Development and psychometric validation of the Nausea/Vomiting Symptom Assessment patient-reported outcome (PRO) instrument for adults with secondary hyperparathyroidism

Journal of Patient-reported Outcomes
Colleen A McHorneyChad J Gwaltney

Abstract

We developed the Nausea/Vomiting Symptom Assessment (NVSA©) patient-reported outcome (PRO) instrument to capture patients' experience with nausea and vomiting while on calcimimetic therapy to treat secondary hyperparathyroidism (SHPT) related to end-stage kidney disease. This report summarizes the content validity and psychometric validation of the NVSA©. The two NVSA© items were drafted by two health outcomes researchers, one medical development lead, and one regulatory lead: it yields three scores: the number of days of vomiting or nausea per week, the number of vomiting episodes per week, and the mean severity of nausea. An eight-week prospective observational study was conducted at ten dialysis centers in the U.S. with 91 subjects. Criterion measures included in the study were the Functional Living Index-Emesis, Kidney Disease Quality of Life Instrument, EQ-5D-5 L, Static Patient Global Assessment, and Patient Global Rating of Change. Analyses included assessment of score distributions, convergent and known-groups validity, test-retest reliability, ability to detect change, and thresholds for meaningful change. Qualitative interviews verified that the NVSA© captures relevant aspects of nausea and vomiting. Patients understo...Continue Reading

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Citations

Jul 4, 2019·American Journal of Medical Genetics. Part C, Seminars in Medical Genetics·Scott OishiTerri Beckwith

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