Original Research

The ethos of medicine has shifted from paternalistic, physician-driven care to patient autonomy and engagement, in which the physician shares information and advises.^1-3 Although there are ethical, legal, and practical reasons to respect patient preferences,^1-4 patient engagement also fosters quality and safety⁵ and may improve clinical outcomes.^5-8 Patients whose preferences are respected are more likely to trust their doctor, feel empowered, and adhere to treatments.⁹

Providers may partner with patients through shared decision-making (SDM).^10,11 Several SDM models describe the process of providers and patients balancing evidence, preferences and context to arrive at a clinical decision.^12-15 The National Academy of Medicine and the American Academy of Pediatrics has called for more SDM,^16,17 including when clinical evidence is limited,² equally beneficial options exist,¹⁸ clinical stakes are high,¹⁹ and even with deferential patients.²⁰ Despite its value, SDM does not reliably occur^21,22 and SDM training is often unavailable.⁴ Clinical decision tools, patient education aids, and various training interventions have shown promising, although inconsistent results.^{23, 24}

Little is known about SDM in inpatient settings where unique patient, clinician, and environmental factors may influence SDM. This study describes the quality and possible predictors of inpatient SDM during attending rounds in 4 academic training settings. Although SDM may occur anytime during a hospitalization, attending rounds present a valuable opportunity for SDM observation given their centrality to inpatient care and teaching.^25,26 Because attending physicians bear ultimate responsibility for patient management, we examined whether SDM performance varies among attendings within each service. In addition, we tested the hypothesis that service-level, team-level, and patient-level features explain variation in SDM quality more than individual attending physicians. Finally, we compared peer-observer perspectives of SDM behaviors with patient and/or guardian perspectives.

Study Design and Setting

This cross-sectional, observational study examined the diversity of SDM practice within and between 4 inpatient services during attending rounds, including the internal medicine and pediatrics services at Stanford University and the University of California, San Francisco (UCSF). Both institutions provide quaternary care to diverse patient populations with approximately half enrolled in Medicare and/or Medicaid.

One institution had 42 internal medicine (Med-1) and 15 pediatric hospitalists (Peds-1) compared to 8 internal medicine (Med-2) and 12 pediatric hospitalists (Peds-2) at the second location. Both pediatric services used family-centered rounds that included discussions between the patients’ families and the whole team. One medicine service used a similar rounding model that did not necessarily involve the patients’ families. In contrast, the smaller medicine service typically began rounds by discussing all patients in a conference room and then visiting select patients afterwards.

From August 2014 to November 2014, peer observers gathered data on team SDM behaviors during attending rounds. After the rounding team departed, nonphysician interviewers surveyed consenting patients’ (or guardians’) views of the SDM experience, yielding paired evaluations for a subset of SDM encounters. Institutional review board approval was obtained from Stanford University and UCSF.

Participants and Inclusion Criteria

Attending physicians were hospitalists who supervised rounds at least 1 month per year, and did not include those conducting the study. All provided verbal assent to be observed on 3 days within a 7-day period. While team composition varied as needed (eg, to include the nurse, pharmacist, interpreter, etc), we restricted study observations to those teams with an attending and at least one learner (eg, resident, intern, medical student) to capture the influence of attending physicians in their training role. Because services vary in number of attendings on staff, rounds assigned per attending, and patients per round, it was not possible to enroll equal sample sizes per service in the study.

Nonintensive care unit patients who were deemed medically stable by the team were eligible for peer observation and participation in a subsequent patient interview once during the study period. Pediatric patients were invited for an interview if they were between 13 and 21 years old and had the option of having a parent or guardian present; if the pediatric patients were less than 13 years old or they were not interested in being interviewed, then their parents or guardians were invited to be interviewed. Interpreters were on rounds, and thus, non-English participants were able to participate in the peer observations, but could not participate in patient interviews because interpreters were not available during afternoons for study purposes. Consent was obtained from all participating patients and/or guardians.

Data Collection

Round and Patient Characteristics

Peer observers recorded rounding, team, and patient characteristics using a standardized form. Rounding data included date, attending name, duration of rounds, and patient census. Patient level data included the decision(s) discussed, the seniority of the clinician leading the discussion, team composition, minutes spent discussing the patient (both with the patient and/or guardian and total time), hospitalization week, and patient’s primary language. Additional patient data obtained from electronic health records included age, gender, race, ethnicity, date of admission, and admitting diagnosis.

SDM Measures

Peer-observed SDM behaviors were quantified per patient encounter using the 9-item Rochester Participatory Decision-Making Scale (RPAD), with credit given for SDM behaviors exhibited by anyone on the rounding team (team-level metric).²⁷ Each item was scored on a 3-point scale (0 = absent, 0.5 = partial, and 1 = present) for a maximum of 9 points, with higher scores indicating higher-quality SDM (Peer-RPAD Score). We created semistructured patient interview guides by adapting each RPAD item into layperson language (Patient-RPAD Score) and adding open-ended questions to assess the patient experience.

Peer-Observer Training

Eight peer-observers (7 hospitalists and 1 palliative care physician) were trained to perform RPAD ratings using videos of patient encounters. Initially, raters viewed videos together and discussed ratings for each RPAD item. The observers incorporated behavioral anchors and clinical examples into the development of an RPAD rating guide, which they subsequently used to independently score 4 videos from an online medical communication library.²⁸ These scores were discussed to resolve any differences before 4 additional videos were independently viewed, scored, and compared. Interrater reliability was achieved when the standard deviation of summed SDM scores across raters was less than 1 for all 4 videos.

Patient Interviewers

Interviewers were English-speaking volunteers without formal medical training. They were educated in hospital etiquette by a physician and in administering patient interviews through peer-to-peer role playing and an observation and feedback interview with at least 1 patient.

Data Analysis

The analysis set included every unique patient with whom a medical decision was made by an eligible clinical team. To account for the nested study design (patient-level scores within rounds, rounds within attending, and attendings within service), we used mixed-effects models to estimate mean (summary or item) RPAD score by levels of fixed covariate(s). The models included random effects accounting for attending-level and round-level correlations among scores via variance components, and allowing the attending-level random effect to differ by service. Analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC). We used descriptive statistics to summarize round- and patient-level characteristics.

SDM Variation by Attending and Service

Box plots were used to summarize raw patient-level, Peer-RPAD scores by service and attending. By using the methods described above, we estimated the mean score overall and by service. In both models, we examined the statistical significance of service-specific variation in attending-level random effects by using likelihood-ratio test (LRT) to compare models.

SDM Variation by Round and Patient Characteristics

We used the models described above to identify covariates associated with Peer-RPAD scores. We fit univariate models separately for each covariate, then fit 2 multivariable models, including (1) all covariates and (2) all effects significant in either model at P ≤ .20 according to F tests. For uniformity of presentation, we express continuous covariates categorically; however, we report P values based on continuous versions. Means generated by the multivariable models were calculated at the mean values of all other covariates in model.

Patient-Level RPAD Data

A subsample of patients completed semistructured interviews with analogous RPAD questions. To identify possible selection bias in the full sample, we summarized response rates by service and patient language and modeled Peer-RPAD scores by interview response status. Among responders, we estimated the mean Peer-RPAD and Patient-RPAD scores and their paired differences and correlations, testing for non-zero correlations via the Spearman rank test.

All Patient Encounters

The median duration of rounding sessions was 1.8 hours, median patient census was 9, and median patient encounter was 13 minutes. The duration of rounds and minutes per patient were longest at Med-2 and shortest at Peds-1. See Table 1 for other team characteristics.

Peer Evaluations of SDM Encounters

Characteristics of Patients

Teams spent a median of 13 minutes per SDM encounter, which was not higher than the round median. SDM topics discussed included 47% treatment, 15% diagnostic, 30% both treatment and diagnostic, and 7% other.

Variation in SDM Quality Among Attending Physicians

Overall Peer-RPAD Scores were normally distributed. After adjusting for the nested study design, the overall mean (standard error) score was 4.16 (0.11). Score variability among attendings differed significantly by service (LRT P = .0067). For example, raw scores were lower and more variable among attending physicians at Med-2 than other among attendings in other services (see Appendix Figure in Supporting Information). However, when service was included in the model as a fixed effect, mean scores varied significantly, from 3.0 at Med-2 to 4.7 at Med-1 (P < .0001), but the random variation among attendings no longer differed significantly by service (P = .13). This finding supports the hypothesis that service-level influences are stronger than influences of individual attending physicians, that is, that variation between services exceeded variation among attendings within service.

Aspects of SDM That Are More Prevalent on Rounds

Rounds and Patient Characteristics Associated With Peer-RPAD Scores

Patient-RPAD Results: Dissimilar Perspectives of Patients and/or Guardians and Physician Observers

Among responders, mean Patient-RPAD scores were 6.8 to 7.1 for medicine services and 7.6 to 7.8 for pediatric services (P = .01). The overall mean Patient-RPAD score, 7.46, was significantly greater than the paired Peer-RPAD score by 3.5 (P = .011); however, correlations were not statistically significantly different from 0 (by service, each P > .12).

To understand drivers of the differences between Peer-RPAD and Patient-RPAD scores, we analyzed findings by item. Each mean patient-item score exceeded its peer counterpart (P ≤ .01; panel B of Figure). Peer-item scores fell below 33% on 2 items (Items 9 and 4) and only exceeded 67% on 2 items (Items 1 and 6), whereas patient-item scores ranged from 60% (Item 8) to 97% (Item 7). Three paired differences exceeded 50% (Items 9, 4, and 7) and 3 were below 20% (Items 6, 8 and 1), underlying the lack of correlation between peer and patient scores.

In this multisite study of SDM during inpatient attending rounds, SDM quality, specific SDM behaviors, and factors contributing to SDM were identified. Our study found an adjusted overall Peer-RPAD Score of 4.4 out of 9, and found the following 3 SDM elements most needing improvement according to trained peer observers: (1) “Checking understanding of the patient’s perspective”, (2) “Examining barriers to follow-through with the treatment plan”, and (3) “Asking if the patient has questions.” Areas of strength included explaining the clinical issue or nature of the decision and matching medical language to the patient’s level of understanding, with each rated highly by both peer-observers and patients. Broadly speaking, physicians were skillful in delivering information to patients but failed to solicit input from patients. Characteristics associated with increased SDM in the multivariate analysis included the following: service, patient gender, timing of rounds during patient’s hospital stay, and amount of time rounding with each patient.

Patients similarly found that physicians could improve their abilities to elicit information from patients and families, noting the 3 lowest patient-rated SDM elements were as follows: (1) asking open-ended questions, (2) discussing alternatives or uncertainties, and (3) discussing barriers to treatment plan follow through. Overall, patients and guardians perceived the quantity and quality of SDM on rounds more favorably than peer observers, which is consistent with other studies of patient perceptions of communication. ^29-31 It is possible that patient ratings are more influenced by demand characteristics, fear of negatively impacting their patient-provider relationships, and conflation of overall satisfaction with quality of communication.³² This difference in patient perception of SDM is worthy of further study.

Prior work has revealed that SDM may occur infrequently during inpatient rounds.¹¹ This study further elucidates specific SDM behaviors used along with univariate and multivariate modeling to explore possible contributing factors. The strengths and weaknesses found were similar at all 4 services and the influence of the service was more important than variability across attendings. This study’s findings are similar to a study by Shields et al.,³³ in which the findings in a geographically different outpatient setting 10 years earlier suggesting global and enduring challenges to SDM. To our knowledge, this is the first published study to characterize inpatient SDM behaviors and may serve as the basis for future interventions.

Although the item-level components were ranked similarly across services, on average the summary Peer-RPAD score was lowest at Med-2, where we observed high variability within and between attendings, and was highest at Med-1, where variability was low. Med-2 carried the highest caseload and held the longest rounds, while Med-1 carried the lowest caseload, suggesting that modifiable burdens may hamper SDM performance. Prior studies suggest that patients are often selected based on teaching opportunities, immediate medical need and being newly admitted.³⁴ The high scores at Med-1 may reflect that service’s prediscussion of patients during card-flipping rounds or their selection of which patients to round on as a team. Consistent with prior studies^29,35 of SDM and the family-centered rounding model, which includes the involvement of nurses, respiratory therapists, pharmacists, case managers, social workers, and interpreters on rounds, both pediatrics services showed higher SDM scores.

In contrast to prior studies,^34,36 team size and number of learners did not affect SDM performance, nor did decision type. Despite teams having up to 17 members, 8 learners, and 14 complex patients, SDM scores did not vary significantly by team. Nonetheless, trends were in the directions expected: Scores tended to decrease as the team size or the percentage of trainees grew, and increased with the seniority of the presenting physician. Interestingly, SDM performance decreased with round-average minutes per patient, which may be measuring on-going intensity across cases that leads to exhaustion. Statistically significant patient factors for increased SDM included longer duration of patient encounters, second week of hospital stay, and female patient gender. Although we anticipated that the high number of decisions made early in hospitalization would facilitate higher SDM scores, continuity and stronger patient-provider relationships may enhance SDM.³⁶ We report service-specific team and patient characteristics, in addition to SDM findings in anticipation that some readers will identify with 1 service more than others.

This study has several important limitations. First, our peer observers were not blinded and primarily observed encounters at their own site. To minimize bias, observers periodically rated videos to recalibrate RPAD scoring. Second, additional SDM conversations with a patient and/or guardian may have occurred outside of rounds and were not captured, and poor patient recall may have affected Patient-RPAD scores despite interviewer prompts and timeliness of interviews within 12 hours of rounds. Third, there might have been a selection bias for the one service who selected a smaller number of patients to see, compared with the three other services that performed bedside rounds on all patients. It is possible that attending physicians selected patients who were deemed most able to have SDM conversations, thus affecting RPAD scores on that service. Fourth, study services had fewer patients on average than other academic hospitals (median 9, range 3-14), which might limit its generalizability. Last, as in any observational study, there is always the possibility of the Hawthorne effect. However, neither teams nor patients knew the study objectives.

Nevertheless, important findings emerged through the use of RPAD Scores to evaluate inpatient SDM practices. In particular, we found that to increase SDM quality in inpatient settings, practitioners should (1) check their understanding of the patient’s perspective, (2) examine barriers to follow-through with the treatment plan, and (3) ask if the patient has questions. Variation among services remained very influential after adjusting for team and patient characteristics, which suggests that “climate” or service culture should be targeted by an intervention, rather than individual attendings or subgroups defined by team or patient characteristics. Notably, team size, number of learners, patient census, and type of decision being made did not affect SDM performance, suggesting that even large, busy services can perform SDM if properly trained.

Acknowledgments

The authors thank the patients, families, pediatric and internal medicine residents, and hospitalists at Stanford School of Medicine and University of California, San Francisco School of Medicine for their participation in this study. We would also like to thank the student volunteers who collected patient perspectives on the encounters.

Disclosure 

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by an NIH/NCCIH grant R25 AT006573.

The ethos of medicine has shifted from paternalistic, physician-driven care to patient autonomy and engagement, in which the physician shares information and advises.^1-3 Although there are ethical, legal, and practical reasons to respect patient preferences,^1-4 patient engagement also fosters quality and safety⁵ and may improve clinical outcomes.^5-8 Patients whose preferences are respected are more likely to trust their doctor, feel empowered, and adhere to treatments.⁹

Providers may partner with patients through shared decision-making (SDM).^10,11 Several SDM models describe the process of providers and patients balancing evidence, preferences and context to arrive at a clinical decision.^12-15 The National Academy of Medicine and the American Academy of Pediatrics has called for more SDM,^16,17 including when clinical evidence is limited,² equally beneficial options exist,¹⁸ clinical stakes are high,¹⁹ and even with deferential patients.²⁰ Despite its value, SDM does not reliably occur^21,22 and SDM training is often unavailable.⁴ Clinical decision tools, patient education aids, and various training interventions have shown promising, although inconsistent results.^{23, 24}

Little is known about SDM in inpatient settings where unique patient, clinician, and environmental factors may influence SDM. This study describes the quality and possible predictors of inpatient SDM during attending rounds in 4 academic training settings. Although SDM may occur anytime during a hospitalization, attending rounds present a valuable opportunity for SDM observation given their centrality to inpatient care and teaching.^25,26 Because attending physicians bear ultimate responsibility for patient management, we examined whether SDM performance varies among attendings within each service. In addition, we tested the hypothesis that service-level, team-level, and patient-level features explain variation in SDM quality more than individual attending physicians. Finally, we compared peer-observer perspectives of SDM behaviors with patient and/or guardian perspectives.

Study Design and Setting

This cross-sectional, observational study examined the diversity of SDM practice within and between 4 inpatient services during attending rounds, including the internal medicine and pediatrics services at Stanford University and the University of California, San Francisco (UCSF). Both institutions provide quaternary care to diverse patient populations with approximately half enrolled in Medicare and/or Medicaid.

One institution had 42 internal medicine (Med-1) and 15 pediatric hospitalists (Peds-1) compared to 8 internal medicine (Med-2) and 12 pediatric hospitalists (Peds-2) at the second location. Both pediatric services used family-centered rounds that included discussions between the patients’ families and the whole team. One medicine service used a similar rounding model that did not necessarily involve the patients’ families. In contrast, the smaller medicine service typically began rounds by discussing all patients in a conference room and then visiting select patients afterwards.

From August 2014 to November 2014, peer observers gathered data on team SDM behaviors during attending rounds. After the rounding team departed, nonphysician interviewers surveyed consenting patients’ (or guardians’) views of the SDM experience, yielding paired evaluations for a subset of SDM encounters. Institutional review board approval was obtained from Stanford University and UCSF.

Participants and Inclusion Criteria

Attending physicians were hospitalists who supervised rounds at least 1 month per year, and did not include those conducting the study. All provided verbal assent to be observed on 3 days within a 7-day period. While team composition varied as needed (eg, to include the nurse, pharmacist, interpreter, etc), we restricted study observations to those teams with an attending and at least one learner (eg, resident, intern, medical student) to capture the influence of attending physicians in their training role. Because services vary in number of attendings on staff, rounds assigned per attending, and patients per round, it was not possible to enroll equal sample sizes per service in the study.

Nonintensive care unit patients who were deemed medically stable by the team were eligible for peer observation and participation in a subsequent patient interview once during the study period. Pediatric patients were invited for an interview if they were between 13 and 21 years old and had the option of having a parent or guardian present; if the pediatric patients were less than 13 years old or they were not interested in being interviewed, then their parents or guardians were invited to be interviewed. Interpreters were on rounds, and thus, non-English participants were able to participate in the peer observations, but could not participate in patient interviews because interpreters were not available during afternoons for study purposes. Consent was obtained from all participating patients and/or guardians.

Data Collection

Round and Patient Characteristics

Peer observers recorded rounding, team, and patient characteristics using a standardized form. Rounding data included date, attending name, duration of rounds, and patient census. Patient level data included the decision(s) discussed, the seniority of the clinician leading the discussion, team composition, minutes spent discussing the patient (both with the patient and/or guardian and total time), hospitalization week, and patient’s primary language. Additional patient data obtained from electronic health records included age, gender, race, ethnicity, date of admission, and admitting diagnosis.

SDM Measures

Peer-observed SDM behaviors were quantified per patient encounter using the 9-item Rochester Participatory Decision-Making Scale (RPAD), with credit given for SDM behaviors exhibited by anyone on the rounding team (team-level metric).²⁷ Each item was scored on a 3-point scale (0 = absent, 0.5 = partial, and 1 = present) for a maximum of 9 points, with higher scores indicating higher-quality SDM (Peer-RPAD Score). We created semistructured patient interview guides by adapting each RPAD item into layperson language (Patient-RPAD Score) and adding open-ended questions to assess the patient experience.

Peer-Observer Training

Eight peer-observers (7 hospitalists and 1 palliative care physician) were trained to perform RPAD ratings using videos of patient encounters. Initially, raters viewed videos together and discussed ratings for each RPAD item. The observers incorporated behavioral anchors and clinical examples into the development of an RPAD rating guide, which they subsequently used to independently score 4 videos from an online medical communication library.²⁸ These scores were discussed to resolve any differences before 4 additional videos were independently viewed, scored, and compared. Interrater reliability was achieved when the standard deviation of summed SDM scores across raters was less than 1 for all 4 videos.

Patient Interviewers

Interviewers were English-speaking volunteers without formal medical training. They were educated in hospital etiquette by a physician and in administering patient interviews through peer-to-peer role playing and an observation and feedback interview with at least 1 patient.

Data Analysis

The analysis set included every unique patient with whom a medical decision was made by an eligible clinical team. To account for the nested study design (patient-level scores within rounds, rounds within attending, and attendings within service), we used mixed-effects models to estimate mean (summary or item) RPAD score by levels of fixed covariate(s). The models included random effects accounting for attending-level and round-level correlations among scores via variance components, and allowing the attending-level random effect to differ by service. Analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC). We used descriptive statistics to summarize round- and patient-level characteristics.

SDM Variation by Attending and Service

Box plots were used to summarize raw patient-level, Peer-RPAD scores by service and attending. By using the methods described above, we estimated the mean score overall and by service. In both models, we examined the statistical significance of service-specific variation in attending-level random effects by using likelihood-ratio test (LRT) to compare models.

SDM Variation by Round and Patient Characteristics

We used the models described above to identify covariates associated with Peer-RPAD scores. We fit univariate models separately for each covariate, then fit 2 multivariable models, including (1) all covariates and (2) all effects significant in either model at P ≤ .20 according to F tests. For uniformity of presentation, we express continuous covariates categorically; however, we report P values based on continuous versions. Means generated by the multivariable models were calculated at the mean values of all other covariates in model.

Patient-Level RPAD Data

A subsample of patients completed semistructured interviews with analogous RPAD questions. To identify possible selection bias in the full sample, we summarized response rates by service and patient language and modeled Peer-RPAD scores by interview response status. Among responders, we estimated the mean Peer-RPAD and Patient-RPAD scores and their paired differences and correlations, testing for non-zero correlations via the Spearman rank test.

All Patient Encounters

The median duration of rounding sessions was 1.8 hours, median patient census was 9, and median patient encounter was 13 minutes. The duration of rounds and minutes per patient were longest at Med-2 and shortest at Peds-1. See Table 1 for other team characteristics.

Peer Evaluations of SDM Encounters

Characteristics of Patients

Teams spent a median of 13 minutes per SDM encounter, which was not higher than the round median. SDM topics discussed included 47% treatment, 15% diagnostic, 30% both treatment and diagnostic, and 7% other.

Variation in SDM Quality Among Attending Physicians

Overall Peer-RPAD Scores were normally distributed. After adjusting for the nested study design, the overall mean (standard error) score was 4.16 (0.11). Score variability among attendings differed significantly by service (LRT P = .0067). For example, raw scores were lower and more variable among attending physicians at Med-2 than other among attendings in other services (see Appendix Figure in Supporting Information). However, when service was included in the model as a fixed effect, mean scores varied significantly, from 3.0 at Med-2 to 4.7 at Med-1 (P < .0001), but the random variation among attendings no longer differed significantly by service (P = .13). This finding supports the hypothesis that service-level influences are stronger than influences of individual attending physicians, that is, that variation between services exceeded variation among attendings within service.

Aspects of SDM That Are More Prevalent on Rounds

Rounds and Patient Characteristics Associated With Peer-RPAD Scores

Patient-RPAD Results: Dissimilar Perspectives of Patients and/or Guardians and Physician Observers

Among responders, mean Patient-RPAD scores were 6.8 to 7.1 for medicine services and 7.6 to 7.8 for pediatric services (P = .01). The overall mean Patient-RPAD score, 7.46, was significantly greater than the paired Peer-RPAD score by 3.5 (P = .011); however, correlations were not statistically significantly different from 0 (by service, each P > .12).

To understand drivers of the differences between Peer-RPAD and Patient-RPAD scores, we analyzed findings by item. Each mean patient-item score exceeded its peer counterpart (P ≤ .01; panel B of Figure). Peer-item scores fell below 33% on 2 items (Items 9 and 4) and only exceeded 67% on 2 items (Items 1 and 6), whereas patient-item scores ranged from 60% (Item 8) to 97% (Item 7). Three paired differences exceeded 50% (Items 9, 4, and 7) and 3 were below 20% (Items 6, 8 and 1), underlying the lack of correlation between peer and patient scores.

In this multisite study of SDM during inpatient attending rounds, SDM quality, specific SDM behaviors, and factors contributing to SDM were identified. Our study found an adjusted overall Peer-RPAD Score of 4.4 out of 9, and found the following 3 SDM elements most needing improvement according to trained peer observers: (1) “Checking understanding of the patient’s perspective”, (2) “Examining barriers to follow-through with the treatment plan”, and (3) “Asking if the patient has questions.” Areas of strength included explaining the clinical issue or nature of the decision and matching medical language to the patient’s level of understanding, with each rated highly by both peer-observers and patients. Broadly speaking, physicians were skillful in delivering information to patients but failed to solicit input from patients. Characteristics associated with increased SDM in the multivariate analysis included the following: service, patient gender, timing of rounds during patient’s hospital stay, and amount of time rounding with each patient.

Patients similarly found that physicians could improve their abilities to elicit information from patients and families, noting the 3 lowest patient-rated SDM elements were as follows: (1) asking open-ended questions, (2) discussing alternatives or uncertainties, and (3) discussing barriers to treatment plan follow through. Overall, patients and guardians perceived the quantity and quality of SDM on rounds more favorably than peer observers, which is consistent with other studies of patient perceptions of communication. ^29-31 It is possible that patient ratings are more influenced by demand characteristics, fear of negatively impacting their patient-provider relationships, and conflation of overall satisfaction with quality of communication.³² This difference in patient perception of SDM is worthy of further study.

Prior work has revealed that SDM may occur infrequently during inpatient rounds.¹¹ This study further elucidates specific SDM behaviors used along with univariate and multivariate modeling to explore possible contributing factors. The strengths and weaknesses found were similar at all 4 services and the influence of the service was more important than variability across attendings. This study’s findings are similar to a study by Shields et al.,³³ in which the findings in a geographically different outpatient setting 10 years earlier suggesting global and enduring challenges to SDM. To our knowledge, this is the first published study to characterize inpatient SDM behaviors and may serve as the basis for future interventions.

Although the item-level components were ranked similarly across services, on average the summary Peer-RPAD score was lowest at Med-2, where we observed high variability within and between attendings, and was highest at Med-1, where variability was low. Med-2 carried the highest caseload and held the longest rounds, while Med-1 carried the lowest caseload, suggesting that modifiable burdens may hamper SDM performance. Prior studies suggest that patients are often selected based on teaching opportunities, immediate medical need and being newly admitted.³⁴ The high scores at Med-1 may reflect that service’s prediscussion of patients during card-flipping rounds or their selection of which patients to round on as a team. Consistent with prior studies^29,35 of SDM and the family-centered rounding model, which includes the involvement of nurses, respiratory therapists, pharmacists, case managers, social workers, and interpreters on rounds, both pediatrics services showed higher SDM scores.

In contrast to prior studies,^34,36 team size and number of learners did not affect SDM performance, nor did decision type. Despite teams having up to 17 members, 8 learners, and 14 complex patients, SDM scores did not vary significantly by team. Nonetheless, trends were in the directions expected: Scores tended to decrease as the team size or the percentage of trainees grew, and increased with the seniority of the presenting physician. Interestingly, SDM performance decreased with round-average minutes per patient, which may be measuring on-going intensity across cases that leads to exhaustion. Statistically significant patient factors for increased SDM included longer duration of patient encounters, second week of hospital stay, and female patient gender. Although we anticipated that the high number of decisions made early in hospitalization would facilitate higher SDM scores, continuity and stronger patient-provider relationships may enhance SDM.³⁶ We report service-specific team and patient characteristics, in addition to SDM findings in anticipation that some readers will identify with 1 service more than others.

This study has several important limitations. First, our peer observers were not blinded and primarily observed encounters at their own site. To minimize bias, observers periodically rated videos to recalibrate RPAD scoring. Second, additional SDM conversations with a patient and/or guardian may have occurred outside of rounds and were not captured, and poor patient recall may have affected Patient-RPAD scores despite interviewer prompts and timeliness of interviews within 12 hours of rounds. Third, there might have been a selection bias for the one service who selected a smaller number of patients to see, compared with the three other services that performed bedside rounds on all patients. It is possible that attending physicians selected patients who were deemed most able to have SDM conversations, thus affecting RPAD scores on that service. Fourth, study services had fewer patients on average than other academic hospitals (median 9, range 3-14), which might limit its generalizability. Last, as in any observational study, there is always the possibility of the Hawthorne effect. However, neither teams nor patients knew the study objectives.

Nevertheless, important findings emerged through the use of RPAD Scores to evaluate inpatient SDM practices. In particular, we found that to increase SDM quality in inpatient settings, practitioners should (1) check their understanding of the patient’s perspective, (2) examine barriers to follow-through with the treatment plan, and (3) ask if the patient has questions. Variation among services remained very influential after adjusting for team and patient characteristics, which suggests that “climate” or service culture should be targeted by an intervention, rather than individual attendings or subgroups defined by team or patient characteristics. Notably, team size, number of learners, patient census, and type of decision being made did not affect SDM performance, suggesting that even large, busy services can perform SDM if properly trained.

Acknowledgments

The authors thank the patients, families, pediatric and internal medicine residents, and hospitalists at Stanford School of Medicine and University of California, San Francisco School of Medicine for their participation in this study. We would also like to thank the student volunteers who collected patient perspectives on the encounters.

Disclosure 

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by an NIH/NCCIH grant R25 AT006573.

The ethos of medicine has shifted from paternalistic, physician-driven care to patient autonomy and engagement, in which the physician shares information and advises.^1-3 Although there are ethical, legal, and practical reasons to respect patient preferences,^1-4 patient engagement also fosters quality and safety⁵ and may improve clinical outcomes.^5-8 Patients whose preferences are respected are more likely to trust their doctor, feel empowered, and adhere to treatments.⁹

Providers may partner with patients through shared decision-making (SDM).^10,11 Several SDM models describe the process of providers and patients balancing evidence, preferences and context to arrive at a clinical decision.^12-15 The National Academy of Medicine and the American Academy of Pediatrics has called for more SDM,^16,17 including when clinical evidence is limited,² equally beneficial options exist,¹⁸ clinical stakes are high,¹⁹ and even with deferential patients.²⁰ Despite its value, SDM does not reliably occur^21,22 and SDM training is often unavailable.⁴ Clinical decision tools, patient education aids, and various training interventions have shown promising, although inconsistent results.^{23, 24}

Little is known about SDM in inpatient settings where unique patient, clinician, and environmental factors may influence SDM. This study describes the quality and possible predictors of inpatient SDM during attending rounds in 4 academic training settings. Although SDM may occur anytime during a hospitalization, attending rounds present a valuable opportunity for SDM observation given their centrality to inpatient care and teaching.^25,26 Because attending physicians bear ultimate responsibility for patient management, we examined whether SDM performance varies among attendings within each service. In addition, we tested the hypothesis that service-level, team-level, and patient-level features explain variation in SDM quality more than individual attending physicians. Finally, we compared peer-observer perspectives of SDM behaviors with patient and/or guardian perspectives.

Study Design and Setting

This cross-sectional, observational study examined the diversity of SDM practice within and between 4 inpatient services during attending rounds, including the internal medicine and pediatrics services at Stanford University and the University of California, San Francisco (UCSF). Both institutions provide quaternary care to diverse patient populations with approximately half enrolled in Medicare and/or Medicaid.

One institution had 42 internal medicine (Med-1) and 15 pediatric hospitalists (Peds-1) compared to 8 internal medicine (Med-2) and 12 pediatric hospitalists (Peds-2) at the second location. Both pediatric services used family-centered rounds that included discussions between the patients’ families and the whole team. One medicine service used a similar rounding model that did not necessarily involve the patients’ families. In contrast, the smaller medicine service typically began rounds by discussing all patients in a conference room and then visiting select patients afterwards.

From August 2014 to November 2014, peer observers gathered data on team SDM behaviors during attending rounds. After the rounding team departed, nonphysician interviewers surveyed consenting patients’ (or guardians’) views of the SDM experience, yielding paired evaluations for a subset of SDM encounters. Institutional review board approval was obtained from Stanford University and UCSF.

Participants and Inclusion Criteria

Attending physicians were hospitalists who supervised rounds at least 1 month per year, and did not include those conducting the study. All provided verbal assent to be observed on 3 days within a 7-day period. While team composition varied as needed (eg, to include the nurse, pharmacist, interpreter, etc), we restricted study observations to those teams with an attending and at least one learner (eg, resident, intern, medical student) to capture the influence of attending physicians in their training role. Because services vary in number of attendings on staff, rounds assigned per attending, and patients per round, it was not possible to enroll equal sample sizes per service in the study.

Nonintensive care unit patients who were deemed medically stable by the team were eligible for peer observation and participation in a subsequent patient interview once during the study period. Pediatric patients were invited for an interview if they were between 13 and 21 years old and had the option of having a parent or guardian present; if the pediatric patients were less than 13 years old or they were not interested in being interviewed, then their parents or guardians were invited to be interviewed. Interpreters were on rounds, and thus, non-English participants were able to participate in the peer observations, but could not participate in patient interviews because interpreters were not available during afternoons for study purposes. Consent was obtained from all participating patients and/or guardians.

Data Collection

Round and Patient Characteristics

Peer observers recorded rounding, team, and patient characteristics using a standardized form. Rounding data included date, attending name, duration of rounds, and patient census. Patient level data included the decision(s) discussed, the seniority of the clinician leading the discussion, team composition, minutes spent discussing the patient (both with the patient and/or guardian and total time), hospitalization week, and patient’s primary language. Additional patient data obtained from electronic health records included age, gender, race, ethnicity, date of admission, and admitting diagnosis.

SDM Measures

Peer-observed SDM behaviors were quantified per patient encounter using the 9-item Rochester Participatory Decision-Making Scale (RPAD), with credit given for SDM behaviors exhibited by anyone on the rounding team (team-level metric).²⁷ Each item was scored on a 3-point scale (0 = absent, 0.5 = partial, and 1 = present) for a maximum of 9 points, with higher scores indicating higher-quality SDM (Peer-RPAD Score). We created semistructured patient interview guides by adapting each RPAD item into layperson language (Patient-RPAD Score) and adding open-ended questions to assess the patient experience.

Peer-Observer Training

Eight peer-observers (7 hospitalists and 1 palliative care physician) were trained to perform RPAD ratings using videos of patient encounters. Initially, raters viewed videos together and discussed ratings for each RPAD item. The observers incorporated behavioral anchors and clinical examples into the development of an RPAD rating guide, which they subsequently used to independently score 4 videos from an online medical communication library.²⁸ These scores were discussed to resolve any differences before 4 additional videos were independently viewed, scored, and compared. Interrater reliability was achieved when the standard deviation of summed SDM scores across raters was less than 1 for all 4 videos.

Patient Interviewers

Interviewers were English-speaking volunteers without formal medical training. They were educated in hospital etiquette by a physician and in administering patient interviews through peer-to-peer role playing and an observation and feedback interview with at least 1 patient.

Data Analysis

The analysis set included every unique patient with whom a medical decision was made by an eligible clinical team. To account for the nested study design (patient-level scores within rounds, rounds within attending, and attendings within service), we used mixed-effects models to estimate mean (summary or item) RPAD score by levels of fixed covariate(s). The models included random effects accounting for attending-level and round-level correlations among scores via variance components, and allowing the attending-level random effect to differ by service. Analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC). We used descriptive statistics to summarize round- and patient-level characteristics.

