分配隐藏和意向性分析对腰痛随机对照试验中物理治疗干预效果的影响：一项元流行病学研究方案
Influence of allocation concealment and intention-to-treat analysis on treatment effects of physical therapy interventions in low back pain randomised controlled trials: a protocol of a meta-epidemiological study.
作者信息
Almeida Matheus Oliveira, Saragiotto Bruno T, Maher Chris G, Pena Costa Leonardo Oliveira
机构信息
Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, São Paulo, Brazil.
Musculoskeletal Health Sydney, School of Public Health, Sydney Medical School, The University of Sidney, Sydney, Australia.
出版信息
BMJ Open. 2017 Sep 27;7(9):e017301. doi: 10.1136/bmjopen-2017-017301.
INTRODUCTION
Meta-epidemiological studies examining the influence of methodological characteristics, such as allocation concealment and intention-to-treat analysis have been performed in a large number of healthcare areas. However, there are no studies investigating these characteristics in physical therapy interventions for patients with low back pain. The aim of this study is to investigate the influence of allocation concealment and the use of intention-to-treat analysis on estimates of treatment effects of physical therapy interventions in low back pain clinical trials.
METHODS AND ANALYSIS
Searches on PubMed, Embase, Cochrane Database of Systematic Reviews, Physiotherapy Evidence Database (PEDro) and CINAHL databases will be performed. We will search for systematic reviews that include a meta-analysis of randomised controlled trials that compared physical therapy interventions in patients with low back pain with placebo or no intervention, and have pain intensity or disability as the primary outcomes. Information about selection (allocation concealment) and attrition bias (intention-to-treat analysis) will be extracted from the PEDro database for each included trial. Information about bibliographic data, study characteristics, participants' characteristics and study results will be extracted. A random-effects model will be used to provide separate estimates of treatment effects for trials with and without allocation concealment and with and without intention-to-treat analysis (eg, four estimates). A meta-regression will be performed to measure the association between methodological features and treatment effects from each trial. The dependent variable will be the treatment effect (the mean between-group differences) for the primary outcomes (pain or disability), while the independent variables will be the methodological features of interest (allocation concealment and intention-to-treat analysis). Other covariates will include sample size and sequence generation.
ETHICS AND DISSEMINATION
No ethical approval will be required for this study. The study findings will be published in a peer-reviewed journal and presented at international conferences.
REGISTRATION NUMBER
International Prospective Register of Systematic Reviews (CRD42016052347).
引言
在大量医疗保健领域开展了元流行病学研究，以考察诸如分配隐藏和意向性分析等方法学特征的影响。然而，尚无研究对腰痛患者物理治疗干预措施的这些特征进行调查。本研究旨在探讨分配隐藏和意向性分析的运用对腰痛临床试验中物理治疗干预措施治疗效果估计值的影响。
方法与分析
将检索PubMed、Embase、Cochrane系统评价数据库、物理治疗证据数据库（PEDro）和CINAHL数据库。我们将检索系统评价，这些系统评价纳入了对随机对照试验的荟萃分析，这些试验比较了腰痛患者的物理治疗干预措施与安慰剂或无干预措施，并将疼痛强度或残疾作为主要结局。将从PEDro数据库中为每项纳入试验提取有关选择（分配隐藏）和失访偏倚（意向性分析）的信息。将提取有关书目数据、研究特征、参与者特征和研究结果的信息。将使用随机效应模型分别对采用和未采用分配隐藏以及采用和未采用意向性分析的试验提供治疗效果估计值（例如，四个估计值）。将进行元回归以测量各试验方法学特征与治疗效果之间的关联。因变量将是主要结局（疼痛或残疾）的治疗效果（组间平均差异），而自变量将是感兴趣的方法学特征（分配隐藏和意向性分析）。其他协变量将包括样本量和序列产生。
伦理与传播
本研究无需伦理批准。研究结果将发表在同行评审期刊上，并在国际会议上展示。
注册号
国际系统评价前瞻性注册库（CRD42016052347）。
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