Reporting of confidence intervals, achievement of intended sample size, and adjustment for multiple primary outcomes in randomised trials of physical therapy interventions: an analysis of 100 representatively sampled trials

随机对照试验中置信区间报告、预期样本量达成情况以及对多个主要结局指标的调整:一项对100项具有代表性抽样的试验的分析

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Abstract

BACKGROUND: The physical therapy profession has made efforts to increase the use of confidence intervals due to the valuable information they provide for clinical decision-making. Confidence intervals indicate the precision of the results and describe the strength and direction of a treatment effect measure. OBJECTIVES: To determine the prevalence of reporting of confidence intervals, achievement of intended sample size, and adjustment for multiple primary outcomes in randomised trials of physical therapy interventions. METHODS: We randomly selected 100 trials published in 2021 and indexed on the Physiotherapy Evidence Database. Two independent reviewers extracted the number of participants, any sample size calculation, and any adjustments for multiple primary outcomes. We extracted whether at least one between-group comparison was reported with a 95 % confidence interval and whether any confidence intervals were interpreted. RESULTS: The prevalence of use of confidence intervals was 47 % (95 % CI 38, 57). Only 6 % of trials (95 % CI: 3, 12) both reported and interpreted a confidence interval. Among the 100 trials, 59 (95 % CI: 49, 68) calculated and achieved the required sample size. Among the 100 trials, 19 % (95 % CI: 13, 28) had a problem with unadjusted multiplicity on the primary outcomes. CONCLUSIONS: Around half of trials of physical therapy interventions published in 2021 reported confidence intervals around between-group differences. This represents an increase of 5 % from five years earlier. Very few trials interpreted the confidence intervals. Most trials reported a sample size calculation, and among these most achieved that sample size. There is still a need to increase the use of adjustment for multiple comparisons.

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