Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Incidence of Subsequent Surgical Intervention at Short-term Follow-up in Previously Healing and Stable Juvenile Osteochondritis Dissecans of the Knee.

BACKGROUND: Juvenile osteochondritis dissecans (OCD) of the knee is a defect of subchondral bone seen primarily in active children and adolescents. Studies have evaluated the incidence of surgery in knee OCD, but the incidence of subsequent surgery in patients with stable, healing lesions cleared to return to activities is unknown. This study sought to determine the incidence of surgery in participants with knee OCD lesions cleared to return to activities and evaluate predictors of subsequent surgery. METHODS: A single center, retrospective review was performed of participants aged 7 to 18 with knee OCD. Inclusion criteria were stable lesion, skeletal immaturity, no history of previous knee surgery, release to activity without surgery, and at least 12 months of follow-up. Documentation of subsequent surgery was queried in the electronic health record. Participants with no recorded surgery were contacted through phone. Analysis included bivariate and logistic regression. RESULTS: Twenty-five individuals were included in this study, with 7 undergoing surgery after returning to activity. Medial femoral condyle lesions were less likely to undergo surgery (B=-2.6, P=0.038). Average lesion size for the Surgery and No Surgery groups was 1.76±0.65 and 1.32±0.81 cm2, respectively, though not significantly different (P=0.21). The Surgery group returned to activity sooner (3.7 mo, range 1.1 to 6.4) than the No Surgery group (8.1 mo, range 1.8 to 35.4), though not significantly different (P=0.18). Mean follow-up time for the study was 42.7 (range 12.6 to 77.6) months. No participants contacted by phone progressed to surgery or reported symptoms that limited their activities. CONCLUSIONS: While the majority of participants with stable, healing, and asymptomatic knee OCD lesions have favorable outcomes with nonoperative management, some lesions may progress to surgery. Lesions on the medial femoral condyle may be predictive of lower likelihood of progression to surgery. Our study provides insight on the outcomes of nonoperative management of OCD lesions. LEVEL OF EVIDENCE: Level IV-prognostic study.

COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures.

PURPOSE: To develop a set of consensus and empirically based reporting recommendations for primary studies of the measurement properties of patient-reported outcome measures (PROMs). METHODS: This study included four phases: 1. Conducting an extensive literature review of recommendations for reporting of studies testing measurement properties of PROMs; 2. Preparing for the Delphi study by identifying experts; 3. Conducting three Delphi rounds aiming for consensus on the item list of recommendations found in phase 1; 4. Developing the COSMIN reporting guideline and user manual. RESULTS: The literature review resulted in 93 reporting items, included in the first Delphi round. A total of 84 individuals (from 12 countries) agreed to participate in the Delphi study, with 47, 30 and 25 responding in rounds one, two and three, respectively. After three rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on measurement properties) and 41 "specific" items (exclusively relevant to one of the nine measurement properties). CONCLUSION: Consensus was achieved on a set of 71 items for inclusion in a reporting guideline for studies on measurement properties of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of measurement properties of PROMs. This guideline will likely improve the completeness of reporting of these important studies.

Humeral Head Ossification Growth Prediction: Can This Method Be Reproduced?

