Birang Daruganora: what do Aboriginal and Torres Strait Islander communities need in a new hospital? A qualitative study.

OBJECTIVES: To elicit the Aboriginal community's cultural and healthcare needs and views about six prominent and emerging models of care, to inform the development of a new hospital. DESIGN: Cross-sectional qualitative study co-designed and co-implemented by Aboriginal team members. SETTING: Western Sydney, New South Wales, Australia. PARTICIPANTS: Aboriginal and Torres Strait Islander healthcare providers (n=2) and community members (n=18) aged between 21 and 60+ years participated in yarning circles (20 participants; 14 female, 6 male). RESULTS: Handwritten notes from yarning circles were inductively analysed to synthesise the cultural and healthcare needs of providers and community members in relation to a new hospital and six models of care. Three primary themes emerged in relation to future hospitals. These were 'culturally responsive spaces', 'culturally responsive systems' and 'culturally responsive models of care'. Strengths (eg, comfort, reduced waiting time, holistic care), barriers (eg, logistics, accessibility, literacy) and enablers (eg, patient navigator role, communication pathways, streamlined processes) were identified for each of the six models of care. CONCLUSIONS: Aboriginal and Torres Strait Islander community members and providers are invested in the co-creation of an innovative, well-integrated hospital that meets the needs of the community. Common themes of respect and recognition, relationships and partnering, and capacity building emerged as important consumer and provider considerations when developing and evaluating care services. Participants supported a range of models citing concerns about accessibility and choice when discussing evidence-based models of care.

Is it possible to make 'living' guidelines? An evaluation of the Australian Living Stroke Guidelines.

BACKGROUND: Keeping best practice guidelines up-to-date with rapidly emerging research evidence is challenging. 'Living guidelines' approaches enable continual incorporation of new research, assisting healthcare professionals to apply the latest evidence to their clinical practice. However, information about how living guidelines are developed, maintained and applied is limited. The Stroke Foundation in Australia was one of the first organisations to apply living guideline development methods for their Living Stroke Guidelines (LSGs), presenting a unique opportunity to evaluate the process and impact of this novel approach. METHODS: A mixed-methods study was conducted to understand the experience of LSGs developers and end-users. We used thematic analysis of one-on-one semi-structured interview and online survey data to determine the feasibility, acceptability, and facilitators and barriers of the LSGs. Website analytics data were also reviewed to understand usage. RESULTS: Overall, the living guidelines approach was both feasible and acceptable to developers and users. Facilitators to use included collaboration with multidisciplinary clinicians and stroke survivors or carers. Increased workload for developers, workload unpredictability, and limited information sharing, and interoperability of technological platforms were identified as barriers. Users indicated increased trust in the LSGs (69%), likelihood of following the LSGs (66%), and frequency of access (58%), compared with previous static versions. Web analytics data showed individual access by 16,517 users in 2016 rising to 53,154 users in 2020, a threefold increase. There was also a fourfold increase in unique LSG pageviews from 2016 to 2020. CONCLUSIONS: This study, the first evaluation of living guidelines, demonstrates that this approach to stroke guideline development is feasible and acceptable, that these approaches may add value to developers and users, and may increase guideline use. Future evaluations should be embedded along with guideline implementation to capture data prospectively.

Paediatric medication incident reporting: a multicentre comparison study of medication errors identified at audit, detected by staff and reported to an incident system.

OBJECTIVES: To compare medication errors identified at audit and via direct observation with medication errors reported to an incident reporting system at paediatric hospitals and to investigate differences in types and severity of errors detected and reported by staff. METHODS: This is a comparison study at two tertiary referral paediatric hospitals between 2016 and 2020 in Australia. Prescribing errors were identified from a medication chart audit of 7785 patient records. Medication administration errors were identified from a prospective direct observational study of 5137 medication administration doses to 1530 patients. Medication errors reported to the hospitals' incident reporting system were identified and matched with errors identified at audit and observation. RESULTS: Of 11 302 clinical prescribing errors identified at audit, 3.2 per 1000 errors (95% CI 2.3 to 4.4, n=36) had an incident report. Of 2224 potentially serious prescribing errors from audit, 26.1% (95% CI 24.3 to 27.9, n=580) were detected by staff and 11.2 per 1000 errors (95% CI 7.6 to 16.5, n=25) were reported to the incident system. Although the prescribing error detection rates varied between the two hospitals, there was no difference in incident reporting rates regardless of error severity. Of 40 errors associated with actual patient harm, only 7 (17.5%; 95% CI 8.7% to 31.9%) were detected by staff and 4 (10.0%; 95% CI 4.0% to 23.1%) had an incident report. None of the 2883 clinical medication administration errors observed, including 903 potentially serious errors and 144 errors associated with actual patient harm, had incident reports. CONCLUSION: Incident reporting data do not provide an accurate reflection of medication errors and related harm to children in hospitals. Failure to detect medication errors is likely to be a significant contributor to low error reporting rates. In an era of electronic health records, new automated approaches to monitor medication safety should be pursued to provide real-time monitoring.

Innovative Models of Care for Hospitals of the Future.

New ways of providing acute care outside of traditional hospital building complexes, such as virtual care or hospital in the home, are becoming more common. Despite this, many hospitals are still conceived as "bricks and mortar" centralised constructions, and few health service infrastructure organisations meet intensively with consumers or clinicians prior to conceptualising hospital design. Our study sought to understand the needs and expectation of community members and healthcare providers, and co-design innovative models of acute care to inform development of a new metropolitan hospital in Australia. Our study used a three-step approach, consisting of academic and grey literature reviews; a demographic analysis of the hospital catchment population; and a series of 20 workshops and 6 supplementary interviews with community members and local healthcare providers. We found that care should be tailored to the healthcare needs and expectations of each consumer, with consumers cared for in the community where possible and safe. We propose an innovative model of care for hospitals of the future, consisting of fully integrated acute care underpinned by appropriate digital architecture to deliver care that is community focussed. It is vital that new hospitals build in sufficient adaptability to leverage future innovation and meet the needs of growing and changing communities.

Co-worker unprofessional behaviour and patient safety risks: an analysis of co-worker reports across eight Australian hospitals.

A key component of professional accountability programmes is online reporting tools that allow hospital staff to report co-worker unprofessional behaviour. Few studies have analysed data from these systems to further understand the nature or impact of unprofessional behaviour amongst staff. Ethos is a whole-of-hospital professional accountability programme that includes an online messaging system. Ethos has now been implemented across multiple Australian hospitals. This study examined reported unprofessional behaviour that staff indicated created a risk to patient safety. This study included 1310 Ethos submissions reporting co-worker unprofessional behaviour between 2017 and 2020 across eight Australian hospitals. Submissions that indicated the behaviour increased the risk to patient safety were identified. Descriptive summary statistics were presented for reporters and subjects of submissions about unprofessional behaviour. Logistic regression was applied to examine the association between each unprofessional behaviour (of the six most frequently reported in the Ethos submissions) and patient safety risk reported in the submissions. The descriptions in the reports were reviewed and the patient safety risks were coded using a framework aligned with the World Health Organization's International Classification for Patient Safety. Of 1310 submissions about unprofessional behaviour, 395 (30.2%) indicated that there was a risk to patient safety. Nurses made the highest number of submissions that included a patient safety risk [3.47 submissions per 100 nursing staff, 95% confidence interval (CI): 3.09-3.9] compared to other professional groups. Medical professionals had the highest rate as subjects of submissions for unprofessional behaviour with a patient safety risk (5.19 submissions per 100 medical staff, 95% CI: 4.44-6.05). 'Opinions being ignored' (odds ratio: 1.68; 95% CI: 1.23-2.22; P < .001) and 'someone withholding information which affects work performance' were behaviours strongly associated with patient safety risk in the submissions (odds ratio: 2.50; 95% CI: 1.73-3.62; P < .001) compared to submissions without a patient safety risk. The two main types of risks to patient safety described were related to clinical process/procedure and clinical administration. Commonly reported events included staff not following policy or protocol; doctors refusing to review a patient; and interruptions and inadequate information during handover. Our findings indicate that unprofessional behaviour was associated with risks to patient safety. Co-worker reports about unprofessional behaviour have significant value as they can be used by organizations to better understand how unprofessional behaviour can disrupt work practices and lead to risks to patient safety.

