Abstract PS5-11-21: Evaluation of patient experience from participation in a randomised trial

Abstract Background: There are persistent barriers to recruitment of patients into surgical trials, especially those involving the process of randomization whereby there is uncertainty about allocation to an experimental intervention or standard treatment. A key challenge to recruitment relates to discrepant surgeon and patient preferences with lack of equipoise and a belief that outcomes for treatment options may differ in a predictable manner1. Trials involving novel methodology with limited data on efficacy compound these problems of recruitment. Minimal research has been undertaken on the process of randomization from a patient’s perspective and how this removes an element of management choice with a perceived obligation to accept the allocated treatment and not withdraw from the trial after randomization. This study aimed to explore patient experience from participation in a randomised trial evaluating fluorescent navigation with indocyanine green (ICG) for sentinel node localization in early breast cancer2. Methods: A questionnaire was issued retrospectively to all trial patients (n=100) with key themes that explored motivation for trial participation, attitudes to randomization, adequacy of information provision and concerns about standard tracer agents. Almost half (45%) of patients responded with data quantified using a 10 point Likert scale (strongly agree [1], strongly disagree [10]. A one-sample T-test determined significance of deviation from the hypothesized neutral value of six. A mixed-methods approach provided holistic assessment of patients’ experience with open-ended questions generating qualitative data for context. Employing a comprehensive post-study analysis, several positive messages were identified from this INFLUENCE trial that might inform the design and conduct of future surgical trials Results: A principle motivation for trial participation was a desire to help future patients (1.22; p