An Official American Thoracic Society Research Statement: Comparative Effectiveness Research in Pulmonary, Critical Care, and Sleep Medicine

• Published in: American journal of respiratory and critical care medicine Vol. 188; no. 10; pp. 1253 - 1261
• Main Authors: CARSON, Shannon S, GOSS, Christopher H, MULARSKI, Richard A, RIEKERT, Kristin A, RUBENFELD, Gordon D, WEAVER, Terri E, KRISHNAN, Jerry A, PATEL, Sanjay R, ANZUETO, Antonio, AU, David H, ELBORN, Stuart, GERALD, Joe K, GERALD, Lynn B, KAHN, Jeremy M, MALHOTRA, Atul
• Format: Journal Article
• Language: English
• Published: New York, NY American Thoracic Society 15.11.2013
• Subjects: American Thoracic Society Documents; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Behavioral sciences; Biological and medical sciences; Caregivers; Clinical medicine; Clinical trials; Comparative Effectiveness Research - methods; Comparative Effectiveness Research - standards; Critical care; Critical Care - methods; Critical Care - standards; Decision making; Health services; Humans; Intensive care medicine; Internal validity; Intervention; Medical sciences; Medicine; Outcome Assessment (Health Care); Patient Protection & Affordable Care Act 2010-US; Patients; Pneumology; Pulmonary Medicine - methods; Pulmonary Medicine - standards; Quality improvement; Research centers; Research Design; Research methodology; Sleep; Sleep Medicine Specialty - methods; Sleep Medicine Specialty - standards; Working groups; United States; North America; America; United States > US; Patient-centered approach; Intensive care; Prognosis; American; Respiratory disease; Lung; Thorax; patient-centered outcomes research; efficacy research; Medicine; Sleep; Efficiency; Scientific research; Clinical trial; Evolution; comparative effectiveness research; Society; pragmatic trials; Comparative study; Resuscitation
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/rccm.201310-1790ST

Comparative effectiveness research (CER) is intended to inform decision making in clinical practice, and is central to patient-centered outcomes research (PCOR). To summarize key aspects of CER definitions and provide examples highlighting the complementary nature of efficacy and CER studies in pulmonary, critical care, and sleep medicine. An ad hoc working group of the American Thoracic Society with experience in clinical trials, health services research, quality improvement, and behavioral sciences in pulmonary, critical care, and sleep medicine was convened. The group used an iterative consensus process, including a review by American Thoracic Society committees and assemblies. The traditional efficacy paradigm relies on clinical trials with high internal validity to evaluate interventions in narrowly defined populations and in research settings. Efficacy studies address the question, "Can it work in optimal conditions?" The CER paradigm employs a wide range of study designs to understand the effects of interventions in clinical settings. CER studies address the question, "Does it work in practice?" The results of efficacy and CER studies may or may not agree. CER incorporates many attributes of outcomes research and health services research, while placing greater emphasis on meeting the expressed needs of nonresearcher stakeholders (e.g., patients, clinicians, and others). CER complements traditional efficacy research by placing greater emphasis on the effects of interventions in practice, and developing evidence to address the needs of the many stakeholders involved in health care decisions. Stakeholder engagement is an important component of CER.