Patient characteristics of, and remedial interventions for, complaints and medico-legal claims against doctors: a rapid review of the literature.

BACKGROUND: It is uncertain if patient's characteristics are associated with complaints and claims against doctors. Additionally, evidence for the effectiveness of remedial interventions on rates of complaints and claims against doctors has not been synthesised. METHODS: We conducted a rapid review of recent literature to answer: Question 1 "What are the common characteristics and circumstances of patients who are most likely to complain or bring a claim about the care they have received from a doctor?" and Question 2 "What initiatives or interventions have been shown to be effective at reducing complaints and claims about the care patients have received from a doctor?". We used a systematic search (most recently in July 2023) of PubMed, Scopus, Web of Science and grey literature. Studies were screened against inclusion criteria and critically appraised in duplicate using standard tools. Results were summarised using narrative synthesis. RESULTS: From 8079 search results, we reviewed the full text of 250 studies. We included 25 studies: seven for Question 1 (6 comparative studies with controls and one systematic review) and 18 studies for Question 2 (14 uncontrolled pre-post studies, 2 comparative studies with controls and 2 systematic reviews). Most studies were set in hospitals across a mix of medical specialties. Other than for patients with mental health conditions (two studies), no other patient characteristics demonstrated either a strong or consistent effect on the rate of complaints or claims against their treating doctors. Risk management programs (6 studies), and communication and resolution programs (5 studies) were the most studied of 6 intervention types. Evidence for reducing complaints and medico-legal claims, costs or premiums and more timely management was apparent for both types of programs. Only 1 to 3 studies were included for peer programs, medical remediation, shared decision-making, simulation training and continuing professional development, with few generalisable results. CONCLUSION: Few patient characteristics can be reliably related to the likelihood of medico-legal complaints or claims. There is some evidence that interventions can reduce the number and costs of claims, the number of complaints, and the timeliness of claims. However, across both questions, the strength of the evidence is very weak and is based on only a few studies or study designs that are highly prone to bias.

Programme theories to describe how different general practitioner service models work in different contexts in or alongside emergency departments (GP-ED): realist evaluation.

BACKGROUND: Addressing increasing patient demand and improving ED patient flow is a key ambition for NHS England. Delivering general practitioner (GP) services in or alongside EDs (GP-ED) was advocated in 2017 for this reason, supported by £100 million (US$130 million) of capital funding. Current evidence shows no overall improvement in addressing demand and reducing waiting times, but considerable variation in how different service models operate, subject to local context. METHODS: We conducted mixed-methods analysis using inductive and deductive approaches for qualitative (observations, interviews) and quantitative data (time series analyses of attendances, reattendances, hospital admissions, length of stay) based on previous research using a purposive sample of 13 GP-ED service models (3 inside-integrated, 4 inside-parallel service, 3 outside-onsite and 3 with no GPs) in England and Wales. We used realist methodology to understand the relationship between contexts, mechanisms and outcomes to develop programme theories about how and why different GP-ED service models work. RESULTS: GP-ED service models are complex, with variation in scope and scale of the service, influenced by individual, departmental and external factors. Quantitative data were of variable quality: overall, no reduction in attendances and waiting times, a mixed picture for hospital admissions and length of hospital stay. Our programme theories describe how the GP-ED service models operate: inside the ED, integrated with patient flow and general ED demand, with a wider GP role than usual primary care; outside the ED, addressing primary care demand with an experienced streaming nurse facilitating the 'right patients' are streamed to the GP; or within the ED as a parallel service with most variability in the level of integration and GP role. CONCLUSION: GP-ED services are complex . Our programme theories inform recommendations on how services could be modified in particular contexts to address local demand, or whether alternative healthcare services should be considered.

Evaluation of different models of general practitioners working in or alongside emergency departments: a mixed-methods realist evaluation.

