Cross-sectional analysis of the reporting of continuous outcome measures and clinical significance of results in randomized trials of non-pharmacological interventions
Cross-sectional analysis of the reporting of continuous outcome measures and clinical significance of results in randomized trials of non-pharmacological interventions
复制标题
DOI：
10.1186/1745-6215-15-362
复制
发表时间：
2014-09-17
期刊：
影响因子：
2.5
通讯作者：
Glasziou, Paul P.
中科院分区：
文献类型：
--
作者：
Hoffmann, Tammy C.;Thomas, Sarah T.;Glasziou, Paul P.
背景资料：报告随机试验中连续结局指标的评分详细信息可以让读者解释干预措施的任何效果的大小。本研究旨在确定随机试验样本中：1）连续结局指标评分细节报告的完整性，以及2）试验作者是否对统计学显著性试验结果的临床意义进行了评论。方法：对2009年发表在6种主要综合医学期刊上的非药物干预随机试验进行描述性分析（n = 138），并且使用至少一个连续的结果测量（n = 85）。从每个试验报告中，两名作者独立地提取以下信息，每个连续的结果测量：报告的评分细节，介绍其结果，并报告和理由的临床意义的results.Results：在84项试验中，我们确定了336个连续的结果措施。共有146项（44%）是已发表的测量，12项（4%）是从已发表的测量改编的，5项（1%）是为试验开发的，173项（51%）是不需要评分细节（如体重）的“常规测量”。对于163项非常规结局指标中的57项（35%），试验报告中未提供评分详情或结局指标参考。在159个结果的措施，具有统计学意义的结果，临床意义没有提到81（51%），并没有任何阐述或理由的39（25%）them.Conclusions：评分的详细资料，连续结果的措施，在这个样本中使用的非药物干预的随机试验报告不完全，这妨碍了解释试验的结果。在考虑结果的临床意义时，完整报告评分详细信息非常重要。在决定干预措施时，掌握这些信息可能有助于临床医生与患者就干预措施的可能益处和危害及其大小进行对话。
Background: Reporting the scoring details of continuous outcome measures in randomized trials allows readers to interpret the size of any effect of the intervention. This study aimed to determine, in a sample of randomized trials: 1) the completeness of reporting of scoring details for continuous outcome measures, and 2) whether trial authors comment on the clinical significance of statistically significant trial results.Methods: A descriptive analysis of randomized trials of non-pharmacological interventions published during 2009 in the six leading general medical journals (n = 138), and which used at least one continuous outcome measure (n = 85). From each trial report, two authors independently extracted the following information about each continuous outcome measure: the reporting of its scoring details, presentation of its results, and the reporting and justification of the clinical significance of the results.Results: Across the 84 trials, we identified 336 continuous outcome measures. A total of 146 (44%) were published measures, 12 (4%) were adapted from published measures, 5 (1%) were developed for the trial, and 173 (51%) were 'conventional measures' for which scoring details are not necessary (such as weight). For 57 (35%) of the 163 non-conventional outcome measures no scoring details or reference to the outcome measure were provided in the trial report. Of the 159 outcome measures with a statistically significant result, clinical significance was not mentioned for 81 (51%) and was reported without any elaboration or justification for 39 (25%) of them.Conclusions: Scoring details of continuous outcome measures used in this sample of randomized trials of non-pharmacological interventions were incompletely reported, which hampers interpretation of a trial's results. Complete reporting of scoring details is important when considering the clinical significance of the results. When deciding about an intervention, having this information may help clinicians in their conversations with patients about the possible benefits and harms, and their size, of the intervention.