BACKGROUND: Radiographically assessing skeletal maturity is of paramount importance to guide appropriate management for patients with adolescent idiopathic scoliosis. The reported advantages of the Humeral Head Ossification System (HHOS) are an even distribution around peak growth age (PGA), the presence of an optimal view of the humeral head in most scoliosis radiographs, and an interobserver and intraobserver reliability of 0.95 and 0.96, respectively. The goal of this study was to determine whether similar reliability could be achieved at an institution other than the one at which the HHOS was originally described. METHODS: Six raters used the HHOS to stage the humeral head on 30 deidentified posteroanterior spine radiographs. This process was repeated 2 weeks later. All raters were provided with a document demonstrating the radiographic parameters of each stage, as well as annotations to aid with classification. Intraclass coefficients were calculated. A secondary analysis was then performed grouping stages 1-2 as "pre-PGA" and 3-5 as "post-PGA." RESULTS: Fair to moderate interobserver and intraobserver reliability was achieved when determining each individual HHOS stage. This improved to good to excellent when the humeral was classified as pre-PGA or post-PGA. Subanalysis did not show any correlation between intraobserver reliability and level of orthopaedic experience. CONCLUSIONS: We found fair to moderate interobserver and intraobserver reliability with the HHOS and this was independent of level of orthopaedic experience. This is much lower than reported by the authors who developed the system, and suggests that the HHOS might not be as easy to incorporate into a scoliosis management algorithm as previously noted. The improved reliability achieved when staging the humeral head as pre-PGA or post-PGA might be the true benefit of this system. LEVEL OF EVIDENCE: Level III-diagnostic.

Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses.

BACKGROUND: Most randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup effect or interaction), in which the effect of an intervention varies by another variable (e.g., age or disease severity). Assessing the credibility of an apparent effect modification presents challenges; therefore, we developed the Instrument for assessing the Credibility of Effect Modification Analyses (ICEMAN). METHODS: To develop ICEMAN, we established a detailed concept; identified candidate credibility considerations in a systematic survey of the literature; together with experts, performed a consensus study to identify key considerations and develop them into instrument items; and refined the instrument based on feedback from trial investigators, systematic review authors and journal editors, who applied drafts of ICEMAN to published claims of effect modification. RESULTS: The final instrument consists of a set of preliminary considerations, core questions (5 for RCTs, 8 for meta-analyses) with 4 response options, 1 optional item for additional considerations and a rating of credibility on a visual analogue scale ranging from very low to high. An accompanying manual provides rationales, detailed instructions and examples from the literature. Seventeen potential users tested ICEMAN; their suggestions improved the user-friendliness of the instrument. INTERPRETATION: The Instrument for assessing the Credibility of Effect Modification Analyses offers explicit guidance for investigators, systematic reviewers, journal editors and others considering making a claim of effect modification or interpreting a claim made by others.

Comparison of EOSQ-24 and SRS-22 Scores in Congenital Scoliosis: A Preliminary Study.

BACKGROUND: The 24-item Early-Onset Scoliosis Questionnaire (EOSQ-24) and 22-item Scoliosis Research Society (SRS-22) questionnaire measure health-related quality of life in patients with scoliosis. The EOSQ-24 has been recently validated in early-onset scoliosis (EOS), including congenital scoliosis (CS). The SRS-22 has been validated in idiopathic scoliosis. The EOSQ-24 is completed by the caregiver and the SRS-22 is completed by the patient. The primary purpose of this study was to compare the EOSQ-24 and SRS-22 in patients with CS. The secondary purpose was to compare scores by age and also in developmentally delayed patients. We hypothesized that the SRS-22 is appropriate for children with EOS from CS who do not have a diagnosis of developmental delay. METHODS: This was a prospective comparative study. A prospective institutional CS database was queried to identify patients who had the EOSQ-24 and SRS-22 completed at the same time point. Children without a diagnosis of developmental delay completed both questionnaires if they understood the questions, regardless of age. Otherwise, the caregiver completed both questionnaires. For the analysis, similar questions were matched so that the EOSQ-24 questions fit into the SRS-22 domains of Function, Pain, Mental Health, and Satisfaction. Pearson correlation coefficients (r) were used to compare domain scores, with r≥0.70 indicating a strong relationship. RESULTS: The final study group included 98 patients. The average age at completion of the questionnaires was 9.5 years. A strong correlation was found for all domains except Satisfaction when the patient or caregiver completed both questionnaires. Subanalysis demonstrated the strongest relationship between domains in the age group 0 to 5 years. In developmentally delayed patients, a weak correlation was noted for all domain scores except Pain, which showed a strong correlation. There was a strong correlation for Pain and a weak correlation for Satisfaction domains across all subgroups. CONCLUSIONS: The SRS-22 may be appropriate for children with EOS from CS who do not have a diagnosis of developmental delay. Our findings suggest that the results of previous studies that collected the SRS-22 and future studies that collect the EOSQ-24 can be correlated. It remains unclear which questionnaire is more suitable for developmentally delayed patients. LEVEL OF EVIDENCE: Level I-diagnostic.

