临床试验注册在物理治疗中变得越来越普遍,但它仍然不足:一个元研究研究
Nayara Santos Silva1, Mark R Elkins2, Ítalo R Lemes3
1Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.
Musculoskeletal science & practice
|September 1, 2023
概括
物理治疗试验的注册有所改善,但仍然不足,在2019年仅有8%的患者得到了充分注册. 选择性结果报告也增加,强调需要更好地遵守注册指南.
科学领域:
- 临床研究方法论 临床研究方法论
- 基于证据的物理治疗实践.
背景情况:
- 2009年的一项研究显示,在物理治疗中患病率低,试验注册不足.
- 2013年的一篇社论建议在物理治疗期刊中注册.
研究的目的:
- 评估2019年发表的物理治疗中充分注册的随机试验的比例.
- 评估这些试验中选择性结果报告的程度.
- 将2019年的数据与2009年的同等数据进行比较.
主要方法:
- 一项元研究研究分析了2019年发表的200项物理治疗试验的随机样本.
- 通过试验注册和作者联系,验证了注册状态.
- 数据与2009年的数据进行了比较,并评估了选择性结果报告.
主要成果:
- 注册试验的比例从2009年的34%增加到2019年的63%.
- 具有明确初级结果的充分预期注册率从3%上升到8%.
- 选择性结果报告从2009年的47%增加到2019年的73%.
结论:
- 虽然物理治疗试验的注册在过去十年中有所改善,但仍然不足.
- 需要加大努力来实施和执行适当的试验注册实践.
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