SDM Variation by Attending and Service

Box plots were used to summarize raw patient-level, Peer-RPAD scores by service and attending. By using the methods described above, we estimated the mean score overall and by service. In both models, we examined the statistical significance of service-specific variation in attending-level random effects by using likelihood-ratio test (LRT) to compare models.

SDM Variation by Round and Patient Characteristics

We used the models described above to identify covariates associated with Peer-RPAD scores. We fit univariate models separately for each covariate, then fit 2 multivariable models, including (1) all covariates and (2) all effects significant in either model at P ≤ .20 according to F tests. For uniformity of presentation, we express continuous covariates categorically; however, we report P values based on continuous versions. Means generated by the multivariable models were calculated at the mean values of all other covariates in model.

Patient-Level RPAD Data

A subsample of patients completed semistructured interviews with analogous RPAD questions. To identify possible selection bias in the full sample, we summarized response rates by service and patient language and modeled Peer-RPAD scores by interview response status. Among responders, we estimated the mean Peer-RPAD and Patient-RPAD scores and their paired differences and correlations, testing for non-zero correlations via the Spearman rank test.

All Patient Encounters

The median duration of rounding sessions was 1.8 hours, median patient census was 9, and median patient encounter was 13 minutes. The duration of rounds and minutes per patient were longest at Med-2 and shortest at Peds-1. See Table 1 for other team characteristics.

Peer Evaluations of SDM Encounters

Characteristics of Patients

Teams spent a median of 13 minutes per SDM encounter, which was not higher than the round median. SDM topics discussed included 47% treatment, 15% diagnostic, 30% both treatment and diagnostic, and 7% other.

Variation in SDM Quality Among Attending Physicians

Overall Peer-RPAD Scores were normally distributed. After adjusting for the nested study design, the overall mean (standard error) score was 4.16 (0.11). Score variability among attendings differed significantly by service (LRT P = .0067). For example, raw scores were lower and more variable among attending physicians at Med-2 than other among attendings in other services (see Appendix Figure in Supporting Information). However, when service was included in the model as a fixed effect, mean scores varied significantly, from 3.0 at Med-2 to 4.7 at Med-1 (P < .0001), but the random variation among attendings no longer differed significantly by service (P = .13). This finding supports the hypothesis that service-level influences are stronger than influences of individual attending physicians, that is, that variation between services exceeded variation among attendings within service.

Aspects of SDM That Are More Prevalent on Rounds

Rounds and Patient Characteristics Associated With Peer-RPAD Scores

Patient-RPAD Results: Dissimilar Perspectives of Patients and/or Guardians and Physician Observers

Among responders, mean Patient-RPAD scores were 6.8 to 7.1 for medicine services and 7.6 to 7.8 for pediatric services (P = .01). The overall mean Patient-RPAD score, 7.46, was significantly greater than the paired Peer-RPAD score by 3.5 (P = .011); however, correlations were not statistically significantly different from 0 (by service, each P > .12).

To understand drivers of the differences between Peer-RPAD and Patient-RPAD scores, we analyzed findings by item. Each mean patient-item score exceeded its peer counterpart (P ≤ .01; panel B of Figure). Peer-item scores fell below 33% on 2 items (Items 9 and 4) and only exceeded 67% on 2 items (Items 1 and 6), whereas patient-item scores ranged from 60% (Item 8) to 97% (Item 7). Three paired differences exceeded 50% (Items 9, 4, and 7) and 3 were below 20% (Items 6, 8 and 1), underlying the lack of correlation between peer and patient scores.

In this multisite study of SDM during inpatient attending rounds, SDM quality, specific SDM behaviors, and factors contributing to SDM were identified. Our study found an adjusted overall Peer-RPAD Score of 4.4 out of 9, and found the following 3 SDM elements most needing improvement according to trained peer observers: (1) “Checking understanding of the patient’s perspective”, (2) “Examining barriers to follow-through with the treatment plan”, and (3) “Asking if the patient has questions.” Areas of strength included explaining the clinical issue or nature of the decision and matching medical language to the patient’s level of understanding, with each rated highly by both peer-observers and patients. Broadly speaking, physicians were skillful in delivering information to patients but failed to solicit input from patients. Characteristics associated with increased SDM in the multivariate analysis included the following: service, patient gender, timing of rounds during patient’s hospital stay, and amount of time rounding with each patient.

Patients similarly found that physicians could improve their abilities to elicit information from patients and families, noting the 3 lowest patient-rated SDM elements were as follows: (1) asking open-ended questions, (2) discussing alternatives or uncertainties, and (3) discussing barriers to treatment plan follow through. Overall, patients and guardians perceived the quantity and quality of SDM on rounds more favorably than peer observers, which is consistent with other studies of patient perceptions of communication. ^29-31 It is possible that patient ratings are more influenced by demand characteristics, fear of negatively impacting their patient-provider relationships, and conflation of overall satisfaction with quality of communication.³² This difference in patient perception of SDM is worthy of further study.

Prior work has revealed that SDM may occur infrequently during inpatient rounds.¹¹ This study further elucidates specific SDM behaviors used along with univariate and multivariate modeling to explore possible contributing factors. The strengths and weaknesses found were similar at all 4 services and the influence of the service was more important than variability across attendings. This study’s findings are similar to a study by Shields et al.,³³ in which the findings in a geographically different outpatient setting 10 years earlier suggesting global and enduring challenges to SDM. To our knowledge, this is the first published study to characterize inpatient SDM behaviors and may serve as the basis for future interventions.

Although the item-level components were ranked similarly across services, on average the summary Peer-RPAD score was lowest at Med-2, where we observed high variability within and between attendings, and was highest at Med-1, where variability was low. Med-2 carried the highest caseload and held the longest rounds, while Med-1 carried the lowest caseload, suggesting that modifiable burdens may hamper SDM performance. Prior studies suggest that patients are often selected based on teaching opportunities, immediate medical need and being newly admitted.³⁴ The high scores at Med-1 may reflect that service’s prediscussion of patients during card-flipping rounds or their selection of which patients to round on as a team. Consistent with prior studies^29,35 of SDM and the family-centered rounding model, which includes the involvement of nurses, respiratory therapists, pharmacists, case managers, social workers, and interpreters on rounds, both pediatrics services showed higher SDM scores.

In contrast to prior studies,^34,36 team size and number of learners did not affect SDM performance, nor did decision type. Despite teams having up to 17 members, 8 learners, and 14 complex patients, SDM scores did not vary significantly by team. Nonetheless, trends were in the directions expected: Scores tended to decrease as the team size or the percentage of trainees grew, and increased with the seniority of the presenting physician. Interestingly, SDM performance decreased with round-average minutes per patient, which may be measuring on-going intensity across cases that leads to exhaustion. Statistically significant patient factors for increased SDM included longer duration of patient encounters, second week of hospital stay, and female patient gender. Although we anticipated that the high number of decisions made early in hospitalization would facilitate higher SDM scores, continuity and stronger patient-provider relationships may enhance SDM.³⁶ We report service-specific team and patient characteristics, in addition to SDM findings in anticipation that some readers will identify with 1 service more than others.

This study has several important limitations. First, our peer observers were not blinded and primarily observed encounters at their own site. To minimize bias, observers periodically rated videos to recalibrate RPAD scoring. Second, additional SDM conversations with a patient and/or guardian may have occurred outside of rounds and were not captured, and poor patient recall may have affected Patient-RPAD scores despite interviewer prompts and timeliness of interviews within 12 hours of rounds. Third, there might have been a selection bias for the one service who selected a smaller number of patients to see, compared with the three other services that performed bedside rounds on all patients. It is possible that attending physicians selected patients who were deemed most able to have SDM conversations, thus affecting RPAD scores on that service. Fourth, study services had fewer patients on average than other academic hospitals (median 9, range 3-14), which might limit its generalizability. Last, as in any observational study, there is always the possibility of the Hawthorne effect. However, neither teams nor patients knew the study objectives.

Nevertheless, important findings emerged through the use of RPAD Scores to evaluate inpatient SDM practices. In particular, we found that to increase SDM quality in inpatient settings, practitioners should (1) check their understanding of the patient’s perspective, (2) examine barriers to follow-through with the treatment plan, and (3) ask if the patient has questions. Variation among services remained very influential after adjusting for team and patient characteristics, which suggests that “climate” or service culture should be targeted by an intervention, rather than individual attendings or subgroups defined by team or patient characteristics. Notably, team size, number of learners, patient census, and type of decision being made did not affect SDM performance, suggesting that even large, busy services can perform SDM if properly trained.

Acknowledgments

The authors thank the patients, families, pediatric and internal medicine residents, and hospitalists at Stanford School of Medicine and University of California, San Francisco School of Medicine for their participation in this study. We would also like to thank the student volunteers who collected patient perspectives on the encounters.

Disclosure 

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by an NIH/NCCIH grant R25 AT006573.

Given that multiple disciplines are often involved in caring for patients admitted to the hospital, timely communication, collaboration, and coordination amongst various disciplines is necessary for safe and effective patient care.¹ With the focus on improving patient satisfaction and throughput in hospitals, it is also important to make more accurate predictions of the discharge date and allow time for patients and their families to prepare for discharge.^2-4

Multidisciplinary rounds (MDR) are defined as structured daily communication amongst key members of the patient’s care team (eg, nurses, physicians, case managers, social workers, pharmacists, and rehabilitation services). MDR have shown to be a useful strategy for ensuring that all members of the care team are updated on the plan of care for the patient.⁵ During MDR, a brief “check-in” discussing the patient’s plan of care, pending needs, and barriers to discharge allows all team members, patients, and families to effectively coordinate care and plan and prepare for discharge.

Multiple studies have reported increased collaboration and improved communication between disciplines with the use of such multidisciplinary rounding.^2,5-7 Additionally, MDR have been shown to improve patient outcomes⁸ and reduce adverse events,⁹ length of stay (LOS),^6,8 cost of care,⁸ and readmissions.¹

We redesigned MDR on the general medicine wards at our institution in October 2014 by using Lean management techniques. Lean is defined as a set of philosophies and methods that aim to create transformation in thinking, behavior, and culture in each process, with the goal of maximizing the value for the patients and providers, adding efficiency, and reducing waste and waits.¹⁰

In this study, we evaluate whether this new model of MDR was associated with a decrease in the LOS. We also evaluate whether this new model of MDR was associated with an increase in discharges before noon, documentation of estimated discharge date (EDD) in our electronic health record (EHR), and patient satisfaction.

Setting, Design, and Patients

The study was conducted on the teaching general medicine service at our institution, an urban, 484-bed academic hospital. The general medicine service has patients on 4 inpatient units (total of 95 beds) and is managed by 5 teaching service teams.

We performed a pre-post study. The preperiod (in which the old model of MDR was followed) included 4000 patients discharged between September 1, 2013, and October 22, 2014. The postperiod (in which the new model of MDR was followed) included 2085 patients discharged between October 23, 2014, and April 30, 2015. We excluded 139 patients that died in the hospital prior to discharge and patients on the nonteaching and/or private practice service.

All data were provided by our institution’s Digital Solutions Department. Our institutional review board issued a letter of determination exempting this study from further review because it was deemed to be a quality improvement initiative.

Use of Lean Management to Redesign our MDR

Our institution has incorporated the Lean management system to continually add value to services through the elimination of waste, thus simultaneously optimizing the quality of patient care, cost, and patient satisfaction.¹¹ Lean, derived from the Toyota Production System, has long been used in manufacturing and in recent decades has spread to healthcare.¹² We leveraged the following 3 key Lean techniques to redesign our MDR: (1) value stream management (VSM), (2) rapid process improvement workshops (RPIW), and (3) active daily management (ADM), as detailed in supplementary Appendix 1.

Interventions

Outcomes

The primary outcome was mean LOS. The secondary outcomes were (1) discharges before noon, (2) recording of the EDD in our EHR within 24 hours of admission (as time stamped on our EHR), and (3) patient satisfaction.

Data for patient satisfaction were obtained using the Press Ganey survey. We used data on patient satisfaction scores for the following 2 relevant questions on this survey: (1) extent to which the patient felt ready to be discharged and (2) how well staff worked together to care for the patient. Proportions of the “top-box” (“very good”) were used for the analysis. These survey data were available on 467 patients (11.7%) in the preperiod and 188 patients (9.0%) in the postperiod.

Data Analysis

A sensitivity analysis was conducted on a second cohort that included a subset of patients from the preperiod between November 1, 2013, and April 30, 2014, and a subset of patients from the postperiod between November 1, 2014, and April 1, 2015, to control for the calendar period (supplementary Appendix 2).

All analyses were conducted in R version 3.3.0, with the linear mixed-effects model lme4 statistical package.^13,14

Table 3 shows the differences in the outcomes between the pre- and postperiods. There was no change in the LOS or LOS adjusted for CMI. There was a 3.9% increase in discharges before noon in the postperiod compared with the preperiod (95% CI, 2.4% to 5.3%; P < .001). There was a 9.9% increase in the percentage of patients for whom the EDD was recorded in our EHR within 24 hours of admission (95% CI, 7.4% to 12.4%; P < .001). There was no change in the “top-box” patient satisfaction scores.

There were only marginal differences in the results between the entire cohort and a second subset cohort used for sensitivity analysis (supplementary Appendix 2).

In our study, there was no change in the mean LOS with the new model of MDR. There was an increase in discharges before noon and in recording of the EDD in our EHR within 24 hours of admission in the postperiod when the Lean-based new model of MDR was utilized. There was no change in patient satisfaction. With no change in staffing, we were able to accommodate the increase in the discharge volume in the postperiod.

We believe our results are attributable to several factors, including clearly defined roles and responsibilities for all participants of MDR, the inclusion of more experienced general medicine attending physician (compared with housestaff), Lean management techniques to identify gaps in the patient’s journey from emergency department to discharge using VSM, the development of appropriate workflows and standard work on how the multidisciplinary teams would work together at RPIWs, and ADM to ensure sustainability and engagement among frontline members and institutional leaders. In order to sustain this, we planned to continue monitoring data in daily, weekly, and monthly forums with senior physician and administrative leaders. Planning for additional interventions is underway, including moving MDR to the bedside, instituting an afternoon “check-in” that would enable more detailed action planning, and addressing barriers in a timely manner for patients ready to discharge the following day.

Our study has a few limitations. First, this is an observational study that cannot determine causation. Second, this is a single-center study conducted on patients only on the general medicine teaching service. Third, there were several concurrent interventions implemented at our institution to improve LOS, throughput, and patient satisfaction in addition to MDR, thus making it difficult to isolate the impact of our intervention. Fourth, in the new model of MDR, rounds took place only 5 days per week, thereby possibly limiting the potential impact on our outcomes. Fifth, while we showed improvements in the discharges before noon and recording of EDD in the post period, we were not able to achieve our target of 25% discharges before noon or 100% recording of EDD in this time period. We believe the limited amount of time between the pre- and postperiods to allow for adoption and learning of the processes might have contributed to the underestimation of the impact of the new model of MDR, thereby limiting our ability to achieve our targets. Sixth, the response rate on the Press Ganey survey was low, and we did not directly survey patients or families for their satisfaction with MDR.

Our study has several strengths. To our knowledge, this is the first study to embed Lean management techniques in the design of MDR in the inpatient setting. While several studies have demonstrated improvements in discharges before noon through the implementation of MDR, they have not incorporated Lean management techniques, which we believe are critical to ensure the sustainability of results.^1,3,5,6,8,15 Second, while it was not measured, there was a high level of provider engagement in the process in the new model of MDR. Third, because the MDR were conducted at the nurse’s station on each inpatient unit in the new model instead of in a conference room, it was well attended by all members of the multidisciplinary team. Fourth, the presence of a visibility board allowed for all team members to have easy access to visual feedback throughout the day, even if they were not present at the MDR. Fifth, we believe that there was also more accurate estimation of the date and time of discharge in the new model of MDR because the discussion was facilitated by the case manager, who is experienced in identifying barriers to discharge (compared with the housestaff in the old model of MDR), and included the more experienced attending physician. Finally, the consistent presence of a multidisciplinary team at MDR allowed for the incorporation of everyone’s concerns at one time, thereby limiting the need for paging multiple disciplines throughout the day, which led to quicker resolution of issues and assignment of pending tasks.

In conclusion, our study shows no change in the mean LOS when the Lean-based model of MDR was utilized. Our study demonstrates an increase in discharges before noon and in recording of EDD on our EHR within 24 hours of admission in the post period when the Lean-based model of MDR was utilized. There was no change in patient satisfaction. While this study was conducted at an academic medical center on the general medicine wards, we believe our new model of MDR, which leveraged Lean management techniques, may successfully impact patient flow in all inpatient clinical services and nonteaching hospitals.

Disclosure

The authors report no financial conflicts of interest and have nothing to disclose.

Given that multiple disciplines are often involved in caring for patients admitted to the hospital, timely communication, collaboration, and coordination amongst various disciplines is necessary for safe and effective patient care.¹ With the focus on improving patient satisfaction and throughput in hospitals, it is also important to make more accurate predictions of the discharge date and allow time for patients and their families to prepare for discharge.^2-4

Multidisciplinary rounds (MDR) are defined as structured daily communication amongst key members of the patient’s care team (eg, nurses, physicians, case managers, social workers, pharmacists, and rehabilitation services). MDR have shown to be a useful strategy for ensuring that all members of the care team are updated on the plan of care for the patient.⁵ During MDR, a brief “check-in” discussing the patient’s plan of care, pending needs, and barriers to discharge allows all team members, patients, and families to effectively coordinate care and plan and prepare for discharge.

Multiple studies have reported increased collaboration and improved communication between disciplines with the use of such multidisciplinary rounding.^2,5-7 Additionally, MDR have been shown to improve patient outcomes⁸ and reduce adverse events,⁹ length of stay (LOS),^6,8 cost of care,⁸ and readmissions.¹

We redesigned MDR on the general medicine wards at our institution in October 2014 by using Lean management techniques. Lean is defined as a set of philosophies and methods that aim to create transformation in thinking, behavior, and culture in each process, with the goal of maximizing the value for the patients and providers, adding efficiency, and reducing waste and waits.¹⁰

In this study, we evaluate whether this new model of MDR was associated with a decrease in the LOS. We also evaluate whether this new model of MDR was associated with an increase in discharges before noon, documentation of estimated discharge date (EDD) in our electronic health record (EHR), and patient satisfaction.

Setting, Design, and Patients

The study was conducted on the teaching general medicine service at our institution, an urban, 484-bed academic hospital. The general medicine service has patients on 4 inpatient units (total of 95 beds) and is managed by 5 teaching service teams.

We performed a pre-post study. The preperiod (in which the old model of MDR was followed) included 4000 patients discharged between September 1, 2013, and October 22, 2014. The postperiod (in which the new model of MDR was followed) included 2085 patients discharged between October 23, 2014, and April 30, 2015. We excluded 139 patients that died in the hospital prior to discharge and patients on the nonteaching and/or private practice service.

All data were provided by our institution’s Digital Solutions Department. Our institutional review board issued a letter of determination exempting this study from further review because it was deemed to be a quality improvement initiative.

Use of Lean Management to Redesign our MDR

Our institution has incorporated the Lean management system to continually add value to services through the elimination of waste, thus simultaneously optimizing the quality of patient care, cost, and patient satisfaction.¹¹ Lean, derived from the Toyota Production System, has long been used in manufacturing and in recent decades has spread to healthcare.¹² We leveraged the following 3 key Lean techniques to redesign our MDR: (1) value stream management (VSM), (2) rapid process improvement workshops (RPIW), and (3) active daily management (ADM), as detailed in supplementary Appendix 1.

Interventions

Outcomes

The primary outcome was mean LOS. The secondary outcomes were (1) discharges before noon, (2) recording of the EDD in our EHR within 24 hours of admission (as time stamped on our EHR), and (3) patient satisfaction.

Data for patient satisfaction were obtained using the Press Ganey survey. We used data on patient satisfaction scores for the following 2 relevant questions on this survey: (1) extent to which the patient felt ready to be discharged and (2) how well staff worked together to care for the patient. Proportions of the “top-box” (“very good”) were used for the analysis. These survey data were available on 467 patients (11.7%) in the preperiod and 188 patients (9.0%) in the postperiod.

Data Analysis

A sensitivity analysis was conducted on a second cohort that included a subset of patients from the preperiod between November 1, 2013, and April 30, 2014, and a subset of patients from the postperiod between November 1, 2014, and April 1, 2015, to control for the calendar period (supplementary Appendix 2).

All analyses were conducted in R version 3.3.0, with the linear mixed-effects model lme4 statistical package.^13,14

Table 3 shows the differences in the outcomes between the pre- and postperiods. There was no change in the LOS or LOS adjusted for CMI. There was a 3.9% increase in discharges before noon in the postperiod compared with the preperiod (95% CI, 2.4% to 5.3%; P < .001). There was a 9.9% increase in the percentage of patients for whom the EDD was recorded in our EHR within 24 hours of admission (95% CI, 7.4% to 12.4%; P < .001). There was no change in the “top-box” patient satisfaction scores.

There were only marginal differences in the results between the entire cohort and a second subset cohort used for sensitivity analysis (supplementary Appendix 2).

In our study, there was no change in the mean LOS with the new model of MDR. There was an increase in discharges before noon and in recording of the EDD in our EHR within 24 hours of admission in the postperiod when the Lean-based new model of MDR was utilized. There was no change in patient satisfaction. With no change in staffing, we were able to accommodate the increase in the discharge volume in the postperiod.

We believe our results are attributable to several factors, including clearly defined roles and responsibilities for all participants of MDR, the inclusion of more experienced general medicine attending physician (compared with housestaff), Lean management techniques to identify gaps in the patient’s journey from emergency department to discharge using VSM, the development of appropriate workflows and standard work on how the multidisciplinary teams would work together at RPIWs, and ADM to ensure sustainability and engagement among frontline members and institutional leaders. In order to sustain this, we planned to continue monitoring data in daily, weekly, and monthly forums with senior physician and administrative leaders. Planning for additional interventions is underway, including moving MDR to the bedside, instituting an afternoon “check-in” that would enable more detailed action planning, and addressing barriers in a timely manner for patients ready to discharge the following day.

Our study has a few limitations. First, this is an observational study that cannot determine causation. Second, this is a single-center study conducted on patients only on the general medicine teaching service. Third, there were several concurrent interventions implemented at our institution to improve LOS, throughput, and patient satisfaction in addition to MDR, thus making it difficult to isolate the impact of our intervention. Fourth, in the new model of MDR, rounds took place only 5 days per week, thereby possibly limiting the potential impact on our outcomes. Fifth, while we showed improvements in the discharges before noon and recording of EDD in the post period, we were not able to achieve our target of 25% discharges before noon or 100% recording of EDD in this time period. We believe the limited amount of time between the pre- and postperiods to allow for adoption and learning of the processes might have contributed to the underestimation of the impact of the new model of MDR, thereby limiting our ability to achieve our targets. Sixth, the response rate on the Press Ganey survey was low, and we did not directly survey patients or families for their satisfaction with MDR.

Our study has several strengths. To our knowledge, this is the first study to embed Lean management techniques in the design of MDR in the inpatient setting. While several studies have demonstrated improvements in discharges before noon through the implementation of MDR, they have not incorporated Lean management techniques, which we believe are critical to ensure the sustainability of results.^1,3,5,6,8,15 Second, while it was not measured, there was a high level of provider engagement in the process in the new model of MDR. Third, because the MDR were conducted at the nurse’s station on each inpatient unit in the new model instead of in a conference room, it was well attended by all members of the multidisciplinary team. Fourth, the presence of a visibility board allowed for all team members to have easy access to visual feedback throughout the day, even if they were not present at the MDR. Fifth, we believe that there was also more accurate estimation of the date and time of discharge in the new model of MDR because the discussion was facilitated by the case manager, who is experienced in identifying barriers to discharge (compared with the housestaff in the old model of MDR), and included the more experienced attending physician. Finally, the consistent presence of a multidisciplinary team at MDR allowed for the incorporation of everyone’s concerns at one time, thereby limiting the need for paging multiple disciplines throughout the day, which led to quicker resolution of issues and assignment of pending tasks.

In conclusion, our study shows no change in the mean LOS when the Lean-based model of MDR was utilized. Our study demonstrates an increase in discharges before noon and in recording of EDD on our EHR within 24 hours of admission in the post period when the Lean-based model of MDR was utilized. There was no change in patient satisfaction. While this study was conducted at an academic medical center on the general medicine wards, we believe our new model of MDR, which leveraged Lean management techniques, may successfully impact patient flow in all inpatient clinical services and nonteaching hospitals.

Disclosure

The authors report no financial conflicts of interest and have nothing to disclose.

Given that multiple disciplines are often involved in caring for patients admitted to the hospital, timely communication, collaboration, and coordination amongst various disciplines is necessary for safe and effective patient care.¹ With the focus on improving patient satisfaction and throughput in hospitals, it is also important to make more accurate predictions of the discharge date and allow time for patients and their families to prepare for discharge.^2-4

Multidisciplinary rounds (MDR) are defined as structured daily communication amongst key members of the patient’s care team (eg, nurses, physicians, case managers, social workers, pharmacists, and rehabilitation services). MDR have shown to be a useful strategy for ensuring that all members of the care team are updated on the plan of care for the patient.⁵ During MDR, a brief “check-in” discussing the patient’s plan of care, pending needs, and barriers to discharge allows all team members, patients, and families to effectively coordinate care and plan and prepare for discharge.

Multiple studies have reported increased collaboration and improved communication between disciplines with the use of such multidisciplinary rounding.^2,5-7 Additionally, MDR have been shown to improve patient outcomes⁸ and reduce adverse events,⁹ length of stay (LOS),^6,8 cost of care,⁸ and readmissions.¹

We redesigned MDR on the general medicine wards at our institution in October 2014 by using Lean management techniques. Lean is defined as a set of philosophies and methods that aim to create transformation in thinking, behavior, and culture in each process, with the goal of maximizing the value for the patients and providers, adding efficiency, and reducing waste and waits.¹⁰

In this study, we evaluate whether this new model of MDR was associated with a decrease in the LOS. We also evaluate whether this new model of MDR was associated with an increase in discharges before noon, documentation of estimated discharge date (EDD) in our electronic health record (EHR), and patient satisfaction.

Setting, Design, and Patients

The study was conducted on the teaching general medicine service at our institution, an urban, 484-bed academic hospital. The general medicine service has patients on 4 inpatient units (total of 95 beds) and is managed by 5 teaching service teams.

We performed a pre-post study. The preperiod (in which the old model of MDR was followed) included 4000 patients discharged between September 1, 2013, and October 22, 2014. The postperiod (in which the new model of MDR was followed) included 2085 patients discharged between October 23, 2014, and April 30, 2015. We excluded 139 patients that died in the hospital prior to discharge and patients on the nonteaching and/or private practice service.

All data were provided by our institution’s Digital Solutions Department. Our institutional review board issued a letter of determination exempting this study from further review because it was deemed to be a quality improvement initiative.

Use of Lean Management to Redesign our MDR

Our institution has incorporated the Lean management system to continually add value to services through the elimination of waste, thus simultaneously optimizing the quality of patient care, cost, and patient satisfaction.¹¹ Lean, derived from the Toyota Production System, has long been used in manufacturing and in recent decades has spread to healthcare.¹² We leveraged the following 3 key Lean techniques to redesign our MDR: (1) value stream management (VSM), (2) rapid process improvement workshops (RPIW), and (3) active daily management (ADM), as detailed in supplementary Appendix 1.

Interventions

Outcomes

The primary outcome was mean LOS. The secondary outcomes were (1) discharges before noon, (2) recording of the EDD in our EHR within 24 hours of admission (as time stamped on our EHR), and (3) patient satisfaction.

Data for patient satisfaction were obtained using the Press Ganey survey. We used data on patient satisfaction scores for the following 2 relevant questions on this survey: (1) extent to which the patient felt ready to be discharged and (2) how well staff worked together to care for the patient. Proportions of the “top-box” (“very good”) were used for the analysis. These survey data were available on 467 patients (11.7%) in the preperiod and 188 patients (9.0%) in the postperiod.

Data Analysis

A sensitivity analysis was conducted on a second cohort that included a subset of patients from the preperiod between November 1, 2013, and April 30, 2014, and a subset of patients from the postperiod between November 1, 2014, and April 1, 2015, to control for the calendar period (supplementary Appendix 2).

All analyses were conducted in R version 3.3.0, with the linear mixed-effects model lme4 statistical package.^13,14

Table 3 shows the differences in the outcomes between the pre- and postperiods. There was no change in the LOS or LOS adjusted for CMI. There was a 3.9% increase in discharges before noon in the postperiod compared with the preperiod (95% CI, 2.4% to 5.3%; P < .001). There was a 9.9% increase in the percentage of patients for whom the EDD was recorded in our EHR within 24 hours of admission (95% CI, 7.4% to 12.4%; P < .001). There was no change in the “top-box” patient satisfaction scores.

There were only marginal differences in the results between the entire cohort and a second subset cohort used for sensitivity analysis (supplementary Appendix 2).

In our study, there was no change in the mean LOS with the new model of MDR. There was an increase in discharges before noon and in recording of the EDD in our EHR within 24 hours of admission in the postperiod when the Lean-based new model of MDR was utilized. There was no change in patient satisfaction. With no change in staffing, we were able to accommodate the increase in the discharge volume in the postperiod.

We believe our results are attributable to several factors, including clearly defined roles and responsibilities for all participants of MDR, the inclusion of more experienced general medicine attending physician (compared with housestaff), Lean management techniques to identify gaps in the patient’s journey from emergency department to discharge using VSM, the development of appropriate workflows and standard work on how the multidisciplinary teams would work together at RPIWs, and ADM to ensure sustainability and engagement among frontline members and institutional leaders. In order to sustain this, we planned to continue monitoring data in daily, weekly, and monthly forums with senior physician and administrative leaders. Planning for additional interventions is underway, including moving MDR to the bedside, instituting an afternoon “check-in” that would enable more detailed action planning, and addressing barriers in a timely manner for patients ready to discharge the following day.

Our study has a few limitations. First, this is an observational study that cannot determine causation. Second, this is a single-center study conducted on patients only on the general medicine teaching service. Third, there were several concurrent interventions implemented at our institution to improve LOS, throughput, and patient satisfaction in addition to MDR, thus making it difficult to isolate the impact of our intervention. Fourth, in the new model of MDR, rounds took place only 5 days per week, thereby possibly limiting the potential impact on our outcomes. Fifth, while we showed improvements in the discharges before noon and recording of EDD in the post period, we were not able to achieve our target of 25% discharges before noon or 100% recording of EDD in this time period. We believe the limited amount of time between the pre- and postperiods to allow for adoption and learning of the processes might have contributed to the underestimation of the impact of the new model of MDR, thereby limiting our ability to achieve our targets. Sixth, the response rate on the Press Ganey survey was low, and we did not directly survey patients or families for their satisfaction with MDR.

Our study has several strengths. To our knowledge, this is the first study to embed Lean management techniques in the design of MDR in the inpatient setting. While several studies have demonstrated improvements in discharges before noon through the implementation of MDR, they have not incorporated Lean management techniques, which we believe are critical to ensure the sustainability of results.^1,3,5,6,8,15 Second, while it was not measured, there was a high level of provider engagement in the process in the new model of MDR. Third, because the MDR were conducted at the nurse’s station on each inpatient unit in the new model instead of in a conference room, it was well attended by all members of the multidisciplinary team. Fourth, the presence of a visibility board allowed for all team members to have easy access to visual feedback throughout the day, even if they were not present at the MDR. Fifth, we believe that there was also more accurate estimation of the date and time of discharge in the new model of MDR because the discussion was facilitated by the case manager, who is experienced in identifying barriers to discharge (compared with the housestaff in the old model of MDR), and included the more experienced attending physician. Finally, the consistent presence of a multidisciplinary team at MDR allowed for the incorporation of everyone’s concerns at one time, thereby limiting the need for paging multiple disciplines throughout the day, which led to quicker resolution of issues and assignment of pending tasks.

In conclusion, our study shows no change in the mean LOS when the Lean-based model of MDR was utilized. Our study demonstrates an increase in discharges before noon and in recording of EDD on our EHR within 24 hours of admission in the post period when the Lean-based model of MDR was utilized. There was no change in patient satisfaction. While this study was conducted at an academic medical center on the general medicine wards, we believe our new model of MDR, which leveraged Lean management techniques, may successfully impact patient flow in all inpatient clinical services and nonteaching hospitals.

Disclosure

The authors report no financial conflicts of interest and have nothing to disclose.

Many hospitals are considering or currently employing initiatives to contact patients after discharge. Whether conducted via telephone or other means, the purpose of the contact is to help patients adhere to discharge plans, fulfill discharge needs, and alleviate postdischarge issues (PDIs). The effectiveness of hospital-initiated postdischarge phone calls has been studied in adult patients after hospitalization, and though some studies report positive outcomes,^1-3 a 2006 Cochrane review found insufficient evidence to recommend for or against the practice.⁴

Little is known about follow-up contact after hospitalization for children.^5-11 Rates of PDI vary substantially across hospitals. For example, one single-center study of postdischarge telephone contact after hospitalization on a general pediatric ward identified PDIs in ~20% of patients.¹⁰ Another study identified PDIs in 84% of patients discharged from a pediatric rehabilitation facility.¹¹ Telephone follow-up has been associated with reduced health resource utilization and improved patient satisfaction for children discharged after an elective surgical procedure⁶ and for children discharged home from the emergency department.^7-9

More information is needed on the clinical experiences of postdischarge contact in hospitalized children to improve the understanding of how the contact is made, who makes it, and which patients are most likely to report a PDI. These experiences are crucial to understand given the expense and time commitment involved in postdischarge contact, as many hospitals may not be positioned to contact all discharged patients. Therefore, we conducted a pragmatic, retrospective, naturalistic study of differing approaches to postdischarge contact occurring in multiple hospitals. Our main objective was to describe the prevalence and types of PDIs identified by the different approaches for follow-up contact across 4 children’s hospitals. We also assessed the characteristics of children who have the highest likelihood of having a PDI identified from the contact within each hospital.

Study Design, Setting, and Population

Main Outcome Measures

The main outcome measure was identification of a PDI, defined as a medication, appointment, or other discharge-related issue, that was reported and recorded by the child’s caregiver during conversation from the standardized questions that were asked during follow-up contact as part of routine discharge care (Table 1). Medication PDIs included issues filling prescriptions and tolerating medications. Appointment PDIs included not having a follow-up appointment scheduled. Other PDIs included issues with the child’s health condition, discharge instructions, or any other concerns. All PDIs had been recorded prospectively by hospital contact personnel (hospitals A, B, and D) or through an automated texting system into a database (hospital C). Where available, free text comments that were recorded by contact personnel were reviewed by one of the authors (KB) and categorized via an existing framework of PDI designed by Heath et al.¹⁰ in order to further understand the problems that were reported.

