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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
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spelling 2025-02-04T12:12:54.1024959 v2 68403 2024-12-02 Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 2024-12-02 HSOC 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. Journal Article BMJ Open 14 9 e084935 BMJ 2044-6055 2044-6055 10 9 2024 2024-09-10 10.1136/bmjopen-2024-084935 COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University Another institution paid the OA fee Funding for this study was provided by the EORTC Quality of Life Group (grant number 008- 2023). 2025-02-04T12:12:54.1024959 2024-12-02T09:24:11.0175975 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Public Health Jens Lehmann 0000-0002-4670-7517 1 Daniela Krepper 2 Madeline Pe 3 Dagmara Kuliś 4 Johannes M Giesinger 5 Monika Sztankay 6 Scottie Kern 7 Deborah Fitzsimmons 0000-0002-7286-8410 8 Bernhard Holzner 9 68403__33490__d7aac69510c6485f84331fd19f02c062.pdf 68403.VoR.pdf 2025-02-04T12:10:47.8193669 Output 258897 application/pdf Version of Record true © Author(s) (or their employer(s)) 2024. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license. true eng http://creativecommons.org/licenses/by-nc/4.0/
title Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review
spellingShingle Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review
Deborah Fitzsimmons
title_short Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review
title_full Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review
title_fullStr Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review
title_full_unstemmed Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review
title_sort Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review
author_id_str_mv e900d99a0977beccf607233b10c66b43
author_id_fullname_str_mv e900d99a0977beccf607233b10c66b43_***_Deborah Fitzsimmons
author Deborah Fitzsimmons
author2 Jens Lehmann
Daniela Krepper
Madeline Pe
Dagmara Kuliś
Johannes M Giesinger
Monika Sztankay
Scottie Kern
Deborah Fitzsimmons
Bernhard Holzner
format Journal article
container_title BMJ Open
container_volume 14
container_issue 9
container_start_page e084935
publishDate 2024
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2024-084935
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care - Public Health{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Public Health
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description 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.
published_date 2024-09-10T05:25:23Z
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