title: An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine.
abstract: BACKGROUND
  Comparative effectiveness research (CER) is intended to inform decision making in clinical practice, and is central to patient-centered outcomes research (PCOR).
  
  
  OBJECTIVE
  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 sleep medicine was convened. The group used an iterative consensus process, including a review by American 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.
authors.forename: Shannon S
authors.initials: SS
authors.lastname: Carson
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Goss
authors.forename: Sanjay R
authors.initials: SR
authors.lastname: Patel
authors.forename: Antonio
authors.initials: A
authors.lastname: Anzueto
authors.forename: David H
authors.initials: DH
authors.lastname: Au
authors.forename: Stuart
authors.initials: S
authors.lastname: Elborn
authors.forename: Joe K
authors.initials: JK
authors.lastname: Gerald
authors.forename: Lynn B
authors.initials: LB
authors.lastname: Gerald
authors.forename: Jeremy M
authors.initials: JM
authors.lastname: Kahn
authors.forename: Atul
authors.initials: A
authors.lastname: Malhotra
authors.forename: Richard A
authors.initials: RA
authors.lastname: Mularski
authors.forename: Kristin A
authors.initials: KA
authors.lastname: Riekert
authors.forename: Gordon D
authors.initials: GD
authors.lastname: Rubenfeld
authors.forename: Terri E
authors.initials: TE
authors.lastname: Weaver
authors.forename: Jerry A
authors.initials: JA
authors.lastname: Krishnan
mesh_terms: D057186:Comparative Effectiveness Research / Q000379:methods* / Q000592:standards; D003422:Critical Care / Q000379:methods* / Q000592:standards; D006801:Humans; D017063:Outcome Assessment, Health Care; D015272:Pulmonary Medicine / Q000379:methods* / Q000592:standards; D012107:Research Design; D056508:Sleep Medicine Specialty / Q000379:methods* / Q000592:standards