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BMJ Open. 2017 Feb 17;7(2):e013786. doi: 10.1136/bmjopen-2016-013786.

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

Author information

1
Division of Primary Care, School of Medicine, University of Nottingham Medical School, Queen's Medical Centre, Nottingham, UK.
2
NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre, Centre for Primary Care, Institute of Population Health, University of Manchester, Manchester, UK.
3
Centre for Research and Action in Public Health (CeRAPH), University of Canberra, University Drive, Bruce, Australian Capital Territory, Australia.
4
Division of Population Medicine, Cardiff University School of Medicine, Neuadd Meirionnydd Heath Park, Cardiff, UK.
5
NIHR Research Design Service, School of Medicine, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
6
68 Brighton Cottages, Copyhold Lane, Lindfield, Haywards Heath, UK.
7
PRIMER (Primary Care Research in Manchester Engagement Resource), The University of Manchester, Manchester, UK.
8
Centre for Pharmacoepidemiology and Drug Safety, University of Manchester, Manchester, UK.
9
School of Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
10
The School of Health in Social Science, Teviot Place, The University of Edinburgh, Midlothian, Edinburgh, UK.
11
Usher Institute of Population Health Sciences and Informatics, Teviot Place, The University of Edinburgh, Midlothian, Edinburgh, UK.
12
Division of Pharmacy Practice and Policy, School of Pharmacy, University of Nottingham, University Park, Nottingham, UK.

Erratum in

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 16 general practices from 3 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).

KEYWORDS:

GENERAL MEDICINE (see Internal Medicine); PRIMARY CARE

PMID:
28213602
PMCID:
PMC5318597
DOI:
10.1136/bmjopen-2016-013786
[Indexed for MEDLINE]
Free PMC Article

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