Roura Sonia, Alvarez Gerard, Hohenschurz-Schmidt David, Solà Ivan, Núñez-Cortés Rodrigo, Bracchiglione Javier, Fernández-Jané Carles, Phalip Jules, Gich Ignasi, Sitjà-Rabert Mercè, Urrútia Gerard
PhD Student in Biomedical Research Methodology and Public Health in the Medical Department of the Universitat Autonoma de Barcelona, Barcelona, Spain.
Iberoamerican Cochrane Centre, Institut de Recerca Sant Pau (IR SANT PAU), Barcelona, Spain; Facultat de Ciències de la Salut Blanquerna, Universitat Ramon Llull, Barcelona, Spain.
J Clin Epidemiol. 2025 Jul;183:111817. doi: 10.1016/j.jclinepi.2025.111817. Epub 2025 May 8.
The study aimed to assess the design, reporting, and risk of bias in effectiveness trials (ETs) in manual therapy (MT), comparing pragmatic with nonpragmatic trials and trials with and without placebo controls.
We searched MEDLINE and the Cochrane Central Register of Controlled Trials for randomized controlled trials with the term "effectiveness" in the title or abstract in the field of MT from inception to January 2024. Two independent reviewers extracted data on specific study characteristics, their reporting, and risk of bias and assessed them using the PRagmatic Explanatory Continuum Indicatory Summary-2 tool (PRECIS-2). Descriptive analysis using frequencies and percentages and a relation analysis between PRECIS-2 scores and specific study characteristics were performed.
Of the 113 trials, 39 were self-labeled as pragmatic, 39 used usual care or other interventions, and 35 used placebo controls. ETs have increased in recent years. They are moderately pragmatic, whether they are self-described as pragmatic or not, and whether they use a placebo control group or not. Despite their aim to resemble clinical practice, the pragmatic features of these trials are often unclear. Pragmatic features are common in trials' eligibility, recruitment, and outcome domains, but intervention and setting are rated as very explanatory. Compared to self-labeled pragmatic trials, "effectiveness" trials are less likely to follow reporting guidelines.
The term effectiveness is used in MT trials independently of its pragmatic connotations. Using a placebo or active control does not modify the pragmatic attitude of the ETs.
本研究旨在评估手法治疗（MT）有效性试验（ET）的设计、报告及偏倚风险，比较务实性试验与非务实性试验，以及有和没有安慰剂对照的试验。
我们在MEDLINE和Cochrane对照试验中心注册库中检索了从建库至2024年1月期间，标题或摘要中含有“有效性”一词的手法治疗领域随机对照试验。两名独立评审员提取了关于具体研究特征、报告情况及偏倚风险的数据，并使用务实性解释连续统指示性总结工具-2（PRECIS-2）对其进行评估。采用频率和百分比进行描述性分析，并对PRECIS-2评分与具体研究特征之间进行相关性分析。
在113项试验中，39项自称为务实性试验，39项采用常规护理或其他干预措施，35项采用安慰剂对照。近年来，有效性试验有所增加。无论是否自称为务实性试验，也无论是否使用安慰剂对照组，这些试验的务实程度都处于中等水平。尽管其目的是贴近临床实践，但这些试验的务实特征往往不明确。务实特征在试验的纳入标准、招募和结局领域较为常见，但干预措施和试验背景被评为非常具有解释性。与自称为务实性的试验相比，“有效性”试验不太可能遵循报告指南。
在手法治疗试验中，“有效性”一词的使用与其务实内涵无关。使用安慰剂或活性对照并不会改变有效性试验的务实态度。
