Rogers, SN, Lowe, D, Highet, V et al. (4 more authors) (2022) Patient characteristics and refusal to participate in a head and neck cancer intervention trial: experience of two tertiary UK head and neck cancer centres. Annals of The Royal College of Surgeons of England, 104 (2). pp. 121-124. ISSN 0035-8843
Abstract
Introduction
Randomised clinical trials are an essential component for robust clinical evaluation. They are expensive to deliver but can fail to achieve the required outcomes. This paper reports details of trial recruitment in a head and neck Patient Concerns Inventory intervention trial from two UK head and neck tertiary centres.
Materials and methods
Data were collected for a pragmatic cluster preference randomised control trial with 15 consultants recruiting patients treated with curative intent after a diagnosis of head and neck cancer (all sites, disease stages, treatments). Ethical approval was given to report on those not recruited by the following characteristics: trial site, trial arm, age, sex, tumour site, overall stage, index of multiple deprivation quintile, timeframe.
Results
There were 368 patients approached who remained eligible and 80 (22%) declined to participate. Logistic regression suggested that age group (p = 0.008) and index of multiple deprivation quintile group (p = 0.003) were independent predictors of refusal.
Conclusions
Although recruitment to the trial was very good, it raised the issue of lower recruitment in the more deprived older group and lower social economic strata. Innovative ways need to be explored to facilitate the ‘hard to reach’ group contributing to, and benefiting from, clinical trials.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2021, All rights reserved by the Royal College of Surgeons of England. This is an author produced version of an article published in Annals of The Royal College of Surgeons of England. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Head and neck cancer recruitment; Health-related quality of life; Intervention; Patient concerns inventory; Prompt list; Randomised clinical trial |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Dentistry (Leeds) > School of Dentistry Visitors (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 05 May 2021 10:33 |
Last Modified: | 25 Jun 2023 22:38 |
Published Version: | https://publishing.rcseng.ac.uk/doi/10.1308/rcsann... |
Status: | Published |
Publisher: | Royal College of Surgeons of England |
Identification Number: | 10.1308/rcsann.2021.0166 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:173347 |