An Educational Digital Tool to Improve the Implementation of Switching to a Biosimilar (Rapid Switch Trainer): Tool Development and Validation Study

Abstract

BACKGROUND: Switching to biosimilars is an effective and safe practice in treating inflammatory diseases; however, a nocebo effect may arise as a result of the way in which the switch is communicated to a given patient. OBJECTIVE: We aimed to design a gaming-based digital educational tool (including a discussion algorithm) to support the training of health care professionals in efficiently communicating the switch to biosimilars, minimizing the generation of a nocebo effect and thus serving as an implementation strategy for the recommended switch. METHODS: The tool was developed based on interviews and focus group discussions with key stakeholders, both patients and health care professionals. Messages likely to either generate trust or to trigger a nocebo effect were generated on the basis of the interviews and focus group discussions. RESULTS: A total 7 clinicians and 4 nurses specializing in rheumatology, gastroenterology, and dermatology, with balanced levels of responsibility and experience, as well as balance between geographic regions, participated in the structured direct interviews and provided a list of arguments they commonly used, or saw used, to justify the switching, and objections given by the patients they attended. Patients with immune-mediated inflammatory diseases who were taking biologic drugs with (n=4) and without (n=5) experience in switching attended the focus groups and interviews. Major topics of discussion were the reason for the change, the nature of biosimilars, and their quality, safety, efficacy, and cost. Based on these discussions, a list of objections and of potential arguments was produced. Patients and health care professionals rated the arguments for their potential to evoke trust or a nocebo effect. Two sets of arguments, related to savings and sustainability, showed discrepant ratings between patients and health care professionals. Objections and arguments were organized by categories and incorporated into the tool as algorithms. The educators then developed additional arguments (with inadequate answers) to complement the valid ones worked on in the focus groups. The tool was then developed as a collection of clinical situations or vignettes that appear randomly to the user, who then has to choose an argument to counteract the given objections. After each interaction, the tool provides feedback. The tool was further supported by accredited medical training on biosimilars and switching. CONCLUSIONS: We have developed a digital training tool to improve communication on switching to biosimilars in the clinic and prevent a nocebo effect based on broad and in-depth experiences of patients and health care professionals. The validation of this implementation strategy is ongoing.