Post-operative urinary retention after lower extremity arthroplasty and the peri-operative role of selective alpha-1 adrenergic blocking agents in adult male patients: a propensity-matched retrospective cohort study.

PURPOSE: The purpose of this study was to determine whether male patients taking pre-operative selective alpha-1 adrenergic blocking agents have a lower likelihood of developing post-operative urinary retention (POUR) and a shorter length of hospitalization following lower extremity arthroplasty. METHODS: A retrospective cohort study was conducted of patients who underwent primary or revision total hip or knee arthroplasty, or unicompartmental knee arthroplasty at an academic institution from January 2002 to May 2014. A cohort of male patients aged 35 and older who were taking a selective alpha-1 blocker prior to surgery (N = 229) were compared with a control group (N = 330) not taking one of these medications. Propensity score-matched logistic regression was performed to isolate the effect of taking a selective alpha-1 blocker on POUR. RESULTS: When evaluating for the outcome of POUR while controlling for age, hypertension, benign prostatic hyperplasia, urinary tract infections, type of anaesthesia, and procedure, those patients taking an alpha-1 blocker had a 12.1% decreased relative risk (95% CI 3.4 to 20.8%; p = 0.007) of developing POUR compared with patients not taking these medications. Mean length of stay was 3.8 days (95% CI 3.6 to 4.1) in the cohort taking selective alpha-1 blockers compared with 4.7 days (95% CI 4.4 to 4.9) for the control cohort. CONCLUSIONS: After controlling for known risk factors for the development of POUR, the use of selective alpha-1 blockers pre-operatively reduces the risk of developing urinary retention after lower extremity arthroplasty and is associated with a 1-day decreased length of stay.

Patients' experience of shoulder disorders: a systematic review of qualitative studies for the OMERACT Shoulder Core Domain Set.

OBJECTIVES: To describe the experiences (including symptoms and perceived impacts on daily living) of people with a shoulder disorder. METHODS: Systematic review of qualitative studies. We searched for eligible qualitative studies indexed in Ovid MEDLINE, Ovid Embase, CINAHL (EBSCO), SportDiscus (EBSCO) and Ovid PsycINFO up until November 2017. Two authors independently screened studies for inclusion, appraised their methodological quality using the Critical Appraisal Skills Programme checklist, used thematic synthesis methods to generate themes describing the experiences reported by participants and assessed the confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual) approach. RESULTS: The inclusion criteria were met by eight studies, which included 133 participants (49 females and 84 males) with either rotator cuff disease, adhesive capsulitis, proximal humeral fracture, shoulder instability or unspecified shoulder pain. We generated seven themes to describe what people in the included studies reported experiencing: pain; physical function/activity limitations; participation restriction; sleep disruption; cognitive dysfunction; emotional distress; and other pathophysiological manifestations (other than pain). There were interactions between the themes, with particular experiences impacting on others (e.g. pain leading to reduced activities and sleep disruption). Following grading of the evidence, we considered it likely that most of the review findings were a reasonable representation of the experiences of people with shoulder disorders. CONCLUSION: Patients with shoulder disorders contend with considerable disruption to their life. The experiences described should be considered by researchers seeking to select the most appropriate outcomes to measure in clinical trials and other research studies in people with shoulder disorders.

The AAHKS Clinical Research Award: Prophylactic Tamsulosin Does Not Reduce the Risk of Urinary Retention Following Lower Extremity Arthroplasty: A Double-Blinded Randomized Controlled Trial.

