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

van der Weijst,Lotte; Machingura,Abigirl; Alanya,Ahu; Lidington,Emma; Velikova,Galina; Flechtner,Hans-Henning; Schmidt,Heike; Lehmann,Jens; Ramage,John K.; Ringash,Jolie; Wac,Katarzyna; Oliver,Kathy; Taylor,Katherine J.; Wintner,Lisa; Senna,L鷆ia P. C.; Koller,Michael; Husson,Olga; Bultijnck,Ren閑; Wilson,Roger; Singer,Susanne

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

All Authors

van der Weijst,Lotte

Machingura,Abigirl

Alanya,Ahu

Lidington,Emma

Velikova,Galina

Flechtner,Hans-Henning

Schmidt,Heike

Lehmann,Jens

Ramage,John K.

Ringash,Jolie

Show 10 more

LTHT Author

Velikova, Galina

LTHT Department

Oncology

Publication Date

2024

Item Type

Article

Abstract

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. 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. 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. 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. � Missing patient-reported outcome (PRO) data hinders the quality of cancer trial data. � Numerous strategies were identified to boost PRO measurement (PROM) completion rates. � Additional research is needed to assess feasibility and prioritize PROM completion strategies.