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神经病学随机对照试验中干预措施报告的完整性:一项回顾性、横断面研究。

Completeness of intervention reporting in neurology randomized controlled trials: a retrospective, cross-sectional study.

机构信息

Department of Institutional Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.

出版信息

Int J Evid Based Healthc. 2020 Jun;18(2):212-221. doi: 10.1097/XEB.0000000000000224.

Abstract

AIM

Incomplete reporting of interventions in randomized controlled trials (RCTs) may hinder the replicability of studies and thus lead to adverse clinical outcomes for patients. Currently, little is known about the completeness of intervention reporting in neurology clinical trials. This study's primary objective was to determine the completeness of intervention reporting in neurology RCTs, as measured by the Template for Intervention Description and Replication (TIDieR) checklist. The secondary objectives of this study were to compare the completeness of intervention reporting before and after TIDieR publication and to evaluate factors associated with intervention reporting.

METHODS

We conducted a cross-sectional, pilot-tested, double-blind investigation of 141 neurology RCTs to determine the completeness of intervention reporting in neurology.

RESULTS

Overall, the average number of TIDieR checklist items that reached completion per study was 7.4 out of 12 (61.7%). We found no increase in intervention reporting following the publication of TIDieR (P = 0.35). Our generalized estimating equation analysis found that poorer TIDieR adherence was associated with trials lacking a trial registration (P = 0.03).

CONCLUSION

Our findings showed that on average, authors reported only 61.7% of items on the TIDieR checklist. These findings have significant implications, because incomplete reporting may hinder the replicability of studies and thus negatively affect clinical outcomes for patients.

摘要

目的

随机对照试验(RCT)中干预措施报告的不完整可能会阻碍研究的可重复性,从而对患者的临床结果产生不利影响。目前,人们对神经病学临床试验中干预措施报告的完整性知之甚少。本研究的主要目的是使用干预措施描述和复制工具(TIDieR)清单来确定神经病学 RCT 中干预措施报告的完整性。本研究的次要目的是比较 TIDieR 发表前后干预措施报告的完整性,并评估与干预措施报告相关的因素。

方法

我们对 141 项神经病学 RCT 进行了横断面、试点测试、双盲调查,以确定神经病学中干预措施报告的完整性。

结果

总体而言,每项研究达到完成状态的 TIDieR 清单项目平均为 12 项中的 7.4 项(61.7%)。我们没有发现 TIDieR 发表后干预措施报告的增加(P=0.35)。我们的广义估计方程分析发现,TIDieR 遵守情况较差与缺乏试验注册的试验有关(P=0.03)。

结论

我们的研究结果表明,作者平均仅报告了 TIDieR 清单上 61.7%的项目。这些发现意义重大,因为不完整的报告可能会阻碍研究的可重复性,从而对患者的临床结果产生负面影响。

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