Background: Emergency healthcare services are under intense pressure to meet increasing patient demands. Many patients presenting to emergency departments could be managed by general practitioners in general practitioner-emergency department service models. Objectives: To evaluate the effectiveness, safety, patient experience and system implications of the different general practitioner-emergency department models. Design: Mixed-methods realist evaluation. Methods: Phase 1 (2017-8), to understand current practice: rapid realist literature review, national survey and follow-up key informant interviews, national stakeholder event and safety data analysis. Phase 2 (2018-21), to collect and analyse qualitative (observations, interviews) and quantitative data (time series analysis); cost-consequences analysis of routine data; and case site data for 'marker condition' analysis from a purposive sample of 13 case sites in England and Wales. Phase 3 (2021-2), to conduct mixed-methods analysis for programme theory and toolkit development. Results: General practitioners commonly work in emergency departments, but delivery models vary widely in terms of the scope of the general practitioner role and the scale of the general practitioner service. We developed a taxonomy to describe general practitioner-emergency department service models (Integrated with the emergency department service, Parallel within the emergency department, Outside the emergency department on the hospital site) and present a programme theory as principal output of the study to describe how these service models were observed to operate. Routine data were of variable quality, limiting our analysis. Time series analysis demonstrated trends across intervention sites for: increased time spent in the emergency department; increased emergency department attendances and reattendances; and mixed results for hospital admissions. Evidence on patient experience was limited but broadly supportive; we identified department-level processes to optimise the safety of general practitioner-emergency department models. Limitations: The quality, heterogeneity and extent of routine emergency department data collection during the study period limited the conclusions. Recruitment was limited by criteria for case sites (time series requirements) and individual patients (with 'marker conditions'). Pandemic and other pressures limited data collection for marker condition analysis. Data collected and analysed were pre pandemic; new approaches such as 'telephone first' and their relevance to our findings remains unexplored. Conclusion: Findings suggest that general practitioner-emergency department service models do not meet the aim of reducing the overall emergency department waiting times and improving patient flow with limited evidence of cost savings. Qualitative data indicated that general practitioners were often valued as members of the wider emergency department team. We have developed a toolkit, based on our findings, to provide guidance for implementing and delivering general practitioner-emergency department services. Future work: The emergency care data set has since been introduced across England to help standardise data collection to facilitate further research. We would advocate the systematic capture of patient experience measures and patient-reported outcome measures as part of routine care. More could be done to support the development of the general practitioner in emergency department role, including a core set of competencies and governance structure, to reflect the different general practitioner-emergency department models and to evaluate the effectiveness and cost effectiveness to guide future policy. Study registration: This study is registered as PROSPERO CRD42017069741. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/145/04) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 10. See the NIHR Funding and Awards website for further award information.

Hospital emergency departments are under huge pressure. Patients are waiting many hours to be seen, some with problems that general practitioners could deal with. To reduce waiting times and improve patient care, arrangements have been put in place for general practitioners to work in or alongside emergency departments (general practitioner­emergency department models). We studied the different ways of working to find out what works well, how and for whom. We brought together a lot of information. We reviewed existing evidence, sent out surveys to 184 emergency departments, spent time in the emergency departments observing how they operated and interviewing 106 staff in 13 hospitals and 24 patients who visited those emergency departments. We also looked at statistical information recorded by hospitals. Two public contributors were involved from the beginning, and we held two stakeholder events to ensure the relevance of our research to professionals and patients. Getting reliable figures to compare the various general practitioner­emergency department set-ups (inside, parallel to or outside the emergency department) was difficult. Our findings suggest that over time more people are coming to emergency departments and overall waiting times did not generally improve due to general practitioner­emergency department models. Evidence that general practitioners might admit fewer patients to hospital was mixed, with limited findings of cost savings. Patients were generally supportive of the care they received, although we could not speak to as many patients as we planned. The skills and experience of general practitioners were often valued as members of the wider emergency department team. We identified how the care provided was kept safe with: strong leaders, good communication between different types of staff, highly trained and experienced nurses responsible for streaming and specific training for general practitioners on how they were expected to work. We have produced a guide to help professionals develop and improve general practitioner­emergency department services and we have written easy-to-read summaries of all the articles we published.

Marked variations in medical provider and out-of-pocket costs for radical prostatectomy procedures in Australia.

