Chief Physician, Centre for Health and Social Economics, National Institute for Health and Welfare, Mannerheimintie 166, 00270 Helsinki, Finland.
J Clin Epidemiol. 2019 Mar;107:36-41. doi: 10.1016/j.jclinepi.2018.11.014. Epub 2018 Nov 17.
To document reporting of study characteristics of randomized controlled trials (RCTs) in the four leading general medical journals and to appraise the generalizability of the evidence.
All RCTs in BMJ, JAMA, Lancet, and NEJM from January 1, 2017 to September 30, 2017 were searched by hand, and data were extracted according to the benchmarking method.
Hundred sixty-one RCTs were found; 67% assessed pharmacological therapy. The percentages of adequate documentation were patients' path before randomization 3% to 33% of trials; characteristics of the health care settings 0% to 75%; at least two comorbid conditions 25% to 50%; at least one measure was reported of functioning 42% to 54%, of behavioral factors 25% to 58%, of environmental factors 3% to 25%, and of inequity-related factors 28% to 68%; cointerventions 6% to 25%; and reasons for dropping out of follow-up 39% to 100%.
Almost all RCTs showed deficiencies in description of patient selection and study setting and in reporting of patient characteristics related to functioning, comorbidities, and to behavioral, environmental, and inequity factors. The findings indicate that generalizability of this evidence may be limited. The benchmarking method can be used for planning and appraisal of clinical trials and systematic reviews.
记录四大普通医学期刊中随机对照试验（RCT）的研究特征报告情况，并评价证据的普遍性。
通过手工检索，从 2017 年 1 月 1 日至 2017 年 9 月 30 日，在《英国医学杂志》、《美国医学会杂志》、《柳叶刀》和《新英格兰医学杂志》中查找所有 RCT，并按照基准方法提取数据。
共发现 161 项 RCT，其中 67%评估了药物治疗。充分记录的比例为患者随机分组前的路径为 3%至 33%的试验；医疗保健环境特征为 0%至 75%；至少有两种合并症为 25%至 50%；至少有一项功能、行为因素、环境因素和与不公平相关因素的测量结果报告，报告比例为 42%至 54%、25%至 58%、3%至 25%和 28%至 68%；联合干预为 6%至 25%；以及失访原因报告为 39%至 100%。
几乎所有 RCT 在描述患者选择和研究环境以及报告与功能、合并症以及行为、环境和不公平因素相关的患者特征方面都存在不足。研究结果表明，该证据的普遍性可能有限。基准方法可用于临床试验和系统评价的规划和评估。
