title: Understanding the epidemiology of avoidable significant harm in primary care: protocol for a retrospective cross-sectional study.
abstract: 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.
  
  
  
  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.
  
  
  
  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regarding participation by general practices in the study is entirely voluntary; the consent to participate may be withdrawn at any time.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).
authors.affiliation: Division of Primary Care, School of Medicine, University of Nottingham Medical School, Queen's Medical Centre, Nottingham, UK.
authors.forename: Brian G
authors.initials: BG
authors.lastname: Bell
authors.affiliation: NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre, Centre for Primary Care, Institute of Population Health, University of Manchester, Manchester, UK.|Centre for Research and Action in Public Health (CeRAPH), University of Canberra, University Drive, Bruce, Australian Capital Territory, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Campbell
authors.affiliation: Division of Population Medicine, Cardiff University School of Medicine, Neuadd Meirionnydd Heath Park, Cardiff, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Carson-Stevens
authors.affiliation: Division of Population Medicine, Cardiff University School of Medicine, Neuadd Meirionnydd Heath Park, Cardiff, UK.
authors.forename: Huw Prosser
authors.initials: HP
authors.lastname: Evans
authors.affiliation: Division of Population Medicine, Cardiff University School of Medicine, Neuadd Meirionnydd Heath Park, Cardiff, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Cooper
authors.affiliation: Division of Primary Care, School of Medicine, University of Nottingham Medical School, Queen's Medical Centre, Nottingham, UK.
authors.forename: Christina
authors.initials: C
authors.lastname: Sheehan
authors.affiliation: Division of Primary Care, School of Medicine, University of Nottingham Medical School, Queen's Medical Centre, Nottingham, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Rodgers
authors.affiliation: Division of Primary Care, School of Medicine, University of Nottingham Medical School, Queen's Medical Centre, Nottingham, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: Johnson
authors.affiliation: Division of Population Medicine, Cardiff University School of Medicine, Neuadd Meirionnydd Heath Park, Cardiff, UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Edwards
authors.affiliation: NIHR Research Design Service, School of Medicine, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Armstrong
authors.affiliation: NIHR Research Design Service, School of Medicine, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
authors.forename: Rajnikant
authors.initials: R
authors.lastname: Mehta
authors.affiliation: 68 Brighton Cottages, Copyhold Lane, Lindfield, Haywards Heath, UK.
authors.forename: Antony
authors.initials: A
authors.lastname: Chuter
authors.affiliation: PRIMER (Primary Care Research in Manchester Engagement Resource), The University of Manchester, Manchester, UK.
authors.forename: Ailsa
authors.initials: A
authors.lastname: Donnelly
authors.affiliation: NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre, Centre for Primary Care, Institute of Population Health, University of Manchester, Manchester, UK.|Centre for Pharmacoepidemiology and Drug Safety, University of Manchester, Manchester, UK.
authors.forename: Darren M
authors.initials: DM
authors.lastname: Ashcroft
authors.affiliation: School of Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Lymn
authors.affiliation: The School of Health in Social Science, Teviot Place, The University of Edinburgh, Midlothian, Edinburgh, UK.
authors.forename: Pam
authors.initials: P
authors.lastname: Smith
authors.affiliation: Usher Institute of Population Health Sciences and Informatics, Teviot Place, The University of Edinburgh, Midlothian, Edinburgh, UK.
authors.forename: Aziz
authors.initials: A
authors.lastname: Sheikh
authors.affiliation: Division of Pharmacy Practice and Policy, School of Pharmacy, University of Nottingham, University Park, Nottingham, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Boyd
authors.affiliation: Division of Primary Care, School of Medicine, University of Nottingham Medical School, Queen's Medical Centre, Nottingham, UK.
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Avery
mesh_terms: D003430:Cross-Sectional Studies; D003625:Data Collection; D057286:Electronic Health Records; D004739:England / Q000453:epidemiology; D058006:General Practice / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D019300:Medical Errors / Q000145:classification / Q000517:prevention & control / Q000706:statistics & numerical data*; D061214:Patient Safety / Q000706:statistics & numerical data*; D011320:Primary Health Care / Q000706:statistics & numerical data*; D012107:Research Design; D012189:Retrospective Studies; D012307:Risk Factors
keywords: GENERAL MEDICINE (see Internal Medicine); PRIMARY CARE