While the complaints process is intended to improve healthcare, some doctors appear to practise defensive medicine after receiving a complaint. This response occurs in countries that use a tort-based medicolegal system as well as in countries with less professional liability. Defensive medicine is based on avoiding malpractice liability rather than considering a risk-benefit analysis for both investigations and treatment. There is also evidence that this style of practice is low quality in terms of decision-making, cost and patient outcomes. Western medical practice is based on biomedicine: determining medical failure using the underlying, taken-for-granted assumptions of biomedicine can potentially contribute to a response of shame after an adverse outcome or a complaint. Shame is implicated in the observable changes in practising behaviour after receipt of a complaint. Identifying and responding to shame is required if doctors are to respond to a complaint with an overall improvement in clinical practice. This will eventually improve the outcomes of the complaints process.

BackgroundKnowing where and why harm occurs in general practice will assist patients, doctors, and others in making informed decisions about the risks and benefits of treatment options. Research to date has been unable to verify the safety of primary health care and epidemiological research about patient harms in general practice is now a top priority for advancing health systems safety.ObjectiveWe aim to study the incidence, distribution, severity, and preventability of the harms patients experience due to their health care, from the whole-of-health-system lens afforded by electronic general practice patient records.Methods“Harm” is defined as disease, injury, disability, suffering, and death, arising from the health system. The study design is a stratified, 2-level cluster, retrospective records review study. Both general practices and patients will be randomly selected so that the study’s results will apply nationally, after weighting. Stratification by practice size and rurality will allow comparisons between 6 study groups (large, medium-sized, small; urban and rural practices). Records of equal numbers of patients from each study group will be included in the study because there may be systematic differences in patient harms in different types of practices. Eight general practitioner investigators will review 3 years of electronic general practice health records (consultation notes, prescriptions, investigations, referrals, and summaries of hospital care) from 9000 patients registered in 60 general practices. Double-blinded reviews will check the concordance of reviewers’ assessments. Study data will comprise demographic data of all 9000 patients and reviewers’ assessments of whether patients experienced harm arising from health care. Where patient harm is identified, their types, preventability, severity, and outcomes will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) 18.0.ResultsWe have recruited practices and collected electronic records from 9078 patients. Reviews of these records are under way. The study is expected to be completed in August 2017.ConclusionsThe design of this complex study is presented with discussion on data collection methods, sampling weights, power analysis, and statistical approach. This study will show the epidemiology of patient harms recorded in general practice records for all of New Zealand and will show whether this epidemiology differs by rural location and clinic size.

INTRODUCTION Practice size and location may affect the quality and safety of health care. Little is known about contemporary New Zealand general practice characteristics in terms of staffing, ownership and services. AIM To describe and compare the characteristics of small, medium and large general practices in rural and urban New Zealand. METHODS Seventy-two general practices were randomly selected from the 2014 Primary Health Organisation database and invited to participate in a records review study. Forty-five recruited practices located throughout New Zealand provided data on staff, health-care services and practice ownership. Chi-square and other non-parametric statistical analyses were used to compare practices. RESULTS The 45 study practices constituted 4.6% of New Zealand practices. Rural practices were located further from the nearest regional base hospital (rural median 65.0 km, urban 7.5 km (P < 0.001)), nearest local hospital (rural 25.7 km, urban 7.0 km (P = 0.002)) and nearest neighbouring general practitioner (GP) (rural 16.0 km, urban 1.0 km (P = 0.007)). In large practices, there were more enrolled patients per GP FTE than both medium-sized and small practices (mean 1827 compared to 1457 and 1120 respectively, P = 0.019). Nurses in large practices were more likely to insert intravenous lines (P = 0.026) and take blood (P = 0.049). There were no significant differences in practice ownership arrangements according to practice size or rurality. CONCLUSION Study practices were relatively homogenous. Unsurprisingly, rural practices were further away from hospitals. Larger practices had higher patient-to-doctor ratios and increased nursing scope. The study sample is small; findings need to be confirmed by specifically powered research.

General practitioners are increasingly approached to participate in research and share de-identified patient information. Research using electronic health records has considerable potential for improving the quality and safety of patient care. Obtaining individual patient consent for the use of the information is usually not feasible. In this article we explore the ethical issues in using personal health information in research without patient consent including the threat to confidentially and the doctor-patient relationship, and we discuss how the risks can be minimised and managed drawing on our experience as general practitioners and researchers.

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