Patient Characteristics

Patient hospitalization, demographic, and clinical characteristics were obtained from administrative health data at each institution and compared between children with versus without a PDI. Hospitalization characteristics included length of stay, season of admission, and reason for admission. Reason for admission was categorized by using 3M Health’s All Patient Refined Diagnosis Related Groups (APR-DRG) (3M, Maplewood, MN). Demographic characteristics included age at admission in years, insurance type (eg, public, private, and other), and race/ethnicity (Asian/Pacific Islander, Hispanic, non-Hispanic black, non-Hispanic white, and other).

Clinical characteristics included a count of the different classes of medications (eg, antibiotics, antiepileptic medications, digestive motility medications, etc.) administered to the child during admission, the type and number of chronic conditions, and assistance with medical technology (eg, gastrostomy, tracheostomy, etc.). Except for medications, these characteristics were assessed with International Classification of Diseases, Ninth Revision-Clinical Modification (ICD-9-CM) diagnosis codes.

We used the Agency for Healthcare Research and Quality Chronic Condition Indicator classification system, which categorizes over 14,000 ICD-9-CM diagnosis codes into chronic versus nonchronic conditions to identify the presence and number of chronic conditions.¹² Children hospitalized with a chronic condition were further classified as having a complex chronic condition (CCC) by using the ICD-9-CM diagnosis classification scheme of Feudtner et al.¹³ CCCs represent defined diagnosis groupings of conditions expected to last longer than 12 months and involve either multiple organ systems or a single organ system severely enough to require specialty pediatric care and hospitalization.^13,14 Children requiring medical technology were identified by using ICD-9-CM codes indicating their use of a medical device to manage and treat a chronic illness (eg, ventricular shunt to treat hydrocephalus) or to maintain basic body functions necessary for sustaining life (eg a tracheostomy tube for breathing).^15,16

Statistical Analysis

Given that the primary purpose for this study was to leverage the natural heterogeneity in the approach to follow-up contact across hospitals, we assessed and reported the prevalence and type of PDIs independently for each hospital. Relatedly, we assessed the relationship between patient characteristics and PDI likelihood independently within each hospital as well rather than pool the data and perform a central analysis across hospitals. Of note, APR-DRG and medication class were not assessed for hospital D, as this information was unavailable. We used χ² tests for univariable analysis and logistic regression with a backwards elimination derivation process (for variables with P ≥ .05) for multivariable analysis; all patient demographic, clinical, and hospitalization characteristics were entered initially into the models. All statistical analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC), and P < .05 was considered statistically significant. This study was approved by the institutional review board at all hospitals.

Study Population

There were 12,986 (51.4%) of 25,259 patients reached by follow-up contact after discharge across the 4 hospitals. Median age at admission for contacted patients was 4.0 years (interquartile range [IQR] 0-11). Of those contacted, 45.2% were female, 59.9% were non-Hispanic white, 51.0% used Medicaid, and 95.4% were discharged to home. Seventy-one percent had a chronic condition (of any complexity) and 40.8% had a CCC. Eighty percent received a prescribed medication during the hospitalization. Median (IQR) length of stay was 2.0 days (IQR 1-4 days). The top 5 most common reasons for admission were bronchiolitis (6.3%), pneumonia (6.2%), asthma (5.2%), seizure (4.9%), and tonsil and adenoid procedures (4.1%).

PDIs

Characteristics Associated with PDIs

Age

Older age was a consistent characteristic associated with PDIs in 3 hospitals. For example, PDI rates in children 10 to 18 years versus <1 year were 30.8% versus 21.4% (P < .001) in hospital A, 19.4% versus 13.7% (P = .002) in hospital B, and 70.3% versus 62.8% (P < .001) in hospital D. In multivariable analysis, age 10 to 18 years versus <1 year at admission was associated with an increased likelihood of PDI in hospital A (odds ratio [OR] 1.7; 95% CI, 1.4-2.0), hospital B (OR 1.4; 95% CI, 1.1-1.8), and hospital D (OR 1.7; 95% CI, 0.9-3.0) (Table 3 and Figure).

Medications

Length of Stay

Shorter length of stay was associated with PDI in 1 hospital. In hospital A, the PDI rate increased significantly (P < .001) from 19.0% to 33.9% as length of stay decreased from ≥7 days to ≤1 day (Table 3). In multivariable analysis, length of stay to ≤1 day versus ≥7 days was associated with increased likelihood of PDI (OR 2.1; 95% CI, 1.7-2.5) in hospital A (Table 3 and Figure).

CCCs

A neuromuscular CCC was associated with PDI in 2 hospitals. In hospital B, the PDI rate was higher in children with a neuromuscular CCC compared with a malignancy CCC (21.3% vs 11.2%). In hospital D, the PDI rates were higher in children with a neuromuscular CCC compared with a respiratory CCC (68.9% vs 40.6%) (Table 3). In multivariable analysis, children with versus without a neuromuscular CCC had an increased likelihood of PDI (OR 1.3; 95% CI, 1.0-1.7) in hospital B (Table 3 and Figure).

In this retrospective, pragmatic, multicentered study of follow-up contact with a standardized set of questions asked after discharge for hospitalized children, we found that PDIs were identified often, regardless of who made the contact or how the contact was made. The PDI rates varied substantially across hospitals and were likely influenced by the different follow-up approaches that were used. Most PDIs were related to appointments; fewer PDIs were related to medications and other problems. Older age, shorter length of stay, and neuromuscular CCCs were among the identified risk factors for PDIs.

Our assessment of PDIs was, by design, associated with variation in methods and approach for detection across sites. Further investigation is needed to understand how different approaches for follow-up contact after discharge may influence the identification of PDIs. For example, in the current study, the hospital with the highest PDI rate (hospital D) used hospitalists who provided inpatient care for the patient to make follow-up contact. Although not determined from the current study, this approach could have led the hospitalists to ask questions beyond the standardized ones when assessing for PDIs. Perhaps some of the hospitalists had a better understanding of how to probe for PDIs specific to each patient; this understanding may not have been forthcoming for staff in the other hospitals who were unfamiliar with the patients’ hospitalization course and medical history.

Similar to previous studies in adults, our study reported that appointment PDIs in children may be more common than other types of PDIs.¹⁷ Appointment PDIs could have been due to scheduling difficulties, inadequate discharge instructions, lack of adherence to recommended follow-up, or other reasons. Further investigation is needed to elucidate these reasons and to determine how to reduce PDIs related to postdischarge appointments. Some children’s hospitals schedule follow-up appointments prior to discharge to mitigate appointment PDIs that might arise.¹⁸ However, doing that for every hospitalized child is challenging, especially for very short admissions or for weekend discharges when many outpatient and community practices are not open to schedule appointments. Additional exploration is necessary to assess whether this might help explain why some children in the current study with a short versus long length of stay had a higher likelihood of PDI.

The rate of medication PDIs (5.2%) observed in the current study is lower than the rate that is reported in prior literature. Dudas et al.¹ found that medication PDIs occurred in 21% of hospitalized adult patients. One reason for the lower rate of medication PDIs in children may be that they require the use of postdischarge medications less often than adults. Most medication PDIs in the current study involved problems filling a prescription. There was not enough information in the notes taken from the follow-up contact to distinguish the medication PDI etiologies (eg, a prescription was not sent from the hospital team to the pharmacy, prior authorization from an insurance company for a prescription was not obtained, the pharmacy did not stock the medication). To help overcome medication access barriers, some hospitals fill and deliver discharge medications to the patients’ bedside. One study found that children discharged with medication in hand were less likely to have emergency department revisits within 30 days of discharge.¹⁹ Further investigation is needed to assess whether initiatives like these help mitigate medication PDIs in children.

Hospitals may benefit from considering how risk factors for PDIs can be used to prioritize which patients receive follow-up contact, especially in hospitals where contact for all hospitalized patients is not feasible. In the current study, there was variation across hospitals in the profile of risk factors that correlated with increased likelihood of PDI. Some of the risk factors are easier to explain than others. For example, as mentioned above, for some hospitalized children, short length of stay might not permit enough time for hospital staff to set up discharge plans that may sufficiently prevent PDIs. Other risk factors, including older age and neuromuscular CCCs, may require additional assessment (eg, through chart review or in-depth patient and provider interviews) to discover the reasons why they were associated with increased likelihood of PDI. There are additional risk factors that might influence the likelihood of PDI that the current study was not positioned to assess, including health literacy, transportation availability, and language spoken.^20-23

This study has several other limitations in addition to the ones already mentioned. Some children may have experienced PDIs that were not reported at contact (eg, the respondent was unaware that an issue was present), which may have led to an undercounting of PDIs. Alternatively, some caregivers may have been more likely to respond to the contact if their child was experiencing a PDI, which may have led to overcounting. PDIs of nonrespondents were not measured. PDIs identified by postdischarge outpatient and community providers or by families outside of contact were not measured. The current study was not positioned to assess the severity of the PDIs or what interventions (including additional health services) were needed to address them. Although we assessed medication use during admission, we were unable to assess the number and type of medications that were prescribed for use postdischarge. Information about the number and type of follow-up visits needed for each child was not assessed. Given the variety of approaches for follow-up contact, the findings may generalize best to individual hospitals by using an approach that best matches to one of them. The current study is not positioned to correlate quality of discharge care with the rate of PDI.

Despite these limitations, the findings from the current study reinforce that PDIs identified through follow-up contact in discharged patients appear to be common. Of PDIs identified, appointment problems were more prevalent than medication or other types of problems. Short length of stay, older age, and other patient and/or hospitalization attributes were associated with an increased likelihood of PDI. Hospitals caring for children may find this information useful as they strive to optimize their processes for follow-up contact after discharge. To help further evaluate the value and importance of contacting patients after discharge, additional study of PDI in children is warranted, including (1) actions taken to resolve PDIs, (2) the impact of identifying and addressing PDIs on hospital readmission, and (3) postdischarge experiences and health outcomes of children who responded versus those who did not respond to the follow-up contact. Moreover, future multisite, comparative effectiveness studies of PDI may wish to consider standardization of follow-up contact procedures with controlled manipulation of key processes (eg, contact by administrator vs nurse vs physician) to assess best practices.

Disclosure

Mr. Blaine, Ms. O’Neill, and Drs. Berry, Brittan, Rehm, and Steiner were supported by the Lucile Packard Foundation for Children’s Health. The authors have no financial relationships relative to this article to disclose. The authors have no conflicts of interest to disclose.

Many hospitals are considering or currently employing initiatives to contact patients after discharge. Whether conducted via telephone or other means, the purpose of the contact is to help patients adhere to discharge plans, fulfill discharge needs, and alleviate postdischarge issues (PDIs). The effectiveness of hospital-initiated postdischarge phone calls has been studied in adult patients after hospitalization, and though some studies report positive outcomes,^1-3 a 2006 Cochrane review found insufficient evidence to recommend for or against the practice.⁴

Little is known about follow-up contact after hospitalization for children.^5-11 Rates of PDI vary substantially across hospitals. For example, one single-center study of postdischarge telephone contact after hospitalization on a general pediatric ward identified PDIs in ~20% of patients.¹⁰ Another study identified PDIs in 84% of patients discharged from a pediatric rehabilitation facility.¹¹ Telephone follow-up has been associated with reduced health resource utilization and improved patient satisfaction for children discharged after an elective surgical procedure⁶ and for children discharged home from the emergency department.^7-9

More information is needed on the clinical experiences of postdischarge contact in hospitalized children to improve the understanding of how the contact is made, who makes it, and which patients are most likely to report a PDI. These experiences are crucial to understand given the expense and time commitment involved in postdischarge contact, as many hospitals may not be positioned to contact all discharged patients. Therefore, we conducted a pragmatic, retrospective, naturalistic study of differing approaches to postdischarge contact occurring in multiple hospitals. Our main objective was to describe the prevalence and types of PDIs identified by the different approaches for follow-up contact across 4 children’s hospitals. We also assessed the characteristics of children who have the highest likelihood of having a PDI identified from the contact within each hospital.

Study Design, Setting, and Population

Main Outcome Measures

The main outcome measure was identification of a PDI, defined as a medication, appointment, or other discharge-related issue, that was reported and recorded by the child’s caregiver during conversation from the standardized questions that were asked during follow-up contact as part of routine discharge care (Table 1). Medication PDIs included issues filling prescriptions and tolerating medications. Appointment PDIs included not having a follow-up appointment scheduled. Other PDIs included issues with the child’s health condition, discharge instructions, or any other concerns. All PDIs had been recorded prospectively by hospital contact personnel (hospitals A, B, and D) or through an automated texting system into a database (hospital C). Where available, free text comments that were recorded by contact personnel were reviewed by one of the authors (KB) and categorized via an existing framework of PDI designed by Heath et al.¹⁰ in order to further understand the problems that were reported.

Patient Characteristics

Patient hospitalization, demographic, and clinical characteristics were obtained from administrative health data at each institution and compared between children with versus without a PDI. Hospitalization characteristics included length of stay, season of admission, and reason for admission. Reason for admission was categorized by using 3M Health’s All Patient Refined Diagnosis Related Groups (APR-DRG) (3M, Maplewood, MN). Demographic characteristics included age at admission in years, insurance type (eg, public, private, and other), and race/ethnicity (Asian/Pacific Islander, Hispanic, non-Hispanic black, non-Hispanic white, and other).

Clinical characteristics included a count of the different classes of medications (eg, antibiotics, antiepileptic medications, digestive motility medications, etc.) administered to the child during admission, the type and number of chronic conditions, and assistance with medical technology (eg, gastrostomy, tracheostomy, etc.). Except for medications, these characteristics were assessed with International Classification of Diseases, Ninth Revision-Clinical Modification (ICD-9-CM) diagnosis codes.

We used the Agency for Healthcare Research and Quality Chronic Condition Indicator classification system, which categorizes over 14,000 ICD-9-CM diagnosis codes into chronic versus nonchronic conditions to identify the presence and number of chronic conditions.¹² Children hospitalized with a chronic condition were further classified as having a complex chronic condition (CCC) by using the ICD-9-CM diagnosis classification scheme of Feudtner et al.¹³ CCCs represent defined diagnosis groupings of conditions expected to last longer than 12 months and involve either multiple organ systems or a single organ system severely enough to require specialty pediatric care and hospitalization.^13,14 Children requiring medical technology were identified by using ICD-9-CM codes indicating their use of a medical device to manage and treat a chronic illness (eg, ventricular shunt to treat hydrocephalus) or to maintain basic body functions necessary for sustaining life (eg a tracheostomy tube for breathing).^15,16

Statistical Analysis

Given that the primary purpose for this study was to leverage the natural heterogeneity in the approach to follow-up contact across hospitals, we assessed and reported the prevalence and type of PDIs independently for each hospital. Relatedly, we assessed the relationship between patient characteristics and PDI likelihood independently within each hospital as well rather than pool the data and perform a central analysis across hospitals. Of note, APR-DRG and medication class were not assessed for hospital D, as this information was unavailable. We used χ² tests for univariable analysis and logistic regression with a backwards elimination derivation process (for variables with P ≥ .05) for multivariable analysis; all patient demographic, clinical, and hospitalization characteristics were entered initially into the models. All statistical analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC), and P < .05 was considered statistically significant. This study was approved by the institutional review board at all hospitals.

Study Population

There were 12,986 (51.4%) of 25,259 patients reached by follow-up contact after discharge across the 4 hospitals. Median age at admission for contacted patients was 4.0 years (interquartile range [IQR] 0-11). Of those contacted, 45.2% were female, 59.9% were non-Hispanic white, 51.0% used Medicaid, and 95.4% were discharged to home. Seventy-one percent had a chronic condition (of any complexity) and 40.8% had a CCC. Eighty percent received a prescribed medication during the hospitalization. Median (IQR) length of stay was 2.0 days (IQR 1-4 days). The top 5 most common reasons for admission were bronchiolitis (6.3%), pneumonia (6.2%), asthma (5.2%), seizure (4.9%), and tonsil and adenoid procedures (4.1%).

PDIs

Characteristics Associated with PDIs

Age

Older age was a consistent characteristic associated with PDIs in 3 hospitals. For example, PDI rates in children 10 to 18 years versus <1 year were 30.8% versus 21.4% (P < .001) in hospital A, 19.4% versus 13.7% (P = .002) in hospital B, and 70.3% versus 62.8% (P < .001) in hospital D. In multivariable analysis, age 10 to 18 years versus <1 year at admission was associated with an increased likelihood of PDI in hospital A (odds ratio [OR] 1.7; 95% CI, 1.4-2.0), hospital B (OR 1.4; 95% CI, 1.1-1.8), and hospital D (OR 1.7; 95% CI, 0.9-3.0) (Table 3 and Figure).

Medications

Length of Stay

Shorter length of stay was associated with PDI in 1 hospital. In hospital A, the PDI rate increased significantly (P < .001) from 19.0% to 33.9% as length of stay decreased from ≥7 days to ≤1 day (Table 3). In multivariable analysis, length of stay to ≤1 day versus ≥7 days was associated with increased likelihood of PDI (OR 2.1; 95% CI, 1.7-2.5) in hospital A (Table 3 and Figure).

CCCs

A neuromuscular CCC was associated with PDI in 2 hospitals. In hospital B, the PDI rate was higher in children with a neuromuscular CCC compared with a malignancy CCC (21.3% vs 11.2%). In hospital D, the PDI rates were higher in children with a neuromuscular CCC compared with a respiratory CCC (68.9% vs 40.6%) (Table 3). In multivariable analysis, children with versus without a neuromuscular CCC had an increased likelihood of PDI (OR 1.3; 95% CI, 1.0-1.7) in hospital B (Table 3 and Figure).

In this retrospective, pragmatic, multicentered study of follow-up contact with a standardized set of questions asked after discharge for hospitalized children, we found that PDIs were identified often, regardless of who made the contact or how the contact was made. The PDI rates varied substantially across hospitals and were likely influenced by the different follow-up approaches that were used. Most PDIs were related to appointments; fewer PDIs were related to medications and other problems. Older age, shorter length of stay, and neuromuscular CCCs were among the identified risk factors for PDIs.

Our assessment of PDIs was, by design, associated with variation in methods and approach for detection across sites. Further investigation is needed to understand how different approaches for follow-up contact after discharge may influence the identification of PDIs. For example, in the current study, the hospital with the highest PDI rate (hospital D) used hospitalists who provided inpatient care for the patient to make follow-up contact. Although not determined from the current study, this approach could have led the hospitalists to ask questions beyond the standardized ones when assessing for PDIs. Perhaps some of the hospitalists had a better understanding of how to probe for PDIs specific to each patient; this understanding may not have been forthcoming for staff in the other hospitals who were unfamiliar with the patients’ hospitalization course and medical history.

Similar to previous studies in adults, our study reported that appointment PDIs in children may be more common than other types of PDIs.¹⁷ Appointment PDIs could have been due to scheduling difficulties, inadequate discharge instructions, lack of adherence to recommended follow-up, or other reasons. Further investigation is needed to elucidate these reasons and to determine how to reduce PDIs related to postdischarge appointments. Some children’s hospitals schedule follow-up appointments prior to discharge to mitigate appointment PDIs that might arise.¹⁸ However, doing that for every hospitalized child is challenging, especially for very short admissions or for weekend discharges when many outpatient and community practices are not open to schedule appointments. Additional exploration is necessary to assess whether this might help explain why some children in the current study with a short versus long length of stay had a higher likelihood of PDI.

The rate of medication PDIs (5.2%) observed in the current study is lower than the rate that is reported in prior literature. Dudas et al.¹ found that medication PDIs occurred in 21% of hospitalized adult patients. One reason for the lower rate of medication PDIs in children may be that they require the use of postdischarge medications less often than adults. Most medication PDIs in the current study involved problems filling a prescription. There was not enough information in the notes taken from the follow-up contact to distinguish the medication PDI etiologies (eg, a prescription was not sent from the hospital team to the pharmacy, prior authorization from an insurance company for a prescription was not obtained, the pharmacy did not stock the medication). To help overcome medication access barriers, some hospitals fill and deliver discharge medications to the patients’ bedside. One study found that children discharged with medication in hand were less likely to have emergency department revisits within 30 days of discharge.¹⁹ Further investigation is needed to assess whether initiatives like these help mitigate medication PDIs in children.

Hospitals may benefit from considering how risk factors for PDIs can be used to prioritize which patients receive follow-up contact, especially in hospitals where contact for all hospitalized patients is not feasible. In the current study, there was variation across hospitals in the profile of risk factors that correlated with increased likelihood of PDI. Some of the risk factors are easier to explain than others. For example, as mentioned above, for some hospitalized children, short length of stay might not permit enough time for hospital staff to set up discharge plans that may sufficiently prevent PDIs. Other risk factors, including older age and neuromuscular CCCs, may require additional assessment (eg, through chart review or in-depth patient and provider interviews) to discover the reasons why they were associated with increased likelihood of PDI. There are additional risk factors that might influence the likelihood of PDI that the current study was not positioned to assess, including health literacy, transportation availability, and language spoken.^20-23

This study has several other limitations in addition to the ones already mentioned. Some children may have experienced PDIs that were not reported at contact (eg, the respondent was unaware that an issue was present), which may have led to an undercounting of PDIs. Alternatively, some caregivers may have been more likely to respond to the contact if their child was experiencing a PDI, which may have led to overcounting. PDIs of nonrespondents were not measured. PDIs identified by postdischarge outpatient and community providers or by families outside of contact were not measured. The current study was not positioned to assess the severity of the PDIs or what interventions (including additional health services) were needed to address them. Although we assessed medication use during admission, we were unable to assess the number and type of medications that were prescribed for use postdischarge. Information about the number and type of follow-up visits needed for each child was not assessed. Given the variety of approaches for follow-up contact, the findings may generalize best to individual hospitals by using an approach that best matches to one of them. The current study is not positioned to correlate quality of discharge care with the rate of PDI.

Despite these limitations, the findings from the current study reinforce that PDIs identified through follow-up contact in discharged patients appear to be common. Of PDIs identified, appointment problems were more prevalent than medication or other types of problems. Short length of stay, older age, and other patient and/or hospitalization attributes were associated with an increased likelihood of PDI. Hospitals caring for children may find this information useful as they strive to optimize their processes for follow-up contact after discharge. To help further evaluate the value and importance of contacting patients after discharge, additional study of PDI in children is warranted, including (1) actions taken to resolve PDIs, (2) the impact of identifying and addressing PDIs on hospital readmission, and (3) postdischarge experiences and health outcomes of children who responded versus those who did not respond to the follow-up contact. Moreover, future multisite, comparative effectiveness studies of PDI may wish to consider standardization of follow-up contact procedures with controlled manipulation of key processes (eg, contact by administrator vs nurse vs physician) to assess best practices.

Disclosure

Mr. Blaine, Ms. O’Neill, and Drs. Berry, Brittan, Rehm, and Steiner were supported by the Lucile Packard Foundation for Children’s Health. The authors have no financial relationships relative to this article to disclose. The authors have no conflicts of interest to disclose.

Many hospitals are considering or currently employing initiatives to contact patients after discharge. Whether conducted via telephone or other means, the purpose of the contact is to help patients adhere to discharge plans, fulfill discharge needs, and alleviate postdischarge issues (PDIs). The effectiveness of hospital-initiated postdischarge phone calls has been studied in adult patients after hospitalization, and though some studies report positive outcomes,^1-3 a 2006 Cochrane review found insufficient evidence to recommend for or against the practice.⁴

Little is known about follow-up contact after hospitalization for children.^5-11 Rates of PDI vary substantially across hospitals. For example, one single-center study of postdischarge telephone contact after hospitalization on a general pediatric ward identified PDIs in ~20% of patients.¹⁰ Another study identified PDIs in 84% of patients discharged from a pediatric rehabilitation facility.¹¹ Telephone follow-up has been associated with reduced health resource utilization and improved patient satisfaction for children discharged after an elective surgical procedure⁶ and for children discharged home from the emergency department.^7-9

More information is needed on the clinical experiences of postdischarge contact in hospitalized children to improve the understanding of how the contact is made, who makes it, and which patients are most likely to report a PDI. These experiences are crucial to understand given the expense and time commitment involved in postdischarge contact, as many hospitals may not be positioned to contact all discharged patients. Therefore, we conducted a pragmatic, retrospective, naturalistic study of differing approaches to postdischarge contact occurring in multiple hospitals. Our main objective was to describe the prevalence and types of PDIs identified by the different approaches for follow-up contact across 4 children’s hospitals. We also assessed the characteristics of children who have the highest likelihood of having a PDI identified from the contact within each hospital.

Study Design, Setting, and Population

Main Outcome Measures

The main outcome measure was identification of a PDI, defined as a medication, appointment, or other discharge-related issue, that was reported and recorded by the child’s caregiver during conversation from the standardized questions that were asked during follow-up contact as part of routine discharge care (Table 1). Medication PDIs included issues filling prescriptions and tolerating medications. Appointment PDIs included not having a follow-up appointment scheduled. Other PDIs included issues with the child’s health condition, discharge instructions, or any other concerns. All PDIs had been recorded prospectively by hospital contact personnel (hospitals A, B, and D) or through an automated texting system into a database (hospital C). Where available, free text comments that were recorded by contact personnel were reviewed by one of the authors (KB) and categorized via an existing framework of PDI designed by Heath et al.¹⁰ in order to further understand the problems that were reported.

Patient Characteristics

Patient hospitalization, demographic, and clinical characteristics were obtained from administrative health data at each institution and compared between children with versus without a PDI. Hospitalization characteristics included length of stay, season of admission, and reason for admission. Reason for admission was categorized by using 3M Health’s All Patient Refined Diagnosis Related Groups (APR-DRG) (3M, Maplewood, MN). Demographic characteristics included age at admission in years, insurance type (eg, public, private, and other), and race/ethnicity (Asian/Pacific Islander, Hispanic, non-Hispanic black, non-Hispanic white, and other).

Clinical characteristics included a count of the different classes of medications (eg, antibiotics, antiepileptic medications, digestive motility medications, etc.) administered to the child during admission, the type and number of chronic conditions, and assistance with medical technology (eg, gastrostomy, tracheostomy, etc.). Except for medications, these characteristics were assessed with International Classification of Diseases, Ninth Revision-Clinical Modification (ICD-9-CM) diagnosis codes.

We used the Agency for Healthcare Research and Quality Chronic Condition Indicator classification system, which categorizes over 14,000 ICD-9-CM diagnosis codes into chronic versus nonchronic conditions to identify the presence and number of chronic conditions.¹² Children hospitalized with a chronic condition were further classified as having a complex chronic condition (CCC) by using the ICD-9-CM diagnosis classification scheme of Feudtner et al.¹³ CCCs represent defined diagnosis groupings of conditions expected to last longer than 12 months and involve either multiple organ systems or a single organ system severely enough to require specialty pediatric care and hospitalization.^13,14 Children requiring medical technology were identified by using ICD-9-CM codes indicating their use of a medical device to manage and treat a chronic illness (eg, ventricular shunt to treat hydrocephalus) or to maintain basic body functions necessary for sustaining life (eg a tracheostomy tube for breathing).^15,16

Statistical Analysis

Given that the primary purpose for this study was to leverage the natural heterogeneity in the approach to follow-up contact across hospitals, we assessed and reported the prevalence and type of PDIs independently for each hospital. Relatedly, we assessed the relationship between patient characteristics and PDI likelihood independently within each hospital as well rather than pool the data and perform a central analysis across hospitals. Of note, APR-DRG and medication class were not assessed for hospital D, as this information was unavailable. We used χ² tests for univariable analysis and logistic regression with a backwards elimination derivation process (for variables with P ≥ .05) for multivariable analysis; all patient demographic, clinical, and hospitalization characteristics were entered initially into the models. All statistical analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC), and P < .05 was considered statistically significant. This study was approved by the institutional review board at all hospitals.

Study Population

There were 12,986 (51.4%) of 25,259 patients reached by follow-up contact after discharge across the 4 hospitals. Median age at admission for contacted patients was 4.0 years (interquartile range [IQR] 0-11). Of those contacted, 45.2% were female, 59.9% were non-Hispanic white, 51.0% used Medicaid, and 95.4% were discharged to home. Seventy-one percent had a chronic condition (of any complexity) and 40.8% had a CCC. Eighty percent received a prescribed medication during the hospitalization. Median (IQR) length of stay was 2.0 days (IQR 1-4 days). The top 5 most common reasons for admission were bronchiolitis (6.3%), pneumonia (6.2%), asthma (5.2%), seizure (4.9%), and tonsil and adenoid procedures (4.1%).

PDIs

Characteristics Associated with PDIs

Age

Older age was a consistent characteristic associated with PDIs in 3 hospitals. For example, PDI rates in children 10 to 18 years versus <1 year were 30.8% versus 21.4% (P < .001) in hospital A, 19.4% versus 13.7% (P = .002) in hospital B, and 70.3% versus 62.8% (P < .001) in hospital D. In multivariable analysis, age 10 to 18 years versus <1 year at admission was associated with an increased likelihood of PDI in hospital A (odds ratio [OR] 1.7; 95% CI, 1.4-2.0), hospital B (OR 1.4; 95% CI, 1.1-1.8), and hospital D (OR 1.7; 95% CI, 0.9-3.0) (Table 3 and Figure).

Medications

Length of Stay

Shorter length of stay was associated with PDI in 1 hospital. In hospital A, the PDI rate increased significantly (P < .001) from 19.0% to 33.9% as length of stay decreased from ≥7 days to ≤1 day (Table 3). In multivariable analysis, length of stay to ≤1 day versus ≥7 days was associated with increased likelihood of PDI (OR 2.1; 95% CI, 1.7-2.5) in hospital A (Table 3 and Figure).

CCCs

A neuromuscular CCC was associated with PDI in 2 hospitals. In hospital B, the PDI rate was higher in children with a neuromuscular CCC compared with a malignancy CCC (21.3% vs 11.2%). In hospital D, the PDI rates were higher in children with a neuromuscular CCC compared with a respiratory CCC (68.9% vs 40.6%) (Table 3). In multivariable analysis, children with versus without a neuromuscular CCC had an increased likelihood of PDI (OR 1.3; 95% CI, 1.0-1.7) in hospital B (Table 3 and Figure).

In this retrospective, pragmatic, multicentered study of follow-up contact with a standardized set of questions asked after discharge for hospitalized children, we found that PDIs were identified often, regardless of who made the contact or how the contact was made. The PDI rates varied substantially across hospitals and were likely influenced by the different follow-up approaches that were used. Most PDIs were related to appointments; fewer PDIs were related to medications and other problems. Older age, shorter length of stay, and neuromuscular CCCs were among the identified risk factors for PDIs.

Our assessment of PDIs was, by design, associated with variation in methods and approach for detection across sites. Further investigation is needed to understand how different approaches for follow-up contact after discharge may influence the identification of PDIs. For example, in the current study, the hospital with the highest PDI rate (hospital D) used hospitalists who provided inpatient care for the patient to make follow-up contact. Although not determined from the current study, this approach could have led the hospitalists to ask questions beyond the standardized ones when assessing for PDIs. Perhaps some of the hospitalists had a better understanding of how to probe for PDIs specific to each patient; this understanding may not have been forthcoming for staff in the other hospitals who were unfamiliar with the patients’ hospitalization course and medical history.

Similar to previous studies in adults, our study reported that appointment PDIs in children may be more common than other types of PDIs.¹⁷ Appointment PDIs could have been due to scheduling difficulties, inadequate discharge instructions, lack of adherence to recommended follow-up, or other reasons. Further investigation is needed to elucidate these reasons and to determine how to reduce PDIs related to postdischarge appointments. Some children’s hospitals schedule follow-up appointments prior to discharge to mitigate appointment PDIs that might arise.¹⁸ However, doing that for every hospitalized child is challenging, especially for very short admissions or for weekend discharges when many outpatient and community practices are not open to schedule appointments. Additional exploration is necessary to assess whether this might help explain why some children in the current study with a short versus long length of stay had a higher likelihood of PDI.

The rate of medication PDIs (5.2%) observed in the current study is lower than the rate that is reported in prior literature. Dudas et al.¹ found that medication PDIs occurred in 21% of hospitalized adult patients. One reason for the lower rate of medication PDIs in children may be that they require the use of postdischarge medications less often than adults. Most medication PDIs in the current study involved problems filling a prescription. There was not enough information in the notes taken from the follow-up contact to distinguish the medication PDI etiologies (eg, a prescription was not sent from the hospital team to the pharmacy, prior authorization from an insurance company for a prescription was not obtained, the pharmacy did not stock the medication). To help overcome medication access barriers, some hospitals fill and deliver discharge medications to the patients’ bedside. One study found that children discharged with medication in hand were less likely to have emergency department revisits within 30 days of discharge.¹⁹ Further investigation is needed to assess whether initiatives like these help mitigate medication PDIs in children.

Hospitals may benefit from considering how risk factors for PDIs can be used to prioritize which patients receive follow-up contact, especially in hospitals where contact for all hospitalized patients is not feasible. In the current study, there was variation across hospitals in the profile of risk factors that correlated with increased likelihood of PDI. Some of the risk factors are easier to explain than others. For example, as mentioned above, for some hospitalized children, short length of stay might not permit enough time for hospital staff to set up discharge plans that may sufficiently prevent PDIs. Other risk factors, including older age and neuromuscular CCCs, may require additional assessment (eg, through chart review or in-depth patient and provider interviews) to discover the reasons why they were associated with increased likelihood of PDI. There are additional risk factors that might influence the likelihood of PDI that the current study was not positioned to assess, including health literacy, transportation availability, and language spoken.^20-23

This study has several other limitations in addition to the ones already mentioned. Some children may have experienced PDIs that were not reported at contact (eg, the respondent was unaware that an issue was present), which may have led to an undercounting of PDIs. Alternatively, some caregivers may have been more likely to respond to the contact if their child was experiencing a PDI, which may have led to overcounting. PDIs of nonrespondents were not measured. PDIs identified by postdischarge outpatient and community providers or by families outside of contact were not measured. The current study was not positioned to assess the severity of the PDIs or what interventions (including additional health services) were needed to address them. Although we assessed medication use during admission, we were unable to assess the number and type of medications that were prescribed for use postdischarge. Information about the number and type of follow-up visits needed for each child was not assessed. Given the variety of approaches for follow-up contact, the findings may generalize best to individual hospitals by using an approach that best matches to one of them. The current study is not positioned to correlate quality of discharge care with the rate of PDI.

Despite these limitations, the findings from the current study reinforce that PDIs identified through follow-up contact in discharged patients appear to be common. Of PDIs identified, appointment problems were more prevalent than medication or other types of problems. Short length of stay, older age, and other patient and/or hospitalization attributes were associated with an increased likelihood of PDI. Hospitals caring for children may find this information useful as they strive to optimize their processes for follow-up contact after discharge. To help further evaluate the value and importance of contacting patients after discharge, additional study of PDI in children is warranted, including (1) actions taken to resolve PDIs, (2) the impact of identifying and addressing PDIs on hospital readmission, and (3) postdischarge experiences and health outcomes of children who responded versus those who did not respond to the follow-up contact. Moreover, future multisite, comparative effectiveness studies of PDI may wish to consider standardization of follow-up contact procedures with controlled manipulation of key processes (eg, contact by administrator vs nurse vs physician) to assess best practices.

Disclosure

Mr. Blaine, Ms. O’Neill, and Drs. Berry, Brittan, Rehm, and Steiner were supported by the Lucile Packard Foundation for Children’s Health. The authors have no financial relationships relative to this article to disclose. The authors have no conflicts of interest to disclose.

