Epidemiology of Patient Harms in New Zealand: Protocol of a General Practice Records Review Study

Abstract

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.

Characteristics of a stratified random sample of New Zealand general practices

“…The study's bespoke data extraction software could access only the medtech patient management system (PmS), so its use was a prerequisite for participation. 12 We aimed to enrol 10 general practices in each study group to ensure SHarP achieved national geographic distribution by the sampling process. Before sampling, we estimated that 80% of general practices used medtech, and oversampled to account for expected ineligibility (due to incompatible PmSs), drawing a simple random sample of 12 general practices in each study group.…”

“…little is known about the structural in the Safety, Harms and risk reduction Project (SHarP), we postulated that the size and location of general practices may affect patient safety. 12 european research found doctors worked more hours in smaller practices. 13 in the United States, small practices judged themselves safer 14 and more responsive to quality improvement incentives, 15 yet were less likely to introduce quality improvement activities than large practices.…”

“…25 SHarP is a study using retrospective records review over the calendar years 2011, 2012 and 2013, aiming to describe the epidemiology of patient harm observable in general practice records. 12 The protocol for this stratified, twolevel cluster, retrospective records review study has been described elsewhere. 12 The study design allows comparison between six study groups: small rural, medium rural, large rural, small urban, medium urban and large urban general practices.…”

“…12 The protocol for this stratified, twolevel cluster, retrospective records review study has been described elsewhere. 12 The study design allows comparison between six study groups: small rural, medium rural, large rural, small urban, medium urban and large urban general practices. The current research aims to describe the characteristics of the SHarP practices, and to compare the characteristics of the six study groups of practices to assist the interpretation of study data later when we compare differences between study groups in terms of patients' experiences of harm rates arising from health care.…”

Research using electronic health records: Balancing confidentiality and public good

“…We conducted a retrospective records review study in general practice to identify and describe patient harms: the SHARP study (Safety, Harms And Risk reduction Project). 16 Eight GP reviewers reviewed three years of de-identified electronic health records from 9000 randomly selected patients. The focus of the study was on harm, not error, defined as the physical or emotional negative consequences arising from healthcare.…”