Background
Review objective and research questions
Methods
Scope of the review
Inclusion and exclusion criteria
Inclusion criteria (both Question 1 and Question 2) | ||
---|---|---|
Setting | Inpatient, outpatient, primary and secondary care; public & private; high income countries; English language | |
Care type | Chronic care, acute care, surgical and hospital interventions | |
Complaints/claims | Regulatory or direct to practice/hospital complaints. Litigated or unlitigated claims | |
Study design | Systematic reviews, randomised controlled trials, cohort, case–control, interrupted time series, pre-post | |
Question 1—patient characteristics | Question 2—remedial interventions | |
Participants | Patients and family members | Doctors |
Exposure/intervention characteristics | Patient socio-demographics (e.g. age, gender, nationality), diagnosis, medical history, relationship with doctor, setting, family involvement | Education for doctors including communication and risk mitigation strategies, workflow, change roles and responsibilities |
Outcomes | Number or rate of complaints/claims | Number or rate of complaints/claims, claims management, patient or doctor satisfaction, doctor risk profile or performance, doctor confidence |
Search strategy and selection criteria
Quality appraisal
Data collection
Synthesis
Results
Literature search
Question 1
First author (year) [citation] | Design | Critical appraisal | Country | Setting | Specialty | Condition | Type | Warranted or unwarranted | Patient characteristics | ||
---|---|---|---|---|---|---|---|---|---|---|---|
Y | N | NA or CD | |||||||||
Facchin (2023) [29] | A comparative study with concurrent controls | 6 | 4 | 2 | Italy | In-patient hospital | Bariatric surgery | Obesity | Malpractice claims | Both | Type of body contouring procedure |
Grandizio (2021) [24] | A comparative study with concurrent controls | 8 | 2 | 2 | USA | Mixed | Hand surgery | Hand surgery | Complaint | n/s | Age, sex, BMI > 30, race, marital status, employment status, tobacco use, insurance status, mental behavioural or neurological disorder, diagnosis, treatment, complications |
Jones (2021) [27] | A comparative study with concurrent controls | 8 | 2 | 2 | UK | In-patient hospital | Neurosurgery | Chronic subdural haematoma | Complaint | n/s | Age, sex, complainant, ASA score, referred from other hospital, LOS, time from admission to operation, reoperation, complications |
Kynes (2013) [25] | A comparative study with concurrent controls | 9 | 2 | 1 | USA | In-patient hospital | Anaesthesiology | Mixed | Complaint | n/s | Age, sex, race, procedural features (e.g. use of anaesthesia, actual minus scheduled start time), ASA score |
Rae (2022) [26] | A comparative study with concurrent controls | 9 | 1 | 2 | USA | In-patient hospital | Orthopaedic surgery | Spinal surgery | Complaint | n/s | Age, sex, BMI > 30, race, marital status, employment status, tobacco use, insurance status, treatment (surgery), mental behavioural or neurological disorder, worker's compensation |
Reader (2014) [3] | Other: systematic review of non-RCTs or literature review | 4 | 7 | 5 | – | Mixed | Mixed | Mixed | Complaint | n/s | Sex, complainant, setting |
Robin Taylor (2020) [28] | A comparative study with concurrent controls | 10 | 0 | 2 | UK | In-patient hospital | Medical and surgical wards | End of life | Complaint | n/s | Age, sex, expected death, setting, LOS, advance plans, clinical 'problems', non-beneficial interventions, harms, treatment escalation limitation plan (TELP) |
Question 2
First author (year) [citation] | Design NHMRC | Critical appraisal | Country | Setting | Specialty | Condition | Type | Warranted or unwarranted | Intervention type | ||
---|---|---|---|---|---|---|---|---|---|---|---|
Y | N | NA or CD | |||||||||
Adams (2014) [15] | Case series | 8 | 2 | 2 | USA | In-patient hospital | Gastroenterology | Gastrointestinal diseases | Malpractice claims | n/s | Communication and resolution program |
Barragry (2016) [42] | Case series | 9 | 1 | 2 | Ireland | Primary care | General practice | Mixed | Complaint | n/s | Risk management program |
Cardoso (2017) [31] | Other—Systematic review of non-RCTs | 9 | 2 | 5 | USA | Secondary care (specialist) | Obstetrics | Obstetrics and gynaecology | Malpractice claims | n/s | Communication and resolution program; Risk management program |
Cosman (2011) [30] | Case series | 4 | 3 | 4 | USA | In-patient hospital | General surgery | n/a | Regulatory | n/s | Medical remediation program |
Diraviam (2018) [32] | Case series | 3 | 5 | 4 | USA | In-patient hospital | Mixed | Mixed | Malpractice claims | n/s | Risk management program |
Durand (2015) [44] | A systematic review of Level II studies | 11 | 2 | 3 | – | Mixed | Mixed | Mixed | Malpractice claims | n/s | Shared decision-making |
Fustino (2019) [33] | Case series | 6 | 3 | 3 | USA | In-patient hospital | Mixed | Mixed | Complaint | n/s | Communication and resolution program |
Juo (2019) [34] | Case series | 6 | 5 | 1 | USA | In-patient hospital | General surgery | n/a | Malpractice claims | n/s | Risk management program |