Objectives Unwarranted clinical variations in radical prostatectomy (RP) procedures are frequently reported, yet less attention is given to the variations in associated costs. This issue can further widen disparities in access to care and provoke questions about the overall value of the procedure. The present paper aimed to delve into the disparities in hospital, medical provider and out-of-pocket costs for RP procedures in Australia, discussing plausible causes and potential policy opportunities. Methods A retrospective cohort study using Medibank Private claims data for RP procedures conducted in Australian hospitals between 1 January 2015 and 31 December 2020 was undertaken. Results Considerable variations in both medical provider and out-of-pocket costs were observed across the country, with variations evident between different states or territories. Particularly striking were the discrepancies in the costs charged by medical providers, with a notable contrast between the 10th and 90th percentiles revealing a substantial difference of A$9925. Hospitals in Australia exhibited relatively comparable charges for RP procedures. Conclusions Initiatives such as enhancing transparency regarding individual medical provider costs and implementing fee regulations with healthcare providers may be useful in curbing the variations in RP procedure costs.

Implementation of large, multi-site hospital interventions: a realist evaluation of strategies for developing capability.

BACKGROUND: This study presents guidelines for implementation distilled from the findings of a realist evaluation. The setting was local health districts in New South Wales, Australia that implemented three clinical improvement initiatives as part of a state-wide program. We focussed on implementation strategies designed to develop health professionals' capability to deliver value-based care initiatives for multisite programs. Capability, which increases implementers' ability to cope with unexpected scenarios is key to managing change. METHODS: We used a mixed methods realist evaluation which tested and refined program theories elucidating the complex dynamic between context (C), mechanism (M) and outcome (O) to determine what works, for whom, under what circumstances. Data was drawn from program documents, a realist synthesis, informal discussions with implementation designers, and interviews with 10 key informants (out of 37 identified) from seven sites. Data analysis employed a retroductive approach to interrogate the causal factors identified as contributors to outcomes. RESULTS: CMO statements were refined for four initial program theories: Making it Relevant- where participation in activities was increased when targeted to the needs of the staff; Investment in Quality Improvement- where engagement in capability development was enhanced when it was valued by all levels of the organisation; Turnover and Capability Loss- where the effects of staff turnover were mitigated; and Community-Wide Priority- where there was a strategy of spanning sites. From these data five guiding principles for implementers were distilled: (1) Involve all levels of the health system to effectively implement large-scale capability development, (2) Design capability development activities in a way that supports a learning culture, (3) Plan capability development activities with staff turnover in mind, (4) Increased capability should be distributed across teams to avoid bottlenecks in workflows and the risk of losing key staff, (5) Foster cross-site collaboration to focus effort, reduce variation in practice and promote greater cohesion in patient care. CONCLUSIONS: A key implementation strategy for interventions to standardise high quality practice is development of clinical capability. We illustrate how leadership support, attention to staff turnover patterns, and making activities relevant to current issues, can lead to an emergent learning culture.

Strategies to improve care for older adults who present to the emergency department: a systematic review.

BACKGROUND: The aim of this systematic review was to examine the relationship between strategies to improve care delivery for older adults in ED and evaluation measures of patient outcomes, patient experience, staff experience, and system performance. METHODS: A systematic review of English language studies published since inception to December 2022, available from CINAHL, Embase, Medline, and Scopus was conducted. Studies were reviewed by pairs of independent reviewers and included if they met the following criteria: participant mean age of ≥ 65 years; ED setting or directly influenced provision of care in the ED; reported on improvement interventions and strategies; reported patient outcomes, patient experience, staff experience, or system performance. The methodological quality of the studies was assessed by pairs of independent reviewers using The Joanna Briggs Institute critical appraisal tools. Data were synthesised using a hermeneutic approach. RESULTS: Seventy-six studies were included in the review, incorporating strategies for comprehensive assessment and multi-faceted care (n = 32), targeted care such as management of falls risk, functional decline, or pain management (n = 27), medication safety (n = 5), and trauma care (n = 12). We found a misalignment between comprehensive care delivered in ED for older adults and ED performance measures oriented to rapid assessment and referral. Eight (10.4%) studies reported patient experience and five (6.5%) reported staff experience. CONCLUSION: It is crucial that future strategies to improve care delivery in ED align the needs of older adults with the purpose of the ED system to ensure sustainable improvement effort and critical functioning of the ED as an interdependent component of the health system. Staff and patient input at the design stage may advance prioritisation of higher-impact interventions aligned with the pace of change and illuminate experience measures. More consistent reporting of interventions would inform important contextual factors and allow for replication.