BACKGROUND: Postoperative urinary retention (POUR) is common. Selective alpha-1 adrenergic antagonists, such as tamsulosin, are effective for treating urinary retention. The purpose of this study is to determine whether perioperative prophylactic tamsulosin reduces the incidence of POUR following total hip and knee arthroplasty. METHODS: Male patients 35 years of age and older undergoing primary total hip or knee arthroplasty at a single center from 2015 to 2018 were eligible for inclusion. Patients were randomized to receive tamsulosin 0.4 mg or placebo daily for 5 days preoperatively, the morning of surgery, and the first postoperative day. The incidence of POUR was determined during the postoperative hospitalization. RESULTS: A total of 176 patients were enrolled in the study. Two patients were withdrawn prior to randomization. The remaining 174 were randomized to tamsulosin (n = 87) or placebo (n = 87). After an additional 43 patients were withdrawn prior to surgery, 131 patients completed the study (tamsulosin, n = 64; placebo, n = 67). A total of 42 patients (32.1%) developed POUR, with 18 cases (28.1%) in the tamsulosin group and 24 cases (35.8%) in the placebo group (P = .345), resulting in an odds ratio of 0.701 and a risk difference of 7.69%. CONCLUSION: Prophylactic tamsulosin did not reduce the incidence of POUR after hip and knee arthroplasty compared to placebo. The odds ratio indicates an approximately 30% decreased odds of developing POUR in the tamsulosin group, albeit not statistically significant. Tamsulosin does not appear to be effective as a prophylactic measure for reducing POUR in male hip and knee arthroplasty patients.

Does Increased Body Mass Index Influence Outcomes After Rotator Cuff Repair?

PURPOSE: To investigate the influence of pre-existing obesity (body mass index [BMI] ≥ 30) on outcomes after rotator cuff repair surgery. METHODS: We collected data on adult patients who underwent surgical repair for symptomatic full-thickness rotator cuff tears confirmed by imaging between 2012 and 2015. The required follow-up was 3 years. At baseline and 6, 12, 24, and 36 months, the American Shoulder and Elbow Surgeons score, Western Ontario Rotator Cuff index, and visual analog scale pain scores were collected. Complications were assessed by a chart review. Obesity was defined as BMI ≥ 30. Chi-square analysis and Student's t-test examined differences between categorical and continuous variables at baseline. Generalized estimating equations examined the effects of fixed factors on outcome variables longitudinally from baseline to 36 months. RESULTS: Thirty-nine percent of 213 subjects were obese (mean BMI = 29.2; range, 16-48; standard deviation, 5.8). There were no statistically significant differences between obese and nonobese subjects in other baseline characteristics. When controlling for covariates, obese subjects reported no differences in Western Ontario Rotator Cuff, American Shoulder and Elbow Surgeons, or visual analog scale pain scores when compared with nonobese subjects at baseline and over 3 years from surgery. Although obese patients were more likely to have inpatient surgery, there was no difference in the incidence of postoperative complications. CONCLUSIONS: Contrary to our hypothesis, obese participants who underwent rotator cuff repair reported no difference in functional outcome or pain scores compared with nonobese participants over 3 years. In addition, obesity was not associated with postoperative complications in this study. However, as we hypothesized, obese participants were more likely than nonobese participants to have repair in the inpatient setting. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Establishing minimally important differences for the American Shoulder and Elbow Surgeons score and the Western Ontario Rotator Cuff Index in patients with full-thickness rotator cuff tears.

