JMIR Publications

ABSTRACT

Background:

Real world data from electronic health records (EHR) represent a wealth of information to study the benefits and risks of medical treatment. However, they are also limited in scope and should be complemented by information from the patient perspective.

Objective:

To develop an innovative research infrastructure that combines information from EHR with patient experiences reported in questionnaires to monitor risks and benefits of medical treatment.

Methods:

We focused on treatment of overactive bladder (OAB) in general practice as a use case. To develop the Benefit, Risk of Medical Treatment Monitor (BRIMM) infrastructure, we first performed a requirement analysis. BRIMM’s starting point are routinely recorded general practice EHR data which are sent to the Dutch Nivel Primary Care Database (Nivel-PCD) on a weekly basis. Patients with OAB were flagged weekly on the basis of diagnoses and prescriptions. They were invited subsequently for participation by their general practitioner (GP), via a trusted third party. Patients received a series of questionnaires on disease status, (non)pharmacological treatments, adverse drug reactions, drug adherence, and quality of life. The questionnaires and a dedicated feedback portal were developed in collaboration with patient association for pelvic related diseases “Bekkenbodem4All”. Participating patients and GPs received feedback. An expert meeting was organized to assess strengths, weaknesses and opportunities and threats of the new research infrastructure.

Results:

The BRIMM infrastructure was developed and implemented. In Nivel-PCD 2,933 patients with OAB from 27 general practices were flagged. GPs selected 1,636 patients (56%) who were eligible for the study, of whom 295 (18% of eligible patients) filled out the first questionnaire. 288 patients (98%) consented to linkage of their questionnaire data to their EHR data. According to experts, strengths of the infrastructure were the linkage of patient reported outcomes (PRO) with EHR data, comparison of (non) pharmacological treatments, flexibility of the infrastructure and low registration burden for GPs. Methodological weaknesses, such as susceptibility to bias, patient selection, and low participation rate among GPs and patients were seen as weakness and threat. Opportunities represent usefulness for policy makers, health professionals, and conditional approval of medication, data linkage to other data sources, and feedback to patients.

Conclusions:

The BRIMM research infrastructure has the potential to assess benefits and safety of (medical) treatment in real life situations, using a unique combination of EHRs and PROs. As patient involvement is an important aspect of the treatment process, generating knowledge from a clinical and patient perspective is valuable for healthcare providers, patients and policy makers. The developed methodology can be easily applied to other treatments and health problems.