this association.
Methods Twenty-three clinicians (21 internal medicine physicians, 2 nurse practitioners) were recruited from 4 Veteran Affairs Medical Center (VAMC) clinics located in San Diego, Calif. Five to 6 patients for most clinicians (one patient each for 2 of the clinicians) were recruited to participate in a study of patient-physician communication. The clinicians’ computer use and the patient-clinician interactions in the exam room were captured in real time via video recordings of the interactions and the computer screen, and through the use of the Morae usability testing software system, which recorded clinician clicks and scrolls on the computer. After the visit, patients were asked to complete a satisfaction survey.
Results The final sample consisted of 126 consultations. Total patient satisfaction (beta=0.014; P=.027) and patient satisfaction with patient-centered communication (beta=0.02; P=.02) were significantly associated with higher clinician “gaze time” at the patient. A higher percentage of gaze time during a visit (controlling for the length of the visit) was significantly associated with greater satisfaction with patient-centered communication (beta=0.628; P=.033).
Conclusions Higher clinician gaze time at the patient predicted greater patient satisfaction. This suggests that clinicians would be well served to refine their multitasking skills so that they communicate in a patient-centered manner while performing necessary computer-related tasks. These findings also have important implications for clinical training with respect to using an electronic health record (EHR) system in ways that do not impede the one-on-one conversation between clinician and patient.
Primary care physicians’ use of electronic health record (EHR) systems has markedly increased in recent years. For example, a 2008 study of more than 1000 randomly selected practicing physicians in Massachusetts found that 33% utilized an EHR.1 Many physicians believe that EHR systems are beneficial to patient care,2 and several studies have supported this perception, showing clear benefits of EHR use. A study of one component of EHR systems—computerized physician order entry (CPOE)—found that CPOEs resulted in a >50% decrease in serious medication errors.3 Other errors have declined with the use of EHR systems, as well; Virapongse et al1 found a trend towards fewer paid malpractice claims against physicians who used an EHR compared to those physicians using paper charting.
EHR systems may also improve efficiency. In a study of a health maintenance organization (HMO) model, initiating an EHR system improved efficiency by decreasing office visits.4 Widespread adoption of EHR systems could save an estimated $81 billion annually through reductions in errors and adverse events, and improved preventive care and chronic disease management.5 In a survey of approximately 300 patients who had been evaluated at a family medicine clinic for hypertension, high blood pressure without hypertension, or hyperlipidemia, 75% indicated that they felt EHRs had a positive impact on their care.6
However, some clinicians are concerned about the possible negative impact of EHR systems on health care. One major concern is that EHR systems might increase physician workload7 and the amount of time spent using a computer during patient visits. A study that examined physician EHR use found that while time spent on certain tasks, such as prescription writing and lab ordering, was reduced, there was an overall increase in time spent on computer tasks related to charting, preventive care, and chronic disease management.8 Baron et al9 also found an increase in time spent using the EHR during each clinic session in one private practice setting.
Physicians are also concerned that EHR systems might interfere with the patient-physician interaction (eg, maintaining eye contact, paying attention to patients’ concerns) by directing the physician’s attention away from the patient and toward the computer.10 In one study, this concern increased after physicians started utilizing a new EHR system.11 Although a survey of inpatients indicated that residents engaged in greater patient-physician communication after an EHR was implemented,12 a separate study conducted in an outpatient setting found physicians spent less time looking at patients after converting from a paper-based system to an EHR system.13
Very few studies have quantitatively examined the association of patient satisfaction with clinician EHR usage. The goal of this study was to examine the correlation of patient satisfaction with actual EHR usage in an ambulatory setting. The data reported in this paper are part of a larger study aimed at understanding EHR use in a VAMC.
METHODS
Study design and sample
The study participants were clinicians in 4 VAMC community clinics located in San Diego, Calif. Twenty-three clinicians (21 general internal medicine physicians and 2 nurse practitioners) were enrolled in the study. Most clinicians identified 5 to 6 patients from their practices to participate in the study (2 participants identified only one patient each). All patients were visiting their clinician for either an acute visit or a follow-up visit.
Although there were slight variations in clinic room size and shape, all rooms were equipped with a compact desk against a wall, a rolling desk chair, a desktop computer with keyboard and mouse, and a second, fixed chair placed diagonal to the physician’s chair. Two rooms had dual monitors. There was a standard examination table in all examination rooms.
The clinicians’ computer use and the patient-clinician interactions in the exam room were captured in real time via video recordings of the interactions and the computer screen. A usability testing software system (Morae) was used to record clinicians’ computer activities, including mouse clicks and scrolls on the computer. The Computerized Patient Records System (CPRS) was the EHR used by all clinicians in this study.
At the end of the visit, patients were asked to complete a satisfaction survey with questions in 3 domains: the physician’s engagement in patient-centered communication, the physician’s clinical skills, and the physician’s interpersonal skills.
Data analysis
Descriptive statistics were used to document patient characteristics, the clinicians’ EHR usage (total number of mouse clicks and scrolls during the visit) and interaction with the patient (gaze time at EHR vs at patient and companion), and to summarize patient satisfaction with the visit. To account for clinician cluster effect, a linear mixed effects model was used to assess the associations between patient satisfaction with the clinician and 2 variables: the amount of clinician time spent viewing or using the computer and the clinician time spent interacting with the patient.
We also assessed the above associations by controlling for visit length. Visit lengths not significant at P<.10 were reported as unadjusted analyses.
All analyses were performed using R statistical software, with a P value of <.05 interpreted as statistically significant.
RESULTS
Satisfaction surveys and video and Morae data were collected for 126 individual patient office visits to the 23 participating physicians and nurses. A majority of the patients who participated in the study were older (mean: 60.5 years; standard deviation [SD]=13.4 years), male as expected in a VA setting (96.8%), Caucasian (65.1%), and had at least some college education (81.7%, TABLE 1).
Patients rated their satisfaction in 3 domains—patient-centered communication, physician clinical skills, and physician interpersonal skills—using a 1 to 5 scale (1=least satisfied, 5=most satisfied). Patients in this study were highly satisfied with their physician or nurse in all 3 domains and overall (TABLE 2), with an average satisfaction score of 4.52 ± 0.51 for patient-centered communication, 4.71 ± 0.56 for physician clinical skills, 4.86 ± 0.32 for physician interpersonal skills, and 4.64 ± 0.38 for total satisfaction.
The physicians and nurses used their EHR system extensively during the visits as delineated by the number of clicks and scrolls on the computer. The average number of clicks and scrolls was 192, with a maximum of 685 clicks and scrolls during one visit. The average visit lasted 30.7 minutes, and on average the clinician spent 12.7 minutes (SD: 8.22 minutes), or an average of about 39.4% of total visit time, viewing or working on the EHR; an average of 10.8 minutes (SD: 5.63 minutes), or an average of about 36.3% of total visit time, was spent interacting with the patient (TABLE 3).
Without adjusting for visit length, patient satisfaction with the clinicians’ patientcentered communication (beta=0.02; P=.02) and total satisfaction (beta=0.014; P=.027) were significantly associated with clinicians’ gaze time at the patient; more clinician gaze time at the patient resulted in greater patient satisfaction (TABLE 4). Adding visit length to the above models had no significant effect (P>.10); therefore, we did not include it in the models.
Patient satisfaction with clinicians’ interpersonal skills was positively associated with gaze time at the patient (beta=0.013, P =.017) without adjusting for visit length. Since the normal assumption of residuals was not plausible based on a normal probability plot, we also assessed the association by dichotomizing the score (5=very satisfied vs <5=not very satisfied) and this significance disappeared. This association was not significant while controlling for visit length.
The percentage of gaze time at the patient (the fraction of patient gaze time over the entire visit) was not significantly associated with patient-centered communication (beta=0.483, P=.12, TABLE 4) when not adjusted for visit length. After adjusting for visit length (P=.052), the association became significant (beta=0.628, P=.033); thus, the higher percentage of time the clinician spent interacting with the patient, the more satisfied the patient was.
DISCUSSION
In this study, patients were highly satisfied with their clinicians despite often high usage of the EHR. Gadd and Penrod11 reported that patients perceived no impact on communication or eye contact with the clinician despite the initiation of an EHR system in 6 large academic medical practices. Another study demonstrated no significant differences in patient satisfaction with their physicians when comparing patients whose physicians used a paper charting system with those who used an EHR system.14
The fact that patients demonstrated high levels of satisfaction with patient-clinician communication even for clinicians with high EHR usage is somewhat surprising. However, Hsu et al15 found patients’ satisfaction with their clinicians’ communication about medical issues and familiarity with them increased 7 months after implementing an EHR system. In a different study that analyzed videotaped interactions between patients and 5 physicians, the patients found it disturbing not knowing what their doctor was doing when he or she worked on the computer, and preferred being able to see the computer screen.16 This study suggests that it’s advisable for clinicians to describe what they are doing when they use the computer, so that patients better understand how this time spent inputting data actually benefits them.
EHRs can be time-consuming. Physicians and nurses in our study interacted with the EHR a great deal during the office visit, as evidenced by the large average number of clicks and scrolls. This finding confirms clinicians’ perceptions of the amount of work the EHR system requires. For example, in a semi-structured interview of physicians regarding their use of a VA EHR system,10 one respondent noted that the reminders in the EHR required hundreds of clicks.
In our study, the average number of clicks and scrolls during the visit was 192, with some clinicians registering hundreds more. In fact, concerns about the time involved in the use of the EHR and about the adequacy of data collection may lead some clinicians who currently don’t have an EHR system to be reluctant to integrate one into their practices.17
Makoul et al18 found that compared with physicians who used a paper chart, physicians who used an EHR system were more active in clarifying information from the patient and encouraging patient questions during visits, although the study found a trend toward less active roles in more patient-centered communication when using an EHR system. This latter finding is similar to the concerns raised in our study.
Clinical and communication skills are factors, too. One study found that compared to patients who were cared for by more experienced physicians, patients seen by residents using EHRs were more likely to feel that the physician spent less time talking with them and examining them; they were also more likely to report that the visit felt less personal.19 Another study found that clinicians with poor baseline communication skills had more difficulties interacting with patients when an EHR system was introduced than those who had better baseline communication skills.20
Training needed to improve communication during EHR use. Research has shown that when used properly and thoughtfully, EHR use can result in greater patient engagement.21 But, as noted above, there are challenges, suggesting a need for training clinicians to more successfully use an EHR system while simultaneously communicating with their patients.
Study limitations. This study was conducted at a single site, using a single EHR system deployed in the VA clinics. We cannot generalize our findings to other sites or types of clinic systems. Other EHR systems may have different functionalities, which may affect the time required to provide the same type of medical care.
In addition, the study involved only 23 physicians and nurses in a single health system. Other clinicians may have patterns different from those we studied, although a wide range of patterns was seen among the participants, as demonstrated by the large variation in the number of clicks and scrolls. Another limitation is that study patients were not randomly selected, but rather referred by the provider, and the visits were not blinded to either the provider or patient. This may cause some selection bias.
In this study of VA clinicians’ EHR use, patients expressed satisfaction with the clinicians’ clinical skills and patient-centered communication when the clinician spent more time and a greater percentage of the visit engaging the patient. EHR systems need to be designed in a clinician-friendly manner that allows for increased time during the interaction for face-to-face communication between the clinician and the patient, and to ease the workload of EHR documentation. In the meantime, clinicians should be trained in how to expedite their use of the EHR during the clinical visit as well as outside of the exam room in order to improve their patients’ satisfaction.
CORRESPONDENCE
Neil J. Farber, MD, University of California, San Diego, 8939 Villa La Jolla Drive, La Jolla, CA 92037; [email protected].
1. Virapongse A, Bates DW, Shi P, et al. Electronic health records and malpractice claims in office practice. Arch Intern Med. 2008;168:2362-2367.
2. DesRoches CM, Campbell EG, Rao SR, et al. Electronic health records in ambulatory care—a national survey of physicians. N Engl J Med. 2008;359:50-60.
3. Bates DW, Leape LL, Cullen DJ, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998;280:1311-1316.
4. Chen C, Garrido T, Chock D, et al. The Kaiser Permanente Electronic Health Record: transforming and streamlining modalities of care. Health Aff (Millwood). 2009;28:323-333.
5. Hillestad R, Bigelow J, Bower A, et al. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Aff (Millwood). 2005;24:1103-1117.
6. Garrison GM, Bernard ME, Rasmussen NH. 21st-century health care: the effect of computer use by physicians on patient satisfaction at a family medicine clinic. Fam Med. 2002;34:362-368.
7. Likourezos A, Chalfin DB, Murphy DG, et al. Physician and nurse satisfaction with an Electronic Medical Record system. J Emerg Med. 2004;27:419-424.
8. Howard J, Clark EC, Friedman A, et al. Electronic health record impact on work burden in small, unaffiliated, community-based primary care practices. J Gen Intern Med. 2013;28:107-113.
9. Baron RJ. What’s keeping us so busy in primary care? A snapshot from one practice. N Engl J Med. 2010;362:1632-1636.
10. Bonner LM, Simons CE, Parker LE, et al. ‘To take care of the patients’: Qualitative analysis of Veterans Health Administration personnel experiences with a clinical informatics system. Implement Sci. 2010;5:63.
11. Gadd CS, Penrod LE. Dichotomy between physicians’ and patients’ attitudes regarding EMR use during outpatient encounters. Proc AMIA Symp. 2000:275-279.
12. Migdal CW, Namavar AA, Mosley VN, et al. Impact of electronic health records on the patient experience in a hospital setting. J Hosp Med. 2014;9:627-633.
13. Asan O, D Smith P, Montague E. More screen time, less face time - implications for EHR design. J Eval Clin Pract. 2014;20:896-901.
14. Legler JD, Oates R. Patients’ reactions to physician use of a computerized medical record system during clinical encounters. J Fam Pract. 1993;37:241-244.
15. Hsu J, Huang J, Fung V, et al. Health information technology and physician-patient interactions: impact of computers on communication during outpatient primary care visits. J Am Med Inform Assoc. 2005;12:474-480.
16. Als AB. The desk-top computer as a magic box: patterns of behaviour connected with the desk-top computer; GPs’ and patients’ perceptions. Fam Pract. 1997;14:17-23.
17. Bates DW. Physicians and ambulatory electronic health records. Health Aff (Millwood). 2005;24:1180-1189.
18. Makoul G, Curry RH, Tang PC. The use of electronic medical records: communication patterns in outpatient encounters. J Am Med Inform Assoc. 2001;8:610-615.
19. Rouf E, Whittle J, Lu N, et al. Computers in the exam room: differences in physician-patient interaction may be due to physician experience. J Gen Intern Med. 2007;22:43-48.
20. Frankel R, Altschuler A, George S, et al. Effects of exam-room computing on clinician-patient communication: a longitudinal qualitative study. J Gen Intern Med. 2005;20:677-682.
21. Asan O, Young HN, Chewning B, et al. How physician electronic health record screen sharing affects patient and doctor nonverbal communication in primary care. Patient Educ Couns. 2015;98:310-316.
1. Virapongse A, Bates DW, Shi P, et al. Electronic health records and malpractice claims in office practice. Arch Intern Med. 2008;168:2362-2367.
2. DesRoches CM, Campbell EG, Rao SR, et al. Electronic health records in ambulatory care—a national survey of physicians. N Engl J Med. 2008;359:50-60.
3. Bates DW, Leape LL, Cullen DJ, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998;280:1311-1316.
4. Chen C, Garrido T, Chock D, et al. The Kaiser Permanente Electronic Health Record: transforming and streamlining modalities of care. Health Aff (Millwood). 2009;28:323-333.
5. Hillestad R, Bigelow J, Bower A, et al. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Aff (Millwood). 2005;24:1103-1117.
6. Garrison GM, Bernard ME, Rasmussen NH. 21st-century health care: the effect of computer use by physicians on patient satisfaction at a family medicine clinic. Fam Med. 2002;34:362-368.
7. Likourezos A, Chalfin DB, Murphy DG, et al. Physician and nurse satisfaction with an Electronic Medical Record system. J Emerg Med. 2004;27:419-424.
8. Howard J, Clark EC, Friedman A, et al. Electronic health record impact on work burden in small, unaffiliated, community-based primary care practices. J Gen Intern Med. 2013;28:107-113.
9. Baron RJ. What’s keeping us so busy in primary care? A snapshot from one practice. N Engl J Med. 2010;362:1632-1636.
10. Bonner LM, Simons CE, Parker LE, et al. ‘To take care of the patients’: Qualitative analysis of Veterans Health Administration personnel experiences with a clinical informatics system. Implement Sci. 2010;5:63.
11. Gadd CS, Penrod LE. Dichotomy between physicians’ and patients’ attitudes regarding EMR use during outpatient encounters. Proc AMIA Symp. 2000:275-279.
12. Migdal CW, Namavar AA, Mosley VN, et al. Impact of electronic health records on the patient experience in a hospital setting. J Hosp Med. 2014;9:627-633.
13. Asan O, D Smith P, Montague E. More screen time, less face time - implications for EHR design. J Eval Clin Pract. 2014;20:896-901.
14. Legler JD, Oates R. Patients’ reactions to physician use of a computerized medical record system during clinical encounters. J Fam Pract. 1993;37:241-244.
15. Hsu J, Huang J, Fung V, et al. Health information technology and physician-patient interactions: impact of computers on communication during outpatient primary care visits. J Am Med Inform Assoc. 2005;12:474-480.
16. Als AB. The desk-top computer as a magic box: patterns of behaviour connected with the desk-top computer; GPs’ and patients’ perceptions. Fam Pract. 1997;14:17-23.
17. Bates DW. Physicians and ambulatory electronic health records. Health Aff (Millwood). 2005;24:1180-1189.
18. Makoul G, Curry RH, Tang PC. The use of electronic medical records: communication patterns in outpatient encounters. J Am Med Inform Assoc. 2001;8:610-615.
19. Rouf E, Whittle J, Lu N, et al. Computers in the exam room: differences in physician-patient interaction may be due to physician experience. J Gen Intern Med. 2007;22:43-48.
20. Frankel R, Altschuler A, George S, et al. Effects of exam-room computing on clinician-patient communication: a longitudinal qualitative study. J Gen Intern Med. 2005;20:677-682.
21. Asan O, Young HN, Chewning B, et al. How physician electronic health record screen sharing affects patient and doctor nonverbal communication in primary care. Patient Educ Couns. 2015;98:310-316.
Medicaid Insurance Is Associated With Larger Curves in Patients Who Require Scoliosis Surgery
Rising health care costs have led many health insurers to limit benefits, which may be a problem for children in need of specialty care. Uninsured children have poorer access to specialty care than insured children. Children with public health coverage have better access to specialty care than uninsured children but inferior access compared with privately insured children.1,2 It is well documented that children with government insurance have limited access to orthopedic care for fractures, ligamentous knee injuries, and other injuries.1,3-5 Adolescent idiopathic scoliosis (AIS) differs from many other conditions managed by pediatric orthopedists, as it may be progressive, with management becoming increasingly more complex as the curve magnitude increases.6 The ability to access care earlier in the disease process may allow for earlier nonoperative interventions, such as bracing. For patients who require spinal fusion, earlier diagnosis and referral to a specialist could potentially result in shorter fusions and preserve distal motion segments. The ability to access the health care system in a timely fashion would therefore be of utmost importance for patients with scoliosis.
The literature on AIS is lacking in studies focused on care access based on insurance coverage and the potential impact that this may have on curve progression.7-9 We conducted a study to determine whether there is a difference between patients with and without private insurance who present to a busy urban pediatric orthopedic practice for management of scoliosis that eventually resulted in surgical treatment.
Materials and Methods
After obtaining institutional review board approval for this study, we retrospectively reviewed the medical records of patients (age, 10-18 years) who underwent posterior spinal fusion (PSF) for newly diagnosed AIS between 2008 and 2012. We excluded patients treated with growing spine instrumentation (growing rods), patients younger than 10 years or older than 18 years at presentation, and patients without adequate radiographs or clinical data, including insurance status. To focus on newly diagnosed scoliosis, we also excluded patients who had been seen for second opinions or whose scoliosis had been managed elsewhere in the past. Patients with syndromic, neuromuscular, or congenital scoliosis were also excluded.
Medical records were checked to ascertain time from initial evaluation to decision for surgery, time from recommendation for surgery until actual procedure, and insurance status. Distance traveled was figured from patients’ home addresses. Cobb angles were calculated from initial preoperative and final preoperative posteroanterior (PA) radiographs. Curves as seen on PA, lateral, and maximal effort, supine bending thoracic and lumbar radiographs from the initial preoperative visit were classified using the system of Lenke and colleagues.10 Hospital records were queried to determine number of levels fused at surgery, number of implants placed, and length of stay. Patients were evaluated without prior screening of insurance status and without prior consultation with referring physicians. Surgical procedures were scheduled on a first-come, first-served basis without preference for insurance status.
Results
We identified 135 consecutive patients with newly diagnosed AIS treated with PSF by our group between January 2008 and December 2012 (Table 1). Sixty-one percent had private insurance; 39% had Medicaid. There was no difference in age or ASA (American Society of Anesthesiologists) score between groups. Mean (SD) Cobb angle at initial presentation was 47.5° (14.3°) (range, 18.0°-86.0°) for the private insurance group and 57.2° (15.7°) (range, 23.0°-95.0°) for the Medicaid group (P < .0001). At time of surgery, mean (SD) Cobb angles were 54.6° (11.7°) and 60.6° (13.9°) for the private insurance and Medicaid groups, respectively (P = .008). There was no difference in curve types (Lenke and colleagues10 classification) between groups (Table 2, P = .83). Medicaid patients traveled a shorter mean (SD) distance for care, 56.3 (57.0) miles, versus 73.7 (66.7) miles (P = .05). There was no statistical difference (P = .14) in mean (SD) surgical wait time from surgery recommendation to actual surgery, 103.1 (62.4) days and 128.8 (137.5) days for the private insurance and Medicaid groups, respectively. The difference between patient groups in mean (SD) number of levels fused did not reach statistical significance (P = .16), 10.3 (2.2) levels for the Medicaid group and 9.7 (2.3) levels for the private insurance group. Mean (SD) estimated blood loss was higher for Medicaid patients, 445.7 (415.9) mL versus 335.1 (271.5) mL (P = .06), though there was no difference in use of posterior column osteotomies between groups. There was no difference (P = .11) in mean (SD) length of hospital stay between Medicaid patients, 2.6 (0.8) days, and private insurance patients, 2.4 (0.5) days.
Discussion
According to an extensive body of literature, patients with government insurance have limited access to specialty care.1,11,12 Medicaid-insured children in need of orthopedic care are no exception. Sabharwal and colleagues13 examined a database of pediatric fracture cases and found that 52% of the privately insured patients and 22% of the publicly insured patients received orthopedic care (P = .013).13 When Pierce and colleagues14 called 42 orthopedic practices regarding a fictitious 14-year-old patient with an anterior cruciate ligament tear, 38 offered an appointment within 2 weeks to a privately insured patient, and 6 offered such an appointment to a publicly insured patient. Skaggs and colleagues4 surveyed 230 orthopedic practices nationally and found that Medicaid-insured children had limited access to orthopedic care; 41 practices (18%) would not see a child with Medicaid under any circumstances. Using a fictitious case of a 10-year-old boy with a forearm fracture, Iobst and colleagues3 tried making an appointment at 100 orthopedic offices. Eight gave an appointment within 1 week to a Medicaid-insured patient, and 36 gave an appointment to a privately insured patient.3
There are few data regarding insurance status and scoliosis care in children. Spinal deformity differs from simple fractures and ligamentous injuries, as timely care may result in a less invasive treatment (bracing) if the curvature is caught early. Goldstein and colleagues9 recently evaluated 642 patients who presented for scoliosis evaluation over a 10-year period. There was no difference in curve magnitudes between patients with and without Medicaid insurance. Thirty-two percent of these patients were evaluated for a second opinion, and the authors chose not to subdivide patients on the basis of curve severity and treatment needed, noting only no difference between groups. There was no discussion of the potential difference between patients with and without private insurance with respect to surgically versus nonsurgically treated curves. We wanted to focus specifically on patients who required surgical intervention, as our experience has been that many patients with government insurance present with either very mild scoliosis (10°) or very large curves that were not identified because of lack of primary care access or inadequate school screening. Although summing these 2 groups would result in a similar average, they would represent a different cohort than patients with curves along a bell curve. Furthermore, it is the group of patients who would require surgical intervention that is so critical to identify early in order to intervene.
Our data suggest a difference in presenting curves between patients with and without private insurance. The approximately 10° difference between patient groups in this study could potentially represent the difference between bracing and surgery. Furthermore, Miyanji and colleagues6 evaluated the relationship between Cobb angle and health care consumption and correlated larger curve magnitudes with more levels fused, longer surgeries, and higher rates of transfusion. Specifically, every 10° increase in curve magnitude resulted in 7.8 more minutes of operative time, 0.3 extra levels fused, and 1.5 times increased risk for requiring a blood transfusion.
Cho and Egorova15 recently evaluated insurance status with respect to surgical outcomes using a national inpatient database and found that 42.4% of surgeries for AIS in children with Medicaid had fusions involving 9 or more levels, whereas only 33.6% of privately insured patients had fusions of 9 or more levels. There was no difference in osteotomy or reoperation for pseudarthrosis between groups, but there was a slightly higher rate of infectious (1.1% vs 0.6%) and hemorrhagic (2.5% vs 1.7%) complications in the Medicaid group. Hospital stay was longer in patients with Medicaid, though complications were not different between groups.
The mean difference in the magnitude of the curves treated in our study was not more than 10° between patients with and without Medicaid, perhaps explaining the lack of a statistically significant difference in number of levels fused between groups. Although the groups were similar with respect to the percentage requiring posterior column spinal osteotomies, we noted a difference in estimated blood loss between groups, likely explained by the fact that a junior surgeon was added just before initiation of the study period, potentially skewing the estimated blood loss as this surgeon gained experience. Payer status has been correlated to length of hospital stay in children with scoliosis. Vitale and colleagues8 reviewed the effect of payer status on surgical outcomes in 3606 scoliosis patients from a statewide database in California and concluded that, compared with patients having all other payment sources, Medicaid patients had higher odds for complications and longer hospital stay. Our hospital has adopted a highly coordinated care pathway that allows for discharge on postoperative day 2, likely explaining the lack of any difference in postoperative stay.16
The disparity in curve magnitudes among patients with and without private insurance is striking and probably multifactorial. Very likely, the combination of schools with limited screening programs within urban or rural school systems,17 restricted access to pediatricians,18,19 and longer waits to see orthopedic specialists20 all contribute to this disparity. It should be noted that school screening is mandatory in our state. This discrepancy may be related to a previously established tendency in minority populations toward waiting longer to seek care and refusing surgical recommendations, though we were unable to query socioeconomic factors such as race and household income.21,22 It is clearly important to increase access to care for underinsured patients with scoliosis. A comprehensive approach, including providing better education in the schools, establishing communication with referring primary care providers, and increasing access through more physicians or physician extenders, is likely needed. Orthopedists should perhaps treat scoliosis evaluation with the same sense of urgency given to minor fractures, and primary care providers should try to ensure that appropriate referrals for scoliosis are made. Also curious was the shorter travel distance for Medicaid patients versus private insurance patients in this study. We hypothesize this is related to our urban location and its large Medicaid population.
Our study had several limitations. Our electronic medical records (EMR) system does not store data related to the time a patient calls for an initial appointment, limiting our ability to determine how long patients waited for their initial consultation. Furthermore, the decision to undergo surgery is multifactorial and cannot be simplified into time from initial recommendation to surgery, as some patients delay surgery because of school or other obligations. These data should be reasonably consistent over time, as patients seen in the early spring in both groups may delay surgery until the summer, and those diagnosed in June may prefer earlier surgery.
Summary
Children with AIS are at risk for curve progression. Therefore, delays in providing timely care may result in worsening scoliosis. Compared with private insurance patients, Medicaid patients presented with larger curve magnitudes. Further study is needed to better delineate ways to improve care access for patients with scoliosis in communities with larger Medicaid populations.
1. Skaggs DL. Less access to care for children with Medicaid. Orthopedics. 2003;26(12):1184, 1186.
2. Skinner AC, Mayer ML. Effects of insurance status on children’s access to specialty care: a systematic review of the literature. BMC Health Serv Res. 2007;7:194.
3. Iobst C, King W, Baitner A, Tidwell M, Swirsky S, Skaggs DL. Access to care for children with fractures. J Pediatr Orthop. 2010;30(3):244-247.
4. Skaggs DL, Lehmann CL, Rice C, et al. Access to orthopaedic care for children with Medicaid versus private insurance: results of a national survey. J Pediatr Orthop. 2006;26(3):400-404.
5. Skaggs DL, Oda JE, Lerman L, et al. Insurance status and delay in orthotic treatment in children. J Pediatr Orthop. 2007;27(1):94-97.
6. Miyanji F, Slobogean GP, Samdani AF, et al. Is larger scoliosis curve magnitude associated with increased perioperative health-care resource utilization? A multicenter analysis of 325 adolescent idiopathic scoliosis curves. J Bone Joint Surg Am. 2012;94(9):809-813.
7. Nuno M, Drazin DG, Acosta FL Jr. Differences in treatments and outcomes for idiopathic scoliosis patients treated in the United States from 1998 to 2007: impact of socioeconomic variables and ethnicity. Spine J. 2013;13(2):116-123.
8. Vitale MA, Arons RR, Hyman JE, Skaggs DL, Roye DP, Vitale MG. The contribution of hospital volume, payer status, and other factors on the surgical outcomes of scoliosis patients: a review of 3,606 cases in the state of California. J Pediatr Orthop. 2005;25(3):393-399.
9. Goldstein RY, Joiner ER, Skaggs DL. Insurance status does not predict curve magnitude in adolescent idiopathic scoliosis at first presentation to an orthopaedic surgeon. J Pediatr Orthop. 2015;35(1):39-42.
10. Lenke LG, Betz RR, Harms J, et al. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001;83(8):1169-1181.
11. Alosh H, Riley LH 3rd, Skolasky RL. Insurance status, geography, race, and ethnicity as predictors of anterior cervical spine surgery rates and in-hospital mortality: an examination of United States trends from 1992 to 2005. Spine. 2009;34(18):1956-1962.
12. Newacheck PW, Hughes DC, Hung YY, Wong S, Stoddard JJ. The unmet health needs of America’s children. Pediatrics. 2000;105(4 pt 2):989-997.
13. Sabharwal S, Zhao C, McClemens E, Kaufmann A. Pediatric orthopaedic patients presenting to a university emergency department after visiting another emergency department: demographics and health insurance status. J Pediatr Orthop. 2007;27(6):690-694.
14. Pierce TR, Mehlman CT, Tamai J, Skaggs DL. Access to care for the adolescent anterior cruciate ligament patient with Medicaid versus private insurance. J Pediatr Orthop. 2012;32(3):245-248.
15. Cho SK, Egorova NN. The association between insurance status and complications, length of stay, and costs for pediatric idiopathic scoliosis. Spine. 2015;40(4):247-256.
16. Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW Jr. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014;8(3):257-263.
17. Kasper MJ, Robbins L, Root L, Peterson MG, Allegrante JP. A musculoskeletal outreach screening, treatment, and education program for urban minority children. Arthritis Care Res. 1993;6(3):126-133.
18. Berman S, Dolins J, Tang SF, Yudkowsky B. Factors that influence the willingness of private primary care pediatricians to accept more Medicaid patients. Pediatrics. 2002;110(2 pt 1):239-248.
19. Sommers BD. Protecting low-income children’s access to care: are physician visits associated with reduced patient dropout from Medicaid and the Children’s Health Insurance Program? Pediatrics. 2006;118(1):e36-e42.
20. Bisgaier J, Polsky D, Rhodes KV. Academic medical centers and equity in specialty care access for children. Arch Pediatr Adolesc Med. 2012;166(4):304-310.
21. Sedlis SP, Fisher VJ, Tice D, Esposito R, Madmon L, Steinberg EH. Racial differences in performance of invasive cardiac procedures in a Department of Veterans Affairs medical center. J Clin Epidemiol. 1997;50(8):899-901.
22. Mitchell JB, McCormack LA. Time trends in late-stage diagnosis of cervical cancer. Differences by race/ethnicity and income. Med Care. 1997;35(12):1220-1224.
Rising health care costs have led many health insurers to limit benefits, which may be a problem for children in need of specialty care. Uninsured children have poorer access to specialty care than insured children. Children with public health coverage have better access to specialty care than uninsured children but inferior access compared with privately insured children.1,2 It is well documented that children with government insurance have limited access to orthopedic care for fractures, ligamentous knee injuries, and other injuries.1,3-5 Adolescent idiopathic scoliosis (AIS) differs from many other conditions managed by pediatric orthopedists, as it may be progressive, with management becoming increasingly more complex as the curve magnitude increases.6 The ability to access care earlier in the disease process may allow for earlier nonoperative interventions, such as bracing. For patients who require spinal fusion, earlier diagnosis and referral to a specialist could potentially result in shorter fusions and preserve distal motion segments. The ability to access the health care system in a timely fashion would therefore be of utmost importance for patients with scoliosis.
The literature on AIS is lacking in studies focused on care access based on insurance coverage and the potential impact that this may have on curve progression.7-9 We conducted a study to determine whether there is a difference between patients with and without private insurance who present to a busy urban pediatric orthopedic practice for management of scoliosis that eventually resulted in surgical treatment.
Materials and Methods
After obtaining institutional review board approval for this study, we retrospectively reviewed the medical records of patients (age, 10-18 years) who underwent posterior spinal fusion (PSF) for newly diagnosed AIS between 2008 and 2012. We excluded patients treated with growing spine instrumentation (growing rods), patients younger than 10 years or older than 18 years at presentation, and patients without adequate radiographs or clinical data, including insurance status. To focus on newly diagnosed scoliosis, we also excluded patients who had been seen for second opinions or whose scoliosis had been managed elsewhere in the past. Patients with syndromic, neuromuscular, or congenital scoliosis were also excluded.
Medical records were checked to ascertain time from initial evaluation to decision for surgery, time from recommendation for surgery until actual procedure, and insurance status. Distance traveled was figured from patients’ home addresses. Cobb angles were calculated from initial preoperative and final preoperative posteroanterior (PA) radiographs. Curves as seen on PA, lateral, and maximal effort, supine bending thoracic and lumbar radiographs from the initial preoperative visit were classified using the system of Lenke and colleagues.10 Hospital records were queried to determine number of levels fused at surgery, number of implants placed, and length of stay. Patients were evaluated without prior screening of insurance status and without prior consultation with referring physicians. Surgical procedures were scheduled on a first-come, first-served basis without preference for insurance status.
Results
We identified 135 consecutive patients with newly diagnosed AIS treated with PSF by our group between January 2008 and December 2012 (Table 1). Sixty-one percent had private insurance; 39% had Medicaid. There was no difference in age or ASA (American Society of Anesthesiologists) score between groups. Mean (SD) Cobb angle at initial presentation was 47.5° (14.3°) (range, 18.0°-86.0°) for the private insurance group and 57.2° (15.7°) (range, 23.0°-95.0°) for the Medicaid group (P < .0001). At time of surgery, mean (SD) Cobb angles were 54.6° (11.7°) and 60.6° (13.9°) for the private insurance and Medicaid groups, respectively (P = .008). There was no difference in curve types (Lenke and colleagues10 classification) between groups (Table 2, P = .83). Medicaid patients traveled a shorter mean (SD) distance for care, 56.3 (57.0) miles, versus 73.7 (66.7) miles (P = .05). There was no statistical difference (P = .14) in mean (SD) surgical wait time from surgery recommendation to actual surgery, 103.1 (62.4) days and 128.8 (137.5) days for the private insurance and Medicaid groups, respectively. The difference between patient groups in mean (SD) number of levels fused did not reach statistical significance (P = .16), 10.3 (2.2) levels for the Medicaid group and 9.7 (2.3) levels for the private insurance group. Mean (SD) estimated blood loss was higher for Medicaid patients, 445.7 (415.9) mL versus 335.1 (271.5) mL (P = .06), though there was no difference in use of posterior column osteotomies between groups. There was no difference (P = .11) in mean (SD) length of hospital stay between Medicaid patients, 2.6 (0.8) days, and private insurance patients, 2.4 (0.5) days.
Discussion
According to an extensive body of literature, patients with government insurance have limited access to specialty care.1,11,12 Medicaid-insured children in need of orthopedic care are no exception. Sabharwal and colleagues13 examined a database of pediatric fracture cases and found that 52% of the privately insured patients and 22% of the publicly insured patients received orthopedic care (P = .013).13 When Pierce and colleagues14 called 42 orthopedic practices regarding a fictitious 14-year-old patient with an anterior cruciate ligament tear, 38 offered an appointment within 2 weeks to a privately insured patient, and 6 offered such an appointment to a publicly insured patient. Skaggs and colleagues4 surveyed 230 orthopedic practices nationally and found that Medicaid-insured children had limited access to orthopedic care; 41 practices (18%) would not see a child with Medicaid under any circumstances. Using a fictitious case of a 10-year-old boy with a forearm fracture, Iobst and colleagues3 tried making an appointment at 100 orthopedic offices. Eight gave an appointment within 1 week to a Medicaid-insured patient, and 36 gave an appointment to a privately insured patient.3
There are few data regarding insurance status and scoliosis care in children. Spinal deformity differs from simple fractures and ligamentous injuries, as timely care may result in a less invasive treatment (bracing) if the curvature is caught early. Goldstein and colleagues9 recently evaluated 642 patients who presented for scoliosis evaluation over a 10-year period. There was no difference in curve magnitudes between patients with and without Medicaid insurance. Thirty-two percent of these patients were evaluated for a second opinion, and the authors chose not to subdivide patients on the basis of curve severity and treatment needed, noting only no difference between groups. There was no discussion of the potential difference between patients with and without private insurance with respect to surgically versus nonsurgically treated curves. We wanted to focus specifically on patients who required surgical intervention, as our experience has been that many patients with government insurance present with either very mild scoliosis (10°) or very large curves that were not identified because of lack of primary care access or inadequate school screening. Although summing these 2 groups would result in a similar average, they would represent a different cohort than patients with curves along a bell curve. Furthermore, it is the group of patients who would require surgical intervention that is so critical to identify early in order to intervene.
Our data suggest a difference in presenting curves between patients with and without private insurance. The approximately 10° difference between patient groups in this study could potentially represent the difference between bracing and surgery. Furthermore, Miyanji and colleagues6 evaluated the relationship between Cobb angle and health care consumption and correlated larger curve magnitudes with more levels fused, longer surgeries, and higher rates of transfusion. Specifically, every 10° increase in curve magnitude resulted in 7.8 more minutes of operative time, 0.3 extra levels fused, and 1.5 times increased risk for requiring a blood transfusion.
Cho and Egorova15 recently evaluated insurance status with respect to surgical outcomes using a national inpatient database and found that 42.4% of surgeries for AIS in children with Medicaid had fusions involving 9 or more levels, whereas only 33.6% of privately insured patients had fusions of 9 or more levels. There was no difference in osteotomy or reoperation for pseudarthrosis between groups, but there was a slightly higher rate of infectious (1.1% vs 0.6%) and hemorrhagic (2.5% vs 1.7%) complications in the Medicaid group. Hospital stay was longer in patients with Medicaid, though complications were not different between groups.
