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A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes

机译：类风湿关节炎的随机对照试验的系统评价：综合结果中缺失数据的报告和处理

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Background Most reported outcome measures in rheumatoid arthritis (RA) trials are composite, whose components comprise single measures that are combined into one outcome. The aims of this review were to assess the range of missing data rates in primary composite outcomes and to document the current practice for handling and reporting missing data in published RA trials compared to the Consolidated Standards of Reporting Trials (CONSORT) recommendations. Methods A systematic search for randomised controlled trials was conducted for RA trials published between 2008 and 2013 in four rheumatology and four high impact general medical journals. Results A total of 51 trials with a composite primary outcome were identified, of which 38 (75?%) used the binary American College of Rheumatology responder index and 13 (25?%) used the Disease Activity Score for 28 joints (DAS28). Forty-four trials (86?%) reported on an intention-to-treat analysis population, while 7 trials (14?%) analysed according to a modified intention-to-treat population. Missing data rates for the primary composite outcome ranged from 2–53?% and were above 30?% in 9 trials, 20–30?% in 11 trials, 10–20?% in 18 trials and below 10?% in 13 trials. Thirty-eight trials (75?%) used non-responder imputation and 10 (20?%) used last observation carried forward to impute missing composite outcome data at the primary time point. The rate of dropout was on average 61?% times higher in the placebo group compared to the treatment group in the 34 placebo controlled trials (relative rate 1.61, 95?% CI: 1.29, 2.02). Thirty-seven trials (73?%) did not report the use of sensitivity analyses to assess the handling of missing data in the primary analysis as recommended by CONSORT guidelines. Conclusions This review highlights an improvement in rheumatology trial practice since the revision of CONSORT guidelines, in terms of power calculation and participant’s flow diagram. However, there is a need to improve the handling and reporting of missing composite outcome data and their components in RA trials. In particular, sensitivity analyses need to be more widely used in RA trials because imputation is widespread and generally uses single imputation methods, and in this area the missing data rates are commonly differentially higher in the placebo group.
机译：背景类风湿性关节炎（RA）试验中大多数报告的结局指标是综合的，其组成部分由单一指标组成，并组合成一个结局。这次审查的目的是评估主要综合结局中缺失数据率的范围，并记录与已发表的《临床试验标准》（CONSORT）建议相比，已发表的RA试验中处理和报告缺失数据的当前做法。方法对2008年至2013年间发表在4种风湿病学和4种高影响力普通医学期刊上的RA试验进行了系统的随机对照试验研究。结果总共鉴定出51项具有综合主要结果的试验，其中38项（75％）使用二元美国风湿病学会反应指数，13项（25 %%）使用28个关节的疾病活动评分（DAS28）。有44项试验（占86％）报告了意向性治疗人群，而有7项试验（占14％）是根据经过修饰的意向性治疗人群进行的。主要综合结局的数据丢失率在2–53％之间，在9个试验中高于30％，在11个试验中为20–30％，在18个试验中为10-20％，在13个试验中低于10％。 。 38项试验（75％）使用无应答推算，而10项试验（20 %%）使用最后观察推算得出主要时间点缺失的综合结局数据。在34个安慰剂对照试验中，与治疗组相比，安慰剂组的辍学率平均高出61％（相对率1.61、95％CI：1.29、2.02）。根据CONSORT指南的建议，三十七项试验（占73％）没有报告使用敏感性分析来评估主要分析中缺失数据的处理。结论这篇综述着重介绍了自CONSORT指南修订以来风湿病临床试验的改进，包括功率计算和参与者流程图。但是，有必要在RA试验中改进对缺失的综合结果数据及其组成部分的处理和报告。特别是，敏感性分析需要在RA试验中更广泛地使用，因为插补很普遍，并且通常使用单一插补方法，在这一领域，安慰剂组的缺失数据率通常差异较大。

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