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

Autor:	Lehmann J; University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria jens.lehmann@i-med.ac.at., Krepper D; University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria., Pe M; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., Kuliś D; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., Giesinger JM; University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria., Sztankay M; University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria., Kern S; Electronic Clinical Outcome Assessment Consortium, Critical Path Institute, Tucson, Arizona, USA., Fitzsimmons D; Swansea Centre for Health Economics, Swansea University, Swansea, UK., Holzner B; University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Sep 10; Vol. 14 (9), pp. e084935. Date of Electronic Publication: 2024 Sep 10.
DOI:	10.1136/bmjopen-2024-084935
Abstrakt:	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. Competing Interests: Competing interests: BH owns intellectual property rights to the software CHES, a software for electronic data capture. JL reports consultancy for Evaluation Software Development Gmbh. All remaining authors declare no conflicts of interest. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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