The mean difference in the magnitude of the curves treated in our study was not more than 10° between patients with and without Medicaid, perhaps explaining the lack of a statistically significant difference in number of levels fused between groups. Although the groups were similar with respect to the percentage requiring posterior column spinal osteotomies, we noted a difference in estimated blood loss between groups, likely explained by the fact that a junior surgeon was added just before initiation of the study period, potentially skewing the estimated blood loss as this surgeon gained experience. Payer status has been correlated to length of hospital stay in children with scoliosis. Vitale and colleagues8 reviewed the effect of payer status on surgical outcomes in 3606 scoliosis patients from a statewide database in California and concluded that, compared with patients having all other payment sources, Medicaid patients had higher odds for complications and longer hospital stay. Our hospital has adopted a highly coordinated care pathway that allows for discharge on postoperative day 2, likely explaining the lack of any difference in postoperative stay.16
The disparity in curve magnitudes among patients with and without private insurance is striking and probably multifactorial. Very likely, the combination of schools with limited screening programs within urban or rural school systems,17 restricted access to pediatricians,18,19 and longer waits to see orthopedic specialists20 all contribute to this disparity. It should be noted that school screening is mandatory in our state. This discrepancy may be related to a previously established tendency in minority populations toward waiting longer to seek care and refusing surgical recommendations, though we were unable to query socioeconomic factors such as race and household income.21,22 It is clearly important to increase access to care for underinsured patients with scoliosis. A comprehensive approach, including providing better education in the schools, establishing communication with referring primary care providers, and increasing access through more physicians or physician extenders, is likely needed. Orthopedists should perhaps treat scoliosis evaluation with the same sense of urgency given to minor fractures, and primary care providers should try to ensure that appropriate referrals for scoliosis are made. Also curious was the shorter travel distance for Medicaid patients versus private insurance patients in this study. We hypothesize this is related to our urban location and its large Medicaid population.
Our study had several limitations. Our electronic medical records (EMR) system does not store data related to the time a patient calls for an initial appointment, limiting our ability to determine how long patients waited for their initial consultation. Furthermore, the decision to undergo surgery is multifactorial and cannot be simplified into time from initial recommendation to surgery, as some patients delay surgery because of school or other obligations. These data should be reasonably consistent over time, as patients seen in the early spring in both groups may delay surgery until the summer, and those diagnosed in June may prefer earlier surgery.
Summary
Children with AIS are at risk for curve progression. Therefore, delays in providing timely care may result in worsening scoliosis. Compared with private insurance patients, Medicaid patients presented with larger curve magnitudes. Further study is needed to better delineate ways to improve care access for patients with scoliosis in communities with larger Medicaid populations.
Rising health care costs have led many health insurers to limit benefits, which may be a problem for children in need of specialty care. Uninsured children have poorer access to specialty care than insured children. Children with public health coverage have better access to specialty care than uninsured children but inferior access compared with privately insured children.1,2 It is well documented that children with government insurance have limited access to orthopedic care for fractures, ligamentous knee injuries, and other injuries.1,3-5 Adolescent idiopathic scoliosis (AIS) differs from many other conditions managed by pediatric orthopedists, as it may be progressive, with management becoming increasingly more complex as the curve magnitude increases.6 The ability to access care earlier in the disease process may allow for earlier nonoperative interventions, such as bracing. For patients who require spinal fusion, earlier diagnosis and referral to a specialist could potentially result in shorter fusions and preserve distal motion segments. The ability to access the health care system in a timely fashion would therefore be of utmost importance for patients with scoliosis.
The literature on AIS is lacking in studies focused on care access based on insurance coverage and the potential impact that this may have on curve progression.7-9 We conducted a study to determine whether there is a difference between patients with and without private insurance who present to a busy urban pediatric orthopedic practice for management of scoliosis that eventually resulted in surgical treatment.
Materials and Methods
After obtaining institutional review board approval for this study, we retrospectively reviewed the medical records of patients (age, 10-18 years) who underwent posterior spinal fusion (PSF) for newly diagnosed AIS between 2008 and 2012. We excluded patients treated with growing spine instrumentation (growing rods), patients younger than 10 years or older than 18 years at presentation, and patients without adequate radiographs or clinical data, including insurance status. To focus on newly diagnosed scoliosis, we also excluded patients who had been seen for second opinions or whose scoliosis had been managed elsewhere in the past. Patients with syndromic, neuromuscular, or congenital scoliosis were also excluded.
Medical records were checked to ascertain time from initial evaluation to decision for surgery, time from recommendation for surgery until actual procedure, and insurance status. Distance traveled was figured from patients’ home addresses. Cobb angles were calculated from initial preoperative and final preoperative posteroanterior (PA) radiographs. Curves as seen on PA, lateral, and maximal effort, supine bending thoracic and lumbar radiographs from the initial preoperative visit were classified using the system of Lenke and colleagues.10 Hospital records were queried to determine number of levels fused at surgery, number of implants placed, and length of stay. Patients were evaluated without prior screening of insurance status and without prior consultation with referring physicians. Surgical procedures were scheduled on a first-come, first-served basis without preference for insurance status.
Results
We identified 135 consecutive patients with newly diagnosed AIS treated with PSF by our group between January 2008 and December 2012 (Table 1). Sixty-one percent had private insurance; 39% had Medicaid. There was no difference in age or ASA (American Society of Anesthesiologists) score between groups. Mean (SD) Cobb angle at initial presentation was 47.5° (14.3°) (range, 18.0°-86.0°) for the private insurance group and 57.2° (15.7°) (range, 23.0°-95.0°) for the Medicaid group (P < .0001). At time of surgery, mean (SD) Cobb angles were 54.6° (11.7°) and 60.6° (13.9°) for the private insurance and Medicaid groups, respectively (P = .008). There was no difference in curve types (Lenke and colleagues10 classification) between groups (Table 2, P = .83). Medicaid patients traveled a shorter mean (SD) distance for care, 56.3 (57.0) miles, versus 73.7 (66.7) miles (P = .05). There was no statistical difference (P = .14) in mean (SD) surgical wait time from surgery recommendation to actual surgery, 103.1 (62.4) days and 128.8 (137.5) days for the private insurance and Medicaid groups, respectively. The difference between patient groups in mean (SD) number of levels fused did not reach statistical significance (P = .16), 10.3 (2.2) levels for the Medicaid group and 9.7 (2.3) levels for the private insurance group. Mean (SD) estimated blood loss was higher for Medicaid patients, 445.7 (415.9) mL versus 335.1 (271.5) mL (P = .06), though there was no difference in use of posterior column osteotomies between groups. There was no difference (P = .11) in mean (SD) length of hospital stay between Medicaid patients, 2.6 (0.8) days, and private insurance patients, 2.4 (0.5) days.
Discussion
According to an extensive body of literature, patients with government insurance have limited access to specialty care.1,11,12 Medicaid-insured children in need of orthopedic care are no exception. Sabharwal and colleagues13 examined a database of pediatric fracture cases and found that 52% of the privately insured patients and 22% of the publicly insured patients received orthopedic care (P = .013).13 When Pierce and colleagues14 called 42 orthopedic practices regarding a fictitious 14-year-old patient with an anterior cruciate ligament tear, 38 offered an appointment within 2 weeks to a privately insured patient, and 6 offered such an appointment to a publicly insured patient. Skaggs and colleagues4 surveyed 230 orthopedic practices nationally and found that Medicaid-insured children had limited access to orthopedic care; 41 practices (18%) would not see a child with Medicaid under any circumstances. Using a fictitious case of a 10-year-old boy with a forearm fracture, Iobst and colleagues3 tried making an appointment at 100 orthopedic offices. Eight gave an appointment within 1 week to a Medicaid-insured patient, and 36 gave an appointment to a privately insured patient.3
There are few data regarding insurance status and scoliosis care in children. Spinal deformity differs from simple fractures and ligamentous injuries, as timely care may result in a less invasive treatment (bracing) if the curvature is caught early. Goldstein and colleagues9 recently evaluated 642 patients who presented for scoliosis evaluation over a 10-year period. There was no difference in curve magnitudes between patients with and without Medicaid insurance. Thirty-two percent of these patients were evaluated for a second opinion, and the authors chose not to subdivide patients on the basis of curve severity and treatment needed, noting only no difference between groups. There was no discussion of the potential difference between patients with and without private insurance with respect to surgically versus nonsurgically treated curves. We wanted to focus specifically on patients who required surgical intervention, as our experience has been that many patients with government insurance present with either very mild scoliosis (10°) or very large curves that were not identified because of lack of primary care access or inadequate school screening. Although summing these 2 groups would result in a similar average, they would represent a different cohort than patients with curves along a bell curve. Furthermore, it is the group of patients who would require surgical intervention that is so critical to identify early in order to intervene.
Our data suggest a difference in presenting curves between patients with and without private insurance. The approximately 10° difference between patient groups in this study could potentially represent the difference between bracing and surgery. Furthermore, Miyanji and colleagues6 evaluated the relationship between Cobb angle and health care consumption and correlated larger curve magnitudes with more levels fused, longer surgeries, and higher rates of transfusion. Specifically, every 10° increase in curve magnitude resulted in 7.8 more minutes of operative time, 0.3 extra levels fused, and 1.5 times increased risk for requiring a blood transfusion.
Cho and Egorova15 recently evaluated insurance status with respect to surgical outcomes using a national inpatient database and found that 42.4% of surgeries for AIS in children with Medicaid had fusions involving 9 or more levels, whereas only 33.6% of privately insured patients had fusions of 9 or more levels. There was no difference in osteotomy or reoperation for pseudarthrosis between groups, but there was a slightly higher rate of infectious (1.1% vs 0.6%) and hemorrhagic (2.5% vs 1.7%) complications in the Medicaid group. Hospital stay was longer in patients with Medicaid, though complications were not different between groups.
The mean difference in the magnitude of the curves treated in our study was not more than 10° between patients with and without Medicaid, perhaps explaining the lack of a statistically significant difference in number of levels fused between groups. Although the groups were similar with respect to the percentage requiring posterior column spinal osteotomies, we noted a difference in estimated blood loss between groups, likely explained by the fact that a junior surgeon was added just before initiation of the study period, potentially skewing the estimated blood loss as this surgeon gained experience. Payer status has been correlated to length of hospital stay in children with scoliosis. Vitale and colleagues8 reviewed the effect of payer status on surgical outcomes in 3606 scoliosis patients from a statewide database in California and concluded that, compared with patients having all other payment sources, Medicaid patients had higher odds for complications and longer hospital stay. Our hospital has adopted a highly coordinated care pathway that allows for discharge on postoperative day 2, likely explaining the lack of any difference in postoperative stay.16
The disparity in curve magnitudes among patients with and without private insurance is striking and probably multifactorial. Very likely, the combination of schools with limited screening programs within urban or rural school systems,17 restricted access to pediatricians,18,19 and longer waits to see orthopedic specialists20 all contribute to this disparity. It should be noted that school screening is mandatory in our state. This discrepancy may be related to a previously established tendency in minority populations toward waiting longer to seek care and refusing surgical recommendations, though we were unable to query socioeconomic factors such as race and household income.21,22 It is clearly important to increase access to care for underinsured patients with scoliosis. A comprehensive approach, including providing better education in the schools, establishing communication with referring primary care providers, and increasing access through more physicians or physician extenders, is likely needed. Orthopedists should perhaps treat scoliosis evaluation with the same sense of urgency given to minor fractures, and primary care providers should try to ensure that appropriate referrals for scoliosis are made. Also curious was the shorter travel distance for Medicaid patients versus private insurance patients in this study. We hypothesize this is related to our urban location and its large Medicaid population.
Our study had several limitations. Our electronic medical records (EMR) system does not store data related to the time a patient calls for an initial appointment, limiting our ability to determine how long patients waited for their initial consultation. Furthermore, the decision to undergo surgery is multifactorial and cannot be simplified into time from initial recommendation to surgery, as some patients delay surgery because of school or other obligations. These data should be reasonably consistent over time, as patients seen in the early spring in both groups may delay surgery until the summer, and those diagnosed in June may prefer earlier surgery.
Summary
Children with AIS are at risk for curve progression. Therefore, delays in providing timely care may result in worsening scoliosis. Compared with private insurance patients, Medicaid patients presented with larger curve magnitudes. Further study is needed to better delineate ways to improve care access for patients with scoliosis in communities with larger Medicaid populations.
1. Skaggs DL. Less access to care for children with Medicaid. Orthopedics. 2003;26(12):1184, 1186.
2. Skinner AC, Mayer ML. Effects of insurance status on children’s access to specialty care: a systematic review of the literature. BMC Health Serv Res. 2007;7:194.
3. Iobst C, King W, Baitner A, Tidwell M, Swirsky S, Skaggs DL. Access to care for children with fractures. J Pediatr Orthop. 2010;30(3):244-247.
4. Skaggs DL, Lehmann CL, Rice C, et al. Access to orthopaedic care for children with Medicaid versus private insurance: results of a national survey. J Pediatr Orthop. 2006;26(3):400-404.
5. Skaggs DL, Oda JE, Lerman L, et al. Insurance status and delay in orthotic treatment in children. J Pediatr Orthop. 2007;27(1):94-97.
6. Miyanji F, Slobogean GP, Samdani AF, et al. Is larger scoliosis curve magnitude associated with increased perioperative health-care resource utilization? A multicenter analysis of 325 adolescent idiopathic scoliosis curves. J Bone Joint Surg Am. 2012;94(9):809-813.
7. Nuno M, Drazin DG, Acosta FL Jr. Differences in treatments and outcomes for idiopathic scoliosis patients treated in the United States from 1998 to 2007: impact of socioeconomic variables and ethnicity. Spine J. 2013;13(2):116-123.
8. Vitale MA, Arons RR, Hyman JE, Skaggs DL, Roye DP, Vitale MG. The contribution of hospital volume, payer status, and other factors on the surgical outcomes of scoliosis patients: a review of 3,606 cases in the state of California. J Pediatr Orthop. 2005;25(3):393-399.
9. Goldstein RY, Joiner ER, Skaggs DL. Insurance status does not predict curve magnitude in adolescent idiopathic scoliosis at first presentation to an orthopaedic surgeon. J Pediatr Orthop. 2015;35(1):39-42.
10. Lenke LG, Betz RR, Harms J, et al. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001;83(8):1169-1181.
11. Alosh H, Riley LH 3rd, Skolasky RL. Insurance status, geography, race, and ethnicity as predictors of anterior cervical spine surgery rates and in-hospital mortality: an examination of United States trends from 1992 to 2005. Spine. 2009;34(18):1956-1962.
12. Newacheck PW, Hughes DC, Hung YY, Wong S, Stoddard JJ. The unmet health needs of America’s children. Pediatrics. 2000;105(4 pt 2):989-997.
13. Sabharwal S, Zhao C, McClemens E, Kaufmann A. Pediatric orthopaedic patients presenting to a university emergency department after visiting another emergency department: demographics and health insurance status. J Pediatr Orthop. 2007;27(6):690-694.
14. Pierce TR, Mehlman CT, Tamai J, Skaggs DL. Access to care for the adolescent anterior cruciate ligament patient with Medicaid versus private insurance. J Pediatr Orthop. 2012;32(3):245-248.
15. Cho SK, Egorova NN. The association between insurance status and complications, length of stay, and costs for pediatric idiopathic scoliosis. Spine. 2015;40(4):247-256.
16. Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW Jr. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014;8(3):257-263.
17. Kasper MJ, Robbins L, Root L, Peterson MG, Allegrante JP. A musculoskeletal outreach screening, treatment, and education program for urban minority children. Arthritis Care Res. 1993;6(3):126-133.
18. Berman S, Dolins J, Tang SF, Yudkowsky B. Factors that influence the willingness of private primary care pediatricians to accept more Medicaid patients. Pediatrics. 2002;110(2 pt 1):239-248.
19. Sommers BD. Protecting low-income children’s access to care: are physician visits associated with reduced patient dropout from Medicaid and the Children’s Health Insurance Program? Pediatrics. 2006;118(1):e36-e42.
20. Bisgaier J, Polsky D, Rhodes KV. Academic medical centers and equity in specialty care access for children. Arch Pediatr Adolesc Med. 2012;166(4):304-310.
21. Sedlis SP, Fisher VJ, Tice D, Esposito R, Madmon L, Steinberg EH. Racial differences in performance of invasive cardiac procedures in a Department of Veterans Affairs medical center. J Clin Epidemiol. 1997;50(8):899-901.
22. Mitchell JB, McCormack LA. Time trends in late-stage diagnosis of cervical cancer. Differences by race/ethnicity and income. Med Care. 1997;35(12):1220-1224.
1. Skaggs DL. Less access to care for children with Medicaid. Orthopedics. 2003;26(12):1184, 1186.
2. Skinner AC, Mayer ML. Effects of insurance status on children’s access to specialty care: a systematic review of the literature. BMC Health Serv Res. 2007;7:194.
3. Iobst C, King W, Baitner A, Tidwell M, Swirsky S, Skaggs DL. Access to care for children with fractures. J Pediatr Orthop. 2010;30(3):244-247.
4. Skaggs DL, Lehmann CL, Rice C, et al. Access to orthopaedic care for children with Medicaid versus private insurance: results of a national survey. J Pediatr Orthop. 2006;26(3):400-404.
5. Skaggs DL, Oda JE, Lerman L, et al. Insurance status and delay in orthotic treatment in children. J Pediatr Orthop. 2007;27(1):94-97.
6. Miyanji F, Slobogean GP, Samdani AF, et al. Is larger scoliosis curve magnitude associated with increased perioperative health-care resource utilization? A multicenter analysis of 325 adolescent idiopathic scoliosis curves. J Bone Joint Surg Am. 2012;94(9):809-813.
7. Nuno M, Drazin DG, Acosta FL Jr. Differences in treatments and outcomes for idiopathic scoliosis patients treated in the United States from 1998 to 2007: impact of socioeconomic variables and ethnicity. Spine J. 2013;13(2):116-123.
8. Vitale MA, Arons RR, Hyman JE, Skaggs DL, Roye DP, Vitale MG. The contribution of hospital volume, payer status, and other factors on the surgical outcomes of scoliosis patients: a review of 3,606 cases in the state of California. J Pediatr Orthop. 2005;25(3):393-399.
9. Goldstein RY, Joiner ER, Skaggs DL. Insurance status does not predict curve magnitude in adolescent idiopathic scoliosis at first presentation to an orthopaedic surgeon. J Pediatr Orthop. 2015;35(1):39-42.
10. Lenke LG, Betz RR, Harms J, et al. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001;83(8):1169-1181.
11. Alosh H, Riley LH 3rd, Skolasky RL. Insurance status, geography, race, and ethnicity as predictors of anterior cervical spine surgery rates and in-hospital mortality: an examination of United States trends from 1992 to 2005. Spine. 2009;34(18):1956-1962.
12. Newacheck PW, Hughes DC, Hung YY, Wong S, Stoddard JJ. The unmet health needs of America’s children. Pediatrics. 2000;105(4 pt 2):989-997.
13. Sabharwal S, Zhao C, McClemens E, Kaufmann A. Pediatric orthopaedic patients presenting to a university emergency department after visiting another emergency department: demographics and health insurance status. J Pediatr Orthop. 2007;27(6):690-694.
14. Pierce TR, Mehlman CT, Tamai J, Skaggs DL. Access to care for the adolescent anterior cruciate ligament patient with Medicaid versus private insurance. J Pediatr Orthop. 2012;32(3):245-248.
15. Cho SK, Egorova NN. The association between insurance status and complications, length of stay, and costs for pediatric idiopathic scoliosis. Spine. 2015;40(4):247-256.
16. Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW Jr. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014;8(3):257-263.
17. Kasper MJ, Robbins L, Root L, Peterson MG, Allegrante JP. A musculoskeletal outreach screening, treatment, and education program for urban minority children. Arthritis Care Res. 1993;6(3):126-133.
18. Berman S, Dolins J, Tang SF, Yudkowsky B. Factors that influence the willingness of private primary care pediatricians to accept more Medicaid patients. Pediatrics. 2002;110(2 pt 1):239-248.
19. Sommers BD. Protecting low-income children’s access to care: are physician visits associated with reduced patient dropout from Medicaid and the Children’s Health Insurance Program? Pediatrics. 2006;118(1):e36-e42.
20. Bisgaier J, Polsky D, Rhodes KV. Academic medical centers and equity in specialty care access for children. Arch Pediatr Adolesc Med. 2012;166(4):304-310.
21. Sedlis SP, Fisher VJ, Tice D, Esposito R, Madmon L, Steinberg EH. Racial differences in performance of invasive cardiac procedures in a Department of Veterans Affairs medical center. J Clin Epidemiol. 1997;50(8):899-901.
22. Mitchell JB, McCormack LA. Time trends in late-stage diagnosis of cervical cancer. Differences by race/ethnicity and income. Med Care. 1997;35(12):1220-1224.
Is the Orthopedic Fellowship Interview Process Broken? A Survey of Program Directors and Residents
Over the past several decades, an increasing number of orthopedic surgery residents have pursued fellowship training.1 This inclination parallels market trends toward subspecialization.2-5 In 1984, 83% of orthopedics job announcements were for general orthopedists. Twenty-five years later, almost 70% of orthopedic opportunities were for fellowship-trained surgeons.6 Further, between 1990 and 2006, the proportion of practicing orthopedic generalists decreased from 44% to 29%.3 In 2007, the American Academy of Orthopaedic Surgery (AAOS) reported 90% of graduating residents were planning to pursue fellowship training.7 Reasons for the explosion in subspecialty training are plentiful and well documented.2-5 Subspecialty positions now dominate the job market, further reinforcing incentives for residents to pursue fellowship training.
The past several decades have seen numerous changes in the orthopedic fellowship interview process. Early on, it was largely unregulated, dependent on personal and professional connections, and flush with the classic “exploding offer” (residents were given a fellowship offer that expired within hours or days). In the 1980s, as the number of fellowship applications surged, the Accreditation Council for Graduate Medical Education (ACGME) pushed for a more regulated process.8 To further standardize the system, the American Orthopaedic Association (AOA), the AAOS, and several other specialty organizations created the Orthopaedic Fellowship Match Program Initiative in 2008.9 Currently, all orthopedic specialties are represented in either the San Francisco Match Program or National Residency Match Program.
As the system currently stands, postgraduate year 4 (PGY-4) residents are required to interview across the country to secure postgraduate training. This process necessitates residents’ absence from their program, reducing educational opportunities and placing potential continuity-of-care constraints on the residency program. Despite the growing competitiveness for fellowship positions, the increasing number of fellowships available, the rising educational debt of residents, and the limitations of the 80-hour work week, the impact of the interview process on both residents and residency programs has received minimal attention.
We conducted a study to elucidate the impact of the fellowship interview process on residents and residency programs. We hypothesized the time and financial costs for fellowship interviews would be substantial.
Materials and Methods
We obtained institutional review board (IRB) approval for this study. Then, in April 2014, we sent 2 mixed-response questionnaires to orthopedic surgery residency directors and residents. There were 8 items on the director questionnaire and 11 on the resident questionnaire. The surveys were designed to determine the impact of the fellowship interview process on residents and residency programs with respect to finances, time, education, and continuity of care. Each survey had at least 1 free-response question, providing the opportunity to recommend changes to the interview process. The surveys were reviewed and approved by our IRB.
An email was sent to 155 orthopedic surgery program directors or their secretaries. The email asked that the director complete the director questionnaire and that the resident questionnaire be forwarded to senior-level residents, PGY-4s and PGY-5s, who had completed the fellowship interview process. Forty-five (29%) of the 155 directors responded, as did 129 (estimated 9.5%) of an estimated 1354 potential PGY-4s and PGY-5s.10
The Survey Monkey surveys could be completed over a 3-week period. All responses were anonymous. Using Survey Monkey, we aggregated individual responses into predefined clusters before performing statistical analysis. Descriptive statistics were generated with Microsoft Excel.
Results
Survey respondents represented all the orthopedic subspecialties (Table). Seventy-eight percent of residents applied to at least 13 programs (average, 19) (Figure 1). Ninety-two percent received at least 8 interview offers (average, 14). Eighty-three percent attended 8 or more interviews (average, 11). Seventy-one percent of all interviews were granted when requested, and 79% of all interviews were attended when offered.
Residents spent an average of $5875 (range, $500-$12,000+) on the fellowship interview process (Figure 2). The highest percentage of respondents, 39.5%, selected an average expense between $4000 and $6000. Forty-nine percent of residents borrowed money (from credit cards, additional loans, family members) to pay their expenses.
Average number of days away from residency programs was 11, with 86% of residents missing more than 8 days (Figure 1). About one-third of residents reported being away from their home program for almost 2 weeks during the interview season. Further, 74% of residents wanted changes made to the fellowship application process.
Thirty-seven (82%) of the 45 program directors were from academic programs, the other 8 from community-based programs. Average number of residents in programs per year was 4 (73% of the programs had 4-6 residents per year). Respondents rated the disruption caused by residents’ interview absences from 1 (least disruptive) to 10 (most disruptive) (Figure 3); the average rating was over 7 (high level of disruption). Although 9% of directors thought the process caused little or no disruption (rating, 1-3), 62% thought it extremely disruptive (rating, 8-10).
Thirty-one (69%) of the 45 directors agreed that the fellowship interview process should undergo fundamental change. Asked about possible solutions to current complaints, 60% of the directors agreed that interviews should be conducted in a central location. Of the directors who thought fundamental change was needed, 59% indicated AAOS and other specialty societies together should lead the change in the fellowship interview process.
Both residents and program directors were given the opportunity to write in suggestions regarding how to improve the fellowship interview process. Suggestions were made by 85 (66%) of the 129 residents and 24 (53%) of the 45 directors (Appendix).
Discussion
Graduating residents are entering a health care environment in which they must be financially conscious because of increasing education debt and decreasing reimbursement prospects.3 Nevertheless, an overwhelming majority of residents delay entering practice to pursue fellowship training—an estimated opportunity cost of $350,000.3 Minimal attention has been given to the potential costs of the fellowship interview process.
Our study results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial. On average, residents applied to 19 programs, received 14 interview offers, attended 11 interviews, were away from residency training 11 days, and spent $5875 on travel. The great majority of both residents and program directors wanted changes in the current paradigm governing the orthopedic fellowship interview process.
It is reasonable to think that the number of days residents spend away on interviews would reduce the time available for education and patient care. Although unknown, it is plausible that residents of programs outside major metropolitan centers and residents who apply to more competitive fellowships may be forced to spend even more time away from training. Outside the focus of this study are the impact that residents’ absence might have on their education and the impact of this absence on the people who do the residents’ work while they are away.
Mean fellowship expense was similar to that reported by residents pursuing a pediatric general surgery fellowship ($6974) or a plastic surgery fellowship ($6100).11,12 Unfortunately, we were unable to determine if average cost is influenced by choice of fellowship specialty or location of residency program. Regardless, fellowship cost may impose an additional financial burden on residents. According to the Association of American Medical Colleges (AAMC), the median salary for PGY-4 residents was $56,380 in 2013. Therefore, on average, the fellowship process consumes more than 10% of a resident’s pretax salary. For perspective, this equates to more than $40,000 for a practicing orthopedic surgeon with a median salary of $413,000.13 With an average medical student graduate debt of $175,000 and continuing decreases in reimbursement, further financial hardships to newly graduating residents cannot be understated.5,11,12
Almost 70% of program directors thought the fellowship process significantly disrupted their program. Reasons given for this disruption mainly involved residents’ time away from the program and the resulting strains placed on maintaining adequate coverage for patient care. The overall disruption score of 7.4 out of 10 was consistent with the great majority thinking that the fellowship process negatively affects their residency program. Altering the fellowship interview process may provide unintended benefits to programs and program directors.
Both program directors and residents communicated that change is needed, but there was little consensus regarding how to effect change and who should lead. This lack of consensus highlights how important it is for the various orthopedic leadership committees to actively and collectively participate in discussions about redefining the system. It has been proposed that it would be ideal for the AOA to lead the change, as the AOA consists of a representative cohort of academic orthopedists and leaders across the spectrum of all fellowship specialties.14 Given the abundant concern of both residents and program directors, we find it prudent to issue a call to arms of sorts to the AAOS and the individual orthopedic subspecialty societies to work together on a common goal that would benefit residents, programs, and subspecialties within orthopedics.
In trying to understand the challenges that residents, program directors, and programs face, as well as the inherent complexity of the current system, we incorporated respondents’ write-in comments into suggested ways of improving the fellowship interview process. These comments had broad perspectives but overall were consistent with the survey results (Appendix).
Technology
Health care is continually finding new ways to take advantage of technological advances. This is occurring with the fellowship interview schema. Numerous disciplines are using videoconferencing platforms (eg, Skype) to conduct interviews. This practice is becoming more commonplace in the business sector. In a recent survey, more than 60% of human resource managers reported conducting video interviews.15 Two independent residency programs have used video interviews with mixed success.16,17
Another technological change requested by residents is the creation and updating of fellowship web pages with standardized information. Such a service may prove useful to residents researching a program and may even lead to limiting the number of programs residents apply to, as they may be able to dial in on exactly what distinguishes one program from another before traveling for an interview. A recent study of orthopedic sports medicine fellowship programs found that most of these programs lacked pertinent information on their websites.18 Important information regarding case logs from current and former fellows; number of faculty, residents, and fellows; and schedules and facilities of interview sites are a few of the online data points that may help residents differentiate particular programs.19,20 Questions like these are often asked at interviews and site visits. Having accurate information easily available online may reduce or eliminate the need to travel to a site for such information. Standardizing information would also increase transparency among available fellowships. Although not specifically mentioned, organizational software that improves the productivity of the process may help limit the large number of programs applied to, the interviews offered and attended, the days away, and the financial costs without reducing the match rate.
Timing and Location
The issue of timing—with respect to geographical or meteorological concerns—was another recurring theme among respondents. Numerous respondents indicated that certain programs located in geographic proximity tried to minimize travel by offering interviews around the same time. This coordination potentially minimizes travel expenses and time away from the residency program by allowing residents to interview at multiple locations during a single trip per region. The sports medicine fellowship process was identified as a good example of aligning interviews based on geography. Several respondents suggested an option that also reflects the practice of nonsurgical fellowships—delaying the interview season to bypass potential weather concerns. Winter 2013–2014 saw the most flight delays or cancellations in more than a decade; about 50% of all flights scheduled between December and February were delayed or canceled.21 Beyond the additional factor of more time away or missing an interview because of the weather are safety concerns related to the weather. One resident reported having a motor vehicle accident while traveling to an interview in poor weather conditions (Appendix).
National Meetings
Each orthopedic subspecialty has numerous national meetings. Many programs offer applicants the opportunity to interview at these meetings. One respondent mentioned that the annual meeting of the Orthopaedic Trauma Association offers trauma applicants the opportunity to interview with multiple programs. It might be beneficial to endorse this practice on a larger scale to help reduce travel and time away. We recognize that visiting individual programs is an important aspect of the match process, but doing so on a targeted level may make more sense, increasing financial efficiency and reducing time away from programs.
Proposed Solution
A combined proposed solution that can be implemented without a radical overhaul or significant investments might involve moving the interview season to early spring, switching to a 2-tiered system with a centralized first round of interview screening coinciding with subspecialty national meetings or the AAOS annual meeting, and standardizing online information for all orthopedic fellowship programs. A 2-tiered interview process would allow programs and candidates to obtain exposure to a significant number of programs in the first round without incurring significant costs and then would impose a cap on the number of programs to visit. This would level the playing field between candidates with more time and money and candidates who are more constrained in their training environment and finances. A stopgap or adjunct to residents or fellowship programs unable to attend a centralized meeting would be to combine technological tools, such as Internet-based videoconferencing (Skype), before site visits by residents. After this first round of introductions and interviews, residents could then decide on a limited number of programs to formally visit, attend, and ultimately rank. This proposed system would still be able to function within the confines of the match, and it would benefit from the protections offered to residents and programs. Although capping the number of interviews attended by residents clearly can lower costs across the board, we recognize the difficulty of enforcing such a requirement. These potential changes to the system are not exhaustive, and we hope this work will serve as a springboard to further discussion.
Our study had several inherent weaknesses. Our data came from survey responses, which reflect the perspectives only of the responding residents and program directors. Unfortunately, a small number of orthopedic residents responded to this survey, so there was a potential for bias. However, we think the central themes discovered in this survey are only echoes of the concerns of the larger population of residents and program directors. Our hope in designing such a study was to bring to light some of the discrepancies in the fellowship interview process, the goal being to stimulate interest among the orthopedic leadership representing future orthopedic surgeons. More study is needed to clarify if these issues are reflective of a larger segment of residents and program directors. In addition, action may be needed to fully elucidate the intricate interworking of the fellowship process in order to maximize the interest of the orthopedic surgeons who are seeking fellowship training. Another study limitation was the potential for recall bias in the more senior PGY-5 residents, who were further from the interview process than PGY-4 respondents were. Because of the need for anonymity with the surveys, we could not link some findings (eg, program impact, cost, time away) to individual programs or different specialty fellowships. Although it appears there is a desire for a more cost-effective system, given the financial pressures on medical students and residents, the desire to match increases costs because students are likely to attend more interviews than actually needed. Our proposed solution does not take into account residents’ behavior with respect to the current match system. For example, the prevailing thought is that interviewing at more programs increases the likelihood of matching into a desired subspecialty. Despite these study limitations, we think our results identified important points for discussion, investigation, and potential action by orthopedic leadership.
Conclusion
The challenge of critiquing and improving the orthopedic fellowship process requires the same courageous leadership that was recommended almost a decade ago.14 In this study, we tried to elucidate the impact of the PGY-4 fellowship interview process with respect to residents and residency programs. Our results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial and that both residents and program directors want changes made. Leadership needs to further investigate alternatives to the current process to lessen the impact on all parties in this important process.
1. Simon MA. Evolution of the present status of orthopaedic surgery fellowships. J Bone Joint Surg Am. 1998;80(12):1826-1829.
2. Brunworth LS, Chintalapani SR, Gray RR, Cardoso R, Owens PW. Resident selection of hand surgery fellowships: a survey of the 2011, 2012, and 2013 hand fellowship graduates. Hand. 2013;8(2):164-171.
3. Gaskill T, Cook C, Nunley J, Mather RC. The financial impact of orthopaedic fellowship training. J Bone Joint Surg Am. 2009;91(7):1814-1821.
4. Sarmiento A. Additional thoughts on orthopedic residency and fellowships. Orthopedics. 2010;33(10):712-713.
5. Griffin SM, Stoneback JW. Navigating the Orthopaedic Trauma Fellowship Match from a candidate’s perspective. J Orthop Trauma. 2011;25(suppl 3):S101-S103.
6. Morrell NT, Mercer DM, Moneim MS. Trends in the orthopedic job market and the importance of fellowship subspecialty training. Orthopedics. 2012;35(4):e555-e560.
7. Iorio R, Robb WJ, Healy WL, et al. Orthopaedic surgeon workforce and volume assessment for total hip and knee replacement in the United States: preparing for an epidemic. J Bone Joint Surg Am. 2008;90(7):1598-1605.
8. Emery SE, Guss D, Kuremsky MA, Hamlin BR, Herndon JH, Rubash HE. Resident education versus fellowship training—conflict or synergy? AOA critical issues. J Bone Joint Surg Am. 2012;94(21):e159.
9. Harner CD, Ranawat AS, Niederle M, et al. AOA symposium. Current state of fellowship hiring: is a universal match necessary? Is it possible? J Bone Joint Surg Am. 2008;90(6):1375-1384.
10. Ranawat A, Nunley RM, Genuario JW, Sharan AD, Mehta S; Washington Health Policy Fellows. Current state of the fellowship hiring process: Are we in 1957 or 2007? AAOS Now. 2007;1(8).
11. Little DC, Yoder SM, Grikscheit TC, et al. Cost considerations and applicant characteristics for the Pediatric Surgery Match. J Pediatr Surg. 2005;40(1):69-73.
12. Claiborne JR, Crantford JC, Swett KR, David LR. The Plastic Surgery Match: predicting success and improving the process. Ann Plast Surg. 2013;70(6):698-703.
13. Kane L, Peckham C. Medscape Physician Compensation Report 2014. http://www.medscape.com/features/slideshow/compensation/2014/public/overview. Published April 15, 2014. Accessed September 26, 2015.
14. Swiontkowski MF. A simple formula for continued improvement in orthopaedic surgery postgraduate training: courageous leadership. J Bone Joint Surg Am. 2008;90(6):1175.
15. Survey: six in 10 companies conduct video job interviews [news release]. http://www.prnewswire.com/news-releases/survey-six-in-10-companies-conduct-video-job-interviews-167973406.html. Published August 30, 2012. Accessed September 26, 2015.
16. Kerfoot BP, Asher KP, McCullough DL. Financial and educational costs of the residency interview process for urology applicants. Urology. 2008;71(6):990-994.
17. Edje L, Miller C, Kiefer J, Oram D. Using Skype as an alternative for residency selection interviews. J Grad Med Educ. 2013;5(3):503-505.
18. Mulcahey MK, Gosselin MM, Fadale PD. Evaluation of the content and accessibility of web sites for accredited orthopaedic sports medicine fellowships. J Bone Joint Surg Am. 2013;95(12):e85.
19. Gaeta TJ, Birkhahn RH, Lamont D, Banga N, Bove JJ. Aspects of residency programs’ web sites important to student applicants. Acad Emerg Med. 2005;12(1):89-92.
20. Mahler SA, Wagner MJ, Church A, Sokolosky M, Cline DM. Importance of residency program web sites to emergency medicine applicants. J Emerg Med. 2009;36(1):83-88.
21. Davies A. Winter’s toll: 1 million flights cancelled or delayed, costing travelers $5.3 billion. Business Insider. http://www.businessinsider.com/winter-flights-cancelled-delayed-cost-2014-3. Published March 3, 2014. Accessed September 26, 2015.
Over the past several decades, an increasing number of orthopedic surgery residents have pursued fellowship training.1 This inclination parallels market trends toward subspecialization.2-5 In 1984, 83% of orthopedics job announcements were for general orthopedists. Twenty-five years later, almost 70% of orthopedic opportunities were for fellowship-trained surgeons.6 Further, between 1990 and 2006, the proportion of practicing orthopedic generalists decreased from 44% to 29%.3 In 2007, the American Academy of Orthopaedic Surgery (AAOS) reported 90% of graduating residents were planning to pursue fellowship training.7 Reasons for the explosion in subspecialty training are plentiful and well documented.2-5 Subspecialty positions now dominate the job market, further reinforcing incentives for residents to pursue fellowship training.
The past several decades have seen numerous changes in the orthopedic fellowship interview process. Early on, it was largely unregulated, dependent on personal and professional connections, and flush with the classic “exploding offer” (residents were given a fellowship offer that expired within hours or days). In the 1980s, as the number of fellowship applications surged, the Accreditation Council for Graduate Medical Education (ACGME) pushed for a more regulated process.8 To further standardize the system, the American Orthopaedic Association (AOA), the AAOS, and several other specialty organizations created the Orthopaedic Fellowship Match Program Initiative in 2008.9 Currently, all orthopedic specialties are represented in either the San Francisco Match Program or National Residency Match Program.
As the system currently stands, postgraduate year 4 (PGY-4) residents are required to interview across the country to secure postgraduate training. This process necessitates residents’ absence from their program, reducing educational opportunities and placing potential continuity-of-care constraints on the residency program. Despite the growing competitiveness for fellowship positions, the increasing number of fellowships available, the rising educational debt of residents, and the limitations of the 80-hour work week, the impact of the interview process on both residents and residency programs has received minimal attention.
We conducted a study to elucidate the impact of the fellowship interview process on residents and residency programs. We hypothesized the time and financial costs for fellowship interviews would be substantial.
Materials and Methods
We obtained institutional review board (IRB) approval for this study. Then, in April 2014, we sent 2 mixed-response questionnaires to orthopedic surgery residency directors and residents. There were 8 items on the director questionnaire and 11 on the resident questionnaire. The surveys were designed to determine the impact of the fellowship interview process on residents and residency programs with respect to finances, time, education, and continuity of care. Each survey had at least 1 free-response question, providing the opportunity to recommend changes to the interview process. The surveys were reviewed and approved by our IRB.
