Impact of surrogate outcomes in randomized controlled trials for shoulder rotator cuff tears.

PURPOSE: Surrogate outcomes are clinical endpoints that are used as substitutes for direct measures of how a patient feels, functions, or survives. The present study aims to analyze the impact of surrogate outcomes on the results of randomized controlled trials on shoulder rotator cuff tears disorders. METHODS: Randomized controlled trials (RCTs) related to rotator cuff tear conditions published up until 2021 were retrieved from the PubMed and ACCESSSS databases. The primary outcome of the article was considered a surrogate outcome when the authors used radiological, physiologic, or functional variables. The result of the article was considered positive when results supported the intervention based on the trial's primary outcome. We recorded the sample size, the mean follow-up, and the type of funding. Statistical significance was set at p < 0.05. RESULTS: A total of 112 papers were included in the analysis. The mean sample size was 87.6 patients; mean follow-up period was 25.97 months. Thirty-six out of 112 RCTs used a surrogate outcome as a primary endpoint. More than half of papers using surrogate outcomes reported a positive finding (20 out of 36), while 10 out of 71 RCTs using patient-centered outcomes favored the intervention (14.08%, p < 0.001) [RR = 3.94 (95% CI 2.07-7.51)]. The mean sample size was smaller in trials using surrogate endpoints (75.11 vs 92.35 patients, respectively, p = 0.049), while the follow-up was shorter (14.12 m vs. 31.9 m, p < 0.001). Approximately 25% of the papers that reported surrogate endpoints (22.58%) were industry-funded projects. CONCLUSIONS: The substitution of surrogate endpoints for patient-important outcomes in shoulder rotator cuff trials quadruplicates the chances of obtaining a favorable result that favors the analyzed intervention.

The impact of hip fracture on health-related quality of life and activities of daily living: the SPARE-HIP prospective cohort study.

PURPOSE: The medical morbidity and mortality associated with neck of femur fractures is well-documented, whereas there is limited data for patient-reported outcomes. The aim of this study was to characterize the impact of neck of femur fractures on activities of daily living and patient-reported health-related quality of life. METHODS: Design and participants: Multicentric prospective cohort study. Consecutive sample patients with fragility hip fracture over 50 years old admitted in 48 hospitals in Spain. OUTCOMES: daily living activity function (Barthel Index) and health-related quality of life (EQ-5D) pre-fracture, admission to hospital and at 1- and 4-month follow-up post-fracture. STATISTICS: Barthel and EQ-5D over time are described as mean (SD) and median (interquartile range). RESULTS: A total of 997 patients were recruited at baseline with 4-month outcomes available for, and 856 patients (89.5%). Barthel Index fell from 78.77 (23.75) at baseline to 43.62 (19.86) on admission to hospital with the fracture. Scores partially recovered to 54.89 (25.40) and 64.09 (21.35) at 1- and 4-month post-fracture, respectively. EQ-5D fell from a median of 0.75 (0.47-0.91) to - 0.01 (- 0.03 to 0.51) on admission. Partial recovery was observed again to (0.51 (- 0.06 to 0.67)) and (0.60 (0.10 to 0.80)) at 1- and 4-month post-fracture, respectively. CONCLUSIONS: Hip fracture results in a large decline in the ability to perform activities of daily living and patient-reported health-related quality of life with only partial recovery amongst survivors 4-month post-fracture.