Armijo-Olivo Susan, Fuentes Jorge, Rogers Todd, Hartling Lisa, Saltaji Humam, Cummings Greta G
5-115A Edmonton Clinic Health Academy (ECHA), Outcomes Research Program University of Alberta, 11405 - 87 Avenue, Edmonton, AB T6G 1C9, Canada.
Syst Rev. 2013 Sep 26;2:88. doi: 10.1186/2046-4053-2-88.
Numerous tools and items have been developed in all health areas to assess the risk of bias of randomized controlled trials (RCTs). The Cochrane Collaboration (CC) released a new tool to assess bias in RCTs, based on empirical evidence quantifying the association between some design features and estimates of treatment effects (TEs). However, this evidence is limited to medicine and investigating a selected set of components. No such studies have been conducted in other health areas such as Physical Therapy (PT) and allied health professions. Evidence specific to the PT area is needed to understand and quantify the association between design features and TE estimates to inform practice and decision-making in this field. The overall goal of this project is to provide direction for the design, conduct, reporting and bias assessment of PT RCTs. We will achieve this through the following specific objectives and methods.
METHODS/DESIGN: 1) to measure the association between methodological components and other factors (for example, PT area, type of intervention, type of outcomes) and TE estimates in RCTs in PT, 40 randomly selected meta-analyses of RCTs involving PT interventions will be identified from the Cochrane Database of Systematic Reviews. Trials will be evaluated independently by two reviewers using the most commonly used tools in the PT field. A two-level analysis will be conducted using a meta-meta-analytic approach; 2) to identify relevant items to evaluate risk of bias of PT trials, an exploratory factor analysis (EFA) will be used to identify the latent structure of the items; 3) to develop guidelines for the design, conduct, reporting, and risk of bias assessment of PT RCTs, items obtained from the factor analysis and the meta-epidemiological approach will be further evaluated by experts in PT through a web-based survey following a Delphi procedure.
The results of this project will have a direct impact on research and practice in PT and are valuable to a number of stakeholders: researchers when designing, conducting, and reporting trials; systematic reviewers and meta-analysts when synthesizing trial results; physiotherapists when making day-to-day treatment decision; and, other healthcare decision-makers, such as those developing policy or practice guidelines.
在所有健康领域都开发了许多工具和项目来评估随机对照试验（RCT）的偏倚风险。Cochrane协作网（CC）发布了一种评估RCT偏倚的新工具，该工具基于量化某些设计特征与治疗效果（TE）估计值之间关联的实证证据。然而，这一证据仅限于医学领域，且仅调查了一组选定的组成部分。在物理治疗（PT）和相关健康专业等其他健康领域尚未开展此类研究。需要PT领域的特定证据来理解和量化设计特征与TE估计值之间的关联，以为该领域的实践和决策提供信息。本项目的总体目标是为PT RCT的设计、实施、报告和偏倚评估提供指导。我们将通过以下具体目标和方法来实现这一目标。
方法/设计：1）为了测量方法学组成部分与其他因素（例如，PT领域、干预类型、结局类型）以及PT中RCT的TE估计值之间的关联，将从Cochrane系统评价数据库中随机选择40项涉及PT干预的RCT的荟萃分析。两名评审员将使用PT领域最常用的工具对试验进行独立评估。将采用元荟萃分析方法进行两级分析；2）为了确定评估PT试验偏倚风险的相关项目，将使用探索性因素分析（EFA）来确定项目的潜在结构；3）为了制定PT RCT的设计、实施、报告和偏倚风险评估指南，通过基于网络的调查，按照德尔菲程序，由PT专家对从因素分析和元流行病学方法中获得的项目进行进一步评估。
本项目的结果将对PT的研究和实践产生直接影响，对许多利益相关者具有重要价值：研究人员在设计、实施和报告试验时；系统评价员和荟萃分析人员在综合试验结果时；物理治疗师在做出日常治疗决策时；以及其他医疗保健决策者，例如制定政策或实践指南的人员。
