Mayo Nancy E, Kaur Navaldeep, Barbic Skye P, Fiore Julio, Barclay Ruth, Finch Lois, Kuspinar Ayse, Asano Miho, Figueiredo Sabrina, Aburub Ala' Sami, Alzoubi Fadi, Arafah Alaa, Askari Sorayya, Bakhshi Behtash, Bouchard Vanessa, Higgins Johanne, Hum Stanley, Inceer Mehmet, Letellier Marie Eve, Lourenco Christiane, Mate Kedar, Salbach Nancy M, Moriello Carolina
Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada
Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada.
Clin Rehabil. 2016 Sep;30(9):847-64. doi: 10.1177/0269215516658939.
Research in rehabilitation has grown from a rare phenomenon to a mature science and clinical trials are now common. The purpose of this study is to estimate the extent to which questions posed and methods applied in clinical trials published in Clinical Rehabilitation have evolved over three decades with respect to accepted standards of scientific rigour. Studies were identified by journal, database, and hand searching for the years 1986 to 2016.A total of 390 articles whose titles suggested a clinical trial of an intervention, with or without randomization to form groups, were reviewed. Questions often still focused on methods to be used (57%) rather than what knowledge was to be gained. Less than half (43%) of the studies delineated between primary and secondary outcomes; multiple outcomes were common; and sample sizes were relatively small (mean 83, range 5 to 3312). Blinding of assessors was common (72%); blinding of study subjects was rare (19%). In less than one-third of studies was intention-to-treat analysis done correctly; power was reported in 43%. There is evidence of publication bias as 83% of studies reported either a between-group or a within-group effect. Over time, there was an increase in the use of parameter estimation rather than hypothesis testing and there was evidence that methodological rigour improved.Rehabilitation trialists are answering important questions about their interventions. Outcomes need to be more patient-centred and a measurement framework needs to be explicit. More advanced statistical methods are needed as interventions are complex. Suggestions for moving forward over the next decades are given.
康复研究已从一种罕见现象发展成为一门成熟的科学,如今临床试验已很常见。本研究的目的是评估在《临床康复》杂志上发表的临床试验中所提出的问题和应用的方法,在三十年里相对于公认的科学严谨标准而言是如何演变的。通过期刊、数据库以及手工检索确定了1986年至2016年期间的研究。总共审查了390篇文章,这些文章的标题表明是一项干预措施的临床试验,无论是否进行随机分组。问题通常仍集中在要使用的方法上(57%),而不是要获得什么知识。不到一半(43%)的研究区分了主要结局和次要结局;多个结局很常见;样本量相对较小(平均83,范围为5至3312)。评估者的盲法很常见(72%);研究对象的盲法很少见(19%)。不到三分之一的研究正确地进行了意向性分析;43%的研究报告了检验效能。有证据表明存在发表偏倚,因为83%的研究报告了组间或组内效应。随着时间的推移,参数估计的使用有所增加,而不是假设检验,并且有证据表明方法学严谨性有所提高。康复试验者正在回答有关其干预措施的重要问题。结局需要更加以患者为中心,并且测量框架需要明确。由于干预措施复杂,需要更先进的统计方法。给出了未来几十年向前发展的建议。