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Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures.

Bradley C.

Health Qual Life Outcomes. 2006 Oct 9;4:78.PMID: 17029628 [PubMed - indexed for MEDLINE]Related articlesFree article

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health.

Health Qual Life Outcomes. 2006 Oct 11;4:79.PMID: 17034633 [PubMed - indexed for MEDLINE]Related articlesFree article

The FDA guidance for industry on PROs: the point of view of a pharmaceutical company.

Arpinelli F, Bamfi F.

Health Qual Life Outcomes. 2006 Oct 31;4:85.PMID: 17076891 [PubMed - indexed for MEDLINE]Related articlesFree article

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.

Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M; PRO Harmonization Group.

Value Health. 2003 Sep-Oct;6(5):522-31.PMID: 14627058 [PubMed - indexed for MEDLINE]Related articles

Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency.

Bottomley A, Jones D, Claassens L.

Eur J Cancer. 2009 Feb;45(3):347-53. Epub 2008 Nov 14. Review.PMID: 19013787 [PubMed - indexed for MEDLINE]Related articles

Patient-reported outcomes supporting anticancer product approvals.

Rock EP, Kennedy DL, Furness MH, Pierce WF, Pazdur R, Burke LB.

J Clin Oncol. 2007 Nov 10;25(32):5094-9. Review.PMID: 17991927 [PubMed - indexed for MEDLINE]Related articles

How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure.

Brozek JL, Guyatt GH, Schünemann HJ.

Health Qual Life Outcomes. 2006 Sep 27;4:69.PMID: 17005037 [PubMed - indexed for MEDLINE]Related articlesFree article

Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels.

Willke RJ, Burke LB, Erickson P.

Control Clin Trials. 2004 Dec;25(6):535-52. Review.PMID: 15588741 [PubMed - indexed for MEDLINE]Related articles

Health-related quality of life in clinical practice.

[No authors listed]

J Neurosci Nurs. 1999 Dec;31(6):366-8.PMID: 10726246 [PubMed - indexed for MEDLINE]Related articles

Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

Revicki DA, Gnanasakthy A, Weinfurt K.

Qual Life Res. 2007 May;16(4):717-23. Epub 2007 Feb 1.PMID: 17268927 [PubMed - indexed for MEDLINE]Related articles

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.

Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation.

Value Health. 2005 Mar-Apr;8(2):94-104.PMID: 15804318 [PubMed - indexed for MEDLINE]Related articles

Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life.

Wiklund I.

Fundam Clin Pharmacol. 2004 Jun;18(3):351-63. Review.PMID: 15147288 [PubMed - indexed for MEDLINE]Related articles

Comments on the ISPOR Task Force Report on Translation and Adaptation of Outcomes Measures: guidelines and the need for more research.

Lenderking WR.

Value Health. 2005 Mar-Apr;8(2):92-3. No abstract available. PMID: 15804317 [PubMed - indexed for MEDLINE]Related articles

Patient-reported outcomes in cystic fibrosis.

Goss CH, Quittner AL.

Proc Am Thorac Soc. 2007 Aug 1;4(4):378-86. Review.PMID: 17652505 [PubMed - indexed for MEDLINE]Related articlesFree article

Patient-reported outcomes in cancer: a review of recent research and policy initiatives.

Lipscomb J, Gotay CC, Snyder CF.

CA Cancer J Clin. 2007 Sep-Oct;57(5):278-300. Review.PMID: 17855485 [PubMed - indexed for MEDLINE]Related articlesFree article

Health-related quality of life measurement in symptom management trials.

Ganz PA, Goodwin PJ.

J Natl Cancer Inst Monogr. 2007;(37):47-52. Review.PMID: 17951231 [PubMed - indexed for MEDLINE]Related articles

The translation and cultural adaptation of patient-reported outcome measures.

McKenna SP, Doward LC.

Value Health. 2005 Mar-Apr;8(2):89-91. No abstract available. PMID: 15804316 [PubMed - indexed for MEDLINE]Related articles

Quality of life: questionnaires and questions.

Mooney A.

J Health Commun. 2006 Apr-May;11(3):327-41.PMID: 16624797 [PubMed - indexed for MEDLINE]Related articles

[Health status and health-related quality of life. A facet in the evaluation of outcomes in orthopaedic surgery]

Roposch A.

Orthopade. 2005 Apr;34(4):375-9; quiz 380-1. German. PMID: 15803333 [PubMed - indexed for MEDLINE]Related articles

PROs: defining clinical benefit from the patient's perspective. Draft guidance provides direction in evaluating patient-reported outcomes.

Pazdur R.

Oncology (Williston Park). 2006 May;20(6):660. No abstract available. PMID: 16773848 [PubMed - indexed for MEDLINE]Related articles