van der Weijst, L., Machingura, A., Alanya, A. et al. (21 more authors) (2024) Improving completion rates of patient-reported outcome measures in cancer clinical trials: Scoping review investigating the implications for trial designs. European Journal of Cancer, 212. 114313. ISSN 0959-8049
Abstract
Background Patient-reported outcomes (PROs) play a crucial role in cancer clinical trials. Despite the availability of validated PRO measures (PROMs), challenges related to low completion rates and missing data remain, potentially affecting the trial results’ validity. This review explored strategies to improve and maintain high PROM completion rates in cancer clinical trials. Methodology A scoping review was performed across Medline, Embase and Scopus and regulatory guidelines. Key recommendations were synthesized into categories such as stakeholder involvement, study design, PRO assessment, mode of assessment, participant support, and monitoring. Results The review identified 114 recommendations from 18 papers (16 peer-reviewed articles and 2 policy documents). The recommendations included integrating comprehensive PRO information into the study protocol, enhancing patient involvement during the protocol development phase and in education, and collecting relevant PRO data at clinically meaningful time points. Electronic data collection, effective monitoring systems, and sufficient time, capacity, workforce and financial resources were highlighted. Discussion Further research needs to evaluate the effectiveness of these strategies in various context and to tailor these recommendations into practical and effective strategies. This will enhance PRO completion rates and patient-centred care. However, obstacles such as patient burden, low health literacy, and conflicting recommendations may present challenges in application.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2024 The Author(s). This is an open access article under the terms of the Creative Commons Attribution License (CC-BY-NC-ND 4.0). |
Keywords: | Patient reported outcome measures, Review, Neoplasms, Completion rates, Trial conduct, Missing data |
Dates: |
|
Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Medical Research (LIMR) > Division of Oncology |
Depositing User: | Symplectic Publications |
Date Deposited: | 17 Oct 2024 08:56 |
Last Modified: | 18 Feb 2025 13:41 |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.ejca.2024.114313 |
Related URLs: | |
Sustainable Development Goals: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:218503 |