Medial Patellofemoral Ligament Reconstruction in Obese Patients Results in Low Complication Rates and Improved Subjective Outcomes.

Purpose: To compare outcomes, activity scores, and complication rates of obese and non-obese patients undergoing medial patellofemoral ligament (MPFL) reconstruction. Methods: A retrospective review identified patients undergoing MPFL reconstruction for recurrent patellofemoral instability. Patients were included if they had undergone MPFL reconstruction and had follow-up for a minimum of 6 months. Patients were excluded if they underwent surgery less than 6 months earlier, had no outcome data recorded, or underwent concomitant bony procedures. Patients were divided into 2 groups based on body mass index (BMI): BMI of 30 or greater and BMI less than 30. Presurgical and postsurgical patient-reported outcomes including Knee Injury and Osteoarthritis Outcome Score (KOOS) domains and the Tegner score were collected. Complications requiring reoperation were recorded. P < .05 was defined as a statistically significant difference. Results: A total of 55 patients (57 knees) were included. There were 26 knees with a BMI of 30 or greater and 31 knees with a BMI less than 30. There were no differences in patient demographic characteristics between the 2 groups. Preoperatively, no significant differences were found in KOOS subscores or Tegner scores (P = .21) between groups. At minimum 6-month follow-up (range, 6.1-70.5 months), patients with a BMI of 30 or greater showed statistically significant improvements in the KOOS Pain, Activities of Daily Living, Symptoms, and Sport/Recreation subscores. Patients with a BMI less than 30 showed a statistically significant improvement in the KOOS Quality of Life subscore. The group with a BMI of 30 or greater had significantly lower KOOS Quality of Life (33.34 ± 19.10 vs 54.47 ± 28.00, P = .03) and Tegner (2.56 ± 1.59 vs 4.78 ± 2.68, P = .05) scores. Complication rates were low, with 2 knees (7.69%) requiring reoperation in the cohort with a BMI of 30 or greater and 4 knees (12.90%) requiring reoperation in the cohort with a BMI less than 30, including 1 reoperation for recurrent patellofemoral instability (P = .68). Conclusions: In this study, MPFL reconstruction in obese patients was safe and effective, with low complication rates and improvements in most patient-reported outcomes. Compared with patients with a BMI less than 30, obese patients had lower quality-of-life and activity scores at final follow-up. Level of Evidence: Level III, retrospective cohort study.

Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals.

BACKGROUND: Noninferiority trials are increasingly being performed. However, little is known about their methodological quality. We sought to characterize noninferiority cardiovascular trials published in the highest-impact journals, features that may bias results toward noninferiority, features related to reporting of noninferiority trials, and the time trends. METHODS: We identified cardiovascular noninferiority trials published in JAMA, Lancet, or New England Journal of Medicine from 1990 to 2016. Two independent reviewers extracted the data. Data elements included the noninferiority margin and the success of studies in achieving noninferiority. The proportion of trials showing major or minor features that may have affected the noninferiority inference was determined. Major factors included the lack of presenting the results in both intention-to-treat and per-protocol/as-treated cohorts, α>0.05, the new intervention not being compared with the best alternative, not justifying the noninferiority margin, and exclusion or loss of ≥10% of the cohort. Minor factors included suboptimal blinding, allocation concealment, and others. RESULTS: From 2544 screened studies, we identified 111 noninferiority cardiovascular trials. Noninferiority margins varied widely: risk differences of 0.4% to 25%, hazard ratios of 1.05 to 2.85, odds ratios of 1.1 to 2.0, and relative risks of 1.1 to 1.8. Eighty-six trials claimed noninferiority, of which 20 showed superiority, whereas 23 (21.1%) did not show noninferiority, of which 8 also demonstrated inferiority. Only 7 (6.3%) trials were considered low risk for all the major and minor biasing factors. Among common major factors for bias, 41 (37%) did not confirm the findings in both intention-to-treat and per-protocol/as-treated cohorts and 4 (3.6%) reported discrepant results between intention-to-treat and per-protocol analyses. Forty-three (38.7%) did not justify the noninferiority margin. Overall, 27 (24.3%) underenrolled or had >10% exclusions. Sixty trials (54.0%) were open label. Allocation concealment was not maintained or unclear in 11 (9.9%). Publication of noninferiority trials increased over time (P<0.001). Fifty-two (46.8%) were published after 2010 and had a lower risk of methodological or reporting limitations for major (P=0.03) and minor factors (P=0.002). CONCLUSIONS: Noninferiority trials in highest-impact journals commonly conclude noninferiority of the tested intervention, but vary markedly in the selected noninferiority margin, and frequently have limitations that may impact the inference related to noninferiority.

Adherence to Methodological Standards in Research Using the National Inpatient Sample.

Importance: Publicly available data sets hold much potential, but their unique design may require specific analytic approaches. Objective: To determine adherence to appropriate research practices for a frequently used large public database, the National Inpatient Sample (NIS) of the Agency for Healthcare Research and Quality (AHRQ). Design, Setting, and Participants: In this observational study of the 1082 studies published using the NIS from January 2015 through December 2016, a representative sample of 120 studies was systematically evaluated for adherence to practices required by AHRQ for the design and conduct of research using the NIS. Exposures: None. Main Outcomes and Measures: All studies were evaluated on 7 required research practices based on AHRQ's recommendations and compiled under 3 domains: (1) data interpretation (interpreting data as hospitalization records rather than unique patients); (2) research design (avoiding use in performing state-, hospital-, and physician-level assessments where inappropriate; not using nonspecific administrative secondary diagnosis codes to study in-hospital events); and (3) data analysis (accounting for complex survey design of the NIS and changes in data structure over time). Results: Of 120 published studies, 85% (n = 102) did not adhere to 1 or more required practices and 62% (n = 74) did not adhere to 2 or more required practices. An estimated 925 (95% CI, 852-998) NIS publications did not adhere to 1 or more required practices and 696 (95% CI, 596-796) NIS publications did not adhere to 2 or more required practices. A total of 79 sampled studies (68.3% [95% CI, 59.3%-77.3%]) among the 1082 NIS studies screened for eligibility did not account for the effects of sampling error, clustering, and stratification; 62 (54.4% [95% CI, 44.7%-64.0%]) extrapolated nonspecific secondary diagnoses to infer in-hospital events; 45 (40.4% [95% CI, 30.9%-50.0%]) miscategorized hospitalizations as individual patients; 10 (7.1% [95% CI, 2.1%-12.1%]) performed state-level analyses; and 3 (2.9% [95% CI, 0.0%-6.2%]) reported physician-level volume estimates. Of 27 studies (weighted; 218 studies [95% CI, 134-303]) spanning periods of major changes in the data structure of the NIS, 21 (79.7% [95% CI, 62.5%-97.0%]) did not account for the changes. Among the 24 studies published in journals with an impact factor of 10 or greater, 16 (67%) did not adhere to 1 or more practices, and 9 (38%) did not adhere to 2 or more practices. Conclusions and Relevance: In this study of 120 recent publications that used data from the NIS, the majority did not adhere to required practices. Further research is needed to identify strategies to improve the quality of research using the NIS and assess whether there are similar problems with use of other publicly available data sets.