Development of a novel patient-reporting tool to assist identification of medicines-related issues for people with epilepsy

Medicines-related issues (M-RIs) experienced with the use of antiepileptic drugs (AEDs) are common, multifactorial and complex for People with Epilepsy (PwE), and a leading cause of treatment failure. M-RIs, further hindered by lack of communication between the patient and healthcare professionals (HCPs), can lead to suboptimal therapeutic self-management for PwE, non-adherence and discontinuation of vital medicines. Without timely intervention by the HCP, outcomes for patients are detrimental to health and often fatal. While health policy organisations have recommended development of standardised patient tools to assist with self-management and shared decision-making in the clinical setting, few exist, and none addressing M-RIs for PwE. The aim of this research was to investigate M-RIs from the perspective of PwE and their HCPs, and what tool may be developed to help and empower PwE to improve their experience of managing medicines.

This research programme applied a mixed methods approach, over three phases. In the exploratory phase, a generic scale - the Living with Medicines Questionnaire (LMQ-3) - was identified through systematic review as the most favourable starting point to explore M-RIs, then validated for use in a cohort of n=563 PwE and finally used to measure medicines burden in a UK representative sample of PwE. Next, in the development phase, interviews were conducted with n=61 PwE, and interviews and focus groups were held with n=24 HCPs from a variety of settings involving care of PwE to explore M-RIs. Interviews from this phase and qualitative data from questions from the exploratory phase were used to inform the initial item content, digital design, and proposed application of a comprehensive questionnaire battery – DeMIE (Determining Medicines-Related Issues for PwE) – addressing a range of topics identified as medicines-related issues. Finally, DeMIE was face validated by PwE, revised, and finalised as a patient reporting tool. The original contribution to knowledge presented in this thesis shows PwE in the UK experience a higher measured medicines burden score than the general population of medicine users, and that this is associated with particular demographic characteristics – particularly young people and those in need of carer assistance.

Furthermore, findings in this thesis show PwE were keen to advocate for themselves but needed further communication support to assist them to report medicines-related issues. The LMQ-3 was perceived by PwE to be a helpful instrument to report M-RIs but required more detail to allow reporting of issues. Using LMQ-3, PwE described their medicines-related issues, providing prominent themes of side effects, lack of effectiveness, interference in daily life, brands, supply and adherence, and later in this thesis, six main themes emerged from interviews, all of which were barriers to medicines self-management. Notably, some PwE reported feeling rushed or dismissed by HCPs, which led to mistrust. Healthcare professionals described the vital information required during consultations to deliver optimum care in an often time- and resource-pressured environment. The novel DeMIE questionnaire battery and summary report was developed in this study as digital tool from views of PwE and HCPs in response to patient needs for self-advocacy and self-management, and HCP required information. DeMIE is validated to enquire into all identified aspects of M-RIs for PwE, empowering the patient to communicate issues during consultation. For the healthcare professional, DeMIE provides a concise means to alleviate healthcare time pressures by allowing focus on vital detail for intervention and monitoring over time. Such instruments may be a vital link for improving patient monitoring and outcomes and informing future epilepsy healthcare policy and strategies.