BACKGROUND: The American Shoulder and Elbow Surgeons (ASES) score and the Western Ontario Rotator Cuff Index (WORC) are frequently used measures in clinical research for patients with rotator cuff tears (RCTs). The minimally important differences (MIDs) for these measures have not been established in patients with RCTs. The purpose of this study was to establish the MIDs for patients with known RCTs treated both surgically or nonsurgically. METHODS: We included 222 subjects with full-thickness RCTs. The WORC and ASES were collected at baseline and at 4, 8, 16, 32, 48, and 64 weeks, as was an end of study form with questions about change in the condition after treatment. We calculated anchor-based and distribution-based MIDs. We used regression modeling to determine change in MIDs as predicted by several variables. RESULTS: For the anchor-based method, we found an MID of 21.9 for the ASES and -282.6 for the WORC. When using the distribution-based method of ½ and ⅓ the standard deviation, we arrived at an MID of 26.9 and 17.9 points for the ASES and -588.7 and -392.5 points for the WORC. No variables predicted MID changes. CONCLUSION: This is the first study to report MIDs for the ASES and WORC in a population of patients with only full-thickness RCTs. This information will directly improve our ability to determine when patients with RCTs are changing in a meaningful manner and accurately power clinical studies using these outcome measures.

A systematic review of measurement properties of patient-reported outcome measures for use in patients with foot or ankle diseases.

PURPOSE: To identify currently available patient-reported outcome measures (PROMs) used in patients with foot or ankle diseases; and to critically appraise, compare and synthesize the psychometric evidence for the identified PROMs. METHODS: Literature searches were performed in Medline and EMBASE from their inception to January 25th, 2016. Methodological quality was evaluated using the COSMIN checklist. The final rating of the methodological quality of each study for each property was the lowest rating among the items within that property. The psychometric evidence of the properties investigated in the included articles was assessed using the quality criteria established by Terwee et al. The methodological quality ratings and psychometric evidence assessments were synthesized using the method first proposed by Schellingerhout et al. RESULTS: In total, 3077 articles were identified by the literature search, from which 115 studies investigating 50 PRO instruments were included in the review process. The Foot Function Index (FFI) was the most explored instrument, while the Manchester-Oxford Foot Questionnaire (MOXFQ) demonstrated the best properties. CONCLUSION: Most PROMs on foot and ankle diseases have limited evidence for their psychometric properties. The MOXFQ, with the highest overall ratings, could be a useful PROM for evaluating patients with foot or ankle diseases, based on current available evidence. More research is needed to improve the quality of the standards used to assess PROMs and the studies making these assessments.

Comparison of Outcomes 1 Year After Rotator Cuff Repair With and Without Concomitant Biceps Surgery.

PURPOSE: To compare the outcomes of patients who undergo a long head of the biceps (LHB) procedure (tenotomy or tenodesis) concomitant with rotator cuff repair (RCR) to those of patients who undergo isolated RCR. METHODS: Prospectively collected data were retrospectively reviewed on 80 patients, >18 years old, who underwent repair of a full-thickness rotator cuff tear and with 1-year patient-reported outcome scores collected June 2012 to March 2015. The exclusion criteria were concomitant procedures other than LHB tenotomy, tenodesis, or subacromial decompression; prior shoulder surgery; or other shoulder pathology. The 3 patient groups are as follows: RCR + tenotomy, RCR + tenodesis, and isolated RCR. The primary outcome measures were American Shoulder and Elbow Surgeons (ASES) score, Western Ontario Rotator Cuff (WORC) index, and visual analog scale (VAS) for pain. A t-test measured the mean improvement in LHB patients compared with isolated RCR patients and compared the LHB tenotomy and tenodesis groups. Stepwise linear progression used LHB tenotomy or tenodesis as the primary predictor. RESULTS: The biceps procedure group had more female patients (22 vs 7, P = .01); otherwise there were no significant baseline differences. The LHB procedure group had significantly worse baseline ASES scores (mean, 48.9 vs 58.7; P = .032). All RCR patients showed significant improvement in all 3 outcome measures. Patients who had either LHB tenotomy or tenodesis (n = 45) demonstrated significantly greater mean improvement in ASES (mean, 42.7 vs 23.8; P = .002), VAS (mean, 49.2 vs 35.7; P = .020), and WORC scores (mean, 928 vs 743; P = .029) at 1-year follow-up compared with patients who had isolated RCR. ASES scores at 1 year were significantly better in the biceps group (91.6 vs 82.5; P = .023). Linear regression found a biceps procedure to be predictive of a significantly greater improvement in ASES score (P = .01). Analysis of variance revealed that both the LHB tenotomy (P = .04) and tenodesis (P = .01) groups demonstrated more favorable improvement in ASES when compared with RCR alone. CONCLUSIONS: Patients who underwent a concomitant biceps procedure when indicated at the time of RCR demonstrated inferior baseline patient-reported outcome measures and greater improvement after 1 year, as well as more favorable ASES scores at 1 year compared with isolated RCR patients. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Insurance status affects postoperative morbidity and complication rate after shoulder arthroplasty.

BACKGROUND: Shoulder arthroplasty is an effective procedure for managing patients with shoulder pain secondary to end-stage arthritis. Insurance status has been shown to be a predictor of patient morbidity and mortality. The current study evaluated the effect of patient insurance status on perioperative outcomes after shoulder replacement surgery. METHODS: Data between 2004 and 2011 were obtained from the Nationwide Inpatient Sample. Analysis included patients undergoing shoulder arthroplasty (partial, total, and reverse) procedures determined by International Classification of Disease, 9th Revision procedure codes. The primary outcome was medical and surgical complications occurring during the same hospitalization, with secondary analyses of mortality and hospital charges. Additional analyses using the coarsened exact matching algorithm were performed to assess the influence of insurance type in predicting outcomes. RESULTS: A data inquiry identified 103,290 shoulder replacement patients (68,578 Medicare, 27,159 private insurance, 3544 Medicaid/uninsured, 4009 other). The overall complication rate was 17.2% (n = 17,810) and the mortality rate was 0.20% (n = 208). Medicare and Medicaid/uninsured patients had a significantly higher rate of medical, surgical, and overall complications compared with private insurance using the controlled match data. Multivariate regression analysis found that having private insurance was associated with fewer overall medical complications. CONCLUSION: Private insurance payer status is associated with a lower risk of perioperative medical and surgical complications compared with an age- and sex-matched Medicare and Medicaid/uninsured payer status. Mortality was not statistically associated with payer status. Primary insurance payer status should be considered as an independent risk factor during preoperative risk stratification for shoulder arthroplasty procedures.

Prevalence of Femoroacetabular Impingement Morphology in Asymptomatic Adolescents.

BACKGROUND: Femoroacetabular impingement (FAI) can lead to acetabular chondrolabral damage and has been theorized as a causative factor in the development of osteoarthritis. The pathogenesis of FAI is unknown. The purpose of this study was to determine the prevalence of FAI morphology in asymptomatic adolescents. METHODS: We identified children 10 to 18 years of age who had undergone a pelvic CT between 2007 and 2012. Exclusion criteria included hip pain, any hip pathology, bone tumor, long-term steroid use, history of chemotherapy or radiation therapy, nonambulatory status, neuromuscular disorder, chromosomal abnormality, and metabolic bone disease. Multiplanar reformatted images were created from axial images to calculate α angles and lateral center-edge angles (LCEA). Cam morphology was defined as an α-angle ≥55 degrees and pincer morphology as a LCEA≥40 degrees. RESULTS: We analyzed 558 patients (1116 hips). There were 276 males and 282 females. The average age was 14.4 years (range, 10.0 to 18.2 y). The mean α-angle was 47.9 degrees (range, 25.7 to 78 degrees) and the mean LCEA was 34.4 degrees (range, 3.9 to 58.6 degrees). Males had a significantly higher mean α-angle (49.7 vs. 46.0 degrees) (P<0.0005) and females had a significantly higher mean LCEA (35.7 vs. 33.0 degrees) (P<0.0005). Ninety-four adolescents (16.8%) had an α-angle ≥55 degrees. Cam morphology was significantly more common in males (23.9% vs. 9.9%) (P<0.001). A total of 181 adolescents (32.4%) had a LCEA≥40 degrees. Pincer morphology was equally common in males and females (29.7% vs. 35.1%) (P=0.17). Thirty-four adolescents (6.1%) had mixed morphologies. Mixed morphologies were found in 21 males (7.6%) and 13 females (4.6%) (P=0.19). The prevalence of pincer morphology increased significantly with increased age in males (P<0.001). CONCLUSIONS: The prevalence of cam-type FAI morphology in asymptomatic adolescents is similar to the reported prevalence in asymptomatic adults. Pincer morphology may be more common than cam morphology in adolescents. Cam morphology is more prevalent in males, whereas pincer and mixed morphologies are equally prevalent in both sexes. LEVEL OF EVIDENCE: Level III-diagnostic.

