title: Review of patient-reported outcome measures in chronic hepatitis C.
abstract: BACKGROUND
  Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design.
  
  
  METHODS
  A three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest.
  
  
  RESULTS
  This multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations.
  
  
  CONCLUSIONS
  This review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to ensure that CHC clinical trials evaluate concepts that are important to patients and include measures that have evidence supporting content validity, reliability, construct validity, and responsiveness.
authors.affiliation: United BioSource Corporation, Bethesda, MD, USA. leah.kleinman@unitedbiosource.com
authors.forename: Leah
authors.initials: L
authors.lastname: Kleinman
authors.forename: Sally
authors.initials: S
authors.lastname: Mannix
authors.forename: Yong
authors.initials: Y
authors.lastname: Yuan
authors.forename: Shannon
authors.initials: S
authors.lastname: Kummer
authors.forename: Gilbert
authors.initials: G
authors.lastname: L'Italien
authors.forename: Dennis
authors.initials: D
authors.lastname: Revicki
mesh_terms: D002986:Clinical Trials as Topic; D006304:Health Status; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011788:Quality of Life; D057566:Self Report