Mhatre Shivani K, Sansgiry Sujit S
Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, Houston, Texas, USA.
Hepatol Res. 2016 Jan;46(1):29-39. doi: 10.1111/hepr.12521. Epub 2015 May 22.
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.
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.
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.
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.
美国食品药品监督管理局的指南强调，临床试验中使用的患者报告结局（PRO）工具必须基于概念模型开发，但目前丙型肝炎病毒（HCV）患者临床试验中使用的现有PRO工具并非基于预先确定的模型。本研究的目的是通过回顾HCV患者的定性研究文章，确定可能是HCV特有的与健康相关生活质量（HRQoL）主题的综合列表。从回顾中收集的信息用于建立HCV患者HRQoL的初步模型。
检索1989年至2012年Ovid Medline、Ovid Embase、Ovid PsycINFO和PubMed上的同行评审期刊。采用设定的纳入/排除标准，重点关注HCV患者的HRQoL。对符合质量评估标准的合格文章进行元综合分析，以生成类别和主题，从而提出一个概念模型。
对10篇符合纳入/排除标准和质量评估标准的文章进行了回顾。确定了11个主题：身体症状、身体活动、内疚、耻辱感、情绪困扰、心理行为、社会关系、社会活动、工作功能、性功能和认知功能。这些主题进一步被归为六个HRQoL领域：身体、心理/情绪、社会、工作、性和认知功能。
系统评价和提出的模型是对HCV患者使用的PRO工具概念基础进行批判性评估的有用起点。
