J Rehabil Med. 2020 Mar 18;52(3):jrm00031. doi: 10.2340/16501977-2659.
To assess how items relevant for the assessment of the generalizability of findings from randomized controlled trials were recorded in systematic reviews published in leading general medical journals.
All systematic reviews and meta-analyses published in the Annals of Internal Medicine, BMJ, JAMA (The Journal of the American Medical Association) and Lancet from 1 January 2016 to 28 February 2019 were searched via PubMed. Reporting of the characteristics of randomized controlled trials in the systematic reviews was documented by the benchmarking method.
A total of 115 systematic reviews were found. Of these, 71% included pharmacological interventions, 35% included other conservative treatments, 13% included surgical interventions, and 0% included rehabilitation interventions. None of the systematic reviews assessed patient selection, 35% reported disorder-specific clinical features, 25 % reported comorbid conditions, and 21% reported patients' behavioural factors in randomized controlled trials. Functioning, environmental factors and inequity-related factors were recorded in 3%, 0% and 9%, respectively, of the systematic reviews; and adherence to interventions, crossovers, and co-interventions in 7%, 0% and 2%, respectively; follow-up percentages in 8%; and adequacy of statistical analyses in 3%.
In all systematic reviews the recording of characteristics of patients, adherence to interventions, follow-up, and statistical analyses in the RCTs was insufficient. The data did not allow assessment of the clinical homogeneity of the randomized controlled trials, or provide justification for meta-analysis, or allow generalizability of the findings.
评估在主要综合医学期刊发表的系统评价中,与评估随机对照试验结果可推广性相关的项目是如何记录的。
通过 PubMed 搜索 2016 年 1 月 1 日至 2019 年 2 月 28 日期间发表在《内科学年鉴》《英国医学杂志》《美国医学会杂志》和《柳叶刀》上的所有系统评价和荟萃分析。通过基准测试方法记录系统评价中对随机对照试验特征的报告。
共发现 115 篇系统评价。其中,71%的系统评价包括药理学干预,35%的系统评价包括其他保守治疗,13%的系统评价包括手术干预,而 0%的系统评价包括康复干预。没有一篇系统评价评估患者选择,35%的系统评价报告了特定疾病的临床特征,25%的系统评价报告了合并症,21%的系统评价报告了随机对照试验中的患者行为因素。在系统评价中,分别有 3%、0%和 9%记录了功能、环境因素和与不公平相关的因素;7%、0%和 2%分别记录了对干预措施的依从性、交叉和共同干预措施;8%记录了随访百分比;3%记录了统计分析的充分性。
在所有系统评价中,对 RCT 中患者特征、干预措施的依从性、随访和统计分析的记录都不充分。这些数据无法评估随机对照试验的临床同质性,也无法为荟萃分析提供依据,或无法推广研究结果。