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Background: Core outcome sets aim to select and standardize the choice of important outcomes reported in clinical trials to encourage more effective data synthesis, increase the reliability of comparing results, and minimize reporting bias. A core outcome set for elective shoulder surgery has yet to be defined, and therefore a systematic assessment of outcomes and methodology is necessary to inform the development of a core outcome set.Questions/purposes: The purpose of this study was to examine randomized controlled trials (RCTs) of patients having elective major or minor shoulder surgery to (1) identify the outcome domains reported; (2) determine specific outcome measurement tools that were utilized; and (3) assess the work for methodological quality and risk of bias.Methods: We conducted a scoping review (a review that identifies the nature and extent of research evidence) to explore the reported outcome domains, outcome tools, and methodological quality from RCTs conducted in shoulder surgery. We considered both major shoulder surgery (defined as arthroplasty, rotator cuff repair, stabilization procedures, biceps tenodesis, or Bankart repairs) and minor shoulder surgery (simple arthroscopy, capsular plication, lateral clavicular excisions, or subacromial decompression). We queried 10 electronic databases for studies published between January 2006 and January 2015. Studies were included if they were prospective, randomized controlled, clinical trials enrolling patients who received an elective shoulder surgical intervention. We extracted data relating to trial characteristics, primary outcomes, tools used to measure these outcomes as well as methodological quality indicators. We assessed indicators of methodological quality by exploring (1) the reproducibility of power analyses; and (2) whether the primary outcomes were powered to minimum clinically important differences. Risk of bias was also assessed with the Jadad score with scores between 0 (very high risk of bias) and 5 (very low risk). Findings were qualitatively analyzed and reported according to systematic and scoping review guidelines. We included 315 studies involving 30,232 patients; 266 studies investigated anesthetic, analgesic, or surgical interventions.Results: Of the 315 studies included, the most common outcome domains evaluated were analgesic (n = 104), functional (n = 87), anesthetic (n = 56), and radiologic (n = 29) outcomes, with temporal patterns noted. Studies of major shoulder surgery most commonly reported functional primary outcome domains, whereas minor shoulder surgery studies most frequently reported analgesic primary outcome domains. There were 85 different primary outcome tools utilized, which included 20 functional, 20 anesthetic, 13 analgesic, and 12 radiologic. A methodological quality assessment revealed that 24% of studies had reproducible power analyses, 13% were powered to minimum clinically important differences, and risk of bias assessment demonstrated a median (interquartile range [range]) Jadad score of 4 (3-5 [1-5]).Conclusions: A wide range of outcome domains and outcome assessment tools are in common use in contemporary trials of patients undergoing elective surgery. Although some diversity is important to allow the assessment of patient populations that may have different goals, the large number of tools in common use may impair the ability of future meta-analyses to pool results effectively or even for systematic reviews to synthesize what is known. The limitations of methodological quality in RCTs may be improved by researchers following standard guidelines and considering the minimum clinically important differences in their trials to be of greater use to clinicians and their patients.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

Background: Hospital-related factors associated with mortality and morbidity after hip fracture surgery are not completely understood. The Veterans Health Administration (VHA) is the largest single-payer, networked healthcare system in the country serving a relatively homogenous patient population with facilities that vary in size and resource availability. These characteristics provide some degree of financial and patient-level controls to explore the association, if any, between surgical volume and facility resource availability and hospital performance regarding postoperative complications after hip fracture surgery.Questions/purposes: (1) Do VHA facilities with the highest complexity level designation (Level 1a) have a disproportionate number of better-than-expected performance outliers for major postoperative complications compared with lower-complexity level facilities? (2) Do VHA facilities with higher hip fracture surgical volume have a disproportionate number of better-than-expected performance outliers for major postoperative complications compared with lower-volume facilities?Methods: We explored the Veterans Affairs Surgical Quality Improvement Project (VASQIP) database from October 2001 to September 2012 for records of hip fracture surgery performed. Data reliability of the VASQIP database has been previously validated. We excluded nine of the 98 VHA facilities for contributing fewer than 30 records. The remaining 89 VHA facilities provided 23,029 records. The VHA designates a complexity level to each facility based on multiple criteria. We labeled facilities with a complexity Level 1a (38 facilities)-the highest achievable VHA designated complexity level-as high complexity; we labeled all other complexity level designations as low complexity (51 facilities). Facility volume was divided into tertiles: high (> 277 hip fracture procedures during the sampling frame), medium (204 to 277 procedures), and low (< 204 procedures). The patient population treated by low-complexity facilities was older, had a higher prevalence of severe chronic obstructive pulmonary disease (26% versus 22%, p < 0.001), and had a higher percentage of patients having surgery within 2 days of hospital admission (83% versus 76%, p < 0.001). High-complexity facilities treated more patients with recent congestive heart failure exacerbation (4% versus 3%, p < 0.001). We defined major postoperative complications as having at least one of the following: death within 30 days of surgery, cardiac arrest requiring cardiopulmonary resuscitation, new q-wave myocardial infarction, deep vein thrombosis and/or pulmonary embolism, ventilator dependence for at least 48 hours after surgery, reintubation for respiratory or cardiac failure, acute renal failure requiring renal replacement therapy, progressive renal insufficiency with a rise in serum creatinine of at least 2 mg/dL from preoperative value, pneumonia, or surgical site infection. We used the observed-to-expected ratio (O/E ratio)-a risk-adjusted metric to classify facility performance-for major postoperative complications to assess the performance of VHA facilities. Outlier facilities with 95% confidence intervals (95% CI) for O/E ratio completely less than 1.0 were labeled "exceed expectation;" those that were completely greater than 1.0 were labeled "below expectation." We compared differences in the distribution of outlier facilities between high and low-complexity facilities, and between high-, medium-, and low-volume facilities using Fisher's exact test.Results: We observed no association between facility complexity level and the distribution of outlier facilities (high-complexity: 5% exceeded expectation, 5% below expectation; low-complexity: 8% exceeded expectation, 2% below expectation; p = 0.742). Compared with high-complexity facilities, the adjusted odds ratio for major postoperative complications for low-complexity facilities was 0.85 (95% CI, 0.67-1.09; p = 0.108).We observed no association between facility volume and the distribution of outlier facilities: 3% exceeded expectation and 3% below expectation for high-volume; 10% exceeded expectation and 3% below expectation for medium-volume; and 7% exceeded expectation and 3% below expectation for low-volume; p = 0.890). The adjusted odds ratios for major postoperative complications were 0.87 (95% CI, 0.73-1.05) for low- versus high-volume facilities and 0.89 (95% CI, 0.79-1.02] for medium- versus high-volume facilities (p = 0.155).Conclusions: These results do not support restricting facilities from treating hip fracture patients based on historical surgical volume or facility resource availability. Identification of consistent performance outliers may help health care organizations with multiple facilities determine allocation of services and identify characteristics and processes that determine outlier status in the interest of continued quality improvement.Level Of Evidence: Level III, therapeutic study. [ABSTRACT FROM AUTHOR]