Toxic epidermal necrolysis (TEN) is a rare, life-threatening adverse drug reaction with an estimated incidence of 0.4 to 1.9 cases per million persons per year worldwide and an estimated mortality rate of 25% to 35%.^1,2 This dermatologic emergency is characterized by extensive detachment of the epidermis and erosions of the mucous membranes secondary to massive keratinocyte cell death via apoptosis, evolving quickly into full-thickness epidermal necrosis.

Primary treatment of TEN includes (1) prompt discontinuation of the suspected medication; (2) rapid transfer to an intensive care unit, burn center, or other specialty unit; and (3) supportive care, including wound care, fluid and electrolyte maintenance, and treatment of infections. Aside from the primary treatment, controversy remains over the most effective adjunctive therapy for TEN, as none has proven consistent superiority over well-conducted primary treatment alone. Therefore, established therapeutic guidelines do not exist.^1-3

The use of adjunctive systemic therapy in TEN (eg, corticosteroids, intravenous immunoglobulin [IVIG], cyclosporine, plasmapheresis, granulocyte-colony stimulating factor) is based primarily on theories of pathogenesis, which unfortunately remain unclear. Activated CD8⁺ T cells are thought to increase the expression and production of granulysin, granzyme B, and perforins, leading to keratinocyte apoptosis. Fas ligand and tumor necrosis factor α (TNF-α) also are implicated as secondary mediators of cell death via the inducible nitric oxide synthase pathway.^1,4-6

Since TNF-α was found to be elevated in serum and blister fluid in patients with TEN,^7,8 medications aimed at decreasing the TNF-α concentration, such as pentoxifylline (PTX) and thalidomide, have been attempted for treatment.^9,10 Biologic inhibitors of TNF-α, such as infliximab and etanercept, are novel therapeutic options in the treatment of TEN, as numerous reports document their successful use in the treatment of this disease.^11-24 The purpose of this study is to systematically review the current literature on the use of TNF-α antagonists in the treatment of TEN.

METHODS

A PubMed search of all available articles indexed for MEDLINE using the terms toxic epidermal necrolysis and TNF-alpha and pentoxifylline or thalidomide or infliximab or etanercept or adalimumab was conducted.

RESULTS

Sixteen articles published between 1994 and 2014 were retrieved from PubMed and reviewed.^9-24 Fourteen articles were case reports and case series involving the use of TNF-α inhibitors as either monotherapy, second-line agents, or in combination with other medications in the treatment of TEN, providing a total of 28 patients.^9,11-23 Two articles were prospective trials, one evaluating the efficacy of thalidomide¹⁰ and the other infliximab²⁴ in treating TEN. All studies implemented primary treatment (ie, prompt discontinuation of the suspected medication and aggressive supportive care) in addition to TNF-α inhibition.

Pentoxifylline

The first case report describing the use of an anti–TNF-α inhibitor for TEN was with PTX in 1994.⁹ Pentoxifylline, a vasoactive drug with immunomodulatory properties including the downregulation of TNF-α synthesis, was used to treat a 26-year-old woman with TEN on phenylhydantoin 15 days following resection of a grade II astrocytoma. The patient initially received intravenous N-acetylcysteine (NAC) (9 g once daily) and S-adenosyl-L-methionine (100 mg once daily) for antioxidant effects. On the second day of treatment, intravenous PTX (900 mg once daily) was added for TNF-α inhibition. Following PTX administration, the investigators reported quick stabilization of the eruption and achievement of reepithelialization after 7 days of therapy. Upon cessation of PTX therapy, a recurrence of generalized erythema occurred, suggesting a relapse of TEN; therefore, PTX was reinitiated for an additional 3 days, and the patient’s skin remained clear.⁹

Thalidomide

The earliest prospective trial we reviewed using anti–TNF-α therapy in TEN occurred in 1998 with thalidomide, a moderate inhibitor of TNF-α.¹⁰ In this randomized controlled trial, 22 TEN patients received either a 5-day course of thalidomide (400 mg once daily) or placebo. There was increased mortality in the thalidomide group (10/12 [83.3%]) versus the placebo group (3/10 [30.0%]). Additionally, the plasma TNF-α concentrations in the thalidomide group were higher than the control group. This study was stopped prematurely due to the excess mortality in the thalidomide group.¹⁰

Biologic TNF-α Antagonists

Following the PTX case report and the thalidomide trial, there was increased interest in using newer-generation TNF-α inhibitors, such as the monoclonal antibody infliximab or the fusion protein etanercept, in the treatment of TEN. To date, there are 10 known published case reports,^{11,12,15-21,23} 3 case series,^13,14,22 and 1 trial²⁴ describing the use of these agents; however, treatment protocols vary. Categories of treatment protocols include the use of TNF-α inhibitors as monotherapy, following failure of other systemic agents, and in combination with other systemic therapies.

TNF-α Inhibitors as Monotherapy
Review of the literature yielded 2 case reports using infliximab monotherapy^11,12 and 2 case series using infliximab or etanercept monotherapy^13,14 with a total of 14 patients (Table 1). Fischer et al¹¹ was the first of these reports to describe a patient successfully treated with supportive care and a single dose of infliximab 5 mg/kg. The dose was given 4 days after the onset of symptoms, and the rapid progression of the disease was stopped, with complete recovery in less than 4 weeks.¹¹ Hunger et al¹² also described the successful treatment of a patient using a similar protocol: a single dose of infliximab 5 mg/kg given 3 days after symptom onset. Epidermal detachment was abated within 24 hours and the patient had almost complete reepithelialization within 5 days.¹² In a case series published by Zárate-Correa et al,¹³ 2 patients with near 100% body surface area involvement were successfully treated with a single dose of infliximab 300 mg. Although both of these patients experienced fairly rapid recoveries, one patient’s course was complicated by methicillin-resistant Staphylococcus aureus bacteremia.¹³ Paradisi et al¹⁴ described 10 consecutive patients treated with a single dose of etanercept 50 mg given within 6 hours of hospital admission and within 72 hours of symptom onset. The SCORTEN (SCORe of Toxic Epidermal Necrolysis) scale—a severity-of-illness assessment for TEN based on body surface area involvement, comorbidities, and metabolic abnormalities—was used to predict mortality in these patients. The investigators reported an expected mortality of 46.9%; however, the observed mortality was 0%, and there were no reported infections.¹⁴

TNF-α Inhibitors Following Failure of Other Systemic Agents in TEN
Seven case reports and 1 case series using anti–TNF-α therapy following failure of other systemic agents were reviewed for a total of 9 patients (3 pediatric/adolescent patients, 6 adult patients)(Table 2).^13,15-21 Seven patients were treated with infliximab,^{13,15,17,19-21} and the remaining 2 patients were treated with etanercept.^16,18 All patients were treated initially with corticosteroids and/or IVIG. In each case, anti–TNF-α therapy was introduced when prior treatment failed to halt the progression of TEN. Most reports claimed a rapid and beneficial response to anti–TNF-α therapy. Eight of 9 (88.9%) patients recovered.^13,15,17-21 Famularo et al¹⁶ described 1 patient who was treated with 2 doses of etanercept following prednisolone but died on the tenth day of hospitalization secondary to disseminated intravascular coagulation and multiorgan failure; however, the patient reportedly had near-complete reepithelialization of the skin on the sixth day of the hospital course.¹⁶ Of the 8 surviving patients, 3 (37.5%) experienced hospital courses complicated by nosocomial gram-negative bacteremia, including Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae.^13,15 Interestingly, a patient described by Worsnop et al²⁰ developed erosive lichen planus of the mouth and vulva 31 days after infliximab infusion.

Combination of TNF-α Inhibitor With Other Systemic Agents in TEN
One case series²² and 1 case report²³ using infliximab in combination with other systemic therapies were reviewed with a total of 4 patients (Table 3). Both reports utilized the same treatment protocol, which consisted of a single bolus of intravenous methylprednisolone 500 mg followed by a single dose of infliximab 5 mg/kg and then IVIG 2 g/kg over 5 days. Three of 4 (75%) patients recovered.^22,23 Gaitanis et al²² reported a patient who died on the ninth day of hospitalization secondary to multiorgan dysfunction caused by a catheter-related bacteremia. Similar to the patient described by Famularo et al,¹⁶ this patient also was noted to have remarkably improved skin prior to death. Two of the other 3 patients that survived had their hospital course complicated by infection, requiring antibiotics.²² In the Gaitanis et al²² series, the average predicted mortality according to a SCORTEN assessment was 50.8%; however, mortality was observed in 33.3% (1/3) of patients in the case series.

N-Acetylcysteine and Infliximab
The combination of NAC and infliximab was studied in a randomized controlled trial using TNF-α inhibition in TEN.²⁴ In this study, 10 patients were admitted to a burn unit and treated with either 3 doses of intravenous NAC (150 mg/kg per dose) plus 1 dose of infliximab 5 mg/kg or NAC alone. Unlike some of the previously described articles, Paquet et al²⁴ utilized an illness auxiliary score (IAS), which predicts both disease duration and mortality. An IAS was taken at admission and again 48 hours after completion of NAC and/or infliximab administration. The mean clinical IAS score was reported to have remained unchanged at treatment completion in the NAC group and slightly worsened in the NAC-infliximab group. One patient died in the NAC group and 2 patients died in the NAC-infliximab group, each due to infection. These fatalities corresponded to a mean mortality of 20% in the NAC-treated group and 40% for the NAC-infliximab group. To compare, the predicted mortalities based on the IAS were 20.4% and 21.4%, respectively.²⁴

COMMENT

Tumor necrosis factor α inhibition in the treatment of TEN was first utilized in the 1990s with PTX and thalidomide.^9,10 In 1994, PTX in addition to antioxidant therapy was found to successfully treat a 26-year-old woman with TEN attributed to anticonvulsant therapy.⁹ Other reports of PTX in the treatment of TEN were not found; however, there is a case series describing the successful treatment of 2 pediatric patients with Stevens-Johnson syndrome (SJS) and SJS-TEN overlap with PTX.²⁵ Thalidomide, however, proved detrimental to patients with TEN as evidenced by an increased mortality in the 1998 trial.¹⁰ Paradoxically, the treatment group was found to have increased rather than decreased TNF-α concentrations, which was hypothesized to be the cause of increased mortality. This finding furthered the theory that TNF-α is an important mediator in TEN pathogenesis and a potential novel target in disease management.¹⁰

Since the PTX case report and the thalidomide trial, many physicians have reported the beneficial effects of biologic TNF-α inhibitors in the course of TEN; however, most of the literature is composed of case reports and case series describing a small number of patients. Therefore, the beneficial effects of anti–TNF-α therapy in TEN cannot be conclusively derived. Furthermore, cases using TNF-α inhibitors in combination with or after other systemic agents complicate the effects of TNF-α inhibitors themselves. Most of these case reports and case series describe the beneficial effects of TNF-α inhibitors in TEN; however, it is important to remember that cases in which these agents were ineffective are less likely to be published. The strongest evidence for TNF-α inhibitor use in the treatment TEN comes from the Paradisi et al¹⁴ case series, which showed a decrease in expected mortality with etanercept monotherapy in a relatively large cohort of patients. However, when evaluated prospectively by Paquet et al,²⁴ there was no benefit seen by adding infliximab to NAC therapy and possibly an increased mortality in the group treated with both agents.

In the cases reviewed, a total of 32 patients were treated with infliximab or etanercept, and of these patients there were 4 deaths (12.5%).^16,22,24 Three deaths were attributed to infection and 1 was attributed to disseminated intravascular coagulation. Furthermore, infection complicated the hospital course of 9 (28.1%) patients.^13,15,22,24 The bacteria cultured from these patients included methicillin-resistant S aureus, P aeruginosa, E coli, Enterobacter aerogenes, and K pneumoniae. Patients who received TNF-α antagonists in combination with or after other systemic immunosuppressants appeared to have a higher incidence of infections. All patients treated with TNF-α antagonists in TEN should undergo careful evaluation and monitoring for infections due to the immunosuppressant effect of these drugs.

In our review, a total of 3 pediatric/adolescent patients received a TNF-α inhibitor for the treatment of TEN.^13,17,21 Two patients received infliximab as a second-line medication after failure of IVIG to arrest progression of disease^13,17 and one patient received infliximab as a second-line medication after dexamethasone.²¹ Each of these patients recovered without any reported infections or long-term complications.

Although excluded from this review, both infliximab and etanercept have been reported to show benefit in acute generalized exanthematous pustulosis/TEN overlap.^26,27 Interestingly, in postmarketing surveillance, rare reports have implicated both infliximab and etanercept in causing both SJS and TEN.²⁸ Also, there have been case reports of adalimumab causing SJS, but no cases of it causing TEN were identified.^29,30

CONCLUSION

Rapid discontinuation of the culprit drug and aggressive supportive care remain the primary treatment of TEN. Tumor necrosis factor α inhibitors as monotherapy or as second-line agents show promise in the treatment of this complex disease state in both the adult and pediatric populations. The risks of these potent immunosuppressants must be weighed, and if administered, patients must be closely monitored for infections. Additional studies are needed to further characterize the role of TNF-α inhibition in the treatment of TEN.

Toxic epidermal necrolysis (TEN) is a rare, life-threatening adverse drug reaction with an estimated incidence of 0.4 to 1.9 cases per million persons per year worldwide and an estimated mortality rate of 25% to 35%.^1,2 This dermatologic emergency is characterized by extensive detachment of the epidermis and erosions of the mucous membranes secondary to massive keratinocyte cell death via apoptosis, evolving quickly into full-thickness epidermal necrosis.

Primary treatment of TEN includes (1) prompt discontinuation of the suspected medication; (2) rapid transfer to an intensive care unit, burn center, or other specialty unit; and (3) supportive care, including wound care, fluid and electrolyte maintenance, and treatment of infections. Aside from the primary treatment, controversy remains over the most effective adjunctive therapy for TEN, as none has proven consistent superiority over well-conducted primary treatment alone. Therefore, established therapeutic guidelines do not exist.^1-3

The use of adjunctive systemic therapy in TEN (eg, corticosteroids, intravenous immunoglobulin [IVIG], cyclosporine, plasmapheresis, granulocyte-colony stimulating factor) is based primarily on theories of pathogenesis, which unfortunately remain unclear. Activated CD8⁺ T cells are thought to increase the expression and production of granulysin, granzyme B, and perforins, leading to keratinocyte apoptosis. Fas ligand and tumor necrosis factor α (TNF-α) also are implicated as secondary mediators of cell death via the inducible nitric oxide synthase pathway.^1,4-6

Since TNF-α was found to be elevated in serum and blister fluid in patients with TEN,^7,8 medications aimed at decreasing the TNF-α concentration, such as pentoxifylline (PTX) and thalidomide, have been attempted for treatment.^9,10 Biologic inhibitors of TNF-α, such as infliximab and etanercept, are novel therapeutic options in the treatment of TEN, as numerous reports document their successful use in the treatment of this disease.^11-24 The purpose of this study is to systematically review the current literature on the use of TNF-α antagonists in the treatment of TEN.

METHODS

A PubMed search of all available articles indexed for MEDLINE using the terms toxic epidermal necrolysis and TNF-alpha and pentoxifylline or thalidomide or infliximab or etanercept or adalimumab was conducted.

RESULTS

Sixteen articles published between 1994 and 2014 were retrieved from PubMed and reviewed.^9-24 Fourteen articles were case reports and case series involving the use of TNF-α inhibitors as either monotherapy, second-line agents, or in combination with other medications in the treatment of TEN, providing a total of 28 patients.^9,11-23 Two articles were prospective trials, one evaluating the efficacy of thalidomide¹⁰ and the other infliximab²⁴ in treating TEN. All studies implemented primary treatment (ie, prompt discontinuation of the suspected medication and aggressive supportive care) in addition to TNF-α inhibition.

Pentoxifylline

The first case report describing the use of an anti–TNF-α inhibitor for TEN was with PTX in 1994.⁹ Pentoxifylline, a vasoactive drug with immunomodulatory properties including the downregulation of TNF-α synthesis, was used to treat a 26-year-old woman with TEN on phenylhydantoin 15 days following resection of a grade II astrocytoma. The patient initially received intravenous N-acetylcysteine (NAC) (9 g once daily) and S-adenosyl-L-methionine (100 mg once daily) for antioxidant effects. On the second day of treatment, intravenous PTX (900 mg once daily) was added for TNF-α inhibition. Following PTX administration, the investigators reported quick stabilization of the eruption and achievement of reepithelialization after 7 days of therapy. Upon cessation of PTX therapy, a recurrence of generalized erythema occurred, suggesting a relapse of TEN; therefore, PTX was reinitiated for an additional 3 days, and the patient’s skin remained clear.⁹

Thalidomide

The earliest prospective trial we reviewed using anti–TNF-α therapy in TEN occurred in 1998 with thalidomide, a moderate inhibitor of TNF-α.¹⁰ In this randomized controlled trial, 22 TEN patients received either a 5-day course of thalidomide (400 mg once daily) or placebo. There was increased mortality in the thalidomide group (10/12 [83.3%]) versus the placebo group (3/10 [30.0%]). Additionally, the plasma TNF-α concentrations in the thalidomide group were higher than the control group. This study was stopped prematurely due to the excess mortality in the thalidomide group.¹⁰

Biologic TNF-α Antagonists

Following the PTX case report and the thalidomide trial, there was increased interest in using newer-generation TNF-α inhibitors, such as the monoclonal antibody infliximab or the fusion protein etanercept, in the treatment of TEN. To date, there are 10 known published case reports,^{11,12,15-21,23} 3 case series,^13,14,22 and 1 trial²⁴ describing the use of these agents; however, treatment protocols vary. Categories of treatment protocols include the use of TNF-α inhibitors as monotherapy, following failure of other systemic agents, and in combination with other systemic therapies.

TNF-α Inhibitors as Monotherapy
Review of the literature yielded 2 case reports using infliximab monotherapy^11,12 and 2 case series using infliximab or etanercept monotherapy^13,14 with a total of 14 patients (Table 1). Fischer et al¹¹ was the first of these reports to describe a patient successfully treated with supportive care and a single dose of infliximab 5 mg/kg. The dose was given 4 days after the onset of symptoms, and the rapid progression of the disease was stopped, with complete recovery in less than 4 weeks.¹¹ Hunger et al¹² also described the successful treatment of a patient using a similar protocol: a single dose of infliximab 5 mg/kg given 3 days after symptom onset. Epidermal detachment was abated within 24 hours and the patient had almost complete reepithelialization within 5 days.¹² In a case series published by Zárate-Correa et al,¹³ 2 patients with near 100% body surface area involvement were successfully treated with a single dose of infliximab 300 mg. Although both of these patients experienced fairly rapid recoveries, one patient’s course was complicated by methicillin-resistant Staphylococcus aureus bacteremia.¹³ Paradisi et al¹⁴ described 10 consecutive patients treated with a single dose of etanercept 50 mg given within 6 hours of hospital admission and within 72 hours of symptom onset. The SCORTEN (SCORe of Toxic Epidermal Necrolysis) scale—a severity-of-illness assessment for TEN based on body surface area involvement, comorbidities, and metabolic abnormalities—was used to predict mortality in these patients. The investigators reported an expected mortality of 46.9%; however, the observed mortality was 0%, and there were no reported infections.¹⁴

TNF-α Inhibitors Following Failure of Other Systemic Agents in TEN
Seven case reports and 1 case series using anti–TNF-α therapy following failure of other systemic agents were reviewed for a total of 9 patients (3 pediatric/adolescent patients, 6 adult patients)(Table 2).^13,15-21 Seven patients were treated with infliximab,^{13,15,17,19-21} and the remaining 2 patients were treated with etanercept.^16,18 All patients were treated initially with corticosteroids and/or IVIG. In each case, anti–TNF-α therapy was introduced when prior treatment failed to halt the progression of TEN. Most reports claimed a rapid and beneficial response to anti–TNF-α therapy. Eight of 9 (88.9%) patients recovered.^13,15,17-21 Famularo et al¹⁶ described 1 patient who was treated with 2 doses of etanercept following prednisolone but died on the tenth day of hospitalization secondary to disseminated intravascular coagulation and multiorgan failure; however, the patient reportedly had near-complete reepithelialization of the skin on the sixth day of the hospital course.¹⁶ Of the 8 surviving patients, 3 (37.5%) experienced hospital courses complicated by nosocomial gram-negative bacteremia, including Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae.^13,15 Interestingly, a patient described by Worsnop et al²⁰ developed erosive lichen planus of the mouth and vulva 31 days after infliximab infusion.

Combination of TNF-α Inhibitor With Other Systemic Agents in TEN
One case series²² and 1 case report²³ using infliximab in combination with other systemic therapies were reviewed with a total of 4 patients (Table 3). Both reports utilized the same treatment protocol, which consisted of a single bolus of intravenous methylprednisolone 500 mg followed by a single dose of infliximab 5 mg/kg and then IVIG 2 g/kg over 5 days. Three of 4 (75%) patients recovered.^22,23 Gaitanis et al²² reported a patient who died on the ninth day of hospitalization secondary to multiorgan dysfunction caused by a catheter-related bacteremia. Similar to the patient described by Famularo et al,¹⁶ this patient also was noted to have remarkably improved skin prior to death. Two of the other 3 patients that survived had their hospital course complicated by infection, requiring antibiotics.²² In the Gaitanis et al²² series, the average predicted mortality according to a SCORTEN assessment was 50.8%; however, mortality was observed in 33.3% (1/3) of patients in the case series.

N-Acetylcysteine and Infliximab
The combination of NAC and infliximab was studied in a randomized controlled trial using TNF-α inhibition in TEN.²⁴ In this study, 10 patients were admitted to a burn unit and treated with either 3 doses of intravenous NAC (150 mg/kg per dose) plus 1 dose of infliximab 5 mg/kg or NAC alone. Unlike some of the previously described articles, Paquet et al²⁴ utilized an illness auxiliary score (IAS), which predicts both disease duration and mortality. An IAS was taken at admission and again 48 hours after completion of NAC and/or infliximab administration. The mean clinical IAS score was reported to have remained unchanged at treatment completion in the NAC group and slightly worsened in the NAC-infliximab group. One patient died in the NAC group and 2 patients died in the NAC-infliximab group, each due to infection. These fatalities corresponded to a mean mortality of 20% in the NAC-treated group and 40% for the NAC-infliximab group. To compare, the predicted mortalities based on the IAS were 20.4% and 21.4%, respectively.²⁴

COMMENT

Tumor necrosis factor α inhibition in the treatment of TEN was first utilized in the 1990s with PTX and thalidomide.^9,10 In 1994, PTX in addition to antioxidant therapy was found to successfully treat a 26-year-old woman with TEN attributed to anticonvulsant therapy.⁹ Other reports of PTX in the treatment of TEN were not found; however, there is a case series describing the successful treatment of 2 pediatric patients with Stevens-Johnson syndrome (SJS) and SJS-TEN overlap with PTX.²⁵ Thalidomide, however, proved detrimental to patients with TEN as evidenced by an increased mortality in the 1998 trial.¹⁰ Paradoxically, the treatment group was found to have increased rather than decreased TNF-α concentrations, which was hypothesized to be the cause of increased mortality. This finding furthered the theory that TNF-α is an important mediator in TEN pathogenesis and a potential novel target in disease management.¹⁰

Since the PTX case report and the thalidomide trial, many physicians have reported the beneficial effects of biologic TNF-α inhibitors in the course of TEN; however, most of the literature is composed of case reports and case series describing a small number of patients. Therefore, the beneficial effects of anti–TNF-α therapy in TEN cannot be conclusively derived. Furthermore, cases using TNF-α inhibitors in combination with or after other systemic agents complicate the effects of TNF-α inhibitors themselves. Most of these case reports and case series describe the beneficial effects of TNF-α inhibitors in TEN; however, it is important to remember that cases in which these agents were ineffective are less likely to be published. The strongest evidence for TNF-α inhibitor use in the treatment TEN comes from the Paradisi et al¹⁴ case series, which showed a decrease in expected mortality with etanercept monotherapy in a relatively large cohort of patients. However, when evaluated prospectively by Paquet et al,²⁴ there was no benefit seen by adding infliximab to NAC therapy and possibly an increased mortality in the group treated with both agents.

In the cases reviewed, a total of 32 patients were treated with infliximab or etanercept, and of these patients there were 4 deaths (12.5%).^16,22,24 Three deaths were attributed to infection and 1 was attributed to disseminated intravascular coagulation. Furthermore, infection complicated the hospital course of 9 (28.1%) patients.^13,15,22,24 The bacteria cultured from these patients included methicillin-resistant S aureus, P aeruginosa, E coli, Enterobacter aerogenes, and K pneumoniae. Patients who received TNF-α antagonists in combination with or after other systemic immunosuppressants appeared to have a higher incidence of infections. All patients treated with TNF-α antagonists in TEN should undergo careful evaluation and monitoring for infections due to the immunosuppressant effect of these drugs.

In our review, a total of 3 pediatric/adolescent patients received a TNF-α inhibitor for the treatment of TEN.^13,17,21 Two patients received infliximab as a second-line medication after failure of IVIG to arrest progression of disease^13,17 and one patient received infliximab as a second-line medication after dexamethasone.²¹ Each of these patients recovered without any reported infections or long-term complications.

Although excluded from this review, both infliximab and etanercept have been reported to show benefit in acute generalized exanthematous pustulosis/TEN overlap.^26,27 Interestingly, in postmarketing surveillance, rare reports have implicated both infliximab and etanercept in causing both SJS and TEN.²⁸ Also, there have been case reports of adalimumab causing SJS, but no cases of it causing TEN were identified.^29,30

CONCLUSION

Rapid discontinuation of the culprit drug and aggressive supportive care remain the primary treatment of TEN. Tumor necrosis factor α inhibitors as monotherapy or as second-line agents show promise in the treatment of this complex disease state in both the adult and pediatric populations. The risks of these potent immunosuppressants must be weighed, and if administered, patients must be closely monitored for infections. Additional studies are needed to further characterize the role of TNF-α inhibition in the treatment of TEN.

Toxic epidermal necrolysis (TEN) is a rare, life-threatening adverse drug reaction with an estimated incidence of 0.4 to 1.9 cases per million persons per year worldwide and an estimated mortality rate of 25% to 35%.^1,2 This dermatologic emergency is characterized by extensive detachment of the epidermis and erosions of the mucous membranes secondary to massive keratinocyte cell death via apoptosis, evolving quickly into full-thickness epidermal necrosis.

Primary treatment of TEN includes (1) prompt discontinuation of the suspected medication; (2) rapid transfer to an intensive care unit, burn center, or other specialty unit; and (3) supportive care, including wound care, fluid and electrolyte maintenance, and treatment of infections. Aside from the primary treatment, controversy remains over the most effective adjunctive therapy for TEN, as none has proven consistent superiority over well-conducted primary treatment alone. Therefore, established therapeutic guidelines do not exist.^1-3

The use of adjunctive systemic therapy in TEN (eg, corticosteroids, intravenous immunoglobulin [IVIG], cyclosporine, plasmapheresis, granulocyte-colony stimulating factor) is based primarily on theories of pathogenesis, which unfortunately remain unclear. Activated CD8⁺ T cells are thought to increase the expression and production of granulysin, granzyme B, and perforins, leading to keratinocyte apoptosis. Fas ligand and tumor necrosis factor α (TNF-α) also are implicated as secondary mediators of cell death via the inducible nitric oxide synthase pathway.^1,4-6

Since TNF-α was found to be elevated in serum and blister fluid in patients with TEN,^7,8 medications aimed at decreasing the TNF-α concentration, such as pentoxifylline (PTX) and thalidomide, have been attempted for treatment.^9,10 Biologic inhibitors of TNF-α, such as infliximab and etanercept, are novel therapeutic options in the treatment of TEN, as numerous reports document their successful use in the treatment of this disease.^11-24 The purpose of this study is to systematically review the current literature on the use of TNF-α antagonists in the treatment of TEN.

METHODS

A PubMed search of all available articles indexed for MEDLINE using the terms toxic epidermal necrolysis and TNF-alpha and pentoxifylline or thalidomide or infliximab or etanercept or adalimumab was conducted.

RESULTS

Sixteen articles published between 1994 and 2014 were retrieved from PubMed and reviewed.^9-24 Fourteen articles were case reports and case series involving the use of TNF-α inhibitors as either monotherapy, second-line agents, or in combination with other medications in the treatment of TEN, providing a total of 28 patients.^9,11-23 Two articles were prospective trials, one evaluating the efficacy of thalidomide¹⁰ and the other infliximab²⁴ in treating TEN. All studies implemented primary treatment (ie, prompt discontinuation of the suspected medication and aggressive supportive care) in addition to TNF-α inhibition.

Pentoxifylline

The first case report describing the use of an anti–TNF-α inhibitor for TEN was with PTX in 1994.⁹ Pentoxifylline, a vasoactive drug with immunomodulatory properties including the downregulation of TNF-α synthesis, was used to treat a 26-year-old woman with TEN on phenylhydantoin 15 days following resection of a grade II astrocytoma. The patient initially received intravenous N-acetylcysteine (NAC) (9 g once daily) and S-adenosyl-L-methionine (100 mg once daily) for antioxidant effects. On the second day of treatment, intravenous PTX (900 mg once daily) was added for TNF-α inhibition. Following PTX administration, the investigators reported quick stabilization of the eruption and achievement of reepithelialization after 7 days of therapy. Upon cessation of PTX therapy, a recurrence of generalized erythema occurred, suggesting a relapse of TEN; therefore, PTX was reinitiated for an additional 3 days, and the patient’s skin remained clear.⁹

Thalidomide

The earliest prospective trial we reviewed using anti–TNF-α therapy in TEN occurred in 1998 with thalidomide, a moderate inhibitor of TNF-α.¹⁰ In this randomized controlled trial, 22 TEN patients received either a 5-day course of thalidomide (400 mg once daily) or placebo. There was increased mortality in the thalidomide group (10/12 [83.3%]) versus the placebo group (3/10 [30.0%]). Additionally, the plasma TNF-α concentrations in the thalidomide group were higher than the control group. This study was stopped prematurely due to the excess mortality in the thalidomide group.¹⁰

Biologic TNF-α Antagonists

Following the PTX case report and the thalidomide trial, there was increased interest in using newer-generation TNF-α inhibitors, such as the monoclonal antibody infliximab or the fusion protein etanercept, in the treatment of TEN. To date, there are 10 known published case reports,^{11,12,15-21,23} 3 case series,^13,14,22 and 1 trial²⁴ describing the use of these agents; however, treatment protocols vary. Categories of treatment protocols include the use of TNF-α inhibitors as monotherapy, following failure of other systemic agents, and in combination with other systemic therapies.

TNF-α Inhibitors as Monotherapy
Review of the literature yielded 2 case reports using infliximab monotherapy^11,12 and 2 case series using infliximab or etanercept monotherapy^13,14 with a total of 14 patients (Table 1). Fischer et al¹¹ was the first of these reports to describe a patient successfully treated with supportive care and a single dose of infliximab 5 mg/kg. The dose was given 4 days after the onset of symptoms, and the rapid progression of the disease was stopped, with complete recovery in less than 4 weeks.¹¹ Hunger et al¹² also described the successful treatment of a patient using a similar protocol: a single dose of infliximab 5 mg/kg given 3 days after symptom onset. Epidermal detachment was abated within 24 hours and the patient had almost complete reepithelialization within 5 days.¹² In a case series published by Zárate-Correa et al,¹³ 2 patients with near 100% body surface area involvement were successfully treated with a single dose of infliximab 300 mg. Although both of these patients experienced fairly rapid recoveries, one patient’s course was complicated by methicillin-resistant Staphylococcus aureus bacteremia.¹³ Paradisi et al¹⁴ described 10 consecutive patients treated with a single dose of etanercept 50 mg given within 6 hours of hospital admission and within 72 hours of symptom onset. The SCORTEN (SCORe of Toxic Epidermal Necrolysis) scale—a severity-of-illness assessment for TEN based on body surface area involvement, comorbidities, and metabolic abnormalities—was used to predict mortality in these patients. The investigators reported an expected mortality of 46.9%; however, the observed mortality was 0%, and there were no reported infections.¹⁴

TNF-α Inhibitors Following Failure of Other Systemic Agents in TEN
Seven case reports and 1 case series using anti–TNF-α therapy following failure of other systemic agents were reviewed for a total of 9 patients (3 pediatric/adolescent patients, 6 adult patients)(Table 2).^13,15-21 Seven patients were treated with infliximab,^{13,15,17,19-21} and the remaining 2 patients were treated with etanercept.^16,18 All patients were treated initially with corticosteroids and/or IVIG. In each case, anti–TNF-α therapy was introduced when prior treatment failed to halt the progression of TEN. Most reports claimed a rapid and beneficial response to anti–TNF-α therapy. Eight of 9 (88.9%) patients recovered.^13,15,17-21 Famularo et al¹⁶ described 1 patient who was treated with 2 doses of etanercept following prednisolone but died on the tenth day of hospitalization secondary to disseminated intravascular coagulation and multiorgan failure; however, the patient reportedly had near-complete reepithelialization of the skin on the sixth day of the hospital course.¹⁶ Of the 8 surviving patients, 3 (37.5%) experienced hospital courses complicated by nosocomial gram-negative bacteremia, including Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae.^13,15 Interestingly, a patient described by Worsnop et al²⁰ developed erosive lichen planus of the mouth and vulva 31 days after infliximab infusion.

Combination of TNF-α Inhibitor With Other Systemic Agents in TEN
One case series²² and 1 case report²³ using infliximab in combination with other systemic therapies were reviewed with a total of 4 patients (Table 3). Both reports utilized the same treatment protocol, which consisted of a single bolus of intravenous methylprednisolone 500 mg followed by a single dose of infliximab 5 mg/kg and then IVIG 2 g/kg over 5 days. Three of 4 (75%) patients recovered.^22,23 Gaitanis et al²² reported a patient who died on the ninth day of hospitalization secondary to multiorgan dysfunction caused by a catheter-related bacteremia. Similar to the patient described by Famularo et al,¹⁶ this patient also was noted to have remarkably improved skin prior to death. Two of the other 3 patients that survived had their hospital course complicated by infection, requiring antibiotics.²² In the Gaitanis et al²² series, the average predicted mortality according to a SCORTEN assessment was 50.8%; however, mortality was observed in 33.3% (1/3) of patients in the case series.

