Recommendations for Incorporating Patient-Reported Outcomes Into Clinical Comparative Effectiveness Research in Adult Oncology
Abstract
Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.
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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].”
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“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].”
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- Authors
- 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., Frank, E. S., Lipscomb, J., Raymond, S. A., Spencer, M., & Tunis, S.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2012-12-01
- Volume
- 30
- Issue
- 34
- Pages
- 4249-4255
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2087202287
- Cited by
- 476
- References
- 25
- Citations by year
- 2026: 11 · 2025: 19 · 2024: 18 · 2023: 27 · 2022: 28 · 2021: 35 · 2020: 50 · 2019: 31 · 2018: 35 · 2017: 41 · 2016: 50 · 2015: 44 · 2014: 51 · 2013: 27 · 2012: 4
- FWCI
- 19.92
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- patient-reported outcomes, comparative effectiveness research, adult oncology, health-related quality of life, symptom assessment, EORTC QLQ-C30, facts, PRO-CTCAE, PROMIS, electronic data collection, missing data, responder analysis, patient experience
- MeSH terms
- Adult, Humans, Medical Oncology, Neoplasms, Research Design, Outcome Assessment, Health Care, Comparative Effectiveness Research, Self Report
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