141
Views
11
CrossRef citations to date
0
Altmetric
Research Article

A Practical Guide on Incorporating and Evaluating Patient-Reported Outcomes in Clinical Trials

&
Pages 197-211 | Published online: 16 Dec 2008

REFERENCES

  • C Acquadro, R Berzon, D Dubois, NK Leidy, P Marquis, D Revicki, and M Rothman. (2003). Incorporating the patient's perspective into drug development and communication: An ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health. 6:522–531.
  • LB Burke, P Erickson, NK Leidy, D Patrick, and C Petrie. Patient Reported Outcomes – Selecting, Evaluating and Documenting Support for Existing Instruments for Labeling Claims: Content Validity. Task Force Presentation at the International Society for Pharmacoeconomics and Outcomes Research Annual International Meeting, (May 3–7, 2008), Toronto, Ontario, Canada.
  • DL Fairclough. (2004). Patient reported outcomes as endpoints in medical research. Stat Methods Med Res. 13:115–138.
  • P Fayers, and D Machin. Quality of Life: The Assessment, Analysis and Interpretation of Patient-Reported Outcomes. 2nd ed. West Sussex, England: John Wiley & Sons Ltd.; (2007).
  • DA Revicki, A Gnanasakthy, and K Weinfurt. (2007). Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier. Qual Lif Res. 16:717–723.
  • U.S. Food and Drug Administration. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (DRAFT). U.S. Department of Health and Human Services, Food and Drug Administration: Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH). February 2006. Available from: http://www.fda.gov/cder/guidance/5460dft.htm. Accessed January 6, 2008.
  • ML Rothman, P Beltran, JC Cappelleri, J Lipscomb, and B Teschendorf. (2007). the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Patient-reported outcomes: Conceptual issues. Value Health 10 (Suppl 2):S66–S75.
  • JA Sloan, MY Halyard, MH Frost, AC Dueck, B Teschendorf, and ML Rothman. (2007). the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the Food and Drug Administration guidance on patient-reported outcomes. Value Health. 10 (Suppl 2):S59–S63.
  • CF Snyder, ME Watson, JD Jackson, D Cella, and MY Halyard. (2007). the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Patient-reported outcomes instruction selection: Designing a measurement strategy. Value Health. 10 (Suppl 2):S76–S85.
  • RR Turner, AL Quittner, BM Parasuraman, JD Kallich, and CS Cleeland. (2007). the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Patient-reported outcomes: Instrument development and selection issues. Value Health. 10 (Suppl 2):S86–S93.
  • MH Frost, BB Reeve, AM Liepa, BB Reeve, JW Stauffer, and RD Hays. (2007). the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. What is sufficient evidence for the reliability and validity of patient-reported outcomes?. Value Health. 10 (Suppl 2):S94–S105.
  • JA Sloan, AC Dueck, PA Erickson, H Guess, DA Revicki, and NC Santanello. (2007). the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Analysis and interpretation of results based on patient-reported outcomes. Value Health. 10 (Suppl 2):S106–S115.
  • DA Revicki, PA Erickson, JA Sloan, A Dueck, H Guess, and NC Santanello. (2007). the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Interpreting and reporting results based on patient-reported outcomes. Value Health. 10 (Suppl 2):S116–S124.
  • DL Patrick, LB Burke, JH Power, JA Scott, EP Rock, S Dawisha, R O'Neil, and DL Kennedy. (2007). Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health. 10 (Suppl 2):S125–S137.
  • RJ Willke, LB Burke, and P Erickson. (2004). Measuring treatment impact: A review of patient-reported outcomes and other efficacy endpoints in approved labels. Controlled Clin Trials 25:S35–S52.
  • NK Leidy, and M Vernon. (2008). Perspectives on patient-reported outcomes. Pharmacoeconomics 26:363–370.
  • DA Revicki, D Osoba, D Fairclough, I Barofsky, R Berzon, NK Leidy, and M Rothman. (2000). Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res. 9:887–900.
  • O Chassany, D Sagnier, P Marquis, S Fulleton, and N Aaronson. (2002). Patient-reported outcomes: The example of health-related quality of life—a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inf J. 36:209–238.
  • ML Rothman, P Beltran, JC Cappelleri, J Lipscomb, and B Teschendorf. (Nov–Dec, 2007). Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Patient-reported outcomes: conceptual issues. Value Health. 10 (Suppl 2):S66–75.
  • JC Nunnally, and IH Bernstein. Psychometric Theory (3rd edition). New York: McGraw Hill, Inc.; (1994).
  • PM Fayers, NK Aaronson, K Bjordal, M Groenvold, D Curran, and A Bottomley. on behalf of the EORTC Quality of Life Group. EORTC QLQ-C30 Scoring Manual (3rd edition). Brussels: EORTC; (2001). ISBN: 2–9300 64-22-6.
  • JC Cappelleri, SS Bell, and RL Siegel. (2007). Interpretation of a self-esteem subscale for erectile dysfunction by cumulative logit model. Drug Information Journal. 41:723–732.
  • DL Steiner, and GR Norman. Health Measurement Scales: A Practical Guide to Their Development and Use. 3rd ed. New York, NY: Oxford University Press; (2003).
  • D Fairclough. Design and Analysis of Quality of Life Studies in Clinical Trials. Boca Raton, Florida: Chapman & Hall/CRC; (2002).
  • RF DeVellis. Scale Development: Theory and Applications. 2nd ed. Thousand Oaks, California: Sage Publications; (2003).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.