Velikova, G., Amdal, C., Falk, R.S. et al. (57 more authors) (Accepted: 2025) SISAQOL-IMI consensus-based guidelines to design, analyse, interpret and present patient-reported outcomes in cancer clinical trials. The Lancet Oncology. ISSN: 1470-2045 (In Press)
Abstract
Standardising the implementation of patient-reported outcomes (PROs) in clinical trials is crucial for evaluating the benefits and risks of cancer treatments. The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) has developed 146 consensus-based recommendations for designing, analysing, interpreting and presenting PROs in cancer clinical trials. This initiative, undertaken from 2021 to 2025, involved experts, including statisticians, PRO measurement experts, clinicians, and patient representatives from 41 organisations representing regulatory agencies, academia, the pharmaceutical industry, health-technology assessment bodies and patient advocates. SISAQOL-IMI provides guidance on implementation of PRO in randomised controlled trials and single arm trials, terminology, definitions and selection of PRO score interpretation thresholds, and visualising PRO results for different audiences. To facilitate the implementation of these standards, in addition to this publication, four key outputs are available: an interactive table, a guidebook, plain language materials and a glossary.
Metadata
| Item Type: | Article |
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| Authors/Creators: |
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| Copyright, Publisher and Additional Information: | This is an author produced version of an article accepted for publication in The Lancet Oncology, made available under the terms of the Creative Commons Attribution License (CC-BY), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited. |
| Keywords: | patient-reported outcomes; quality of life; statistical analysis; recommendations; cancer clinical trials; consensus |
| Dates: |
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| Institution: | The University of Leeds |
| Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) |
| Date Deposited: | 22 Oct 2025 08:42 |
| Last Modified: | 23 Oct 2025 14:31 |
| Status: | In Press |
| Publisher: | Elsevier |
| Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:233264 |
CORE (COnnecting REpositories)
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