Title: Understanding the Nature and Frequency of Avoidable Harm In Primary Care
Funder: Department of Health and Social Care

Abstract: Background Despite widespread concerns about safety in healthcare, surprisingly little is known about the nature and frequency of avoidable harm in primary healthcare. Members of our team have just completed the largest ever systematic review of the burden of harm in primary care involving 16 systematic reviews and 200 primary studies5. Focusing on the more robust studies suggests that errors occur in around 3% of primary care encounters, and around one in 10 of these result in harm that has a substantial impact on the well-being of patients. There is an important need, however, for a large-scale epidemiological study to estimate the incidence of avoidable harm in primary health care in England, as robust evidence is lacking. Aims and objectives Aim: to better understand the nature and frequency of avoidable harm in primary healthcare in England. Objectives: 1) To estimate the incidence of avoidable significant harm in primary care in England 2) To quantify, describe and classify the different types of avoidable significant harm, and their severity 3) To identify ameliorable factors that, if addressed, could help reduce the incidence of avoidable significant harm in primary care in England 4) Based on the findings of the research, to advise on a) the development of new measures for the NHS Outcomes Framework; b) future assessments of avoidable harm in primary care; c) interventions to reduce the incidence of avoidable harm. Research plan and methods of investigation We will undertake a large retrospective cohort study involving case note review of patient records in a geographically-representative random sample of general practices in England. Within the practices we will search the clinical computer systems to identify an enhanced sample of patients most likely to have experienced harm. Experienced GPs, specially trained to undertake the case note reviews, and backed up by a team of other primary care health professionals, will rigorously examine the records of these patients to identify avoidable significant harm over a 12 month period. Detailed anonymised data relating to these patients will be fed back to the research team who will classify and analyse the data to address the objectives of the study. Research team Our team has extensive expertise in relation to patient safety in primary care (Avery, Campbell and Sheikh, each have over 15 years experience). Avery has led a number of relevant major projects including the most comprehensive study internationally of prescribing errors in general practice6. Campbell is Principal Investigator for the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre, and Sheikh leads the WHO Safer Primary Care Expert Working Group (which also includes Avery, Carson-Stevens and Panesar). Our team is currently undertaking a major investigation of the National Reporting and Learning System in relation to errors in primary care (Carson-Stevens, Edwards, Avery, Sheikh, Panesar), which informs the current proposal, and we have well established PPI collaborators (Chuter, Donnelly). Potential impact The findings of our research will almost certainly have an important impact on NHS policy in England in relation to patient safety in primary care. For the first time, the NHS will have robust evidence of the nature and frequency of avoidable harm in primary care and will be able to develop policies and strategic implementation plans to address the problems identified in order to improve patient safety. The research will also help practitioners in primary care to identify the ways in which they can change their working practices to minimise the risk of avoidable harm. The findings will also help patients and patient groups to identify ways in which they can advocate for improvements in safety in primary healthcare.

Lay abstract: Safe care for patients includes not harming them either by actions healthcare professionals have taken or by actions they have not taken ( avoidable harm ). Many studies have been done in hospitals to find out how often this occurs and what the causes may be. However, although most patient consultations occur in primary care, particularly general practice, very little research has been carried out on avoidable harm and how to improve safety for patients in this setting. The first aim of this study is to find out how common avoidable harm is in general practice. We will identify patients potentially at high risk of harm and look back at their records to see if any harm actually occurred. Experienced and independent GPs will examine records of these patients in 16 general practices in different regions in England, covering a population of 100,000. The researchers will analyse this information to find out how often patients have been harmed by failures in their primary healthcare. The second aim of the study will work out why, when and how such harm occurs &ndash; its nature and causes. Our findings will feed into the third aim, where we will use this understanding to advise the NHS in England how to improve safety in primary healthcare. Patients/members of the public have already helped in designing this study, particularly concerning confidentiality of patient records and data protection. They will continue to be involved throughout the study as members of the Project Management Group, advising on all aspects and participating in key discussions and decisions, including classification of avoidable harms and advice to policy makers. Our findings will be published in a report to the Department of Health, and also in professional academic journals. Information will also be made available to the public and organisations/charities concerned with patient safety (using presentations/focus groups, social media, and liaison with the media), so that as many people as possible can be informed and actively involved in increasing patient safety in primary healthcare.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE