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.

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.

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.

Evaluation of American Academy of Orthopaedic Surgeons Appropriate Use Criteria for the management of full-thickness rotator cuff tears.

BACKGROUND: The American Academy of Orthopaedic Surgeons (AAOS) recently released Appropriate Use Criteria (AUC) to aid in determining the appropriateness of treatment options. This study compares AAOS AUC recommendations with a cohort of patients treated for known full-thickness rotator cuff tears (RCTs). METHODS: Prospectively collected demographic information, treatment allocation, and American Shoulder and Elbow Surgeons (ASES) shoulder and Western Ontario Rotator Cuff Index scores of 134 patients were retrospectively reviewed. Other criteria required by the AAOS AUC were collected by retrospective record review. Criteria were entered into the AAOS AUC Web-based application to rate the "appropriateness" of treatment options. Ratings were compared with actual treatments and outcomes at 32- or 48-week follow-up. RESULTS: There was excellent agreement between the AUC recommendations and the actual treatment administered (κ = .945; 95% confidence interval, 0.892-1.000; P <.0001). The administered treatment was "appropriate" for 79% of patients, "may be appropriate" for 19%, and "rarely appropriate" for 2%. Response to previous treatment (P <.0001), American Society of Anesthesiologists Physical Status Classification (P <.0001), and presence of muscle atrophy or fatty infiltration (P = .047) were the only variables that significantly and independently predicted discordance between treatment and the AUC recommendation. In the cases (n = 3) of discordance, the American Shoulder and Elbow Surgeons score improved significantly more (P = .049) than when there was agreement. CONCLUSIONS: Improved clinical outcomes may be achieved for full-thickness RCTs when AAOS AUC recommendations are followed; however, because improved clinical outcomes may also be achieved when the recommendations are not followed, further investigation is needed in a population of patients in whom there is discordance between AAOS AUC recommendations and the treatment administered.

No Difference in Dislocation Seen in Anterior Vs Posterior Approach Total Hip Arthroplasty.

BACKGROUND: The direct anterior approach (DAA) for total hip arthroplasty (THA) has rapidly become popular, but there is little consensus regarding the risks and benefits of this approach in comparison with a modern posterior approach (PA). METHODS: A total of 2147 patients who underwent DAA THA were propensity score matched with patients undergoing PA THA on the basis of age, gender, body mass index, and American Society of Anesthesia classification using data from a state joint replacement registry. Mean age of the matched cohort was 64.8 years, mean body mass index was 29.1 kg/m(2), and 53% were female. Multilevel logistic regression models using generalized estimating equations to control for grouping at the hospital level were used to identify differences in various outcomes. RESULTS: There was no difference in the dislocation rate between patients undergoing DAA (0.84%) and PA (0.79%) THA. Trends indicating a slightly longer length of stay with the PA and a slightly greater risk of fracture, increased blood loss, and hematoma with the DAA are consistent with previous studies. CONCLUSION: On the basis of short-term outcome and complication data, neither approach has a compelling advantage over each other, including no difference in the dislocation risk.

Use of clustering analysis in randomized controlled trials in orthopaedic surgery.

