Open AccessInternational perspectives on suboptimal patient‐reported outcome trial design and reporting in cancer clinical trials: A qualitative study
Author(s) -
Retzer Ameeta,
Calvert Melanie,
Ahmed Khaled,
Keeley Thomas,
Armes Jo,
Brown Julia M.,
Calman Lynn,
Gavin Anna,
Glaser Adam W.,
Greenfield Diana M.,
Lanceley Anne,
Taylor Rachel M.,
Velikova Galina,
Brundage Michael,
Efficace Fabio,
MerciecaBebber Rebecca,
King Madeleine T.,
Kyte Derek
Publication year - 2021
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.4111
Subject(s) - thematic analysis , stakeholder , protocol (science) , inclusion (mineral) , clinical trial , qualitative research , medicine , research design , qualitative property , publication , data collection , medical education , best practice , psychology , family medicine , alternative medicine , public relations , social psychology , political science , computer science , social science , statistics , mathematics , pathology , machine learning , sociology , law
Purpose Evidence suggests that the patient‐reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non‐reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions. Methods Semi‐structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame. Results Forty‐four interviews were undertaken. Several factors were identified that could influenced effective integration of PROs into trials and subsequent findings. Participants described (1) late inclusion of PROs in trial design; (2) PROs being considered a lower priority outcome compared to survival; (3) trialists’ reluctance to collect or report PROs due to participant burden, missing data, and perceived reticence of journals to publish; (4) lack of staff training. Strategies to address these included training research personnel and improved communication with site staff and patients regarding the value of PROs. Examples of good practice were identified. Conclusion Misconceptions relating to PRO methodology and its use may undermine their planning, collection, and reporting. There is a role for funding, regulatory, methodological, and journalistic institutions to address perceptions around the value of PROs, their position within the trial outcomes hierarchy, that PRO training and guidance is available, signposted, and readily accessible, with accompanying measures to ensure compliance with international best practice guidelines.