Abstract
BACKGROUND: Lithium pharmacotherapy is an effective, first line treatment for bipolar disorder and included in the WHO list of essential medicines. However, it is underutilised because it has a narrow therapeutic window and requires therapeutic drug monitoring (TDM) to establish and maintain a safe dose. TDM is a barrier for new patients, increases patient burden, is stigmatising and may contribute to treatment non-compliance. For many clinicians, the narrow therapeutic window is problem enough for them to recommend a different pharmacotherapy. Recent technological advances indicate the potential to develop a small portable device for the TDM of lithium. AIMS & OBJECTIVES: The project aims to discover the views, perceptions and design preferences of clinicians who prescribe lithium and people with lived experience of lithium TDM for a small, portable device for the TDM of lithium. This project bridges the gap between technological innovations and the consumer by using an implementation science framework to explore barriers and facilitators to adopting this new technology. METHOD: Focus groups were used to gather information about experiences and attitudes towards lithium TDM from clinicians who have prescribed lithium to their patients and patients treated with lithium. Focus groups were conducted face to face or online and were recorded. Recordings transcribed for analysis by a commercial transcription company. Text was analysed using NVivo software. RESULTS: The patient focus groups were generally highly favourable towards the development of a portable TDM devise for lithium, mentioning themes of; greater independence and control over their treatment, increased safety and re-assurance, and decreased stigma. One participant disagreed and felt that the current system works well. Patients wanted a device that is easy and convenient to use. A discreet device that fits into a handbag was discussed. Additional features and utilities, such as also monitoring liver and thyroid function was requested. Cost was a major concern. The clinician focus group saw lithium as an essential “gold standard” treatment that is possibly underused due to concerns with safety and tolerability. Themes discussed included TDM as a barrier to treating people with lithium. Clinicians were supportive of a portable TDM device at the point of care. Concern was expressed that patients might use the device to self-titrate their dose. DISCUSSION & CONCLUSIONS: There is strong support for the development of a portable devise from patients and clinicians, evidenced by focus groups. Patients see it as a tool that may give them more independence and control over their treatment. Clinicians see it as a useful point of care tool. The request to also measure liver and thyroid function was rejected because these variables change slowly and are adequately served by current protocols. Important design characteristics are small size, robustness, low cost, and meeting or exceeding performance parameters of accuracy, precision, specificity and sensitivity. Additional functions are desirable, but not if they increase the cost to the consumer.