N-Acetylcysteine and Infliximab
The combination of NAC and infliximab was studied in a randomized controlled trial using TNF-α inhibition in TEN.²⁴ In this study, 10 patients were admitted to a burn unit and treated with either 3 doses of intravenous NAC (150 mg/kg per dose) plus 1 dose of infliximab 5 mg/kg or NAC alone. Unlike some of the previously described articles, Paquet et al²⁴ utilized an illness auxiliary score (IAS), which predicts both disease duration and mortality. An IAS was taken at admission and again 48 hours after completion of NAC and/or infliximab administration. The mean clinical IAS score was reported to have remained unchanged at treatment completion in the NAC group and slightly worsened in the NAC-infliximab group. One patient died in the NAC group and 2 patients died in the NAC-infliximab group, each due to infection. These fatalities corresponded to a mean mortality of 20% in the NAC-treated group and 40% for the NAC-infliximab group. To compare, the predicted mortalities based on the IAS were 20.4% and 21.4%, respectively.²⁴

COMMENT

Tumor necrosis factor α inhibition in the treatment of TEN was first utilized in the 1990s with PTX and thalidomide.^9,10 In 1994, PTX in addition to antioxidant therapy was found to successfully treat a 26-year-old woman with TEN attributed to anticonvulsant therapy.⁹ Other reports of PTX in the treatment of TEN were not found; however, there is a case series describing the successful treatment of 2 pediatric patients with Stevens-Johnson syndrome (SJS) and SJS-TEN overlap with PTX.²⁵ Thalidomide, however, proved detrimental to patients with TEN as evidenced by an increased mortality in the 1998 trial.¹⁰ Paradoxically, the treatment group was found to have increased rather than decreased TNF-α concentrations, which was hypothesized to be the cause of increased mortality. This finding furthered the theory that TNF-α is an important mediator in TEN pathogenesis and a potential novel target in disease management.¹⁰

Since the PTX case report and the thalidomide trial, many physicians have reported the beneficial effects of biologic TNF-α inhibitors in the course of TEN; however, most of the literature is composed of case reports and case series describing a small number of patients. Therefore, the beneficial effects of anti–TNF-α therapy in TEN cannot be conclusively derived. Furthermore, cases using TNF-α inhibitors in combination with or after other systemic agents complicate the effects of TNF-α inhibitors themselves. Most of these case reports and case series describe the beneficial effects of TNF-α inhibitors in TEN; however, it is important to remember that cases in which these agents were ineffective are less likely to be published. The strongest evidence for TNF-α inhibitor use in the treatment TEN comes from the Paradisi et al¹⁴ case series, which showed a decrease in expected mortality with etanercept monotherapy in a relatively large cohort of patients. However, when evaluated prospectively by Paquet et al,²⁴ there was no benefit seen by adding infliximab to NAC therapy and possibly an increased mortality in the group treated with both agents.

In the cases reviewed, a total of 32 patients were treated with infliximab or etanercept, and of these patients there were 4 deaths (12.5%).^16,22,24 Three deaths were attributed to infection and 1 was attributed to disseminated intravascular coagulation. Furthermore, infection complicated the hospital course of 9 (28.1%) patients.^13,15,22,24 The bacteria cultured from these patients included methicillin-resistant S aureus, P aeruginosa, E coli, Enterobacter aerogenes, and K pneumoniae. Patients who received TNF-α antagonists in combination with or after other systemic immunosuppressants appeared to have a higher incidence of infections. All patients treated with TNF-α antagonists in TEN should undergo careful evaluation and monitoring for infections due to the immunosuppressant effect of these drugs.

In our review, a total of 3 pediatric/adolescent patients received a TNF-α inhibitor for the treatment of TEN.^13,17,21 Two patients received infliximab as a second-line medication after failure of IVIG to arrest progression of disease^13,17 and one patient received infliximab as a second-line medication after dexamethasone.²¹ Each of these patients recovered without any reported infections or long-term complications.

Although excluded from this review, both infliximab and etanercept have been reported to show benefit in acute generalized exanthematous pustulosis/TEN overlap.^26,27 Interestingly, in postmarketing surveillance, rare reports have implicated both infliximab and etanercept in causing both SJS and TEN.²⁸ Also, there have been case reports of adalimumab causing SJS, but no cases of it causing TEN were identified.^29,30

CONCLUSION

Rapid discontinuation of the culprit drug and aggressive supportive care remain the primary treatment of TEN. Tumor necrosis factor α inhibitors as monotherapy or as second-line agents show promise in the treatment of this complex disease state in both the adult and pediatric populations. The risks of these potent immunosuppressants must be weighed, and if administered, patients must be closely monitored for infections. Additional studies are needed to further characterize the role of TNF-α inhibition in the treatment of TEN.

ABSTRACT

In a previous study, compared with throwing athletes with superior labral anterior posterior (SLAP) tears, those with concomitant SLAP tears and rotator cuff tears (RCTs) had significantly poorer outcome scores and return to play. Posterior shoulder instability also occurs in throwing athletes, but no studies currently exist regarding outcomes of these patients with concomitant RCTs.

The authors hypothesized that throwing athletes treated with arthroscopic capsulolabral repair for posterior shoulder instability with coexistent rotator cuff pathology would have poorer outcome scores and return to play.

Fifty-six consecutive throwing athletes with unidirectional posterior shoulder instability underwent arthroscopic capsulolabral repair. Preoperative and postoperative patient-centered outcomes of pain, stability, function, range of motion, strength, and American Shoulder and Elbow Surgeons Shoulder (ASES) scores, as well as return to play, were evaluated. Patients with and without rotator cuff pathology were compared.

Forty-three percent (24/56) of throwing athletes had rotator cuff pathology in addition to posterior capsulolabral pathology. All RCTs were débrided. At a mean of 3 years, there were no differences in preoperative and postoperative patient-centered outcomes between those with and without RCTs. Return-to-play rates showed no between-group differences; 92% (22/24) of athletes with concomitant RCTs returned to sport (P = .414) and 67% (16/24) returned to the same level (P = .430).

Arthroscopic capsulolabral reconstruction is successful in throwing athletes with RCTs treated with arthroscopic débridement. Unlike the previous study evaluating throwers outcomes after surgical treatment for concomitant SLAP tears and RCTs, the authors found no difference in patient-reported outcome measures or return to play for throwing athletes with concomitant posterior shoulder instability and RCTs. In throwing athletes with concomitant posterior instability and RCTs, arthroscopic posterior capsulolabral repair with rotator cuff débridement is successful.

Continue to: Posterior shoulder instability...

Posterior shoulder instability is an important and increasingly recognized pathology among throwers. Like the superior labrum, the posterior capsulolabral complex is also susceptible to injury during the throwing motion; the posterior labrum being most at risk during the late cocking and follow-through phases. Recent studies have found that arthroscopic capsulolabral reconstruction in posterior shoulder instability is successful in allowing athletes to return to their preinjury sports activities, with 2 studies detailing outcomes in throwing athletes.^1-4 However, superior labral anterior posterior (SLAP) tears are common in throwing athletes and have been treated with varying and limited success. Further, in a study of outcomes of arthroscopic repair of SLAP lesions, Neri and colleagues⁵ found that, compared with throwing athletes with SLAP tears, throwing athletes with concomitant SLAP tears and partial-thickness rotator cuff tears (RCTs) had significantly poorer outcomes and return-to-play rates after surgical repair.

The purpose of this study was to determine outcome scores and return to play of throwing athletes treated with arthroscopic capsulolabral repair for posterior shoulder instability with coexistent RCTs and to compare them with outcome scores as well as return to play of throwing athletes with isolated posterior shoulder instability. It was hypothesized that throwing athletes with a combination of posterior shoulder instability and RCT would have poorer outcomes and poorer return to play after surgery.⁵

METHODS

PATIENT SELECTION

After Institutional Review Board approval, informed consent was obtained, and consecutive throwing athletes who underwent arthroscopic posterior capsulolabral reconstruction for posterior shoulder instability were followed in the perioperative period. Inclusion criteria were throwing athletes participating in competitive sports at the high school, collegiate, or professional level, minimum 1-year follow-up, presence of unidirectional posterior instability, and absence of symptoms of instability in any direction other than posterior. Patients with inferior instability, SLAP pathology on examination and on magnetic resonance imaging, multidirectional instability, or habitual or psychogenic voluntary shoulder subluxations were excluded. Patients with diagnoses of both posterior shoulder instability and impingement treated with subacromial decompression and distal clavicle resection were also excluded.

After this cohort was identified, patient records were reviewed for pertinent operative data, such as procedure, complications, and evidence of RCT by operative report and arthroscopic photographs. A partial RCT was defined as a tear of 10% to 50%; those with rotator cuff fraying were determined not to be significant.

PATIENT EVALUATION

Surgeries were performed between January 1998 and December 2009 by the senior author (JPB). All patients were followed with clinical examinations, radiographs, and subjective grading scales. Recorded patient demographic data included age, sex, sport, position, competition level, and follow-up duration.

Continue to: All patients had...

All patients had symptomatic posterior shoulder instability, including posterior shoulder pain, clicking, a sensation of subluxation, or instability/apprehension with motion. Each athlete’s shoulder was palpated for tenderness and tested for impingement. Specific posterior glenohumeral instability tests, including the Kim test,⁶ the circumduction test, the jerk test,⁷ the posterior load-and-shift test,⁸ and the posterior stress test,⁹ were performed on all patients. Patients with multidirectional instability on the sulcus test, as well as provocative tests indicating SLAP pathology, such as the Crank test and the active compression test, were not included. Standard radiography and magnetic resonance arthrography (MRA) were performed to further narrow inclusion and exclusion criteria.

Both before surgery and at latest follow-up, patient outcomes were evaluated using the American Shoulder and Elbow Surgeons (ASES) score (range, 0-100) which combines a subjective functional scale measuring activities of daily living (0-3 for each of 10 tasks, with a total of 0-30) and a subjective pain scale (0-10, with 10 being worst pain). Values >80 were described as excellent, and failures were defined as scores <60 after surgery.¹⁰ A subjective stability scale (0-10, with 0 indicating completely stable and 10 completely unstable), strength scale (0-3, with 0 indicating none, 1 markedly decreased, 2 slightly decreased, and 3 normal), and ROM scale (0-3, with 0 indicating poor, 1 limited, 2 satisfactory, and 3 full) were evaluated both before surgery and at the latest follow-up. A stability score >5 after surgery was defined as a failure.^1,2,11 Patients were also asked if, based on their current state, they would undergo surgery again. Intraoperative findings and specific surgical procedures performed were correlated with the aforementioned subjective and objective outcome scores.

OPERATIVE TREATMENT

Throwing athletes who met inclusion criteria and failed nonoperative management underwent surgery by the senior author (JPB). Each patient was examined under anesthesia and, with the patient in the lateral decubitus position, a diagnostic arthroscopy was performed to identify posterior capsulolabral complex pathology, including a patulous capsule, capsular tears, labral fraying, and labral tears. A careful examination for rotator cuff pathology was also performed. Based on preoperative clinical examination, MRA, examination under anesthesia, pathologic findings at diagnostic arthroscopic surgery, and surgeon experience, capsulolabral plication was performed with or without suture anchors.^2,5 After capsulolabral repair, the capsule was evaluated for residual laxity, and additional plication sutures were placed, as indicated, with care to avoid overconstraint in these throwing athletes.¹ Posterior glenohumeral stability restoration was judged by removing traction and performing posterior load-and-shift and posterior stress tests. Any RCT with <50% thickness was débrided. Postoperative care and rehabilitation were carried out as previously described and were not altered by the presence or absence of a RCT.³

STATISTICAL ANALYSIS

Preoperative and latest follow-up ASES scores, stability scores, functional scores, and pain-level findings were compared using paired-samples Comparisons between groups, including throwing athletes with and without rotator cuff pathology, were done using the Student t test. Outcome comparisons between multiple groups, which included intraoperative findings and surgical fixation methods, were analyzed with c² modeling for nonparametric data. Statistical significance was set at P < .05. A power analysis found that this study was able to detect a meaningful difference of 10 ASES points.

RESULTS

PATIENT DEMOGRAPHIC CHARACTERISTICS

Of the 56 throwing athletes who met the inclusion criteria, 24 were found to have rotator cuff pathology in addition to posterior capsulolabral pathology, while 32 were found to have capsulolabral pathology alone. Demographic data are listed in Table 1. Mean age was 20.1 years for patients with rotator cuff pathology and 17.8 years for patients without RCTs. All 24 athletes with rotator cuff pathology were treated with arthroscopic débridement. Mean follow-up was 38.6 months (range, 16.5-63.6 months) for patients with RCTs and 39.1 months (range, 12-98.8 months) for patients without RCTs. No significant difference was found in age, sports level, or follow-up between groups.

Table 1. Demographic Data for Athletes With Posterior Instability With and Without Rotator Cuff Tears (N = 56 Shoulders)^a

^aThe majority of athletes were males in high school and their mean follow-up was 3 years.

Continue to: Outcomes

Table 2 lists the preoperative and postoperative scores for shoulder performance in throwing athletes with posterior shoulder instability, with and without RCTs.

Table 2. Preoperative and Postoperative Scores for Shoulder Performance in Throwing Athletes With Posterior Shoulder Instability With and Without Rotator Cuff Tears^a

^aThere was no difference in ASES, stability, pain, or functional scores between athletes with posterior instability alone compared with patients with concomitant rotator cuff tears.

Abbreviation: ASES, American Shoulder and Elbow Surgeons.

ASES Scores. Mean preoperative ASES scores for patients with RCTs improved significantly (t = –13.8, P < .001), as did those for patients without rotator cuff pathology (t = –8.9, P < .001). No significant differences in ASES score were found between patients with and without rotator cuff pathology before or after surgery (t = 1.9, P = .07; t = .58, P = .06). In addition, 70.8% (17/24) of throwing athletes with rotator cuff pathology had an excellent postoperative outcome (ASES score >80), and 29.2% (7/24) had a satisfactory outcome (ASES score, 60-80). Thus, 100% of those with concomitant posterior shoulder instability and RCTs had a good or excellent outcome after surgical intervention. In those without rotator cuff pathology, 78.1% (25/32) had an excellent outcome, 12.5% (4/32) had a satisfactory outcome, and 9.4% (3/32) had a poor outcome. Thus, 91% of those without rotator cuff pathology had a good or excellent outcome after surgery.

Stability. Preoperative stability scores improved significantly after surgery in both groups (t = 7.2, P < .001; t = 10.5, P < .001). There were no statistical differences between preoperative or postoperative stability scores in those with or without rotator cuff pathology (t = 1.7, P = .095; t = .03, P = .975). Of throwing athletes with RCTs, 54.2% (13/24) had an excellent outcome, 33.3% (8/24) a good outcome, and 12.5% (3/24) a satisfactory outcome. Thus, 87.5% (21/24) of those with RCTs had a good or excellent outcome in terms of stability. In those without rotator cuff pathology, 46.9% (15/32) had excellent stability, 46.9% (15/32) had good stability, and 3.1% (1/32) had satisfactory stability after surgery. Thus, 93.8% (30/32) of throwing athletes without rotator cuff pathology had good or excellent stability after surgery.

Pain. Mean preoperative pain scores for those with and without rotator cuff pathology improved significantly (t = 13.4, P < .001; t = 7.1, P < .001). There was no statistical difference in preoperative or postoperative pain scores between those with and without rotator cuff pathology (t = 1.99, P = .051; t = .49, P = .627).

Function. Mean preoperative function scores for both groups improved significantly (t = 7.7, P < .001; t = 8.0, P < .001). There was no difference in improvement in functional scores between the two groups before or after surgery (t = .36, P = .721; t = .5, P = .622).

Continue to: ROM

ROM. Of those with rotator cuff pathology, 54% (13/24) had normal ROM, 42% (10/24) had satisfactory ROM, and 4% (1/24) had limited ROM. In throwing athletes without rotator cuff pathology, 34% (11/32) had normal ROM, 53.1% (17/32) had satisfactory ROM, and 9% (3/32) had limited ROM after surgery. There was no significant difference in ROM between the groups (c² = 2.7, P = .260).

Strength. Of those with RCTs, 67% (16/24) reported normal strength, 29% (7/24) slightly decreased strength, and 4% (1/24) markedly decreased strength. Of those throwing athletes without rotator cuff pathology, 50% (16/32) had normal strength, 41% (13/32) had slightly decreased strength, and 9% (3/32) had markedly decreased strength. No statistical difference was noted between the two groups (c² = 1.7, P = .429).

Return to Sport. Of those with RCTs, 92% (22/24) returned to sport while 84% (27/32) of throwing athletes without RCTs returned to sport. There was no difference between the two groups (c² = .667, P = .414). Sixty-seven percent (16/24) of those with RCTs and 56% (18/32) of those without RCTs returned to the same level of sport. No statistical difference was found in return to play between throwing athletes with and without rotator cuff pathology (c² = .624, P = .430).

Failures. According to ASES scores, no throwers with RCTs failed, while 9.4% (3/32) with posterior instability alone failed. Regarding stability, 8.3% (2/24) of athletes with RCTs failed, while 6.3% (2/32) with posterior instability alone failed. 

SURGICAL FINDINGS AND PROCEDURES

Of the 24 throwing athletes with rotator cuff pathology, 92% (22/24) had labral tears, while 78% (25/32) of those without RCTs had labral tears. The majority of RCTs were in the posterior supraspinatus and anterior infraspinatus regions. This was not significantly different between groups (c² = 1.86, P = .172). All labral pathology was posterior-inferior, and all RCTs were <50% thickness, and therefore were débrided. Fifty-four percent (13/24) of those with RCTs had a patulous capsule and 63% (20/32) of throwing athletes without rotator cuff pathology had a patulous capsule. There was no significant difference between groups (c² = .393, P = .530). Of those with RCTs, 92% (22/24) had surgical fixation with anchors, while 78% (25/32) of those without rotator cuff pathology underwent repair with anchor fixation. There was no statistically significant difference in anchor use between groups (c² = 1.86, P = .172).

Continue to: Discussion

Throwing athletes with and without RCTs had similar rates of recovery and return to play after arthroscopic capsular labral repair, with rotator cuff débridement if a tear was present. The mean follow-up was 3.2 years. Further, there was no difference in return to play (92% vs 84%), ASES score, stability, pain, function, ROM, or strength between the 2 groups before or after surgery. In this cohort of 56 patients, 24 throwing athletes (43%) were found to have RCTs.

Return-to-play rates showed no between-group differences; 92% (22/24) of athletes with concomitant RCTs returned to sport, and 67% (16/24) returned to the same level. Eight percent of throwing athletes with RCTs were unable to return to sport after surgery. These return-to-play rates are an improvement over most previously reported rates in throwing athletes and in posterior shoulder instability in general.^1-4,11 When these athletes are compared with their counterparts with combined SLAP tears and RCTs, return-to-play rates are notably higher. There may be discrepancies in interpreting return-to-play between the two studies, but in the current study, 67% of those with concomitant RCTs achieved return to preinjury level of play. This is 10% higher than the rate reported in athletes with SLAP tears alone (57%) and even higher than in those with concomitant SLAP and RCTs. It is also essential to note that a number of this cohort’s athletes who did not return to play did so for factors (eg, graduation) unrelated to the shoulder. However, the study by Neri and colleagues⁵ included professional athletes who likely all attempted to return to play and, if unable to perform at the same level, likely were unable to continue their professional career.⁵

All patients with RCTs had a good or excellent outcome (ASES score), and 70.8% had an excellent outcome. Similarly, 97% of those without rotator cuff pathology had a good or excellent outcome, and 81.3% had an excellent outcome. There was no significant difference between the two groups. These results parallel those of Neri and colleagues’⁵ study of SLAP tears with RCTs, where 96% (22/23) of throwing athletes had a good or excellent outcome. Despite these high outcome scores in patients with SLAP tears, only 57% were able to return to elite pitching.⁵ In the current study, pain was slightly higher for those with rotator cuff pathology before surgery—a finding consistent with pain frequently being found in patients with isolated partial-thickness RCTs. Their postoperative pain scores were actually lower on average than those of patients without RCTs, which suggests simple débridement of undersurface tears adequately addressed the pathology. The authors theorize that the main pain generator in this population may be posterior instability, and that the rotator cuff has less of an influence. In the SLAP population, the main pain generator likely is the RCT.

Failures by ASES score or strength were fairly rare in this cohort. Many patients opted to have revision surgery because of continued instability, pain, decreased function, or reinjury. One potential cause of failure in this cohort is inadequate capsular shift. However, capsular plication in throwing athletes is difficult to address, as overtensioning the repair can lead to the inability to adequately perform overhead activites.^3,4 This cannot be overemphasized, particularly with pitchers.

Partial-thickness RCTs, particularly those on the articular side, are common in throwing athletes because of high tensile and compressive loads.¹² Despite the known risk of RCTs with posterior shoulder instability in throwing athletes, the authors are unaware of reports of the incidence or treatment of this pathology. RCTs in this posterior instability group likely represent a pathology other than internal impingement. The high proportion of throwing athletes with RCTs in this study (43%) indicates a need for close evaluation of rotator cuff pathology in young throwing athletes. Ide et al found that 75% of patients with SLAP tears had partial articular-sided RCTs.¹³ In the current study, all RCTs were small partial tears, and arthroscopic débridement was performed. It is unknown whether repair of these RCTs would impact return to play. However, rotator cuff repair in this population has been shown to have poor outcomes. Tear thickness typically is used to determine treatment, with débridement performed if <50% tendon thickness is affected. More recently, many have advocated having greater tendon involvement in throwers before repair, because of poor outcomes. Although studies are limited, tear size does seem to correlate with outcomes.¹⁴

Continue to: Study Limitations

Limitations of this study include its small number of professional throwing athletes, with the majority being high school athletes. Further, although ASES scores are consistently used in posterior shoulder instability studies, these scores are influenced highly by pain scores, and some argue that other scoring systems may provide more useful information. However, none of the more modern scoring systems have been studied extensively in posterior glenohumeral instability. Further, because the authors used the present scoring systems previously,^1-4 they were continued to be used for comparison and consistency. Outcomes such as ROM and strength may carry more weight if measured and documented by clinical examination. Further testing, such as clinical evaluation of the jerk test or the posterior load-and-shift test, and their comparison before and after surgery may provide more objective data.

CONCLUSION

Arthroscopic capsulolabral reconstruction is successful in throwing athletes with RCTs treated with arthroscopic débridement. Unlike a previous study of throwing athletes’ outcomes after surgery for concomitant SLAP tears and RCTs,⁵ this study of throwing athletes with concomitant posterior shoulder instability and RCTs found no difference in patient-reported outcome measures or return to play. In throwing athletes with posterior instability and RCTs, arthroscopic posterior capsulolabral repair with rotator cuff débridement is successful.

ABSTRACT

In a previous study, compared with throwing athletes with superior labral anterior posterior (SLAP) tears, those with concomitant SLAP tears and rotator cuff tears (RCTs) had significantly poorer outcome scores and return to play. Posterior shoulder instability also occurs in throwing athletes, but no studies currently exist regarding outcomes of these patients with concomitant RCTs.

The authors hypothesized that throwing athletes treated with arthroscopic capsulolabral repair for posterior shoulder instability with coexistent rotator cuff pathology would have poorer outcome scores and return to play.

Fifty-six consecutive throwing athletes with unidirectional posterior shoulder instability underwent arthroscopic capsulolabral repair. Preoperative and postoperative patient-centered outcomes of pain, stability, function, range of motion, strength, and American Shoulder and Elbow Surgeons Shoulder (ASES) scores, as well as return to play, were evaluated. Patients with and without rotator cuff pathology were compared.

Forty-three percent (24/56) of throwing athletes had rotator cuff pathology in addition to posterior capsulolabral pathology. All RCTs were débrided. At a mean of 3 years, there were no differences in preoperative and postoperative patient-centered outcomes between those with and without RCTs. Return-to-play rates showed no between-group differences; 92% (22/24) of athletes with concomitant RCTs returned to sport (P = .414) and 67% (16/24) returned to the same level (P = .430).

Arthroscopic capsulolabral reconstruction is successful in throwing athletes with RCTs treated with arthroscopic débridement. Unlike the previous study evaluating throwers outcomes after surgical treatment for concomitant SLAP tears and RCTs, the authors found no difference in patient-reported outcome measures or return to play for throwing athletes with concomitant posterior shoulder instability and RCTs. In throwing athletes with concomitant posterior instability and RCTs, arthroscopic posterior capsulolabral repair with rotator cuff débridement is successful.

Continue to: Posterior shoulder instability...

Posterior shoulder instability is an important and increasingly recognized pathology among throwers. Like the superior labrum, the posterior capsulolabral complex is also susceptible to injury during the throwing motion; the posterior labrum being most at risk during the late cocking and follow-through phases. Recent studies have found that arthroscopic capsulolabral reconstruction in posterior shoulder instability is successful in allowing athletes to return to their preinjury sports activities, with 2 studies detailing outcomes in throwing athletes.^1-4 However, superior labral anterior posterior (SLAP) tears are common in throwing athletes and have been treated with varying and limited success. Further, in a study of outcomes of arthroscopic repair of SLAP lesions, Neri and colleagues⁵ found that, compared with throwing athletes with SLAP tears, throwing athletes with concomitant SLAP tears and partial-thickness rotator cuff tears (RCTs) had significantly poorer outcomes and return-to-play rates after surgical repair.

The purpose of this study was to determine outcome scores and return to play of throwing athletes treated with arthroscopic capsulolabral repair for posterior shoulder instability with coexistent RCTs and to compare them with outcome scores as well as return to play of throwing athletes with isolated posterior shoulder instability. It was hypothesized that throwing athletes with a combination of posterior shoulder instability and RCT would have poorer outcomes and poorer return to play after surgery.⁵

METHODS

PATIENT SELECTION

After Institutional Review Board approval, informed consent was obtained, and consecutive throwing athletes who underwent arthroscopic posterior capsulolabral reconstruction for posterior shoulder instability were followed in the perioperative period. Inclusion criteria were throwing athletes participating in competitive sports at the high school, collegiate, or professional level, minimum 1-year follow-up, presence of unidirectional posterior instability, and absence of symptoms of instability in any direction other than posterior. Patients with inferior instability, SLAP pathology on examination and on magnetic resonance imaging, multidirectional instability, or habitual or psychogenic voluntary shoulder subluxations were excluded. Patients with diagnoses of both posterior shoulder instability and impingement treated with subacromial decompression and distal clavicle resection were also excluded.

After this cohort was identified, patient records were reviewed for pertinent operative data, such as procedure, complications, and evidence of RCT by operative report and arthroscopic photographs. A partial RCT was defined as a tear of 10% to 50%; those with rotator cuff fraying were determined not to be significant.

PATIENT EVALUATION

Surgeries were performed between January 1998 and December 2009 by the senior author (JPB). All patients were followed with clinical examinations, radiographs, and subjective grading scales. Recorded patient demographic data included age, sex, sport, position, competition level, and follow-up duration.

Continue to: All patients had...

All patients had symptomatic posterior shoulder instability, including posterior shoulder pain, clicking, a sensation of subluxation, or instability/apprehension with motion. Each athlete’s shoulder was palpated for tenderness and tested for impingement. Specific posterior glenohumeral instability tests, including the Kim test,⁶ the circumduction test, the jerk test,⁷ the posterior load-and-shift test,⁸ and the posterior stress test,⁹ were performed on all patients. Patients with multidirectional instability on the sulcus test, as well as provocative tests indicating SLAP pathology, such as the Crank test and the active compression test, were not included. Standard radiography and magnetic resonance arthrography (MRA) were performed to further narrow inclusion and exclusion criteria.

Both before surgery and at latest follow-up, patient outcomes were evaluated using the American Shoulder and Elbow Surgeons (ASES) score (range, 0-100) which combines a subjective functional scale measuring activities of daily living (0-3 for each of 10 tasks, with a total of 0-30) and a subjective pain scale (0-10, with 10 being worst pain). Values >80 were described as excellent, and failures were defined as scores <60 after surgery.¹⁰ A subjective stability scale (0-10, with 0 indicating completely stable and 10 completely unstable), strength scale (0-3, with 0 indicating none, 1 markedly decreased, 2 slightly decreased, and 3 normal), and ROM scale (0-3, with 0 indicating poor, 1 limited, 2 satisfactory, and 3 full) were evaluated both before surgery and at the latest follow-up. A stability score >5 after surgery was defined as a failure.^1,2,11 Patients were also asked if, based on their current state, they would undergo surgery again. Intraoperative findings and specific surgical procedures performed were correlated with the aforementioned subjective and objective outcome scores.

OPERATIVE TREATMENT

Throwing athletes who met inclusion criteria and failed nonoperative management underwent surgery by the senior author (JPB). Each patient was examined under anesthesia and, with the patient in the lateral decubitus position, a diagnostic arthroscopy was performed to identify posterior capsulolabral complex pathology, including a patulous capsule, capsular tears, labral fraying, and labral tears. A careful examination for rotator cuff pathology was also performed. Based on preoperative clinical examination, MRA, examination under anesthesia, pathologic findings at diagnostic arthroscopic surgery, and surgeon experience, capsulolabral plication was performed with or without suture anchors.^2,5 After capsulolabral repair, the capsule was evaluated for residual laxity, and additional plication sutures were placed, as indicated, with care to avoid overconstraint in these throwing athletes.¹ Posterior glenohumeral stability restoration was judged by removing traction and performing posterior load-and-shift and posterior stress tests. Any RCT with <50% thickness was débrided. Postoperative care and rehabilitation were carried out as previously described and were not altered by the presence or absence of a RCT.³

STATISTICAL ANALYSIS

Preoperative and latest follow-up ASES scores, stability scores, functional scores, and pain-level findings were compared using paired-samples Comparisons between groups, including throwing athletes with and without rotator cuff pathology, were done using the Student t test. Outcome comparisons between multiple groups, which included intraoperative findings and surgical fixation methods, were analyzed with c² modeling for nonparametric data. Statistical significance was set at P < .05. A power analysis found that this study was able to detect a meaningful difference of 10 ASES points.

RESULTS

PATIENT DEMOGRAPHIC CHARACTERISTICS

Of the 56 throwing athletes who met the inclusion criteria, 24 were found to have rotator cuff pathology in addition to posterior capsulolabral pathology, while 32 were found to have capsulolabral pathology alone. Demographic data are listed in Table 1. Mean age was 20.1 years for patients with rotator cuff pathology and 17.8 years for patients without RCTs. All 24 athletes with rotator cuff pathology were treated with arthroscopic débridement. Mean follow-up was 38.6 months (range, 16.5-63.6 months) for patients with RCTs and 39.1 months (range, 12-98.8 months) for patients without RCTs. No significant difference was found in age, sports level, or follow-up between groups.

Table 1. Demographic Data for Athletes With Posterior Instability With and Without Rotator Cuff Tears (N = 56 Shoulders)^a

^aThe majority of athletes were males in high school and their mean follow-up was 3 years.

Continue to: Outcomes

Table 2 lists the preoperative and postoperative scores for shoulder performance in throwing athletes with posterior shoulder instability, with and without RCTs.

Table 2. Preoperative and Postoperative Scores for Shoulder Performance in Throwing Athletes With Posterior Shoulder Instability With and Without Rotator Cuff Tears^a

^aThere was no difference in ASES, stability, pain, or functional scores between athletes with posterior instability alone compared with patients with concomitant rotator cuff tears.

Abbreviation: ASES, American Shoulder and Elbow Surgeons.

ASES Scores. Mean preoperative ASES scores for patients with RCTs improved significantly (t = –13.8, P < .001), as did those for patients without rotator cuff pathology (t = –8.9, P < .001). No significant differences in ASES score were found between patients with and without rotator cuff pathology before or after surgery (t = 1.9, P = .07; t = .58, P = .06). In addition, 70.8% (17/24) of throwing athletes with rotator cuff pathology had an excellent postoperative outcome (ASES score >80), and 29.2% (7/24) had a satisfactory outcome (ASES score, 60-80). Thus, 100% of those with concomitant posterior shoulder instability and RCTs had a good or excellent outcome after surgical intervention. In those without rotator cuff pathology, 78.1% (25/32) had an excellent outcome, 12.5% (4/32) had a satisfactory outcome, and 9.4% (3/32) had a poor outcome. Thus, 91% of those without rotator cuff pathology had a good or excellent outcome after surgery.

Stability. Preoperative stability scores improved significantly after surgery in both groups (t = 7.2, P < .001; t = 10.5, P < .001). There were no statistical differences between preoperative or postoperative stability scores in those with or without rotator cuff pathology (t = 1.7, P = .095; t = .03, P = .975). Of throwing athletes with RCTs, 54.2% (13/24) had an excellent outcome, 33.3% (8/24) a good outcome, and 12.5% (3/24) a satisfactory outcome. Thus, 87.5% (21/24) of those with RCTs had a good or excellent outcome in terms of stability. In those without rotator cuff pathology, 46.9% (15/32) had excellent stability, 46.9% (15/32) had good stability, and 3.1% (1/32) had satisfactory stability after surgery. Thus, 93.8% (30/32) of throwing athletes without rotator cuff pathology had good or excellent stability after surgery.

Pain. Mean preoperative pain scores for those with and without rotator cuff pathology improved significantly (t = 13.4, P < .001; t = 7.1, P < .001). There was no statistical difference in preoperative or postoperative pain scores between those with and without rotator cuff pathology (t = 1.99, P = .051; t = .49, P = .627).

Function. Mean preoperative function scores for both groups improved significantly (t = 7.7, P < .001; t = 8.0, P < .001). There was no difference in improvement in functional scores between the two groups before or after surgery (t = .36, P = .721; t = .5, P = .622).

Continue to: ROM

ROM. Of those with rotator cuff pathology, 54% (13/24) had normal ROM, 42% (10/24) had satisfactory ROM, and 4% (1/24) had limited ROM. In throwing athletes without rotator cuff pathology, 34% (11/32) had normal ROM, 53.1% (17/32) had satisfactory ROM, and 9% (3/32) had limited ROM after surgery. There was no significant difference in ROM between the groups (c² = 2.7, P = .260).

Strength. Of those with RCTs, 67% (16/24) reported normal strength, 29% (7/24) slightly decreased strength, and 4% (1/24) markedly decreased strength. Of those throwing athletes without rotator cuff pathology, 50% (16/32) had normal strength, 41% (13/32) had slightly decreased strength, and 9% (3/32) had markedly decreased strength. No statistical difference was noted between the two groups (c² = 1.7, P = .429).

Return to Sport. Of those with RCTs, 92% (22/24) returned to sport while 84% (27/32) of throwing athletes without RCTs returned to sport. There was no difference between the two groups (c² = .667, P = .414). Sixty-seven percent (16/24) of those with RCTs and 56% (18/32) of those without RCTs returned to the same level of sport. No statistical difference was found in return to play between throwing athletes with and without rotator cuff pathology (c² = .624, P = .430).

Failures. According to ASES scores, no throwers with RCTs failed, while 9.4% (3/32) with posterior instability alone failed. Regarding stability, 8.3% (2/24) of athletes with RCTs failed, while 6.3% (2/32) with posterior instability alone failed. 

SURGICAL FINDINGS AND PROCEDURES

Of the 24 throwing athletes with rotator cuff pathology, 92% (22/24) had labral tears, while 78% (25/32) of those without RCTs had labral tears. The majority of RCTs were in the posterior supraspinatus and anterior infraspinatus regions. This was not significantly different between groups (c² = 1.86, P = .172). All labral pathology was posterior-inferior, and all RCTs were <50% thickness, and therefore were débrided. Fifty-four percent (13/24) of those with RCTs had a patulous capsule and 63% (20/32) of throwing athletes without rotator cuff pathology had a patulous capsule. There was no significant difference between groups (c² = .393, P = .530). Of those with RCTs, 92% (22/24) had surgical fixation with anchors, while 78% (25/32) of those without rotator cuff pathology underwent repair with anchor fixation. There was no statistically significant difference in anchor use between groups (c² = 1.86, P = .172).

