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Items: 1 to 20 of 129


Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements.

Nixon A, Kerr C, Breheny K, Wild D.

Health Qual Life Outcomes. 2013 Mar 11;11:38. doi: 10.1186/1477-7525-11-38. Review.


Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union.

Clark MJ, Harris N, Griebsch I, Kaschinski D, Copley-Merriman C.

Health Qual Life Outcomes. 2014 Jul 4;12:104. doi: 10.1186/s12955-014-0104-5.


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for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.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


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.


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.


Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).

DeMuro C, Clark M, Doward L, Evans E, Mordin M, Gnanasakthy A.

Value Health. 2013 Dec;16(8):1150-5. doi: 10.1016/j.jval.2013.08.2293. Epub 2013 Oct 17.


Systematic review of patient-reported outcome instruments for gastroesophageal reflux disease symptoms.

Vakil NB, Halling K, Becher A, Rydén A.

Eur J Gastroenterol Hepatol. 2013 Jan;25(1):2-14. doi: 10.1097/MEG.0b013e328358bf74. Review.


Potential of patient-reported outcomes as nonprimary endpoints in clinical trials.

Gnanasakthy A, Lewis S, Clark M, Mordin M, DeMuro C.

Health Qual Life Outcomes. 2013 May 15;11:83. doi: 10.1186/1477-7525-11-83.


Patient-Reported Outcomes in Chronic Heart Failure: Applicability for Regulatory Approval.

Psotka MA, von Maltzahn R, Anatchkova M, Agodoa I, Chau D, Malik FI, Patrick DL, Spertus JA, Wiklund I, Teerlink JR.

JACC Heart Fail. 2016 Oct;4(10):791-804. doi: 10.1016/j.jchf.2016.04.010. Epub 2016 Jul 6.


The use of patient-reported outcomes in advanced breast cancer clinical trials: a review of the published literature.

Turner-Bowker DM, Hao Y, Foley C, Galipeau N, Mazar I, Krohe M, Globe D, Shields AL.

Curr Med Res Opin. 2016 Oct;32(10):1709-17. doi: 10.1080/03007995.2016.1205005. Epub 2016 Aug 9. Review.


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.

Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD.

Value Health. 2009 Nov-Dec;12(8):1075-83. doi: 10.1111/j.1524-4733.2009.00603.x. Epub 2009 Sep 25. Review.


Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006-2010.

DeMuro C, Clark M, Mordin M, Fehnel S, Copley-Merriman C, Gnanasakthy A.

Value Health. 2012 May;15(3):443-8. doi: 10.1016/j.jval.2012.01.010.


A review of patient-reported outcome measures to assess female infertility-related quality of life.

Kitchen H, Aldhouse N, Trigg A, Palencia R, Mitchell S.

Health Qual Life Outcomes. 2017 Apr 27;15(1):86. doi: 10.1186/s12955-017-0666-0. Review.


Clinical effectiveness, tolerability and cost-effectiveness of newer drugs for epilepsy in adults: a systematic review and economic evaluation.

Wilby J, Kainth A, Hawkins N, Epstein D, McIntosh H, McDaid C, Mason A, Golder S, O'Meara S, Sculpher M, Drummond M, Forbes C.

Health Technol Assess. 2005 Apr;9(15):1-157, iii-iv. Review.


Rapid detection of major depression in epilepsy: a multicentre study.

Gilliam FG, Barry JJ, Hermann BP, Meador KJ, Vahle V, Kanner AM.

Lancet Neurol. 2006 May;5(5):399-405.


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.


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