Shivani K Mhatre1, Sujit S Sansgiry1. 1. Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, Houston, Texas, USA.
Abstract
AIM: The Food and Drug Administration guidelines emphasize that patient-reported outcome (PRO) instruments used in clinical trials must be developed based on a conceptual model, yet existing PRO instruments currently used in clinical trials of hepatitis C virus (HCV) patients are not based on a predetermined model. The purpose of this study was to identify a comprehensive list of health-related quality of life (HRQoL) themes that may be unique to HCV by reviewing qualitative research articles of HCV patients. The information collected from the review was used to develop a preliminary model of HRQoL in HCV patients. METHODS: Ovid Medline, Ovid Embase, Ovid PsycINFO and PubMed were searched for peer-reviewed journals from 1989 to 2012. Set inclusion/exclusion criteria were utilized with a focus on HRQoL among HCV patients. Eligible articles that met quality assessment criteria were analyzed using meta-synthesis to generate categories and themes to propose a conceptual model. RESULTS: Ten articles that met the inclusion/exclusion criteria and the quality assessment criteria were reviewed. Eleven themes were identified: physical symptoms, physical activities, guilt, stigma, emotional distress, psychological behavior, social relationship, social activities, work function, sexual function and cognitive function. These were further grouped into six HRQoL domains: physical, psychological/emotional, social, work, sexual and cognitive functionality. CONCLUSION: The systematic review and the proposed model represent a useful starting point in the critical appraisal of the conceptual underpinnings of PRO instruments used in HCV patients.
AIM: The Food and Drug Administration guidelines emphasize that patient-reported outcome (PRO) instruments used in clinical trials must be developed based on a conceptual model, yet existing PRO instruments currently used in clinical trials of hepatitis C virus (HCV) patients are not based on a predetermined model. The purpose of this study was to identify a comprehensive list of health-related quality of life (HRQoL) themes that may be unique to HCV by reviewing qualitative research articles of HCVpatients. The information collected from the review was used to develop a preliminary model of HRQoL in HCVpatients. METHODS: Ovid Medline, Ovid Embase, Ovid PsycINFO and PubMed were searched for peer-reviewed journals from 1989 to 2012. Set inclusion/exclusion criteria were utilized with a focus on HRQoL among HCVpatients. Eligible articles that met quality assessment criteria were analyzed using meta-synthesis to generate categories and themes to propose a conceptual model. RESULTS: Ten articles that met the inclusion/exclusion criteria and the quality assessment criteria were reviewed. Eleven themes were identified: physical symptoms, physical activities, guilt, stigma, emotional distress, psychological behavior, social relationship, social activities, work function, sexual function and cognitive function. These were further grouped into six HRQoL domains: physical, psychological/emotional, social, work, sexual and cognitive functionality. CONCLUSION: The systematic review and the proposed model represent a useful starting point in the critical appraisal of the conceptual underpinnings of PRO instruments used in HCVpatients.
Authors: Andrew Trigg; Eric Chan; Helen Kitchen; Tom Willgoss; Kai Fai Ho; Renee Pierson; Jane Scott Journal: J Health Econ Outcomes Res Date: 2019-02-18