Improving completion rates of patient-reported outcome measures in cancer clinical trials: Scoping review investigating the implications for trial designs

Lotte van der Weijst*, Abigirl Machingura, Ahu Alanya, Emma Lidington, Galina Velikova, Hans Henning Flechtner, Heike Schmidt, Jens Lehmann, John K. Ramage, Jolie Ringash, Katarzyna Wac, Kathy Oliver, Katherine J. Taylor, Lisa Wintner, Lúcia P.C. Senna, Michael Koller, Olga Husson, Renée Bultijnck, Roger Wilson, Susanne SingerVesna Bjelic-Radisic, Winette T.A. van der Graaf, Madeline Pe

*Corresponding author for this work

Research output: Contribution to journalReview articleAcademicpeer-review

2 Downloads (Pure)

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.

Original languageEnglish
Article number114313
JournalEuropean Journal of Cancer
Volume212
DOIs
Publication statusPublished - Nov 2024

Bibliographical note

Publisher Copyright:
© 2024 The Authors

Fingerprint

Dive into the research topics of 'Improving completion rates of patient-reported outcome measures in cancer clinical trials: Scoping review investigating the implications for trial designs'. Together they form a unique fingerprint.

Cite this