神经病学随机对照试验干预报告的完整性:一项回顾性横断面研究。

William Roberts, Craig Beavers, Samuel Jellison, Matt Vassar
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引用次数: 0

摘要

目的:随机对照试验(RCTs)中干预措施的不完整报告可能会阻碍研究的可重复性,从而导致患者不良的临床结果。目前,对神经病学临床试验干预报告的完整性了解甚少。本研究的主要目的是通过干预描述和复制模板(TIDieR)检查表来确定神经病学随机对照试验中干预报告的完整性。本研究的次要目的是比较TIDieR发表前后干预报告的完整性,并评估与干预报告相关的因素。方法:我们对141项神经病学随机对照试验进行了横断面、试点、双盲调查,以确定神经病学干预报告的完整性。结果:总体而言,每项研究完成的TIDieR检查表项目的平均数量为7.4 / 12(61.7%)。我们发现TIDieR发表后干预报告没有增加(P = 0.35)。我们的广义估计方程分析发现,较差的TIDieR依从性与缺乏试验注册的试验相关(P = 0.03)。结论:我们的研究结果显示,平均而言,作者仅报告了TIDieR清单上61.7%的项目。这些发现具有重要意义,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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Completeness of intervention reporting in neurology randomized controlled trials: a retrospective, cross-sectional study.

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.

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来源期刊
CiteScore
1.80
自引率
0.00%
发文量
39
期刊介绍: ​​The International Journal of Evidence-Based Healthcare is the official journal of the Joanna Briggs Institute. It is a fully refereed journal that publishes manuscripts relating to evidence-based medicine and evidence-based practice. It publishes papers containing reliable evidence to assist health professionals in their evaluation and decision-making, and to inform health professionals, students and researchers of outcomes, debates and developments in evidence-based medicine and healthcare. ​ The journal provides a unique home for publication of systematic reviews (quantitative, qualitative, mixed methods, economic, scoping and prevalence) and implementation projects including the synthesis, transfer and utilisation of evidence in clinical practice. Original scholarly work relating to the synthesis (translation science), transfer (distribution) and utilization (implementation science and evaluation) of evidence to inform multidisciplinary healthcare practice is considered for publication. The journal also publishes original scholarly commentary pieces relating to the generation and synthesis of evidence for practice and quality improvement, the use and evaluation of evidence in practice, and the process of conducting systematic reviews (methodology) which covers quantitative, qualitative, mixed methods, economic, scoping and prevalence methods. In addition, the journal’s content includes implementation projects including the transfer and utilisation of evidence in clinical practice as well as providing a forum for the debate of issues surrounding evidence-based healthcare.
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