ISPOR Patient Reported Outcomes and
Quality of Life Initiatives

 

PATIENT REPORTED OUTCOMES 

July 2013 Matza LS, Patrick D, Riley AW et al. Pediatric patient-reported outcome instruments for research to support medical product labeling: Report of the ISPOR PRO good research practices for the assessment of children and adolescents task force. Value Health 2013:16;461-79.
http://www.ispor.org/TaskForces/PROChildrenAdolescents.asp
 

Zbrozek A, Hebert J, Gogates G, et al. Validation of electronic systems to collect patient-reported outcome (PRO) data - Recommendations for clinical trial teams: Report of the ISPOR ePRO systems validation good research practices task force. Value Health 2013:16:480-9 http://www.ispor.org/sigs/ePROsystemvalidationsg.asp

October 2011

Patrick DL, Burke LB, Gwaltney CJ, et al.  Content validity - Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1 - Eliciting concepts for a new PRO instrument.  Value Health 2011;14; 967-977. http://www.ispor.org/workpaper/Content-Validity-New-PRO-Eliciting-Concepts-for-a-New-PRO-Instrument.asp

  Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity - Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) Instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 2 – Assessing respondent understanding. Value Health 2011;14; 978-988. http://www.ispor.org/workpaper/Content-Validity-New-PRO-Assessing-respondent-understanding.asp
December 2009

Rothman M, Burke L, Erickson P, et al. Use of Existing Patient-Reported Outcome (PRO) Instruments and Their Modification: The ISPOR Good Research Practices for Evaluating and Documenting Content Validity for The Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health 2009;12;1075-83. http://www.ispor.org/TaskForces/PROInstrumentsUse.asp

June 2009 Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations On Evidence Needed To Support Measurement Equivalence Between Electronic And Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report. Value Health 2009;12(4):419-429. http://www.ispor.org/TaskForces/ePROTF.asp
  Wild D, Eremenco S, Mear I, et al. Multinational trials – Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: the ISPOR Patient Reported Outcomes Translation & Linguistic Validation Good Research Practices Task Force Report.Value Health 2009;12:430-440. http://www.ispor.org/TaskForces/CCLPROTF.asp
April 2006 ISPOR Comments on FDA Guidance for Industry – Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims http://www.ispor.org/workpaper/ISPOR%20Response%20to%20FDA%20PRO%20Guidance.pdf
March 2005

Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation
Published in Value in Health, Vol. 8, Issue 2, 2005 pp 95-104 http://www.ispor.org/workpaper/research_practices/PRO_tlva.asp

September 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
http://www.ispor.org/workpaper/research_practices/PRO_mc.asp

May 2002

Patient Reported Outcomes “PRO’ Symposium: Conceptual and Methodological Issues, May 19, 2002 (ISPOR pre-meeting symposium) http://www.ispor.org/meetings/va0502/symposium.asp 

  QUALITY OF LIFE
February 2001

Health-related Quality of Life Harmonization Meeting, FDA, February 16, 2001http://www.ispor.org/news/articles/0704/patientrep.htm

May 2000 Quality of Life Promotional Claims: Methodological Issues and Potential Solutions ISPOR pre-meeting Symposium, May 21, 2000
http://www.ispor.org/meetings/ql0500/index_.asp
March 2000

Health-related Quality of Life Harmonization Meeting (Mapi Research Institute, ERIQA Group, and PhRMA HOC) 

April 1999

Quality of Life Promotional and Label Claim Issues for Drugs, Biologicals, and Devices Report Issues and Comments published at: http://www.ispor.org/workpaper/consensus/index.asp#issue1

Development of a Consensus Document as a Supporting Document for FDA and Other Health Regulatory Authorities on Health-Related Quality of Life Guidances: Issues identified and comments given at: http://www.ispor.org/research_initiatives/concensus_document.pdf

March 1999

Recommendations for Evaluating the Validity of Quality of Life Claims for Labeling and Promotion by Nancy K Leidy, Dennis Ricki, and Bernard Geneste
Published in Value in Health  Vol. 2, Issue 2, March-April 1999