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Results: 1 to 20 of 1404

1.

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]
2.

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.

Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, Lenderking WR, Cella D, Basch E; ISPOR ePRO Task Force.

Value Health. 2009 Jun;12(4):419-29. doi: 10.1111/j.1524-4733.2008.00470.x. Epub 2008 Nov 11.

PMID:
19900250
[PubMed - indexed for MEDLINE]
3.

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]
4.

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]
5.

The International Liaison Committee on Resuscitation (ILCOR) consensus on science with treatment recommendations for pediatric and neonatal patients: pediatric basic and advanced life support.

International Liaison Committee on Resuscitation.

Pediatrics. 2006 May;117(5):e955-77. Epub 2006 Apr 17.

PMID:
16618790
[PubMed - indexed for MEDLINE]
Free Article
6.

Regulatory issues for health-related quality of life--PhRMA Health Outcomes Committee workshop, 1999.

Santanello NC, Baker D, Cappelleri JC, Copley-Merriman K, DeMarinis R, Gagnon JP, Hsuan A, Jackson J, Mahmoud R, Miller D, Morgan M, Osterhaus J, Tilson H, Willke R.

Value Health. 2002 Jan-Feb;5(1):14-25.

PMID:
11873379
[PubMed - indexed for MEDLINE]
7.

The ISPOR Good Practices for Quality Improvement of Cost-Effectiveness Research Task Force Report.

McGhan WF, Al M, Doshi JA, Kamae I, Marx SE, Rindress D.

Value Health. 2009 Nov-Dec;12(8):1086-99. doi: 10.1111/j.1524-4733.2009.00605.x. Epub 2009 Sep 10.

PMID:
19744291
[PubMed - indexed for MEDLINE]
8.

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]
9.

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]
Free PMC Article
10.

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. doi: 10.1016/j.ejca.2008.09.032. Epub 2008 Nov 14. Review.

PMID:
19013787
[PubMed - indexed for MEDLINE]
11.

Lessons learned from independent central review.

Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J.

Eur J Cancer. 2009 Jan;45(2):268-74. doi: 10.1016/j.ejca.2008.10.031.

PMID:
19101138
[PubMed - indexed for MEDLINE]
12.

Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices--budget impact analysis.

Mauskopf JA, Sullivan SD, Annemans L, Caro J, Mullins CD, Nuijten M, Orlewska E, Watkins J, Trueman P.

Value Health. 2007 Sep-Oct;10(5):336-47.

PMID:
17888098
[PubMed - indexed for MEDLINE]
13.

Task Force report of the Patient-Reported Outcomes Harmonization Group: too much harmony, not enough melody?

Lenderking W.

Value Health. 2003 Sep-Oct;6(5):503-4. No abstract available.

PMID:
14627056
[PubMed - indexed for MEDLINE]
14.

Using patient-reported outcomes in clinical practice: challenges and opportunities.

Lohr KN, Zebrack BJ.

Qual Life Res. 2009 Feb;18(1):99-107. doi: 10.1007/s11136-008-9413-7. Epub 2008 Nov 25.

PMID:
19034690
[PubMed - indexed for MEDLINE]
15.

Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks.

Bruner DW, Bryan CJ, Aaronson N, Blackmore CC, Brundage M, Cella D, Ganz PA, Gotay C, Hinds PS, Kornblith AB, Movsas B, Sloan J, Wenzel L, Whalen G; National Cancer Institute.

J Clin Oncol. 2007 Nov 10;25(32):5051-7. Review.

PMID:
17991920
[PubMed - indexed for MEDLINE]
16.

Committee on Natural Toxins and Food Allergens. Marine and freshwater toxins.

Hungerford JM.

J AOAC Int. 2005 Jan-Feb;88(1):299-313.

PMID:
15759755
[PubMed - indexed for MEDLINE]
18.

Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report.

Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD.

Value Health. 2007 Sep-Oct;10(5):326-35.

PMID:
17888097
[PubMed - indexed for MEDLINE]
19.

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]
20.

Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels.

Gondek K, Sagnier PP, Gilchrist K, Woolley JM.

J Clin Oncol. 2007 Nov 10;25(32):5087-93. Review.

PMID:
17991926
[PubMed - indexed for MEDLINE]

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