Objective To estimate the incidence of avoidable significant harm in primary care in England; describe and classify the associated patient safety incidents and generate suggestions to mitigate risks of ameliorable factors contributing to the incidents.
Design Retrospective case note review. Patients with significant health problems were identified and clinical judgements were made on avoidability and severity of harm. Factors contributing to avoidable harm were identified and recorded.
Setting Primary care.
Participants Thirteen general practitioners (GPs) undertook a retrospective case note review of a sample of 14 407 primary care patients registered with 12 randomly selected general practices from three regions in England (total list size: 92 255 patients).
Main outcome measures The incidence of significant harm considered at least ‘probably avoidable’ and the nature of the safety incidents.
Results The rate of significant harm considered at least probably avoidable was 35.6 (95% CI 23.3 to 48.0) per 100 000 patient-years (57.9, 95% CI 42.2 to 73.7, per 100 000 based on a sensitivity analysis). Overall, 74 cases of avoidable harm were detected, involving 72 patients. Three types of incident accounted for more than 90% of the problems: problems with diagnosis accounted for 45/74 (60.8%) primary incidents, followed by medication-related problems (n=19, 25.7%) and delayed referrals (n=8, 10.8%). In 59 (79.7%) cases, the significant harm could have been identified sooner (n=48) or prevented (n=11) if the GP had taken actions aligned with evidence-based guidelines.
Conclusion There is likely to be a substantial burden of avoidable significant harm attributable to primary care in England with diagnostic error accounting for most harms. Based on the contributory factors we found, improvements could be made through more effective implementation of existing information technology, enhanced team coordination and communication, and greater personal and informational continuity of care.
- primary care
- general practice
- patient safety
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Contributors All authors made a substantial contribution to the conception or design of the work; or the acquisition, analysis or interpretation of data for the work. Specifically, AJA, ACh, AC-S, AD, AE, AS, DMA, HPE, MJB, SMC, SA and SR conceived the study; AJA, ACh, AC-S, AD, AE, AS, DMA, HPE, JL, MJB, PS, RM, SMC, SA and SR designed the study; AJA, AC-S, CS, DMA, SMC and SR recruited the general practitioner (GP) reviewers and practices; AJA, AC-S, AE, CS and HPE trained the GP reviewers; AJA, ACh, ACo, AC-S, AD, AE, CS, DMA, HPE, JL, MJB, SMC, SH and SR designed the data collection process; AJA, ACo, AC-S, AE, BB, HW and SH processed the data; AJA, ACo, AC-S, AE, HW, and SH contributed to team judgements of avoidability of harm; AJA, ACo, AC-S, AE, BB and HW analysed the data, and all authors were involved in interpretation of the data; AJA, AC-S, AE, AS, BB, CS, DMA and SMC drafted the paper and all authors revised it critically for important intellectual content; all authors gave the final approval of the version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. AJA is the guarantor for the paper and accepts full responsibility for the work and/or the conduct of the study, had access to the data and controlled the decision to publish.
Funding This paper is based on independent research commissioned and funded by the National Institute for Health Research (NIHR) Policy Research Programme (‘Understanding the Nature and Frequency of Avoidable Harm in Primary Care’, Ref: PR-R11-0914-11001). General practitioner time was funded by the NIHR Greater Manchester Patient Safety Translational Research Centre (NIHR Greater Manchester PSTRC).
Disclaimer The views expressed in the publication are those of the authors and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study had NHS research ethics committee approval and was granted a favourable opinion by the East Midlands Nottingham 2 Research Ethics Committee on 15 January 2016 (reference: 15/EM/0411) and Confidentiality Advisory Group approval for access to medical records without consent under section 251 of the NHS Act 2006 on 11 April 2016 (reference: 15/CAG/0182). Research and development approval was obtained for the Clinical Commissioning Groups, where the study occurred.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Anonymised summary data extracted from patient records regarding the avoidable harms detected in this study will be available upon reasonable request.
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