A Systematic Review of Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Knee Arthroplasty.

BACKGROUND: While clinical research on total knee arthroplasty (TKA) outcomes is prevalent in the literature, studies often have poor methodological and reporting quality. A high-quality patient-reported outcome instrument is reliable, valid, and responsive. Many studies evaluate these properties, but none have done so with a systematic and accepted method. The objectives of this study were to identify patient-reported outcome measures (PROMs) for TKA, and to critically appraise, compare, and summarize their psychometric properties using accepted methods. METHODS: MEDLINE, EMBASE, SCOPUS, Web of Science, PsycINFO, and SPORTDiscus were systematically searched for articles with the following inclusion criteria: publication before December 2014, English language, non-generic PRO, and evaluation in the TKA population. Methodological quality and evidence of psychometric properties were assessed with the COnsensus-based standards for the selection of health Status Measurement INstruments (COSMIN) checklist and criteria for psychometric evidence proposed by the COSMIN group and Terwee et al. RESULTS: One-hundred fifteen studies on 32 PROMs were included in this review. Only the Work, Osteoarthritis or joint-Replacement Questionnaire, the Oxford Knee Score, and the Western Ontario and McMaster Universities Arthritis Index had 4 or more properties with positive evidence. CONCLUSION: Most TKA PROMs have limited evidence for their psychometric properties. Although not all the properties were studied, the Work, Osteoarthritis or joint-Replacement Questionnaire, with the highest overall ratings, could be a useful PROM for evaluating patients undergoing TKA. The methods and reporting of this literature can improve by following accepted guidelines.

Applicable or non-applicable: investigations of clinical heterogeneity in systematic reviews.

BACKGROUND: Clinical heterogeneity can be defined as differences in participant characteristics, types or timing of outcome measurements and intervention characteristics. Clinical heterogeneity in systematic reviews has the possibility to significantly affect statistical heterogeneity leading to inaccurate conclusions and misled decision making. The aim of this study is to identify to what extent investigators are assessing clinical heterogeneity in both Cochrane and non-Cochrane systematic reviews. METHODS: The most recent 100 systematic reviews from the top five journals in medicine-JAMA, Archives of Internal Medicine, British Medical Journal, The Lancet, and PLOS Medicine-and the 100 most recently published and/or updated systematic reviews from Cochrane were collected. Various defined items of clinical heterogeneity were extracted from the included reviews. Investigators used chi-squared tests, logarithmic modeling and linear regressions to determine if the presence of such items served as a predictor for clinical heterogeneity when comparing Cochrane to non-Cochrane reviews. Extracted variables include number of studies, number of participants, presence of quantitative synthesis, exploration of clinical heterogeneity, heterogeneous characteristics explored, basis and methods used for investigating clinical heterogeneity, plotting/visual aids, author contact, inferences from clinical heterogeneity investigation, reporting assessment, and the presence of a priori or post-hoc analysis. RESULTS: A total of 317 systematic reviews were considered, of which 199 were in the final analysis. A total of 81% of Cochrane reviews and 90% of non-Cochrane reviews explored characteristics that are considered aspects of clinical heterogeneity and also described the methods they planned to use to investigate the influence of those characteristics. Only 1% of non-Cochrane reviews and 8% of Cochrane reviews explored the clinical characteristics they initially chose as potential for clinical heterogeneity. Very few studies mentioned clinician training, compliance, brand, co-interventions, dose route, ethnicity, prognostic markers and psychosocial variables as covariates to investigate as potentially clinically heterogeneous. Addressing aspects of clinical heterogeneity was not different between Cochrane and non-Cochrane reviews. CONCLUSIONS: The ability to quantify and compare the clinical differences of trials within a meta-analysis is crucial to determining its applicability and use in clinical practice. Despite Cochrane Collaboration emphasis on methodology, the proportion of reviews that assess clinical heterogeneity is less than those of non-Cochrane reviews. Our assessment reveals that there is room for improvement in assessing clinical heterogeneity in both Cochrane and non-Cochrane reviews.

