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Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review

Jens Lehmann Orcid Logo, Daniela Krepper, Madeline Pe, Dagmara Kuliś, Johannes M Giesinger, Monika Sztankay, Scottie Kern, Deborah Fitzsimmons Orcid Logo, Bernhard Holzner

BMJ Open, Volume: 14, Issue: 9, Start page: e084935

Swansea University Author: Deborah Fitzsimmons Orcid Logo

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DOI (Published version): 10.1136/bmjopen-2024-084935

Abstract

Background There are different modes and ways to assess patient-reported outcomes (PROs) in clinical trials. However, there is little systematic information on how often different modes of assessment (MOA) are used in cancer clinical trials and how exactly assessments are conducted. The goal of this...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: BMJ 2024
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URI: https://cronfa.swan.ac.uk/Record/cronfa68403
Abstract: Background There are different modes and ways to assess patient-reported outcomes (PROs) in clinical trials. However, there is little systematic information on how often different modes of assessment (MOA) are used in cancer clinical trials and how exactly assessments are conducted. The goal of this scoping review is to gain an understanding of the MOA and data management of PROs in cancer randomised controlled trials (RCTs) and the reporting quality thereof.Methods and analysis This scoping review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Relevant trials will be identified via their indexed publications. We will search PubMed for RCTs conducted in cancer populations that evaluate a biomedical treatment with a PRO endpoint. Trials with publications published between January 2019 and November 2023 will be included. Two independent reviewers will review the references for both the abstract and full-text screening. We will extract data from the publications from a trial and the trial protocol if a protocol can be traced. Data will be summarised at the trial level. We will focus on a descriptive analysis of the MOA of PROs and on the relative frequencies of the different MOA. We will also evaluate the quality of reporting for the relevant SPIRIT and CONSORT guidelines that refer to the assessment of PROs in trials. Due to the scoping nature of our review, we will not perform a dedicated quality assessment of all trials.Ethics and dissemination The proposed review is based on secondary, published data. Hence, no ethics review is necessary. The review is part of an ongoing project on the use of electronic data capture methods in cancer clinical trials. The findings from the review will support the project and contribute to synthesising guidance to ultimately improve the (electronic) measurement of patient-reported outcome measures in clinical trials.
College: Faculty of Medicine, Health and Life Sciences
Funders: Funding for this study was provided by the EORTC Quality of Life Group (grant number 008- 2023).
Issue: 9
Start Page: e084935

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