The RAPID-RT study: results from a citizens’ jury exploring acceptable consent methods for the collection and analysis of real-world patient data

Abstract

Background: RAPID-RT uses routinely collected 'real-world' data to quickly determine the impact of changes in standard-of-care radiotherapy practices on patient outcomes. The study will provide an exemplar of how real-world data may provide prospective evidence in situations where randomised controlled trials, which are often non-inclusive, are impractical, such as the introduction of a heart-dose limit in curative-intent radiotherapy for patients with lung cancer. Ensuring patients are fully informed of how their data will be used in RAPID-RT is a key priority. Method(s): To choose an appropriate consent mechanism for the collection of anonymised routine patient data, we gauged the opinion of former patients, their carers, and members of the public in a 2-day citizens' jury. Contributors (n=24) heard about the background/ design of RAPID-RT, the ethical and legal bases of consent, different consent options, and from patients and researchers with direct experience of opt-in or opt-out processes. Jurors were polled at the start, middle, and end of the event, voting on: (1) what method of consent should be used to allow collection of patient data; and (2) how information on the study should be delivered to patients. Result(s): Jurors thought the study low risk to participants: all patients will receive standard-of-care radiotherapy and data are anonymised. Thus, 'opt-out' processes (79% agreement) were preferred. The jury unanimously stressed healthcare professionals should explain RAPID-RT to participants, alongside providing written information. The RAPID-RT study will therefore use informed verbal opt-out for anonymised data use following curative-intent radiotherapy for all patients with stage I-III lung cancer receiving the new standard-of-care heart-sparing radiotherapy protocol. RAPID-RT will be explained during patients' initial consultation, a simplified participant information sheet provided, and the option of viewing an information video given. Conclusion(s): This citizens' jury demonstrated that verbal opt-out for data collection is acceptable, minimising patient burden and ensuring inclusivity. Disclosure: No significant relationships. [Figure presented]Copyright © 2023 Elsevier B.V.