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

José Joaquín Mira, Irene Carrillo, María Teresa Gea Velázquez de Castro, Carmen Silvestre, Guadalupe Olivera, Johanna Caro-Mendivelso, Pastora Pérez-Pérez, Yolanda Agra, Ana Mª Fernández, Jesús Maria Aranaz-Andrés, SOBRINA Research Team, Ana María Ariztegui, María Pilar Astier, María Concepción Carratalá, Ana María Cebrián, Javier González, Cristina Mª Nebot, Mª Ángeles Nuin, Ángela Rincón, José María Ruiz, María Luisa Torijano, Julián Vitaller, Elena Zavala, José Joaquín Mira, Irene Carrillo, María Teresa Gea Velázquez de Castro, Carmen Silvestre, Guadalupe Olivera, Johanna Caro-Mendivelso, Pastora Pérez-Pérez, Yolanda Agra, Ana Mª Fernández, Jesús Maria Aranaz-Andrés, SOBRINA Research Team, Ana María Ariztegui, María Pilar Astier, María Concepción Carratalá, Ana María Cebrián, Javier González, Cristina Mª Nebot, Mª Ángeles Nuin, Ángela Rincón, José María Ruiz, María Luisa Torijano, Julián Vitaller, Elena Zavala

Abstract

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.

Keywords: overuse; patient safety; primary care; quality assurance; scientific societies.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Steps in the design, review and approval of this study.
Figure 2
Figure 2
Flow diagram for the SOBRINA study. AEs, adverse events.
Figure 3
Figure 3
Overview of methods, data sources, sampling and measures of SOBRINA study. DNDs, do-not-do recommendations; AEs, adverse events.

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