Continue to: Discussion

Throwing athletes with and without RCTs had similar rates of recovery and return to play after arthroscopic capsular labral repair, with rotator cuff débridement if a tear was present. The mean follow-up was 3.2 years. Further, there was no difference in return to play (92% vs 84%), ASES score, stability, pain, function, ROM, or strength between the 2 groups before or after surgery. In this cohort of 56 patients, 24 throwing athletes (43%) were found to have RCTs.

Return-to-play rates showed no between-group differences; 92% (22/24) of athletes with concomitant RCTs returned to sport, and 67% (16/24) returned to the same level. Eight percent of throwing athletes with RCTs were unable to return to sport after surgery. These return-to-play rates are an improvement over most previously reported rates in throwing athletes and in posterior shoulder instability in general.^1-4,11 When these athletes are compared with their counterparts with combined SLAP tears and RCTs, return-to-play rates are notably higher. There may be discrepancies in interpreting return-to-play between the two studies, but in the current study, 67% of those with concomitant RCTs achieved return to preinjury level of play. This is 10% higher than the rate reported in athletes with SLAP tears alone (57%) and even higher than in those with concomitant SLAP and RCTs. It is also essential to note that a number of this cohort’s athletes who did not return to play did so for factors (eg, graduation) unrelated to the shoulder. However, the study by Neri and colleagues⁵ included professional athletes who likely all attempted to return to play and, if unable to perform at the same level, likely were unable to continue their professional career.⁵

All patients with RCTs had a good or excellent outcome (ASES score), and 70.8% had an excellent outcome. Similarly, 97% of those without rotator cuff pathology had a good or excellent outcome, and 81.3% had an excellent outcome. There was no significant difference between the two groups. These results parallel those of Neri and colleagues’⁵ study of SLAP tears with RCTs, where 96% (22/23) of throwing athletes had a good or excellent outcome. Despite these high outcome scores in patients with SLAP tears, only 57% were able to return to elite pitching.⁵ In the current study, pain was slightly higher for those with rotator cuff pathology before surgery—a finding consistent with pain frequently being found in patients with isolated partial-thickness RCTs. Their postoperative pain scores were actually lower on average than those of patients without RCTs, which suggests simple débridement of undersurface tears adequately addressed the pathology. The authors theorize that the main pain generator in this population may be posterior instability, and that the rotator cuff has less of an influence. In the SLAP population, the main pain generator likely is the RCT.

Failures by ASES score or strength were fairly rare in this cohort. Many patients opted to have revision surgery because of continued instability, pain, decreased function, or reinjury. One potential cause of failure in this cohort is inadequate capsular shift. However, capsular plication in throwing athletes is difficult to address, as overtensioning the repair can lead to the inability to adequately perform overhead activites.^3,4 This cannot be overemphasized, particularly with pitchers.

Partial-thickness RCTs, particularly those on the articular side, are common in throwing athletes because of high tensile and compressive loads.¹² Despite the known risk of RCTs with posterior shoulder instability in throwing athletes, the authors are unaware of reports of the incidence or treatment of this pathology. RCTs in this posterior instability group likely represent a pathology other than internal impingement. The high proportion of throwing athletes with RCTs in this study (43%) indicates a need for close evaluation of rotator cuff pathology in young throwing athletes. Ide et al found that 75% of patients with SLAP tears had partial articular-sided RCTs.¹³ In the current study, all RCTs were small partial tears, and arthroscopic débridement was performed. It is unknown whether repair of these RCTs would impact return to play. However, rotator cuff repair in this population has been shown to have poor outcomes. Tear thickness typically is used to determine treatment, with débridement performed if <50% tendon thickness is affected. More recently, many have advocated having greater tendon involvement in throwers before repair, because of poor outcomes. Although studies are limited, tear size does seem to correlate with outcomes.¹⁴

Continue to: Study Limitations

Limitations of this study include its small number of professional throwing athletes, with the majority being high school athletes. Further, although ASES scores are consistently used in posterior shoulder instability studies, these scores are influenced highly by pain scores, and some argue that other scoring systems may provide more useful information. However, none of the more modern scoring systems have been studied extensively in posterior glenohumeral instability. Further, because the authors used the present scoring systems previously,^1-4 they were continued to be used for comparison and consistency. Outcomes such as ROM and strength may carry more weight if measured and documented by clinical examination. Further testing, such as clinical evaluation of the jerk test or the posterior load-and-shift test, and their comparison before and after surgery may provide more objective data.

CONCLUSION

Arthroscopic capsulolabral reconstruction is successful in throwing athletes with RCTs treated with arthroscopic débridement. Unlike a previous study of throwing athletes’ outcomes after surgery for concomitant SLAP tears and RCTs,⁵ this study of throwing athletes with concomitant posterior shoulder instability and RCTs found no difference in patient-reported outcome measures or return to play. In throwing athletes with posterior instability and RCTs, arthroscopic posterior capsulolabral repair with rotator cuff débridement is successful.

ABSTRACT

In a previous study, compared with throwing athletes with superior labral anterior posterior (SLAP) tears, those with concomitant SLAP tears and rotator cuff tears (RCTs) had significantly poorer outcome scores and return to play. Posterior shoulder instability also occurs in throwing athletes, but no studies currently exist regarding outcomes of these patients with concomitant RCTs.

The authors hypothesized that throwing athletes treated with arthroscopic capsulolabral repair for posterior shoulder instability with coexistent rotator cuff pathology would have poorer outcome scores and return to play.

Fifty-six consecutive throwing athletes with unidirectional posterior shoulder instability underwent arthroscopic capsulolabral repair. Preoperative and postoperative patient-centered outcomes of pain, stability, function, range of motion, strength, and American Shoulder and Elbow Surgeons Shoulder (ASES) scores, as well as return to play, were evaluated. Patients with and without rotator cuff pathology were compared.

Forty-three percent (24/56) of throwing athletes had rotator cuff pathology in addition to posterior capsulolabral pathology. All RCTs were débrided. At a mean of 3 years, there were no differences in preoperative and postoperative patient-centered outcomes between those with and without RCTs. Return-to-play rates showed no between-group differences; 92% (22/24) of athletes with concomitant RCTs returned to sport (P = .414) and 67% (16/24) returned to the same level (P = .430).

Arthroscopic capsulolabral reconstruction is successful in throwing athletes with RCTs treated with arthroscopic débridement. Unlike the previous study evaluating throwers outcomes after surgical treatment for concomitant SLAP tears and RCTs, the authors found no difference in patient-reported outcome measures or return to play for throwing athletes with concomitant posterior shoulder instability and RCTs. In throwing athletes with concomitant posterior instability and RCTs, arthroscopic posterior capsulolabral repair with rotator cuff débridement is successful.

Continue to: Posterior shoulder instability...

Posterior shoulder instability is an important and increasingly recognized pathology among throwers. Like the superior labrum, the posterior capsulolabral complex is also susceptible to injury during the throwing motion; the posterior labrum being most at risk during the late cocking and follow-through phases. Recent studies have found that arthroscopic capsulolabral reconstruction in posterior shoulder instability is successful in allowing athletes to return to their preinjury sports activities, with 2 studies detailing outcomes in throwing athletes.^1-4 However, superior labral anterior posterior (SLAP) tears are common in throwing athletes and have been treated with varying and limited success. Further, in a study of outcomes of arthroscopic repair of SLAP lesions, Neri and colleagues⁵ found that, compared with throwing athletes with SLAP tears, throwing athletes with concomitant SLAP tears and partial-thickness rotator cuff tears (RCTs) had significantly poorer outcomes and return-to-play rates after surgical repair.

The purpose of this study was to determine outcome scores and return to play of throwing athletes treated with arthroscopic capsulolabral repair for posterior shoulder instability with coexistent RCTs and to compare them with outcome scores as well as return to play of throwing athletes with isolated posterior shoulder instability. It was hypothesized that throwing athletes with a combination of posterior shoulder instability and RCT would have poorer outcomes and poorer return to play after surgery.⁵

METHODS

PATIENT SELECTION

After Institutional Review Board approval, informed consent was obtained, and consecutive throwing athletes who underwent arthroscopic posterior capsulolabral reconstruction for posterior shoulder instability were followed in the perioperative period. Inclusion criteria were throwing athletes participating in competitive sports at the high school, collegiate, or professional level, minimum 1-year follow-up, presence of unidirectional posterior instability, and absence of symptoms of instability in any direction other than posterior. Patients with inferior instability, SLAP pathology on examination and on magnetic resonance imaging, multidirectional instability, or habitual or psychogenic voluntary shoulder subluxations were excluded. Patients with diagnoses of both posterior shoulder instability and impingement treated with subacromial decompression and distal clavicle resection were also excluded.

After this cohort was identified, patient records were reviewed for pertinent operative data, such as procedure, complications, and evidence of RCT by operative report and arthroscopic photographs. A partial RCT was defined as a tear of 10% to 50%; those with rotator cuff fraying were determined not to be significant.

PATIENT EVALUATION

Surgeries were performed between January 1998 and December 2009 by the senior author (JPB). All patients were followed with clinical examinations, radiographs, and subjective grading scales. Recorded patient demographic data included age, sex, sport, position, competition level, and follow-up duration.

Continue to: All patients had...

All patients had symptomatic posterior shoulder instability, including posterior shoulder pain, clicking, a sensation of subluxation, or instability/apprehension with motion. Each athlete’s shoulder was palpated for tenderness and tested for impingement. Specific posterior glenohumeral instability tests, including the Kim test,⁶ the circumduction test, the jerk test,⁷ the posterior load-and-shift test,⁸ and the posterior stress test,⁹ were performed on all patients. Patients with multidirectional instability on the sulcus test, as well as provocative tests indicating SLAP pathology, such as the Crank test and the active compression test, were not included. Standard radiography and magnetic resonance arthrography (MRA) were performed to further narrow inclusion and exclusion criteria.

Both before surgery and at latest follow-up, patient outcomes were evaluated using the American Shoulder and Elbow Surgeons (ASES) score (range, 0-100) which combines a subjective functional scale measuring activities of daily living (0-3 for each of 10 tasks, with a total of 0-30) and a subjective pain scale (0-10, with 10 being worst pain). Values >80 were described as excellent, and failures were defined as scores <60 after surgery.¹⁰ A subjective stability scale (0-10, with 0 indicating completely stable and 10 completely unstable), strength scale (0-3, with 0 indicating none, 1 markedly decreased, 2 slightly decreased, and 3 normal), and ROM scale (0-3, with 0 indicating poor, 1 limited, 2 satisfactory, and 3 full) were evaluated both before surgery and at the latest follow-up. A stability score >5 after surgery was defined as a failure.^1,2,11 Patients were also asked if, based on their current state, they would undergo surgery again. Intraoperative findings and specific surgical procedures performed were correlated with the aforementioned subjective and objective outcome scores.

OPERATIVE TREATMENT

Throwing athletes who met inclusion criteria and failed nonoperative management underwent surgery by the senior author (JPB). Each patient was examined under anesthesia and, with the patient in the lateral decubitus position, a diagnostic arthroscopy was performed to identify posterior capsulolabral complex pathology, including a patulous capsule, capsular tears, labral fraying, and labral tears. A careful examination for rotator cuff pathology was also performed. Based on preoperative clinical examination, MRA, examination under anesthesia, pathologic findings at diagnostic arthroscopic surgery, and surgeon experience, capsulolabral plication was performed with or without suture anchors.^2,5 After capsulolabral repair, the capsule was evaluated for residual laxity, and additional plication sutures were placed, as indicated, with care to avoid overconstraint in these throwing athletes.¹ Posterior glenohumeral stability restoration was judged by removing traction and performing posterior load-and-shift and posterior stress tests. Any RCT with <50% thickness was débrided. Postoperative care and rehabilitation were carried out as previously described and were not altered by the presence or absence of a RCT.³

STATISTICAL ANALYSIS

Preoperative and latest follow-up ASES scores, stability scores, functional scores, and pain-level findings were compared using paired-samples Comparisons between groups, including throwing athletes with and without rotator cuff pathology, were done using the Student t test. Outcome comparisons between multiple groups, which included intraoperative findings and surgical fixation methods, were analyzed with c² modeling for nonparametric data. Statistical significance was set at P < .05. A power analysis found that this study was able to detect a meaningful difference of 10 ASES points.

RESULTS

PATIENT DEMOGRAPHIC CHARACTERISTICS

Of the 56 throwing athletes who met the inclusion criteria, 24 were found to have rotator cuff pathology in addition to posterior capsulolabral pathology, while 32 were found to have capsulolabral pathology alone. Demographic data are listed in Table 1. Mean age was 20.1 years for patients with rotator cuff pathology and 17.8 years for patients without RCTs. All 24 athletes with rotator cuff pathology were treated with arthroscopic débridement. Mean follow-up was 38.6 months (range, 16.5-63.6 months) for patients with RCTs and 39.1 months (range, 12-98.8 months) for patients without RCTs. No significant difference was found in age, sports level, or follow-up between groups.

Table 1. Demographic Data for Athletes With Posterior Instability With and Without Rotator Cuff Tears (N = 56 Shoulders)^a

^aThe majority of athletes were males in high school and their mean follow-up was 3 years.

Continue to: Outcomes

Table 2 lists the preoperative and postoperative scores for shoulder performance in throwing athletes with posterior shoulder instability, with and without RCTs.

Table 2. Preoperative and Postoperative Scores for Shoulder Performance in Throwing Athletes With Posterior Shoulder Instability With and Without Rotator Cuff Tears^a

^aThere was no difference in ASES, stability, pain, or functional scores between athletes with posterior instability alone compared with patients with concomitant rotator cuff tears.

Abbreviation: ASES, American Shoulder and Elbow Surgeons.

ASES Scores. Mean preoperative ASES scores for patients with RCTs improved significantly (t = –13.8, P < .001), as did those for patients without rotator cuff pathology (t = –8.9, P < .001). No significant differences in ASES score were found between patients with and without rotator cuff pathology before or after surgery (t = 1.9, P = .07; t = .58, P = .06). In addition, 70.8% (17/24) of throwing athletes with rotator cuff pathology had an excellent postoperative outcome (ASES score >80), and 29.2% (7/24) had a satisfactory outcome (ASES score, 60-80). Thus, 100% of those with concomitant posterior shoulder instability and RCTs had a good or excellent outcome after surgical intervention. In those without rotator cuff pathology, 78.1% (25/32) had an excellent outcome, 12.5% (4/32) had a satisfactory outcome, and 9.4% (3/32) had a poor outcome. Thus, 91% of those without rotator cuff pathology had a good or excellent outcome after surgery.

Stability. Preoperative stability scores improved significantly after surgery in both groups (t = 7.2, P < .001; t = 10.5, P < .001). There were no statistical differences between preoperative or postoperative stability scores in those with or without rotator cuff pathology (t = 1.7, P = .095; t = .03, P = .975). Of throwing athletes with RCTs, 54.2% (13/24) had an excellent outcome, 33.3% (8/24) a good outcome, and 12.5% (3/24) a satisfactory outcome. Thus, 87.5% (21/24) of those with RCTs had a good or excellent outcome in terms of stability. In those without rotator cuff pathology, 46.9% (15/32) had excellent stability, 46.9% (15/32) had good stability, and 3.1% (1/32) had satisfactory stability after surgery. Thus, 93.8% (30/32) of throwing athletes without rotator cuff pathology had good or excellent stability after surgery.

Pain. Mean preoperative pain scores for those with and without rotator cuff pathology improved significantly (t = 13.4, P < .001; t = 7.1, P < .001). There was no statistical difference in preoperative or postoperative pain scores between those with and without rotator cuff pathology (t = 1.99, P = .051; t = .49, P = .627).

Function. Mean preoperative function scores for both groups improved significantly (t = 7.7, P < .001; t = 8.0, P < .001). There was no difference in improvement in functional scores between the two groups before or after surgery (t = .36, P = .721; t = .5, P = .622).

Continue to: ROM

ROM. Of those with rotator cuff pathology, 54% (13/24) had normal ROM, 42% (10/24) had satisfactory ROM, and 4% (1/24) had limited ROM. In throwing athletes without rotator cuff pathology, 34% (11/32) had normal ROM, 53.1% (17/32) had satisfactory ROM, and 9% (3/32) had limited ROM after surgery. There was no significant difference in ROM between the groups (c² = 2.7, P = .260).

Strength. Of those with RCTs, 67% (16/24) reported normal strength, 29% (7/24) slightly decreased strength, and 4% (1/24) markedly decreased strength. Of those throwing athletes without rotator cuff pathology, 50% (16/32) had normal strength, 41% (13/32) had slightly decreased strength, and 9% (3/32) had markedly decreased strength. No statistical difference was noted between the two groups (c² = 1.7, P = .429).

Return to Sport. Of those with RCTs, 92% (22/24) returned to sport while 84% (27/32) of throwing athletes without RCTs returned to sport. There was no difference between the two groups (c² = .667, P = .414). Sixty-seven percent (16/24) of those with RCTs and 56% (18/32) of those without RCTs returned to the same level of sport. No statistical difference was found in return to play between throwing athletes with and without rotator cuff pathology (c² = .624, P = .430).

Failures. According to ASES scores, no throwers with RCTs failed, while 9.4% (3/32) with posterior instability alone failed. Regarding stability, 8.3% (2/24) of athletes with RCTs failed, while 6.3% (2/32) with posterior instability alone failed. 

SURGICAL FINDINGS AND PROCEDURES

Of the 24 throwing athletes with rotator cuff pathology, 92% (22/24) had labral tears, while 78% (25/32) of those without RCTs had labral tears. The majority of RCTs were in the posterior supraspinatus and anterior infraspinatus regions. This was not significantly different between groups (c² = 1.86, P = .172). All labral pathology was posterior-inferior, and all RCTs were <50% thickness, and therefore were débrided. Fifty-four percent (13/24) of those with RCTs had a patulous capsule and 63% (20/32) of throwing athletes without rotator cuff pathology had a patulous capsule. There was no significant difference between groups (c² = .393, P = .530). Of those with RCTs, 92% (22/24) had surgical fixation with anchors, while 78% (25/32) of those without rotator cuff pathology underwent repair with anchor fixation. There was no statistically significant difference in anchor use between groups (c² = 1.86, P = .172).

Continue to: Discussion

Throwing athletes with and without RCTs had similar rates of recovery and return to play after arthroscopic capsular labral repair, with rotator cuff débridement if a tear was present. The mean follow-up was 3.2 years. Further, there was no difference in return to play (92% vs 84%), ASES score, stability, pain, function, ROM, or strength between the 2 groups before or after surgery. In this cohort of 56 patients, 24 throwing athletes (43%) were found to have RCTs.

Return-to-play rates showed no between-group differences; 92% (22/24) of athletes with concomitant RCTs returned to sport, and 67% (16/24) returned to the same level. Eight percent of throwing athletes with RCTs were unable to return to sport after surgery. These return-to-play rates are an improvement over most previously reported rates in throwing athletes and in posterior shoulder instability in general.^1-4,11 When these athletes are compared with their counterparts with combined SLAP tears and RCTs, return-to-play rates are notably higher. There may be discrepancies in interpreting return-to-play between the two studies, but in the current study, 67% of those with concomitant RCTs achieved return to preinjury level of play. This is 10% higher than the rate reported in athletes with SLAP tears alone (57%) and even higher than in those with concomitant SLAP and RCTs. It is also essential to note that a number of this cohort’s athletes who did not return to play did so for factors (eg, graduation) unrelated to the shoulder. However, the study by Neri and colleagues⁵ included professional athletes who likely all attempted to return to play and, if unable to perform at the same level, likely were unable to continue their professional career.⁵

All patients with RCTs had a good or excellent outcome (ASES score), and 70.8% had an excellent outcome. Similarly, 97% of those without rotator cuff pathology had a good or excellent outcome, and 81.3% had an excellent outcome. There was no significant difference between the two groups. These results parallel those of Neri and colleagues’⁵ study of SLAP tears with RCTs, where 96% (22/23) of throwing athletes had a good or excellent outcome. Despite these high outcome scores in patients with SLAP tears, only 57% were able to return to elite pitching.⁵ In the current study, pain was slightly higher for those with rotator cuff pathology before surgery—a finding consistent with pain frequently being found in patients with isolated partial-thickness RCTs. Their postoperative pain scores were actually lower on average than those of patients without RCTs, which suggests simple débridement of undersurface tears adequately addressed the pathology. The authors theorize that the main pain generator in this population may be posterior instability, and that the rotator cuff has less of an influence. In the SLAP population, the main pain generator likely is the RCT.

Failures by ASES score or strength were fairly rare in this cohort. Many patients opted to have revision surgery because of continued instability, pain, decreased function, or reinjury. One potential cause of failure in this cohort is inadequate capsular shift. However, capsular plication in throwing athletes is difficult to address, as overtensioning the repair can lead to the inability to adequately perform overhead activites.^3,4 This cannot be overemphasized, particularly with pitchers.

Partial-thickness RCTs, particularly those on the articular side, are common in throwing athletes because of high tensile and compressive loads.¹² Despite the known risk of RCTs with posterior shoulder instability in throwing athletes, the authors are unaware of reports of the incidence or treatment of this pathology. RCTs in this posterior instability group likely represent a pathology other than internal impingement. The high proportion of throwing athletes with RCTs in this study (43%) indicates a need for close evaluation of rotator cuff pathology in young throwing athletes. Ide et al found that 75% of patients with SLAP tears had partial articular-sided RCTs.¹³ In the current study, all RCTs were small partial tears, and arthroscopic débridement was performed. It is unknown whether repair of these RCTs would impact return to play. However, rotator cuff repair in this population has been shown to have poor outcomes. Tear thickness typically is used to determine treatment, with débridement performed if <50% tendon thickness is affected. More recently, many have advocated having greater tendon involvement in throwers before repair, because of poor outcomes. Although studies are limited, tear size does seem to correlate with outcomes.¹⁴

Continue to: Study Limitations

Limitations of this study include its small number of professional throwing athletes, with the majority being high school athletes. Further, although ASES scores are consistently used in posterior shoulder instability studies, these scores are influenced highly by pain scores, and some argue that other scoring systems may provide more useful information. However, none of the more modern scoring systems have been studied extensively in posterior glenohumeral instability. Further, because the authors used the present scoring systems previously,^1-4 they were continued to be used for comparison and consistency. Outcomes such as ROM and strength may carry more weight if measured and documented by clinical examination. Further testing, such as clinical evaluation of the jerk test or the posterior load-and-shift test, and their comparison before and after surgery may provide more objective data.

CONCLUSION

Arthroscopic capsulolabral reconstruction is successful in throwing athletes with RCTs treated with arthroscopic débridement. Unlike a previous study of throwing athletes’ outcomes after surgery for concomitant SLAP tears and RCTs,⁵ this study of throwing athletes with concomitant posterior shoulder instability and RCTs found no difference in patient-reported outcome measures or return to play. In throwing athletes with posterior instability and RCTs, arthroscopic posterior capsulolabral repair with rotator cuff débridement is successful.

ABSTRACT

We conducted a study to determine the common characteristics of patients who developed radiculopathy symptoms and corresponding heterotopic ossification (HO) from transforaminal lumbar interbody fusions (TLIF) using recombinant human bone morphogenetic protein 2 (rhBMP-2). HO can arise from a disk space with rhBMP-2 use in TLIF. Formation of bone around nerve roots or the thecal sac can cause a radiculopathy with a consistent pattern of symptoms.

We identified 38 patients (26 males, 12 females) with a mean (SD) age of 50.8 (7.5) years who developed radiculopathy symptoms and corresponding HO from TLIF with rhBMP-2 in the disk space between 2002 and 2015. To document this complication and improve its recognition, we recorded common patterns of symptom development and radiologic findings: specifically, time from implantation of rhBMP-2 to symptom development, consistency with side of TLIF placement, and radiologic findings.

Radicular pain generally developed a mean (SD) of 3.8 (1.0) months after TLIF with rhBMP-2. Development of radiculopathy symptoms corresponded to consistent “pseudo-pedicle”-like HO. In all 38 patients, HO arising from the annulotomy site showed a distinct pseudo-pedicle pattern encompassing nerve roots and the thecal sac. In addition, development of radiculopathy symptoms and corresponding HO appear to be independent of amount of rhBMP-2. HO resulting from TLIF with rhBMP-2 in the disk space is a pain generator and a recognizable complication that can be diagnosed by assessment of symptoms and computed tomography characteristics.

Continue to: Bone morphogenetic proteins...

Bone morphogenetic proteins (BMPs), first isolated by Urist in 1964¹, are a family of growth factors that stimulate the cascade of bone formation. Recombinant human BMP (rhBMP), specifically rhBMP-2 and rhBMP-7 (also known as osteogenic protein 1 [OP-1]), was developed in the 1990s after the advent of gene splicing. Then, in 2002, the US Food and Drug Administration (FDA) approved use of rhBMP to stimulate fusion in the human spine. Specifically, rhBMP-2 (Medtronic) was approved for use in combination with a specific brand of interbody cage in 1-level anterior lumbar interbody fusion.² Over the past decade, off-label use of rhBMP-2 to achieve osseous union has increased dramatically, particularly in spinal surgery: transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion, and posterolateral lumbar fusion.^3-9 However, this widespread off-label use for posterior spinal fusion began despite FDA data indicating that specific complications were underreported in the peer-reviewed literature.^10,11 Although rhBMP-2 is very effective in increasing osteoblast formation and improving osteogenesis and subsequent bone healing in spinal surgery,^12,13 its use in TLIF resulted in significant adverse side effects, including radiculopathy with and without neuroforaminal heterotopic ossification (HO); ^14-24 complications in the FDA studies; ^14,22,25-27 and osteolysis causing intervertebral cage subsidence, inflammatory radiculitis, genitourinary complications, infections, possible systemic effects, and significant HO complications.^10,28-30 Of these, HO complications involved rhBMP leakage through the annulotomy to the disk space that led to HO. Specifically, rhBMP leaked directly out of the disk space and formed a pillar of bone that encased the nerve roots and dura, which led to occlusion of the foramen and symptoms of radiculopathy.^10,28-30

Despite this frequent finding of HO in the intervertebral space outside the target fusion area, use of rhBMP-2 with intervertebral cages increased so rapidly that rhBMP-2 was used more often than autologous bone.^5,11,17,31 In this study, we reviewed the common characteristics of patients who developed HO and subsequent radiculopathy from TLIF with rhBMP.

METHODS

After this study received Institutional Review Board approval, we retrospectively reviewed cases of radiculopathy symptoms that developed after TLIF with rhBMP between January 2002 and January 2015. During this period, 38 patients (26 males, 12 females) with a mean (SD) age of 50.8 (7.5) years and radiculopathy symptoms arising from TLIF with rhBMP-2 were identified to determine commonalities and defining characteristics that will help facilitate diagnosis.

Inclusion criteria were computed tomography (CT)–documented HO arising from the TLIF annulotomy site in continuity with bone in the disk space or ectopic bone forming a distinctive shell with contouring around the thecal sac or nerve roots, as well as recurrence or initial occurrence of radiculopathy with signs and symptoms corresponding to the CT site of aberrant bone growth in terms of laterality and particular nerve root(s) involved. Exclusion criteria were malplacement of interbody cage or pedicle screws, disk herniation, systemic neuropathic disease, and new or unresolved radiculopathy immediately after index surgery.

To improve recognition of this complication, we also documented the amount of BMP used, common patterns of radiculopathy symptom development, and radiologic findings. Type and timing of radiculopathy symptom onset and consistency with side of TLIF placement were documented as well. Radiculopathy symptoms included shooting pain in the legs, incontinence, sexual dysfunction, and severe paralysis. Radiologic findings were specific to bone formation from the disk space (detected with CT).

Continue to: RESULTS

All 38 selected patients had radiculopathy symptoms from HO out of the intervertebral space. The Table lists the patients’ overall characteristics. The left side had the most radiculopathy symptoms (31/38 patients), followed by the right side (5/38) and both sides (2/38). Radiculopathy symptoms began a mean (SD) of 3.8 (1.0) months (range, 2-6 months) after index surgery. The 38 patients had 4 characteristics in common:

Table. Transforaminal Lumbar Interbody Fusion With Recombinant Human Bone Morphogenetic Protein 2: Onset Time for Radiculopathy Symptoms, Surgery Level, Side of Pseudo-Pedicle Bone Formation, and Subsequent Complications

1. Bone growing out of the annulotomy site for TLIF cage placement was present and in continuity with the disk space in 33 (87%) of the 38 cases. In the other 5 cases (13%), HO was present around the neural tissue, but not necessarily in continuity with the disk space. This bone appeared ectopic and not osteophytic and facet-related, as it formed a shell around either the nerve root or the thecal sac, contouring to the structure.

2. The common, novel finding on CT was a “pseudo-pedicle” (Figures 1A, 1B), which appeared as ectopic growth from the disk space—a solid piece of bone in the same direction as the anatomical pedicle. Confusing similarity to the anatomical pedicle is present on axial cuts and during surgery. The pseudo-pedicle varied in thickness and extent out of the disk space, but was always presented as a bar of bone arising from the annulotomy site. After arising from the disk space, the HO could disperse in any direction, further calcifying neural structures or the facet joints above or below. There was no apparent distinguishable repeating pattern, given the variable nature of arthritic facet changes, scoliotic deformities, size of annulotomies, amount of rhBMP used, and placement in cage and disk space or only in cage.

3. In 36 (95%) of the 38 cases, the initial interpretation of HO on magnetic resonance imaging (MRI) was of tissue other than bone, such as fibrous tissue, granulation tissue, recurrent disk herniation, or postoperative changes. However, this tissue was later determined to be bone from HO complications, which we confirmed with CT in all 38 cases. It is important to note that HO on MRI (Figures 2A, 2B) was initially interpreted by a radiologist as fibrous tissue, but same-level CT of the same case (Figures 3A, 3B) showed clear HO.

4. The radiculopathy symptoms caused by HO were independent of the amount of rhBMP-2 used in TLIF. Of the 38 patients, 19 had 1 rhBMP-2 sponge placed in the cage, 12 had a small kit sponge (1.05 mg), 5 had 1 sponge placed in the cage and 1 sponge placed directly in the disk space before cage placement (no notation of precise size or amount of rhBMP-2), and 2 had 1 sponge placed in the cage (no notation of rhBMP-2 amount). The data showed that HO can occur with even a small amount of rhBMP-2.

Continue to: Bone formation with rhBMP-2...

Bone formation with rhBMP-2 is robust and beneficial, but HO-related complications are significant, and identifiable on assessment of radiculopathy symptoms and CT characteristics.

DISCUSSION

We identified 38 patients with a recognizable and consistent pattern of complications of off-label use of rhBMP-2 in TLIF performed at our institution between 2002 and 2015. This pattern included consistent radiculopathy symptoms with corresponding HO at the annulotomy site in continuity with bone in the disk space or ectopic bone forming a distinctive shell around the thecal sac or nerve roots, as well as showing a distinct pseudo-pedicle pattern encompassing nerve roots and the thecal sac. Our finding differs from other findings of similar complication characteristics, but with much larger variations without consistency within the patient population.^19,20,22,24 Specifically, previous studies found an association between off-label rhBMP-2 use in the posterior spine and radiculopathy with and without neuroforaminal HO. However, our study found consistent radiculopathy symptoms with pseudo-pedicle-like HO complications in all its 38 patients a mean (SD) of 3.8 (1.0) months after surgery.

In this study, consistent radiculopathy symptoms with pseudo-pedicle-like HO complications were independent of the amount of rhBMP-2 used, as some complications occurred with use of small pack rhBMP-2 with TLIF. It is well understood that high doses of rhBMP-2 may be required to improve fusion rates, but to our knowledge an optimal dosing strategy for TLIF has not been reported, particularly with respect to potential complications.^8,20,31-33 For anterior lumbar interbody fusion surgery, the FDA-approved use of rhBMP-2 appears to have a significantly decreased risk of neuroforaminal HO complications. This may be attributable to the protective presence of the intact posterior annulus and longitudinal ligament for this procedure.^20,33 For TLIF, it has been suggested that rhBMP-2 should be placed only along the anterior annulus with a posterior strut and morselized bone allograft barricade,³³ and that fibrin glue should be used to limit BMP diffusion through the annulotomy site³¹ to prevent this complication.

Our study results suggest that radiculopathy symptoms with pseudo-pedicle-like HO complications appear to be caused by leakage of rhBMP-2 from the disk space through the annulotomy site. This was often initially interpreted incorrectly on MRI in the first year after surgery as being fibrous or granulation tissue, or even postoperative changes that the heterotopic tissue was bone was obvious only on CT. Even then the tissue may be incorrectly identified, as the encasing nerve roots in bone are similar to the scar tissue having no compressive effect. HO may compress, but it also has an inflammatory component that the scars lack. Additionally, the HO from the disk space, caused by leakage of the BMP placed in or around the fusion cage, can create a pseudo-pedicle of varying size and extent. This was present in all 38 of our cases.

This retrospective case series had its limitations. Its clinical and radiographic findings were not blinded. Confounding variables cannot be isolated for causal relationships, if any, to the complication in a case series such as this.

Bone formation with rhBMP-2 is robust and beneficial, but HO-related complications are significant, and identifiable on assessment of radiculopathy symptoms and CT characteristics.

ABSTRACT

We conducted a study to determine the common characteristics of patients who developed radiculopathy symptoms and corresponding heterotopic ossification (HO) from transforaminal lumbar interbody fusions (TLIF) using recombinant human bone morphogenetic protein 2 (rhBMP-2). HO can arise from a disk space with rhBMP-2 use in TLIF. Formation of bone around nerve roots or the thecal sac can cause a radiculopathy with a consistent pattern of symptoms.

We identified 38 patients (26 males, 12 females) with a mean (SD) age of 50.8 (7.5) years who developed radiculopathy symptoms and corresponding HO from TLIF with rhBMP-2 in the disk space between 2002 and 2015. To document this complication and improve its recognition, we recorded common patterns of symptom development and radiologic findings: specifically, time from implantation of rhBMP-2 to symptom development, consistency with side of TLIF placement, and radiologic findings.

Radicular pain generally developed a mean (SD) of 3.8 (1.0) months after TLIF with rhBMP-2. Development of radiculopathy symptoms corresponded to consistent “pseudo-pedicle”-like HO. In all 38 patients, HO arising from the annulotomy site showed a distinct pseudo-pedicle pattern encompassing nerve roots and the thecal sac. In addition, development of radiculopathy symptoms and corresponding HO appear to be independent of amount of rhBMP-2. HO resulting from TLIF with rhBMP-2 in the disk space is a pain generator and a recognizable complication that can be diagnosed by assessment of symptoms and computed tomography characteristics.

Continue to: Bone morphogenetic proteins...