An email was sent to 155 orthopedic surgery program directors or their secretaries. The email asked that the director complete the director questionnaire and that the resident questionnaire be forwarded to senior-level residents, PGY-4s and PGY-5s, who had completed the fellowship interview process. Forty-five (29%) of the 155 directors responded, as did 129 (estimated 9.5%) of an estimated 1354 potential PGY-4s and PGY-5s.10
The Survey Monkey surveys could be completed over a 3-week period. All responses were anonymous. Using Survey Monkey, we aggregated individual responses into predefined clusters before performing statistical analysis. Descriptive statistics were generated with Microsoft Excel.
Results
Survey respondents represented all the orthopedic subspecialties (Table). Seventy-eight percent of residents applied to at least 13 programs (average, 19) (Figure 1). Ninety-two percent received at least 8 interview offers (average, 14). Eighty-three percent attended 8 or more interviews (average, 11). Seventy-one percent of all interviews were granted when requested, and 79% of all interviews were attended when offered.
Residents spent an average of $5875 (range, $500-$12,000+) on the fellowship interview process (Figure 2). The highest percentage of respondents, 39.5%, selected an average expense between $4000 and $6000. Forty-nine percent of residents borrowed money (from credit cards, additional loans, family members) to pay their expenses.
Average number of days away from residency programs was 11, with 86% of residents missing more than 8 days (Figure 1). About one-third of residents reported being away from their home program for almost 2 weeks during the interview season. Further, 74% of residents wanted changes made to the fellowship application process.
Thirty-seven (82%) of the 45 program directors were from academic programs, the other 8 from community-based programs. Average number of residents in programs per year was 4 (73% of the programs had 4-6 residents per year). Respondents rated the disruption caused by residents’ interview absences from 1 (least disruptive) to 10 (most disruptive) (Figure 3); the average rating was over 7 (high level of disruption). Although 9% of directors thought the process caused little or no disruption (rating, 1-3), 62% thought it extremely disruptive (rating, 8-10).
Thirty-one (69%) of the 45 directors agreed that the fellowship interview process should undergo fundamental change. Asked about possible solutions to current complaints, 60% of the directors agreed that interviews should be conducted in a central location. Of the directors who thought fundamental change was needed, 59% indicated AAOS and other specialty societies together should lead the change in the fellowship interview process.
Both residents and program directors were given the opportunity to write in suggestions regarding how to improve the fellowship interview process. Suggestions were made by 85 (66%) of the 129 residents and 24 (53%) of the 45 directors (Appendix).
Discussion
Graduating residents are entering a health care environment in which they must be financially conscious because of increasing education debt and decreasing reimbursement prospects.3 Nevertheless, an overwhelming majority of residents delay entering practice to pursue fellowship training—an estimated opportunity cost of $350,000.3 Minimal attention has been given to the potential costs of the fellowship interview process.
Our study results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial. On average, residents applied to 19 programs, received 14 interview offers, attended 11 interviews, were away from residency training 11 days, and spent $5875 on travel. The great majority of both residents and program directors wanted changes in the current paradigm governing the orthopedic fellowship interview process.
It is reasonable to think that the number of days residents spend away on interviews would reduce the time available for education and patient care. Although unknown, it is plausible that residents of programs outside major metropolitan centers and residents who apply to more competitive fellowships may be forced to spend even more time away from training. Outside the focus of this study are the impact that residents’ absence might have on their education and the impact of this absence on the people who do the residents’ work while they are away.
Mean fellowship expense was similar to that reported by residents pursuing a pediatric general surgery fellowship ($6974) or a plastic surgery fellowship ($6100).11,12 Unfortunately, we were unable to determine if average cost is influenced by choice of fellowship specialty or location of residency program. Regardless, fellowship cost may impose an additional financial burden on residents. According to the Association of American Medical Colleges (AAMC), the median salary for PGY-4 residents was $56,380 in 2013. Therefore, on average, the fellowship process consumes more than 10% of a resident’s pretax salary. For perspective, this equates to more than $40,000 for a practicing orthopedic surgeon with a median salary of $413,000.13 With an average medical student graduate debt of $175,000 and continuing decreases in reimbursement, further financial hardships to newly graduating residents cannot be understated.5,11,12
Almost 70% of program directors thought the fellowship process significantly disrupted their program. Reasons given for this disruption mainly involved residents’ time away from the program and the resulting strains placed on maintaining adequate coverage for patient care. The overall disruption score of 7.4 out of 10 was consistent with the great majority thinking that the fellowship process negatively affects their residency program. Altering the fellowship interview process may provide unintended benefits to programs and program directors.
Both program directors and residents communicated that change is needed, but there was little consensus regarding how to effect change and who should lead. This lack of consensus highlights how important it is for the various orthopedic leadership committees to actively and collectively participate in discussions about redefining the system. It has been proposed that it would be ideal for the AOA to lead the change, as the AOA consists of a representative cohort of academic orthopedists and leaders across the spectrum of all fellowship specialties.14 Given the abundant concern of both residents and program directors, we find it prudent to issue a call to arms of sorts to the AAOS and the individual orthopedic subspecialty societies to work together on a common goal that would benefit residents, programs, and subspecialties within orthopedics.
In trying to understand the challenges that residents, program directors, and programs face, as well as the inherent complexity of the current system, we incorporated respondents’ write-in comments into suggested ways of improving the fellowship interview process. These comments had broad perspectives but overall were consistent with the survey results (Appendix).
Technology
Health care is continually finding new ways to take advantage of technological advances. This is occurring with the fellowship interview schema. Numerous disciplines are using videoconferencing platforms (eg, Skype) to conduct interviews. This practice is becoming more commonplace in the business sector. In a recent survey, more than 60% of human resource managers reported conducting video interviews.15 Two independent residency programs have used video interviews with mixed success.16,17
Another technological change requested by residents is the creation and updating of fellowship web pages with standardized information. Such a service may prove useful to residents researching a program and may even lead to limiting the number of programs residents apply to, as they may be able to dial in on exactly what distinguishes one program from another before traveling for an interview. A recent study of orthopedic sports medicine fellowship programs found that most of these programs lacked pertinent information on their websites.18 Important information regarding case logs from current and former fellows; number of faculty, residents, and fellows; and schedules and facilities of interview sites are a few of the online data points that may help residents differentiate particular programs.19,20 Questions like these are often asked at interviews and site visits. Having accurate information easily available online may reduce or eliminate the need to travel to a site for such information. Standardizing information would also increase transparency among available fellowships. Although not specifically mentioned, organizational software that improves the productivity of the process may help limit the large number of programs applied to, the interviews offered and attended, the days away, and the financial costs without reducing the match rate.
Timing and Location
The issue of timing—with respect to geographical or meteorological concerns—was another recurring theme among respondents. Numerous respondents indicated that certain programs located in geographic proximity tried to minimize travel by offering interviews around the same time. This coordination potentially minimizes travel expenses and time away from the residency program by allowing residents to interview at multiple locations during a single trip per region. The sports medicine fellowship process was identified as a good example of aligning interviews based on geography. Several respondents suggested an option that also reflects the practice of nonsurgical fellowships—delaying the interview season to bypass potential weather concerns. Winter 2013–2014 saw the most flight delays or cancellations in more than a decade; about 50% of all flights scheduled between December and February were delayed or canceled.21 Beyond the additional factor of more time away or missing an interview because of the weather are safety concerns related to the weather. One resident reported having a motor vehicle accident while traveling to an interview in poor weather conditions (Appendix).
National Meetings
Each orthopedic subspecialty has numerous national meetings. Many programs offer applicants the opportunity to interview at these meetings. One respondent mentioned that the annual meeting of the Orthopaedic Trauma Association offers trauma applicants the opportunity to interview with multiple programs. It might be beneficial to endorse this practice on a larger scale to help reduce travel and time away. We recognize that visiting individual programs is an important aspect of the match process, but doing so on a targeted level may make more sense, increasing financial efficiency and reducing time away from programs.
Proposed Solution
A combined proposed solution that can be implemented without a radical overhaul or significant investments might involve moving the interview season to early spring, switching to a 2-tiered system with a centralized first round of interview screening coinciding with subspecialty national meetings or the AAOS annual meeting, and standardizing online information for all orthopedic fellowship programs. A 2-tiered interview process would allow programs and candidates to obtain exposure to a significant number of programs in the first round without incurring significant costs and then would impose a cap on the number of programs to visit. This would level the playing field between candidates with more time and money and candidates who are more constrained in their training environment and finances. A stopgap or adjunct to residents or fellowship programs unable to attend a centralized meeting would be to combine technological tools, such as Internet-based videoconferencing (Skype), before site visits by residents. After this first round of introductions and interviews, residents could then decide on a limited number of programs to formally visit, attend, and ultimately rank. This proposed system would still be able to function within the confines of the match, and it would benefit from the protections offered to residents and programs. Although capping the number of interviews attended by residents clearly can lower costs across the board, we recognize the difficulty of enforcing such a requirement. These potential changes to the system are not exhaustive, and we hope this work will serve as a springboard to further discussion.
Our study had several inherent weaknesses. Our data came from survey responses, which reflect the perspectives only of the responding residents and program directors. Unfortunately, a small number of orthopedic residents responded to this survey, so there was a potential for bias. However, we think the central themes discovered in this survey are only echoes of the concerns of the larger population of residents and program directors. Our hope in designing such a study was to bring to light some of the discrepancies in the fellowship interview process, the goal being to stimulate interest among the orthopedic leadership representing future orthopedic surgeons. More study is needed to clarify if these issues are reflective of a larger segment of residents and program directors. In addition, action may be needed to fully elucidate the intricate interworking of the fellowship process in order to maximize the interest of the orthopedic surgeons who are seeking fellowship training. Another study limitation was the potential for recall bias in the more senior PGY-5 residents, who were further from the interview process than PGY-4 respondents were. Because of the need for anonymity with the surveys, we could not link some findings (eg, program impact, cost, time away) to individual programs or different specialty fellowships. Although it appears there is a desire for a more cost-effective system, given the financial pressures on medical students and residents, the desire to match increases costs because students are likely to attend more interviews than actually needed. Our proposed solution does not take into account residents’ behavior with respect to the current match system. For example, the prevailing thought is that interviewing at more programs increases the likelihood of matching into a desired subspecialty. Despite these study limitations, we think our results identified important points for discussion, investigation, and potential action by orthopedic leadership.
Conclusion
The challenge of critiquing and improving the orthopedic fellowship process requires the same courageous leadership that was recommended almost a decade ago.14 In this study, we tried to elucidate the impact of the PGY-4 fellowship interview process with respect to residents and residency programs. Our results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial and that both residents and program directors want changes made. Leadership needs to further investigate alternatives to the current process to lessen the impact on all parties in this important process.
Over the past several decades, an increasing number of orthopedic surgery residents have pursued fellowship training.1 This inclination parallels market trends toward subspecialization.2-5 In 1984, 83% of orthopedics job announcements were for general orthopedists. Twenty-five years later, almost 70% of orthopedic opportunities were for fellowship-trained surgeons.6 Further, between 1990 and 2006, the proportion of practicing orthopedic generalists decreased from 44% to 29%.3 In 2007, the American Academy of Orthopaedic Surgery (AAOS) reported 90% of graduating residents were planning to pursue fellowship training.7 Reasons for the explosion in subspecialty training are plentiful and well documented.2-5 Subspecialty positions now dominate the job market, further reinforcing incentives for residents to pursue fellowship training.
The past several decades have seen numerous changes in the orthopedic fellowship interview process. Early on, it was largely unregulated, dependent on personal and professional connections, and flush with the classic “exploding offer” (residents were given a fellowship offer that expired within hours or days). In the 1980s, as the number of fellowship applications surged, the Accreditation Council for Graduate Medical Education (ACGME) pushed for a more regulated process.8 To further standardize the system, the American Orthopaedic Association (AOA), the AAOS, and several other specialty organizations created the Orthopaedic Fellowship Match Program Initiative in 2008.9 Currently, all orthopedic specialties are represented in either the San Francisco Match Program or National Residency Match Program.
As the system currently stands, postgraduate year 4 (PGY-4) residents are required to interview across the country to secure postgraduate training. This process necessitates residents’ absence from their program, reducing educational opportunities and placing potential continuity-of-care constraints on the residency program. Despite the growing competitiveness for fellowship positions, the increasing number of fellowships available, the rising educational debt of residents, and the limitations of the 80-hour work week, the impact of the interview process on both residents and residency programs has received minimal attention.
We conducted a study to elucidate the impact of the fellowship interview process on residents and residency programs. We hypothesized the time and financial costs for fellowship interviews would be substantial.
Materials and Methods
We obtained institutional review board (IRB) approval for this study. Then, in April 2014, we sent 2 mixed-response questionnaires to orthopedic surgery residency directors and residents. There were 8 items on the director questionnaire and 11 on the resident questionnaire. The surveys were designed to determine the impact of the fellowship interview process on residents and residency programs with respect to finances, time, education, and continuity of care. Each survey had at least 1 free-response question, providing the opportunity to recommend changes to the interview process. The surveys were reviewed and approved by our IRB.
An email was sent to 155 orthopedic surgery program directors or their secretaries. The email asked that the director complete the director questionnaire and that the resident questionnaire be forwarded to senior-level residents, PGY-4s and PGY-5s, who had completed the fellowship interview process. Forty-five (29%) of the 155 directors responded, as did 129 (estimated 9.5%) of an estimated 1354 potential PGY-4s and PGY-5s.10
The Survey Monkey surveys could be completed over a 3-week period. All responses were anonymous. Using Survey Monkey, we aggregated individual responses into predefined clusters before performing statistical analysis. Descriptive statistics were generated with Microsoft Excel.
Results
Survey respondents represented all the orthopedic subspecialties (Table). Seventy-eight percent of residents applied to at least 13 programs (average, 19) (Figure 1). Ninety-two percent received at least 8 interview offers (average, 14). Eighty-three percent attended 8 or more interviews (average, 11). Seventy-one percent of all interviews were granted when requested, and 79% of all interviews were attended when offered.
Residents spent an average of $5875 (range, $500-$12,000+) on the fellowship interview process (Figure 2). The highest percentage of respondents, 39.5%, selected an average expense between $4000 and $6000. Forty-nine percent of residents borrowed money (from credit cards, additional loans, family members) to pay their expenses.
Average number of days away from residency programs was 11, with 86% of residents missing more than 8 days (Figure 1). About one-third of residents reported being away from their home program for almost 2 weeks during the interview season. Further, 74% of residents wanted changes made to the fellowship application process.
Thirty-seven (82%) of the 45 program directors were from academic programs, the other 8 from community-based programs. Average number of residents in programs per year was 4 (73% of the programs had 4-6 residents per year). Respondents rated the disruption caused by residents’ interview absences from 1 (least disruptive) to 10 (most disruptive) (Figure 3); the average rating was over 7 (high level of disruption). Although 9% of directors thought the process caused little or no disruption (rating, 1-3), 62% thought it extremely disruptive (rating, 8-10).
Thirty-one (69%) of the 45 directors agreed that the fellowship interview process should undergo fundamental change. Asked about possible solutions to current complaints, 60% of the directors agreed that interviews should be conducted in a central location. Of the directors who thought fundamental change was needed, 59% indicated AAOS and other specialty societies together should lead the change in the fellowship interview process.
Both residents and program directors were given the opportunity to write in suggestions regarding how to improve the fellowship interview process. Suggestions were made by 85 (66%) of the 129 residents and 24 (53%) of the 45 directors (Appendix).
Discussion
Graduating residents are entering a health care environment in which they must be financially conscious because of increasing education debt and decreasing reimbursement prospects.3 Nevertheless, an overwhelming majority of residents delay entering practice to pursue fellowship training—an estimated opportunity cost of $350,000.3 Minimal attention has been given to the potential costs of the fellowship interview process.
Our study results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial. On average, residents applied to 19 programs, received 14 interview offers, attended 11 interviews, were away from residency training 11 days, and spent $5875 on travel. The great majority of both residents and program directors wanted changes in the current paradigm governing the orthopedic fellowship interview process.
It is reasonable to think that the number of days residents spend away on interviews would reduce the time available for education and patient care. Although unknown, it is plausible that residents of programs outside major metropolitan centers and residents who apply to more competitive fellowships may be forced to spend even more time away from training. Outside the focus of this study are the impact that residents’ absence might have on their education and the impact of this absence on the people who do the residents’ work while they are away.
Mean fellowship expense was similar to that reported by residents pursuing a pediatric general surgery fellowship ($6974) or a plastic surgery fellowship ($6100).11,12 Unfortunately, we were unable to determine if average cost is influenced by choice of fellowship specialty or location of residency program. Regardless, fellowship cost may impose an additional financial burden on residents. According to the Association of American Medical Colleges (AAMC), the median salary for PGY-4 residents was $56,380 in 2013. Therefore, on average, the fellowship process consumes more than 10% of a resident’s pretax salary. For perspective, this equates to more than $40,000 for a practicing orthopedic surgeon with a median salary of $413,000.13 With an average medical student graduate debt of $175,000 and continuing decreases in reimbursement, further financial hardships to newly graduating residents cannot be understated.5,11,12
Almost 70% of program directors thought the fellowship process significantly disrupted their program. Reasons given for this disruption mainly involved residents’ time away from the program and the resulting strains placed on maintaining adequate coverage for patient care. The overall disruption score of 7.4 out of 10 was consistent with the great majority thinking that the fellowship process negatively affects their residency program. Altering the fellowship interview process may provide unintended benefits to programs and program directors.
Both program directors and residents communicated that change is needed, but there was little consensus regarding how to effect change and who should lead. This lack of consensus highlights how important it is for the various orthopedic leadership committees to actively and collectively participate in discussions about redefining the system. It has been proposed that it would be ideal for the AOA to lead the change, as the AOA consists of a representative cohort of academic orthopedists and leaders across the spectrum of all fellowship specialties.14 Given the abundant concern of both residents and program directors, we find it prudent to issue a call to arms of sorts to the AAOS and the individual orthopedic subspecialty societies to work together on a common goal that would benefit residents, programs, and subspecialties within orthopedics.
In trying to understand the challenges that residents, program directors, and programs face, as well as the inherent complexity of the current system, we incorporated respondents’ write-in comments into suggested ways of improving the fellowship interview process. These comments had broad perspectives but overall were consistent with the survey results (Appendix).
Technology
Health care is continually finding new ways to take advantage of technological advances. This is occurring with the fellowship interview schema. Numerous disciplines are using videoconferencing platforms (eg, Skype) to conduct interviews. This practice is becoming more commonplace in the business sector. In a recent survey, more than 60% of human resource managers reported conducting video interviews.15 Two independent residency programs have used video interviews with mixed success.16,17
Another technological change requested by residents is the creation and updating of fellowship web pages with standardized information. Such a service may prove useful to residents researching a program and may even lead to limiting the number of programs residents apply to, as they may be able to dial in on exactly what distinguishes one program from another before traveling for an interview. A recent study of orthopedic sports medicine fellowship programs found that most of these programs lacked pertinent information on their websites.18 Important information regarding case logs from current and former fellows; number of faculty, residents, and fellows; and schedules and facilities of interview sites are a few of the online data points that may help residents differentiate particular programs.19,20 Questions like these are often asked at interviews and site visits. Having accurate information easily available online may reduce or eliminate the need to travel to a site for such information. Standardizing information would also increase transparency among available fellowships. Although not specifically mentioned, organizational software that improves the productivity of the process may help limit the large number of programs applied to, the interviews offered and attended, the days away, and the financial costs without reducing the match rate.
Timing and Location
The issue of timing—with respect to geographical or meteorological concerns—was another recurring theme among respondents. Numerous respondents indicated that certain programs located in geographic proximity tried to minimize travel by offering interviews around the same time. This coordination potentially minimizes travel expenses and time away from the residency program by allowing residents to interview at multiple locations during a single trip per region. The sports medicine fellowship process was identified as a good example of aligning interviews based on geography. Several respondents suggested an option that also reflects the practice of nonsurgical fellowships—delaying the interview season to bypass potential weather concerns. Winter 2013–2014 saw the most flight delays or cancellations in more than a decade; about 50% of all flights scheduled between December and February were delayed or canceled.21 Beyond the additional factor of more time away or missing an interview because of the weather are safety concerns related to the weather. One resident reported having a motor vehicle accident while traveling to an interview in poor weather conditions (Appendix).
National Meetings
Each orthopedic subspecialty has numerous national meetings. Many programs offer applicants the opportunity to interview at these meetings. One respondent mentioned that the annual meeting of the Orthopaedic Trauma Association offers trauma applicants the opportunity to interview with multiple programs. It might be beneficial to endorse this practice on a larger scale to help reduce travel and time away. We recognize that visiting individual programs is an important aspect of the match process, but doing so on a targeted level may make more sense, increasing financial efficiency and reducing time away from programs.
Proposed Solution
A combined proposed solution that can be implemented without a radical overhaul or significant investments might involve moving the interview season to early spring, switching to a 2-tiered system with a centralized first round of interview screening coinciding with subspecialty national meetings or the AAOS annual meeting, and standardizing online information for all orthopedic fellowship programs. A 2-tiered interview process would allow programs and candidates to obtain exposure to a significant number of programs in the first round without incurring significant costs and then would impose a cap on the number of programs to visit. This would level the playing field between candidates with more time and money and candidates who are more constrained in their training environment and finances. A stopgap or adjunct to residents or fellowship programs unable to attend a centralized meeting would be to combine technological tools, such as Internet-based videoconferencing (Skype), before site visits by residents. After this first round of introductions and interviews, residents could then decide on a limited number of programs to formally visit, attend, and ultimately rank. This proposed system would still be able to function within the confines of the match, and it would benefit from the protections offered to residents and programs. Although capping the number of interviews attended by residents clearly can lower costs across the board, we recognize the difficulty of enforcing such a requirement. These potential changes to the system are not exhaustive, and we hope this work will serve as a springboard to further discussion.
Our study had several inherent weaknesses. Our data came from survey responses, which reflect the perspectives only of the responding residents and program directors. Unfortunately, a small number of orthopedic residents responded to this survey, so there was a potential for bias. However, we think the central themes discovered in this survey are only echoes of the concerns of the larger population of residents and program directors. Our hope in designing such a study was to bring to light some of the discrepancies in the fellowship interview process, the goal being to stimulate interest among the orthopedic leadership representing future orthopedic surgeons. More study is needed to clarify if these issues are reflective of a larger segment of residents and program directors. In addition, action may be needed to fully elucidate the intricate interworking of the fellowship process in order to maximize the interest of the orthopedic surgeons who are seeking fellowship training. Another study limitation was the potential for recall bias in the more senior PGY-5 residents, who were further from the interview process than PGY-4 respondents were. Because of the need for anonymity with the surveys, we could not link some findings (eg, program impact, cost, time away) to individual programs or different specialty fellowships. Although it appears there is a desire for a more cost-effective system, given the financial pressures on medical students and residents, the desire to match increases costs because students are likely to attend more interviews than actually needed. Our proposed solution does not take into account residents’ behavior with respect to the current match system. For example, the prevailing thought is that interviewing at more programs increases the likelihood of matching into a desired subspecialty. Despite these study limitations, we think our results identified important points for discussion, investigation, and potential action by orthopedic leadership.
Conclusion
The challenge of critiquing and improving the orthopedic fellowship process requires the same courageous leadership that was recommended almost a decade ago.14 In this study, we tried to elucidate the impact of the PGY-4 fellowship interview process with respect to residents and residency programs. Our results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial and that both residents and program directors want changes made. Leadership needs to further investigate alternatives to the current process to lessen the impact on all parties in this important process.
1. Simon MA. Evolution of the present status of orthopaedic surgery fellowships. J Bone Joint Surg Am. 1998;80(12):1826-1829.
2. Brunworth LS, Chintalapani SR, Gray RR, Cardoso R, Owens PW. Resident selection of hand surgery fellowships: a survey of the 2011, 2012, and 2013 hand fellowship graduates. Hand. 2013;8(2):164-171.
3. Gaskill T, Cook C, Nunley J, Mather RC. The financial impact of orthopaedic fellowship training. J Bone Joint Surg Am. 2009;91(7):1814-1821.
4. Sarmiento A. Additional thoughts on orthopedic residency and fellowships. Orthopedics. 2010;33(10):712-713.
5. Griffin SM, Stoneback JW. Navigating the Orthopaedic Trauma Fellowship Match from a candidate’s perspective. J Orthop Trauma. 2011;25(suppl 3):S101-S103.
6. Morrell NT, Mercer DM, Moneim MS. Trends in the orthopedic job market and the importance of fellowship subspecialty training. Orthopedics. 2012;35(4):e555-e560.
7. Iorio R, Robb WJ, Healy WL, et al. Orthopaedic surgeon workforce and volume assessment for total hip and knee replacement in the United States: preparing for an epidemic. J Bone Joint Surg Am. 2008;90(7):1598-1605.
8. Emery SE, Guss D, Kuremsky MA, Hamlin BR, Herndon JH, Rubash HE. Resident education versus fellowship training—conflict or synergy? AOA critical issues. J Bone Joint Surg Am. 2012;94(21):e159.
9. Harner CD, Ranawat AS, Niederle M, et al. AOA symposium. Current state of fellowship hiring: is a universal match necessary? Is it possible? J Bone Joint Surg Am. 2008;90(6):1375-1384.
10. Ranawat A, Nunley RM, Genuario JW, Sharan AD, Mehta S; Washington Health Policy Fellows. Current state of the fellowship hiring process: Are we in 1957 or 2007? AAOS Now. 2007;1(8).
11. Little DC, Yoder SM, Grikscheit TC, et al. Cost considerations and applicant characteristics for the Pediatric Surgery Match. J Pediatr Surg. 2005;40(1):69-73.
12. Claiborne JR, Crantford JC, Swett KR, David LR. The Plastic Surgery Match: predicting success and improving the process. Ann Plast Surg. 2013;70(6):698-703.
13. Kane L, Peckham C. Medscape Physician Compensation Report 2014. http://www.medscape.com/features/slideshow/compensation/2014/public/overview. Published April 15, 2014. Accessed September 26, 2015.
14. Swiontkowski MF. A simple formula for continued improvement in orthopaedic surgery postgraduate training: courageous leadership. J Bone Joint Surg Am. 2008;90(6):1175.
15. Survey: six in 10 companies conduct video job interviews [news release]. http://www.prnewswire.com/news-releases/survey-six-in-10-companies-conduct-video-job-interviews-167973406.html. Published August 30, 2012. Accessed September 26, 2015.
16. Kerfoot BP, Asher KP, McCullough DL. Financial and educational costs of the residency interview process for urology applicants. Urology. 2008;71(6):990-994.
17. Edje L, Miller C, Kiefer J, Oram D. Using Skype as an alternative for residency selection interviews. J Grad Med Educ. 2013;5(3):503-505.
18. Mulcahey MK, Gosselin MM, Fadale PD. Evaluation of the content and accessibility of web sites for accredited orthopaedic sports medicine fellowships. J Bone Joint Surg Am. 2013;95(12):e85.
19. Gaeta TJ, Birkhahn RH, Lamont D, Banga N, Bove JJ. Aspects of residency programs’ web sites important to student applicants. Acad Emerg Med. 2005;12(1):89-92.
20. Mahler SA, Wagner MJ, Church A, Sokolosky M, Cline DM. Importance of residency program web sites to emergency medicine applicants. J Emerg Med. 2009;36(1):83-88.
21. Davies A. Winter’s toll: 1 million flights cancelled or delayed, costing travelers $5.3 billion. Business Insider. http://www.businessinsider.com/winter-flights-cancelled-delayed-cost-2014-3. Published March 3, 2014. Accessed September 26, 2015.
1. Simon MA. Evolution of the present status of orthopaedic surgery fellowships. J Bone Joint Surg Am. 1998;80(12):1826-1829.
2. Brunworth LS, Chintalapani SR, Gray RR, Cardoso R, Owens PW. Resident selection of hand surgery fellowships: a survey of the 2011, 2012, and 2013 hand fellowship graduates. Hand. 2013;8(2):164-171.
3. Gaskill T, Cook C, Nunley J, Mather RC. The financial impact of orthopaedic fellowship training. J Bone Joint Surg Am. 2009;91(7):1814-1821.
4. Sarmiento A. Additional thoughts on orthopedic residency and fellowships. Orthopedics. 2010;33(10):712-713.
5. Griffin SM, Stoneback JW. Navigating the Orthopaedic Trauma Fellowship Match from a candidate’s perspective. J Orthop Trauma. 2011;25(suppl 3):S101-S103.
6. Morrell NT, Mercer DM, Moneim MS. Trends in the orthopedic job market and the importance of fellowship subspecialty training. Orthopedics. 2012;35(4):e555-e560.
7. Iorio R, Robb WJ, Healy WL, et al. Orthopaedic surgeon workforce and volume assessment for total hip and knee replacement in the United States: preparing for an epidemic. J Bone Joint Surg Am. 2008;90(7):1598-1605.
8. Emery SE, Guss D, Kuremsky MA, Hamlin BR, Herndon JH, Rubash HE. Resident education versus fellowship training—conflict or synergy? AOA critical issues. J Bone Joint Surg Am. 2012;94(21):e159.
9. Harner CD, Ranawat AS, Niederle M, et al. AOA symposium. Current state of fellowship hiring: is a universal match necessary? Is it possible? J Bone Joint Surg Am. 2008;90(6):1375-1384.
10. Ranawat A, Nunley RM, Genuario JW, Sharan AD, Mehta S; Washington Health Policy Fellows. Current state of the fellowship hiring process: Are we in 1957 or 2007? AAOS Now. 2007;1(8).
11. Little DC, Yoder SM, Grikscheit TC, et al. Cost considerations and applicant characteristics for the Pediatric Surgery Match. J Pediatr Surg. 2005;40(1):69-73.
12. Claiborne JR, Crantford JC, Swett KR, David LR. The Plastic Surgery Match: predicting success and improving the process. Ann Plast Surg. 2013;70(6):698-703.
13. Kane L, Peckham C. Medscape Physician Compensation Report 2014. http://www.medscape.com/features/slideshow/compensation/2014/public/overview. Published April 15, 2014. Accessed September 26, 2015.
14. Swiontkowski MF. A simple formula for continued improvement in orthopaedic surgery postgraduate training: courageous leadership. J Bone Joint Surg Am. 2008;90(6):1175.
15. Survey: six in 10 companies conduct video job interviews [news release]. http://www.prnewswire.com/news-releases/survey-six-in-10-companies-conduct-video-job-interviews-167973406.html. Published August 30, 2012. Accessed September 26, 2015.
16. Kerfoot BP, Asher KP, McCullough DL. Financial and educational costs of the residency interview process for urology applicants. Urology. 2008;71(6):990-994.
17. Edje L, Miller C, Kiefer J, Oram D. Using Skype as an alternative for residency selection interviews. J Grad Med Educ. 2013;5(3):503-505.
18. Mulcahey MK, Gosselin MM, Fadale PD. Evaluation of the content and accessibility of web sites for accredited orthopaedic sports medicine fellowships. J Bone Joint Surg Am. 2013;95(12):e85.
19. Gaeta TJ, Birkhahn RH, Lamont D, Banga N, Bove JJ. Aspects of residency programs’ web sites important to student applicants. Acad Emerg Med. 2005;12(1):89-92.
20. Mahler SA, Wagner MJ, Church A, Sokolosky M, Cline DM. Importance of residency program web sites to emergency medicine applicants. J Emerg Med. 2009;36(1):83-88.
21. Davies A. Winter’s toll: 1 million flights cancelled or delayed, costing travelers $5.3 billion. Business Insider. http://www.businessinsider.com/winter-flights-cancelled-delayed-cost-2014-3. Published March 3, 2014. Accessed September 26, 2015.
Risk Factors for Discharge to Rehabilitation Among Hip Fracture Patients
Length of stay (LOS) is a significant driver of costs after hip fracture surgery.1-3 Multiple studies have identified factors associated with increased LOS in hip fracture patients. These factors include admission time, delay to surgery, presence of comorbidities, and older age.4-9
One significant and potentially modifiable factor affecting LOS is delayed transfer to a rehabilitation center after surgery.8-11 Although patients after orthopedic surgeries require additional rehabilitation services or subacute care directly attributable to their injuries, specialized rehabilitation centers may not always have beds readily available.6-11 Studies have shown that delays in transfer to skilled nursing facilities or rehabilitation centers are highly common among orthopedic patients.8 It is therefore imperative that orthopedists have a mechanism for predicting and identifying which patients require rehabilitation services early in the postoperative period. Identifying risk factors and stratifying patients who are most likely to require rehabilitation would facilitate the early transfer of these patients and thereby directly decrease LOS and hospitalization-related costs.
In this article, we report results from prospective, national, multicenter data to identify commonly measured risk factors for discharge to rehabilitation facilities for hip fracture patients. Through multivariate analysis of ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program) data, we determined which risk factors significantly predispose patients to discharge to rehabilitation centers versus discharge home. Knowledge of these risk factors allows the practicing orthopedist to be better equipped to identify patients who require additional rehabilitation early in the postoperative course. By mobilizing case managers and social workers to help avoid delays in the transfers of these identified patients, LOS-associated costs may ultimately decrease.
Materials and Methods
After obtaining institutional review board approval for this study from the Office of Research at Vanderbilt University, we prospectively collected 2011 discharge data from the ACS-NSQIP database (these data are unavailable for earlier years). All patients who underwent hip fracture surgery in 2011 were identified by CPT (Current Procedural Terminology) codes. Cases of patients with unknown discharge information and of those who died during their hospitalizations were excluded from analysis. For the remaining patients, discharge information as categorized by ACS-NSQIP included skilled care (eg, subacute hospital, skilled nursing home), unskilled facility (eg, nursing home, assisted facility), separate acute care, and rehabilitation. All other patients were discharged home without additional assistance or to the previous home where they received chronic care, assisted living, or unskilled aid. Patients were dichotomized according to whether they were discharged home or to one of the rehabilitation facilities mentioned.
To determine which risk factors significantly contributed to a patient’s discharge to rehabilitation, we ran univariate analyses using Fisher exact tests for categorical variables and Student t tests for continuous variables on multiple patient factors, including demographics, preoperative comorbidities, and operative factors. Demographics included age and sex. Preoperative comorbidities included 32 conditions: diabetes mellitus, active smoking status, current alcohol use, dyspnea, history of chronic obstructive pulmonary disease, history of congestive heart failure, hypertension requiring medication, history of esophageal varices, history of myocardial infarction, current renal failure, current dialysis dependence, steroid use, recent weight loss, existing bleeding disorder, transfusion before discharge, presence of central nervous system tumor, recent chemotherapy, recent radiation therapy, previous percutaneous coronary intervention, previous percutaneous coronary stenting, history of angina, peripheral vascular disease, cerebrovascular accidents, recent surgery (within 30 days), rest pain, impaired sensorium, history of transient ischemic attacks, current hemiplegia status, current paraplegia status, current quadriplegia status, current ascites, hypertension, and disseminated cancer. Operative factors included wound infection, DNR (do not resuscitate) status, ventilator support, anesthesia type, wound class, ASA (American Society of Anesthesiologists) class, and operative time.
For the univariate analyses, significance was set at P < .05. Demographics, preoperative comorbidities, and operative factors that were significantly associated with discharge to a rehabilitation facility in the univariate analysis were selected as covariates for a multivariate analysis. We incorporated a binary logistic regression to analyze which of these significant risk factors are correlated with a patient’s discharge to a rehabilitation facility after hip fracture surgery.
Results
A total of 4974 patients undergoing surgery for hip fractures in 2011 were identified. Of these patients, 4815 had complete information on discharge location and were included in the analysis.
Table 1 lists the results of the univariate analysis comparing demographics, preoperative comorbidities, and operative factors between the home and rehabilitation groups. Both age (P < .001) and sex (P = .012) were significantly different between groups; the rehabilitation group was older by about 10 years and included significantly more females. In addition to demographic factors, 16 preoperative comorbidities, and 5 surgical factors were significantly associated with discharge to rehabilitation.
Surgery type significantly affected discharge to rehabilitation (Figure). Patients who were undergoing open plating of a femoral neck fracture or intramedullary nailing of an intertrochanteric, peritrochanteric, or subtrochanteric femoral fracture constituted 30% of all patients discharged to rehabilitation centers. In contrast, patients undergoing percutaneous skeletal fixation of a proximal femoral fracture constituted only 5.5% of all patients discharged to rehabilitation. Based on surgery type, we broke down discharge location further, into categories of skilled nursing facility, unskilled facility (not patient’s previous home), separate acute-care facility, dedicated rehabilitation center, and home. Of all 4815 patients combined, 2102 (43.6%) were discharged to a skilled nursing facility, 31 (0.6%) to an unskilled facility (not home), 106 (2.2%) to separate acute care, 1312 (27.2%) to a dedicated rehabilitation center, and 950 (19.7%) home.
Table 2 lists the significant results from the multivariate logistical analysis comparing discharge to a rehabilitation center and discharge home after controlling for the significant risk factors (Table 1). Current diabetes, history of dyspnea, previous myocardial infarction, history of ischemic attacks, current bleeding disorder, transfusion during hospitalization, previous percutaneous cardiac stenting, chemotherapy, past cerebrovascular accident, presence of cancer, surgery type based on CPT code, history of chronic obstructive pulmonary disease or congestive heart failure, current smoking status, and operative time longer than 90 minutes were not significantly correlated with discharge to rehabilitation in the multivariate analysis. All significant factors were associated with higher odds of discharge to rehabilitation except for DNR status. DNR patients were 2.04 times more likely (95% CI, 1.49-2.78; P < .001) to be discharged home than to rehabilitation centers.
Applying these adjusted odds ratios, we see that an elderly woman (age, >65 years) who underwent general anesthesia with an ASA class higher than 2 was 17.63 times more likely than a patient without these risk factors to be discharged to rehabilitation. If this patient were also dialysis-dependent, she would be 61.52 times more likely than a similar patient without dialysis needs to be discharged to rehabilitation.
Even when controlling for all significant and nonsignificant variables in multivariate logistical analysis, age over 65 years (β = 1.05; P < .001), female sex (β = 1.76; P = .004), dialysis dependence (β = 12.98; P = .036), hypertension requiring medication (β = 1.53; P = .032), and ASA class higher than 2 (β = 1.98; P = .001) were found to be significant risk factors for discharge to rehabilitation.
Discussion
This study was the first to investigate the issue of which patient risk factors allow the practicing orthopedist to identify patients who require rehabilitation after hip fracture surgery. Through our multivariate analysis, which controlled for demographics, comorbidities, and operative factors, we found that older age, female sex, history of percutaneous coronary intervention, dialysis dependence, general anesthesia, and ASA class higher than 2 significantly increased the odds of discharge to a rehabilitation center versus home.
