背景:确定对某些干预措施有不同反应的患者的特征称为治疗效果调节剂。一些研究不适当地报告了治疗效果调节剂的存在,而没有适当的研究设计。
目的:评估在主要的物理治疗期刊上发表的单组研究的比例不适当地报告了治疗效果调节剂,并评估比例是否随时间或期刊之间的变化而变化。
方法:对自2000年以来发表在八种主要物理治疗期刊上的研究进行了系统综述。符合条件的研究是单组研究(例如,队列研究或随机对照试验治疗组的二次分析)调查任何情况,治疗或结果。研究表明,具有某些基线特征的参与者对治疗的反应更好或更差。被认为报告不当。研究报告具有某些基线特征的参与者有改善的结果,但没有说明这是由于治疗被认为是适当的报告。随着时间的推移和期刊之间的不适当报告的比例进行了比较。
结果:在纳入的145项研究中,73(50.3%)被归类为不适当报告的治疗效果调节剂。不适当报告的比例在最近一个时期最高,2018-2022年(59.6%)和2006-2011年(55.6%)。不适当报告的比例在期刊之间差异很大,从0%(物理治疗杂志)到91.7%(神经物理治疗杂志)。
结论:在领先的物理治疗期刊中,很大比例(50.3%)的单臂研究不适当地报告了治疗效果调节剂。在为个别患者选择干预措施时,这种不适当的报告可能会误导临床医生。
BACKGROUND: Characteristics that identify patients who respond differently to certain interventions are called treatment effect modifiers. Some studies inappropriately report the presence of treatment effect modifiers without adequate study designs.
OBJECTIVE: To evaluate what proportion of single-group studies published in leading physical therapy journals inappropriately report treatment effect modifiers, and to assess whether the proportion varies over time or between journals.
METHODS: A systematic
review was conducted of studies published in eight leading physical therapy journals since 2000. Eligible studies were single-group studies (e.g., cohort study or secondary analysis of treatment arm of randomised controlled trial) that investigated any condition, treatment or outcome. Studies that suggested participants with certain baseline characteristics responded better/or worse to the treatment, were considered to have reported inappropriately. Studies reporting that participants with certain baseline characteristics had improved outcomes but did not state it was due to the treatment were considered to have reported appropriately. The proportion of inappropriate reporting was compared over time and between journals.
RESULTS: Of the 145 included studies, 73 (50.3%) were categorised as inappropriately reporting treatment effect modifiers. The proportion of inappropriate reporting was highest in the most recent period, 2018 - 2022 (59.6%) and 2006 - 2011 (55.6%). The proportion of inappropriate reporting varied substantially between journals from 0% (Journal of Physiotherapy) to 91.7% (Journal of Neurologic Physical Therapy).
CONCLUSIONS: A large proportion (50.3%) of single-arm studies in leading physical therapy journals inappropriately report treatment effect modifiers. This inappropriate reporting risks misleading clinicians when selecting interventions for individual patients.