International perspectives on suboptimal patient‐reported outcome trial design and reporting in cancer clinical trials: A qualitative study. (5th July 2021)

• Record Type: Journal Article
• Authors: 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; Mercieca‐Bebber, Rebecca; King, Madeleine T.; Kyte, Derek
• Is Part Of: Cancer medicine. Volume 10:Number 16(2021)
• Page Start: 5475
• Page End: 5487
• Publication Date: 2021-07-05
• Subjects: cancer -- patient‐reported outcomes -- protocol -- qualitative -- reporting -- trials; 616.994005
• DOI: 10.1002/cam4.4111
• Languages: English
• ISSNs: 2045-7634

Abstract

Abstract: 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. Abstract : Patient‐reported outcomes (PROs) capture patients' experience of the physical, functional, and psychological effects of disease and treatment. However, research to date indicates the design and reporting of PRO data in cancer clinical trials are suboptimal. Our findings highlight a number of potential factors contributing to observed suboptimal PRO protocol quality and reporting in cancer clinical trials. We provide potential solutions to uphold best practice to improve the quality of PRO data for the benefit of cancer patients.