Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain
Duke Clinical Research Institute and Department of Cardiology, Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
J Investig Med. 2021 Jun;69(5):1056-1058. doi: 10.1136/jim-2021-001789. Epub 2021 Mar 22.
Clinical research is a discipline prone to the use of technical terms that may be particularly at risk for misunderstanding given the complex interpretation that is required. In this century, what is happening with the word 'pragmatic' when describing a randomized controlled trial (RCT) with medicines deserves a public reflection. Explanatory trials are conducted in ideal conditions to assess the comparative efficacy of interventions and are useful to explain whether interventions work. Pragmatic trials are those conducted in a way that resembles usual clinical practice conditions to assess the comparative effectiveness of interventions in a manner directly applicable for decision-makers. This, however, did not prevent 36% of authors of placebo-controlled, or prelicensing trials to identify their medicines RCTs as pragmatic in the title of their articles. The current situation is such that scientific literature has accepted that 'pragmatic' can convey the original meaning-that obtained in trials mimicking usual clinical practice-and a distorted one-that is focused on streamlining any trial procedure. Those involved in clinical trials should emphasize the importance of precision in the use of terms when describing RCTs through standardized solutions when possible. Unless clinical trial stakeholders agree when it would be correct to label an RCT as pragmatic, in a short period of time the term will be in danger of becoming meaningless. It is suggested that the Enhancing the Quality and Transparency of Health Research (EQUATOR) network, the Consolidated Standards of Reporting Trials (CONSORT) group and the International Committee of Medical Journal Editors (ICMJE) could address this topic and provide a consensus way forward.
临床研究是一门容易使用专业术语的学科,由于需要复杂的解释,这些术语尤其容易产生误解。在本世纪,当描述药物的随机对照试验(RCT)时,“实用主义”这个词的使用情况值得公众反思。解释性试验是在理想条件下进行的,以评估干预措施的比较疗效,并有助于解释干预措施是否有效。实用主义试验是指在类似于常规临床实践条件下进行的试验,以直接适用于决策者的方式评估干预措施的比较效果。然而,这并没有阻止 36%的安慰剂对照或许可前试验的作者在文章标题中将其药物 RCT 标识为实用主义。目前的情况是,科学文献已经接受了“实用主义”可以传达出原始含义——即在模拟常规临床实践的试验中获得的含义,以及一种扭曲的含义——即专注于简化任何试验程序。参与临床试验的人员应在描述 RCT 时,通过标准化的解决方案,强调在使用术语时精确性的重要性。除非临床试验利益相关者在将 RCT 标记为实用主义时达成正确的共识,否则在短时间内,该术语将有失去意义的危险。建议增强健康研究质量和透明度网络(EQUATOR)、临床试验报告标准(CONSORT)组和国际医学期刊编辑委员会(ICMJE)可以解决这个问题,并提供一个共识的前进方向。