Kachalia (2018) [13] | A comparative study with concurrent controls | 8 | 3 | 1 | USA | In-patient hospital | Mixed | Mixed | Malpractice litigation | n/s | Communication and resolution program |
LeCraw (2018) [35] | Case series | 10 | 1 | 1 | USA | In-patient hospital | Mixed | Mixed | Malpractice claims | n/s | Communication and resolution program |
Lillis (2014) [43] | Case series | 7 | 4 | 1 | New Zealand | Mixed | Mixed | n/a | Regulatory | n/s | Medical remediation program |
Milne (2013) [40] | Case series | 6 | 5 | 1 | Canada | In-patient hospital | Mixed | Obstetrics and gynaecology | Malpractice claims | n/s | Risk management program |
Nassiri (2019) [36] | Case series | 11 | 1 | 0 | USA | In-patient hospital | Otolaryngology | u/k | Complaint | n/s | Peer program |
O'Brien (2014) [12] | Case series | 8 | 4 | 0 | UK | Mixed | Mixed | n/a | Mix | n/s | Medical remediation program |
Pichert (2013) [25] | Case series | 11 | 1 | 0 | USA | In-patient hospital | Mixed | u/k | Complaint | n/s | Peer program |
Raper (2017) [38] | Case series | 7 | 2 | 3 | USA | In-patient hospital | General surgery | Surgical | Malpractice claims | n/s | Risk management program |
Schaffer (2021) [39] | Case series | 11 | 0 | 1 | USA | In-patient hospital | Obstetrics and gynaecology | Obstetrics and gynaecology | Malpractice claims | n/s | Simulation training |
Wenghofer (2015) [41] | A comparative study with concurrent controls | 8 | 3 | 1 | Canada | Mixed | Mixed | n/a | Complaint | Warranted | Continuing professional development |
Type of intervention | Definition | Total | ↓Claims | ↓ Complaints | ↓ Claims costs, or premiums | More timely management | ↓ Doctor risk profile/ ↑ performance | ↑ Staff confidence/knowledge | ↑ Culture | ↑ Patient satisfaction |
---|---|---|---|---|---|---|---|---|---|---|
Risk management program | “a formal approach encompassing evaluation of complaints, improved communication in relation to complaints, and more direct use of insights gained from complaints analysis” [42] | 6 | ~ [31] | ✓ [42] | ✓[42] | – | ✓[40] | – | ||
Communication and resolution program | CRPs aim to better communicate adverse events to patients, investigate and explain what happened; provide emotional support; and apologise and proactively offer compensation if appropriate [35]. CRPs involve communication between doctor and patient outside the court setting to reach a mutual agreement to resolve the dispute and fair compensation and include apology laws in which apologies made by medical practitioners cannot be used as evidence in medical malpractice litigation [31] | 5 | ~ [13] | ✓ [33] | ~ [13] | ~ [13] | – | – | – | ✓ [33] |
Medical remediation | The process by which a doctor’s poor performance is ‘remedied’, which permits the doctor to return to safe practice [45]. It is formally defined as ‘an intervention, or suite of interventions, required in response to assessment against threshold standards’, with thresholds set by regulatory bodies (e.g. AHPRA in Australia) to keep patients safe [46] | 3 | ✓ [12] | – | – | – | – | – | – | |
Peer program | An organised effort whereby people (peers) critically appraise, systematically assess, monitor, make judgements, determine their strengths and weaknesses and review the quality of their practice, to provide evidence to use as the basis of recommendations by obtaining the opinion of their peers” [47, 48]. The use of peer messengers (doctors) involves the provision of feedback to doctors deemed at higher risk of experiencing a patient complaint or malpractice claim | 2 | – | ✓ [36] | – | – | ✓ [37] | – | – | – |
Shared decision-making | “Involving a patient and health care provider who work together to deliberate about the harms and benefits of two or more reasonable options, in order to choose a course of care that is ideally aligned with the patient’s preferences” (p. 2) [44] | 1 | ~ [44] | – | – | – | – | – | – | – |
Simulation training | “A technique for practice and learning that can be applied to many different disciplines and types of trainees. It is a technique (not a technology) to replace and amplify real experiences with guided ones, often ‘immersive’ in nature, that evoke or replicate substantial aspects of the real world in a fully interactive fashion” (p. 349) [49] | 1 | ✓ [39] | – | ~ [39] | – | – | – | – | – |
Continuing professional development | A range of activities undertaken to maintain clinical skills and knowledge, as well as competence in the delivery of patient-centred care [50]. Participation in CPD is mandatory for doctors in several countries, including Australia and Canada, while being used to evaluate maintenance of competence in the USA | 1 | – | ✓ [41] | – | – | – | – | – | – |
Summary of the evidence
Component | A | B | C | D |
---|---|---|---|---|
Excellent | Good | Satisfactory | Poor | |
Evidence base | Q1 Q2 | |||
Consistency | Q2a | Q1a | ||
Clinical impact | Q2 | Q1 | ||
Generalisability | Q1 Q2 | |||
Applicability | Q1 Q2 |