An official American thoracic society research statement: Comparative effectiveness research in pulmonary, critical care, and sleep medicine

Shannon S. Carson, Christopher H. Goss, Sanjay R. Patel, Antonio Anzueto, David H. Au, Stuart Elborn, Joe K. Gerald, Lynn B. Gerald, Jeremy M. Kahn, Atul Malhotra, Richard A. Mularski, Kristin A. Riekert, Gordon D. Rubenfeld, Terri E. Weaver, Jerry A. Krishnan

Research output: Contribution to journalArticle

37 Scopus citations

Abstract

Background: Comparative effectiveness research (CER) is intended to inform decision making in clinical practice, and is central to patientcentered outcomes research (PCOR). Purpose: 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. Methods: 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 sleepmedicinewas convened. The group used an iterative consensus process, including a reviewbyAmerican Thoracic Society committees and assemblies. Results: 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). Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)1253-1261
Number of pages9
JournalAmerican journal of respiratory and critical care medicine
Volume188
Issue number10
DOIs
StatePublished - Nov 15 2013

Keywords

  • Comparative effectiveness research
  • Efficacy research
  • Patient-centered outcomes research
  • Pragmatic trials

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

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    Carson, S. S., Goss, C. H., Patel, S. R., Anzueto, A., Au, D. H., Elborn, S., Gerald, J. K., Gerald, L. B., Kahn, J. M., Malhotra, A., Mularski, R. A., Riekert, K. A., Rubenfeld, G. D., Weaver, T. E., & Krishnan, J. A. (2013). An official American thoracic society research statement: Comparative effectiveness research in pulmonary, critical care, and sleep medicine. American journal of respiratory and critical care medicine, 188(10), 1253-1261. https://doi.org/10.1164/rccm.201310-1790ST