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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]

Background: Studies suggest a trend in the selection of younger and healthier individuals to undergo bilateral TKAs in an attempt to diminish the incidence of complications. It remains unclear whether this development has reduced overall perioperative morbidity and mortality.Questions/purposes: We investigated whether changes in demographics and comorbidity patterns of patients undergoing bilateral TKAs are detectable and coincide with changes in length and cost of hospitalization, incidence of perioperative complications, morbidity, and mortality.Methods: We accessed Nationwide Inpatient Survey data files between 1999 and 2008. One-year periods were created and changes in demographics, length of in-hospital stay, and perioperative morbidity and mortality were analyzed.Results: An estimated 258,524 bilateral TKAs were performed between 1999 and 2008 in the United States. The number of annual procedures increased from 19,288 to 33,679 (75%). Length of hospital stay decreased from 4.98 to 4.01 days. Absolute in-hospital mortality rates decreased at an average rate of 10% per year. The unadjusted percent and adjusted incidence per 1000 inpatient days decreased from 0.42% and 0.85 to 0.16% and 0.39. Although the unadjusted incidence of pneumonia, pulmonary embolism, and nonmyocardial infarction cardiac complications did not change, an increase with time was detectible after adjustment for length of stay. No changes in adjusted incidence were seen for other complications.Conclusions: Although a decreased incidence was seen for some major complications, others either remained unchanged or had an increased incidence when adjusted for length of stay. Future interventions should focus on reducing perioperative risk to improve patient safety. [ABSTRACT FROM AUTHOR]

Background: Although anterior (ACDF) and posterior cervical fusion (PCDF) are relatively common procedures and both are associated with certain complications, the relative frequency and severity of these complications is unclear. Since for some patients either approach might be reasonable it is important to know the relative perioperative risks for decision-making. Questions/purposes: The purposes of this study were to: (1) characterize the patient population undergoing ACDF and PCDF; (2) compare perioperative complication rates; (3) determine independent risk factors for adverse perioperative events; and (4) aid in surgical decision-making in cases in which clinical equipoise exists between anterior and posterior cervical fusion procedures. Methods: The National Inpatient Sample was used and entries for ACDF and PCDF between 1998 and 2006 were analyzed. Demographics and complication rates were determined and regression analysis was performed to identify independent risk factors for mortality after ACDF and PCDF. Results: ACDF had a shorter length of stay and their procedures were more frequently performed at nonteaching institutions. The incidence of complications and mortality was 4.14% and 0.26% among patients undergoing ACDF and 15.35% and 1.44% for patients undergoing PCDF, respectively. When controlling for overall comorbidity burden and other demographic variables, PCDF was associated with a twofold increased risk of a fatal outcome compared with ACDF. Pulmonary, circulatory, and renal disease were associated with the highest odds for in-hospital mortality. Conclusions: PCDF procedures were associated with higher perioperative rates of complications and mortality compared with ACDF surgeries. Despite limitations, these data should be considered in cases in which clinical equipoise exists between both approaches. Level of Evidence: Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Unlabelled: Patients undergoing bilateral total knee arthroplasty (BTKA) may have higher complication rates and mortality than those undergoing a unilateral procedure (UTKA). To evaluate this hypothesis, we analyzed nationally representative data collected for the National Hospital Discharge Survey on discharges after BTKA, UTKA, and revision TKA (RTKA) between 1990 and 2004. The demographics, comorbidities, in-hospital stay, complications, and mortality of each procedure were compared. An estimate of 4,159,661 discharges (153,259 BTKAs; 3,672,247 UTKAs; 334,155 RTKAs) were included. Patients undergoing BTKA were younger (1.5 years) and had a lower prevalence of comorbidities for hypertension (versus UTKA), diabetes, pulmonary disease, and coronary artery disease (versus UTKA and RTKA). The length of hospitalization was 5.8 days for BTKA, 5.3 for UTKA, and 5.4 for RTKA. Despite similar length of hospitalization, the prevalence of procedure-related complications was higher for BTKA (12.2%) compared with UTKA (8.2%) and RTKA (8.7%). In-hospital mortality was highest for patients undergoing BTKA (BTKA, 0.5%; UTKA, 0.3%; RTKA, 0.3%). Patients undergoing BTKA had a 1.6 times higher rate of procedure-related complications and mortality compared with those undergoing UTKA. Outcomes for patients undergoing RTKA for most variables were similar to those for UTKA. BTKA, advanced age, and male gender were independent risk factors for complications and mortality after TKA.Level Of Evidence: Level III, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]