Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.
Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.
复制标题
DOI：
10.1164/rccm.202010-3943st
复制
发表时间：
2021-01-01
影响因子：
24.7
通讯作者：
Krishnan JA
中科院分区：
文献类型：
--
作者：
Gershon AS;Lindenauer PK;Wilson KC;Rose L;Walkey AJ;Sadatsafavi M;Anstrom KJ;Au DH;Bender BG;Brookhart MA;Dweik RA;Han MK;Joo MJ;Lavergne V;Mehta AB;Miravitlles M;Mularski RA;Roche N;Oren E;Riekert KA;Schoenberg NC;Stukel TA;Weiss CH;Wunsch H;Africk JJ;Krishnan JA
基本原理：医学决策是在知识和推理的基础上做出的，通常是在考虑临床实践指南建议，个人偏好和个人目标的情况下与患者和家属进行共享对话。观察性研究可以为指导方针、决策和政策提供有价值的知识。目的：美国胸科学会（ATS）成立了一个多学科特设委员会，以制定一项研究声明，阐明观察性研究与随机对照试验（RCT）在为肺部、重症监护和睡眠医学的临床决策提供信息方面的作用。研究方法：委员会审查了评估因果关系的观察性研究的优势，它们如何补充RCT，影响观察性研究质量的因素，观察性研究的看法，以及最后将观察性研究纳入ATS临床实践指南的实用性。测量和主要结果：观察性研究和随机对照试验都有优点和缺点。观察性研究可以在代表性和多样化的患者人群中提供证据。在制定ATS临床实践指南和一般医疗决策时，应寻求高质量的观察性研究，当1）未识别出RCT或RCT被评估为低质量或极低质量时（替代）; 2）RCT由于间接性、不精确性或不一致性而质量中等，观察性研究减轻了RCT证据被降级的原因（补充）;或3）随机对照试验没有提供指南委员会认为对决策至关重要的结果的证据（例如，罕见或长期结果;“连续”）。结论：在制定临床实践指南和做出临床决策时应考虑观察性研究。
Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy. Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies—alongside randomized controlled trials (RCTs)—in informing clinical decisions in pulmonary, critical care, and sleep medicine. Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines. Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (replacement); 2) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (complementary); or 3) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; “sequential”). Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.