Consumer and provider perceptions of the specialist unit model of care: A qualitative study.

BACKGROUND: Specialist care units cater to targeted cohorts of patients, applying evidence-based practice to people with a specific condition (e.g., dementia) or meeting other specific criteria (e.g., children). This paper aimed to collate perceptions of local consumers and health providers around specialist care units, as a model of care that may be considered for a new local healthcare facility. METHODS: This was a qualitative study using two-hour workshops and interviews to collect data. Participants were consumers and health providers in the planned facility's catchment: 49 suburbs in metropolitan Australia. Consumers and health providers were recruited through advertisements and emails. An initial survey collected demographic details. Consumers and health providers participated in separate two-hour workshops in which a scenario around the specialist unit model was presented and discussion on benefits, barriers and enablers of the model was led by researchers. Detailed notes were taken for analysis. RESULTS: Five consumer workshops (n = 22 participants) and five health provider workshops (n = 42) were conducted. Participants were representative of this culturally diverse region. Factors identified by participants as relevant to the specialist unit model of care included: accessibility; a perceived narrow scope of practice; coordination with other services; resources and infrastructure; and awareness and expectations of the units. Some factors identified as risks or barriers when absent were identified as strengths and enablers when present by both groups of participants. CONCLUSIONS: Positive views of the model centred on the higher perceived quality of care received in the units. Negative views centred on a perceived narrow scope of care and lack of flexibility. Consumers hinted, and providers stated explicitly, that the model needed to be complemented by an integrated model of care model to enable continuity of care and easy transfer of patients into and out of the specialist unit.

The quality of care delivered to residents in long-term care in Australia: an indicator-based review of resident records (CareTrack Aged study).

BACKGROUND: This study estimated the prevalence of evidence-based care received by a population-based sample of Australian residents in long-term care (LTC) aged ≥ 65 years in 2021, measured by adherence to clinical practice guideline (CPG) recommendations. METHODS: Sixteen conditions/processes of care amendable to estimating evidence-based care at a population level were identified from prevalence data and CPGs. Candidate recommendations (n = 5609) were extracted from 139 CPGs which were converted to indicators. National experts in each condition rated the indicators via the RAND-UCLA Delphi process. For the 16 conditions, 236 evidence-based care indicators were ratified. A multi-stage sampling of LTC facilities and residents was undertaken. Trained aged-care nurses then undertook manual structured record reviews of care delivered between 1 March and 31 May 2021 (our record review period) to assess adherence with the indicators. RESULTS: Care received by 294 residents with 27,585 care encounters in 25 LTC facilities was evaluated. Residents received care for one to thirteen separate clinical conditions/processes of care (median = 10, mean = 9.7). Adherence to evidence-based care indicators was estimated at 53.2% (95% CI: 48.6, 57.7) ranging from a high of 81.3% (95% CI: 75.6, 86.3) for Bladder and Bowel to a low of 12.2% (95% CI: 1.6, 36.8) for Depression. Six conditions (skin integrity, end-of-life care, infection, sleep, medication, and depression) had less than 50% adherence with indicators. CONCLUSIONS: This is the first study of adherence to evidence-based care for people in LTC using multiple conditions and a standardised method. Vulnerable older people are not receiving evidence-based care for many physical problems, nor care to support their mental health nor for end-of-life care. The six conditions in which adherence with indicators was less than 50% could be the focus of improvement efforts.

Four System Enablers of Large-System Transformation in Health Care: A Mixed Methods Realist Evaluation.

