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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.


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.

Matza LS, Patrick DL, Riley AW, Alexander JJ, Rajmil L, Pleil AM, Bullinger M.

Value Health. 2013 Jun;16(4):461-79. doi: 10.1016/j.jval.2013.04.004.


Development and content validity of a patient reported outcomes measure to assess symptoms of major depressive disorder.

Lasch KE, Hassan M, Endicott J, Piault-Luis EC, Locklear J, Fitz-Randolph M, Pathak S, Hwang S, Jernigan K.

BMC Psychiatry. 2012 Apr 25;12:34. doi: 10.1186/1471-244X-12-34.


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.


What is sufficient evidence for the reliability and validity of patient-reported outcome measures?

Frost MH, Reeve BB, Liepa AM, Stauffer JW, Hays RD; Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group;.

Value Health. 2007 Nov-Dec;10 Suppl 2:S94-S105.


The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease.

Hareendran A, Palsgrove AC, Mocarski M, Schaefer ML, Setyawan J, Carson R, Make B.

Health Qual Life Outcomes. 2013 Jun 25;11:104. doi: 10.1186/1477-7525-11-104. Review.


Patient-Centered Research to Support the Development of the Symptoms of Major Depressive Disorder Scale (SMDDS): Initial Qualitative Research.

McCarrier KP, Deal LS, Abraham L, Blum SI, Bush EN, Martin ML, Thase ME, Coons SJ; PRO Consortium’s Depression Working Group.

Patient. 2016 Apr;9(2):117-34. doi: 10.1007/s40271-015-0132-1.


Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients' experience.

Brédart A, Marrel A, Abetz-Webb L, Lasch K, Acquadro C.

Health Qual Life Outcomes. 2014 Feb 5;12:15. doi: 10.1186/1477-7525-12-15. Review.


[Caregiver burden in relatives of persons with schizophrenia: an overview of measure instruments].

Reine G, Lancon C, Simeoni MC, Duplan S, Auquier P.

Encephale. 2003 Mar-Apr;29(2):137-47. Review. French.


Assessment of sleep in patients with fibromyalgia: qualitative development of the fibromyalgia sleep diary.

Kleinman L, Mannix S, Arnold LM, Burbridge C, Howard K, McQuarrie K, Pitman V, Resnick M, Roth T, Symonds T.

Health Qual Life Outcomes. 2014 Jul 14;12:111. doi: 10.1186/s12955-014-0111-6.


Procedures and methods of benefit assessments for medicines in Germany.

Bekkering GE, Kleijnen J.

Eur J Health Econ. 2008 Nov;9 Suppl 1:5-29. doi: 10.1007/s10198-008-0122-5.


[Procedures and methods of benefit assessments for medicines in Germany].

Bekkering GE, Kleijnen J.

Dtsch Med Wochenschr. 2008 Dec;133 Suppl 7:S225-46. doi: 10.1055/s-0028-1100954. Epub 2008 Nov 25. German.


[Validation of the QFS measuring the frequency and satisfaction in social behaviours in psychiatric adult population].

Zanello A, Weber Rouget B, Gex-Fabry M, Maercker A, Guimon J.

Encephale. 2006 Jan-Feb;32(1 Pt 1):45-59. French.


Qualitative Development and Content Validity of the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-reported Outcome Instrument.

McCarrier KP, Atkinson TM, DeBusk KP, Liepa AM, Scanlon M, Coons SJ; Patient-Reported Outcome Consortium, Non–Small Cell Lung Cancer Working Group.

Clin Ther. 2016 Apr;38(4):794-810. doi: 10.1016/j.clinthera.2016.03.012. Epub 2016 Apr 1.


Development of an instrument to measure the quality of documented nursing diagnoses, interventions and outcomes: the Q-DIO.

Müller-Staub M, Lunney M, Odenbreit M, Needham I, Lavin MA, van Achterberg T.

J Clin Nurs. 2009 Apr;18(7):1027-37. doi: 10.1111/j.1365-2702.2008.02603.x. Epub 2009 Feb 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.


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