Using our study’s results, we can create a risk stratification model for patients and thereby a means of targeting patients who need rehabilitation and starting the process of finding a rehabilitation bed early in the postoperative course. Our study’s variables are easily measured metrics that may be collected in any hospital setting. Especially for hip fracture patients, early planning and discharge to the appropriate rehabilitation center are important in decreasing LOS and associated hospitalization costs. According to one report,3 about 85% of all hip fracture costs are directly related to LOS, given the unnecessarily long rehabilitation periods in hospitals. Hollingworth and colleagues2 compared costs for patients who remained in the hospital with costs for those discharged with rehabilitation services. Overall costs were significantly lower for patients discharged home with rehabilitation. The authors concluded that 40% of hip fracture patients may be suitable for early discharge.2 In an analysis of Medicare payments for hip fracture treatment, hospital costs including LOS accounted for 60% of all payments.12 The results of these 2 studies suggest that the overall driver of hip fracture costs is prolonged LOS and that, if patients are discharged to rehabilitation, then overall costs may be lowered through a direct reduction in hospital LOS. Given that hip fractures account for almost 350,000 hospital admissions in the United States each year, and using our institution’s average hospital charge per day ($4500), about $1.6 billion may be saved if each patient’s LOS decreased by 1 day.13 Although multiple factors affect LOS, discharge planning is under orthopedists’ direct control. Therefore, early identification of patients who will require rehabilitation may help reduce LOS-associated costs in our health care system.
The patient variables that were significantly associated with discharge to rehabilitation are also associated with increased morbidity and mortality in hip fracture patients, according to the literature,14-20 which provides some external validation of using these risk factors as predictors for rehabilitation. A patient with one of these risk factors may require rehabilitation, given that rehabilitation services are specifically linked to lower morbidity and mortality rates among hip fracture patients. For example, patients with dialysis needs were 3.49 times more likely to be discharged to a rehabilitation center in our study. In a 2000 study by Coco and Rush,16 hip fracture patients on dialysis had a 1-year mortality rate 2.5 times higher than that of patients who were not dialysis-dependent. In 2010, Cameron and colleagues17 found that cardiovascular disease was associated with a 2.68 times higher risk of mortality in hip fracture patients. Similarly in our study, both hypertension and history of percutaneous coronary intervention were associated with discharge to rehabilitation. We found higher odds of discharge to rehabilitation with higher ASA classes, which mirror results from a study by Michel and colleagues,15 who found that higher (vs lower) preoperative ASA classes were associated with higher 1-year mortality in hip fracture patients. Interestingly, DNR status was associated with higher odds of discharge home, which may reflect patients’ desires to forgo noninvasive or lifesaving procedures that may be performed at rehabilitation facilities. Although general anesthesia predisposed patients to discharge to a rehabilitation center, multiple studies have found no association between anesthesia type and postoperative mortality rates for hip fracture patients.18,19 Last, Marcantonio and colleagues20 found delirium specifically had a higher odds ratio for discharge, but our univariate analysis did not find a significant association between impaired sensorium and discharge location. Given the correlation of our risk factors with increased morbidity and mortality in the literature, our study’s results provide the initial groundwork for creating a risk calculator that orthopedists can use to predict discharge to rehabilitation.
Our study had some limitations. Although we analyzed a large number of demographics, preoperative comorbidities, and surgical factors, our univariate analysis was limited to information in the ACS-NSQIP database. We did not incorporate other clinically relevant factors (eg, social factors, including patients’ support networks) that may influence discharge decisions. Furthermore, ACS-NSQIP records patient data only up to 30 days after surgery. Discharge information for the time after that was missing for a subset of hip fracture patients, and these patients had to be excluded, potentially skewing our data. ACS-NSQIP also does not collect cost data for patients based on hospitalization or LOS, so we could not determine whether patients discharged to rehabilitation incurred higher costs because of longer hospitalizations.
Nevertheless, our study identified significant patient and operative variables that are associated with discharge to a rehabilitation center. By identifying hip fracture patients with these risk factors early and mobilizing the appropriate resources, practicing orthopedists should be better equipped to help facilitate the discharge of patients to the appropriate location after surgery. Validation of these risk factors should be prospectively determined with an analysis of LOS and cost implications. Use of a risk calculator may in fact result in decreased LOS and hospital-related costs. Furthermore, using these risk factors in a prospective patient cohort would help validate their use and determine whether there is clinical correlation. The orthopedists in our institution are becoming more aware of these risk factors, but validation is necessary.
1. Garcia AE, Bonnaig JV, Yoneda ZT, et al. Patient variables which may predict length of stay and hospital costs in elderly patients with hip fracture. J Orthop Trauma. 2012;26(11):620-623.
2. Hollingworth W, Todd C, Parker M, Roberts JA, Williams R. Cost analysis of early discharge after hip fracture. BMJ. 1993;307(6909):903-906.
3. Sund R, Riihimäki J, Mäkelä M, et al. Modeling the length of the care episode after hip fracture: does the type of fracture matter? Scand J Surg. 2009;98(3):169-174.
4. Fox KM, Magaziner J, Hebel JR, Kenzora JE, Kashner TM. Intertrochanteric versus femoral neck hip fractures: differential characteristics, treatment, and sequelae. J Gerontol A Biol Sci Med Sci. 1999;54(12):M635-M640.
5. Foss NB, Palm H, Krasheninnikoff M, Kehlet H, Gebuhr P. Impact of surgical complications on length of stay after hip fracture surgery. Injury. 2007;38(7):780-784.
6. Lefaivre KA, Macadam SA, Davidson DJ, Gandhi R, Chan H, Broekhuyse HM. Length of stay, mortality, morbidity and delay to surgery in hip fractures. J Bone Joint Surg Br. 2009;91(7):922-927.
7. Clague JE, Craddock E, Andrew G, Horan MA, Pendleton N. Predictors of outcome following hip fracture. Admission time predicts length of stay and in-hospital mortality. Injury. 2002;33(1):1-6.
8. Parker MJ, Todd CJ, Palmer CR, et al. Inter-hospital variations in length of hospital stay following hip fracture. Age Ageing. 1998;27(31):333-337.
9. Brasel KJ, Rasmussen J, Cauley C, Weigelt JA. Reasons for delayed discharge of trauma patients. J Surg Res. 2002;107(2):223-226.
10. Bonar SK, Tinetti ME, Speechley M, Cooney LM. Factors associated with short- versus long-term skilled nursing facility placement among community-living hip fracture patients. J Am Geriatr Soc. 1990;38(10):1139-1144.
11. Bentler SE, Liu L, Obrizan M, et al. The aftermath of hip fracture: discharge placement, functional status change, and mortality. Am J Epidemiol. 2009;170(10):1290-1299.
12. Birkmeyer JD, Gust C, Baser O, Dimick JB, Sutherland JM, Skinner JS. Medicare payments for common inpatient procedures: implications for episode-based payment bundling. Health Serv Res. 2010;45(6 pt 1):1783-1795.
13. American Academy of Orthopaedic Surgeons. Burden of Musculoskeletal Diseases in the United States: Prevalence, Societal and Economic Cost. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2008.
14. Maciejewski ML, Radcliff A, Henderson WG, et al. Determinants of postsurgical discharge setting for male hip fracture patients. J Rehabil Res Dev. 2013;50(9):1267-1276.
15. Michel JP, Klopfenstein C, Hoffmeyer P, Stern R, Grab B. Hip fracture surgery: is the pre-operative American Society of Anesthesiologists (ASA) score a predictor of functional outcome? Aging Clin Exp Res. 2002;14(5):389-394.
16. Coco M, Rush H. Increased incidence of hip fractures in dialysis patients with low serum parathyroid hormone. Am J Kidney Dis. 2000;36(6):1115-1121.
17. Cameron ID, Chen JS, March LM, et al. Hip fracture causes excess mortality owing to cardiovascular and infectious disease in institutionalized older people: a prospective 5-year study. J Bone Miner Res. 2010;25(4):866-872.
18. White SM, Moppett IK, Griffiths R. Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset. Anaesthesia. 2014;69(3):224-230.
19. Le-Wendling L, Bihorac A, Baslanti TO, et al. Regional anesthesia as compared with general anesthesia for surgery in geriatric patients with hip fracture: does it decrease morbidity, mortality, and health care costs? Results of a single-centered study. Pain Med. 2012;13(7):948-956.
20. Marcantonio ER, Flacker JM, Michaels M, Resnick NM. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000;48(6):618-624.
Length of stay (LOS) is a significant driver of costs after hip fracture surgery.1-3 Multiple studies have identified factors associated with increased LOS in hip fracture patients. These factors include admission time, delay to surgery, presence of comorbidities, and older age.4-9
One significant and potentially modifiable factor affecting LOS is delayed transfer to a rehabilitation center after surgery.8-11 Although patients after orthopedic surgeries require additional rehabilitation services or subacute care directly attributable to their injuries, specialized rehabilitation centers may not always have beds readily available.6-11 Studies have shown that delays in transfer to skilled nursing facilities or rehabilitation centers are highly common among orthopedic patients.8 It is therefore imperative that orthopedists have a mechanism for predicting and identifying which patients require rehabilitation services early in the postoperative period. Identifying risk factors and stratifying patients who are most likely to require rehabilitation would facilitate the early transfer of these patients and thereby directly decrease LOS and hospitalization-related costs.
In this article, we report results from prospective, national, multicenter data to identify commonly measured risk factors for discharge to rehabilitation facilities for hip fracture patients. Through multivariate analysis of ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program) data, we determined which risk factors significantly predispose patients to discharge to rehabilitation centers versus discharge home. Knowledge of these risk factors allows the practicing orthopedist to be better equipped to identify patients who require additional rehabilitation early in the postoperative course. By mobilizing case managers and social workers to help avoid delays in the transfers of these identified patients, LOS-associated costs may ultimately decrease.
Materials and Methods
After obtaining institutional review board approval for this study from the Office of Research at Vanderbilt University, we prospectively collected 2011 discharge data from the ACS-NSQIP database (these data are unavailable for earlier years). All patients who underwent hip fracture surgery in 2011 were identified by CPT (Current Procedural Terminology) codes. Cases of patients with unknown discharge information and of those who died during their hospitalizations were excluded from analysis. For the remaining patients, discharge information as categorized by ACS-NSQIP included skilled care (eg, subacute hospital, skilled nursing home), unskilled facility (eg, nursing home, assisted facility), separate acute care, and rehabilitation. All other patients were discharged home without additional assistance or to the previous home where they received chronic care, assisted living, or unskilled aid. Patients were dichotomized according to whether they were discharged home or to one of the rehabilitation facilities mentioned.
To determine which risk factors significantly contributed to a patient’s discharge to rehabilitation, we ran univariate analyses using Fisher exact tests for categorical variables and Student t tests for continuous variables on multiple patient factors, including demographics, preoperative comorbidities, and operative factors. Demographics included age and sex. Preoperative comorbidities included 32 conditions: diabetes mellitus, active smoking status, current alcohol use, dyspnea, history of chronic obstructive pulmonary disease, history of congestive heart failure, hypertension requiring medication, history of esophageal varices, history of myocardial infarction, current renal failure, current dialysis dependence, steroid use, recent weight loss, existing bleeding disorder, transfusion before discharge, presence of central nervous system tumor, recent chemotherapy, recent radiation therapy, previous percutaneous coronary intervention, previous percutaneous coronary stenting, history of angina, peripheral vascular disease, cerebrovascular accidents, recent surgery (within 30 days), rest pain, impaired sensorium, history of transient ischemic attacks, current hemiplegia status, current paraplegia status, current quadriplegia status, current ascites, hypertension, and disseminated cancer. Operative factors included wound infection, DNR (do not resuscitate) status, ventilator support, anesthesia type, wound class, ASA (American Society of Anesthesiologists) class, and operative time.
For the univariate analyses, significance was set at P < .05. Demographics, preoperative comorbidities, and operative factors that were significantly associated with discharge to a rehabilitation facility in the univariate analysis were selected as covariates for a multivariate analysis. We incorporated a binary logistic regression to analyze which of these significant risk factors are correlated with a patient’s discharge to a rehabilitation facility after hip fracture surgery.
Results
A total of 4974 patients undergoing surgery for hip fractures in 2011 were identified. Of these patients, 4815 had complete information on discharge location and were included in the analysis.
Table 1 lists the results of the univariate analysis comparing demographics, preoperative comorbidities, and operative factors between the home and rehabilitation groups. Both age (P < .001) and sex (P = .012) were significantly different between groups; the rehabilitation group was older by about 10 years and included significantly more females. In addition to demographic factors, 16 preoperative comorbidities, and 5 surgical factors were significantly associated with discharge to rehabilitation.
Surgery type significantly affected discharge to rehabilitation (Figure). Patients who were undergoing open plating of a femoral neck fracture or intramedullary nailing of an intertrochanteric, peritrochanteric, or subtrochanteric femoral fracture constituted 30% of all patients discharged to rehabilitation centers. In contrast, patients undergoing percutaneous skeletal fixation of a proximal femoral fracture constituted only 5.5% of all patients discharged to rehabilitation. Based on surgery type, we broke down discharge location further, into categories of skilled nursing facility, unskilled facility (not patient’s previous home), separate acute-care facility, dedicated rehabilitation center, and home. Of all 4815 patients combined, 2102 (43.6%) were discharged to a skilled nursing facility, 31 (0.6%) to an unskilled facility (not home), 106 (2.2%) to separate acute care, 1312 (27.2%) to a dedicated rehabilitation center, and 950 (19.7%) home.
Table 2 lists the significant results from the multivariate logistical analysis comparing discharge to a rehabilitation center and discharge home after controlling for the significant risk factors (Table 1). Current diabetes, history of dyspnea, previous myocardial infarction, history of ischemic attacks, current bleeding disorder, transfusion during hospitalization, previous percutaneous cardiac stenting, chemotherapy, past cerebrovascular accident, presence of cancer, surgery type based on CPT code, history of chronic obstructive pulmonary disease or congestive heart failure, current smoking status, and operative time longer than 90 minutes were not significantly correlated with discharge to rehabilitation in the multivariate analysis. All significant factors were associated with higher odds of discharge to rehabilitation except for DNR status. DNR patients were 2.04 times more likely (95% CI, 1.49-2.78; P < .001) to be discharged home than to rehabilitation centers.
Applying these adjusted odds ratios, we see that an elderly woman (age, >65 years) who underwent general anesthesia with an ASA class higher than 2 was 17.63 times more likely than a patient without these risk factors to be discharged to rehabilitation. If this patient were also dialysis-dependent, she would be 61.52 times more likely than a similar patient without dialysis needs to be discharged to rehabilitation.
Even when controlling for all significant and nonsignificant variables in multivariate logistical analysis, age over 65 years (β = 1.05; P < .001), female sex (β = 1.76; P = .004), dialysis dependence (β = 12.98; P = .036), hypertension requiring medication (β = 1.53; P = .032), and ASA class higher than 2 (β = 1.98; P = .001) were found to be significant risk factors for discharge to rehabilitation.
Discussion
This study was the first to investigate the issue of which patient risk factors allow the practicing orthopedist to identify patients who require rehabilitation after hip fracture surgery. Through our multivariate analysis, which controlled for demographics, comorbidities, and operative factors, we found that older age, female sex, history of percutaneous coronary intervention, dialysis dependence, general anesthesia, and ASA class higher than 2 significantly increased the odds of discharge to a rehabilitation center versus home.
Using our study’s results, we can create a risk stratification model for patients and thereby a means of targeting patients who need rehabilitation and starting the process of finding a rehabilitation bed early in the postoperative course. Our study’s variables are easily measured metrics that may be collected in any hospital setting. Especially for hip fracture patients, early planning and discharge to the appropriate rehabilitation center are important in decreasing LOS and associated hospitalization costs. According to one report,3 about 85% of all hip fracture costs are directly related to LOS, given the unnecessarily long rehabilitation periods in hospitals. Hollingworth and colleagues2 compared costs for patients who remained in the hospital with costs for those discharged with rehabilitation services. Overall costs were significantly lower for patients discharged home with rehabilitation. The authors concluded that 40% of hip fracture patients may be suitable for early discharge.2 In an analysis of Medicare payments for hip fracture treatment, hospital costs including LOS accounted for 60% of all payments.12 The results of these 2 studies suggest that the overall driver of hip fracture costs is prolonged LOS and that, if patients are discharged to rehabilitation, then overall costs may be lowered through a direct reduction in hospital LOS. Given that hip fractures account for almost 350,000 hospital admissions in the United States each year, and using our institution’s average hospital charge per day ($4500), about $1.6 billion may be saved if each patient’s LOS decreased by 1 day.13 Although multiple factors affect LOS, discharge planning is under orthopedists’ direct control. Therefore, early identification of patients who will require rehabilitation may help reduce LOS-associated costs in our health care system.
The patient variables that were significantly associated with discharge to rehabilitation are also associated with increased morbidity and mortality in hip fracture patients, according to the literature,14-20 which provides some external validation of using these risk factors as predictors for rehabilitation. A patient with one of these risk factors may require rehabilitation, given that rehabilitation services are specifically linked to lower morbidity and mortality rates among hip fracture patients. For example, patients with dialysis needs were 3.49 times more likely to be discharged to a rehabilitation center in our study. In a 2000 study by Coco and Rush,16 hip fracture patients on dialysis had a 1-year mortality rate 2.5 times higher than that of patients who were not dialysis-dependent. In 2010, Cameron and colleagues17 found that cardiovascular disease was associated with a 2.68 times higher risk of mortality in hip fracture patients. Similarly in our study, both hypertension and history of percutaneous coronary intervention were associated with discharge to rehabilitation. We found higher odds of discharge to rehabilitation with higher ASA classes, which mirror results from a study by Michel and colleagues,15 who found that higher (vs lower) preoperative ASA classes were associated with higher 1-year mortality in hip fracture patients. Interestingly, DNR status was associated with higher odds of discharge home, which may reflect patients’ desires to forgo noninvasive or lifesaving procedures that may be performed at rehabilitation facilities. Although general anesthesia predisposed patients to discharge to a rehabilitation center, multiple studies have found no association between anesthesia type and postoperative mortality rates for hip fracture patients.18,19 Last, Marcantonio and colleagues20 found delirium specifically had a higher odds ratio for discharge, but our univariate analysis did not find a significant association between impaired sensorium and discharge location. Given the correlation of our risk factors with increased morbidity and mortality in the literature, our study’s results provide the initial groundwork for creating a risk calculator that orthopedists can use to predict discharge to rehabilitation.
Our study had some limitations. Although we analyzed a large number of demographics, preoperative comorbidities, and surgical factors, our univariate analysis was limited to information in the ACS-NSQIP database. We did not incorporate other clinically relevant factors (eg, social factors, including patients’ support networks) that may influence discharge decisions. Furthermore, ACS-NSQIP records patient data only up to 30 days after surgery. Discharge information for the time after that was missing for a subset of hip fracture patients, and these patients had to be excluded, potentially skewing our data. ACS-NSQIP also does not collect cost data for patients based on hospitalization or LOS, so we could not determine whether patients discharged to rehabilitation incurred higher costs because of longer hospitalizations.
Nevertheless, our study identified significant patient and operative variables that are associated with discharge to a rehabilitation center. By identifying hip fracture patients with these risk factors early and mobilizing the appropriate resources, practicing orthopedists should be better equipped to help facilitate the discharge of patients to the appropriate location after surgery. Validation of these risk factors should be prospectively determined with an analysis of LOS and cost implications. Use of a risk calculator may in fact result in decreased LOS and hospital-related costs. Furthermore, using these risk factors in a prospective patient cohort would help validate their use and determine whether there is clinical correlation. The orthopedists in our institution are becoming more aware of these risk factors, but validation is necessary.
Length of stay (LOS) is a significant driver of costs after hip fracture surgery.1-3 Multiple studies have identified factors associated with increased LOS in hip fracture patients. These factors include admission time, delay to surgery, presence of comorbidities, and older age.4-9
One significant and potentially modifiable factor affecting LOS is delayed transfer to a rehabilitation center after surgery.8-11 Although patients after orthopedic surgeries require additional rehabilitation services or subacute care directly attributable to their injuries, specialized rehabilitation centers may not always have beds readily available.6-11 Studies have shown that delays in transfer to skilled nursing facilities or rehabilitation centers are highly common among orthopedic patients.8 It is therefore imperative that orthopedists have a mechanism for predicting and identifying which patients require rehabilitation services early in the postoperative period. Identifying risk factors and stratifying patients who are most likely to require rehabilitation would facilitate the early transfer of these patients and thereby directly decrease LOS and hospitalization-related costs.
In this article, we report results from prospective, national, multicenter data to identify commonly measured risk factors for discharge to rehabilitation facilities for hip fracture patients. Through multivariate analysis of ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program) data, we determined which risk factors significantly predispose patients to discharge to rehabilitation centers versus discharge home. Knowledge of these risk factors allows the practicing orthopedist to be better equipped to identify patients who require additional rehabilitation early in the postoperative course. By mobilizing case managers and social workers to help avoid delays in the transfers of these identified patients, LOS-associated costs may ultimately decrease.
Materials and Methods
After obtaining institutional review board approval for this study from the Office of Research at Vanderbilt University, we prospectively collected 2011 discharge data from the ACS-NSQIP database (these data are unavailable for earlier years). All patients who underwent hip fracture surgery in 2011 were identified by CPT (Current Procedural Terminology) codes. Cases of patients with unknown discharge information and of those who died during their hospitalizations were excluded from analysis. For the remaining patients, discharge information as categorized by ACS-NSQIP included skilled care (eg, subacute hospital, skilled nursing home), unskilled facility (eg, nursing home, assisted facility), separate acute care, and rehabilitation. All other patients were discharged home without additional assistance or to the previous home where they received chronic care, assisted living, or unskilled aid. Patients were dichotomized according to whether they were discharged home or to one of the rehabilitation facilities mentioned.
To determine which risk factors significantly contributed to a patient’s discharge to rehabilitation, we ran univariate analyses using Fisher exact tests for categorical variables and Student t tests for continuous variables on multiple patient factors, including demographics, preoperative comorbidities, and operative factors. Demographics included age and sex. Preoperative comorbidities included 32 conditions: diabetes mellitus, active smoking status, current alcohol use, dyspnea, history of chronic obstructive pulmonary disease, history of congestive heart failure, hypertension requiring medication, history of esophageal varices, history of myocardial infarction, current renal failure, current dialysis dependence, steroid use, recent weight loss, existing bleeding disorder, transfusion before discharge, presence of central nervous system tumor, recent chemotherapy, recent radiation therapy, previous percutaneous coronary intervention, previous percutaneous coronary stenting, history of angina, peripheral vascular disease, cerebrovascular accidents, recent surgery (within 30 days), rest pain, impaired sensorium, history of transient ischemic attacks, current hemiplegia status, current paraplegia status, current quadriplegia status, current ascites, hypertension, and disseminated cancer. Operative factors included wound infection, DNR (do not resuscitate) status, ventilator support, anesthesia type, wound class, ASA (American Society of Anesthesiologists) class, and operative time.
For the univariate analyses, significance was set at P < .05. Demographics, preoperative comorbidities, and operative factors that were significantly associated with discharge to a rehabilitation facility in the univariate analysis were selected as covariates for a multivariate analysis. We incorporated a binary logistic regression to analyze which of these significant risk factors are correlated with a patient’s discharge to a rehabilitation facility after hip fracture surgery.
Results
A total of 4974 patients undergoing surgery for hip fractures in 2011 were identified. Of these patients, 4815 had complete information on discharge location and were included in the analysis.
Table 1 lists the results of the univariate analysis comparing demographics, preoperative comorbidities, and operative factors between the home and rehabilitation groups. Both age (P < .001) and sex (P = .012) were significantly different between groups; the rehabilitation group was older by about 10 years and included significantly more females. In addition to demographic factors, 16 preoperative comorbidities, and 5 surgical factors were significantly associated with discharge to rehabilitation.
Surgery type significantly affected discharge to rehabilitation (Figure). Patients who were undergoing open plating of a femoral neck fracture or intramedullary nailing of an intertrochanteric, peritrochanteric, or subtrochanteric femoral fracture constituted 30% of all patients discharged to rehabilitation centers. In contrast, patients undergoing percutaneous skeletal fixation of a proximal femoral fracture constituted only 5.5% of all patients discharged to rehabilitation. Based on surgery type, we broke down discharge location further, into categories of skilled nursing facility, unskilled facility (not patient’s previous home), separate acute-care facility, dedicated rehabilitation center, and home. Of all 4815 patients combined, 2102 (43.6%) were discharged to a skilled nursing facility, 31 (0.6%) to an unskilled facility (not home), 106 (2.2%) to separate acute care, 1312 (27.2%) to a dedicated rehabilitation center, and 950 (19.7%) home.
Table 2 lists the significant results from the multivariate logistical analysis comparing discharge to a rehabilitation center and discharge home after controlling for the significant risk factors (Table 1). Current diabetes, history of dyspnea, previous myocardial infarction, history of ischemic attacks, current bleeding disorder, transfusion during hospitalization, previous percutaneous cardiac stenting, chemotherapy, past cerebrovascular accident, presence of cancer, surgery type based on CPT code, history of chronic obstructive pulmonary disease or congestive heart failure, current smoking status, and operative time longer than 90 minutes were not significantly correlated with discharge to rehabilitation in the multivariate analysis. All significant factors were associated with higher odds of discharge to rehabilitation except for DNR status. DNR patients were 2.04 times more likely (95% CI, 1.49-2.78; P < .001) to be discharged home than to rehabilitation centers.
Applying these adjusted odds ratios, we see that an elderly woman (age, >65 years) who underwent general anesthesia with an ASA class higher than 2 was 17.63 times more likely than a patient without these risk factors to be discharged to rehabilitation. If this patient were also dialysis-dependent, she would be 61.52 times more likely than a similar patient without dialysis needs to be discharged to rehabilitation.
Even when controlling for all significant and nonsignificant variables in multivariate logistical analysis, age over 65 years (β = 1.05; P < .001), female sex (β = 1.76; P = .004), dialysis dependence (β = 12.98; P = .036), hypertension requiring medication (β = 1.53; P = .032), and ASA class higher than 2 (β = 1.98; P = .001) were found to be significant risk factors for discharge to rehabilitation.
Discussion
This study was the first to investigate the issue of which patient risk factors allow the practicing orthopedist to identify patients who require rehabilitation after hip fracture surgery. Through our multivariate analysis, which controlled for demographics, comorbidities, and operative factors, we found that older age, female sex, history of percutaneous coronary intervention, dialysis dependence, general anesthesia, and ASA class higher than 2 significantly increased the odds of discharge to a rehabilitation center versus home.
Using our study’s results, we can create a risk stratification model for patients and thereby a means of targeting patients who need rehabilitation and starting the process of finding a rehabilitation bed early in the postoperative course. Our study’s variables are easily measured metrics that may be collected in any hospital setting. Especially for hip fracture patients, early planning and discharge to the appropriate rehabilitation center are important in decreasing LOS and associated hospitalization costs. According to one report,3 about 85% of all hip fracture costs are directly related to LOS, given the unnecessarily long rehabilitation periods in hospitals. Hollingworth and colleagues2 compared costs for patients who remained in the hospital with costs for those discharged with rehabilitation services. Overall costs were significantly lower for patients discharged home with rehabilitation. The authors concluded that 40% of hip fracture patients may be suitable for early discharge.2 In an analysis of Medicare payments for hip fracture treatment, hospital costs including LOS accounted for 60% of all payments.12 The results of these 2 studies suggest that the overall driver of hip fracture costs is prolonged LOS and that, if patients are discharged to rehabilitation, then overall costs may be lowered through a direct reduction in hospital LOS. Given that hip fractures account for almost 350,000 hospital admissions in the United States each year, and using our institution’s average hospital charge per day ($4500), about $1.6 billion may be saved if each patient’s LOS decreased by 1 day.13 Although multiple factors affect LOS, discharge planning is under orthopedists’ direct control. Therefore, early identification of patients who will require rehabilitation may help reduce LOS-associated costs in our health care system.
The patient variables that were significantly associated with discharge to rehabilitation are also associated with increased morbidity and mortality in hip fracture patients, according to the literature,14-20 which provides some external validation of using these risk factors as predictors for rehabilitation. A patient with one of these risk factors may require rehabilitation, given that rehabilitation services are specifically linked to lower morbidity and mortality rates among hip fracture patients. For example, patients with dialysis needs were 3.49 times more likely to be discharged to a rehabilitation center in our study. In a 2000 study by Coco and Rush,16 hip fracture patients on dialysis had a 1-year mortality rate 2.5 times higher than that of patients who were not dialysis-dependent. In 2010, Cameron and colleagues17 found that cardiovascular disease was associated with a 2.68 times higher risk of mortality in hip fracture patients. Similarly in our study, both hypertension and history of percutaneous coronary intervention were associated with discharge to rehabilitation. We found higher odds of discharge to rehabilitation with higher ASA classes, which mirror results from a study by Michel and colleagues,15 who found that higher (vs lower) preoperative ASA classes were associated with higher 1-year mortality in hip fracture patients. Interestingly, DNR status was associated with higher odds of discharge home, which may reflect patients’ desires to forgo noninvasive or lifesaving procedures that may be performed at rehabilitation facilities. Although general anesthesia predisposed patients to discharge to a rehabilitation center, multiple studies have found no association between anesthesia type and postoperative mortality rates for hip fracture patients.18,19 Last, Marcantonio and colleagues20 found delirium specifically had a higher odds ratio for discharge, but our univariate analysis did not find a significant association between impaired sensorium and discharge location. Given the correlation of our risk factors with increased morbidity and mortality in the literature, our study’s results provide the initial groundwork for creating a risk calculator that orthopedists can use to predict discharge to rehabilitation.
Our study had some limitations. Although we analyzed a large number of demographics, preoperative comorbidities, and surgical factors, our univariate analysis was limited to information in the ACS-NSQIP database. We did not incorporate other clinically relevant factors (eg, social factors, including patients’ support networks) that may influence discharge decisions. Furthermore, ACS-NSQIP records patient data only up to 30 days after surgery. Discharge information for the time after that was missing for a subset of hip fracture patients, and these patients had to be excluded, potentially skewing our data. ACS-NSQIP also does not collect cost data for patients based on hospitalization or LOS, so we could not determine whether patients discharged to rehabilitation incurred higher costs because of longer hospitalizations.
Nevertheless, our study identified significant patient and operative variables that are associated with discharge to a rehabilitation center. By identifying hip fracture patients with these risk factors early and mobilizing the appropriate resources, practicing orthopedists should be better equipped to help facilitate the discharge of patients to the appropriate location after surgery. Validation of these risk factors should be prospectively determined with an analysis of LOS and cost implications. Use of a risk calculator may in fact result in decreased LOS and hospital-related costs. Furthermore, using these risk factors in a prospective patient cohort would help validate their use and determine whether there is clinical correlation. The orthopedists in our institution are becoming more aware of these risk factors, but validation is necessary.
1. Garcia AE, Bonnaig JV, Yoneda ZT, et al. Patient variables which may predict length of stay and hospital costs in elderly patients with hip fracture. J Orthop Trauma. 2012;26(11):620-623.
2. Hollingworth W, Todd C, Parker M, Roberts JA, Williams R. Cost analysis of early discharge after hip fracture. BMJ. 1993;307(6909):903-906.
3. Sund R, Riihimäki J, Mäkelä M, et al. Modeling the length of the care episode after hip fracture: does the type of fracture matter? Scand J Surg. 2009;98(3):169-174.
4. Fox KM, Magaziner J, Hebel JR, Kenzora JE, Kashner TM. Intertrochanteric versus femoral neck hip fractures: differential characteristics, treatment, and sequelae. J Gerontol A Biol Sci Med Sci. 1999;54(12):M635-M640.
5. Foss NB, Palm H, Krasheninnikoff M, Kehlet H, Gebuhr P. Impact of surgical complications on length of stay after hip fracture surgery. Injury. 2007;38(7):780-784.
6. Lefaivre KA, Macadam SA, Davidson DJ, Gandhi R, Chan H, Broekhuyse HM. Length of stay, mortality, morbidity and delay to surgery in hip fractures. J Bone Joint Surg Br. 2009;91(7):922-927.
7. Clague JE, Craddock E, Andrew G, Horan MA, Pendleton N. Predictors of outcome following hip fracture. Admission time predicts length of stay and in-hospital mortality. Injury. 2002;33(1):1-6.
8. Parker MJ, Todd CJ, Palmer CR, et al. Inter-hospital variations in length of hospital stay following hip fracture. Age Ageing. 1998;27(31):333-337.
9. Brasel KJ, Rasmussen J, Cauley C, Weigelt JA. Reasons for delayed discharge of trauma patients. J Surg Res. 2002;107(2):223-226.
10. Bonar SK, Tinetti ME, Speechley M, Cooney LM. Factors associated with short- versus long-term skilled nursing facility placement among community-living hip fracture patients. J Am Geriatr Soc. 1990;38(10):1139-1144.
11. Bentler SE, Liu L, Obrizan M, et al. The aftermath of hip fracture: discharge placement, functional status change, and mortality. Am J Epidemiol. 2009;170(10):1290-1299.
12. Birkmeyer JD, Gust C, Baser O, Dimick JB, Sutherland JM, Skinner JS. Medicare payments for common inpatient procedures: implications for episode-based payment bundling. Health Serv Res. 2010;45(6 pt 1):1783-1795.
13. American Academy of Orthopaedic Surgeons. Burden of Musculoskeletal Diseases in the United States: Prevalence, Societal and Economic Cost. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2008.
14. Maciejewski ML, Radcliff A, Henderson WG, et al. Determinants of postsurgical discharge setting for male hip fracture patients. J Rehabil Res Dev. 2013;50(9):1267-1276.
15. Michel JP, Klopfenstein C, Hoffmeyer P, Stern R, Grab B. Hip fracture surgery: is the pre-operative American Society of Anesthesiologists (ASA) score a predictor of functional outcome? Aging Clin Exp Res. 2002;14(5):389-394.
16. Coco M, Rush H. Increased incidence of hip fractures in dialysis patients with low serum parathyroid hormone. Am J Kidney Dis. 2000;36(6):1115-1121.
17. Cameron ID, Chen JS, March LM, et al. Hip fracture causes excess mortality owing to cardiovascular and infectious disease in institutionalized older people: a prospective 5-year study. J Bone Miner Res. 2010;25(4):866-872.
18. White SM, Moppett IK, Griffiths R. Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset. Anaesthesia. 2014;69(3):224-230.
19. Le-Wendling L, Bihorac A, Baslanti TO, et al. Regional anesthesia as compared with general anesthesia for surgery in geriatric patients with hip fracture: does it decrease morbidity, mortality, and health care costs? Results of a single-centered study. Pain Med. 2012;13(7):948-956.
20. Marcantonio ER, Flacker JM, Michaels M, Resnick NM. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000;48(6):618-624.
1. Garcia AE, Bonnaig JV, Yoneda ZT, et al. Patient variables which may predict length of stay and hospital costs in elderly patients with hip fracture. J Orthop Trauma. 2012;26(11):620-623.
2. Hollingworth W, Todd C, Parker M, Roberts JA, Williams R. Cost analysis of early discharge after hip fracture. BMJ. 1993;307(6909):903-906.
3. Sund R, Riihimäki J, Mäkelä M, et al. Modeling the length of the care episode after hip fracture: does the type of fracture matter? Scand J Surg. 2009;98(3):169-174.
4. Fox KM, Magaziner J, Hebel JR, Kenzora JE, Kashner TM. Intertrochanteric versus femoral neck hip fractures: differential characteristics, treatment, and sequelae. J Gerontol A Biol Sci Med Sci. 1999;54(12):M635-M640.
5. Foss NB, Palm H, Krasheninnikoff M, Kehlet H, Gebuhr P. Impact of surgical complications on length of stay after hip fracture surgery. Injury. 2007;38(7):780-784.
6. Lefaivre KA, Macadam SA, Davidson DJ, Gandhi R, Chan H, Broekhuyse HM. Length of stay, mortality, morbidity and delay to surgery in hip fractures. J Bone Joint Surg Br. 2009;91(7):922-927.
7. Clague JE, Craddock E, Andrew G, Horan MA, Pendleton N. Predictors of outcome following hip fracture. Admission time predicts length of stay and in-hospital mortality. Injury. 2002;33(1):1-6.
8. Parker MJ, Todd CJ, Palmer CR, et al. Inter-hospital variations in length of hospital stay following hip fracture. Age Ageing. 1998;27(31):333-337.
9. Brasel KJ, Rasmussen J, Cauley C, Weigelt JA. Reasons for delayed discharge of trauma patients. J Surg Res. 2002;107(2):223-226.
10. Bonar SK, Tinetti ME, Speechley M, Cooney LM. Factors associated with short- versus long-term skilled nursing facility placement among community-living hip fracture patients. J Am Geriatr Soc. 1990;38(10):1139-1144.
11. Bentler SE, Liu L, Obrizan M, et al. The aftermath of hip fracture: discharge placement, functional status change, and mortality. Am J Epidemiol. 2009;170(10):1290-1299.
12. Birkmeyer JD, Gust C, Baser O, Dimick JB, Sutherland JM, Skinner JS. Medicare payments for common inpatient procedures: implications for episode-based payment bundling. Health Serv Res. 2010;45(6 pt 1):1783-1795.
13. American Academy of Orthopaedic Surgeons. Burden of Musculoskeletal Diseases in the United States: Prevalence, Societal and Economic Cost. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2008.
14. Maciejewski ML, Radcliff A, Henderson WG, et al. Determinants of postsurgical discharge setting for male hip fracture patients. J Rehabil Res Dev. 2013;50(9):1267-1276.
15. Michel JP, Klopfenstein C, Hoffmeyer P, Stern R, Grab B. Hip fracture surgery: is the pre-operative American Society of Anesthesiologists (ASA) score a predictor of functional outcome? Aging Clin Exp Res. 2002;14(5):389-394.
16. Coco M, Rush H. Increased incidence of hip fractures in dialysis patients with low serum parathyroid hormone. Am J Kidney Dis. 2000;36(6):1115-1121.
17. Cameron ID, Chen JS, March LM, et al. Hip fracture causes excess mortality owing to cardiovascular and infectious disease in institutionalized older people: a prospective 5-year study. J Bone Miner Res. 2010;25(4):866-872.
18. White SM, Moppett IK, Griffiths R. Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset. Anaesthesia. 2014;69(3):224-230.
19. Le-Wendling L, Bihorac A, Baslanti TO, et al. Regional anesthesia as compared with general anesthesia for surgery in geriatric patients with hip fracture: does it decrease morbidity, mortality, and health care costs? Results of a single-centered study. Pain Med. 2012;13(7):948-956.
20. Marcantonio ER, Flacker JM, Michaels M, Resnick NM. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000;48(6):618-624.
Incidence and Functional Outcomes of Malunion of Nonoperatively Treated Humeral Shaft Fractures
Humeral shaft fractures account for about 1% of all fractures.1 With the exception of the few absolute indications for surgical intervention, such as the presence of an open fracture, the current teaching on treatment of these fractures is that the majority can be successfully managed nonoperatively.1-3 These conservative measures consist of bandages, abduction splints, U-casts, hanging arm casts, and, most commonly, functional bracing, which is considered the gold standard for treatment of humeral shaft fractures by many authors.1-3 One of the most often cited disadvantages of nonoperative management over surgical treatment is the higher incidence of residual deformity, the most common of which is varus angulation.4
The incidence of malunion (>20° of angulation in any plane or shortening of ≥2.5 cm) after nonoperative treatment varies in the literature from 0% to 13%,2,4-9 with a recent literature review documenting a mean incidence of 4.4% within the frontal plane and 2% within the sagittal plane across all studies.2 As reported initially by Sarmiento and colleagues3,9 and echoed by other authors,2,5,8 angular deformity of less than 20° is thought to be both cosmetically and functionally acceptable. Whether angular deformities or malunion of more than 20° actually leads to functional limitations is unknown. Although some observational reports suggest that the degree of radiographic malalignment does not necessarily correlate with functional outcome,8 no studies have specifically evaluated patient outcomes of humeral shaft fracture malunions.