Bone morphogenetic proteins (BMPs), first isolated by Urist in 1964¹, are a family of growth factors that stimulate the cascade of bone formation. Recombinant human BMP (rhBMP), specifically rhBMP-2 and rhBMP-7 (also known as osteogenic protein 1 [OP-1]), was developed in the 1990s after the advent of gene splicing. Then, in 2002, the US Food and Drug Administration (FDA) approved use of rhBMP to stimulate fusion in the human spine. Specifically, rhBMP-2 (Medtronic) was approved for use in combination with a specific brand of interbody cage in 1-level anterior lumbar interbody fusion.² Over the past decade, off-label use of rhBMP-2 to achieve osseous union has increased dramatically, particularly in spinal surgery: transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion, and posterolateral lumbar fusion.^3-9 However, this widespread off-label use for posterior spinal fusion began despite FDA data indicating that specific complications were underreported in the peer-reviewed literature.^10,11 Although rhBMP-2 is very effective in increasing osteoblast formation and improving osteogenesis and subsequent bone healing in spinal surgery,^12,13 its use in TLIF resulted in significant adverse side effects, including radiculopathy with and without neuroforaminal heterotopic ossification (HO); ^14-24 complications in the FDA studies; ^14,22,25-27 and osteolysis causing intervertebral cage subsidence, inflammatory radiculitis, genitourinary complications, infections, possible systemic effects, and significant HO complications.^10,28-30 Of these, HO complications involved rhBMP leakage through the annulotomy to the disk space that led to HO. Specifically, rhBMP leaked directly out of the disk space and formed a pillar of bone that encased the nerve roots and dura, which led to occlusion of the foramen and symptoms of radiculopathy.^10,28-30

Despite this frequent finding of HO in the intervertebral space outside the target fusion area, use of rhBMP-2 with intervertebral cages increased so rapidly that rhBMP-2 was used more often than autologous bone.^5,11,17,31 In this study, we reviewed the common characteristics of patients who developed HO and subsequent radiculopathy from TLIF with rhBMP.

METHODS

After this study received Institutional Review Board approval, we retrospectively reviewed cases of radiculopathy symptoms that developed after TLIF with rhBMP between January 2002 and January 2015. During this period, 38 patients (26 males, 12 females) with a mean (SD) age of 50.8 (7.5) years and radiculopathy symptoms arising from TLIF with rhBMP-2 were identified to determine commonalities and defining characteristics that will help facilitate diagnosis.

Inclusion criteria were computed tomography (CT)–documented HO arising from the TLIF annulotomy site in continuity with bone in the disk space or ectopic bone forming a distinctive shell with contouring around the thecal sac or nerve roots, as well as recurrence or initial occurrence of radiculopathy with signs and symptoms corresponding to the CT site of aberrant bone growth in terms of laterality and particular nerve root(s) involved. Exclusion criteria were malplacement of interbody cage or pedicle screws, disk herniation, systemic neuropathic disease, and new or unresolved radiculopathy immediately after index surgery.

To improve recognition of this complication, we also documented the amount of BMP used, common patterns of radiculopathy symptom development, and radiologic findings. Type and timing of radiculopathy symptom onset and consistency with side of TLIF placement were documented as well. Radiculopathy symptoms included shooting pain in the legs, incontinence, sexual dysfunction, and severe paralysis. Radiologic findings were specific to bone formation from the disk space (detected with CT).

Continue to: RESULTS

All 38 selected patients had radiculopathy symptoms from HO out of the intervertebral space. The Table lists the patients’ overall characteristics. The left side had the most radiculopathy symptoms (31/38 patients), followed by the right side (5/38) and both sides (2/38). Radiculopathy symptoms began a mean (SD) of 3.8 (1.0) months (range, 2-6 months) after index surgery. The 38 patients had 4 characteristics in common:

Table. Transforaminal Lumbar Interbody Fusion With Recombinant Human Bone Morphogenetic Protein 2: Onset Time for Radiculopathy Symptoms, Surgery Level, Side of Pseudo-Pedicle Bone Formation, and Subsequent Complications

1. Bone growing out of the annulotomy site for TLIF cage placement was present and in continuity with the disk space in 33 (87%) of the 38 cases. In the other 5 cases (13%), HO was present around the neural tissue, but not necessarily in continuity with the disk space. This bone appeared ectopic and not osteophytic and facet-related, as it formed a shell around either the nerve root or the thecal sac, contouring to the structure.

2. The common, novel finding on CT was a “pseudo-pedicle” (Figures 1A, 1B), which appeared as ectopic growth from the disk space—a solid piece of bone in the same direction as the anatomical pedicle. Confusing similarity to the anatomical pedicle is present on axial cuts and during surgery. The pseudo-pedicle varied in thickness and extent out of the disk space, but was always presented as a bar of bone arising from the annulotomy site. After arising from the disk space, the HO could disperse in any direction, further calcifying neural structures or the facet joints above or below. There was no apparent distinguishable repeating pattern, given the variable nature of arthritic facet changes, scoliotic deformities, size of annulotomies, amount of rhBMP used, and placement in cage and disk space or only in cage.

3. In 36 (95%) of the 38 cases, the initial interpretation of HO on magnetic resonance imaging (MRI) was of tissue other than bone, such as fibrous tissue, granulation tissue, recurrent disk herniation, or postoperative changes. However, this tissue was later determined to be bone from HO complications, which we confirmed with CT in all 38 cases. It is important to note that HO on MRI (Figures 2A, 2B) was initially interpreted by a radiologist as fibrous tissue, but same-level CT of the same case (Figures 3A, 3B) showed clear HO.

4. The radiculopathy symptoms caused by HO were independent of the amount of rhBMP-2 used in TLIF. Of the 38 patients, 19 had 1 rhBMP-2 sponge placed in the cage, 12 had a small kit sponge (1.05 mg), 5 had 1 sponge placed in the cage and 1 sponge placed directly in the disk space before cage placement (no notation of precise size or amount of rhBMP-2), and 2 had 1 sponge placed in the cage (no notation of rhBMP-2 amount). The data showed that HO can occur with even a small amount of rhBMP-2.

Continue to: Bone formation with rhBMP-2...

Bone formation with rhBMP-2 is robust and beneficial, but HO-related complications are significant, and identifiable on assessment of radiculopathy symptoms and CT characteristics.

DISCUSSION

We identified 38 patients with a recognizable and consistent pattern of complications of off-label use of rhBMP-2 in TLIF performed at our institution between 2002 and 2015. This pattern included consistent radiculopathy symptoms with corresponding HO at the annulotomy site in continuity with bone in the disk space or ectopic bone forming a distinctive shell around the thecal sac or nerve roots, as well as showing a distinct pseudo-pedicle pattern encompassing nerve roots and the thecal sac. Our finding differs from other findings of similar complication characteristics, but with much larger variations without consistency within the patient population.^19,20,22,24 Specifically, previous studies found an association between off-label rhBMP-2 use in the posterior spine and radiculopathy with and without neuroforaminal HO. However, our study found consistent radiculopathy symptoms with pseudo-pedicle-like HO complications in all its 38 patients a mean (SD) of 3.8 (1.0) months after surgery.

In this study, consistent radiculopathy symptoms with pseudo-pedicle-like HO complications were independent of the amount of rhBMP-2 used, as some complications occurred with use of small pack rhBMP-2 with TLIF. It is well understood that high doses of rhBMP-2 may be required to improve fusion rates, but to our knowledge an optimal dosing strategy for TLIF has not been reported, particularly with respect to potential complications.^8,20,31-33 For anterior lumbar interbody fusion surgery, the FDA-approved use of rhBMP-2 appears to have a significantly decreased risk of neuroforaminal HO complications. This may be attributable to the protective presence of the intact posterior annulus and longitudinal ligament for this procedure.^20,33 For TLIF, it has been suggested that rhBMP-2 should be placed only along the anterior annulus with a posterior strut and morselized bone allograft barricade,³³ and that fibrin glue should be used to limit BMP diffusion through the annulotomy site³¹ to prevent this complication.

Our study results suggest that radiculopathy symptoms with pseudo-pedicle-like HO complications appear to be caused by leakage of rhBMP-2 from the disk space through the annulotomy site. This was often initially interpreted incorrectly on MRI in the first year after surgery as being fibrous or granulation tissue, or even postoperative changes that the heterotopic tissue was bone was obvious only on CT. Even then the tissue may be incorrectly identified, as the encasing nerve roots in bone are similar to the scar tissue having no compressive effect. HO may compress, but it also has an inflammatory component that the scars lack. Additionally, the HO from the disk space, caused by leakage of the BMP placed in or around the fusion cage, can create a pseudo-pedicle of varying size and extent. This was present in all 38 of our cases.

This retrospective case series had its limitations. Its clinical and radiographic findings were not blinded. Confounding variables cannot be isolated for causal relationships, if any, to the complication in a case series such as this.

Bone formation with rhBMP-2 is robust and beneficial, but HO-related complications are significant, and identifiable on assessment of radiculopathy symptoms and CT characteristics.

ABSTRACT

We conducted a study to determine the common characteristics of patients who developed radiculopathy symptoms and corresponding heterotopic ossification (HO) from transforaminal lumbar interbody fusions (TLIF) using recombinant human bone morphogenetic protein 2 (rhBMP-2). HO can arise from a disk space with rhBMP-2 use in TLIF. Formation of bone around nerve roots or the thecal sac can cause a radiculopathy with a consistent pattern of symptoms.

We identified 38 patients (26 males, 12 females) with a mean (SD) age of 50.8 (7.5) years who developed radiculopathy symptoms and corresponding HO from TLIF with rhBMP-2 in the disk space between 2002 and 2015. To document this complication and improve its recognition, we recorded common patterns of symptom development and radiologic findings: specifically, time from implantation of rhBMP-2 to symptom development, consistency with side of TLIF placement, and radiologic findings.

Radicular pain generally developed a mean (SD) of 3.8 (1.0) months after TLIF with rhBMP-2. Development of radiculopathy symptoms corresponded to consistent “pseudo-pedicle”-like HO. In all 38 patients, HO arising from the annulotomy site showed a distinct pseudo-pedicle pattern encompassing nerve roots and the thecal sac. In addition, development of radiculopathy symptoms and corresponding HO appear to be independent of amount of rhBMP-2. HO resulting from TLIF with rhBMP-2 in the disk space is a pain generator and a recognizable complication that can be diagnosed by assessment of symptoms and computed tomography characteristics.

Continue to: Bone morphogenetic proteins...

Bone morphogenetic proteins (BMPs), first isolated by Urist in 1964¹, are a family of growth factors that stimulate the cascade of bone formation. Recombinant human BMP (rhBMP), specifically rhBMP-2 and rhBMP-7 (also known as osteogenic protein 1 [OP-1]), was developed in the 1990s after the advent of gene splicing. Then, in 2002, the US Food and Drug Administration (FDA) approved use of rhBMP to stimulate fusion in the human spine. Specifically, rhBMP-2 (Medtronic) was approved for use in combination with a specific brand of interbody cage in 1-level anterior lumbar interbody fusion.² Over the past decade, off-label use of rhBMP-2 to achieve osseous union has increased dramatically, particularly in spinal surgery: transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion, and posterolateral lumbar fusion.^3-9 However, this widespread off-label use for posterior spinal fusion began despite FDA data indicating that specific complications were underreported in the peer-reviewed literature.^10,11 Although rhBMP-2 is very effective in increasing osteoblast formation and improving osteogenesis and subsequent bone healing in spinal surgery,^12,13 its use in TLIF resulted in significant adverse side effects, including radiculopathy with and without neuroforaminal heterotopic ossification (HO); ^14-24 complications in the FDA studies; ^14,22,25-27 and osteolysis causing intervertebral cage subsidence, inflammatory radiculitis, genitourinary complications, infections, possible systemic effects, and significant HO complications.^10,28-30 Of these, HO complications involved rhBMP leakage through the annulotomy to the disk space that led to HO. Specifically, rhBMP leaked directly out of the disk space and formed a pillar of bone that encased the nerve roots and dura, which led to occlusion of the foramen and symptoms of radiculopathy.^10,28-30

Despite this frequent finding of HO in the intervertebral space outside the target fusion area, use of rhBMP-2 with intervertebral cages increased so rapidly that rhBMP-2 was used more often than autologous bone.^5,11,17,31 In this study, we reviewed the common characteristics of patients who developed HO and subsequent radiculopathy from TLIF with rhBMP.

METHODS

After this study received Institutional Review Board approval, we retrospectively reviewed cases of radiculopathy symptoms that developed after TLIF with rhBMP between January 2002 and January 2015. During this period, 38 patients (26 males, 12 females) with a mean (SD) age of 50.8 (7.5) years and radiculopathy symptoms arising from TLIF with rhBMP-2 were identified to determine commonalities and defining characteristics that will help facilitate diagnosis.

Inclusion criteria were computed tomography (CT)–documented HO arising from the TLIF annulotomy site in continuity with bone in the disk space or ectopic bone forming a distinctive shell with contouring around the thecal sac or nerve roots, as well as recurrence or initial occurrence of radiculopathy with signs and symptoms corresponding to the CT site of aberrant bone growth in terms of laterality and particular nerve root(s) involved. Exclusion criteria were malplacement of interbody cage or pedicle screws, disk herniation, systemic neuropathic disease, and new or unresolved radiculopathy immediately after index surgery.

To improve recognition of this complication, we also documented the amount of BMP used, common patterns of radiculopathy symptom development, and radiologic findings. Type and timing of radiculopathy symptom onset and consistency with side of TLIF placement were documented as well. Radiculopathy symptoms included shooting pain in the legs, incontinence, sexual dysfunction, and severe paralysis. Radiologic findings were specific to bone formation from the disk space (detected with CT).

Continue to: RESULTS

All 38 selected patients had radiculopathy symptoms from HO out of the intervertebral space. The Table lists the patients’ overall characteristics. The left side had the most radiculopathy symptoms (31/38 patients), followed by the right side (5/38) and both sides (2/38). Radiculopathy symptoms began a mean (SD) of 3.8 (1.0) months (range, 2-6 months) after index surgery. The 38 patients had 4 characteristics in common:

Table. Transforaminal Lumbar Interbody Fusion With Recombinant Human Bone Morphogenetic Protein 2: Onset Time for Radiculopathy Symptoms, Surgery Level, Side of Pseudo-Pedicle Bone Formation, and Subsequent Complications

1. Bone growing out of the annulotomy site for TLIF cage placement was present and in continuity with the disk space in 33 (87%) of the 38 cases. In the other 5 cases (13%), HO was present around the neural tissue, but not necessarily in continuity with the disk space. This bone appeared ectopic and not osteophytic and facet-related, as it formed a shell around either the nerve root or the thecal sac, contouring to the structure.

2. The common, novel finding on CT was a “pseudo-pedicle” (Figures 1A, 1B), which appeared as ectopic growth from the disk space—a solid piece of bone in the same direction as the anatomical pedicle. Confusing similarity to the anatomical pedicle is present on axial cuts and during surgery. The pseudo-pedicle varied in thickness and extent out of the disk space, but was always presented as a bar of bone arising from the annulotomy site. After arising from the disk space, the HO could disperse in any direction, further calcifying neural structures or the facet joints above or below. There was no apparent distinguishable repeating pattern, given the variable nature of arthritic facet changes, scoliotic deformities, size of annulotomies, amount of rhBMP used, and placement in cage and disk space or only in cage.

3. In 36 (95%) of the 38 cases, the initial interpretation of HO on magnetic resonance imaging (MRI) was of tissue other than bone, such as fibrous tissue, granulation tissue, recurrent disk herniation, or postoperative changes. However, this tissue was later determined to be bone from HO complications, which we confirmed with CT in all 38 cases. It is important to note that HO on MRI (Figures 2A, 2B) was initially interpreted by a radiologist as fibrous tissue, but same-level CT of the same case (Figures 3A, 3B) showed clear HO.

4. The radiculopathy symptoms caused by HO were independent of the amount of rhBMP-2 used in TLIF. Of the 38 patients, 19 had 1 rhBMP-2 sponge placed in the cage, 12 had a small kit sponge (1.05 mg), 5 had 1 sponge placed in the cage and 1 sponge placed directly in the disk space before cage placement (no notation of precise size or amount of rhBMP-2), and 2 had 1 sponge placed in the cage (no notation of rhBMP-2 amount). The data showed that HO can occur with even a small amount of rhBMP-2.

Continue to: Bone formation with rhBMP-2...

Bone formation with rhBMP-2 is robust and beneficial, but HO-related complications are significant, and identifiable on assessment of radiculopathy symptoms and CT characteristics.

DISCUSSION

We identified 38 patients with a recognizable and consistent pattern of complications of off-label use of rhBMP-2 in TLIF performed at our institution between 2002 and 2015. This pattern included consistent radiculopathy symptoms with corresponding HO at the annulotomy site in continuity with bone in the disk space or ectopic bone forming a distinctive shell around the thecal sac or nerve roots, as well as showing a distinct pseudo-pedicle pattern encompassing nerve roots and the thecal sac. Our finding differs from other findings of similar complication characteristics, but with much larger variations without consistency within the patient population.^19,20,22,24 Specifically, previous studies found an association between off-label rhBMP-2 use in the posterior spine and radiculopathy with and without neuroforaminal HO. However, our study found consistent radiculopathy symptoms with pseudo-pedicle-like HO complications in all its 38 patients a mean (SD) of 3.8 (1.0) months after surgery.

In this study, consistent radiculopathy symptoms with pseudo-pedicle-like HO complications were independent of the amount of rhBMP-2 used, as some complications occurred with use of small pack rhBMP-2 with TLIF. It is well understood that high doses of rhBMP-2 may be required to improve fusion rates, but to our knowledge an optimal dosing strategy for TLIF has not been reported, particularly with respect to potential complications.^8,20,31-33 For anterior lumbar interbody fusion surgery, the FDA-approved use of rhBMP-2 appears to have a significantly decreased risk of neuroforaminal HO complications. This may be attributable to the protective presence of the intact posterior annulus and longitudinal ligament for this procedure.^20,33 For TLIF, it has been suggested that rhBMP-2 should be placed only along the anterior annulus with a posterior strut and morselized bone allograft barricade,³³ and that fibrin glue should be used to limit BMP diffusion through the annulotomy site³¹ to prevent this complication.

Our study results suggest that radiculopathy symptoms with pseudo-pedicle-like HO complications appear to be caused by leakage of rhBMP-2 from the disk space through the annulotomy site. This was often initially interpreted incorrectly on MRI in the first year after surgery as being fibrous or granulation tissue, or even postoperative changes that the heterotopic tissue was bone was obvious only on CT. Even then the tissue may be incorrectly identified, as the encasing nerve roots in bone are similar to the scar tissue having no compressive effect. HO may compress, but it also has an inflammatory component that the scars lack. Additionally, the HO from the disk space, caused by leakage of the BMP placed in or around the fusion cage, can create a pseudo-pedicle of varying size and extent. This was present in all 38 of our cases.

This retrospective case series had its limitations. Its clinical and radiographic findings were not blinded. Confounding variables cannot be isolated for causal relationships, if any, to the complication in a case series such as this.

Bone formation with rhBMP-2 is robust and beneficial, but HO-related complications are significant, and identifiable on assessment of radiculopathy symptoms and CT characteristics.

ABSTRACT

Anterior ankle impingement is a frequent cause of pain and disability in athletes with impingement of soft-tissue or osseous structures along the anterior margin of the tibiotalar joint during dorsiflexion.

In this study, we hypothesized that arthroscopic decompression of anterior ankle impingement would result in significant, reliable, and durable improvement in pain and range of motion (ROM), and would allow National Football League (NFL) players to return to their preoperative level of play.

We reviewed 29 arthroscopic ankle débridements performed by a single surgeon. Each NFL player underwent arthroscopic débridement of pathologic soft tissue and of tibial and talar osteophytes in the anterior ankle. Preoperative and postoperative visual analog scale (VAS) pain scores, American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores, and ankle ROM were compared; time to return to play (RTP), events missed secondary to surgery, and complications were recorded.

All athletes returned to the same level of NFL play at a mean (SD) of 8.4 (4.1) weeks after surgery and continued playing for a mean (SD) of 3.43 (2.57) years after surgery. Mean (SD) VAS pain scores decreased significantly (P < .001), to 0.38 (0.89) from 4.21 (1.52). Mean (SD) active ankle dorsiflexion increased significantly (P < .001), to 18.86° (2.62°) from 8.28° (4.14°). Mean (SD) AOFAS hindfoot scores increased significantly (P < .001), to 97.45 (4.72) from 70.62 (10.39). Degree of arthritis (r = 0.305) and age (r = 0.106) were poorly correlated to time to RTP.

In all cases, arthroscopic débridement of anterior ankle impingement resulted in RTP at the same level at a mean of 2 months after surgery. There were significant improvements in VAS pain scores, AOFAS hindfoot scores, and ROM.

Arthroscopic débridement of anterior ankle impingement relieves pain, restores ROM and function, and results in reliable RTP in professional football players.

Continue to: Anterior ankle impingement...

Anterior ankle impingement is a frequent cause of disability in athletes.¹ This condition results from repetitive trauma over time, which leads to osseous and soft-tissue impingement, pain, and decreased ankle range of motion (ROM).

First termed footballer’s ankle, this condition is linked to repeated, forceful plantarflexion,² though later studies attributed the phenomenon to repeated dorsiflexion resulting in periosteal hemorrhage.³ Both osseous and soft-tissue structures can cause impingement at the tibiotalar joint, often with osteophytes anteromedially at the tibial talar joint. Soft-tissue structures, including hypertrophic synovium, meniscoid lesions, and a thickened anterior talofibular ligament, more often cause anterolateral impingement.^4-6 This process results in pain in extreme dorsiflexion, which comes into play in almost all football maneuvers, including sprinting, back-peddling, and offensive and defensive stances. Therefore, maintenance of pain-free dorsiflexion is required for high-level football. Decreased ROM can lead to decreased ability to perform these high-level athletic functions and can limit performance.

Arthroscopic débridement improves functional outcomes and functional motion in both athletes and nonathletes.^7,8 In addition, findings of a recent systematic review provide support for arthroscopic treatment of ankle impingement.⁹ Although arthroscopic treatment is effective in nonathletes and recreational athletes,¹⁰ there is a paucity of data on the efficacy of this procedure and on time to return to play (RTP) in professional football players.

We conducted a study to evaluate the outcomes (pain, ROM, RTP) of arthroscopic débridement for anterior ankle impingement in National Football League (NFL) players. We hypothesized that arthroscopic decompression of anterior ankle impingement would result in significant, reliable, and durable improvement in pain and ROM, and would allow NFL players to return to their preoperative level of play.

METHODS

After this study was granted Institutional Review Board approval, we retrospectively reviewed a consecutive series of arthroscopically treated anterior ankle impingement athletes by a single surgeon (JPB). Indications for surgery were anterior ankle impingement resulting in ankle pain and decreased ROM that interfered with sport. Active NFL players who underwent ankle arthroscopy for symptomatic anterior ankle impingement were included. Excluded were players who underwent surgery after retirement or who retired before returning to play for reasons unrelated to the ankle. Medical records, operative reports, and rehabilitation reports were reviewed.

Continue to: Preoperative and postoperative...

Preoperative and postoperative visual analog scale (VAS) pain scores, American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores, and ankle ROM were compared; time to RTP, events missed secondary to surgery, and complications were recorded. These preoperative and postoperative variables were compared with paired Student 2-way t tests for continuous variables. Pearson correlation coefficients were calculated.

PROCEDURE

Ankle arthroscopy was performed with the patient supine after spinal or general anesthesia was induced. Prophylactic antibiotics were given in each case. Arthroscopy was performed with standard anterolateral and anteromedial portals. First, an incision was made through skin only, followed by blunt subcutaneous dissection down to the ankle capsule. A capsulotomy was then made bluntly. Care was taken to avoid all neurovascular structures. Posterior portals were not used. A 2.7-mm arthroscope was inserted and alternated between the anteromedial and anterolateral portals to maximally visualize the ankle joint. Diagnostic arthroscopy was performed to document synovitis, chondral injury, osseous, and soft-tissue impingement and any other noted pathology (Figures 1A-1C).

A full radius resector was then used to perform a synovectomy and débridement of impinging soft tissue from the anterior talofibular ligament or anterior inferior talofibular ligament. All patients underwent arthroscopic débridement of pathologic soft tissue and of tibial and talar osteophytes in the anterior ankle. A small burr was used to débride and remove the osteophytes on the talus and/or tibia. Soft-tissue and osseous structures were resected until the contours of the talus and tibia were normal. Any unstable articular defects were débrided and loose bodies were removed. Ankle ROM was checked to confirm complete resolution of impingement (Figures 2A-2D). Patients were not immobilized and were allowed progressive weight-bearing as tolerated. Crutches were used for assisted ambulation the first 3 to 5 postoperative days.

Physical therapy progressed through 3 phases: (1) inflammation control and ROM restoration, (2) initiation of ankle strengthening, including eversion and inversion, and (3) agility, proprioception, and functional rehabilitation.

RESULTS

Twenty-five NFL players (29 surgeries) were included in the study. Two players were excluded because they had retired at the end of the season before the surgery for reasons unrelated to the operative ankle. Mean (SD) age was 28.1 (2.9) years. Six included players had a history of ankle sprains, 1 had a history of ipsilateral ankle fracture, and 1 had a history of ipsilateral ankle dislocation. Table 1 lists the positions of players who underwent ankle arthroscopic decompression.

Table 1. Positions of National Football League Players Who Underwent Ankle Arthroscopic Decompression for Anterior Ankle Impingement

Continue to: During diagnostic arthroscopy...

During diagnostic arthroscopy, changes to the articular cartilage were noted: grade 0 in 38% of patients, grade 1 in 17%, grade 2 in 21%, grade 3 in 21%, and grade 4 in 3%. Four patients had an osteochondral lesion (<1 cm in each case), which was treated with chondroplasty without microfracture.

Each included patient returned to NFL play. Mean (SD) time to RTP without restrictions was 8.4 (4.1) weeks after surgery (range, 2-20 weeks). There was a poor correlation between degree of chondrosis and time to RTP (r = 0.305). In addition, there was a poor correlation between age and time to RTP (r = 0.106).

Dorsiflexion improved significantly (P < .001), patients had significantly less pain after surgery (P < .001), and AOFAS hindfoot scores improved significantly (P < .001) (Table 2).

Table 2. Preoperative and Postoperative Dorsiflexion, Pain, and AOFAS Score Before and After Arthroscopic Débridement of Anterior Ankle Impingement^a

^aAll values were significantly improved after surgery (P < .001).

Abbreviations: AOFAS, American Orthopaedic Foot and Ankle Society; VAS, visual analog scale.

The athletes played in the NFL for a mean (SD) of 3.43 (2.57) years after surgery (range, 1-10 seasons). These players included 6 who were still active at time of publication. No patient required revision surgery or additional surgery on the ipsilateral ankle. The one patient who was treated for superficial thrombophlebitis after surgery reported symptoms before surgery as well.

DISCUSSION

Arthroscopic decompression of anterior ankle impingement is safe and significantly improves pain and ROM in professional American football players. The procedure results in reliable RTP at an elite level, with durable results over the time remaining in their NFL careers.

Continue to: before the 1988 study by Hawkins...

Before the 1988 study by Hawkins,¹¹ ankle spurs were removed with open procedures. Hawkins¹¹ used arthroscopy for better and safer visualization of the ankle joint and used a burr for less painful removal of spurs from the tibia and the talus. In 2002, a series of 105 patients (median age, 35 years) had reduced pain and improved function a minimum of 2 years after arthroscopic débridement.¹² These patients had a mix of pathology, including soft-tissue impingement, bony impingement, chondral lesions, loose bodies, and osteoarthritis.

For many elite athletes, anterior ankle impingement can cause significant limitation. Reduced ankle dorsiflexion can alter all limb mechanics and predispose athletes to injury.¹³ In addition, because NFL players’ ankle ROM often approaches or exceeds normal physiologic limits,¹⁴ an ankle ROM limitation will often hinder their performance.

Miyamoto and colleagues¹⁵ studied a series of 9 professional athletes (6 soccer players, 1 baseball pitcher, 1 mixed martial artist, 1 golfer) who underwent decompression of both anterior and posterior impingement. With regard to anterior impingement, they found anterior osteophytes in all the ankles, as was seen in the present study. Furthermore, they noted that mean dorsiflexion improved from 10° before surgery to 15° after surgery and that their athletes returned to play 12 to 15 weeks after surgery. Their results are similar to ours, though we noted more improvement in dorsiflexion, from 8.28° before surgery to 18.86° after surgery.

One of the most important metrics in evaluating treatment options for professional athletes is time from surgery to RTP without restrictions. Mean time to full RTP was shorter in our study (8.4 weeks) than in the study by Miyamoto and colleagues¹⁵ (up to 20 weeks). However, many of their procedures were performed during the off-season, when there was no need to expeditiously clear patients for full sports participation. In addition, the patients in their study had both anterior and posterior pathology.

Faster return to high-level athletics was supported in a study of 11 elite ballet dancers,¹⁶ whose pain and dance performance improved after arthroscopic débridement. Of the 11 patients, 9 returned to dance at a mean of 7 weeks after surgery; the other 2 required reoperation. Although the pathology differed in their study of elite professional soccer players, Calder and colleagues¹⁷ found that mean time to RTP after ankle arthroscopy for posterior impingement was 5 weeks.

Continue to: For the NFL players in our study...

For the NFL players in our study, RTP at their elite level was 100% after arthroscopic débridement of anterior ankle impingement. In the literature, time to RTP varies. Table 3 lists RTP rates for recreational athletes in published studies.^18-27 In their recent systematic literature review, Zwiers and colleagues¹⁰ noted that 24% to 96.4% of recreational athletes returned to play after arthroscopic treatment for anterior ankle impingement. The percentage was significantly higher for the professional athletes in our study. Historical comparison supports an evolution in the indications and techniques for this procedure, with more recent literature suggesting a RTP rate much higher than earlier rates. In addition, compared with recreational athletes, professional athletes have strong financial incentives to return to their sports. Furthermore, our professional cohort was significantly younger than the recreational cohorts in those studies.

Table 3. Frequency of Recreational Athletes’ Return to Play After Arthroscopic Débridement of Anterior Ankle Impingement, as Reported in the Literature

Current recommendations for recreational athletes include initial conservative treatment with rest, ankle bracing, and avoidance of jumping and other repetitive dorsiflexing activities. Physical therapy should include joint mobilization and work along the entire kinetic chain. Night splints or a removable walking boot can be used temporarily, as can a single intra-articular corticosteroid injection to reduce inflammation and evaluate improvement in more refractory cases.²⁸ Commonly, conservative treatments fail if patients remain active, and soft tissue and/or osteophytes can be resected, though resection typically is reserved for recreational athletes for whom nonoperative treatments have been exhausted.^29,30

This study had several limitations, including its retrospective nature and lack of control group. In addition, follow-up was relatively short, and we did not use more recently described outcome measures, such as the Sports subscale of the Foot and Ankle Ability Measure, which may be more sensitive in describing function in elite athletes. However, many of the cases in our study predated these measures, but the rate of RTP at the NFL level requires a very high degree of postoperative ankle function, making this outcome the most meaningful. In the context of professional athletes, specifically the length of their careers, our study results provide valuable information regarding expectations about RTP and the durability of arthroscopic débridement of anterior ankle impingement in a high-demand setting.

CONCLUSION

For all the NFL players in this study, arthroscopic débridement of anterior ankle impingement resulted in return to preoperative level of play at a mean of 2 months after surgery. There were significant improvements in VAS pain scores, AOFAS hindfoot scores, and ROM. Arthroscopic débridement of anterior ankle impingement relieves pain, restores ROM and function, and results in reliable RTP in professional football players.

ABSTRACT

Anterior ankle impingement is a frequent cause of pain and disability in athletes with impingement of soft-tissue or osseous structures along the anterior margin of the tibiotalar joint during dorsiflexion.

In this study, we hypothesized that arthroscopic decompression of anterior ankle impingement would result in significant, reliable, and durable improvement in pain and range of motion (ROM), and would allow National Football League (NFL) players to return to their preoperative level of play.

We reviewed 29 arthroscopic ankle débridements performed by a single surgeon. Each NFL player underwent arthroscopic débridement of pathologic soft tissue and of tibial and talar osteophytes in the anterior ankle. Preoperative and postoperative visual analog scale (VAS) pain scores, American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores, and ankle ROM were compared; time to return to play (RTP), events missed secondary to surgery, and complications were recorded.

All athletes returned to the same level of NFL play at a mean (SD) of 8.4 (4.1) weeks after surgery and continued playing for a mean (SD) of 3.43 (2.57) years after surgery. Mean (SD) VAS pain scores decreased significantly (P < .001), to 0.38 (0.89) from 4.21 (1.52). Mean (SD) active ankle dorsiflexion increased significantly (P < .001), to 18.86° (2.62°) from 8.28° (4.14°). Mean (SD) AOFAS hindfoot scores increased significantly (P < .001), to 97.45 (4.72) from 70.62 (10.39). Degree of arthritis (r = 0.305) and age (r = 0.106) were poorly correlated to time to RTP.

In all cases, arthroscopic débridement of anterior ankle impingement resulted in RTP at the same level at a mean of 2 months after surgery. There were significant improvements in VAS pain scores, AOFAS hindfoot scores, and ROM.

Arthroscopic débridement of anterior ankle impingement relieves pain, restores ROM and function, and results in reliable RTP in professional football players.

Continue to: Anterior ankle impingement...

Anterior ankle impingement is a frequent cause of disability in athletes.¹ This condition results from repetitive trauma over time, which leads to osseous and soft-tissue impingement, pain, and decreased ankle range of motion (ROM).

First termed footballer’s ankle, this condition is linked to repeated, forceful plantarflexion,² though later studies attributed the phenomenon to repeated dorsiflexion resulting in periosteal hemorrhage.³ Both osseous and soft-tissue structures can cause impingement at the tibiotalar joint, often with osteophytes anteromedially at the tibial talar joint. Soft-tissue structures, including hypertrophic synovium, meniscoid lesions, and a thickened anterior talofibular ligament, more often cause anterolateral impingement.^4-6 This process results in pain in extreme dorsiflexion, which comes into play in almost all football maneuvers, including sprinting, back-peddling, and offensive and defensive stances. Therefore, maintenance of pain-free dorsiflexion is required for high-level football. Decreased ROM can lead to decreased ability to perform these high-level athletic functions and can limit performance.

Arthroscopic débridement improves functional outcomes and functional motion in both athletes and nonathletes.^7,8 In addition, findings of a recent systematic review provide support for arthroscopic treatment of ankle impingement.⁹ Although arthroscopic treatment is effective in nonathletes and recreational athletes,¹⁰ there is a paucity of data on the efficacy of this procedure and on time to return to play (RTP) in professional football players.

We conducted a study to evaluate the outcomes (pain, ROM, RTP) of arthroscopic débridement for anterior ankle impingement in National Football League (NFL) players. We hypothesized that arthroscopic decompression of anterior ankle impingement would result in significant, reliable, and durable improvement in pain and ROM, and would allow NFL players to return to their preoperative level of play.

METHODS

After this study was granted Institutional Review Board approval, we retrospectively reviewed a consecutive series of arthroscopically treated anterior ankle impingement athletes by a single surgeon (JPB). Indications for surgery were anterior ankle impingement resulting in ankle pain and decreased ROM that interfered with sport. Active NFL players who underwent ankle arthroscopy for symptomatic anterior ankle impingement were included. Excluded were players who underwent surgery after retirement or who retired before returning to play for reasons unrelated to the ankle. Medical records, operative reports, and rehabilitation reports were reviewed.

Continue to: Preoperative and postoperative...

Preoperative and postoperative visual analog scale (VAS) pain scores, American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores, and ankle ROM were compared; time to RTP, events missed secondary to surgery, and complications were recorded. These preoperative and postoperative variables were compared with paired Student 2-way t tests for continuous variables. Pearson correlation coefficients were calculated.

