title: Incorporating patient preferences into clinical trial design: results of the opinions of patients on treatment implications of new studies (OPTIONS) project.
abstract: BACKGROUND
  Traditionally, clinical outcomes comprising composite end points in cardiovascular trials are assigned equal weights in statistical analyses. However, the importance of weighting outcomes according to their relative severity is now recognized. This study aimed to elicit patients' perceptions of the importance of cardiovascular outcomes and treatment complications and compare them with those of clinicians.
  
  
  RESULTS
  Interviewer-administered surveys, including rating, ranking, point-allocation and trade-off exercises, were conducted in 52 adults with confirmed coronary disease or previous myocardial infarction. Patients viewed "death" as the most severe cardiovascular outcome, followed by cardiogenic shock, congestive heart failure (CHF), and repeat myocardial infarction (re-MI), the same pattern observed in clinician responses in a previous study. Most patients were willing to accept a 3-fold increase in risk of systemic bleed (SB) or nonfatal intracranial hemorrhage (ICH) for a 20% reduction in risk of cardiogenic shock or 60% reduction in risk of CHF, but only a 2-fold increase in the risk of SB or ICH for a 20% reduction in risk of CHF or 60% reduction in risk of re-MI and no increase in risk of SB or ICH for a 20% reduction in risk of re-MI. Similar patterns were seen in a previous study of trade-offs in clinicians.
  
  
  CONCLUSIONS
  Although patients' preferences appear to be comparable with those of clinicians, patients may be less willing than clinicians to tolerate potential treatment complications. The methods used in this study offer a feasible approach to incorporating patient preferences into cardiovascular trials and warrant further investigation in broader patient populations.
authors.affiliation: Health Technology & Policy Unit, School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Tania
authors.initials: T
authors.lastname: Stafinski
authors.affiliation: Health Technology & Policy Unit, School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Devidas
authors.initials: D
authors.lastname: Menon
authors.affiliation: Health Technology & Policy Unit, School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Alex
authors.initials: A
authors.lastname: Nardelli
authors.affiliation: Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Jeff
authors.initials: J
authors.lastname: Bakal
authors.affiliation: Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Justin
authors.initials: J
authors.lastname: Ezekowitz
authors.affiliation: Division of Cardiology, Mazankowski Heart Institute, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Wayne
authors.initials: W
authors.lastname: Tymchak
authors.affiliation: Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Welsh
authors.affiliation: Division of Cardiology, Mazankowski Heart Institute, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Gabor
authors.initials: G
authors.lastname: Gyenes
authors.affiliation: Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada. Electronic address: paul.armstrong@ualberta.ca.
authors.forename: Paul W
authors.initials: PW
authors.lastname: Armstrong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001294:Attitude to Health; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D002543:Cerebral Hemorrhage / Q000453:epidemiology; D002986:Clinical Trials as Topic; D005260:Female; D006333:Heart Failure / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D017063:Outcome Assessment, Health Care; D012008:Recurrence; D012107:Research Design; D018570:Risk Assessment; D012770:Shock, Cardiogenic / Q000628:therapy; D020521:Stroke / Q000453:epidemiology