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

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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.
Keywords
Patient reported outcome measures, Review, Neoplasms, Completion rates, Trial conduct, Missing data, QUALITY-OF-LIFE, ONCOLOGY

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MLA
van der Weijst, Lotte, et al. “Improving Completion Rates of Patient-Reported Outcome Measures in Cancer Clinical Trials : Scoping Review Investigating the Implications for Trial Designs.” EUROPEAN JOURNAL OF CANCER, vol. 212, 2024, doi:10.1016/j.ejca.2024.114313.
APA
van der Weijst, L., Machingura, A., Alanya, A., Lidington, E., Velikova, G., Flechtner, H.-H., … EORTC Quality Life Grp, [missing]. (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. https://doi.org/10.1016/j.ejca.2024.114313
Chicago author-date
Weijst, Lotte van der, Abigirl Machingura, Ahu Alanya, Emma Lidington, Galina Velikova, Hans-Henning Flechtner, Heike Schmidt, et al. 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. https://doi.org/10.1016/j.ejca.2024.114313.
Chicago author-date (all authors)
van der Weijst, Lotte, 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 Singer, Vesna Bjelic-Radisic, Winette T.A. van der Graaf, Madeline Pe, and [missing] EORTC Quality Life Grp. 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. doi:10.1016/j.ejca.2024.114313.
Vancouver
1.
van der Weijst L, Machingura A, Alanya A, Lidington E, Velikova G, Flechtner H-H, et al. Improving completion rates of patient-reported outcome measures in cancer clinical trials : scoping review investigating the implications for trial designs. EUROPEAN JOURNAL OF CANCER. 2024;212.
IEEE
[1]
L. van der Weijst et al., “Improving completion rates of patient-reported outcome measures in cancer clinical trials : scoping review investigating the implications for trial designs,” EUROPEAN JOURNAL OF CANCER, vol. 212, 2024.
@article{01J87DN2FEDQ32ZJAFAZ34M4WP,
  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.}},
  articleno    = {{114313}},
  author       = {{van der Weijst, Lotte and Machingura, Abigirl and Alanya, Ahu and Lidington, Emma and Velikova, Galina and Flechtner, Hans-Henning and Schmidt, Heike and Lehmann, Jens and Ramage, John K. and Ringash, Jolie and Wac, Katarzyna and Oliver, Kathy and Taylor, Katherine J. and Wintner, Lisa and Senna, Lúcia P.C. and Koller, Michael and Husson, Olga and Bultijnck, Renée and Wilson, Roger and Singer, Susanne and Bjelic-Radisic, Vesna and van der Graaf, Winette T.A. and Pe, Madeline and EORTC Quality Life Grp, [missing]}},
  issn         = {{0959-8049}},
  journal      = {{EUROPEAN JOURNAL OF CANCER}},
  keywords     = {{Patient reported outcome measures,Review,Neoplasms,Completion rates,Trial conduct,Missing data,QUALITY-OF-LIFE,ONCOLOGY}},
  language     = {{eng}},
  pages        = {{9}},
  title        = {{Improving completion rates of patient-reported outcome measures in cancer clinical trials : scoping review investigating the implications for trial designs}},
  url          = {{http://doi.org/10.1016/j.ejca.2024.114313}},
  volume       = {{212}},
  year         = {{2024}},
}

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