PROCEDURE

Ankle arthroscopy was performed with the patient supine after spinal or general anesthesia was induced. Prophylactic antibiotics were given in each case. Arthroscopy was performed with standard anterolateral and anteromedial portals. First, an incision was made through skin only, followed by blunt subcutaneous dissection down to the ankle capsule. A capsulotomy was then made bluntly. Care was taken to avoid all neurovascular structures. Posterior portals were not used. A 2.7-mm arthroscope was inserted and alternated between the anteromedial and anterolateral portals to maximally visualize the ankle joint. Diagnostic arthroscopy was performed to document synovitis, chondral injury, osseous, and soft-tissue impingement and any other noted pathology (Figures 1A-1C).

A full radius resector was then used to perform a synovectomy and débridement of impinging soft tissue from the anterior talofibular ligament or anterior inferior talofibular ligament. All patients underwent arthroscopic débridement of pathologic soft tissue and of tibial and talar osteophytes in the anterior ankle. A small burr was used to débride and remove the osteophytes on the talus and/or tibia. Soft-tissue and osseous structures were resected until the contours of the talus and tibia were normal. Any unstable articular defects were débrided and loose bodies were removed. Ankle ROM was checked to confirm complete resolution of impingement (Figures 2A-2D). Patients were not immobilized and were allowed progressive weight-bearing as tolerated. Crutches were used for assisted ambulation the first 3 to 5 postoperative days.

Physical therapy progressed through 3 phases: (1) inflammation control and ROM restoration, (2) initiation of ankle strengthening, including eversion and inversion, and (3) agility, proprioception, and functional rehabilitation.

RESULTS

Twenty-five NFL players (29 surgeries) were included in the study. Two players were excluded because they had retired at the end of the season before the surgery for reasons unrelated to the operative ankle. Mean (SD) age was 28.1 (2.9) years. Six included players had a history of ankle sprains, 1 had a history of ipsilateral ankle fracture, and 1 had a history of ipsilateral ankle dislocation. Table 1 lists the positions of players who underwent ankle arthroscopic decompression.

Table 1. Positions of National Football League Players Who Underwent Ankle Arthroscopic Decompression for Anterior Ankle Impingement

Continue to: During diagnostic arthroscopy...

During diagnostic arthroscopy, changes to the articular cartilage were noted: grade 0 in 38% of patients, grade 1 in 17%, grade 2 in 21%, grade 3 in 21%, and grade 4 in 3%. Four patients had an osteochondral lesion (<1 cm in each case), which was treated with chondroplasty without microfracture.

Each included patient returned to NFL play. Mean (SD) time to RTP without restrictions was 8.4 (4.1) weeks after surgery (range, 2-20 weeks). There was a poor correlation between degree of chondrosis and time to RTP (r = 0.305). In addition, there was a poor correlation between age and time to RTP (r = 0.106).

Dorsiflexion improved significantly (P < .001), patients had significantly less pain after surgery (P < .001), and AOFAS hindfoot scores improved significantly (P < .001) (Table 2).

Table 2. Preoperative and Postoperative Dorsiflexion, Pain, and AOFAS Score Before and After Arthroscopic Débridement of Anterior Ankle Impingement^a

^aAll values were significantly improved after surgery (P < .001).

Abbreviations: AOFAS, American Orthopaedic Foot and Ankle Society; VAS, visual analog scale.

The athletes played in the NFL for a mean (SD) of 3.43 (2.57) years after surgery (range, 1-10 seasons). These players included 6 who were still active at time of publication. No patient required revision surgery or additional surgery on the ipsilateral ankle. The one patient who was treated for superficial thrombophlebitis after surgery reported symptoms before surgery as well.

DISCUSSION

Arthroscopic decompression of anterior ankle impingement is safe and significantly improves pain and ROM in professional American football players. The procedure results in reliable RTP at an elite level, with durable results over the time remaining in their NFL careers.

Continue to: before the 1988 study by Hawkins...

Before the 1988 study by Hawkins,¹¹ ankle spurs were removed with open procedures. Hawkins¹¹ used arthroscopy for better and safer visualization of the ankle joint and used a burr for less painful removal of spurs from the tibia and the talus. In 2002, a series of 105 patients (median age, 35 years) had reduced pain and improved function a minimum of 2 years after arthroscopic débridement.¹² These patients had a mix of pathology, including soft-tissue impingement, bony impingement, chondral lesions, loose bodies, and osteoarthritis.

For many elite athletes, anterior ankle impingement can cause significant limitation. Reduced ankle dorsiflexion can alter all limb mechanics and predispose athletes to injury.¹³ In addition, because NFL players’ ankle ROM often approaches or exceeds normal physiologic limits,¹⁴ an ankle ROM limitation will often hinder their performance.

Miyamoto and colleagues¹⁵ studied a series of 9 professional athletes (6 soccer players, 1 baseball pitcher, 1 mixed martial artist, 1 golfer) who underwent decompression of both anterior and posterior impingement. With regard to anterior impingement, they found anterior osteophytes in all the ankles, as was seen in the present study. Furthermore, they noted that mean dorsiflexion improved from 10° before surgery to 15° after surgery and that their athletes returned to play 12 to 15 weeks after surgery. Their results are similar to ours, though we noted more improvement in dorsiflexion, from 8.28° before surgery to 18.86° after surgery.

One of the most important metrics in evaluating treatment options for professional athletes is time from surgery to RTP without restrictions. Mean time to full RTP was shorter in our study (8.4 weeks) than in the study by Miyamoto and colleagues¹⁵ (up to 20 weeks). However, many of their procedures were performed during the off-season, when there was no need to expeditiously clear patients for full sports participation. In addition, the patients in their study had both anterior and posterior pathology.

Faster return to high-level athletics was supported in a study of 11 elite ballet dancers,¹⁶ whose pain and dance performance improved after arthroscopic débridement. Of the 11 patients, 9 returned to dance at a mean of 7 weeks after surgery; the other 2 required reoperation. Although the pathology differed in their study of elite professional soccer players, Calder and colleagues¹⁷ found that mean time to RTP after ankle arthroscopy for posterior impingement was 5 weeks.

Continue to: For the NFL players in our study...

For the NFL players in our study, RTP at their elite level was 100% after arthroscopic débridement of anterior ankle impingement. In the literature, time to RTP varies. Table 3 lists RTP rates for recreational athletes in published studies.^18-27 In their recent systematic literature review, Zwiers and colleagues¹⁰ noted that 24% to 96.4% of recreational athletes returned to play after arthroscopic treatment for anterior ankle impingement. The percentage was significantly higher for the professional athletes in our study. Historical comparison supports an evolution in the indications and techniques for this procedure, with more recent literature suggesting a RTP rate much higher than earlier rates. In addition, compared with recreational athletes, professional athletes have strong financial incentives to return to their sports. Furthermore, our professional cohort was significantly younger than the recreational cohorts in those studies.

Table 3. Frequency of Recreational Athletes’ Return to Play After Arthroscopic Débridement of Anterior Ankle Impingement, as Reported in the Literature

Current recommendations for recreational athletes include initial conservative treatment with rest, ankle bracing, and avoidance of jumping and other repetitive dorsiflexing activities. Physical therapy should include joint mobilization and work along the entire kinetic chain. Night splints or a removable walking boot can be used temporarily, as can a single intra-articular corticosteroid injection to reduce inflammation and evaluate improvement in more refractory cases.²⁸ Commonly, conservative treatments fail if patients remain active, and soft tissue and/or osteophytes can be resected, though resection typically is reserved for recreational athletes for whom nonoperative treatments have been exhausted.^29,30

This study had several limitations, including its retrospective nature and lack of control group. In addition, follow-up was relatively short, and we did not use more recently described outcome measures, such as the Sports subscale of the Foot and Ankle Ability Measure, which may be more sensitive in describing function in elite athletes. However, many of the cases in our study predated these measures, but the rate of RTP at the NFL level requires a very high degree of postoperative ankle function, making this outcome the most meaningful. In the context of professional athletes, specifically the length of their careers, our study results provide valuable information regarding expectations about RTP and the durability of arthroscopic débridement of anterior ankle impingement in a high-demand setting.

CONCLUSION

For all the NFL players in this study, arthroscopic débridement of anterior ankle impingement resulted in return to preoperative level of play at a mean of 2 months after surgery. There were significant improvements in VAS pain scores, AOFAS hindfoot scores, and ROM. Arthroscopic débridement of anterior ankle impingement relieves pain, restores ROM and function, and results in reliable RTP in professional football players.

ABSTRACT

Anterior ankle impingement is a frequent cause of pain and disability in athletes with impingement of soft-tissue or osseous structures along the anterior margin of the tibiotalar joint during dorsiflexion.

In this study, we hypothesized that arthroscopic decompression of anterior ankle impingement would result in significant, reliable, and durable improvement in pain and range of motion (ROM), and would allow National Football League (NFL) players to return to their preoperative level of play.

We reviewed 29 arthroscopic ankle débridements performed by a single surgeon. Each NFL player underwent arthroscopic débridement of pathologic soft tissue and of tibial and talar osteophytes in the anterior ankle. Preoperative and postoperative visual analog scale (VAS) pain scores, American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores, and ankle ROM were compared; time to return to play (RTP), events missed secondary to surgery, and complications were recorded.

All athletes returned to the same level of NFL play at a mean (SD) of 8.4 (4.1) weeks after surgery and continued playing for a mean (SD) of 3.43 (2.57) years after surgery. Mean (SD) VAS pain scores decreased significantly (P < .001), to 0.38 (0.89) from 4.21 (1.52). Mean (SD) active ankle dorsiflexion increased significantly (P < .001), to 18.86° (2.62°) from 8.28° (4.14°). Mean (SD) AOFAS hindfoot scores increased significantly (P < .001), to 97.45 (4.72) from 70.62 (10.39). Degree of arthritis (r = 0.305) and age (r = 0.106) were poorly correlated to time to RTP.

In all cases, arthroscopic débridement of anterior ankle impingement resulted in RTP at the same level at a mean of 2 months after surgery. There were significant improvements in VAS pain scores, AOFAS hindfoot scores, and ROM.

Arthroscopic débridement of anterior ankle impingement relieves pain, restores ROM and function, and results in reliable RTP in professional football players.

Continue to: Anterior ankle impingement...

Anterior ankle impingement is a frequent cause of disability in athletes.¹ This condition results from repetitive trauma over time, which leads to osseous and soft-tissue impingement, pain, and decreased ankle range of motion (ROM).

First termed footballer’s ankle, this condition is linked to repeated, forceful plantarflexion,² though later studies attributed the phenomenon to repeated dorsiflexion resulting in periosteal hemorrhage.³ Both osseous and soft-tissue structures can cause impingement at the tibiotalar joint, often with osteophytes anteromedially at the tibial talar joint. Soft-tissue structures, including hypertrophic synovium, meniscoid lesions, and a thickened anterior talofibular ligament, more often cause anterolateral impingement.^4-6 This process results in pain in extreme dorsiflexion, which comes into play in almost all football maneuvers, including sprinting, back-peddling, and offensive and defensive stances. Therefore, maintenance of pain-free dorsiflexion is required for high-level football. Decreased ROM can lead to decreased ability to perform these high-level athletic functions and can limit performance.

Arthroscopic débridement improves functional outcomes and functional motion in both athletes and nonathletes.^7,8 In addition, findings of a recent systematic review provide support for arthroscopic treatment of ankle impingement.⁹ Although arthroscopic treatment is effective in nonathletes and recreational athletes,¹⁰ there is a paucity of data on the efficacy of this procedure and on time to return to play (RTP) in professional football players.

We conducted a study to evaluate the outcomes (pain, ROM, RTP) of arthroscopic débridement for anterior ankle impingement in National Football League (NFL) players. We hypothesized that arthroscopic decompression of anterior ankle impingement would result in significant, reliable, and durable improvement in pain and ROM, and would allow NFL players to return to their preoperative level of play.

METHODS

After this study was granted Institutional Review Board approval, we retrospectively reviewed a consecutive series of arthroscopically treated anterior ankle impingement athletes by a single surgeon (JPB). Indications for surgery were anterior ankle impingement resulting in ankle pain and decreased ROM that interfered with sport. Active NFL players who underwent ankle arthroscopy for symptomatic anterior ankle impingement were included. Excluded were players who underwent surgery after retirement or who retired before returning to play for reasons unrelated to the ankle. Medical records, operative reports, and rehabilitation reports were reviewed.

Continue to: Preoperative and postoperative...

Preoperative and postoperative visual analog scale (VAS) pain scores, American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores, and ankle ROM were compared; time to RTP, events missed secondary to surgery, and complications were recorded. These preoperative and postoperative variables were compared with paired Student 2-way t tests for continuous variables. Pearson correlation coefficients were calculated.

PROCEDURE

Ankle arthroscopy was performed with the patient supine after spinal or general anesthesia was induced. Prophylactic antibiotics were given in each case. Arthroscopy was performed with standard anterolateral and anteromedial portals. First, an incision was made through skin only, followed by blunt subcutaneous dissection down to the ankle capsule. A capsulotomy was then made bluntly. Care was taken to avoid all neurovascular structures. Posterior portals were not used. A 2.7-mm arthroscope was inserted and alternated between the anteromedial and anterolateral portals to maximally visualize the ankle joint. Diagnostic arthroscopy was performed to document synovitis, chondral injury, osseous, and soft-tissue impingement and any other noted pathology (Figures 1A-1C).

A full radius resector was then used to perform a synovectomy and débridement of impinging soft tissue from the anterior talofibular ligament or anterior inferior talofibular ligament. All patients underwent arthroscopic débridement of pathologic soft tissue and of tibial and talar osteophytes in the anterior ankle. A small burr was used to débride and remove the osteophytes on the talus and/or tibia. Soft-tissue and osseous structures were resected until the contours of the talus and tibia were normal. Any unstable articular defects were débrided and loose bodies were removed. Ankle ROM was checked to confirm complete resolution of impingement (Figures 2A-2D). Patients were not immobilized and were allowed progressive weight-bearing as tolerated. Crutches were used for assisted ambulation the first 3 to 5 postoperative days.

Physical therapy progressed through 3 phases: (1) inflammation control and ROM restoration, (2) initiation of ankle strengthening, including eversion and inversion, and (3) agility, proprioception, and functional rehabilitation.

RESULTS

Twenty-five NFL players (29 surgeries) were included in the study. Two players were excluded because they had retired at the end of the season before the surgery for reasons unrelated to the operative ankle. Mean (SD) age was 28.1 (2.9) years. Six included players had a history of ankle sprains, 1 had a history of ipsilateral ankle fracture, and 1 had a history of ipsilateral ankle dislocation. Table 1 lists the positions of players who underwent ankle arthroscopic decompression.

Table 1. Positions of National Football League Players Who Underwent Ankle Arthroscopic Decompression for Anterior Ankle Impingement

Continue to: During diagnostic arthroscopy...

During diagnostic arthroscopy, changes to the articular cartilage were noted: grade 0 in 38% of patients, grade 1 in 17%, grade 2 in 21%, grade 3 in 21%, and grade 4 in 3%. Four patients had an osteochondral lesion (<1 cm in each case), which was treated with chondroplasty without microfracture.

Each included patient returned to NFL play. Mean (SD) time to RTP without restrictions was 8.4 (4.1) weeks after surgery (range, 2-20 weeks). There was a poor correlation between degree of chondrosis and time to RTP (r = 0.305). In addition, there was a poor correlation between age and time to RTP (r = 0.106).

Dorsiflexion improved significantly (P < .001), patients had significantly less pain after surgery (P < .001), and AOFAS hindfoot scores improved significantly (P < .001) (Table 2).

Table 2. Preoperative and Postoperative Dorsiflexion, Pain, and AOFAS Score Before and After Arthroscopic Débridement of Anterior Ankle Impingement^a

^aAll values were significantly improved after surgery (P < .001).

Abbreviations: AOFAS, American Orthopaedic Foot and Ankle Society; VAS, visual analog scale.

The athletes played in the NFL for a mean (SD) of 3.43 (2.57) years after surgery (range, 1-10 seasons). These players included 6 who were still active at time of publication. No patient required revision surgery or additional surgery on the ipsilateral ankle. The one patient who was treated for superficial thrombophlebitis after surgery reported symptoms before surgery as well.

DISCUSSION

Arthroscopic decompression of anterior ankle impingement is safe and significantly improves pain and ROM in professional American football players. The procedure results in reliable RTP at an elite level, with durable results over the time remaining in their NFL careers.

Continue to: before the 1988 study by Hawkins...

Before the 1988 study by Hawkins,¹¹ ankle spurs were removed with open procedures. Hawkins¹¹ used arthroscopy for better and safer visualization of the ankle joint and used a burr for less painful removal of spurs from the tibia and the talus. In 2002, a series of 105 patients (median age, 35 years) had reduced pain and improved function a minimum of 2 years after arthroscopic débridement.¹² These patients had a mix of pathology, including soft-tissue impingement, bony impingement, chondral lesions, loose bodies, and osteoarthritis.

For many elite athletes, anterior ankle impingement can cause significant limitation. Reduced ankle dorsiflexion can alter all limb mechanics and predispose athletes to injury.¹³ In addition, because NFL players’ ankle ROM often approaches or exceeds normal physiologic limits,¹⁴ an ankle ROM limitation will often hinder their performance.

Miyamoto and colleagues¹⁵ studied a series of 9 professional athletes (6 soccer players, 1 baseball pitcher, 1 mixed martial artist, 1 golfer) who underwent decompression of both anterior and posterior impingement. With regard to anterior impingement, they found anterior osteophytes in all the ankles, as was seen in the present study. Furthermore, they noted that mean dorsiflexion improved from 10° before surgery to 15° after surgery and that their athletes returned to play 12 to 15 weeks after surgery. Their results are similar to ours, though we noted more improvement in dorsiflexion, from 8.28° before surgery to 18.86° after surgery.

One of the most important metrics in evaluating treatment options for professional athletes is time from surgery to RTP without restrictions. Mean time to full RTP was shorter in our study (8.4 weeks) than in the study by Miyamoto and colleagues¹⁵ (up to 20 weeks). However, many of their procedures were performed during the off-season, when there was no need to expeditiously clear patients for full sports participation. In addition, the patients in their study had both anterior and posterior pathology.

Faster return to high-level athletics was supported in a study of 11 elite ballet dancers,¹⁶ whose pain and dance performance improved after arthroscopic débridement. Of the 11 patients, 9 returned to dance at a mean of 7 weeks after surgery; the other 2 required reoperation. Although the pathology differed in their study of elite professional soccer players, Calder and colleagues¹⁷ found that mean time to RTP after ankle arthroscopy for posterior impingement was 5 weeks.

Continue to: For the NFL players in our study...

For the NFL players in our study, RTP at their elite level was 100% after arthroscopic débridement of anterior ankle impingement. In the literature, time to RTP varies. Table 3 lists RTP rates for recreational athletes in published studies.^18-27 In their recent systematic literature review, Zwiers and colleagues¹⁰ noted that 24% to 96.4% of recreational athletes returned to play after arthroscopic treatment for anterior ankle impingement. The percentage was significantly higher for the professional athletes in our study. Historical comparison supports an evolution in the indications and techniques for this procedure, with more recent literature suggesting a RTP rate much higher than earlier rates. In addition, compared with recreational athletes, professional athletes have strong financial incentives to return to their sports. Furthermore, our professional cohort was significantly younger than the recreational cohorts in those studies.

Table 3. Frequency of Recreational Athletes’ Return to Play After Arthroscopic Débridement of Anterior Ankle Impingement, as Reported in the Literature

Current recommendations for recreational athletes include initial conservative treatment with rest, ankle bracing, and avoidance of jumping and other repetitive dorsiflexing activities. Physical therapy should include joint mobilization and work along the entire kinetic chain. Night splints or a removable walking boot can be used temporarily, as can a single intra-articular corticosteroid injection to reduce inflammation and evaluate improvement in more refractory cases.²⁸ Commonly, conservative treatments fail if patients remain active, and soft tissue and/or osteophytes can be resected, though resection typically is reserved for recreational athletes for whom nonoperative treatments have been exhausted.^29,30

This study had several limitations, including its retrospective nature and lack of control group. In addition, follow-up was relatively short, and we did not use more recently described outcome measures, such as the Sports subscale of the Foot and Ankle Ability Measure, which may be more sensitive in describing function in elite athletes. However, many of the cases in our study predated these measures, but the rate of RTP at the NFL level requires a very high degree of postoperative ankle function, making this outcome the most meaningful. In the context of professional athletes, specifically the length of their careers, our study results provide valuable information regarding expectations about RTP and the durability of arthroscopic débridement of anterior ankle impingement in a high-demand setting.

CONCLUSION

For all the NFL players in this study, arthroscopic débridement of anterior ankle impingement resulted in return to preoperative level of play at a mean of 2 months after surgery. There were significant improvements in VAS pain scores, AOFAS hindfoot scores, and ROM. Arthroscopic débridement of anterior ankle impingement relieves pain, restores ROM and function, and results in reliable RTP in professional football players.

Peripherally inserted central catheters (PICCs) are integral to the care of hospitalized patients in the United States.¹ Consequently, utilization of these devices in acutely ill patients has steadily increased in the past decade.² Although originally designed to support the delivery of total parenteral nutrition, PICCs have found broader applications in the hospital setting given the ease and safety of placement, the advances in technology that facilitate insertion, and the growing availability of specially trained vascular nurses that place these devices at the bedside.³ Furthermore, because they are placed in deeper veins of the arm, PICCs are more durable than peripheral catheters and can support venous access for extended durations.^4-6

However, the growing use of PICCs has led to the realization that these devices are not without attendant risks. For example, PICCs are associated with venous thromboembolism (VTE) and central-line associated blood stream infection (CLABSI).^7,8 Additionally, complications such as catheter occlusion and tip migration commonly occur and may interrupt care or necessitate device removal.^9-11 Hence, thoughtful weighing of the risks against the benefits of PICC use prior to placement is necessary. To facilitate such decision-making, we developed the Michigan Appropriateness Guide for Intravenous (IV) Catheters (MAGIC) criteria,¹² which is an evidence-based tool that defines when the use of a PICC is appropriate in hospitalized adults.

The use of PICCs for infusion of peripherally compatible therapies for 5 or fewer days is rated as inappropriate by MAGIC.¹² This strategy is also endorsed by the Centers for Disease Control and Prevention’s (CDC) guidelines for the prevention of catheter-related infections.¹³ Despite these recommendations, short-term PICC use remains common. For example, a study conducted at a tertiary pediatric care center reported a trend toward shorter PICC dwell times and increasing rates of early removal.² However, factors that prompt such short-term PICC use are poorly understood. Without understanding drivers and outcomes of short-term PICC use, interventions to prevent such practice are unlikely to succeed.

Therefore, by using data from a multicenter cohort study, we examined patterns of short-term PICC use and sought to identify which patient, provider, and device factors were associated with such use. We hypothesized that short-term placement would be associated with difficult venous access and would also be associated with the risk of major and minor complications.

Study Setting and Design

We used data from the Michigan Hospital Medicine Safety (HMS) Consortium to examine patterns and predictors of short-term PICC use.¹⁴ As a multi-institutional clinical quality initiative sponsored by Blue Cross Blue Shield of Michigan and Blue Care Network, HMS aims to improve the quality of care by preventing adverse events in hospitalized medical patients.^4,15-17 In January of 2014, dedicated, trained abstractors started collecting data on PICC placements at participating HMS hospitals by using a standard protocol and template for data collection. Patients who received PICCs while admitted to either a general medicine unit or an intensive care unit (ICU) during clinical care were eligible for inclusion. Patients were excluded if they were (a) under the age of 18 years, (b) pregnant, (c) admitted to a nonmedical service (eg, surgery), or (d) admitted under observation status.

Every 14 days, each hospital collected data on the first 17 eligible patients that received a PICC, with at least 7 of these placements occurring in an ICU setting. All patients were prospectively followed until the PICC was removed, death, or until 70 days after insertion, whichever occurred first. For patients who had their PICC removed prior to hospital discharge, follow-up occurred via a review of medical records. For those discharged with a PICC in place, both medical record review and telephone follow-up were performed. To ensure data quality, annual random audits at each participating hospital were performed by the coordinating center at the University of Michigan.

For this analysis, we included all available data as of June 30, 2016. However, HMS hospitals continue to collect data on PICC use and outcomes as part of an ongoing clinical quality initiative to reduce the incidence of PICC-related complications.

Patient, Provider, and Device Data

Patient characteristics, including demographics, detailed medical history, comorbidities, physical findings, laboratory results, and medications were abstracted directly from medical records. To estimate the comorbidity burden, the Charlson-Deyo comorbidity score was calculated for each patient by using data available in the medical record at the time of PICC placement.¹⁸ Data, such as the documented indication for PICC insertion and the reason for removal, were obtained directly from medical records. Provider characteristics, including the specialty of the attending physician at the time of insertion and the type of operator who inserted the PICC, were also collected. Institutional characteristics, such as total number of beds, teaching versus nonteaching, and urban versus rural, were obtained from hospital publicly reported data and semiannual surveys of HMS sites.^19,20 Data on device characteristics, such as catheter gauge, coating, insertion attempts, tip location, and number of lumens, were abstracted from PICC insertion notes.

Outcomes of Interest

The outcome of interest was short-term PICC use, defined as PICCs removed within 5 days of insertion. Patients who expired with a PICC in situ were excluded. Secondary outcomes of interest included PICC-related complications, categorized as major (eg, symptomatic VTE and CLABSI) or minor (eg, catheter occlusion, superficial thrombosis, mechanical complications [kinking, coiling], exit site infection, and tip migration). Symptomatic VTE was defined as clinically diagnosed deep venous thrombosis (DVT) and/or pulmonary embolism (PE) not present at the time of PICC placement and confirmed via imaging (ultrasound or venogram for DVT; computed tomography scan, ventilation perfusion scan, or pulmonary angiogram for PE). CLABSI was defined in accordance with the CDC’s National Healthcare Safety Network criteria or according to Infectious Diseases Society of America recommendations.^21,22 All minor PICC complications were defined in accordance with prior published definitions.⁴

Statistical Analysis

Cases of short-term PICC use were identified and compared with patients with a PICC dwell time of 6 or more days by patient, provider, and device characteristics. The initial analyses for the associations of putative factors with short-term PICC use were performed using χ2 or Wilcoxon tests for categorical and continuous variables, respectively. Univariable mixed effect logistic regression models (with a random hospital-specific intercept) were then used to control for hospital-level clustering. Next, a mixed effects multivariable logistic regression model was used to identify factors associated with short-term PICC use. Variables with P ≤ .25 were considered as candidate predictors for the final multivariable model, which was chosen through a stepwise variable selection algorithm performed on 1000 bootstrapped data sets.²³ Variables in the final model were retained based on their frequency of selection in the bootstrapped samples, significance level, and contribution to the overall model likelihood. Results were expressed as odds ratios (OR) with corresponding 95% confidence intervals (CI). SAS for Windows (version 9.3, SAS Institute Inc., Cary, NC) was used for analyses.

Ethical and Regulatory Oversight

The study was classified as “not regulated” by the Institutional Review Board at the University of Michigan (HUM00078730).

Overall Characteristics of the Study Cohort

Characteristics of Short-Term Peripherally Inserted Central Catheter Use

Of the 15,397 PICCs included, we identified 3902 PICCs (25.3%) with a dwell time of ≤5 days (median = 3 days; IQR, 2-4 days). When compared to PICCs that were in place for longer durations, no significant differences in age or comorbidity scores were observed. Importantly, despite recommendations to avoid PICCs in patients with moderate to severe chronic kidney disease (glomerular filtration rate [GFR] ≤ 59 ml/min), 1292 (33.1%) short-term PICCs occurred in patients that met such criteria.

Among short-term PICCs, 3618 (92.7%) were power-capable devices, 2785 (71.4%) were 5-French, and 2813 (72.1%) were multilumen. Indications for the use of short-term PICCs differed from longer term devices in important ways (P <  .001). For example, the most common documented indication for short-term PICC use was difficult venous access (28.2%), while for long-term PICCs, it was antibiotic administration (39.8%). General internists and hospitalists were the most common attending physicians for patients with short-term and long-term PICCs (65.1% and 65.5%, respectively [P = .73]). Also, the proportion of critical care physicians responsible for patients with short versus long-term PICC use was similar (14.0% vs 15.0%, respectively [P = .123]). Of the short-term PICCs, 2583 (66.2%) were inserted by vascular access nurses, 795 (20.4%) by interventional radiologists, and 439 (11.3%) by advance practice professionals. Almost all of the PICCs placed ≤5 days (95.5%) were removed during hospitalization.

Complications Associated with Short-Term Peripherally Inserted Central Catheter Use

This large, multisite prospective cohort study is the first to examine patterns and predictors of short-term PICC use in hospitalized adults. By examining clinically granular data derived from the medical records of patients across 52 hospitals, we found that short-term use was common, representing 25% of all PICCs placed. Almost all such PICCs were removed prior to discharge, suggesting that they were placed primarily to meet acute needs during hospitalization. Multivariable models indicated that patients with difficult venous access, multilumen devices, and teaching hospital settings were associated with short-term use. Given that (a) short term PICC use is not recommended by published evidence-based guidelines,^12,13 (b) both major and minor complications were not uncommon despite brief exposure, and (c) specific factors might be targeted to avoid such use, strategies to improve PICC decision-making in the hospital appear increasingly necessary.

In our study, difficult venous access was the most common documented indication for short-term PICC placement. For patients in whom an anticipated catheter dwell time of 5 days or less is expected, MAGIC recommends the consideration of midline or peripheral IV catheters placed under ultrasound guidance.¹² A midline is a type of peripheral IV catheter that is about 7.5 cm to 25 cm in length and is typically inserted in the larger diameter veins of the upper extremity, such as the cephalic or basilic veins, with the tip terminating distal to the subclavian vein.^7,12 While there is a paucity of information that directly compares PICCs to midlines, some data suggest a lower risk of bloodstream infection and thrombosis associated with the latter.^24-26 For example, at one quaternary teaching hospital, house staff who are trained to insert midline catheters under ultrasound guidance in critically ill patients with difficult venous access reported no CLABSI and DVT events.²⁶

Interestingly, multilumen catheters were used twice as often as single lumen catheters in patients with short-term PICCs. In these instances, the use of additional lumens is questionable, as infusion of multiple incompatible fluids was not commonly listed as an indication prompting PICC use. Because multilumen PICCs are associated with higher risks of both VTE and CLABSI compared to single lumen devices, such use represents an important safety concern.^27-29 Institutional efforts that not only limit the use of multilumen PICCs but also fundamentally define when use of a PICC is appropriate may substantially improve outcomes related to vascular access.^28,30,31We observed that short-term PICCs were more common in teaching compared to nonteaching hospitals. While the design of the present study precludes understanding the reasons for such a difference, some plausible theories include the presence of physician trainees who may not appreciate the risks of PICC use, diminishing peripheral IV access securement skills, and the lack of alternatives to PICC use. Educating trainees who most often order PICCs in teaching settings as to when they should or should not consider this device may represent an important quality improvement opportunity.³² Similarly, auditing and assessing the clinical skills of those entrusted to place peripheral IVs might prove helpful.^33,34 Finally, the introduction of a midline program, or similar programs that expand the scope of vascular access teams to place alternative devices, should be explored as a means to improve PICC use and patient safety.

Our study also found that a third of patients who received PICCs for 5 or fewer days had moderate to severe chronic kidney disease. In these patients who may require renal replacement therapy, prior PICC placement is among the strongest predictors of arteriovenous fistula failure.^35,36 Therefore, even though national guidelines discourage the use of PICCs in these patients and recommend alternative routes of venous access,^12,37,38 such practice is clearly not happening. System-based interventions that begin by identifying patients who require vein preservation (eg, those with a GFR < 45 ml/min) and are therefore not appropriate for a PICC would be a welcomed first step in improving care for such patients.^37,38Our study has limitations. First, the observational nature of the study limits the ability to assess for causality or to account for the effects of unmeasured confounders. Second, while the use of medical records to collect granular data is valuable, differences in documentation patterns within and across hospitals, including patterns of missing data, may produce a misclassification of covariates or outcomes. Third, while we found that higher rates of short-term PICC use were associated with teaching hospitals and patients with difficult venous access, we were unable to determine the precise reasons for this practice trend. Qualitative or mixed-methods approaches to understand provider decision-making in these settings would be welcomed.

Our study also has several strengths. First, to our knowledge, this is the first study to systematically describe and evaluate patterns and predictors of short-term PICC use. The finding that PICCs placed for difficult venous access is a dominant category of short-term placement confirms clinical suspicions regarding inappropriate use and strengthens the need for pathways or protocols to manage such patients. Second, the inclusion of medical patients in diverse institutions offers not only real-world insights related to PICC use, but also offers findings that should be generalizable to other hospitals and health systems. Third, the use of a robust data collection strategy that emphasized standardized data collection, dedicated trained abstractors, and random audits to ensure data quality strengthen the findings of this work. Finally, our findings highlight an urgent need to develop policies related to PICC use, including limiting the use of multiple lumens and avoidance in patients with moderate to severe kidney disease.

In conclusion, short-term use of PICCs is prevalent and associated with key patient, provider, and device factors. Such use is also associated with complications, such as catheter occlusion, tip migration, VTE, and CLABSI. Limiting the use of multiple-lumen PICCs, enhancing education for when a PICC should be used, and defining strategies for patients with difficult access may help reduce inappropriate PICC use and improve patient safety. Future studies to examine implementation of such interventions would be welcomed.

Disclosure: Drs. Paje, Conlon, Swaminathan, and Boldenow disclose no conflicts of interest. Dr. Chopra has received honoraria for talks at hospitals as a visiting professor. Dr. Flanders discloses consultancies for the Institute for Healthcare Improvement and the Society of Hospital Medicine, royalties from Wiley Publishing, honoraria for various talks at hospitals as a visiting professor, grants from the CDC Foundation, Agency for Healthcare Research and Quality, Blue Cross Blue Shield of Michigan (BCBSM), and Michigan Hospital Association, and expert witness testimony. Dr. Bernstein discloses consultancies for Blue Care Network and grants from BCBSM, Department of Veterans Affairs, and National Institutes of Health. Dr. Kaatz discloses no relevant conflicts of interest. BCBSM and Blue Care Network provided support for the Michigan HMS Consortium as part of the BCBSM Value Partnerships program. Although BCBSM and HMS work collaboratively, the opinions, beliefs, and viewpoints expressed by the author do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. Dr. Chopra is supported by a career development award from the Agency for Healthcare Research and Quality (1-K08-HS022835-01). BCBSM and Blue Care Network supported data collection at each participating site and funded the data coordinating center but had no role in study concept, interpretation of findings, or in the preparation, final approval, or decision to submit the manuscript.

Peripherally inserted central catheters (PICCs) are integral to the care of hospitalized patients in the United States.¹ Consequently, utilization of these devices in acutely ill patients has steadily increased in the past decade.² Although originally designed to support the delivery of total parenteral nutrition, PICCs have found broader applications in the hospital setting given the ease and safety of placement, the advances in technology that facilitate insertion, and the growing availability of specially trained vascular nurses that place these devices at the bedside.³ Furthermore, because they are placed in deeper veins of the arm, PICCs are more durable than peripheral catheters and can support venous access for extended durations.^4-6