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Understanding the epidemiology of avoidable significant harm in primary care: protocol for a retrospective cross-sectional study

Bell, Brian; Campbell, Stephen; Carson-Stevens, Andrew; Prosser Evans, Huw; Cooper, Alison; Brindley, Christina; Rodgers, Sarah; Johnson, Christine; Edwards, Adrian; Armstrong, Sarah; Mehta, Rajnikant; Chuter, Antony; Donnelly, Alisa; Ashcroft, Darren M.; Lymn, Joanne; Smith, Pam; Sheikh, Aziz; Boyd, Matthew; Avery, Anthony

Authors

Stephen Campbell

Andrew Carson-Stevens

Huw Prosser Evans

Alison Cooper

Christina Brindley

Sarah Rodgers

Adrian Edwards

Rajnikant Mehta

Antony Chuter

Alisa Donnelly

Darren M. Ashcroft

JOANNE LYMN joanne.lymn@nottingham.ac.uk
Professor of Healthcare Education

Pam Smith

Aziz Sheikh



Abstract

Introduction: Most patient safety research has focused on specialist-care settings where there is an appreciation of the frequency and causes of medical errors, and the resulting burden of adverse events. There have, however, been few large-scale robust studies that have investigated the extent and severity of avoidable harm in primary care. To address this, we will conduct a 12-month retrospective cross-sectional study involving case note review of primary care patients.

Methods and Analysis: We will conduct electronic searches of general practice (GP) clinical computer systems to identify patients with avoidable significant harm. Up to sixteen general practices from three areas of England (East Midlands, London and the North West) will be recruited based on practice size, to obtain a sample of around 100,000 patients. Our investigations will include an ‘enhanced sample’ of patients with the highest risk of avoidable significant harm. We will estimate the incidence of avoidable significant harm and express this as ‘per 100,000 patients per year’. Univariate and multivariate analysis will be conducted to identify the factors associated with avoidable significant harm.

Ethics/Dissemination: The decision regarding participation by general practices in the study is entirely voluntary; the consent to participate may be withdrawn at any time. We will not seek individual patient consent for the retrospective case note review, but if patients respond to publicity about the project and say they do not wish their records to be included we will follow these instructions. We will produce a report for the Department of Health’s Policy Research Programme and several high-quality peer-reviewed publications in scientific journals. The study has been granted a favourable opinion by the East Midlands Nottingham 2 Research Ethics Committee (reference 15/EM/0411) and Confidentiality Advisory Group approval for access to medical records without consent under section 251 of the NHS Act 2006 (reference 15/CAG/0182).

Citation

Bell, B., Campbell, S., Carson-Stevens, A., Prosser Evans, H., Cooper, A., Brindley, C., …Avery, A. (2017). Understanding the epidemiology of avoidable significant harm in primary care: protocol for a retrospective cross-sectional study. BMJ Open, 7(2), https://doi.org/10.1136/bmjopen-2016-013786

Journal Article Type Article
Acceptance Date Nov 10, 2016
Online Publication Date Feb 17, 2017
Publication Date Feb 1, 2017
Deposit Date Jan 13, 2017
Publicly Available Date Feb 1, 2017
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 7
Issue 2
Article Number e013786
DOI https://doi.org/10.1136/bmjopen-2016-013786
Keywords Patient safety, Medical errors, Avoidable harm, Primary care
Public URL http://eprints.nottingham.ac.uk/id/eprint/39837
Publisher URL http://bmjopen.bmj.com/content/7/2/e013786
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
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Correction B Bell BMJ Open 2017 e013786.full.pdf (1.2 Mb)
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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