Policy Points The implementation of large-scale health care interventions relies on a shared vision, commitment to change, coordination across sites, and a spanning of siloed knowledge. Enablers of the system should include building an authorizing environment; providing relevant, meaningful, transparent, and timely data; designating and distributing leadership and decision making; and fostering the emergence of a learning culture. Attention to these four enablers can set up a positive feedback loop to foster positive change that can protect against the loss of key staff, the presence of lone disruptors, and the enervating effects of uncertainty. CONTEXT: Large-scale transformative initiatives have the potential to improve the quality, efficiency, and safety of health care. However, change is expensive, complex, and difficult to implement and sustain. This paper advances system enablers, which will help to guide large-scale transformation in health care systems. METHODS: A realist study of the implementation of a value-based health care program between 2017 and 2021 was undertaken in every public hospital (n = 221) in New South Wales (NSW), Australia. Four data sources were used to elucidate initial program theories beginning with a set of literature reviews, a program document review, and informal discussions with key stakeholders. Semistructured interviews were then conducted with 56 stakeholders to confirm, refute, or refine the theories. A retroductive analysis produced a series of context-mechanism-outcome (CMO) statements. Next, the CMOs were validated with three health care quality expert panels (n = 51). Synthesized data were interrogated to distill the overarching system enablers. FINDINGS: Forty-two CMO statements from the eight initial program theory areas were developed, refined, and validated. Four system enablers were identified: (1) build an authorizing environment; (2) provide relevant, authentic, timely, and meaningful data; (3) designate and distribute leadership and decision making; and (4) support the emergence of a learning culture. The system enablers provide a nuanced understanding of large-system transformation that illustrates when, for whom, and in what circumstances large-system transformation worked well or worked poorly. CONCLUSIONS: System enablers offer nuanced guidance for the implementation of large-scale health care interventions. The four enablers may be portable to similar contexts and provide the empirical basis for an implementation model of large-system value-based health care initiatives. With concerted application, these findings can pave the way not just for a better understanding of greater or lesser success in intervening in health care settings but ultimately to contribute higher quality, higher value, and safer care.

Audit and feedback to reduce unwarranted clinical variation at scale: a realist study of implementation strategy mechanisms.

BACKGROUND: Unwarranted clinical variation in hospital care includes the underuse, overuse, or misuse of services. Audit and feedback is a common strategy to reduce unwarranted variation, but its effectiveness varies widely across contexts. We aimed to identify implementation strategies, mechanisms, and contextual circumstances contributing to the impact of audit and feedback on unwarranted clinical variation. METHODS: Realist study examining a state-wide value-based healthcare program implemented between 2017 and 2021 in New South Wales, Australia. Three initiatives within the program included audit and feedback to reduce unwarranted variation in inpatient care for different conditions. Multiple data sources were used to formulate the initial audit and feedback program theory: a systematic review, realist review, program document review, and informal discussions with key program stakeholders. Semi-structured interviews were then conducted with 56 participants to refute, refine, or confirm the initial program theories. Data were analysed retroductively using a context-mechanism-outcome framework for 11 transcripts which were coded into the audit and feedback program theory. The program theory was validated with three expert panels: senior health leaders (n = 19), Agency for Clinical Innovation (n = 11), and Ministry of Health (n = 21) staff. RESULTS: The program's audit and feedback implementation strategy operated through eight mechanistic processes. The strategy worked well when clinicians (1) felt ownership and buy-in, (2) could make sense of the information provided, (3) were motivated by social influence, and (4) accepted responsibility and accountability for proposed changes. The success of the strategy was constrained when the audit process led to (5) rationalising current practice instead of creating a learning opportunity, (6) perceptions of unfairness and concerns about data integrity, 7) development of improvement plans that were not followed, and (8) perceived intrusions on professional autonomy. CONCLUSIONS: Audit and feedback strategies may help reduce unwarranted clinical variation in care where there is engagement between auditors and local clinicians, meaningful audit indicators, clear improvement plans, and respect for clinical expertise. We contribute theoretical development for audit and feedback by proposing a Model for Audit and Feedback Implementation at Scale. Recommendations include limiting the number of audit indicators, involving clinical staff and local leaders in feedback, and providing opportunities for reflection.

Improving patient safety governance and systems through learning from successes and failures: qualitative surveys and interviews with international experts.

