title: The use of patient-reported outcomes (PRO) within comparative effectiveness research: implications for clinical practice and health care policy.
abstract: BACKGROUND
  The goal of comparative effectiveness research (CER) is to explain the differential benefits and harms of alternate methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. To inform decision making, information from the patient's perspective that reflects outcomes that patients care about are needed and can be collected rigorously using appropriate patient-reported outcomes (PRO). It can be challenging to select the most appropriate PRO measure given the proliferation of such questionnaires over the past 20 years.
  
  
  OBJECTIVE
  In this paper, we discuss the value of PROs within CER, types of measures that are likely to be useful in the CER context, PRO instrument selection, and key challenges associated with using PROs in CER.
  
  
  METHODS
  We delineate important considerations for defining the CER context, selecting the appropriate measures, and for the analysis and interpretation of PRO data. Emerging changes that may facilitate CER using PROs as an outcome are also reviewed including implementation of electronic and personal health records, hospital and population-based registries, and the use of PROs in national monitoring initiatives. The potential benefits of linking the information derived from PRO endpoints in CER to decision making is also reviewed.
  
  
  CONCLUSIONS
  The recommendations presented for incorporating PROs in CER are intended to provide a guide to researchers, clinicians, and policy makers to ensure that information derived from PROs is applicable and interpretable for a given CER context. In turn, CER will provide information that is necessary for clinicians, patients, and families to make informed care decisions.
authors.affiliation: School of Physical and Occupational Therapy, McGill University, Clinical Epidemiology, McGill University Health Center, Centre de recherche interdisciplinaire en réadaptation, Montreal, QC, Canada. sara.ahmed@mcgill.ca
authors.forename: Sara
authors.initials: S
authors.lastname: Ahmed
authors.forename: Richard A
authors.initials: RA
authors.lastname: Berzon
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: William R
authors.initials: WR
authors.lastname: Lenderking
authors.forename: Carol M
authors.initials: CM
authors.lastname: Moinpour
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.forename: Albert W
authors.initials: AW
authors.lastname: Wu
mesh_terms: D000203:Activities of Daily Living; D057186:Comparative Effectiveness Research / Q000379:methods*; D015438:Health Behavior; D006291:Health Policy; D006304:Health Status; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D017060:Patient Satisfaction; D018802:Patient-Centered Care; D011788:Quality of Life; D012107:Research Design; D057566:Self Report