We conducted a study to determine the overall incidence and long-term clinical and functional outcomes of patients with malunion after nonoperative management of humeral shaft fractures. Long-term outcomes were assessed with current symptoms, physical examination findings, need for subsequent operative intervention, DASH (Disabilities of the Arm, Shoulder, and Hand) scores, and a self-reported questionnaire. We hypothesized that patients who develop a malunion after nonoperative treatment of a closed humeral shaft fracture will have satisfactory functional outcomes based on subjective reports, physical examination findings, and DASH scores.
Methods
After obtaining institutional review board approval for the study, we selected patients from a retrospective medical record review of all those 18 years or older with a humeral shaft fracture managed nonoperatively at our institution between January 1, 2001, and June 30, 2012, with a minimum 1-year follow-up. We identified 156 patients with nonoperatively managed midshaft humerus fractures. Study exclusion criteria included fracture associated with a tumor (3 patients), ipsilateral upper extremity injury (9), open/ballistic injury (18), nonunion (9), underlying cognitive disability or psychiatric illness (4), and insufficient follow-up to clinical or radiographic healing (22). Ninety-one patients were eligible for study inclusion. Radiographs at time of final clinical visit were reviewed to assess for evidence of malunion at the fracture site, as defined by previously reported criteria3 (>20° angulation in anterior/posterior or varus/valgus plane of motion or shortening of ≥2.5 cm). Fifteen patients met all the inclusion criteria for further evaluation.
Medical records were retrospectively reviewed for information on age at injury, sex, comorbidities (eg, diabetes, osteoporosis, smoking), body mass index, type and duration of immobilization, complications, return to work, cosmetic perception, time to final clinical follow-up, and symptoms at final clinical follow-up. Incidence of potential risk factors associated with malunion—obesity, noncompliance, and comorbidities such as smoking and diabetes—was compared between the 15 patients with malunion and the other study patients, who healed without malunion.
For long-term postoperative follow-up, patients were contacted to be seen in clinic to complete an updated physical examination, self-reported questionnaire, and the DASH form. Physical examination included measurements of range of motion (ROM) and strength involving the shoulder, elbow, and forearm, with ROM reported as the difference between the injured and contralateral upper extremities. Neurovascular status and focal tenderness to palpation were also assessed on examination. When in-person examination was not possible, the questionnaire and DASH form were completed over the telephone. The self-reported questionnaire asked for information on smoking status, pain, functional limitations, cosmetic perception, satisfaction, and whether or not the patient would still opt for nonoperative management if presented with the same injury again. Pain and satisfaction were measured on numerical scales: Pain scores ranged from 0 (no pain) to 10 (worst possible pain), and satisfaction scores ranged from 1 (not satisfied) to 5 (very satisfied). Data are presented as mean values.
Results
Of the 91 study-eligible patients, 15 (16%) met the radiographic criteria for the diagnosis of malunion. Retrospective data were available for all 15 patients from time of injury to final clinical follow-up (mean, 19 weeks; range, 7-53 weeks). Mean age at injury was 39 years (range, 20-79 years). Additional demographics are listed in Table 1. Incidence of potential risk factors, such as body mass index (26.5 vs 25.4), smoking (33% vs 33%), and diabetes (0% vs 8%), was not significantly different between the malunion and healed-without-malunion groups, respectively. Furthermore, all malunion patients were compliant with their treatment protocol.
Radiographs were assessed at time of final follow-up to confirm healing and to document malunion. Varus malunion was found in 13 patients (mean, 24°; range, 20.5°-35.5°), and shortening was documented in the other 2 patients (mean, 4 cm; range, 3-5 cm). Patients were immobilized a mean of 10 weeks (range, 6-13 weeks). Initial fracture management consisted of coaptation splinting for 1 to 2 weeks (12 patients), hanging arm cast for 1 week (1 patient), and posterior splint for 1 week (1 patient). Patients were then transitioned to Sarmiento fracture bracing for the duration of their treatment (range, 5-12 months). One patient, followed initially at an outside institution, was managed in a sling throughout the duration of treatment (12 weeks) (Table 1). All 15 patients were neurovascularly intact at time of final clinical examination, with return of full upper extremity ROM in all but 3 patients. Only 1 of these 3 patients reported residual pain and functional limitations 4 months after injury (Table 2). Twelve patients were evaluated for return to work, with all successfully returning to work without restrictions at time of final follow-up. The 1 minor complication noted during the treatment period involved medial-sided elbow skin breakdown from brace wear, which resolved with local wound care. No patient required or requested surgical intervention for their residual malunion.
Of the 15 patients, 8 (53%) were reached for in-person examination (6 patients) or telephone interview (2 patients) for follow-up assessment by means of DASH form and self-reported questionnaire a mean of 47 months (range, 12-99 months) after initial injury. The 6 patients who had a physical examination were neurovascularly intact, lacked focal tenderness to palpation, and demonstrated full (5/5) strength within the deltoid, biceps, triceps, pronator, and supinator musculature. Each patient had equal ROM compared with the contralateral uninjured extremity on shoulder forward flexion and abduction, elbow flexion and extension, and forearm pronation and supination. Three patients (50%) had mild residual loss of ROM, with 2 demonstrating decreased shoulder external rotation of 10° and 15°, respectively, and 1 demonstrating decreased shoulder internal rotation of 10°.
Mean DASH score was 10.4 (range, 0-49.2). Evaluation of the self-reported questionnaire revealed a mean pain score of 1.1 (range, 0-7), with only 2 patients reporting any ongoing pain. In addition, 2 patients reported functional limitations, both related to overhead activities. However, 6 (75%) of the 8 patients reported noticeable cosmetic deformity, most commonly varus angulation (4 patients), as well as palpable bony prominence (2) and muscle atrophy (1). The majority of patients were satisfied with the outcome of their treatment (mean, 4; range, 2-5), with 6 patients reporting being satisfied or very satisfied, and all 6 indicating they would undergo nonoperative management again if presented with the same injury. Two patients reported being dissatisfied with their outcome, 1 because of cosmetic appearance and 1 because of cosmetic appearance and functional limitations. Both patients indicated they would choose operative management if presented with the same injury. There was no apparent relationship between outcome and degree of residual deformity, as both patients with varus angulation of more than 30° reported no residual pain or functional limitation and were very satisfied with the outcome of their treatment (Table 2).
Of the 7 patients who could not be reached for final follow-up, 2 on initial contact expressed overall satisfaction with their outcome and denied functional limitations. However, both asked to complete the study at a later date. Subsequently, these 2 patients could not be reached to complete the formal follow-up.
Discussion
Humeral shaft fractures are usually managed nonoperatively. One of the most commonly cited disadvantages of nonoperative management is its higher incidence of residual angular deformity, up to 13% in previous studies.4 Our study found a slightly higher incidence, 16%, on review of 91 nonoperatively managed humeral shaft fractures treated over an 11.5 year period. Although previous studies have reported acceptable functional and cosmetic outcomes with residual angular deformity of less than 20°,2,3,5,8,9 only observational reports have suggested acceptable function in patients with a documented malunion.8
To our knowledge, ours is the first study to correlate malunion with functional parameters and subjective patient-reported outcomes. We found that malunion was not associated with significant pain or functional limitation after nonoperative management of humeral shaft fractures. Furthermore, 75% of patients were satisfied or very satisfied with the outcome of their treatment and indicated they would undergo nonoperative management if presented with the same injury again. However, 75% of patients reported a noticeable cosmetic deformity, and one-third of these patients cited it as a major reason for dissatisfaction with their overall outcome. Regarding function, all patients returned to full strength and ROM of the affected extremity, aside from small losses of internal or external shoulder rotation on the magnitude of 10° to 15° in 50% of those patients tested. In addition, 75% of patients returned to regular activity without functional limitations; the other 25% reported trouble with overhead activities. There were no significant complications during the treatment or follow-up period, once the fracture had healed.
The major limitation of this study was its small patient population. (Obtaining a larger series of patients with malunion after nonoperative treatment of humeral shaft fractures likely would require a multicenter study.) Some of our study findings, such as lack of correlation between degree of malunion and subsequent functional or subjective outcomes, would require a larger sample size for verification and more definitive conclusions. Another limitation is that the study was not designed to evaluate the cause of malunion. Therefore, we cannot draw any definitive conclusions regarding what may have contributed to the development of malunion in our study population. However, all our malunion patients were compliant with their treatment protocol, and they showed no significant difference in incidence of potential risk factors (eg, obesity, comorbidities) compared with the patients who healed without malunion.
Conclusion
Malunion after nonoperative management of humeral shaft fractures does not appear to result in significant pain, dissatisfaction, or functional limitation as measured on physical examination and with validated objective outcome measures in the majority of patients. Furthermore, no patients in this study required surgical intervention for any residual limitations or complications after malunion. The majority of patients reported a noticeable cosmetic deformity, which left a small subset of patients dissatisfied. Overall, our study findings can be used to help counsel patients before and during nonoperative management—particularly patients who appear to be healing with some malunion. Our findings suggest that operative intervention to prevent malunion is not necessary, as it likely would not result in any overall improvement in patient function or satisfaction, but patients should be counseled regarding the high likelihood of cosmetic deformity, which may or may not be bothersome.
1. Rockwood CA, Green DP, Bucholz RW, eds. Rockwood and Green’s Fractures in Adults. 7th ed. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2010.
2. Papasoulis E, Drosos GI, Ververidis AN, Verettas DA. Functional bracing of humeral shaft fractures. A review of clinical studies. Injury. 2010;41(7):e21-e27.
3. Sarmiento A, Latta LL. Functional fracture bracing. J Am Acad Orthop Surg. 1999;7(1):66-75.
4. Denard A Jr, Richards JE, Obremskey WT, Tucker MC, Floyd M, Herzog GA. Outcome of nonoperative vs operative treatment of humeral shaft fractures: a retrospective study of 213 patients. Orthopedics. 2010;33(8).
5. Fjalestad T, Strømsøe K, Salvesen P, Rostad B. Functional results of braced humeral diaphyseal fractures: why do 38% lose external rotation of the shoulder? Arch Orthop Trauma Surg. 2000;120(5-6):281-285.
6. Koch PP, Gross DF, Gerber C. The results of functional (Sarmiento) bracing of humeral shaft fractures. J Shoulder Elbow Surg. 2002;11(2):143-150.
7. Ozkurt B, Altay M, Aktekin CN, Toprak A, Tabak Y. The role of functional bracing in the treatment of humeral shaft fractures [in Turkish]. Acta Orthop Traumatol Turc. 2007;41(1):15-20.
8. Rutgers M, Ring D. Treatment of diaphyseal fractures of the humerus using a functional brace. J Orthop Trauma. 2006;20(9):597-601.
9. Sarmiento A, Kinman PB, Galvin EG, Schmitt RH, Phillips JG. Functional bracing of fractures of the shaft of the humerus. J Bone Joint Surg Am. 1977;59(5):596-601.
Humeral shaft fractures account for about 1% of all fractures.1 With the exception of the few absolute indications for surgical intervention, such as the presence of an open fracture, the current teaching on treatment of these fractures is that the majority can be successfully managed nonoperatively.1-3 These conservative measures consist of bandages, abduction splints, U-casts, hanging arm casts, and, most commonly, functional bracing, which is considered the gold standard for treatment of humeral shaft fractures by many authors.1-3 One of the most often cited disadvantages of nonoperative management over surgical treatment is the higher incidence of residual deformity, the most common of which is varus angulation.4
The incidence of malunion (>20° of angulation in any plane or shortening of ≥2.5 cm) after nonoperative treatment varies in the literature from 0% to 13%,2,4-9 with a recent literature review documenting a mean incidence of 4.4% within the frontal plane and 2% within the sagittal plane across all studies.2 As reported initially by Sarmiento and colleagues3,9 and echoed by other authors,2,5,8 angular deformity of less than 20° is thought to be both cosmetically and functionally acceptable. Whether angular deformities or malunion of more than 20° actually leads to functional limitations is unknown. Although some observational reports suggest that the degree of radiographic malalignment does not necessarily correlate with functional outcome,8 no studies have specifically evaluated patient outcomes of humeral shaft fracture malunions.
We conducted a study to determine the overall incidence and long-term clinical and functional outcomes of patients with malunion after nonoperative management of humeral shaft fractures. Long-term outcomes were assessed with current symptoms, physical examination findings, need for subsequent operative intervention, DASH (Disabilities of the Arm, Shoulder, and Hand) scores, and a self-reported questionnaire. We hypothesized that patients who develop a malunion after nonoperative treatment of a closed humeral shaft fracture will have satisfactory functional outcomes based on subjective reports, physical examination findings, and DASH scores.
Methods
After obtaining institutional review board approval for the study, we selected patients from a retrospective medical record review of all those 18 years or older with a humeral shaft fracture managed nonoperatively at our institution between January 1, 2001, and June 30, 2012, with a minimum 1-year follow-up. We identified 156 patients with nonoperatively managed midshaft humerus fractures. Study exclusion criteria included fracture associated with a tumor (3 patients), ipsilateral upper extremity injury (9), open/ballistic injury (18), nonunion (9), underlying cognitive disability or psychiatric illness (4), and insufficient follow-up to clinical or radiographic healing (22). Ninety-one patients were eligible for study inclusion. Radiographs at time of final clinical visit were reviewed to assess for evidence of malunion at the fracture site, as defined by previously reported criteria3 (>20° angulation in anterior/posterior or varus/valgus plane of motion or shortening of ≥2.5 cm). Fifteen patients met all the inclusion criteria for further evaluation.
Medical records were retrospectively reviewed for information on age at injury, sex, comorbidities (eg, diabetes, osteoporosis, smoking), body mass index, type and duration of immobilization, complications, return to work, cosmetic perception, time to final clinical follow-up, and symptoms at final clinical follow-up. Incidence of potential risk factors associated with malunion—obesity, noncompliance, and comorbidities such as smoking and diabetes—was compared between the 15 patients with malunion and the other study patients, who healed without malunion.
For long-term postoperative follow-up, patients were contacted to be seen in clinic to complete an updated physical examination, self-reported questionnaire, and the DASH form. Physical examination included measurements of range of motion (ROM) and strength involving the shoulder, elbow, and forearm, with ROM reported as the difference between the injured and contralateral upper extremities. Neurovascular status and focal tenderness to palpation were also assessed on examination. When in-person examination was not possible, the questionnaire and DASH form were completed over the telephone. The self-reported questionnaire asked for information on smoking status, pain, functional limitations, cosmetic perception, satisfaction, and whether or not the patient would still opt for nonoperative management if presented with the same injury again. Pain and satisfaction were measured on numerical scales: Pain scores ranged from 0 (no pain) to 10 (worst possible pain), and satisfaction scores ranged from 1 (not satisfied) to 5 (very satisfied). Data are presented as mean values.
Results
Of the 91 study-eligible patients, 15 (16%) met the radiographic criteria for the diagnosis of malunion. Retrospective data were available for all 15 patients from time of injury to final clinical follow-up (mean, 19 weeks; range, 7-53 weeks). Mean age at injury was 39 years (range, 20-79 years). Additional demographics are listed in Table 1. Incidence of potential risk factors, such as body mass index (26.5 vs 25.4), smoking (33% vs 33%), and diabetes (0% vs 8%), was not significantly different between the malunion and healed-without-malunion groups, respectively. Furthermore, all malunion patients were compliant with their treatment protocol.
Radiographs were assessed at time of final follow-up to confirm healing and to document malunion. Varus malunion was found in 13 patients (mean, 24°; range, 20.5°-35.5°), and shortening was documented in the other 2 patients (mean, 4 cm; range, 3-5 cm). Patients were immobilized a mean of 10 weeks (range, 6-13 weeks). Initial fracture management consisted of coaptation splinting for 1 to 2 weeks (12 patients), hanging arm cast for 1 week (1 patient), and posterior splint for 1 week (1 patient). Patients were then transitioned to Sarmiento fracture bracing for the duration of their treatment (range, 5-12 months). One patient, followed initially at an outside institution, was managed in a sling throughout the duration of treatment (12 weeks) (Table 1). All 15 patients were neurovascularly intact at time of final clinical examination, with return of full upper extremity ROM in all but 3 patients. Only 1 of these 3 patients reported residual pain and functional limitations 4 months after injury (Table 2). Twelve patients were evaluated for return to work, with all successfully returning to work without restrictions at time of final follow-up. The 1 minor complication noted during the treatment period involved medial-sided elbow skin breakdown from brace wear, which resolved with local wound care. No patient required or requested surgical intervention for their residual malunion.
Of the 15 patients, 8 (53%) were reached for in-person examination (6 patients) or telephone interview (2 patients) for follow-up assessment by means of DASH form and self-reported questionnaire a mean of 47 months (range, 12-99 months) after initial injury. The 6 patients who had a physical examination were neurovascularly intact, lacked focal tenderness to palpation, and demonstrated full (5/5) strength within the deltoid, biceps, triceps, pronator, and supinator musculature. Each patient had equal ROM compared with the contralateral uninjured extremity on shoulder forward flexion and abduction, elbow flexion and extension, and forearm pronation and supination. Three patients (50%) had mild residual loss of ROM, with 2 demonstrating decreased shoulder external rotation of 10° and 15°, respectively, and 1 demonstrating decreased shoulder internal rotation of 10°.
Mean DASH score was 10.4 (range, 0-49.2). Evaluation of the self-reported questionnaire revealed a mean pain score of 1.1 (range, 0-7), with only 2 patients reporting any ongoing pain. In addition, 2 patients reported functional limitations, both related to overhead activities. However, 6 (75%) of the 8 patients reported noticeable cosmetic deformity, most commonly varus angulation (4 patients), as well as palpable bony prominence (2) and muscle atrophy (1). The majority of patients were satisfied with the outcome of their treatment (mean, 4; range, 2-5), with 6 patients reporting being satisfied or very satisfied, and all 6 indicating they would undergo nonoperative management again if presented with the same injury. Two patients reported being dissatisfied with their outcome, 1 because of cosmetic appearance and 1 because of cosmetic appearance and functional limitations. Both patients indicated they would choose operative management if presented with the same injury. There was no apparent relationship between outcome and degree of residual deformity, as both patients with varus angulation of more than 30° reported no residual pain or functional limitation and were very satisfied with the outcome of their treatment (Table 2).
Of the 7 patients who could not be reached for final follow-up, 2 on initial contact expressed overall satisfaction with their outcome and denied functional limitations. However, both asked to complete the study at a later date. Subsequently, these 2 patients could not be reached to complete the formal follow-up.
Discussion
Humeral shaft fractures are usually managed nonoperatively. One of the most commonly cited disadvantages of nonoperative management is its higher incidence of residual angular deformity, up to 13% in previous studies.4 Our study found a slightly higher incidence, 16%, on review of 91 nonoperatively managed humeral shaft fractures treated over an 11.5 year period. Although previous studies have reported acceptable functional and cosmetic outcomes with residual angular deformity of less than 20°,2,3,5,8,9 only observational reports have suggested acceptable function in patients with a documented malunion.8
To our knowledge, ours is the first study to correlate malunion with functional parameters and subjective patient-reported outcomes. We found that malunion was not associated with significant pain or functional limitation after nonoperative management of humeral shaft fractures. Furthermore, 75% of patients were satisfied or very satisfied with the outcome of their treatment and indicated they would undergo nonoperative management if presented with the same injury again. However, 75% of patients reported a noticeable cosmetic deformity, and one-third of these patients cited it as a major reason for dissatisfaction with their overall outcome. Regarding function, all patients returned to full strength and ROM of the affected extremity, aside from small losses of internal or external shoulder rotation on the magnitude of 10° to 15° in 50% of those patients tested. In addition, 75% of patients returned to regular activity without functional limitations; the other 25% reported trouble with overhead activities. There were no significant complications during the treatment or follow-up period, once the fracture had healed.
The major limitation of this study was its small patient population. (Obtaining a larger series of patients with malunion after nonoperative treatment of humeral shaft fractures likely would require a multicenter study.) Some of our study findings, such as lack of correlation between degree of malunion and subsequent functional or subjective outcomes, would require a larger sample size for verification and more definitive conclusions. Another limitation is that the study was not designed to evaluate the cause of malunion. Therefore, we cannot draw any definitive conclusions regarding what may have contributed to the development of malunion in our study population. However, all our malunion patients were compliant with their treatment protocol, and they showed no significant difference in incidence of potential risk factors (eg, obesity, comorbidities) compared with the patients who healed without malunion.
Conclusion
Malunion after nonoperative management of humeral shaft fractures does not appear to result in significant pain, dissatisfaction, or functional limitation as measured on physical examination and with validated objective outcome measures in the majority of patients. Furthermore, no patients in this study required surgical intervention for any residual limitations or complications after malunion. The majority of patients reported a noticeable cosmetic deformity, which left a small subset of patients dissatisfied. Overall, our study findings can be used to help counsel patients before and during nonoperative management—particularly patients who appear to be healing with some malunion. Our findings suggest that operative intervention to prevent malunion is not necessary, as it likely would not result in any overall improvement in patient function or satisfaction, but patients should be counseled regarding the high likelihood of cosmetic deformity, which may or may not be bothersome.
Humeral shaft fractures account for about 1% of all fractures.1 With the exception of the few absolute indications for surgical intervention, such as the presence of an open fracture, the current teaching on treatment of these fractures is that the majority can be successfully managed nonoperatively.1-3 These conservative measures consist of bandages, abduction splints, U-casts, hanging arm casts, and, most commonly, functional bracing, which is considered the gold standard for treatment of humeral shaft fractures by many authors.1-3 One of the most often cited disadvantages of nonoperative management over surgical treatment is the higher incidence of residual deformity, the most common of which is varus angulation.4
The incidence of malunion (>20° of angulation in any plane or shortening of ≥2.5 cm) after nonoperative treatment varies in the literature from 0% to 13%,2,4-9 with a recent literature review documenting a mean incidence of 4.4% within the frontal plane and 2% within the sagittal plane across all studies.2 As reported initially by Sarmiento and colleagues3,9 and echoed by other authors,2,5,8 angular deformity of less than 20° is thought to be both cosmetically and functionally acceptable. Whether angular deformities or malunion of more than 20° actually leads to functional limitations is unknown. Although some observational reports suggest that the degree of radiographic malalignment does not necessarily correlate with functional outcome,8 no studies have specifically evaluated patient outcomes of humeral shaft fracture malunions.
We conducted a study to determine the overall incidence and long-term clinical and functional outcomes of patients with malunion after nonoperative management of humeral shaft fractures. Long-term outcomes were assessed with current symptoms, physical examination findings, need for subsequent operative intervention, DASH (Disabilities of the Arm, Shoulder, and Hand) scores, and a self-reported questionnaire. We hypothesized that patients who develop a malunion after nonoperative treatment of a closed humeral shaft fracture will have satisfactory functional outcomes based on subjective reports, physical examination findings, and DASH scores.
Methods
After obtaining institutional review board approval for the study, we selected patients from a retrospective medical record review of all those 18 years or older with a humeral shaft fracture managed nonoperatively at our institution between January 1, 2001, and June 30, 2012, with a minimum 1-year follow-up. We identified 156 patients with nonoperatively managed midshaft humerus fractures. Study exclusion criteria included fracture associated with a tumor (3 patients), ipsilateral upper extremity injury (9), open/ballistic injury (18), nonunion (9), underlying cognitive disability or psychiatric illness (4), and insufficient follow-up to clinical or radiographic healing (22). Ninety-one patients were eligible for study inclusion. Radiographs at time of final clinical visit were reviewed to assess for evidence of malunion at the fracture site, as defined by previously reported criteria3 (>20° angulation in anterior/posterior or varus/valgus plane of motion or shortening of ≥2.5 cm). Fifteen patients met all the inclusion criteria for further evaluation.
Medical records were retrospectively reviewed for information on age at injury, sex, comorbidities (eg, diabetes, osteoporosis, smoking), body mass index, type and duration of immobilization, complications, return to work, cosmetic perception, time to final clinical follow-up, and symptoms at final clinical follow-up. Incidence of potential risk factors associated with malunion—obesity, noncompliance, and comorbidities such as smoking and diabetes—was compared between the 15 patients with malunion and the other study patients, who healed without malunion.
For long-term postoperative follow-up, patients were contacted to be seen in clinic to complete an updated physical examination, self-reported questionnaire, and the DASH form. Physical examination included measurements of range of motion (ROM) and strength involving the shoulder, elbow, and forearm, with ROM reported as the difference between the injured and contralateral upper extremities. Neurovascular status and focal tenderness to palpation were also assessed on examination. When in-person examination was not possible, the questionnaire and DASH form were completed over the telephone. The self-reported questionnaire asked for information on smoking status, pain, functional limitations, cosmetic perception, satisfaction, and whether or not the patient would still opt for nonoperative management if presented with the same injury again. Pain and satisfaction were measured on numerical scales: Pain scores ranged from 0 (no pain) to 10 (worst possible pain), and satisfaction scores ranged from 1 (not satisfied) to 5 (very satisfied). Data are presented as mean values.
Results
Of the 91 study-eligible patients, 15 (16%) met the radiographic criteria for the diagnosis of malunion. Retrospective data were available for all 15 patients from time of injury to final clinical follow-up (mean, 19 weeks; range, 7-53 weeks). Mean age at injury was 39 years (range, 20-79 years). Additional demographics are listed in Table 1. Incidence of potential risk factors, such as body mass index (26.5 vs 25.4), smoking (33% vs 33%), and diabetes (0% vs 8%), was not significantly different between the malunion and healed-without-malunion groups, respectively. Furthermore, all malunion patients were compliant with their treatment protocol.
Radiographs were assessed at time of final follow-up to confirm healing and to document malunion. Varus malunion was found in 13 patients (mean, 24°; range, 20.5°-35.5°), and shortening was documented in the other 2 patients (mean, 4 cm; range, 3-5 cm). Patients were immobilized a mean of 10 weeks (range, 6-13 weeks). Initial fracture management consisted of coaptation splinting for 1 to 2 weeks (12 patients), hanging arm cast for 1 week (1 patient), and posterior splint for 1 week (1 patient). Patients were then transitioned to Sarmiento fracture bracing for the duration of their treatment (range, 5-12 months). One patient, followed initially at an outside institution, was managed in a sling throughout the duration of treatment (12 weeks) (Table 1). All 15 patients were neurovascularly intact at time of final clinical examination, with return of full upper extremity ROM in all but 3 patients. Only 1 of these 3 patients reported residual pain and functional limitations 4 months after injury (Table 2). Twelve patients were evaluated for return to work, with all successfully returning to work without restrictions at time of final follow-up. The 1 minor complication noted during the treatment period involved medial-sided elbow skin breakdown from brace wear, which resolved with local wound care. No patient required or requested surgical intervention for their residual malunion.
Of the 15 patients, 8 (53%) were reached for in-person examination (6 patients) or telephone interview (2 patients) for follow-up assessment by means of DASH form and self-reported questionnaire a mean of 47 months (range, 12-99 months) after initial injury. The 6 patients who had a physical examination were neurovascularly intact, lacked focal tenderness to palpation, and demonstrated full (5/5) strength within the deltoid, biceps, triceps, pronator, and supinator musculature. Each patient had equal ROM compared with the contralateral uninjured extremity on shoulder forward flexion and abduction, elbow flexion and extension, and forearm pronation and supination. Three patients (50%) had mild residual loss of ROM, with 2 demonstrating decreased shoulder external rotation of 10° and 15°, respectively, and 1 demonstrating decreased shoulder internal rotation of 10°.
Mean DASH score was 10.4 (range, 0-49.2). Evaluation of the self-reported questionnaire revealed a mean pain score of 1.1 (range, 0-7), with only 2 patients reporting any ongoing pain. In addition, 2 patients reported functional limitations, both related to overhead activities. However, 6 (75%) of the 8 patients reported noticeable cosmetic deformity, most commonly varus angulation (4 patients), as well as palpable bony prominence (2) and muscle atrophy (1). The majority of patients were satisfied with the outcome of their treatment (mean, 4; range, 2-5), with 6 patients reporting being satisfied or very satisfied, and all 6 indicating they would undergo nonoperative management again if presented with the same injury. Two patients reported being dissatisfied with their outcome, 1 because of cosmetic appearance and 1 because of cosmetic appearance and functional limitations. Both patients indicated they would choose operative management if presented with the same injury. There was no apparent relationship between outcome and degree of residual deformity, as both patients with varus angulation of more than 30° reported no residual pain or functional limitation and were very satisfied with the outcome of their treatment (Table 2).
Of the 7 patients who could not be reached for final follow-up, 2 on initial contact expressed overall satisfaction with their outcome and denied functional limitations. However, both asked to complete the study at a later date. Subsequently, these 2 patients could not be reached to complete the formal follow-up.
Discussion
Humeral shaft fractures are usually managed nonoperatively. One of the most commonly cited disadvantages of nonoperative management is its higher incidence of residual angular deformity, up to 13% in previous studies.4 Our study found a slightly higher incidence, 16%, on review of 91 nonoperatively managed humeral shaft fractures treated over an 11.5 year period. Although previous studies have reported acceptable functional and cosmetic outcomes with residual angular deformity of less than 20°,2,3,5,8,9 only observational reports have suggested acceptable function in patients with a documented malunion.8
To our knowledge, ours is the first study to correlate malunion with functional parameters and subjective patient-reported outcomes. We found that malunion was not associated with significant pain or functional limitation after nonoperative management of humeral shaft fractures. Furthermore, 75% of patients were satisfied or very satisfied with the outcome of their treatment and indicated they would undergo nonoperative management if presented with the same injury again. However, 75% of patients reported a noticeable cosmetic deformity, and one-third of these patients cited it as a major reason for dissatisfaction with their overall outcome. Regarding function, all patients returned to full strength and ROM of the affected extremity, aside from small losses of internal or external shoulder rotation on the magnitude of 10° to 15° in 50% of those patients tested. In addition, 75% of patients returned to regular activity without functional limitations; the other 25% reported trouble with overhead activities. There were no significant complications during the treatment or follow-up period, once the fracture had healed.
The major limitation of this study was its small patient population. (Obtaining a larger series of patients with malunion after nonoperative treatment of humeral shaft fractures likely would require a multicenter study.) Some of our study findings, such as lack of correlation between degree of malunion and subsequent functional or subjective outcomes, would require a larger sample size for verification and more definitive conclusions. Another limitation is that the study was not designed to evaluate the cause of malunion. Therefore, we cannot draw any definitive conclusions regarding what may have contributed to the development of malunion in our study population. However, all our malunion patients were compliant with their treatment protocol, and they showed no significant difference in incidence of potential risk factors (eg, obesity, comorbidities) compared with the patients who healed without malunion.
Conclusion
Malunion after nonoperative management of humeral shaft fractures does not appear to result in significant pain, dissatisfaction, or functional limitation as measured on physical examination and with validated objective outcome measures in the majority of patients. Furthermore, no patients in this study required surgical intervention for any residual limitations or complications after malunion. The majority of patients reported a noticeable cosmetic deformity, which left a small subset of patients dissatisfied. Overall, our study findings can be used to help counsel patients before and during nonoperative management—particularly patients who appear to be healing with some malunion. Our findings suggest that operative intervention to prevent malunion is not necessary, as it likely would not result in any overall improvement in patient function or satisfaction, but patients should be counseled regarding the high likelihood of cosmetic deformity, which may or may not be bothersome.
1. Rockwood CA, Green DP, Bucholz RW, eds. Rockwood and Green’s Fractures in Adults. 7th ed. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2010.
2. Papasoulis E, Drosos GI, Ververidis AN, Verettas DA. Functional bracing of humeral shaft fractures. A review of clinical studies. Injury. 2010;41(7):e21-e27.
3. Sarmiento A, Latta LL. Functional fracture bracing. J Am Acad Orthop Surg. 1999;7(1):66-75.
4. Denard A Jr, Richards JE, Obremskey WT, Tucker MC, Floyd M, Herzog GA. Outcome of nonoperative vs operative treatment of humeral shaft fractures: a retrospective study of 213 patients. Orthopedics. 2010;33(8).
5. Fjalestad T, Strømsøe K, Salvesen P, Rostad B. Functional results of braced humeral diaphyseal fractures: why do 38% lose external rotation of the shoulder? Arch Orthop Trauma Surg. 2000;120(5-6):281-285.
6. Koch PP, Gross DF, Gerber C. The results of functional (Sarmiento) bracing of humeral shaft fractures. J Shoulder Elbow Surg. 2002;11(2):143-150.
7. Ozkurt B, Altay M, Aktekin CN, Toprak A, Tabak Y. The role of functional bracing in the treatment of humeral shaft fractures [in Turkish]. Acta Orthop Traumatol Turc. 2007;41(1):15-20.
8. Rutgers M, Ring D. Treatment of diaphyseal fractures of the humerus using a functional brace. J Orthop Trauma. 2006;20(9):597-601.
9. Sarmiento A, Kinman PB, Galvin EG, Schmitt RH, Phillips JG. Functional bracing of fractures of the shaft of the humerus. J Bone Joint Surg Am. 1977;59(5):596-601.
1. Rockwood CA, Green DP, Bucholz RW, eds. Rockwood and Green’s Fractures in Adults. 7th ed. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2010.
2. Papasoulis E, Drosos GI, Ververidis AN, Verettas DA. Functional bracing of humeral shaft fractures. A review of clinical studies. Injury. 2010;41(7):e21-e27.
3. Sarmiento A, Latta LL. Functional fracture bracing. J Am Acad Orthop Surg. 1999;7(1):66-75.
4. Denard A Jr, Richards JE, Obremskey WT, Tucker MC, Floyd M, Herzog GA. Outcome of nonoperative vs operative treatment of humeral shaft fractures: a retrospective study of 213 patients. Orthopedics. 2010;33(8).
5. Fjalestad T, Strømsøe K, Salvesen P, Rostad B. Functional results of braced humeral diaphyseal fractures: why do 38% lose external rotation of the shoulder? Arch Orthop Trauma Surg. 2000;120(5-6):281-285.
6. Koch PP, Gross DF, Gerber C. The results of functional (Sarmiento) bracing of humeral shaft fractures. J Shoulder Elbow Surg. 2002;11(2):143-150.
7. Ozkurt B, Altay M, Aktekin CN, Toprak A, Tabak Y. The role of functional bracing in the treatment of humeral shaft fractures [in Turkish]. Acta Orthop Traumatol Turc. 2007;41(1):15-20.
8. Rutgers M, Ring D. Treatment of diaphyseal fractures of the humerus using a functional brace. J Orthop Trauma. 2006;20(9):597-601.
9. Sarmiento A, Kinman PB, Galvin EG, Schmitt RH, Phillips JG. Functional bracing of fractures of the shaft of the humerus. J Bone Joint Surg Am. 1977;59(5):596-601.
Long-Term Elastic Durability of Polymer Matrix Composite Materials After Repeated Steam Sterilization
Polymer matrix composite materials have been widely promoted for orthopedic use in a variety of settings, including surgical instruments, medical devices, implants, and bone models.1-13 These types of composites are engineered from 2 or more constituent materials with significantly different physical or chemical properties; these materials remain separate and distinct on a macroscopic level within the finished composite structure. As a result of ongoing biomaterial research, polymer matrix composite materials can be engineered with a wide range of physical, mechanical, and surface properties, tailored to their application. Given their advantages (eg, high strength-to-weight ratio, radiolucency), these polymer matrix composite materials have gained popularity over traditional metallic materials.
Sterilization is an essential day-to-day procedure in the health care sector, both for single- and multiple-use devices or instruments, and thus a composite material used in medical components should remain unaffected by the process. The type of sterilization most commonly performed is steam sterilization, which achieves microbiological death by moist heat and pressure. Steam is created in an autoclave at a temperature of 132°C (270°F) in typical hospital settings. Steam sterilization cycles last 5 to 14 minutes based on specific manufacturer recommendations. Most medical-grade plastics used in health care have been designed and formulated to withstand the required sterilization cycles without sacrificing key properties. The structure integrity and overall performance of polymer matrix composites may be strongly influenced by the stability of the fiber/polymer interfacial region in terms of physical, chemical, and mechanical characteristics of the material at different scales.14 Absorption of moisture causes dilatational expansion and induces stresses, which are associated with the moisture-induced expansion resulting in degradation of structure stability.15 Thus, steam sterilization could affect the properties of the polymer matrix composite materials by excessive absorption of moisture by the polymer.
To our knowledge, no one has studied whether polymer matrix material properties degrade from long-term, repeated steam sterilization followed by mechanical loading. We conducted a study to evaluate the structural properties (short-beam strength, SBS) of several composite materials exposed to repeated sterilization as compared with traditional metal materials: SS-316L (stainless steel 316L) and Al-7075-T6 (aluminum 7075-T6).
Materials and Methods
We evaluated 3 types of composite materials: Tepex (Tepex Dynalite 201; HiPer Technology Inc.), CFR-PPS (carbon-fiber–reinforced polyphenylene sulfide, Cetex PPS; TenCate Advanced Composites USA Inc.), and HTN-53 (Zytel HTN53G50HSLR NC010; HiPer Technology Inc.) (Figure 1). Tepex is being used for orthopedic applications (knee braces, orthoses, insoles) and sporting goods applications. The performance of this material is superior to that of unreinforced thermoplastics. CFR-PPS represented the state of the art in composite materials for aerospace applications (eg, airframe structures, engine nacelles, fan casings, floorboards, interior parts). This is a high-performance material with exceptional high temperature and aggressive chemical resistance characteristics. CFR-PPS is also used to make filter fabric for coal boilers, papermaking felts, electrical insulation, specialty membranes, gaskets, and packing. It is not solubilized by any known solvents, even in long-term exposure, at temperatures up to 200°C. In addition, it exhibits exceptional resistance to organic and inorganic solutions, acids and alkali solutions, and a wide array of miscellaneous chemicals. HTN-53 is a 50% glass-reinforced, lubricated, high-performance polyamide resin with improved flow, developed for applications requiring excellent surface appearance with water-heated molds. This material has specifically shown survivability in hot, cold, chemically aggressive, and load-bearing environments. In addition, it has shown superior moisture and temperature resistance. These 3 composite materials were compared with SS-316L and Al-7075-T6. SS-316L is commonly used for implants in orthopedics, and Al-7075-T6 is a relatively radiolucent alternative for medical applications. Two different tests were performed to evaluate and validate these composite materials: (1) radiographic density evaluation and (2) structural property tests (short-beam load-to-failure [LTF] test, short-beam cyclic compression loading [CCL] test) before and after sterilization cycling.
Radiographic Density Evaluation
The radiographic density of the 5 materials was evaluated with radiographic images of a cadaveric knee specimen (Figure 2). Radiographic image intensification is the gold standard for repeated radiographic imaging in the operating room. Six different radiographic images were obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). Image-Pro Plus software (Media Cybernetics) was used to measure the radiographic density of the materials from the grayscale of the images.
Structural Properties Testing Before and After Sterilization Cycling
We used a standard SBS testing method to determine whether any degradation of structural properties resulted from standard repeated sterilization. The material geometries of the test specimens were 18.96×6.50×3.37 mm (length × width × thickness). Standard sterilization procedures were performed with steam sterilization using an autoclave at a temperature of 132°C (270°F) for at least 5 minutes (range, 5-14 minutes). Sample interval testing ran at 0, 200, and 400 sterilization cycles for structural properties in terms of SBS and moisture retention, with the structural properties at the 0th sterilization cycle (material before sterilization was performed) used as a baseline for comparison. Materials were subjected to 400 sterilization cycles, which is representative of the number of sterilization cycles per year an instrument or device would be subjected to.
Three structural tests were performed for each sample interval: moisture retention, LTF, and CCL. Moisture retention was investigated before and after repeated sterilization by measuring the weight of the test materials, as steam sterilization is known to affect the amount of moisture that is absorbed by a material. Twelve specimens of each proposed material were weighed at each sample interval, with the structural weight at the 0th sterilization cycle (material before sterilization is performed) serving as a baseline for comparison.
