Ferrarello Francesco, Viligiardi Matteo, Di Bari Mauro
Functional Rehabilitation, Azienda USL Toscana Centro, Via Cavour 118/120, 59100 Prato, Italy.
Outpatient Rehabilitation, CRT Clinica di Riabilitazione Toscana Terranuova Bracciolini Spa, Via Gaetano Donizetti 2, 52028 Terranuova Bracciolini, AR Italy.
Arch Physiother. 2018 Jun 5;8:8. doi: 10.1186/s40945-018-0049-9. eCollection 2018.
Adequate reporting of ethics-related research methods promotes convergence on best ethics practices. In physical therapy, studies on ethics reporting are limited to few aspects, and none focuses on stroke research. Our objectives were to investigate the reporting of multiple ethics-related features and its variation over time, and the characteristics of the studies associated with ethics reporting in Randomized Controlled Trials (RCTs) of physical therapy interventions after stroke.
A random sample of RCTs published in the years 2004, 2009 and 2014, was extracted from the PubMed database, regardless of the publishing journal. For each trial we investigated year of publication, trial registration, sample size, stroke subtype, phase of the disease, setting, interventions and dosing, outcome measures, outcome of the study, PEDro score and 5-year impact factor of the publishing journal. Reporting of ethics-related issues was analyzed. Differences between groups were examined. Multiple regression was used to evaluate the relationship between ethics-related issues reporting and some studies' characteristics.
Eighty studies were reviewed. Groups differed in the proportion of registered trials ( = .009), 5-year impact factor ( = .011), assessment of cognitive capacity ( = .049), declaration about conflict of interest ( < .001), and number of ethics-related issues reported ( = .009). The proportion of issues reported ranged from 92.5% (consent obtaining) to 0% (eventual follow up care). Post-hoc comparisons showed significantly greater reporting of ethics issues in trials published in the year 2014 compared to 2004 ( = .014, 95%CI = 0.40/4.26). Year of publication and PEDro score were significant predictors of adequate reporting.
Authors, editors, and reviewers should be more rigorous and demanding about the reporting of ethic-related methods in randomized controlled trials of physical therapy interventions after stroke.
对伦理相关研究方法进行充分报告有助于促进最佳伦理实践的趋同。在物理治疗领域，关于伦理报告的研究仅限于少数几个方面，且没有一项研究聚焦于中风研究。我们的目标是调查多种伦理相关特征的报告情况及其随时间的变化，以及中风后物理治疗干预随机对照试验（RCT）中与伦理报告相关的研究特征。
从PubMed数据库中随机抽取2004年、2009年和2014年发表的RCT样本，不考虑发表期刊。对于每项试验，我们调查了发表年份、试验注册情况、样本量、中风亚型、疾病阶段、研究背景、干预措施和剂量、结局指标、研究结果、PEDro评分以及发表期刊的5年影响因子。对伦理相关问题的报告进行了分析。检验了组间差异。采用多元回归评估伦理相关问题报告与一些研究特征之间的关系。
共审查了80项研究。各组在注册试验比例（P = 0.009）、5年影响因子（P = 0.011）、认知能力评估（P = 0.049）、利益冲突声明（P < 0.001）以及报告的伦理相关问题数量（P = 0.009）方面存在差异。报告问题的比例从92.5%（获得同意）到0%（最终随访护理）不等。事后比较显示，与2004年相比，2014年发表的试验中伦理问题报告显著更多（P = 0.014，95%CI = 0.40/4.26）。发表年份和PEDro评分是充分报告的显著预测因素。
作者、编辑和审稿人在中风后物理治疗干预随机对照试验中，应对伦理相关方法的报告更加严格和苛刻。
