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A Thematic Survey on the Reporting Quality of Randomized Controlled Trials in Rehabilitation: The Case of Multiple Sclerosis
Journal of Neurologic Physical Therapy ( IF 3.8 ) Pub Date : 2023-02-27 , DOI: 10.1097/npt.0000000000000437
Lucia Ventura , Pedro Moreno-Navarro , Gianluca Martinez , Lucia Cugusi , David Barbado , Francisco Jose Vera-Garcia , Alon Kalron , Zeevi Dvir , Franca Deriu , Andrea Manca

Background and Purpose: 

Optimal reporting is a critical element of scholarly communications. Several initiatives, such as the EQUATOR checklists, have raised authors' awareness about the importance of adequate research reports. On these premises, we aimed at appraising the reporting quality of published randomized controlled trials (RCTs) dealing with rehabilitation interventions. Given the breadth of such literature, we focused on rehabilitation for multiple sclerosis (MS), which was taken as a model of a challenging condition for all the rehabilitation professionals.

A thematic methodological survey was performed to critically examine rehabilitative RCTs published in the last 2 decades in MS populations according to 3 main reporting themes: (1) basic methodological and statistical aspects; (2) reproducibility and responsiveness of measurements; and (3) clinical meaningfulness of the change.

Summary of Key Points: 

Of the initial 526 RCTs retrieved, 370 satisfied the inclusion criteria and were included in the analysis. The survey revealed several sources of weakness affecting all the predefined themes: among these, 25.7% of the studies complemented the P values with the confidence interval of the change; 46.8% reported the effect size of the observed differences; 40.0% conducted power analyses to establish the sample size; 4.3% performed retest procedures to determine the outcomes' reproducibility and responsiveness; and 5.9% appraised the observed differences against thresholds for clinically meaningful change, for example, the minimal important change.

Recommendations for Clinical Practice: 

The RCTs dealing with MS rehabilitation still suffer from incomplete reporting. Adherence to evidence-based checklists and attention to measurement issues and their impact on data interpretation can improve study design and reporting in order to truly advance the field of rehabilitation in people with MS.

Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1 available at: https://links.lww.com/JNPT/A424).



中文翻译:

康复中随机对照试验报告质量的专题调查:多发性硬化症案例

背景与目的: 

最佳报告是学术交流的关键要素。EQUATOR 清单等多项举措提高了作者对充分研究报告重要性的认识。在这些前提下,我们旨在评估已发表的涉及康复干预的随机对照试验 (RCT) 的报告质量。鉴于此类文献的广度,我们将重点放在多发性硬化症 (MS) 的康复上,这被视为对所有康复专业人员具有挑战性的情况的模型。

根据 3 个主要报告主题:(1) 基本方法和统计方面;(2) 测量的再现性和响应性;(3) 变化的临床意义。

要点总结: 

在检索到的最初 526 项随机对照试验中,370 项满足纳入标准并被纳入分析。调查揭示了影响所有预定义主题的几个弱点来源:其中,25.7% 的研究用变化的置信区间补充了P值;46.8% 报告了观察到的差异的影响大小;40.0% 进行了功效分析以确定样本量;4.3% 执行重新测试程序以确定结果的可重复性和响应性;5.9% 的人评估观察到的差异与具有临床意义的变化的阈值,例如最小的重要变化。

临床实践建议: 

处理 MS 康复的随机对照试验仍然存在报告不完整的问题。遵守循证检查表并关注测量问题及其对数据解释的影响可以改进研究设计和报告,从而真正推进 MS 患者的康复领域。

视频摘要可从作者那里获得更多见解(参见视频,补充数字内容 1,网址为: https: //links.lww.com/JNPT/A424)。

更新日期:2023-03-02
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