BACKGROUND: The effects of clustering in randomized controlled trials (RCTs) and the resulting potential violation of assumptions of independence are now well recognized. When patients in a single study are treated by several therapists, there is good reason to suspect that the variation in outcome will be smaller for patients treated in the same group than for patients treated in different groups. This potential correlation of outcomes results in a loss of independence of observations. The purpose of this study is to examine the current use of clustering analysis in RCTs published in the top five journals of orthopaedic surgery. METHODS: RCTs published from 2006 to 2010 in the top five journals of orthopaedic surgery, as determined by 5-year impact factor, that included multiple therapists and/or centers were included. Identified articles were assessed for accounting for the effects of clustering of therapists and/or centers in randomization or analysis. Logistic regression used both univariate and multivariate models, with use of clustering analysis as the outcome. Multivariate models were constructed using stepwise deletion. An alpha level of 0.10 was considered significant. RESULTS: A total of 271 articles classified as RCTs were identified from the five journals included in the study. Thirty-two articles were excluded due to inclusion of nonhuman subjects. Of the remaining 239 articles, 186 were found to include multiple centers and/or therapists. The prevalence of use of clustering analysis was 21.5%. Fewer than half of the studies reported inclusion of a statistician, epidemiologist or clinical trials methodologist on the team. In multivariate modeling, adjusting for clustering was associated with a 6.7 times higher odds of inclusion of any type of specialist on the team (P = 0.08). Likewise, trials that accounted for clustering had 3.3 times the odds of including an epidemiologist/clinical trials methodologist than those that did not account for clustering (P = 0.04). CONCLUSIONS: Including specialists on a study team, especially an epidemiologist or clinical trials methodologist, appears to be important in the decision to account for clustering in RCT reporting. The use of clustering analysis remains an important piece of unbiased reporting, and accounting for clustering in RCTs should be a standard reporting practice.

Evaluation of Quality of Lower Limb Arthroplasty Observational Studies Using the Assessment of Quality in Lower Limb Arthroplasty (AQUILA) Checklist.

UNLABELLED: This study used the assessment of quality in lower limb arthroplasty (AQUILA) checklist to assess the quality of lower limb arthroplasty observational studies. Among 132 studies the mean reporting quality score was 5.4 (SD=1.2) out of 8 possible points. Most studies adequately reported reasons for revisions (98%) and prosthesis brand and fixation (95%) in sufficient detail. Only 3% of studies adequately reported the number of patients unwilling to participate, 15% stated a clear primary research question or hypothesis, 11% reported a worst-case analysis or competing risk analysis for endpoints, and 42% reported more than 5% of patients were lost to follow-up. There is significant room for improvement in the reporting and methodology of lower limb arthroplasty observational studies. LEVEL OF EVIDENCE: Level III.

Herbal medicine for low-back pain.

BACKGROUND: Low-back pain (LBP) is a common condition and imposes a substantial economic burden upon people living in industrialized societies. A large proportion of people with chronic LBP use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in treating people with LBP. This is an update of a Cochrane Review first published in 2006. OBJECTIVES: To determine the effectiveness of herbal medicine for non-specific LBP. SEARCH METHODS: We searched the following electronic databases up to September 2014: MEDLINE, EMBASE, CENTRAL, CINAHL, Clinical Trials.gov, World Health Organization International Clinical Trials Registry Portal and PubMed; checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this area. SELECTION CRITERIA: We included randomized controlled trials (RCTs) examining adults (over 18 years of age) suffering from acute, sub-acute, or chronic non-specific LBP. The interventions were herbal medicines which we defined as plants used for medicinal purposes in any form. Primary outcome measures were pain and function. DATA COLLECTION AND ANALYSIS: A library scientist with the Cochrane Back Review Group conducted the database searches. One review author contacted content experts and acquired relevant citations. We downloaded full references and abstracts of the identified studies and retrieved a hard copy of each study for final inclusion decisions. Two review authors assessed risk of bias, GRADE criteria (GRADE 2004), and CONSORT compliance and a random subset were compared to assessments by a third individual. Two review authors assessed clinical relevance and resolved any disagreements by consensus. MAIN RESULTS: We included 14 RCTs (2050 participants) in this review. One trial on Solidago chilensis M. (Brazilian arnica) (20 participants) found very low quality evidence of reduction in perception of pain and improved flexibility with application of Brazilian arnica-containing gel twice daily as compared to placebo gel. Capsicum frutescens cream or plaster probably produces more favourable results than placebo in people with chronic LBP (three trials, 755 participants, moderate quality evidence). Based on current evidence, it is not clear whether topical capsicum cream is more beneficial for treating people with acute LBP compared to placebo (one trial, 40 participants, low quality evidence). Another trial found equivalence of C. frutescens cream to a homeopathic ointment (one trial, 161 participants, very low quality evidence). Daily doses of Harpagophytum procumbens (devil's claw), standardized to 50 mg or 100 mg harpagoside, may be better than placebo for short-term improvements in pain and may reduce use of rescue medication (two trials, 315 participants, low quality evidence). Another H. procumbens trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib (Vioxx®) but was of very low quality (one trial, 88 participants, very low quality). Daily doses of Salix alba (white willow bark), standardized to 120 mg or 240 mg salicin, are probably better than placebo for short-term improvements in pain and rescue medication (two trials, 261 participants, moderate quality evidence). An additional trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib (one trial, 228 participants) but was graded as very low quality evidence. S. alba minimally affected platelet thrombosis versus a cardioprotective dose of acetylsalicylate (one trial, 51 participants). One trial (120 participants) examining Symphytum officinale L. (comfrey root extract) found low quality evidence that a Kytta-Salbe comfrey extract ointment is better than placebo ointment for short-term improvements in pain as assessed by VAS. Aromatic lavender essential oil applied by acupressure may reduce subjective pain intensity and improve lateral spine flexion and walking time compared to untreated participants (one trial, 61 participants,very low quality evidence). No significant adverse events were noted within the included trials. AUTHORS' CONCLUSIONS: C. frutescens (Cayenne) reduces pain more than placebo. Although H. procumbens, S. alba, S. officinale L., S. chilensis, and lavender essential oil also seem to reduce pain more than placebo, evidence for these substances was of moderate quality at best. Additional well-designed large trials are needed to test these herbal medicines against standard treatments. In general, the completeness of reporting in these trials was poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions.

