TY - JOUR
T1 - Improving completion rates of patient-reported outcome measures in cancer clinical trials
T2 - Scoping review investigating the implications for trial designs
AU - van der Weijst, Lotte
AU - Machingura, Abigirl
AU - Alanya, Ahu
AU - Lidington, Emma
AU - Velikova, Galina
AU - Flechtner, Hans Henning
AU - Schmidt, Heike
AU - Lehmann, Jens
AU - Ramage, John K.
AU - Ringash, Jolie
AU - Wac, Katarzyna
AU - Oliver, Kathy
AU - Taylor, Katherine J.
AU - Wintner, Lisa
AU - Senna, Lúcia P.C.
AU - Koller, Michael
AU - Husson, Olga
AU - Bultijnck, Renée
AU - Wilson, Roger
AU - Singer, Susanne
AU - Bjelic-Radisic, Vesna
AU - van der Graaf, Winette T.A.
AU - Pe, Madeline
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/11
Y1 - 2024/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85204487836&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2024.114313
DO - 10.1016/j.ejca.2024.114313
M3 - Review article
C2 - 39305741
AN - SCOPUS:85204487836
SN - 0959-8049
VL - 212
JO - European Journal of Cancer
JF - European Journal of Cancer
M1 - 114313
ER -