SBS testing was based on the ASTM (American Society for Testing and Materials) D2344 standard16 for LTF and CCL tests (Figure 3). Six samples of material were used for each test at every sample interval, yielding 180 samples. Seven servohydraulic material testing system instruments (1 MTS 810 and 6 MTS 858 Mini Bionix) were used to test the SBS of each material. For LTF testing, each specimen was loaded in compression from 30 N to complete structural failure at a constant displacement rate of 1.0 mm/min (0.05 in/min). Testing was initiated with 5 preconditioning loading cycles from 30 to 100 N at 1 Hz. The load was then applied continuously until failure occurred; force and displacement data were collected every 0.02 second. This procedure was performed for 6 replicates for each sample interval for each test material.
The calculation for SBS, Fsbs (MPa), for the constant loading rate until structural failure is:
Fsbs = 0.75 × Pm
b × h
where Pm (N) is the maximum applied load observed during the test, b is the measured specimen width (mm), and h is the measured specimen thickness (mm).
CCL testing consisted of each test material axially loaded with 100 to 500 N at a frequency of 1 Hz for 100,000 cycles. The maximum load of 500 N was chosen as a standard based on 80% of the minimum ultimate failure load from previous LTF tests. Displacement and force data were collected every 5 cycles at the maximum compressive load. Degradation of the material was calculated using the difference between the deflection of the initial cycle and the deflection of the final cycle (50th cycle and 100,000th cycle). This procedure was performed for 6 replicates for each sample interval for each test material.
Statistical Analysis
LTF and CCL testing data were analyzed for any differences among the test materials using 1-way analysis of variance with the least significant difference multiple comparisons post hoc test method using SPSS Version 16.0, with P < .05 denoting significance. These analyses were used to determine the statistical relevance of the difference between the SBS (LTF and CCL) of each test material. Means and standard deviations were calculated for all tests.
Results
Radiographic Density Evaluation
Overall, all the tested composite materials were significantly more radiolucent than either SS-316L or Al-7075-T6. Figure 4 shows the 6 different radiographic images obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). SS-316L can be considered radiopaque, and Al-7075-T6 has been used as a relatively radiolucent alternative. Tepex was statistically more radiolucent than the other 2 tested composite materials (Table 1). Even with 2 pieces placed anterior to the subject and 2 placed posterior, the radiodensity compared to the cortical bone was still lower than 1 piece of Al-7075-T6 either anterior or posterior to the subject.
Structural Properties Testing
Moisture Retention. Moisture retention was evaluated by weighing the test materials before and after repeated sterilization. There was no significant difference in moisture retention, as weight differences for all the tested materials were less than 0.5 weight percentage compared to the 0th sterilization cycle (Table 2). Therefore, the results of this study showed that all the tested materials exhibited good moisture/temperature resistance after 400 sterilization cycles.
Load to Failure. In the LTF test, significant differences were detected in SBS between all 5 tested materials (P < .05). Figure 5 shows the comparison of the structural properties in terms of SBS between the 5 tested materials, and Figure 6 shows the failure modes for the tested materials. There was no SBS for SS-316L, as the material did not exhibit complete structural failure even after 400 sterilization cycles; however, SS-316L was observed in inelastic deformation failure (Figure 6D). Al-7075-T6 had much higher SBS compared with the other composite materials, and it also resulted in an inelastic deformation failure mode only after 400 sterilization cycles; otherwise, flexure failure modes were observed. Tepex and CFR-PPS exhibited interlaminar shear failure, and HTN-53 exhibited complete structural failure.
Every composite material tested using the short-beam test for LTF showed a decrease in SBS with increased sterilization cycles (Figure 5). This decrease ranged from 17% to 57% compared with the 0th sterilization cycle. SBS was higher for CFR-PPS than for the other 2 composites. No statistically significant difference was found between CFR-PPS and Tepex except at the 200th sterilization cycle. HTN-53 was brittle at the 0th sterilization cycle but performed more like a ductile material at the 200th cycle. In addition, HTN-53 had the lowest SBS in terms of LTF testing when compared with the other 2 composites.
During the complete structural failure test, the failure modes for Tepex and CFR-PPS were visually identified as interlaminar shear failure (Figures 6A, 6B), whereas HTN-53 visually exhibited pure flexure failure (Figure 6C). As for the metals, SS-316L exhibited plastic deformation, and Al-7075-T6 exhibited flexure failure (Figures 6D, 6E).
Cyclic Compression Loading. Tepex was the only material to pass the 100,000 loading cycle without failure (Table 3). HTN-53 had the poorest performance of all: Its failure rates were 33% (2/6 samples) before sterilization (average cycle, 22,213; range, 21,500-22,925), 83% (5/6 samples) at the 200th sterilization cycle (average cycle, 4,210; range, 0-14,360), and 100% after 400 sterilization cycles (average cycle, 12,725; range, 1,190-21,900). CFR-PPS had no failures before the 400th sterilization cycle, and its failure rate after 400 sterilization cycles (average cycle, 50,735; range, 50,270-51,200) was 33% (2/6 samples).
Discussion
The success of a reusable composite material for use in orthopedic surgery depends not only on radiographic density, fabrication methods, and design but also on the ability to withstand repeated sterilization. Over the past 3 decades, investigators have explored several high-performance polymer matrix composite materials for use in orthopedics, especially in trauma, hip stems, and spinal implants.1,3,4,17-34 According to Evans and Gregson,35 composite materials have been widely promoted as possible orthopedic biomaterials but to date have found few successful commercial applications, because of the many challenging problems encountered in fabrication and testing. One of the most important factors in the mechanical properties of many composite materials is the influence of the cooling and loading rates on fiber-matrix interface adhesion.36-38 Our results tended to agree with the findings of Evans and Gregson,35 as some of these composite materials did not withstand repeated sterilizations well.
Guan and colleagues39 evaluated the influence of sterilization treatment on continuous carbon-fiber–reinforced polyolefin composite. Their 3-point bending test results showed that the levels of maximum load of all the specimens undergoing sterilization by autoclave were lower than those of the control group. For these composites, they concluded that autoclave sterilization and Co-60 gamma ray irradiation sterilization should be avoided and that ethylene oxide is the best method. Our results support their findings with a different set of composites.
Although HTN-53 has shown promise in other orthopedic applications because of its superior moisture and temperature resistance, we found that its performance after repeated sterilization was relatively poor. Tepex showed the greatest potential for durability after repeated sterilization; its mechanical properties were stable after 200 steam sterilization cycles.
Clinical Applications
The composite materials investigated in the present study have potential for use in either instrumentation or long-term implantation applications because of their versatility, mechanical strength, fatigue resistance, and biocompatibility. Akay and Aslan40 stated that carbon-fiber–filled composite implants can be designed with more appropriate modulus, strength, toughness, or stiffness by the arrangement of reinforcing fiber volume and orientation, and can provide better fatigue resistance. A notable advantage of using a composite plate with metal screws is that the potential for corrosion of metallic components is eliminated. Another major advantage of composite medical implants (eg, DiPhos-RM) is radiolucency, which allows direct visualization of osseous callus formation as well as monitoring of fracture healing, thereby improving clinical assessment and accuracy.
Numerous studies have documented the successful clinical performance of composite materials in orthopedic, trauma, and spinal surgery applications.41-45 Bagheri and colleagues41 developed a new carbon fiber–flax–epoxy composite plate and biomechanically compared it with a standard clinical metal plate. Their results confirmed that the carbon fiber–flax–epoxy material represents a potential candidate for bone fracture plate applications, as it can simultaneously provide similar mechanical stiffness and lower stress shielding (higher bone stress) compared with a standard clinical metal bone plate. Tarallo and colleagues45 evaluated the clinical results of 40 cases at 12-month follow-up using a new plate made of carbon-fiber–reinforced polyetheretherketon (DiPhos-RM, Lima Corporate) for the treatment of distal radius fractures. They reported good clinical results for this device at early follow-up, and its use allowed maintenance of reduction in complex AO (Arbeitsgemeinschaft für Osteosynthesefragen) fractures.
The main advantage in using composites for surgical instruments is their radiolucency. These materials do not obscure images or radiographs during fluoroscopic visualization. Surgery often requires fluoroscopic visualization of internal organs or bones, which may require temporary removal of radiopaque devices (eg, retractors, clamps, forceps, hooks, distractors). Aside from being inconvenient, removal and subsequent reinsertion consume valuable time and interfere with the smooth flow of an operation.
The shortcomings of using composite materials for surgical instruments involve detectability and sterilization. A significant issue in surgery is the accidental leaving behind of instruments in patients, which can cause serious problems ranging from organ perforation and blood infection to death. Although instrument counting and other safety protocols can reduce the risk of overlooking an instrument, mistakes are bound to happen. The other shortcoming is the influence of repeated sterilization on the mechanical properties of the composite materials, as sterilization is mandatory for surgical instruments used in the operation room. The structural integrity and overall performance of the polymer composite materials—especially the stability of the interface and the interphase zones—are strongly influenced by repeated sterilization.
On the other hand, composite materials have potential advantages that may support their introduction into long-term medical implant applications, as sterilization commonly is performed only once, during packaging. The effects of sterilization by radiation or steam are much less pronounced on composite implants than on composite surgical instruments. However, composite implants require careful consideration with respect to the bioactivity of wear particles that may be produced from articulation. Further, carbon-fiber–reinforced polymer implants are still substantially more difficult to manufacture and more costly than their metallic counterparts.46
Limitations
This study has some limitations. Most important, studies of this nature do not account for biological factors such as corrosion, biological wear, and the soft-tissue attachment effects on structural properties for potential in vivo use. Another limitation was that the study tested only the mechanical properties in terms of SBS and provided no information about other mechanical properties, such as tensile, compression, and torsion strengths. We think SBS testing adequately evaluates challenging scenarios like thin and narrow instruments/devices that are anticipated in application, and information regarding other modes of failure and mechanical properties (compression, tension, torsion) would be a further area of research. An additional limitation was that our model used a relatively small number of samples. A larger study with more samples and varying layout patterns and layers of the carbon fibers may more clearly demonstrate the effect of steam sterilization on composite materials.
Conclusion
This study provided new information on 3 selected composite materials and their structural properties after repeated steam sterilization. We discovered that these composites were similar in radiographic density and water retention but behaved very differently in terms of mechanical durability after repeated steam sterilization. All selected composites demonstrated deterioration of mechanical properties after repeated steam sterilization. Knowing these results could aid in making decisions about the design and manufacturing of operative instruments and orthopedic biomaterials. Although our preliminary findings are intriguing, further study is warranted to seek specific applications for these composite materials in orthopedic surgery.
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44. Kasliwal MK, O’Toole JE. Clinical experience using polyetheretherketone (PEEK) intervertebral structural cage for anterior cervical corpectomy and fusion. J Clin Neurosci. 2014;21(2):217-220.
45. Tarallo L, Mugnai R, Adani R, Zambianchi F, Catani F. A new volar plate made of carbon-fiber–reinforced polyetheretherketon for distal radius fracture: analysis of 40 cases. J Orthop Traumatol. 2014;15(4):277-283.
46. Cordey J, Perren SM, Steinemann SG. Stress protection due to plates: myth or reality? A parametric analysis made using the composite beam theory. Injury. 2000;31(suppl 3):C1-C13.
Polymer matrix composite materials have been widely promoted for orthopedic use in a variety of settings, including surgical instruments, medical devices, implants, and bone models.1-13 These types of composites are engineered from 2 or more constituent materials with significantly different physical or chemical properties; these materials remain separate and distinct on a macroscopic level within the finished composite structure. As a result of ongoing biomaterial research, polymer matrix composite materials can be engineered with a wide range of physical, mechanical, and surface properties, tailored to their application. Given their advantages (eg, high strength-to-weight ratio, radiolucency), these polymer matrix composite materials have gained popularity over traditional metallic materials.
Sterilization is an essential day-to-day procedure in the health care sector, both for single- and multiple-use devices or instruments, and thus a composite material used in medical components should remain unaffected by the process. The type of sterilization most commonly performed is steam sterilization, which achieves microbiological death by moist heat and pressure. Steam is created in an autoclave at a temperature of 132°C (270°F) in typical hospital settings. Steam sterilization cycles last 5 to 14 minutes based on specific manufacturer recommendations. Most medical-grade plastics used in health care have been designed and formulated to withstand the required sterilization cycles without sacrificing key properties. The structure integrity and overall performance of polymer matrix composites may be strongly influenced by the stability of the fiber/polymer interfacial region in terms of physical, chemical, and mechanical characteristics of the material at different scales.14 Absorption of moisture causes dilatational expansion and induces stresses, which are associated with the moisture-induced expansion resulting in degradation of structure stability.15 Thus, steam sterilization could affect the properties of the polymer matrix composite materials by excessive absorption of moisture by the polymer.
To our knowledge, no one has studied whether polymer matrix material properties degrade from long-term, repeated steam sterilization followed by mechanical loading. We conducted a study to evaluate the structural properties (short-beam strength, SBS) of several composite materials exposed to repeated sterilization as compared with traditional metal materials: SS-316L (stainless steel 316L) and Al-7075-T6 (aluminum 7075-T6).
Materials and Methods
We evaluated 3 types of composite materials: Tepex (Tepex Dynalite 201; HiPer Technology Inc.), CFR-PPS (carbon-fiber–reinforced polyphenylene sulfide, Cetex PPS; TenCate Advanced Composites USA Inc.), and HTN-53 (Zytel HTN53G50HSLR NC010; HiPer Technology Inc.) (Figure 1). Tepex is being used for orthopedic applications (knee braces, orthoses, insoles) and sporting goods applications. The performance of this material is superior to that of unreinforced thermoplastics. CFR-PPS represented the state of the art in composite materials for aerospace applications (eg, airframe structures, engine nacelles, fan casings, floorboards, interior parts). This is a high-performance material with exceptional high temperature and aggressive chemical resistance characteristics. CFR-PPS is also used to make filter fabric for coal boilers, papermaking felts, electrical insulation, specialty membranes, gaskets, and packing. It is not solubilized by any known solvents, even in long-term exposure, at temperatures up to 200°C. In addition, it exhibits exceptional resistance to organic and inorganic solutions, acids and alkali solutions, and a wide array of miscellaneous chemicals. HTN-53 is a 50% glass-reinforced, lubricated, high-performance polyamide resin with improved flow, developed for applications requiring excellent surface appearance with water-heated molds. This material has specifically shown survivability in hot, cold, chemically aggressive, and load-bearing environments. In addition, it has shown superior moisture and temperature resistance. These 3 composite materials were compared with SS-316L and Al-7075-T6. SS-316L is commonly used for implants in orthopedics, and Al-7075-T6 is a relatively radiolucent alternative for medical applications. Two different tests were performed to evaluate and validate these composite materials: (1) radiographic density evaluation and (2) structural property tests (short-beam load-to-failure [LTF] test, short-beam cyclic compression loading [CCL] test) before and after sterilization cycling.
Radiographic Density Evaluation
The radiographic density of the 5 materials was evaluated with radiographic images of a cadaveric knee specimen (Figure 2). Radiographic image intensification is the gold standard for repeated radiographic imaging in the operating room. Six different radiographic images were obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). Image-Pro Plus software (Media Cybernetics) was used to measure the radiographic density of the materials from the grayscale of the images.
Structural Properties Testing Before and After Sterilization Cycling
We used a standard SBS testing method to determine whether any degradation of structural properties resulted from standard repeated sterilization. The material geometries of the test specimens were 18.96×6.50×3.37 mm (length × width × thickness). Standard sterilization procedures were performed with steam sterilization using an autoclave at a temperature of 132°C (270°F) for at least 5 minutes (range, 5-14 minutes). Sample interval testing ran at 0, 200, and 400 sterilization cycles for structural properties in terms of SBS and moisture retention, with the structural properties at the 0th sterilization cycle (material before sterilization was performed) used as a baseline for comparison. Materials were subjected to 400 sterilization cycles, which is representative of the number of sterilization cycles per year an instrument or device would be subjected to.
Three structural tests were performed for each sample interval: moisture retention, LTF, and CCL. Moisture retention was investigated before and after repeated sterilization by measuring the weight of the test materials, as steam sterilization is known to affect the amount of moisture that is absorbed by a material. Twelve specimens of each proposed material were weighed at each sample interval, with the structural weight at the 0th sterilization cycle (material before sterilization is performed) serving as a baseline for comparison.
SBS testing was based on the ASTM (American Society for Testing and Materials) D2344 standard16 for LTF and CCL tests (Figure 3). Six samples of material were used for each test at every sample interval, yielding 180 samples. Seven servohydraulic material testing system instruments (1 MTS 810 and 6 MTS 858 Mini Bionix) were used to test the SBS of each material. For LTF testing, each specimen was loaded in compression from 30 N to complete structural failure at a constant displacement rate of 1.0 mm/min (0.05 in/min). Testing was initiated with 5 preconditioning loading cycles from 30 to 100 N at 1 Hz. The load was then applied continuously until failure occurred; force and displacement data were collected every 0.02 second. This procedure was performed for 6 replicates for each sample interval for each test material.
The calculation for SBS, Fsbs (MPa), for the constant loading rate until structural failure is:
Fsbs = 0.75 × Pm
b × h
where Pm (N) is the maximum applied load observed during the test, b is the measured specimen width (mm), and h is the measured specimen thickness (mm).
CCL testing consisted of each test material axially loaded with 100 to 500 N at a frequency of 1 Hz for 100,000 cycles. The maximum load of 500 N was chosen as a standard based on 80% of the minimum ultimate failure load from previous LTF tests. Displacement and force data were collected every 5 cycles at the maximum compressive load. Degradation of the material was calculated using the difference between the deflection of the initial cycle and the deflection of the final cycle (50th cycle and 100,000th cycle). This procedure was performed for 6 replicates for each sample interval for each test material.
Statistical Analysis
LTF and CCL testing data were analyzed for any differences among the test materials using 1-way analysis of variance with the least significant difference multiple comparisons post hoc test method using SPSS Version 16.0, with P < .05 denoting significance. These analyses were used to determine the statistical relevance of the difference between the SBS (LTF and CCL) of each test material. Means and standard deviations were calculated for all tests.
Results
Radiographic Density Evaluation
Overall, all the tested composite materials were significantly more radiolucent than either SS-316L or Al-7075-T6. Figure 4 shows the 6 different radiographic images obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). SS-316L can be considered radiopaque, and Al-7075-T6 has been used as a relatively radiolucent alternative. Tepex was statistically more radiolucent than the other 2 tested composite materials (Table 1). Even with 2 pieces placed anterior to the subject and 2 placed posterior, the radiodensity compared to the cortical bone was still lower than 1 piece of Al-7075-T6 either anterior or posterior to the subject.
Structural Properties Testing
Moisture Retention. Moisture retention was evaluated by weighing the test materials before and after repeated sterilization. There was no significant difference in moisture retention, as weight differences for all the tested materials were less than 0.5 weight percentage compared to the 0th sterilization cycle (Table 2). Therefore, the results of this study showed that all the tested materials exhibited good moisture/temperature resistance after 400 sterilization cycles.
Load to Failure. In the LTF test, significant differences were detected in SBS between all 5 tested materials (P < .05). Figure 5 shows the comparison of the structural properties in terms of SBS between the 5 tested materials, and Figure 6 shows the failure modes for the tested materials. There was no SBS for SS-316L, as the material did not exhibit complete structural failure even after 400 sterilization cycles; however, SS-316L was observed in inelastic deformation failure (Figure 6D). Al-7075-T6 had much higher SBS compared with the other composite materials, and it also resulted in an inelastic deformation failure mode only after 400 sterilization cycles; otherwise, flexure failure modes were observed. Tepex and CFR-PPS exhibited interlaminar shear failure, and HTN-53 exhibited complete structural failure.
Every composite material tested using the short-beam test for LTF showed a decrease in SBS with increased sterilization cycles (Figure 5). This decrease ranged from 17% to 57% compared with the 0th sterilization cycle. SBS was higher for CFR-PPS than for the other 2 composites. No statistically significant difference was found between CFR-PPS and Tepex except at the 200th sterilization cycle. HTN-53 was brittle at the 0th sterilization cycle but performed more like a ductile material at the 200th cycle. In addition, HTN-53 had the lowest SBS in terms of LTF testing when compared with the other 2 composites.
During the complete structural failure test, the failure modes for Tepex and CFR-PPS were visually identified as interlaminar shear failure (Figures 6A, 6B), whereas HTN-53 visually exhibited pure flexure failure (Figure 6C). As for the metals, SS-316L exhibited plastic deformation, and Al-7075-T6 exhibited flexure failure (Figures 6D, 6E).
Cyclic Compression Loading. Tepex was the only material to pass the 100,000 loading cycle without failure (Table 3). HTN-53 had the poorest performance of all: Its failure rates were 33% (2/6 samples) before sterilization (average cycle, 22,213; range, 21,500-22,925), 83% (5/6 samples) at the 200th sterilization cycle (average cycle, 4,210; range, 0-14,360), and 100% after 400 sterilization cycles (average cycle, 12,725; range, 1,190-21,900). CFR-PPS had no failures before the 400th sterilization cycle, and its failure rate after 400 sterilization cycles (average cycle, 50,735; range, 50,270-51,200) was 33% (2/6 samples).
Discussion
The success of a reusable composite material for use in orthopedic surgery depends not only on radiographic density, fabrication methods, and design but also on the ability to withstand repeated sterilization. Over the past 3 decades, investigators have explored several high-performance polymer matrix composite materials for use in orthopedics, especially in trauma, hip stems, and spinal implants.1,3,4,17-34 According to Evans and Gregson,35 composite materials have been widely promoted as possible orthopedic biomaterials but to date have found few successful commercial applications, because of the many challenging problems encountered in fabrication and testing. One of the most important factors in the mechanical properties of many composite materials is the influence of the cooling and loading rates on fiber-matrix interface adhesion.36-38 Our results tended to agree with the findings of Evans and Gregson,35 as some of these composite materials did not withstand repeated sterilizations well.
Guan and colleagues39 evaluated the influence of sterilization treatment on continuous carbon-fiber–reinforced polyolefin composite. Their 3-point bending test results showed that the levels of maximum load of all the specimens undergoing sterilization by autoclave were lower than those of the control group. For these composites, they concluded that autoclave sterilization and Co-60 gamma ray irradiation sterilization should be avoided and that ethylene oxide is the best method. Our results support their findings with a different set of composites.
Although HTN-53 has shown promise in other orthopedic applications because of its superior moisture and temperature resistance, we found that its performance after repeated sterilization was relatively poor. Tepex showed the greatest potential for durability after repeated sterilization; its mechanical properties were stable after 200 steam sterilization cycles.
Clinical Applications
The composite materials investigated in the present study have potential for use in either instrumentation or long-term implantation applications because of their versatility, mechanical strength, fatigue resistance, and biocompatibility. Akay and Aslan40 stated that carbon-fiber–filled composite implants can be designed with more appropriate modulus, strength, toughness, or stiffness by the arrangement of reinforcing fiber volume and orientation, and can provide better fatigue resistance. A notable advantage of using a composite plate with metal screws is that the potential for corrosion of metallic components is eliminated. Another major advantage of composite medical implants (eg, DiPhos-RM) is radiolucency, which allows direct visualization of osseous callus formation as well as monitoring of fracture healing, thereby improving clinical assessment and accuracy.
Numerous studies have documented the successful clinical performance of composite materials in orthopedic, trauma, and spinal surgery applications.41-45 Bagheri and colleagues41 developed a new carbon fiber–flax–epoxy composite plate and biomechanically compared it with a standard clinical metal plate. Their results confirmed that the carbon fiber–flax–epoxy material represents a potential candidate for bone fracture plate applications, as it can simultaneously provide similar mechanical stiffness and lower stress shielding (higher bone stress) compared with a standard clinical metal bone plate. Tarallo and colleagues45 evaluated the clinical results of 40 cases at 12-month follow-up using a new plate made of carbon-fiber–reinforced polyetheretherketon (DiPhos-RM, Lima Corporate) for the treatment of distal radius fractures. They reported good clinical results for this device at early follow-up, and its use allowed maintenance of reduction in complex AO (Arbeitsgemeinschaft für Osteosynthesefragen) fractures.
The main advantage in using composites for surgical instruments is their radiolucency. These materials do not obscure images or radiographs during fluoroscopic visualization. Surgery often requires fluoroscopic visualization of internal organs or bones, which may require temporary removal of radiopaque devices (eg, retractors, clamps, forceps, hooks, distractors). Aside from being inconvenient, removal and subsequent reinsertion consume valuable time and interfere with the smooth flow of an operation.
The shortcomings of using composite materials for surgical instruments involve detectability and sterilization. A significant issue in surgery is the accidental leaving behind of instruments in patients, which can cause serious problems ranging from organ perforation and blood infection to death. Although instrument counting and other safety protocols can reduce the risk of overlooking an instrument, mistakes are bound to happen. The other shortcoming is the influence of repeated sterilization on the mechanical properties of the composite materials, as sterilization is mandatory for surgical instruments used in the operation room. The structural integrity and overall performance of the polymer composite materials—especially the stability of the interface and the interphase zones—are strongly influenced by repeated sterilization.
On the other hand, composite materials have potential advantages that may support their introduction into long-term medical implant applications, as sterilization commonly is performed only once, during packaging. The effects of sterilization by radiation or steam are much less pronounced on composite implants than on composite surgical instruments. However, composite implants require careful consideration with respect to the bioactivity of wear particles that may be produced from articulation. Further, carbon-fiber–reinforced polymer implants are still substantially more difficult to manufacture and more costly than their metallic counterparts.46
Limitations
This study has some limitations. Most important, studies of this nature do not account for biological factors such as corrosion, biological wear, and the soft-tissue attachment effects on structural properties for potential in vivo use. Another limitation was that the study tested only the mechanical properties in terms of SBS and provided no information about other mechanical properties, such as tensile, compression, and torsion strengths. We think SBS testing adequately evaluates challenging scenarios like thin and narrow instruments/devices that are anticipated in application, and information regarding other modes of failure and mechanical properties (compression, tension, torsion) would be a further area of research. An additional limitation was that our model used a relatively small number of samples. A larger study with more samples and varying layout patterns and layers of the carbon fibers may more clearly demonstrate the effect of steam sterilization on composite materials.
Conclusion
This study provided new information on 3 selected composite materials and their structural properties after repeated steam sterilization. We discovered that these composites were similar in radiographic density and water retention but behaved very differently in terms of mechanical durability after repeated steam sterilization. All selected composites demonstrated deterioration of mechanical properties after repeated steam sterilization. Knowing these results could aid in making decisions about the design and manufacturing of operative instruments and orthopedic biomaterials. Although our preliminary findings are intriguing, further study is warranted to seek specific applications for these composite materials in orthopedic surgery.
Polymer matrix composite materials have been widely promoted for orthopedic use in a variety of settings, including surgical instruments, medical devices, implants, and bone models.1-13 These types of composites are engineered from 2 or more constituent materials with significantly different physical or chemical properties; these materials remain separate and distinct on a macroscopic level within the finished composite structure. As a result of ongoing biomaterial research, polymer matrix composite materials can be engineered with a wide range of physical, mechanical, and surface properties, tailored to their application. Given their advantages (eg, high strength-to-weight ratio, radiolucency), these polymer matrix composite materials have gained popularity over traditional metallic materials.
Sterilization is an essential day-to-day procedure in the health care sector, both for single- and multiple-use devices or instruments, and thus a composite material used in medical components should remain unaffected by the process. The type of sterilization most commonly performed is steam sterilization, which achieves microbiological death by moist heat and pressure. Steam is created in an autoclave at a temperature of 132°C (270°F) in typical hospital settings. Steam sterilization cycles last 5 to 14 minutes based on specific manufacturer recommendations. Most medical-grade plastics used in health care have been designed and formulated to withstand the required sterilization cycles without sacrificing key properties. The structure integrity and overall performance of polymer matrix composites may be strongly influenced by the stability of the fiber/polymer interfacial region in terms of physical, chemical, and mechanical characteristics of the material at different scales.14 Absorption of moisture causes dilatational expansion and induces stresses, which are associated with the moisture-induced expansion resulting in degradation of structure stability.15 Thus, steam sterilization could affect the properties of the polymer matrix composite materials by excessive absorption of moisture by the polymer.
To our knowledge, no one has studied whether polymer matrix material properties degrade from long-term, repeated steam sterilization followed by mechanical loading. We conducted a study to evaluate the structural properties (short-beam strength, SBS) of several composite materials exposed to repeated sterilization as compared with traditional metal materials: SS-316L (stainless steel 316L) and Al-7075-T6 (aluminum 7075-T6).
Materials and Methods
We evaluated 3 types of composite materials: Tepex (Tepex Dynalite 201; HiPer Technology Inc.), CFR-PPS (carbon-fiber–reinforced polyphenylene sulfide, Cetex PPS; TenCate Advanced Composites USA Inc.), and HTN-53 (Zytel HTN53G50HSLR NC010; HiPer Technology Inc.) (Figure 1). Tepex is being used for orthopedic applications (knee braces, orthoses, insoles) and sporting goods applications. The performance of this material is superior to that of unreinforced thermoplastics. CFR-PPS represented the state of the art in composite materials for aerospace applications (eg, airframe structures, engine nacelles, fan casings, floorboards, interior parts). This is a high-performance material with exceptional high temperature and aggressive chemical resistance characteristics. CFR-PPS is also used to make filter fabric for coal boilers, papermaking felts, electrical insulation, specialty membranes, gaskets, and packing. It is not solubilized by any known solvents, even in long-term exposure, at temperatures up to 200°C. In addition, it exhibits exceptional resistance to organic and inorganic solutions, acids and alkali solutions, and a wide array of miscellaneous chemicals. HTN-53 is a 50% glass-reinforced, lubricated, high-performance polyamide resin with improved flow, developed for applications requiring excellent surface appearance with water-heated molds. This material has specifically shown survivability in hot, cold, chemically aggressive, and load-bearing environments. In addition, it has shown superior moisture and temperature resistance. These 3 composite materials were compared with SS-316L and Al-7075-T6. SS-316L is commonly used for implants in orthopedics, and Al-7075-T6 is a relatively radiolucent alternative for medical applications. Two different tests were performed to evaluate and validate these composite materials: (1) radiographic density evaluation and (2) structural property tests (short-beam load-to-failure [LTF] test, short-beam cyclic compression loading [CCL] test) before and after sterilization cycling.
Radiographic Density Evaluation
The radiographic density of the 5 materials was evaluated with radiographic images of a cadaveric knee specimen (Figure 2). Radiographic image intensification is the gold standard for repeated radiographic imaging in the operating room. Six different radiographic images were obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). Image-Pro Plus software (Media Cybernetics) was used to measure the radiographic density of the materials from the grayscale of the images.
Structural Properties Testing Before and After Sterilization Cycling
We used a standard SBS testing method to determine whether any degradation of structural properties resulted from standard repeated sterilization. The material geometries of the test specimens were 18.96×6.50×3.37 mm (length × width × thickness). Standard sterilization procedures were performed with steam sterilization using an autoclave at a temperature of 132°C (270°F) for at least 5 minutes (range, 5-14 minutes). Sample interval testing ran at 0, 200, and 400 sterilization cycles for structural properties in terms of SBS and moisture retention, with the structural properties at the 0th sterilization cycle (material before sterilization was performed) used as a baseline for comparison. Materials were subjected to 400 sterilization cycles, which is representative of the number of sterilization cycles per year an instrument or device would be subjected to.
Three structural tests were performed for each sample interval: moisture retention, LTF, and CCL. Moisture retention was investigated before and after repeated sterilization by measuring the weight of the test materials, as steam sterilization is known to affect the amount of moisture that is absorbed by a material. Twelve specimens of each proposed material were weighed at each sample interval, with the structural weight at the 0th sterilization cycle (material before sterilization is performed) serving as a baseline for comparison.
SBS testing was based on the ASTM (American Society for Testing and Materials) D2344 standard16 for LTF and CCL tests (Figure 3). Six samples of material were used for each test at every sample interval, yielding 180 samples. Seven servohydraulic material testing system instruments (1 MTS 810 and 6 MTS 858 Mini Bionix) were used to test the SBS of each material. For LTF testing, each specimen was loaded in compression from 30 N to complete structural failure at a constant displacement rate of 1.0 mm/min (0.05 in/min). Testing was initiated with 5 preconditioning loading cycles from 30 to 100 N at 1 Hz. The load was then applied continuously until failure occurred; force and displacement data were collected every 0.02 second. This procedure was performed for 6 replicates for each sample interval for each test material.
The calculation for SBS, Fsbs (MPa), for the constant loading rate until structural failure is:
Fsbs = 0.75 × Pm
b × h
where Pm (N) is the maximum applied load observed during the test, b is the measured specimen width (mm), and h is the measured specimen thickness (mm).
CCL testing consisted of each test material axially loaded with 100 to 500 N at a frequency of 1 Hz for 100,000 cycles. The maximum load of 500 N was chosen as a standard based on 80% of the minimum ultimate failure load from previous LTF tests. Displacement and force data were collected every 5 cycles at the maximum compressive load. Degradation of the material was calculated using the difference between the deflection of the initial cycle and the deflection of the final cycle (50th cycle and 100,000th cycle). This procedure was performed for 6 replicates for each sample interval for each test material.
Statistical Analysis
LTF and CCL testing data were analyzed for any differences among the test materials using 1-way analysis of variance with the least significant difference multiple comparisons post hoc test method using SPSS Version 16.0, with P < .05 denoting significance. These analyses were used to determine the statistical relevance of the difference between the SBS (LTF and CCL) of each test material. Means and standard deviations were calculated for all tests.
Results
Radiographic Density Evaluation
Overall, all the tested composite materials were significantly more radiolucent than either SS-316L or Al-7075-T6. Figure 4 shows the 6 different radiographic images obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). SS-316L can be considered radiopaque, and Al-7075-T6 has been used as a relatively radiolucent alternative. Tepex was statistically more radiolucent than the other 2 tested composite materials (Table 1). Even with 2 pieces placed anterior to the subject and 2 placed posterior, the radiodensity compared to the cortical bone was still lower than 1 piece of Al-7075-T6 either anterior or posterior to the subject.
Structural Properties Testing
Moisture Retention. Moisture retention was evaluated by weighing the test materials before and after repeated sterilization. There was no significant difference in moisture retention, as weight differences for all the tested materials were less than 0.5 weight percentage compared to the 0th sterilization cycle (Table 2). Therefore, the results of this study showed that all the tested materials exhibited good moisture/temperature resistance after 400 sterilization cycles.
Load to Failure. In the LTF test, significant differences were detected in SBS between all 5 tested materials (P < .05). Figure 5 shows the comparison of the structural properties in terms of SBS between the 5 tested materials, and Figure 6 shows the failure modes for the tested materials. There was no SBS for SS-316L, as the material did not exhibit complete structural failure even after 400 sterilization cycles; however, SS-316L was observed in inelastic deformation failure (Figure 6D). Al-7075-T6 had much higher SBS compared with the other composite materials, and it also resulted in an inelastic deformation failure mode only after 400 sterilization cycles; otherwise, flexure failure modes were observed. Tepex and CFR-PPS exhibited interlaminar shear failure, and HTN-53 exhibited complete structural failure.
Every composite material tested using the short-beam test for LTF showed a decrease in SBS with increased sterilization cycles (Figure 5). This decrease ranged from 17% to 57% compared with the 0th sterilization cycle. SBS was higher for CFR-PPS than for the other 2 composites. No statistically significant difference was found between CFR-PPS and Tepex except at the 200th sterilization cycle. HTN-53 was brittle at the 0th sterilization cycle but performed more like a ductile material at the 200th cycle. In addition, HTN-53 had the lowest SBS in terms of LTF testing when compared with the other 2 composites.
During the complete structural failure test, the failure modes for Tepex and CFR-PPS were visually identified as interlaminar shear failure (Figures 6A, 6B), whereas HTN-53 visually exhibited pure flexure failure (Figure 6C). As for the metals, SS-316L exhibited plastic deformation, and Al-7075-T6 exhibited flexure failure (Figures 6D, 6E).
Cyclic Compression Loading. Tepex was the only material to pass the 100,000 loading cycle without failure (Table 3). HTN-53 had the poorest performance of all: Its failure rates were 33% (2/6 samples) before sterilization (average cycle, 22,213; range, 21,500-22,925), 83% (5/6 samples) at the 200th sterilization cycle (average cycle, 4,210; range, 0-14,360), and 100% after 400 sterilization cycles (average cycle, 12,725; range, 1,190-21,900). CFR-PPS had no failures before the 400th sterilization cycle, and its failure rate after 400 sterilization cycles (average cycle, 50,735; range, 50,270-51,200) was 33% (2/6 samples).
Discussion
The success of a reusable composite material for use in orthopedic surgery depends not only on radiographic density, fabrication methods, and design but also on the ability to withstand repeated sterilization. Over the past 3 decades, investigators have explored several high-performance polymer matrix composite materials for use in orthopedics, especially in trauma, hip stems, and spinal implants.1,3,4,17-34 According to Evans and Gregson,35 composite materials have been widely promoted as possible orthopedic biomaterials but to date have found few successful commercial applications, because of the many challenging problems encountered in fabrication and testing. One of the most important factors in the mechanical properties of many composite materials is the influence of the cooling and loading rates on fiber-matrix interface adhesion.36-38 Our results tended to agree with the findings of Evans and Gregson,35 as some of these composite materials did not withstand repeated sterilizations well.
Guan and colleagues39 evaluated the influence of sterilization treatment on continuous carbon-fiber–reinforced polyolefin composite. Their 3-point bending test results showed that the levels of maximum load of all the specimens undergoing sterilization by autoclave were lower than those of the control group. For these composites, they concluded that autoclave sterilization and Co-60 gamma ray irradiation sterilization should be avoided and that ethylene oxide is the best method. Our results support their findings with a different set of composites.
Although HTN-53 has shown promise in other orthopedic applications because of its superior moisture and temperature resistance, we found that its performance after repeated sterilization was relatively poor. Tepex showed the greatest potential for durability after repeated sterilization; its mechanical properties were stable after 200 steam sterilization cycles.
Clinical Applications
The composite materials investigated in the present study have potential for use in either instrumentation or long-term implantation applications because of their versatility, mechanical strength, fatigue resistance, and biocompatibility. Akay and Aslan40 stated that carbon-fiber–filled composite implants can be designed with more appropriate modulus, strength, toughness, or stiffness by the arrangement of reinforcing fiber volume and orientation, and can provide better fatigue resistance. A notable advantage of using a composite plate with metal screws is that the potential for corrosion of metallic components is eliminated. Another major advantage of composite medical implants (eg, DiPhos-RM) is radiolucency, which allows direct visualization of osseous callus formation as well as monitoring of fracture healing, thereby improving clinical assessment and accuracy.
Numerous studies have documented the successful clinical performance of composite materials in orthopedic, trauma, and spinal surgery applications.41-45 Bagheri and colleagues41 developed a new carbon fiber–flax–epoxy composite plate and biomechanically compared it with a standard clinical metal plate. Their results confirmed that the carbon fiber–flax–epoxy material represents a potential candidate for bone fracture plate applications, as it can simultaneously provide similar mechanical stiffness and lower stress shielding (higher bone stress) compared with a standard clinical metal bone plate. Tarallo and colleagues45 evaluated the clinical results of 40 cases at 12-month follow-up using a new plate made of carbon-fiber–reinforced polyetheretherketon (DiPhos-RM, Lima Corporate) for the treatment of distal radius fractures. They reported good clinical results for this device at early follow-up, and its use allowed maintenance of reduction in complex AO (Arbeitsgemeinschaft für Osteosynthesefragen) fractures.
