SOBRINA Spanish study-analysing the frequency, cost and adverse events associated with overuse in primary care: protocol for a retrospective cohort study

Introduction: Several institutions and quality national agencies have fostered the creation of recommendations on what not to do to reduce overuse in clinical practice. In primary care, their impact has hardly been studied. The frequency of adverse events (AEs) associated with doing what must not be done has not been analysed, either. The aim of this study is to measure the frequency of overuse and AEs associated with doing what must not be done (commission errors) in primary care and their cost.

Methods and analysis: A coordinated, multicentric, national project. A retrospective cohort study using computerised databases of primary care medical records from national agencies and regional health services will be conducted to analyse the frequency of the overuse due to ignore the do-not-do recommendations, and immediately afterwards, depending on their frequency, a representative random sample of medical records will be reviewed with algorithms (triggers) that determine the frequency of AEs associated with these recommendations. Cost will determine by summation of the direct costs due to the consultation, pharmacy, laboratory and imaging activities according to the cases.

Ethics and dissemination: The study protocol has been approved by the Ethics Committee of Primary Care Research of the Valencian Community. We aim to disseminate the findings through international peer-reviewed journals and on the website (http://www.nohacer.es/). Outcomes will be used to incorporate algorithms into the electronic history to assist in making clinical decisions.

Trial registration number: NCT03482232; Pre-results.