Development, implementation and evaluation of a patient handoff tool to improve safety in orthopaedic surgery.

OBJECTIVE: To develop, implement and test the effect of a handoff tool for orthopaedic trauma residents that reduces adverse events associated with the omission of critical information and the transfer of erroneous information. DESIGN: Components of this project included a literature review, resident surveys and observations, checklist development and refinement, implementation and evaluation of impact on adverse events through a chart review of a prospective cohort compared with a historical control group. SETTING: Large teaching hospital. PARTICIPANTS: Findings of a literature review were presented to orthopaedic residents, epidemiologists, orthopaedic surgeons and patient safety experts in face-to-face meetings, during which we developed and refined the contents of a resident handoff tool. The tool was tested in an orthopaedic trauma service and its impact on adverse events was evaluated through a chart review. The handoff tool was developed and refined during the face-to-face meetings and a pilot implementation. Adverse event data were collected on 127 patients (n = 67 baseline period; n = 60 test period). INTERVENTION: A handoff tool for use by orthopaedic residents. MAIN OUTCOME MEASUREMENTS: Adverse events in patients handed off by orthopaedic trauma residents. RESULTS: After controlling for age, gender and comorbidities, testing resulted in fewer events per person (25-27% reduction; P < 0.10). CONCLUSIONS: Preliminary evidence suggests that our resident handoff tool may contribute to a decrease in adverse events in orthopaedic patients.

Surgeon Willingness to Participate in Randomized Controlled Trials for the Treatment of Femoroacetabular Impingement.

PURPOSE: To define surgeon willingness to participate in large, multicenter randomized controlled trials (RCTs) to address common treatment decisions for the management of femoroacetabular impingement (FAI) and to define the feasibility of executing these RCTs. METHODS: Thirty case vignettes of consecutive, symptomatic FAI patients who underwent FAI corrective surgery by a single surgeon were provided to members of the Academic Network of Conservational Hip Outcomes Research (ANCHOR). Each surgeon (n = 10) completed a questionnaire in a blinded fashion to determine willingness to participate and enroll the patient in 6 different potential RCTs. The proportion of yes/no ratings were blindly assessed for all 6 RCTs. Differences were tested with χ(2)-tests, and odds ratios were calculated. RESULTS: Seventy-seven percent and 42% of surgeons were willing to enroll patients in a surgical versus nonoperative FAI RCT with 6-month and 12-month crossover arms, respectively. Only 25% and 53% of surgeons were willing to consider randomization of operative versus nonoperative treatment for femoral and acetabular sided osseous deformities, respectively. Regarding the capsulolabral complex, 63% and 78% were amenable to randomization of labral refixation versus debridement and capsular closure versus no closure, respectively. Statistically, surgeon ratings differed significantly (Pearson χ(2) = 246.302; P < .001). CONCLUSIONS: Surgeons are willing to participate in surgical versus nonsurgical trials with a 6-month crossover endpoint, yet surgeons are reluctant to offer surgical treatment of FAI without correction of osseous deformity, particularly for cam-type pathomorphology. RCTs to address management of the capsulolabral structures may be more feasible and generalizable based on the willingness of hip preservation surgeons to enroll patients. CLINICAL RELEVANCE: The feasibility of completing RCTs for the management of FAI is limited even among high-volume hip preservation surgeons; however, surgeons are willing to participate.