The main advantage in using composites for surgical instruments is their radiolucency. These materials do not obscure images or radiographs during fluoroscopic visualization. Surgery often requires fluoroscopic visualization of internal organs or bones, which may require temporary removal of radiopaque devices (eg, retractors, clamps, forceps, hooks, distractors). Aside from being inconvenient, removal and subsequent reinsertion consume valuable time and interfere with the smooth flow of an operation.
The shortcomings of using composite materials for surgical instruments involve detectability and sterilization. A significant issue in surgery is the accidental leaving behind of instruments in patients, which can cause serious problems ranging from organ perforation and blood infection to death. Although instrument counting and other safety protocols can reduce the risk of overlooking an instrument, mistakes are bound to happen. The other shortcoming is the influence of repeated sterilization on the mechanical properties of the composite materials, as sterilization is mandatory for surgical instruments used in the operation room. The structural integrity and overall performance of the polymer composite materials—especially the stability of the interface and the interphase zones—are strongly influenced by repeated sterilization.
On the other hand, composite materials have potential advantages that may support their introduction into long-term medical implant applications, as sterilization commonly is performed only once, during packaging. The effects of sterilization by radiation or steam are much less pronounced on composite implants than on composite surgical instruments. However, composite implants require careful consideration with respect to the bioactivity of wear particles that may be produced from articulation. Further, carbon-fiber–reinforced polymer implants are still substantially more difficult to manufacture and more costly than their metallic counterparts.46
Limitations
This study has some limitations. Most important, studies of this nature do not account for biological factors such as corrosion, biological wear, and the soft-tissue attachment effects on structural properties for potential in vivo use. Another limitation was that the study tested only the mechanical properties in terms of SBS and provided no information about other mechanical properties, such as tensile, compression, and torsion strengths. We think SBS testing adequately evaluates challenging scenarios like thin and narrow instruments/devices that are anticipated in application, and information regarding other modes of failure and mechanical properties (compression, tension, torsion) would be a further area of research. An additional limitation was that our model used a relatively small number of samples. A larger study with more samples and varying layout patterns and layers of the carbon fibers may more clearly demonstrate the effect of steam sterilization on composite materials.
Conclusion
This study provided new information on 3 selected composite materials and their structural properties after repeated steam sterilization. We discovered that these composites were similar in radiographic density and water retention but behaved very differently in terms of mechanical durability after repeated steam sterilization. All selected composites demonstrated deterioration of mechanical properties after repeated steam sterilization. Knowing these results could aid in making decisions about the design and manufacturing of operative instruments and orthopedic biomaterials. Although our preliminary findings are intriguing, further study is warranted to seek specific applications for these composite materials in orthopedic surgery.
1. Ali MS, French TA, Hastings GW, et al. Carbon fibre composite bone plates. Development, evaluation and early clinical experience. J Bone Joint Surg Br. 1990;72(4):586-591.
2. Brooks RA, Jones E, Storer A, Rushton N. Biological evaluation of carbon-fibre–reinforced polybutyleneterephthalate (CFRPBT) employed in a novel acetabular cup. Biomaterials. 2004;25(17):3429-3438.
3. Brown SA, Hastings RS, Mason JJ, Moet A. Characterization of short-fibre reinforced thermoplastics for fracture fixation devices. Biomaterials. 1990;11(8):541-547.
4. Skinner HB. Composite technology for total hip arthroplasty. Clin Orthop Relat Res. 1988;(235):224-236.
5. Field RE, Jones E, Nuijten P, Storer A, Cronin M, Rushton N. Pre-clinical evaluation of the Cambridge acetabular cup. J Mater Sci Mater Med. 2008;19(8):2791-2798.
6. Han N, Ahmed I, Parsons AJ, et al. Influence of screw holes and gamma sterilization on properties of phosphate glass fiber–reinforced composite bone plates. J Biomater Appl. 2013;27(8):990-1002.
7. Losi P, Munaò A, Spiller D, et al. Evaluation of a new composite prosthesis for the repair of abdominal wall defects. J Mater Sci Mater Med. 2007;18(10):1939-1944.
8. Pait TG, Kaufman HH, Voelker JL, McAllister HP, Willison C. Use of a carbon composite radiolucent anterior cervical retractor system. Neurosurgery. 1993;33(5):941-942.
9. Elfar J, Menorca RM, Reed JD, Stanbury S. Composite bone models in orthopaedic surgery research and education. J Am Acad Orthop Surg. 2014;22(2):111-120.
10. Gardner MP, Chong AC, Pollock AG, Wooley PH. Mechanical evaluation of large-size fourth-generation composite femur and tibia models. Ann Biomed Eng. 2010;38(3):613-620.
11. Heiner AD. Structural properties of fourth-generation composite femurs and tibias. J Biomech. 2008;41(15):3282-3284.
12. Dunlap JT, Chong AC, Lucas GL, Cooke FW. Structural properties of a novel design of composite analogue humeri models. Ann Biomed Eng. 2008;36(11):1922-1926.
13. Grover P, Albert C, Wang M, Harris GF. Mechanical characterization of fourth generation composite humerus. Proc Inst Mech Eng H. 2011;225(12):1169-1176.
14. Zheng Q, Morgan RJ. Synergistic thermal-moisture damage mechanisms of epoxies and their carbon fiber composites. J Compos Mater. 1993;27(15):1465-1478.
15. Ray BC. Temperature effect during humid ageing on interfaces of glass and carbon fibers reinforced epoxy composites. J Colloid Interface Sci. 2006;298(1):111-117.
16. Standard test method for short-beam strength of polymer matrix composite materials and their laminates [ASTM specification D2344/D2344M-00]. In: Annual Book of ASTM Standards. Vol 15.03. West Conshohocken, PA: American Society for Testing and Materials; 2006.
17. Bradley JS, Hastings GW, Johnson-Nurse C. Carbon fibre reinforced epoxy as a high strength, low modulus material for internal fixation plates. Biomaterials. 1980;1(1):38-40.
18. McKenna GB, Bradley GW, Dunn HK, Statton WO. Mechanical properties of some fibre reinforced polymer composites after implantation as fracture fixation plates. Biomaterials. 1980;1(4):189-192.
19. Tayton K, Johnson-Nurse C, McKibbin B, Bradley J, Hastings G. The use of semi-rigid carbon-fibre–reinforced plastic plates for fixation of human fractures. Results of preliminary trials. J Bone Joint Surg Br. 1982;64(1):105-111.
20. Tayton K, Bradley J. How stiff should semi-rigid fixation of the human tibia be? A clue to the answer. J Bone Joint Surg Br. 1983;65(3):312-315.
21. Tayton K. Corrosive effect of carbon-fibre reinforced plastic on stainless-steel screws during implantation into man. J Med Eng Technol. 1983;7(1):24-26.
22. Howard CB, Tayton KJ, Gibbs A. The response of human tissues to carbon reinforced epoxy resin. J Bone Joint Surg Br. 1985;67(4):656-658.
23. Skirving AP, Day R, Macdonald W, McLaren R. Carbon fiber reinforced plastic (CFRP) plates versus stainless steel dynamic compression plates in the treatment of fractures of the tibiae in dogs. Clin Orthop Relat Res. 1987;(224):117-124.
24. Prakash R, Marwah S, Goel SC, Tuli SM. Carbon fibre reinforced epoxy implants for bridging large osteoperiosteal gaps. Biomaterials. 1988;9(2):198-202.
25. Pemberton DJ, McKibbin B, Savage R, Tayton K, Stuart D. Carbon-fibre reinforced plates for problem fractures. J Bone Joint Surg Br. 1992;74(1):88-92.
26. Pemberton DJ, Evans PD, Grant A, McKibbin B. Fractures of the distal femur in the elderly treated with a carbon fibre supracondylar plate. Injury. 1994;25(5):317-321.
27. Kelsey DJ, Springer GS, Goodman SB. Composite implant for bone replacement. J Compos Mater. 1997;31(16):1593-1632.
28. Corvelli AA, Biermann PJ, Roberts JC. Design, analysis and fabrication of a composite segmental bone replacement implant. J Adv Mater. 1997;28:2-8.
29. Glassman AH, Crowninshield RD, Schenck R, Herberts P. A low stiffness composite biologically fixed prosthesis. Clin Orthop Relat Res. 2001;(393):128-136.
30. Williams D. New horizons for thermoplastic polymers. Med Device Technol. 2001;12(4):8-9.
31. Al-Shawi AK, Smith SP, Anderson GH. The use of a carbon fiber plate for periprosthetic supracondylar femoral fractures. J Arthroplasty. 2002;17(3):320-324.
32. Baker D, Kadambande SS, Alderman PM. Carbon fibre plates in the treatment of femoral periprosthetic fractures. Injury. 2004;35(6):596-598.
33. Akhavan S, Matthiesen MM, Schulte L, et al. Clinical and histologic results related to a low-modulus composite total hip replacement stem. J Bone Joint Surg Am. 2006;88(6):1308-1314.
34. Toth JM, Wang M, Estes BT, Scifert JL, Seim HB 3rd, Turner AS. Polyetheretherketone as a biomaterial for spinal applications. Biomaterials. 2006;27(3):324-334.
35. Evans SL, Gregson PJ. Composite technology in load-bearing orthopaedic implants. Biomaterials. 1998;19(15):1329-1342.
36. Gao SL, Kim JK. Cooling rate influences in carbon fibre/PEEK composites. Part I. Crystallinity and interface adhesion. Composites Part A. 2000;31(6):517-530.
37. Gao SL, Kim JK. Cooling rate influences in carbon fibre/PEEK composites. Part II. Interlaminar fracture toughness. Composites Part A. 2001;32(6):763-774.
38. Gao SL, Kim JK. Cooling rate influences in carbon fibre/PEEK composites. Part III. Impact damage performance. Composites Part A. 2001;32(6):775-785.
39. Guan SB, Hou CL, Chen AM, Zhang W, Wang JE. Influence of sterilization treatments on continuous carbon-fiber reinforced polyolefin composite. Zhonghua Yi Xue Za Zhi. 2007;87(31):2228-2231.
40. Akay M, Aslan N. An estimation of fatigue life for a carbon fibre/poly ether ether ketone hip joint prosthesis. Proc Inst Mech Eng H. 1995;209(2):93-103.
41. Bagheri ZS, Tavakkoli Awal P, Bougherara H, Aziz MS, Schemitsch EH, Zdero R. Biomechanical analysis of a new carbon fiber/flax/epoxy bone fracture plate shows less stress shielding compared to a standard clinical metal plate. J Biomech Eng. 2014;136(9):091002.
42. Rhee PC, Shin AY. The rate of successful four-corner arthrodesis with a locking, dorsal circular polyether-ether-ketone (PEEK-Optima) plate. J Hand Surg Eur Vol. 2013;38(7):767-773.
43. Nakahara I, Takao M, Bandoh S, Bertollo N, Walsh WR, Sugano N. In vivo implant fixation of carbon fiber–reinforced PEEK hip prostheses in an ovine model. J Orthop Res. 2013;31(3):485-492.
44. Kasliwal MK, O’Toole JE. Clinical experience using polyetheretherketone (PEEK) intervertebral structural cage for anterior cervical corpectomy and fusion. J Clin Neurosci. 2014;21(2):217-220.
45. Tarallo L, Mugnai R, Adani R, Zambianchi F, Catani F. A new volar plate made of carbon-fiber–reinforced polyetheretherketon for distal radius fracture: analysis of 40 cases. J Orthop Traumatol. 2014;15(4):277-283.
46. Cordey J, Perren SM, Steinemann SG. Stress protection due to plates: myth or reality? A parametric analysis made using the composite beam theory. Injury. 2000;31(suppl 3):C1-C13.
1. Ali MS, French TA, Hastings GW, et al. Carbon fibre composite bone plates. Development, evaluation and early clinical experience. J Bone Joint Surg Br. 1990;72(4):586-591.
2. Brooks RA, Jones E, Storer A, Rushton N. Biological evaluation of carbon-fibre–reinforced polybutyleneterephthalate (CFRPBT) employed in a novel acetabular cup. Biomaterials. 2004;25(17):3429-3438.
3. Brown SA, Hastings RS, Mason JJ, Moet A. Characterization of short-fibre reinforced thermoplastics for fracture fixation devices. Biomaterials. 1990;11(8):541-547.
4. Skinner HB. Composite technology for total hip arthroplasty. Clin Orthop Relat Res. 1988;(235):224-236.
5. Field RE, Jones E, Nuijten P, Storer A, Cronin M, Rushton N. Pre-clinical evaluation of the Cambridge acetabular cup. J Mater Sci Mater Med. 2008;19(8):2791-2798.
6. Han N, Ahmed I, Parsons AJ, et al. Influence of screw holes and gamma sterilization on properties of phosphate glass fiber–reinforced composite bone plates. J Biomater Appl. 2013;27(8):990-1002.
7. Losi P, Munaò A, Spiller D, et al. Evaluation of a new composite prosthesis for the repair of abdominal wall defects. J Mater Sci Mater Med. 2007;18(10):1939-1944.
8. Pait TG, Kaufman HH, Voelker JL, McAllister HP, Willison C. Use of a carbon composite radiolucent anterior cervical retractor system. Neurosurgery. 1993;33(5):941-942.
9. Elfar J, Menorca RM, Reed JD, Stanbury S. Composite bone models in orthopaedic surgery research and education. J Am Acad Orthop Surg. 2014;22(2):111-120.
10. Gardner MP, Chong AC, Pollock AG, Wooley PH. Mechanical evaluation of large-size fourth-generation composite femur and tibia models. Ann Biomed Eng. 2010;38(3):613-620.
11. Heiner AD. Structural properties of fourth-generation composite femurs and tibias. J Biomech. 2008;41(15):3282-3284.
12. Dunlap JT, Chong AC, Lucas GL, Cooke FW. Structural properties of a novel design of composite analogue humeri models. Ann Biomed Eng. 2008;36(11):1922-1926.
13. Grover P, Albert C, Wang M, Harris GF. Mechanical characterization of fourth generation composite humerus. Proc Inst Mech Eng H. 2011;225(12):1169-1176.
14. Zheng Q, Morgan RJ. Synergistic thermal-moisture damage mechanisms of epoxies and their carbon fiber composites. J Compos Mater. 1993;27(15):1465-1478.
15. Ray BC. Temperature effect during humid ageing on interfaces of glass and carbon fibers reinforced epoxy composites. J Colloid Interface Sci. 2006;298(1):111-117.
16. Standard test method for short-beam strength of polymer matrix composite materials and their laminates [ASTM specification D2344/D2344M-00]. In: Annual Book of ASTM Standards. Vol 15.03. West Conshohocken, PA: American Society for Testing and Materials; 2006.
17. Bradley JS, Hastings GW, Johnson-Nurse C. Carbon fibre reinforced epoxy as a high strength, low modulus material for internal fixation plates. Biomaterials. 1980;1(1):38-40.
18. McKenna GB, Bradley GW, Dunn HK, Statton WO. Mechanical properties of some fibre reinforced polymer composites after implantation as fracture fixation plates. Biomaterials. 1980;1(4):189-192.
19. Tayton K, Johnson-Nurse C, McKibbin B, Bradley J, Hastings G. The use of semi-rigid carbon-fibre–reinforced plastic plates for fixation of human fractures. Results of preliminary trials. J Bone Joint Surg Br. 1982;64(1):105-111.
20. Tayton K, Bradley J. How stiff should semi-rigid fixation of the human tibia be? A clue to the answer. J Bone Joint Surg Br. 1983;65(3):312-315.
21. Tayton K. Corrosive effect of carbon-fibre reinforced plastic on stainless-steel screws during implantation into man. J Med Eng Technol. 1983;7(1):24-26.
22. Howard CB, Tayton KJ, Gibbs A. The response of human tissues to carbon reinforced epoxy resin. J Bone Joint Surg Br. 1985;67(4):656-658.
23. Skirving AP, Day R, Macdonald W, McLaren R. Carbon fiber reinforced plastic (CFRP) plates versus stainless steel dynamic compression plates in the treatment of fractures of the tibiae in dogs. Clin Orthop Relat Res. 1987;(224):117-124.
24. Prakash R, Marwah S, Goel SC, Tuli SM. Carbon fibre reinforced epoxy implants for bridging large osteoperiosteal gaps. Biomaterials. 1988;9(2):198-202.
25. Pemberton DJ, McKibbin B, Savage R, Tayton K, Stuart D. Carbon-fibre reinforced plates for problem fractures. J Bone Joint Surg Br. 1992;74(1):88-92.
26. Pemberton DJ, Evans PD, Grant A, McKibbin B. Fractures of the distal femur in the elderly treated with a carbon fibre supracondylar plate. Injury. 1994;25(5):317-321.
27. Kelsey DJ, Springer GS, Goodman SB. Composite implant for bone replacement. J Compos Mater. 1997;31(16):1593-1632.
28. Corvelli AA, Biermann PJ, Roberts JC. Design, analysis and fabrication of a composite segmental bone replacement implant. J Adv Mater. 1997;28:2-8.
29. Glassman AH, Crowninshield RD, Schenck R, Herberts P. A low stiffness composite biologically fixed prosthesis. Clin Orthop Relat Res. 2001;(393):128-136.
30. Williams D. New horizons for thermoplastic polymers. Med Device Technol. 2001;12(4):8-9.
31. Al-Shawi AK, Smith SP, Anderson GH. The use of a carbon fiber plate for periprosthetic supracondylar femoral fractures. J Arthroplasty. 2002;17(3):320-324.
32. Baker D, Kadambande SS, Alderman PM. Carbon fibre plates in the treatment of femoral periprosthetic fractures. Injury. 2004;35(6):596-598.
33. Akhavan S, Matthiesen MM, Schulte L, et al. Clinical and histologic results related to a low-modulus composite total hip replacement stem. J Bone Joint Surg Am. 2006;88(6):1308-1314.
34. Toth JM, Wang M, Estes BT, Scifert JL, Seim HB 3rd, Turner AS. Polyetheretherketone as a biomaterial for spinal applications. Biomaterials. 2006;27(3):324-334.
35. Evans SL, Gregson PJ. Composite technology in load-bearing orthopaedic implants. Biomaterials. 1998;19(15):1329-1342.
36. Gao SL, Kim JK. Cooling rate influences in carbon fibre/PEEK composites. Part I. Crystallinity and interface adhesion. Composites Part A. 2000;31(6):517-530.
37. Gao SL, Kim JK. Cooling rate influences in carbon fibre/PEEK composites. Part II. Interlaminar fracture toughness. Composites Part A. 2001;32(6):763-774.
38. Gao SL, Kim JK. Cooling rate influences in carbon fibre/PEEK composites. Part III. Impact damage performance. Composites Part A. 2001;32(6):775-785.
39. Guan SB, Hou CL, Chen AM, Zhang W, Wang JE. Influence of sterilization treatments on continuous carbon-fiber reinforced polyolefin composite. Zhonghua Yi Xue Za Zhi. 2007;87(31):2228-2231.
40. Akay M, Aslan N. An estimation of fatigue life for a carbon fibre/poly ether ether ketone hip joint prosthesis. Proc Inst Mech Eng H. 1995;209(2):93-103.
41. Bagheri ZS, Tavakkoli Awal P, Bougherara H, Aziz MS, Schemitsch EH, Zdero R. Biomechanical analysis of a new carbon fiber/flax/epoxy bone fracture plate shows less stress shielding compared to a standard clinical metal plate. J Biomech Eng. 2014;136(9):091002.
42. Rhee PC, Shin AY. The rate of successful four-corner arthrodesis with a locking, dorsal circular polyether-ether-ketone (PEEK-Optima) plate. J Hand Surg Eur Vol. 2013;38(7):767-773.
43. Nakahara I, Takao M, Bandoh S, Bertollo N, Walsh WR, Sugano N. In vivo implant fixation of carbon fiber–reinforced PEEK hip prostheses in an ovine model. J Orthop Res. 2013;31(3):485-492.
44. Kasliwal MK, O’Toole JE. Clinical experience using polyetheretherketone (PEEK) intervertebral structural cage for anterior cervical corpectomy and fusion. J Clin Neurosci. 2014;21(2):217-220.
45. Tarallo L, Mugnai R, Adani R, Zambianchi F, Catani F. A new volar plate made of carbon-fiber–reinforced polyetheretherketon for distal radius fracture: analysis of 40 cases. J Orthop Traumatol. 2014;15(4):277-283.
46. Cordey J, Perren SM, Steinemann SG. Stress protection due to plates: myth or reality? A parametric analysis made using the composite beam theory. Injury. 2000;31(suppl 3):C1-C13.
Reinforcing a Spica Cast With a Fiberglass Bar
Femur fractures (Orthopaedic Trauma Association classes 31, 32, 33)1 are common childhood injuries, occurring at a rate of 19 per 100,000 children in the United States.2 Peak occurrence is bimodal at ages 2 and 17 years. The most common mechanism of injury in children under 6 years is a fall, and hip spica casting is the preferred treatment modality in this group.3-5
A bar connecting the legs of the spica cast has been shown to facilitate patient transport5 and significantly decrease mechanical failure of the spica cast.6 This bar often consists of a broom handle or pipe that must be cut to size during the case and subsequently incorporated into the cast—tasks that are often inconvenient and time-consuming for on-call or emergency department staff unfamiliar with orthopedic tools.
In this article, we review a spica cast application that incorporates a low-cost, lightweight technique for fabricating a connecting bar from existing fiberglass casting material. The Institutional Review Board at Connecticut Children’s Medical Center approved this work.
Technique of Double-Leg Spica Casting With Fiberglass Bar
A spica casting table (Orthopedic Systems) with a well-padded post is placed on the operating room table and adjusted to the length of the patient from perineum to just below the shoulders. With the patient under general anesthesia, folded towels are used to provide 2 to 4 cm of padding on the anterior torso, atop which a waterproof pantaloon is applied. The patient is transferred to the spica table, and the patient’s arms are gently secured to the casting table with cast padding or tape in an abducted position at the shoulders. A surgeon controls the legs by holding the feet with the long fingers just above the heels, the index fingers on the anterior ankle, and the thumbs on the soles of the feet. Cast padding is wrapped from the nipple line to the supramalleolar region on each leg. The bony prominences of the malleoli, patella, fibular head, femoral condyles, iliac crests, and coccyx are well padded.
Fiberglass is then rolled without compression onto the patient, beginning with the torso and perineal areas. The injured leg is wrapped to its final length above the malleoli while the uninjured leg is kept free. Maintaining the position of the injured leg with simultaneous molding at the fracture site, typically to promote valgus, allows fracture reduction. The fracture position is then checked under image intensification. For femur fractures, hip abduction and flexion are set to 45° and 90°, respectively, while knee flexion is between 50° and 90°. The uninjured leg is then wrapped with fiberglass. Additional strips of fiberglass can be used to reinforce weak junctional regions between the torso and the legs, posteriorly over the “intern’s triangle” and anteriorly along the hip crease.
A connecting fiberglass bar is then created using a fiberglass roll once the cast is hardened. A 2-inch fiberglass roll is wrapped around one leg to secure its position (Figure 1A) and then rolled around the second limb (Figure 1B). Fiberglass is then pulled taut and rolled around the bridge that has been created in order to thicken the bar (Figure 2). The roll is again brought around the closest limb, wrapped back across the bridge to the other limb, and rolled out to its full length. Last, the legs are abducted 1 to 2 cm to tension the bar (Figure 3). Although this does not produce enough movement to cause a crease and a resultant ulcer, careful inspection of common pressure points (eg, popliteal fossa) should be performed after the cast is complete.
The chest towels are removed, and the final cast is inspected clinically and fluoroscopically at the fracture site before extubation. The cast is trimmed as needed to ensure room for perineal care, as well as full ankle flexion and extension without impingement. Cast edges are further petaled with plastic tape (Hy-Tape International) to provide padding and prevent the waterproof lining from tearing.
Postoperative care involves overnight observation and caregiver practice in perineal care. Frequent rotation from supine to prone is encouraged. Nurses confirm car-seat fit before discharge. If needed, radiographs are obtained 7 to 10 days later to help with wedging adjustment. The cast is removed in the clinic when adequate callus is appreciated on subsequent radiographs.
Case Series
Our experience with this technique in 16 unilateral femur fractures has been favorable (Table). Patient age ranged from 5 months to 3 years. Mean pretreatment angulation was 13° varus and 11° procurvatum. The majority of fractures were femoral shaft fractures; 1 was proximal, 2 distal.
All fractures united without cast revision. Mean cast time was 4.5 weeks (range, 16 days–6 weeks). Immediate postoperative alignment was 2.5° varus (range, 11° valgus to 16° varus) and 7° procurvatum (range, 1° recurvatum to 22° procurvatum). Mean shortening was 1.5 cm (range, 0-2.7 cm). Final alignment was 1° valgus (range, 9° valgus to 12° varus) and 5° procurvatum (range, 0° to 22°). Mean follow-up was 8 months. There were no cases of skin maceration or cast failure. No casts precluded use of a spica car-seat. Figure 4 shows a typical case with a midshaft fracture treated with closed reduction and casting for 4 weeks with good remodeling at final follow-up, 19 months after injury.
Discussion
Although single-leg walking spica casts have been shown to safely treat low-energy femur fractures in children 1 to 6 years old,7 length-unstable femur fractures, bilateral femur fractures, and patients with hip dysplasia continue to be managed with a double-leg hip spica construct. Cast integrity remains fundamental to the control of most fractures and prevention of cast-related complications, such as skin maceration and ulceration. Surgeons typically use spica cast reinforcement schemes—such as cast augments of the torso–limb junction, with multiple layers of casting material or incorporation of a connecting bar between the legs, typically constructed by overwrapping a wooden dowel in casting material—to improve the mechanical stability of casts.6 The present technique of creating a connecting bar from fiberglass casting material significantly simplifies the standard wooden dowel approach and provided excellent results in our treatment group in terms of cast integrity and fracture alignment. In addition, at our institution, a roll of fiberglass costs $2.10, whereas a wooden dowel costs $3 to $10 and can be difficult to locate if not frequently used. Other tube-shaped materials, such as the disposable material used to package implants and tubes, carry an even lower cost. However, we have found that a single fiberglass roll is most readily available and easiest to apply.
Although proper spica cast application remains important in managing pediatric trauma, it lacks a good technical description in the literature. In this technical report, we have presented our standard spica cast application method, which minimizes the range of cast complications that have been reported, from minor skin irritation to superior mesenteric artery syndrome. Two salient technical highlights are use of waterproof pantaloon liners and cast petaling, which we have found almost eliminate the morbidity of potential skin complications, reported to occur at a rate of 28%.8 In addition, we forgo applying the cast on the injured leg in segments. Application of a short-leg cast on the injured leg to allow traction on the leg during cast application is of dubious utility and may be potentially harmful, with described complications of peroneal nerve palsy and compartment syndrome.9-11 Further, it is important to use an abdominal spacer (eg, a stack of towels) under the cast padding to create room for abdominal expansion and minimize pressure thought to induce superior mesenteric artery syndrome. Plastic or rubber abdominal spacers have also been described.12,13 Last, leg position is important for reduction and maintenance of the fracture, as well as patient care. Literature advocates minimizing hip abduction to just that needed for perineal care and maximizing hip flexion and knee extension to optimize car-seat fit and safety.14
Conclusion
Construction of a spica cast lower limb connecting bar from readily available fiberglass casting material allows a facile and rapid addition to the mechanical stability of a spica cast in the treatment of pediatric femur fractures. The technique is low-cost and obviates the need for additional extraneous materials.
1. Slongo TF, Audigé L; AO Pediatric Classification Group. Fracture and dislocation classification compendium for children: the AO Pediatric Comprehensive Classification of Long Bone Fractures (PCCF). J Orthop Trauma. 2007;21(10):S135-S160.
2. Hinton RY, Lincoln A, Crockett MM, Sponseller P, Smith G. Fractures of the femoral shaft in children. Incidence, mechanisms, and sociodemographic risk factors. J Bone Joint Surg Am. 1999;81(4):500-509.
3. Campbell WC, Canale ST, Beaty JH, eds. Campbell’s Operative Orthopaedics. 11th ed. Philadelphia, PA: Mosby Elsevier; 2008.
4. Lovell WW, Winter RB, Morrissy RT, Weinstein SL. Lovell and Winter’s Pediatric Orthopaedics. Philadelphia, PA: Lippincott Williams & Wilkins; 2006.
5. Green NE, Swiontkowski MF, eds. Skeletal Trauma in Children. 4th ed. Philadelphia, PA: Elsevier Health Sciences; 2009.
6. Hosalkar HS, Jones S, Chowdhury M, Chatoo M, Hill RA. Connecting bar for hip spica reinforcement: does it help? J Pediatr Orthop B. 2003;12(2):100-102.
7. Flynn JM, Garner MR, Jones KJ, et al. The treatment of low-energy femoral shaft fractures: a prospective study comparing the “walking spica” with the traditional spica cast. J Bone Joint Surg Am. 2011;93(23):2196-2202.
8. DiFazio R, Vessey J, Zurakowski D, Hresko MT, Matheney T. Incidence of skin complications and associated charges in children treated with hip spica casts for femur fractures. J Pediatr Orthop. 2011;31(1):17-22.
9. Weiss AP, Schenck RC Jr, Sponseller PD, Thompson JD. Peroneal nerve palsy after early cast application for femoral fractures in children. J Pediatr Orthop. 1992;12(1):25-28.
10. Mubarak SJ, Frick S, Sink E, Rathjen K, Noonan KJ. Volkmann contracture and compartment syndromes after femur fractures in children treated with 90/90 spica casts. J Pediatr Orthop. 2006;26(5):567-572.
11. Large TM, Frick SL. Compartment syndrome of the leg after treatment of a femoral fracture with an early sitting spica cast. A report of two cases. J Bone Joint Surg Am. 2003;85(11):2207-2210.
12. Sharma S, Azzopardi T. Reduction of abdominal pressure for prophylaxis of the mesenteric artery syndrome (cast syndrome) in a hip spica—a simple technique. Ann R Coll Surg Engl. 2006;88(3):317.
13. Kiter E, Demirkan F, Kiliç BA, Erkula G. A new technique for creating an abdominal window in a hip spica cast. J Orthop Trauma. 2003;17(6):442-443.
14. Zielinski J, Oliver G, Sybesma J, Walter N, Atkinson P. Casting technique and restraint choice influence child safety during transport of body casted children subjected to a simulated frontal MVA. J Trauma. 2009;66(6):1653-1665.
Femur fractures (Orthopaedic Trauma Association classes 31, 32, 33)1 are common childhood injuries, occurring at a rate of 19 per 100,000 children in the United States.2 Peak occurrence is bimodal at ages 2 and 17 years. The most common mechanism of injury in children under 6 years is a fall, and hip spica casting is the preferred treatment modality in this group.3-5
A bar connecting the legs of the spica cast has been shown to facilitate patient transport5 and significantly decrease mechanical failure of the spica cast.6 This bar often consists of a broom handle or pipe that must be cut to size during the case and subsequently incorporated into the cast—tasks that are often inconvenient and time-consuming for on-call or emergency department staff unfamiliar with orthopedic tools.
In this article, we review a spica cast application that incorporates a low-cost, lightweight technique for fabricating a connecting bar from existing fiberglass casting material. The Institutional Review Board at Connecticut Children’s Medical Center approved this work.
Technique of Double-Leg Spica Casting With Fiberglass Bar
A spica casting table (Orthopedic Systems) with a well-padded post is placed on the operating room table and adjusted to the length of the patient from perineum to just below the shoulders. With the patient under general anesthesia, folded towels are used to provide 2 to 4 cm of padding on the anterior torso, atop which a waterproof pantaloon is applied. The patient is transferred to the spica table, and the patient’s arms are gently secured to the casting table with cast padding or tape in an abducted position at the shoulders. A surgeon controls the legs by holding the feet with the long fingers just above the heels, the index fingers on the anterior ankle, and the thumbs on the soles of the feet. Cast padding is wrapped from the nipple line to the supramalleolar region on each leg. The bony prominences of the malleoli, patella, fibular head, femoral condyles, iliac crests, and coccyx are well padded.
Fiberglass is then rolled without compression onto the patient, beginning with the torso and perineal areas. The injured leg is wrapped to its final length above the malleoli while the uninjured leg is kept free. Maintaining the position of the injured leg with simultaneous molding at the fracture site, typically to promote valgus, allows fracture reduction. The fracture position is then checked under image intensification. For femur fractures, hip abduction and flexion are set to 45° and 90°, respectively, while knee flexion is between 50° and 90°. The uninjured leg is then wrapped with fiberglass. Additional strips of fiberglass can be used to reinforce weak junctional regions between the torso and the legs, posteriorly over the “intern’s triangle” and anteriorly along the hip crease.
A connecting fiberglass bar is then created using a fiberglass roll once the cast is hardened. A 2-inch fiberglass roll is wrapped around one leg to secure its position (Figure 1A) and then rolled around the second limb (Figure 1B). Fiberglass is then pulled taut and rolled around the bridge that has been created in order to thicken the bar (Figure 2). The roll is again brought around the closest limb, wrapped back across the bridge to the other limb, and rolled out to its full length. Last, the legs are abducted 1 to 2 cm to tension the bar (Figure 3). Although this does not produce enough movement to cause a crease and a resultant ulcer, careful inspection of common pressure points (eg, popliteal fossa) should be performed after the cast is complete.
The chest towels are removed, and the final cast is inspected clinically and fluoroscopically at the fracture site before extubation. The cast is trimmed as needed to ensure room for perineal care, as well as full ankle flexion and extension without impingement. Cast edges are further petaled with plastic tape (Hy-Tape International) to provide padding and prevent the waterproof lining from tearing.
Postoperative care involves overnight observation and caregiver practice in perineal care. Frequent rotation from supine to prone is encouraged. Nurses confirm car-seat fit before discharge. If needed, radiographs are obtained 7 to 10 days later to help with wedging adjustment. The cast is removed in the clinic when adequate callus is appreciated on subsequent radiographs.
Case Series
Our experience with this technique in 16 unilateral femur fractures has been favorable (Table). Patient age ranged from 5 months to 3 years. Mean pretreatment angulation was 13° varus and 11° procurvatum. The majority of fractures were femoral shaft fractures; 1 was proximal, 2 distal.
All fractures united without cast revision. Mean cast time was 4.5 weeks (range, 16 days–6 weeks). Immediate postoperative alignment was 2.5° varus (range, 11° valgus to 16° varus) and 7° procurvatum (range, 1° recurvatum to 22° procurvatum). Mean shortening was 1.5 cm (range, 0-2.7 cm). Final alignment was 1° valgus (range, 9° valgus to 12° varus) and 5° procurvatum (range, 0° to 22°). Mean follow-up was 8 months. There were no cases of skin maceration or cast failure. No casts precluded use of a spica car-seat. Figure 4 shows a typical case with a midshaft fracture treated with closed reduction and casting for 4 weeks with good remodeling at final follow-up, 19 months after injury.
Discussion
Although single-leg walking spica casts have been shown to safely treat low-energy femur fractures in children 1 to 6 years old,7 length-unstable femur fractures, bilateral femur fractures, and patients with hip dysplasia continue to be managed with a double-leg hip spica construct. Cast integrity remains fundamental to the control of most fractures and prevention of cast-related complications, such as skin maceration and ulceration. Surgeons typically use spica cast reinforcement schemes—such as cast augments of the torso–limb junction, with multiple layers of casting material or incorporation of a connecting bar between the legs, typically constructed by overwrapping a wooden dowel in casting material—to improve the mechanical stability of casts.6 The present technique of creating a connecting bar from fiberglass casting material significantly simplifies the standard wooden dowel approach and provided excellent results in our treatment group in terms of cast integrity and fracture alignment. In addition, at our institution, a roll of fiberglass costs $2.10, whereas a wooden dowel costs $3 to $10 and can be difficult to locate if not frequently used. Other tube-shaped materials, such as the disposable material used to package implants and tubes, carry an even lower cost. However, we have found that a single fiberglass roll is most readily available and easiest to apply.
Although proper spica cast application remains important in managing pediatric trauma, it lacks a good technical description in the literature. In this technical report, we have presented our standard spica cast application method, which minimizes the range of cast complications that have been reported, from minor skin irritation to superior mesenteric artery syndrome. Two salient technical highlights are use of waterproof pantaloon liners and cast petaling, which we have found almost eliminate the morbidity of potential skin complications, reported to occur at a rate of 28%.8 In addition, we forgo applying the cast on the injured leg in segments. Application of a short-leg cast on the injured leg to allow traction on the leg during cast application is of dubious utility and may be potentially harmful, with described complications of peroneal nerve palsy and compartment syndrome.9-11 Further, it is important to use an abdominal spacer (eg, a stack of towels) under the cast padding to create room for abdominal expansion and minimize pressure thought to induce superior mesenteric artery syndrome. Plastic or rubber abdominal spacers have also been described.12,13 Last, leg position is important for reduction and maintenance of the fracture, as well as patient care. Literature advocates minimizing hip abduction to just that needed for perineal care and maximizing hip flexion and knee extension to optimize car-seat fit and safety.14
Conclusion
Construction of a spica cast lower limb connecting bar from readily available fiberglass casting material allows a facile and rapid addition to the mechanical stability of a spica cast in the treatment of pediatric femur fractures. The technique is low-cost and obviates the need for additional extraneous materials.
Femur fractures (Orthopaedic Trauma Association classes 31, 32, 33)1 are common childhood injuries, occurring at a rate of 19 per 100,000 children in the United States.2 Peak occurrence is bimodal at ages 2 and 17 years. The most common mechanism of injury in children under 6 years is a fall, and hip spica casting is the preferred treatment modality in this group.3-5
A bar connecting the legs of the spica cast has been shown to facilitate patient transport5 and significantly decrease mechanical failure of the spica cast.6 This bar often consists of a broom handle or pipe that must be cut to size during the case and subsequently incorporated into the cast—tasks that are often inconvenient and time-consuming for on-call or emergency department staff unfamiliar with orthopedic tools.
In this article, we review a spica cast application that incorporates a low-cost, lightweight technique for fabricating a connecting bar from existing fiberglass casting material. The Institutional Review Board at Connecticut Children’s Medical Center approved this work.
Technique of Double-Leg Spica Casting With Fiberglass Bar
A spica casting table (Orthopedic Systems) with a well-padded post is placed on the operating room table and adjusted to the length of the patient from perineum to just below the shoulders. With the patient under general anesthesia, folded towels are used to provide 2 to 4 cm of padding on the anterior torso, atop which a waterproof pantaloon is applied. The patient is transferred to the spica table, and the patient’s arms are gently secured to the casting table with cast padding or tape in an abducted position at the shoulders. A surgeon controls the legs by holding the feet with the long fingers just above the heels, the index fingers on the anterior ankle, and the thumbs on the soles of the feet. Cast padding is wrapped from the nipple line to the supramalleolar region on each leg. The bony prominences of the malleoli, patella, fibular head, femoral condyles, iliac crests, and coccyx are well padded.
Fiberglass is then rolled without compression onto the patient, beginning with the torso and perineal areas. The injured leg is wrapped to its final length above the malleoli while the uninjured leg is kept free. Maintaining the position of the injured leg with simultaneous molding at the fracture site, typically to promote valgus, allows fracture reduction. The fracture position is then checked under image intensification. For femur fractures, hip abduction and flexion are set to 45° and 90°, respectively, while knee flexion is between 50° and 90°. The uninjured leg is then wrapped with fiberglass. Additional strips of fiberglass can be used to reinforce weak junctional regions between the torso and the legs, posteriorly over the “intern’s triangle” and anteriorly along the hip crease.
