Monitoring benefits and risks of medicines for overactive bladder in primary care; building a bridge between daily practice and research

Background: Monitoring benefits and risks of medicines in the postmarketing phase is important for a safe and effective treatment of patients. Aim of this project is to develop a flexible infrastructure with general practitioner's (GP) routine electronic health records triggering the collection of patient reported outcomes (PROs) regarding the effect and adverse reactions (ADRs) of pharmaceutical treatment. Objectives: To evaluate the feasibility of acquiring real world data to monitor the effects and ADRs of medicines. Methods: For this pilot study, two general practices in the Netherlands were included. Overactive bladder (OAB) was used as a use case. OAB patients were flagged in electronic health records data that are collected by Nivel on a weekly basis. The GPs checked whether the patient was eligible for the study. PROs were obtained by an electronic survey, using the Lareb Intensive Monitoring system. Questions involved bladder complaints, treatment (physiotherapeutic interventions and medicines), ADRs, therapy compliance, and quality of life. Results: 109 OAB patients were flagged in the electronic health records data. After revision by the GPs, an invitation to participate was sent to 82 (75%) patients. Reasons for excluding patients were: patient cannot work with a computer or questionnaire (10x), cognitive/ mentally not fit to fill in questionnaire (10x), patient in hospital (3x), patient died/moved (2x). GPs were enthusiastic about the study procedure. Nineteen patients (23%) filled in the questionnaire. Average age was 63 years (38-79 years) and 14 of them were women. Patients reported an average score of 4.0 for urogenital complaints, on a scale from 1 (none) to 10 (very much). Eleven patients received physiotherapeutic interventions and 5 received medicines to treat the OAB. Of these, 3 patients experienced ADRs. Conclusions: The developed infrastructure is successful in providing clear information about patients' perspective of the benefit and ADRs of their treatment at relatively low effort. The pilot shows that information about effectiveness and ADRs of medicines can be acquired using this system. The system is designed to be applied to any new medication on the market and has several advantages above more traditional monitoring instruments like longer follow-up, and a real life setting.