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Incorporating patient preferences into clinical trial design: results of the opinions of patients on treatment implications of new studies (OPTIONS) project.

Publication ,  Journal Article
Stafinski, T; Menon, D; Nardelli, A; Bakal, J; Ezekowitz, J; Tymchak, W; Welsh, R; Gyenes, G; Armstrong, PW
Published in: Am Heart J
January 2015

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. METHODS AND 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.

Duke Scholars

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

January 2015

Volume

169

Issue

1

Start / End Page

122 / 31.e22

Location

United States

Related Subject Headings

  • Stroke
  • Shock, Cardiogenic
  • Risk Assessment
  • Research Design
  • Recurrence
  • Outcome Assessment, Health Care
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Humans
 

Citation

APA
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ICMJE
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Stafinski, T., Menon, D., Nardelli, A., Bakal, J., Ezekowitz, J., Tymchak, W., … Armstrong, P. W. (2015). Incorporating patient preferences into clinical trial design: results of the opinions of patients on treatment implications of new studies (OPTIONS) project. Am Heart J, 169(1), 122-31.e22. https://doi.org/10.1016/j.ahj.2014.10.002
Stafinski, Tania, Devidas Menon, Alex Nardelli, Jeff Bakal, Justin Ezekowitz, Wayne Tymchak, Robert Welsh, Gabor Gyenes, and Paul W. Armstrong. “Incorporating patient preferences into clinical trial design: results of the opinions of patients on treatment implications of new studies (OPTIONS) project.Am Heart J 169, no. 1 (January 2015): 122-31.e22. https://doi.org/10.1016/j.ahj.2014.10.002.
Stafinski T, Menon D, Nardelli A, Bakal J, Ezekowitz J, Tymchak W, et al. Incorporating patient preferences into clinical trial design: results of the opinions of patients on treatment implications of new studies (OPTIONS) project. Am Heart J. 2015 Jan;169(1):122-31.e22.
Stafinski, Tania, et al. “Incorporating patient preferences into clinical trial design: results of the opinions of patients on treatment implications of new studies (OPTIONS) project.Am Heart J, vol. 169, no. 1, Jan. 2015, pp. 122-31.e22. Pubmed, doi:10.1016/j.ahj.2014.10.002.
Stafinski T, Menon D, Nardelli A, Bakal J, Ezekowitz J, Tymchak W, Welsh R, Gyenes G, Armstrong PW. Incorporating patient preferences into clinical trial design: results of the opinions of patients on treatment implications of new studies (OPTIONS) project. Am Heart J. 2015 Jan;169(1):122–31.e22.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

January 2015

Volume

169

Issue

1

Start / End Page

122 / 31.e22

Location

United States

Related Subject Headings

  • Stroke
  • Shock, Cardiogenic
  • Risk Assessment
  • Research Design
  • Recurrence
  • Outcome Assessment, Health Care
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Humans