背景:由于为临床决策提供了有价值的信息,因此物理治疗行业已经努力增加置信区间的使用。置信区间表示结果的精度,并描述治疗效果量度的强度和方向。
目的:为了确定报告置信区间的普遍性,达到预期的样本量,并调整物理治疗干预的随机试验中的多个主要结局。
方法:我们随机选择了2021年发表的100项试验,并在物理治疗证据数据库中进行索引。两名独立的审稿人提取了参与者的数量,任何样本量计算,以及对多个主要结果的任何调整。我们提取了是否至少有一个组间比较以95%置信区间报告,以及是否解释了任何置信区间。
结果:使用置信区间的患病率为47%(95%CI38,57)。只有6%的试验(95%CI:3,12)报告并解释了置信区间。在100项试验中,59(95%CI:49,68)计算并达到所需的样本量。在100项试验中,19%(95%CI:13,28)的主要结局存在未调整的多重性问题。
结论:2021年发表的大约一半的物理治疗干预试验报告了围绕组间差异的置信区间。这比五年前增加了5%。很少有试验解释置信区间。大多数试验报告了样本量的计算,在这些样本中,获得最多的样本。仍然需要增加用于多重比较的调整的使用。
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.
OBJECTIVE: 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.