ReviewHealth and quality of life outcomes2012
Review of patient-reported outcome measures in chronic hepatitis C.
Review in Health and quality of life outcomes, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed.
- Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3 study (OPTIMIST-2).Hepatology (Baltimore, Md.) · 2016Trial
- Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection.BMC infectious diseases · 2014Trial
- Measurement properties of the flu-like symptom index from the hepatitis physical symptom severity diary.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014Trial
- Tolvaptan versus other interventions for hyponatraemia in people with cirrhosis.The Cochrane database of systematic reviews · 2025Article
- Article
- Symptoms and functioning improve after chronic hepatitis C cure as assessed by the Memorial Symptom Assessment Scale and PROMIS measures.Journal of viral hepatitis · 2021Article
- Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study.Liver international : official journal of the International Association for the Study of the Liver · 2021Observational
- Evolution of Hepatitis C Virus Treatment During the Era of Sofosbuvir-Based Therapies: A Real-World Experience in France.Digestive diseases and sciences · 2021Article
- Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study.Journal of hepatology · 2019Observational
- Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy.Alimentary pharmacology & therapeutics · 2018Article
- Evaluation of health status in patients with hepatitis c treated with and without interferon.Health and quality of life outcomes · 2018Observational
- Psychosocial and Neurocognitive Factors Associated With Hepatitis C - Implications for Future Health and Wellbeing.Frontiers in psychology · 2018Review
- Observational
- Quality of life in Brazilian patients with treated or untreated chronic hepatitis C.Revista do Instituto de Medicina Tropical de Sao Paulo · 2017Article
- Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.Contemporary clinical trials · 2017Observational
- The International development of PROQOL-HCV: An instrument to assess the health-related quality of life of patients treated for Hepatitis C virus.BMC infectious diseases · 2016Article
- Incorporating patient-reported outcomes into hepatitis C virus treatment studies.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2014Article
- Validation of the Fatigue Severity Scale in chronic hepatitis C.Health and quality of life outcomes · 2014Article
- Development and initial psychometric evaluation of the hepatitis C virus-patient-reported outcomes (HCV-PRO) instrument.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014Article
- Health related quality of life among patients with chronic hepatitis C: a cross-sectional study of sociodemographic, psychopathological and psychiatric determinants.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.