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Development of a conceptual model of health‐related quality of life among hepatitis C patients: A systematic review of qualitative studies
Author(s) -
Mhatre Shivani K.,
Sansgiry Sujit S.
Publication year - 2016
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.12521
Subject(s) - psycinfo , medline , medicine , critical appraisal , quality of life (healthcare) , qualitative research , clinical psychology , cognition , psychology , alternative medicine , psychiatry , nursing , pathology , social science , sociology , political science , law
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.