Review of patient-reported outcome measures in chronic hepatitis C

Abstract

BackgroundChronic 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.MethodsA 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.ResultsThis 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.ConclusionsThis 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.

The importance of fatigue cognitions in chronic hepatitis C infection

“…The FSS showed excellent psychometric properties (internal consistency α = .94; test-retest reliability = .82, convergent validity with SF-36 vitality subscale r = − 0.76) in a multi-center clinical trial in chronic HCV infection [24]. It has been suggested that FSS is used as a patient reported-outcome measure in chronic HCV infection [5].…”

“…In qualitative studies, patients described fatigue as the most concerning symptom of their illness and in quantitative reports fatigue was the second most common patient-reported outcome measure of the infection [5]. In the presence of persistent fatigue, increased effort is required to maintain important social roles and activities.…”

“…Fatigue is among the leading patient-reported symptoms in chronic HCV infection [4,5]. In qualitative studies, patients described fatigue as the most concerning symptom of their illness and in quantitative reports fatigue was the second most common patient-reported outcome measure of the infection [5].…”

Validation of the Fatigue Severity Scale in chronic hepatitis C

“…Examples of the questions asked include “exercise brings on my fatigue” and “my fatigue is very debilitating”; a higher score indicates a higher degree of fatigue for all items [18]. The standard scoring for the FSS was used: the 9 items were averaged to produce an FSS total score that ranges from 1 (no fatigue) to 7 (very severe fatigue) with scores calculated for all patients who answered at least half the FSS items.…”

Incorporating Patient-Reported Outcomes Into Hepatitis C Virus Treatment Studies

“…PROMIS also features an Assessment Center, a free, online data collection tool that allows researchers to create study-specific websites, capture data electronically from patients, verify data integrity, store protected health information, and export to statistical software (http://www.assessmentcenter.net/). The development of new PRO measures specifically for HCV and antiviral therapy is burgeoning and warrants consideration for future PRO studies as well 10, 11 .…”