Establishing the Minimally Important Difference for the KOOS-Joint Replacement and PROMIS Global-10 in Patients After Total Knee Arthroplasty.

Background: Despite the overall prevalence and success of total knee arthroplasty (TKA), a significant portion of patients are dissatisfied with their outcomes. Purpose: To assess the responsiveness and determine the minimally important difference (MID) of 2 patient-reported outcome measures (PROMs)-the Knee injury and Osteoarthritis Outcome Score-Joint Replacement (KOOS-JR) and the Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS 10)-in patients after TKA. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: Included were patients who underwent TKA from August 2015 through August 2019 and completed baseline and postoperative KOOS-JR and PROMIS 10 surveys. The PROMIS 10 consists of 2 domains: physical health and mental health. Estimates for the reliable change index (RCI) and MID, using anchor-based and distribution-based methods, were calculated for each PROM. Regression modeling was used to determine whether patient and clinical factors predicted MID thresholds or MID achievement. Results: A total of 1315 patients were included. Distribution-based MIDs, calculated using various methods from baseline scores, ranged from 19.3 to 31 for the KOOS-JR, and the RCI was 4.38. Of these patients, 293 (22.3%) demonstrated small or moderate improvement, and this cohort was included in the calculation of anchor-based MIDs. The anchor-based MIDs were 16.9 and 24.3 at 3-month and 1-year follow-up, respectively, and 66% of patients achieved the MID at 12 months. Higher preoperative PROM score, male sex, non-White race, and current smoker status were predictive of failing to achieve the anchor-based MID for KOOS-JR at 1 year postoperatively (P < .05). Higher preoperative PROM score and any 90-day adverse event predicted lower thresholds of important change in anchor-based MIDs. Higher baseline PROM scores, younger age, male sex, non-White ethnicity, higher American Society of Anesthesiologists classification, preoperative narcotics use, not smoking, and longer hospital stay were all associated with lower odds of achieving the MID on the KOOS-JR or either of the PROMIS 10 subscales. Conclusion: The study results demonstrated relevant values for interpretation of the KOOS-JR and PROMIS 10. While patient demographics did not accurately predict which patients would achieve the MID, some potential factors predicting successful patient-reported outcomes after TKA were identified.