Incorporating Patient-Reported Outcomes Into Hepatitis C Virus Treatment Studies
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There is a need in clinical hepatology studies to capture patient-reported experiences using patient-reported outcome measures (PROMs) to complement traditional clinician-reported adverse events and laboratory markers.
“There is also a need in clinical hepatology studies to capture patient-reported experiences using patient-reported outcome measures (PROMs) to complement traditional clinician-reported adverse events and laboratory markers [7, 8].”
From Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C (2018) · cites this paper as [8]
In “Incorporating Patient-reported Outcomes into HCV Treatment Studies” (page unavailable), the paper says patient-reported outcomes capture experiences not readily captured by clinician reports or objective markers and provide complementary information about treatment benefits and harms. Its recommendation concerns hepatitis C treatment research specifically; it does not establish the need across clinical hepatology studies generally. (LLM, conf=0.83)
Experimental — accuracy not yet measuredPROMs are used less often in clinical hepatology studies.
“PROMs are often the best method for evaluating clinical improvements in mental and physical health outcomes in other medical populations but are used less often in clinical hepatology studies [8].”
From Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C (2018) · cites this paper as [8]
In “Incorporating Patient-reported Outcomes into HCV Treatment Studies” (page unavailable), the paper contrasts established use of patient-reported outcomes in oncology with their limited publication and proposed wider use in HCV treatment research. That supports the claim for HCV studies, but the paper does not establish that these measures are used less often across clinical hepatology studies generally. (LLM, conf=0.84)
Experimental — accuracy not yet measured
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Cites
U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, & U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health (2006) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-4-79 · Cited by 2,856 · see citing works
Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection
Lawitz, E., Mangia, A., Wyles, D. L., Rodriguez‐Torres, M., Hassanein, T., Gordon, S. C., Schultz, M., Davis, M. N., Kayali, Z., Reddy, K. R., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1214853 · Cited by 1,783 · see citing works
Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options
Jacobson, I. M., Gordon, S. C., Kowdley, K. V., Yoshida, E. M., Rodriguez‐Torres, M., Sulkowski, M., Shiffman, M. L., Lawitz, E., Everson, G. T., Bennett, M., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1214854 · Cited by 1,087 · see citing works
Basch, E., Abernethy, A. P., Mullins, C. D., Reeve, B. B., Smith, M. L., Coons, S. J., Sloan, J., Wenzel, K., Chauhan, C., Eppard, W., et al. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2012.42.5967 · Cited by 476 · see citing works
Ahmed, S., Berzon, R. A., Revicki, D. A., Lenderking, W. R., Moinpour, C. M., Basch, E., Reeve, B. B., & Wu, A. W. (2012) · Medical Care · doi:10.1097/mlr.0b013e318268aaff · Cited by 272 · see citing works
Land, S. R., Wickerham, D. L., Costantino, J. P., Ritter, M. W., Vogel, V. G., Lee, M., Pajon, E. R., Wade, J. L., Dakhil, S. R., Lockhart, J. B., et al. (2006) · JAMA · doi:10.1001/jama.295.23.joc60075 · Cited by 237 · see citing works
Basch, E. (2013) · Annual Review of Medicine · doi:10.1146/annurev-med-010713-141500 · Cited by 139 · see citing works
Patient-Reported Outcomes Assessment in Cancer Trials: Taking Stock, Moving Forward
Lipscomb, J., Reeve, B. B., Clauser, S. B., Abrams, J. S., Bruner, D. W., Burke, L. B., Denicoff, A. M., Ganz, P. A., Gondek, K., Minasian, L. M., et al. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2007.12.4644 · Cited by 135 · see citing works
Younossi, Z. M., Stepanova, M., Henry, L. L., Gane, E. J., Jacobson, I. M., Lawitz, E., Nelson, D. R., Gerber, L. H., Nader, F., & Hunt, S. (2013) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2013.11.032 · Cited by 93 · see citing works
HCV Treatment — No More Room for Interferonologists?
Drenth, J. P. H. (2013) · New England Journal of Medicine · doi:10.1056/nejme1303818 · Cited by 37 · see citing works
Review of patient-reported outcome measures in chronic hepatitis C
Kleinman, L., Mannix, S., Yuan, Y., Kummer, S., L'Italien, G. J., & Revicki, D. A. (2012) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-10-92 · Cited by 32 · see citing works
Anderson, R. T., Baran, R. W., Erickson, P., Revicki, D. A., Dietz, B., & Gooch, K. L. (2013) · Quality of Life Research · doi:10.1007/s11136-013-0519-1 · Cited by 19 · see citing works
Hopwood, M. (2013) · Psychology Health & Medicine · doi:10.1080/13548506.2013.774429 · Cited by 5 · see citing works
Treatment of Hepatitis C Virus Infection in Adults: Future Research Needs
Chou, R., Bougatsos, C., Blazina, I., Dana, T., & Cantor, A. G. (2013) · Cited by 2 · see citing works
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Marcellin, F., Roux, P., Protopopescu, C., Duracinský, M., Spire, B., & Carrieri, P. (2017) · Expert Review of Gastroenterology & Hepatology · doi:10.1080/17474124.2017.1285227 · Cited by 50 · see citing works
Evon, D. M., Golin, C. E., Ruffin, R., Ayres, S., & Fried, M. W. (2018) · Pilot and Feasibility Studies · doi:10.1186/s40814-018-0285-5 · Cited by 8 · see citing works
“There is also a need in clinical hepatology studies to capture patient-reported experiences using patient-reported outcome measures (PROMs) to complement traditional clinician-reported adverse events and laboratory markers [7, 8].”
BackgroundMethodSelf-citationNg, X., Nwankwo, C. N., Arduino, J. M., Corman, S. L., Lasch, K., Lustrino, J., Patel, S., Platt, H. L., Qiu, J., & Šperl, J. (2018) · Patient Preference and Adherence · doi:10.2147/ppa.s172732 · Cited by 8 · see citing works
Impact of Chronic Hepatitis B Infection on Patient-Reported Outcomes
Biswas, R., Golabi, P., & Younossi, Z. M. (2018) · Current Hepatology Reports · doi:10.1007/s11901-018-0434-6
- Authors
- Evon, D. M.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Evon, Donna M.
- ORCID
- Evon, Donna M.
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2014-08
- Volume
- 12
- Issue
- 8
- Pages
- 1360-1362
- ISSN
- 1542-3565 (ISSN-L)
- PMC
- PMC4104216
- OpenAlex
- W1992058806
- Cited by
- 4
- References
- 13
- Citations by year
- 2018: 3 · 2017: 1
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases (P30AI050410)
- National Institute of Diabetes and Digestive and Kidney Diseases (K23DK089004)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (K24HD069204)
- Topics
- Health Sciences › Medicine › Hepatology › Hepatitis C virus research
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- patient-reported outcomes, hepatitis C virus, antiviral therapy, health-related quality of life, symptom reporting, treatment side effects, functional status, clinical trial endpoints
- MeSH terms
- Sofosbuvir, Antiviral Agents, Humans, Interferons, Uridine Monophosphate, Hepatitis C, Chronic
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