title: Epidemiology of Patient Harms in New Zealand: Protocol of a General Practice Records Review Study.
abstract: BACKGROUND
  Knowing 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.
  
  
  OBJECTIVE
  We 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.
  
  
  RESULTS
  We 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Department of General Practice and Rural Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: Susan M
authors.identifier: http://orcid.org/0000-0003-3653-7726
authors.initials: SM
authors.lastname: Dovey
authors.affiliation: Department of General Practice and Rural Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: Sharon
authors.identifier: http://orcid.org/0000-0001-9939-8773
authors.initials: S
authors.lastname: Leitch
authors.affiliation: Department of General Practice and Primary Health Care, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
authors.forename: Katharine A
authors.identifier: http://orcid.org/0000-0002-2580-9362
authors.initials: KA
authors.lastname: Wallis
authors.affiliation: Department of General Practice and Primary Health Care, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
authors.forename: Kyle S
authors.identifier: http://orcid.org/0000-0001-5645-8326
authors.initials: KS
authors.lastname: Eggleton
authors.affiliation: RCSI Medical University Bahrain, Adliya, Bahrain.
authors.forename: Wayne K
authors.identifier: http://orcid.org/0000-0002-9246-4309
authors.initials: WK
authors.lastname: Cunningham
authors.affiliation: Department of General Practice and Rural Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: Martyn I
authors.identifier: http://orcid.org/0000-0003-1237-4045
authors.initials: MI
authors.lastname: Williamson
authors.affiliation: Department of General Practice and Primary Health Care, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
authors.forename: Steven
authors.identifier: http://orcid.org/0000-0002-8051-0443
authors.initials: S
authors.lastname: Lillis
authors.affiliation: Te Ngae Medical Centre, Rotorua, New Zealand.
authors.forename: Andrew W
authors.identifier: http://orcid.org/0000-0003-4772-3786
authors.initials: AW
authors.lastname: McMenamin
authors.affiliation: Department of General Practice and Rural Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: Murray W
authors.identifier: http://orcid.org/0000-0001-8600-929X
authors.initials: MW
authors.lastname: Tilyard
authors.affiliation: Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: David M
authors.identifier: http://orcid.org/0000-0002-2447-365X
authors.initials: DM
authors.lastname: Reith
authors.affiliation: Department of Preventive and Social Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: Ari
authors.identifier: http://orcid.org/0000-0003-4933-9569
authors.initials: A
authors.lastname: Samaranayaka
authors.affiliation: Best Practice Advocacy Centre Inc, Dunedin, New Zealand.
authors.forename: Jason E
authors.identifier: http://orcid.org/0000-0002-8027-4751
authors.initials: JE
authors.lastname: Hall
keywords: New Zealand; electronic health records; general practice; patient harm; retrospective studies; safety