A connecting fiberglass bar is then created using a fiberglass roll once the cast is hardened. A 2-inch fiberglass roll is wrapped around one leg to secure its position (Figure 1A) and then rolled around the second limb (Figure 1B). Fiberglass is then pulled taut and rolled around the bridge that has been created in order to thicken the bar (Figure 2). The roll is again brought around the closest limb, wrapped back across the bridge to the other limb, and rolled out to its full length. Last, the legs are abducted 1 to 2 cm to tension the bar (Figure 3). Although this does not produce enough movement to cause a crease and a resultant ulcer, careful inspection of common pressure points (eg, popliteal fossa) should be performed after the cast is complete.
The chest towels are removed, and the final cast is inspected clinically and fluoroscopically at the fracture site before extubation. The cast is trimmed as needed to ensure room for perineal care, as well as full ankle flexion and extension without impingement. Cast edges are further petaled with plastic tape (Hy-Tape International) to provide padding and prevent the waterproof lining from tearing.
Postoperative care involves overnight observation and caregiver practice in perineal care. Frequent rotation from supine to prone is encouraged. Nurses confirm car-seat fit before discharge. If needed, radiographs are obtained 7 to 10 days later to help with wedging adjustment. The cast is removed in the clinic when adequate callus is appreciated on subsequent radiographs.
Case Series
Our experience with this technique in 16 unilateral femur fractures has been favorable (Table). Patient age ranged from 5 months to 3 years. Mean pretreatment angulation was 13° varus and 11° procurvatum. The majority of fractures were femoral shaft fractures; 1 was proximal, 2 distal.
All fractures united without cast revision. Mean cast time was 4.5 weeks (range, 16 days–6 weeks). Immediate postoperative alignment was 2.5° varus (range, 11° valgus to 16° varus) and 7° procurvatum (range, 1° recurvatum to 22° procurvatum). Mean shortening was 1.5 cm (range, 0-2.7 cm). Final alignment was 1° valgus (range, 9° valgus to 12° varus) and 5° procurvatum (range, 0° to 22°). Mean follow-up was 8 months. There were no cases of skin maceration or cast failure. No casts precluded use of a spica car-seat. Figure 4 shows a typical case with a midshaft fracture treated with closed reduction and casting for 4 weeks with good remodeling at final follow-up, 19 months after injury.
Discussion
Although single-leg walking spica casts have been shown to safely treat low-energy femur fractures in children 1 to 6 years old,7 length-unstable femur fractures, bilateral femur fractures, and patients with hip dysplasia continue to be managed with a double-leg hip spica construct. Cast integrity remains fundamental to the control of most fractures and prevention of cast-related complications, such as skin maceration and ulceration. Surgeons typically use spica cast reinforcement schemes—such as cast augments of the torso–limb junction, with multiple layers of casting material or incorporation of a connecting bar between the legs, typically constructed by overwrapping a wooden dowel in casting material—to improve the mechanical stability of casts.6 The present technique of creating a connecting bar from fiberglass casting material significantly simplifies the standard wooden dowel approach and provided excellent results in our treatment group in terms of cast integrity and fracture alignment. In addition, at our institution, a roll of fiberglass costs $2.10, whereas a wooden dowel costs $3 to $10 and can be difficult to locate if not frequently used. Other tube-shaped materials, such as the disposable material used to package implants and tubes, carry an even lower cost. However, we have found that a single fiberglass roll is most readily available and easiest to apply.
Although proper spica cast application remains important in managing pediatric trauma, it lacks a good technical description in the literature. In this technical report, we have presented our standard spica cast application method, which minimizes the range of cast complications that have been reported, from minor skin irritation to superior mesenteric artery syndrome. Two salient technical highlights are use of waterproof pantaloon liners and cast petaling, which we have found almost eliminate the morbidity of potential skin complications, reported to occur at a rate of 28%.8 In addition, we forgo applying the cast on the injured leg in segments. Application of a short-leg cast on the injured leg to allow traction on the leg during cast application is of dubious utility and may be potentially harmful, with described complications of peroneal nerve palsy and compartment syndrome.9-11 Further, it is important to use an abdominal spacer (eg, a stack of towels) under the cast padding to create room for abdominal expansion and minimize pressure thought to induce superior mesenteric artery syndrome. Plastic or rubber abdominal spacers have also been described.12,13 Last, leg position is important for reduction and maintenance of the fracture, as well as patient care. Literature advocates minimizing hip abduction to just that needed for perineal care and maximizing hip flexion and knee extension to optimize car-seat fit and safety.14
Conclusion
Construction of a spica cast lower limb connecting bar from readily available fiberglass casting material allows a facile and rapid addition to the mechanical stability of a spica cast in the treatment of pediatric femur fractures. The technique is low-cost and obviates the need for additional extraneous materials.
1. Slongo TF, Audigé L; AO Pediatric Classification Group. Fracture and dislocation classification compendium for children: the AO Pediatric Comprehensive Classification of Long Bone Fractures (PCCF). J Orthop Trauma. 2007;21(10):S135-S160.
2. Hinton RY, Lincoln A, Crockett MM, Sponseller P, Smith G. Fractures of the femoral shaft in children. Incidence, mechanisms, and sociodemographic risk factors. J Bone Joint Surg Am. 1999;81(4):500-509.
3. Campbell WC, Canale ST, Beaty JH, eds. Campbell’s Operative Orthopaedics. 11th ed. Philadelphia, PA: Mosby Elsevier; 2008.
4. Lovell WW, Winter RB, Morrissy RT, Weinstein SL. Lovell and Winter’s Pediatric Orthopaedics. Philadelphia, PA: Lippincott Williams & Wilkins; 2006.
5. Green NE, Swiontkowski MF, eds. Skeletal Trauma in Children. 4th ed. Philadelphia, PA: Elsevier Health Sciences; 2009.
6. Hosalkar HS, Jones S, Chowdhury M, Chatoo M, Hill RA. Connecting bar for hip spica reinforcement: does it help? J Pediatr Orthop B. 2003;12(2):100-102.
7. Flynn JM, Garner MR, Jones KJ, et al. The treatment of low-energy femoral shaft fractures: a prospective study comparing the “walking spica” with the traditional spica cast. J Bone Joint Surg Am. 2011;93(23):2196-2202.
8. DiFazio R, Vessey J, Zurakowski D, Hresko MT, Matheney T. Incidence of skin complications and associated charges in children treated with hip spica casts for femur fractures. J Pediatr Orthop. 2011;31(1):17-22.
9. Weiss AP, Schenck RC Jr, Sponseller PD, Thompson JD. Peroneal nerve palsy after early cast application for femoral fractures in children. J Pediatr Orthop. 1992;12(1):25-28.
10. Mubarak SJ, Frick S, Sink E, Rathjen K, Noonan KJ. Volkmann contracture and compartment syndromes after femur fractures in children treated with 90/90 spica casts. J Pediatr Orthop. 2006;26(5):567-572.
11. Large TM, Frick SL. Compartment syndrome of the leg after treatment of a femoral fracture with an early sitting spica cast. A report of two cases. J Bone Joint Surg Am. 2003;85(11):2207-2210.
12. Sharma S, Azzopardi T. Reduction of abdominal pressure for prophylaxis of the mesenteric artery syndrome (cast syndrome) in a hip spica—a simple technique. Ann R Coll Surg Engl. 2006;88(3):317.
13. Kiter E, Demirkan F, Kiliç BA, Erkula G. A new technique for creating an abdominal window in a hip spica cast. J Orthop Trauma. 2003;17(6):442-443.
14. Zielinski J, Oliver G, Sybesma J, Walter N, Atkinson P. Casting technique and restraint choice influence child safety during transport of body casted children subjected to a simulated frontal MVA. J Trauma. 2009;66(6):1653-1665.
1. Slongo TF, Audigé L; AO Pediatric Classification Group. Fracture and dislocation classification compendium for children: the AO Pediatric Comprehensive Classification of Long Bone Fractures (PCCF). J Orthop Trauma. 2007;21(10):S135-S160.
2. Hinton RY, Lincoln A, Crockett MM, Sponseller P, Smith G. Fractures of the femoral shaft in children. Incidence, mechanisms, and sociodemographic risk factors. J Bone Joint Surg Am. 1999;81(4):500-509.
3. Campbell WC, Canale ST, Beaty JH, eds. Campbell’s Operative Orthopaedics. 11th ed. Philadelphia, PA: Mosby Elsevier; 2008.
4. Lovell WW, Winter RB, Morrissy RT, Weinstein SL. Lovell and Winter’s Pediatric Orthopaedics. Philadelphia, PA: Lippincott Williams & Wilkins; 2006.
5. Green NE, Swiontkowski MF, eds. Skeletal Trauma in Children. 4th ed. Philadelphia, PA: Elsevier Health Sciences; 2009.
6. Hosalkar HS, Jones S, Chowdhury M, Chatoo M, Hill RA. Connecting bar for hip spica reinforcement: does it help? J Pediatr Orthop B. 2003;12(2):100-102.
7. Flynn JM, Garner MR, Jones KJ, et al. The treatment of low-energy femoral shaft fractures: a prospective study comparing the “walking spica” with the traditional spica cast. J Bone Joint Surg Am. 2011;93(23):2196-2202.
8. DiFazio R, Vessey J, Zurakowski D, Hresko MT, Matheney T. Incidence of skin complications and associated charges in children treated with hip spica casts for femur fractures. J Pediatr Orthop. 2011;31(1):17-22.
9. Weiss AP, Schenck RC Jr, Sponseller PD, Thompson JD. Peroneal nerve palsy after early cast application for femoral fractures in children. J Pediatr Orthop. 1992;12(1):25-28.
10. Mubarak SJ, Frick S, Sink E, Rathjen K, Noonan KJ. Volkmann contracture and compartment syndromes after femur fractures in children treated with 90/90 spica casts. J Pediatr Orthop. 2006;26(5):567-572.
11. Large TM, Frick SL. Compartment syndrome of the leg after treatment of a femoral fracture with an early sitting spica cast. A report of two cases. J Bone Joint Surg Am. 2003;85(11):2207-2210.
12. Sharma S, Azzopardi T. Reduction of abdominal pressure for prophylaxis of the mesenteric artery syndrome (cast syndrome) in a hip spica—a simple technique. Ann R Coll Surg Engl. 2006;88(3):317.
13. Kiter E, Demirkan F, Kiliç BA, Erkula G. A new technique for creating an abdominal window in a hip spica cast. J Orthop Trauma. 2003;17(6):442-443.
14. Zielinski J, Oliver G, Sybesma J, Walter N, Atkinson P. Casting technique and restraint choice influence child safety during transport of body casted children subjected to a simulated frontal MVA. J Trauma. 2009;66(6):1653-1665.
Total Shoulder Arthroplasty Outcome for Treatment of Osteoarthritis: A Multicenter Study Using a Contemporary Implant
Anatomical total shoulder arthroplasty (TSA) is an effective treatment for advanced osteoarthritis (OA) of the glenohumeral joint.1-4 Over the past 40 years, since the early reports appeared, the implants have evolved from the early monoblock humeral component to modular components, variable neck angled components with eccentric heads, and components that can provide variable neck angles, version angles, and dual eccentricity to match the anatomy of the proximal humerus. The goal of the new implants is to replicate the individual patient’s native anatomy using a combination of modularity, multiple neck and version angles, and dual eccentricity of the neck and head. The flexibility of the implant system is made possible by a replicator plate. There are few reports on outcomes of using these new implants for OA.
In this article, we report outcomes of using a dual eccentric, variable neck angle, variable version angle implant with a replicator plate for the treatment of OA of the shoulder at 4 centers.
Materials and Methods
The Western Institutional Review Board approved this study, and consent was prospectively obtained and retrospectively reviewed.
The data banks of a 4-center consortium were queried. Only primary TSA patients treated for OA with a fourth-generation Exactech Equinoxe implant (Exactech, Inc.) were included. For the center to be included, it had to have an 80% patient follow-up rate at a minimum of 2 years. Four centers qualified for inclusion: University of Florida, Medical College of Georgia, New York University, and Bordeaux-Merignac Clinic. Data were obtained on surgeries sequentially performed between August 1, 2006, and December 31, 2010. All data were obtained prospectively using a common data collection format.
The Equinoxe anatomical TSA allows for independent adaptation of neck angle and humeral version and provides 2 variable offset times (1 on replicator plate, 1 on humeral head) for matching the native anatomy in more than 99% of cases5 (Figure). The replicator plate is eccentric and can be angled 7.5° in any direction and rotated 360° to provide humeral head coverage. Once its optimal position is obtained, the plate is permanently fixed to the humeral stem using a breakaway screw. Some contemporary implants have similar features.
There were 218 primary shoulder arthroplasties performed on 201 patients (98 male, 103 female). Mean age at time of surgery was 67 years (range, 31-87 years), and mean follow-up was 36 months (range, 24-72 months). The collective follow-up rate at the 3-year mean follow-up and 2-year minimal follow-up was 81%. Eleven shoulders had a cemented stem, and 207 had an uncemented stem. Forty-eight shoulders used the 1.5-mm replicator plate, and 170 used the 4.5-mm offset replicator plate. The patients in this study were typically not very healthy: mean American Society of Anesthesiologists (ASA) score was 2.57 (range, 1-3).
Five outcome scores were calculated from the prospectively obtained data: Constant normalized, Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test (SST), UCLA Shoulder Rating Scale (UCLA), and American Shoulder and Elbow Surgeons Shoulder Assessment (ASES). Before initiating data collection, we developed the Metric Form6 so we could calculate multiple scores while asking the minimal possible number of questions. This could be done for all 5 outcome scores, as their questions have significant overlap.
Objective outcomes included active external rotation, active scaption, active abduction, and active internal rotation. Complications, including revisions, were noted and analyzed. We focus on functional outcomes and do not present radiographic outcomes.
Results
A 2-tailed unpaired t test was used to compare preoperative values with final outcome values (P < .05). Four objective outcomes were significantly improved over preoperative levels: active external rotation (preoperative, 15°; postoperative, 42°), active scaption (pre, 92°; post, 137°), active abduction (pre, 80°; post, 121°), and active internal rotation (pre, S3; post, L2). The functional outcome scores that were significantly (P < .05) improved at final follow-up were Constant normalized (pre, 39; post, 79), SPADI (pre, 86; post, 20), SST (pre, 3.3; post, 10), UCLA (pre, 13; post, 31), and ASES (pre, 33; post, 85).
The outcome improvements at latest follow-up were active external rotation (+28), active scaption (+45), active abduction (+42), active internal rotation (+6 anatomical segments), Constant normalized (+40), SPADI (–66), SST (+6.7), UCLA (+18), and ASES (+52).
There were 32 complications in 25 shoulders. There were no bilateral complications. Seven shoulders had multiple complications, of which many were not independent events. For example, rotator cuff deficiency was associated with instability, and infection was associated with glenoid loosening. One patient had 2 procedures, the first an arthroscopic release and the second a revision shoulder arthroplasty for glenoid loosening. The most common postoperative complication was rotator cuff failure (RCF) or suspected RCF (13 shoulders, including 8 treated with revision arthroplasty). RCF occurred most commonly at the rotator cuff interval, followed by the subscapularis and the supraspinatus. RCF location was based on computed tomography scan or intraoperative observation. The few subscapularis failures occurred with both subscapularis tendon repair and osteotomy. The high RCF rate may derive from scrutinizing postoperative radiographs and was not necessarily confirmed with repeat surgery. We think this represents a more realistic estimate of true postoperative rotator cuff dysfunction, rather than including only reoperated cases. The second most common complication was infection (6 shoulders, 1 with a superficial suture abscess and 5 with deep infections). Other complications were instability (4, with 2 caused by rotator cuff insufficiency), glenoid loosening (4, with 2 caused by infection), stiffness (3), nerve issue (1), and hematoma evacuation (1).
In 21 shoulders, these complications were treated with revision shoulder arthroplasty (16 shoulders), arthroscopic capsular release (3), evacuation of postoperative hematoma (1), and débridement of suture abscess (1). The 16 revision shoulder arthroplasties performed were conversion to reverse shoulder arthroplasty (11 shoulders) and placement of an antibiotic spacer for infection (5). The stem was left in place for all revisions, excluding those for infection. This is a significant advantage of the modular platform stem. Details of the complications and treatments are listed in the Table. There was no difference in health status between patients with a complication (ASA, 2.57) and those without one (ASA, 2.56).
Discussion
The implant described in this article consists of a metaphyseal press-fit stem, a replicator plate, multiple eccentric humeral heads, and a glenoid of multiple sizes with 2 radii of curvatures used to match the patient’s native anatomy and still maintain the appropriate radius of curvature mismatch between the humeral head and the glenoid. Between the eccentricity in the replicator plate and the eccentricity in the humeral head, almost any humeral head cut can be covered, more than 99% of the time.1 However, it remains to be seen if a versatile implant that comes close to matching the patient’s native anatomy will make a difference clinically.
The objective and functional outcomes in this study compare well with those of other, large TSA studies using older prostheses.1-4 There are few reports on contemporary implants with sufficient follow-up numbers for the single diagnosis of OA. Norris and Iannotti2 reported on a multicenter study of 176 patients with a Depuy Global TSA. The design of their study comes closest to that of our clinical outcome study. Nineteen surgeons were involved in their study. The follow-up rate is not clear. Their outcomes (with ours in parentheses for comparison) were active external rotation of 45° (42°), active elevation of 138° (137°), ASES of 84 (85), and SST of 9.2 (10). Norris and Iannotti2 noted an overall complication rate of 13% (12% in our series). Their most common postoperative complications were RCF and glenoid loosening; ours were RCF and infection. Another multicenter study with short-term results using a contemporary prosthesis included 268 shoulders followed for a minimum of 12 months.1 At final follow-up, Constant score was 97, active elevation was 145°, and the complication rate was 8.6%. Godenèche and colleagues1 also noted a glenoid lucent-line rate of 58% and reported that rotator cuff pathology adversely affected outcome.
Although the overall clinical outcome results are encouraging and the complication rate is in the reported range, we believe that a focus on the major complication categories may have a significant positive impact on our patients. The present article places significant importance on reporting complications prospectively, which is more accurate than retrospective reporting. The rates of both RCF and infection, the most common complications in our study, need to be decreased. Aldinger and colleagues7 reported a 12% complication rate in 485 primary shoulder arthroplasties—a rate identical to ours here. In their study, nerve injuries and humeral fractures were both more common than rotator cuff tears. We think that rotator cuff deficiency after TSA is underreported because it is often based on revision surgery alone. It is also interesting that the majority of the cuff deficiencies were through the upper subscapularis rotator interval and were not a complete failure of the subscapularis repair. Not all these patients will undergo revision surgery. In the future, the RCF rate may drop with the increasingly common use of reverse shoulder arthroplasty for substandard rotator cuffs.
Use of this contemporary variable neck angle, variable version angle, dual eccentric shoulder arthroplasty with a replicator plate provides satisfying short-term clinical outcomes. Patients with less than optimal health (mean ASA, 2.57) seem to tolerate the procedure well. Continued focus on RCF and infection will have the greatest impact on the overall complication rate.
1. Godenèche A, Boileau P, Favard L, et al. Prosthetic replacement in the treatment of osteoarthritis of the shoulder: early results of 268 cases. J Shoulder Elbow Surg. 2002;11(1):11-18.
2. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.
3. Razmjou H, Holtby R, Christakis M, Axelrod T, Richards R. Impact of prosthetic design on clinical and radiologic outcomes of total shoulder arthroplasty: a prospective study. J Shoulder Elbow Surg. 2013;22(2):206-214.
4. Walch G, Young AA, Melis B, Gazielly D, Loew M, Boileau P. Results of a convex-back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow-up greater than 5 years. J Shoulder Elbow Surg. 2011;20(3):385-394.
5. Irlenbusch U, Rott O, Gebhardt K, Werner A. Reconstruction of the rotational centre of the humeral head with double eccentric adaptable shoulder prosthesis [abstract]. In: Proceedings of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT); May 29-June 1, 2008; Nice, France.
6. Flurin PH, Roche CP, Wright TW, Zuckerman J, Johnson D, Christensen M. A correlation of five commonly used clinical metrics to measure outcomes in shoulder arthroplasty. In: Transactions of the 58th Annual Meeting of the Orthopaedic Research Society (ORS); February 4-7, 2012; San Francisco, CA.
7. Aldinger PR, Raiss P, Rickert M, Loew M. Complications in shoulder arthroplasty: an analysis of 485 cases. Int Orthop. 2010;34(4):517-524.
Anatomical total shoulder arthroplasty (TSA) is an effective treatment for advanced osteoarthritis (OA) of the glenohumeral joint.1-4 Over the past 40 years, since the early reports appeared, the implants have evolved from the early monoblock humeral component to modular components, variable neck angled components with eccentric heads, and components that can provide variable neck angles, version angles, and dual eccentricity to match the anatomy of the proximal humerus. The goal of the new implants is to replicate the individual patient’s native anatomy using a combination of modularity, multiple neck and version angles, and dual eccentricity of the neck and head. The flexibility of the implant system is made possible by a replicator plate. There are few reports on outcomes of using these new implants for OA.
In this article, we report outcomes of using a dual eccentric, variable neck angle, variable version angle implant with a replicator plate for the treatment of OA of the shoulder at 4 centers.
Materials and Methods
The Western Institutional Review Board approved this study, and consent was prospectively obtained and retrospectively reviewed.
The data banks of a 4-center consortium were queried. Only primary TSA patients treated for OA with a fourth-generation Exactech Equinoxe implant (Exactech, Inc.) were included. For the center to be included, it had to have an 80% patient follow-up rate at a minimum of 2 years. Four centers qualified for inclusion: University of Florida, Medical College of Georgia, New York University, and Bordeaux-Merignac Clinic. Data were obtained on surgeries sequentially performed between August 1, 2006, and December 31, 2010. All data were obtained prospectively using a common data collection format.
The Equinoxe anatomical TSA allows for independent adaptation of neck angle and humeral version and provides 2 variable offset times (1 on replicator plate, 1 on humeral head) for matching the native anatomy in more than 99% of cases5 (Figure). The replicator plate is eccentric and can be angled 7.5° in any direction and rotated 360° to provide humeral head coverage. Once its optimal position is obtained, the plate is permanently fixed to the humeral stem using a breakaway screw. Some contemporary implants have similar features.
There were 218 primary shoulder arthroplasties performed on 201 patients (98 male, 103 female). Mean age at time of surgery was 67 years (range, 31-87 years), and mean follow-up was 36 months (range, 24-72 months). The collective follow-up rate at the 3-year mean follow-up and 2-year minimal follow-up was 81%. Eleven shoulders had a cemented stem, and 207 had an uncemented stem. Forty-eight shoulders used the 1.5-mm replicator plate, and 170 used the 4.5-mm offset replicator plate. The patients in this study were typically not very healthy: mean American Society of Anesthesiologists (ASA) score was 2.57 (range, 1-3).
Five outcome scores were calculated from the prospectively obtained data: Constant normalized, Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test (SST), UCLA Shoulder Rating Scale (UCLA), and American Shoulder and Elbow Surgeons Shoulder Assessment (ASES). Before initiating data collection, we developed the Metric Form6 so we could calculate multiple scores while asking the minimal possible number of questions. This could be done for all 5 outcome scores, as their questions have significant overlap.
Objective outcomes included active external rotation, active scaption, active abduction, and active internal rotation. Complications, including revisions, were noted and analyzed. We focus on functional outcomes and do not present radiographic outcomes.
Results
A 2-tailed unpaired t test was used to compare preoperative values with final outcome values (P < .05). Four objective outcomes were significantly improved over preoperative levels: active external rotation (preoperative, 15°; postoperative, 42°), active scaption (pre, 92°; post, 137°), active abduction (pre, 80°; post, 121°), and active internal rotation (pre, S3; post, L2). The functional outcome scores that were significantly (P < .05) improved at final follow-up were Constant normalized (pre, 39; post, 79), SPADI (pre, 86; post, 20), SST (pre, 3.3; post, 10), UCLA (pre, 13; post, 31), and ASES (pre, 33; post, 85).
The outcome improvements at latest follow-up were active external rotation (+28), active scaption (+45), active abduction (+42), active internal rotation (+6 anatomical segments), Constant normalized (+40), SPADI (–66), SST (+6.7), UCLA (+18), and ASES (+52).
There were 32 complications in 25 shoulders. There were no bilateral complications. Seven shoulders had multiple complications, of which many were not independent events. For example, rotator cuff deficiency was associated with instability, and infection was associated with glenoid loosening. One patient had 2 procedures, the first an arthroscopic release and the second a revision shoulder arthroplasty for glenoid loosening. The most common postoperative complication was rotator cuff failure (RCF) or suspected RCF (13 shoulders, including 8 treated with revision arthroplasty). RCF occurred most commonly at the rotator cuff interval, followed by the subscapularis and the supraspinatus. RCF location was based on computed tomography scan or intraoperative observation. The few subscapularis failures occurred with both subscapularis tendon repair and osteotomy. The high RCF rate may derive from scrutinizing postoperative radiographs and was not necessarily confirmed with repeat surgery. We think this represents a more realistic estimate of true postoperative rotator cuff dysfunction, rather than including only reoperated cases. The second most common complication was infection (6 shoulders, 1 with a superficial suture abscess and 5 with deep infections). Other complications were instability (4, with 2 caused by rotator cuff insufficiency), glenoid loosening (4, with 2 caused by infection), stiffness (3), nerve issue (1), and hematoma evacuation (1).
In 21 shoulders, these complications were treated with revision shoulder arthroplasty (16 shoulders), arthroscopic capsular release (3), evacuation of postoperative hematoma (1), and débridement of suture abscess (1). The 16 revision shoulder arthroplasties performed were conversion to reverse shoulder arthroplasty (11 shoulders) and placement of an antibiotic spacer for infection (5). The stem was left in place for all revisions, excluding those for infection. This is a significant advantage of the modular platform stem. Details of the complications and treatments are listed in the Table. There was no difference in health status between patients with a complication (ASA, 2.57) and those without one (ASA, 2.56).
Discussion
The implant described in this article consists of a metaphyseal press-fit stem, a replicator plate, multiple eccentric humeral heads, and a glenoid of multiple sizes with 2 radii of curvatures used to match the patient’s native anatomy and still maintain the appropriate radius of curvature mismatch between the humeral head and the glenoid. Between the eccentricity in the replicator plate and the eccentricity in the humeral head, almost any humeral head cut can be covered, more than 99% of the time.1 However, it remains to be seen if a versatile implant that comes close to matching the patient’s native anatomy will make a difference clinically.
The objective and functional outcomes in this study compare well with those of other, large TSA studies using older prostheses.1-4 There are few reports on contemporary implants with sufficient follow-up numbers for the single diagnosis of OA. Norris and Iannotti2 reported on a multicenter study of 176 patients with a Depuy Global TSA. The design of their study comes closest to that of our clinical outcome study. Nineteen surgeons were involved in their study. The follow-up rate is not clear. Their outcomes (with ours in parentheses for comparison) were active external rotation of 45° (42°), active elevation of 138° (137°), ASES of 84 (85), and SST of 9.2 (10). Norris and Iannotti2 noted an overall complication rate of 13% (12% in our series). Their most common postoperative complications were RCF and glenoid loosening; ours were RCF and infection. Another multicenter study with short-term results using a contemporary prosthesis included 268 shoulders followed for a minimum of 12 months.1 At final follow-up, Constant score was 97, active elevation was 145°, and the complication rate was 8.6%. Godenèche and colleagues1 also noted a glenoid lucent-line rate of 58% and reported that rotator cuff pathology adversely affected outcome.
Although the overall clinical outcome results are encouraging and the complication rate is in the reported range, we believe that a focus on the major complication categories may have a significant positive impact on our patients. The present article places significant importance on reporting complications prospectively, which is more accurate than retrospective reporting. The rates of both RCF and infection, the most common complications in our study, need to be decreased. Aldinger and colleagues7 reported a 12% complication rate in 485 primary shoulder arthroplasties—a rate identical to ours here. In their study, nerve injuries and humeral fractures were both more common than rotator cuff tears. We think that rotator cuff deficiency after TSA is underreported because it is often based on revision surgery alone. It is also interesting that the majority of the cuff deficiencies were through the upper subscapularis rotator interval and were not a complete failure of the subscapularis repair. Not all these patients will undergo revision surgery. In the future, the RCF rate may drop with the increasingly common use of reverse shoulder arthroplasty for substandard rotator cuffs.
Use of this contemporary variable neck angle, variable version angle, dual eccentric shoulder arthroplasty with a replicator plate provides satisfying short-term clinical outcomes. Patients with less than optimal health (mean ASA, 2.57) seem to tolerate the procedure well. Continued focus on RCF and infection will have the greatest impact on the overall complication rate.
Anatomical total shoulder arthroplasty (TSA) is an effective treatment for advanced osteoarthritis (OA) of the glenohumeral joint.1-4 Over the past 40 years, since the early reports appeared, the implants have evolved from the early monoblock humeral component to modular components, variable neck angled components with eccentric heads, and components that can provide variable neck angles, version angles, and dual eccentricity to match the anatomy of the proximal humerus. The goal of the new implants is to replicate the individual patient’s native anatomy using a combination of modularity, multiple neck and version angles, and dual eccentricity of the neck and head. The flexibility of the implant system is made possible by a replicator plate. There are few reports on outcomes of using these new implants for OA.
In this article, we report outcomes of using a dual eccentric, variable neck angle, variable version angle implant with a replicator plate for the treatment of OA of the shoulder at 4 centers.
Materials and Methods
The Western Institutional Review Board approved this study, and consent was prospectively obtained and retrospectively reviewed.
The data banks of a 4-center consortium were queried. Only primary TSA patients treated for OA with a fourth-generation Exactech Equinoxe implant (Exactech, Inc.) were included. For the center to be included, it had to have an 80% patient follow-up rate at a minimum of 2 years. Four centers qualified for inclusion: University of Florida, Medical College of Georgia, New York University, and Bordeaux-Merignac Clinic. Data were obtained on surgeries sequentially performed between August 1, 2006, and December 31, 2010. All data were obtained prospectively using a common data collection format.
The Equinoxe anatomical TSA allows for independent adaptation of neck angle and humeral version and provides 2 variable offset times (1 on replicator plate, 1 on humeral head) for matching the native anatomy in more than 99% of cases5 (Figure). The replicator plate is eccentric and can be angled 7.5° in any direction and rotated 360° to provide humeral head coverage. Once its optimal position is obtained, the plate is permanently fixed to the humeral stem using a breakaway screw. Some contemporary implants have similar features.
There were 218 primary shoulder arthroplasties performed on 201 patients (98 male, 103 female). Mean age at time of surgery was 67 years (range, 31-87 years), and mean follow-up was 36 months (range, 24-72 months). The collective follow-up rate at the 3-year mean follow-up and 2-year minimal follow-up was 81%. Eleven shoulders had a cemented stem, and 207 had an uncemented stem. Forty-eight shoulders used the 1.5-mm replicator plate, and 170 used the 4.5-mm offset replicator plate. The patients in this study were typically not very healthy: mean American Society of Anesthesiologists (ASA) score was 2.57 (range, 1-3).
Five outcome scores were calculated from the prospectively obtained data: Constant normalized, Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test (SST), UCLA Shoulder Rating Scale (UCLA), and American Shoulder and Elbow Surgeons Shoulder Assessment (ASES). Before initiating data collection, we developed the Metric Form6 so we could calculate multiple scores while asking the minimal possible number of questions. This could be done for all 5 outcome scores, as their questions have significant overlap.
Objective outcomes included active external rotation, active scaption, active abduction, and active internal rotation. Complications, including revisions, were noted and analyzed. We focus on functional outcomes and do not present radiographic outcomes.
Results
A 2-tailed unpaired t test was used to compare preoperative values with final outcome values (P < .05). Four objective outcomes were significantly improved over preoperative levels: active external rotation (preoperative, 15°; postoperative, 42°), active scaption (pre, 92°; post, 137°), active abduction (pre, 80°; post, 121°), and active internal rotation (pre, S3; post, L2). The functional outcome scores that were significantly (P < .05) improved at final follow-up were Constant normalized (pre, 39; post, 79), SPADI (pre, 86; post, 20), SST (pre, 3.3; post, 10), UCLA (pre, 13; post, 31), and ASES (pre, 33; post, 85).
The outcome improvements at latest follow-up were active external rotation (+28), active scaption (+45), active abduction (+42), active internal rotation (+6 anatomical segments), Constant normalized (+40), SPADI (–66), SST (+6.7), UCLA (+18), and ASES (+52).
There were 32 complications in 25 shoulders. There were no bilateral complications. Seven shoulders had multiple complications, of which many were not independent events. For example, rotator cuff deficiency was associated with instability, and infection was associated with glenoid loosening. One patient had 2 procedures, the first an arthroscopic release and the second a revision shoulder arthroplasty for glenoid loosening. The most common postoperative complication was rotator cuff failure (RCF) or suspected RCF (13 shoulders, including 8 treated with revision arthroplasty). RCF occurred most commonly at the rotator cuff interval, followed by the subscapularis and the supraspinatus. RCF location was based on computed tomography scan or intraoperative observation. The few subscapularis failures occurred with both subscapularis tendon repair and osteotomy. The high RCF rate may derive from scrutinizing postoperative radiographs and was not necessarily confirmed with repeat surgery. We think this represents a more realistic estimate of true postoperative rotator cuff dysfunction, rather than including only reoperated cases. The second most common complication was infection (6 shoulders, 1 with a superficial suture abscess and 5 with deep infections). Other complications were instability (4, with 2 caused by rotator cuff insufficiency), glenoid loosening (4, with 2 caused by infection), stiffness (3), nerve issue (1), and hematoma evacuation (1).
In 21 shoulders, these complications were treated with revision shoulder arthroplasty (16 shoulders), arthroscopic capsular release (3), evacuation of postoperative hematoma (1), and débridement of suture abscess (1). The 16 revision shoulder arthroplasties performed were conversion to reverse shoulder arthroplasty (11 shoulders) and placement of an antibiotic spacer for infection (5). The stem was left in place for all revisions, excluding those for infection. This is a significant advantage of the modular platform stem. Details of the complications and treatments are listed in the Table. There was no difference in health status between patients with a complication (ASA, 2.57) and those without one (ASA, 2.56).
Discussion
The implant described in this article consists of a metaphyseal press-fit stem, a replicator plate, multiple eccentric humeral heads, and a glenoid of multiple sizes with 2 radii of curvatures used to match the patient’s native anatomy and still maintain the appropriate radius of curvature mismatch between the humeral head and the glenoid. Between the eccentricity in the replicator plate and the eccentricity in the humeral head, almost any humeral head cut can be covered, more than 99% of the time.1 However, it remains to be seen if a versatile implant that comes close to matching the patient’s native anatomy will make a difference clinically.
The objective and functional outcomes in this study compare well with those of other, large TSA studies using older prostheses.1-4 There are few reports on contemporary implants with sufficient follow-up numbers for the single diagnosis of OA. Norris and Iannotti2 reported on a multicenter study of 176 patients with a Depuy Global TSA. The design of their study comes closest to that of our clinical outcome study. Nineteen surgeons were involved in their study. The follow-up rate is not clear. Their outcomes (with ours in parentheses for comparison) were active external rotation of 45° (42°), active elevation of 138° (137°), ASES of 84 (85), and SST of 9.2 (10). Norris and Iannotti2 noted an overall complication rate of 13% (12% in our series). Their most common postoperative complications were RCF and glenoid loosening; ours were RCF and infection. Another multicenter study with short-term results using a contemporary prosthesis included 268 shoulders followed for a minimum of 12 months.1 At final follow-up, Constant score was 97, active elevation was 145°, and the complication rate was 8.6%. Godenèche and colleagues1 also noted a glenoid lucent-line rate of 58% and reported that rotator cuff pathology adversely affected outcome.
Although the overall clinical outcome results are encouraging and the complication rate is in the reported range, we believe that a focus on the major complication categories may have a significant positive impact on our patients. The present article places significant importance on reporting complications prospectively, which is more accurate than retrospective reporting. The rates of both RCF and infection, the most common complications in our study, need to be decreased. Aldinger and colleagues7 reported a 12% complication rate in 485 primary shoulder arthroplasties—a rate identical to ours here. In their study, nerve injuries and humeral fractures were both more common than rotator cuff tears. We think that rotator cuff deficiency after TSA is underreported because it is often based on revision surgery alone. It is also interesting that the majority of the cuff deficiencies were through the upper subscapularis rotator interval and were not a complete failure of the subscapularis repair. Not all these patients will undergo revision surgery. In the future, the RCF rate may drop with the increasingly common use of reverse shoulder arthroplasty for substandard rotator cuffs.
Use of this contemporary variable neck angle, variable version angle, dual eccentric shoulder arthroplasty with a replicator plate provides satisfying short-term clinical outcomes. Patients with less than optimal health (mean ASA, 2.57) seem to tolerate the procedure well. Continued focus on RCF and infection will have the greatest impact on the overall complication rate.
1. Godenèche A, Boileau P, Favard L, et al. Prosthetic replacement in the treatment of osteoarthritis of the shoulder: early results of 268 cases. J Shoulder Elbow Surg. 2002;11(1):11-18.
2. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.
3. Razmjou H, Holtby R, Christakis M, Axelrod T, Richards R. Impact of prosthetic design on clinical and radiologic outcomes of total shoulder arthroplasty: a prospective study. J Shoulder Elbow Surg. 2013;22(2):206-214.
4. Walch G, Young AA, Melis B, Gazielly D, Loew M, Boileau P. Results of a convex-back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow-up greater than 5 years. J Shoulder Elbow Surg. 2011;20(3):385-394.
5. Irlenbusch U, Rott O, Gebhardt K, Werner A. Reconstruction of the rotational centre of the humeral head with double eccentric adaptable shoulder prosthesis [abstract]. In: Proceedings of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT); May 29-June 1, 2008; Nice, France.
6. Flurin PH, Roche CP, Wright TW, Zuckerman J, Johnson D, Christensen M. A correlation of five commonly used clinical metrics to measure outcomes in shoulder arthroplasty. In: Transactions of the 58th Annual Meeting of the Orthopaedic Research Society (ORS); February 4-7, 2012; San Francisco, CA.
7. Aldinger PR, Raiss P, Rickert M, Loew M. Complications in shoulder arthroplasty: an analysis of 485 cases. Int Orthop. 2010;34(4):517-524.
1. Godenèche A, Boileau P, Favard L, et al. Prosthetic replacement in the treatment of osteoarthritis of the shoulder: early results of 268 cases. J Shoulder Elbow Surg. 2002;11(1):11-18.
2. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.
3. Razmjou H, Holtby R, Christakis M, Axelrod T, Richards R. Impact of prosthetic design on clinical and radiologic outcomes of total shoulder arthroplasty: a prospective study. J Shoulder Elbow Surg. 2013;22(2):206-214.
4. Walch G, Young AA, Melis B, Gazielly D, Loew M, Boileau P. Results of a convex-back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow-up greater than 5 years. J Shoulder Elbow Surg. 2011;20(3):385-394.
5. Irlenbusch U, Rott O, Gebhardt K, Werner A. Reconstruction of the rotational centre of the humeral head with double eccentric adaptable shoulder prosthesis [abstract]. In: Proceedings of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT); May 29-June 1, 2008; Nice, France.
6. Flurin PH, Roche CP, Wright TW, Zuckerman J, Johnson D, Christensen M. A correlation of five commonly used clinical metrics to measure outcomes in shoulder arthroplasty. In: Transactions of the 58th Annual Meeting of the Orthopaedic Research Society (ORS); February 4-7, 2012; San Francisco, CA.
7. Aldinger PR, Raiss P, Rickert M, Loew M. Complications in shoulder arthroplasty: an analysis of 485 cases. Int Orthop. 2010;34(4):517-524.
