Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments

Author:

Taylor Fiona,Reasner David S.,Carson Robyn T.,Deal Linda S.,Foley Catherine,Iovin Ramon,Lundy J. Jason,Pompilus Farrah,Shields Alan L.,Silberg Debra G.

Funder

U.S. Food and Drug Administration

Publisher

Springer Science and Business Media LLC

Reference33 articles.

1. Tack J, Talley NJ. Functional dyspepsia–symptoms, definitions and validity of the Rome III criteria. Nat Rev Gastroenterol Hepatol. 2013;10:134–41.

2. Rome Foundation. Rome IV. 2013. http://www.romecriteria.org/romeiv_pub/index.cfm . Accessed 19 Jun 2014.

3. Drossman DA, Corazziari E, Delvaux M, et al. Appendix A: Rome III Diagnostic Criteria for FGIDs. In: Drossman DA, Corazziari E, Delvaux M, et al., editors. Rome III The functional Gastrointestinal Disorders. 3rd ed. McLean: Degnon Associates, Inc.; 2006. p. 885–97.

4. Coons SJ, Kothari S, Monz BU, Burke LB. The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims. Clin Pharmacol Ther. 2011;90:743–8.

5. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009.

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