Patient harm is a leading cause of global disease burden with considerable morbidity, mortality, and economic impacts for individuals, families, and wider society. Large bodies of evidence exist for strategies to improve safety and reduce harm. However, it is not clear which patient safety issues are being addressed globally, and which factors are the most (or least) important contributors to patient safety improvements. We aimed to explore the perspectives of international patient safety experts to identify: (1) the nature and range of patient safety issues being addressed, and (2) aspects of patient safety governance and systems that are perceived to provide value (or not) in improving patient outcomes. English-speaking Fellows and Experts of the International Society for Quality in Healthcare participated in a web-based survey and in-depth semistructured interview, discussing their experience in implementing interventions to improve patient safety. Data collection focused on understanding the elements of patient safety governance that influence outcomes. Demographic survey data were analysed descriptively. Qualitative data were coded, analysed thematically (inductive approach), and mapped deductively to the System-Theoretic Accident Model and Processes framework. Findings are presented as themes and a patient safety governance model. The study was approved by the University of South Australia Human Research Ethics Committee. Twenty-seven experts (59% female) participated. Most hailed from Africa (n = 6, 22%), Australasia, and the Middle East (n = 5, 19% each). The majority were employed in hospital settings (n = 23, 85%), and reported blended experience across healthcare improvement (89%), accreditation (76%), organizational operations (64%), and policy (60%). The number and range of patient safety issues within our sample varied widely with 14 topics being addressed. Thematically, 532 textual segments were grouped into 90 codes (n = 44 barriers, n = 46 facilitators) and used to identify and arrange key patient safety governance actors and factors as a 'system' within the System-Theoretic Accident Model and Processes framework. Four themes for improved patient safety governance were identified: (1) 'safety culture' in healthcare organizations, (2) 'policies and procedures' to investigate, implement, and demonstrate impact from patient safety initiatives, (3) 'supporting staff' to upskill and share learnings, and (4) 'patient engagement, experiences, and expectations'. For sustainable patient safety governance, experts highlighted the importance of safety culture in healthcare organizations, national patient safety policies and regulatory standards, continuing education for staff, and meaningful patient engagement approaches. Our proposed 'patient safety governance model' provides policymakers and researchers with a framework to develop data-driven patient safety policy.

Clinical indicators for diabetic eyecare delivered by optometrists in Australia: a Delphi study.

CLINICAL RELEVANCE: Valid and updated clinical indicators can serve as important tools in assessing and improving eyecare delivery. BACKGROUND: Indicators for diabetic eyecare in Australia were previously developed from guidelines published before 2013 and then used to assess the appropriateness of care delivery through a nationwide patient record card audit (the iCareTrack study). To reflect emerging evidence and contemporary practice, this study aimed to update clinical indicators for optometric care for people with type 2 diabetes in Australia. METHODS: Forty-five candidate indicators, including existing iCareTrack and new indicators derived from nine high-quality evidence-based guidelines, were generated. A two-round modified Delphi process where expert panel members rated the impact, acceptability, and feasibility of the indicators on a 9-point scale and voted for inclusion or exclusion of the candidate indicators was used. Consensus on inclusion was reached when the median scores for impact, acceptability, and feasibility were ≥7 and >75% of experts voted for inclusion. RESULTS: Thirty-two clinical indicators with high acceptability, impact and feasibility ratings (all median scores: 9) were developed. The final indicators were related to history taking (n = 12), physical examination (n = 8), recall period (n = 5), referral (n = 5), and patient education/communication (n = 2). Most (14 of 15) iCareTrack indicators were retained either in the original format or with modifications. New indicators included documenting the type of diabetes, serum lipid level, pregnancy, systemic medications, nephropathy, Indigenous status, general practitioner details, pupil examination, intraocular pressure, optical coherence tomography, diabetic retinopathy grading, recall period for high-risk diabetic patients without retinopathy, referral of high-risk proliferative retinopathy, communication with the general practitioner, and patient education. CONCLUSION: A set of 32 updated diabetic eyecare clinical indicators was developed based on contemporary evidence and expert consensus. These updated indicators inform the development of programs to assess and enhance the eyecare delivery for people with diabetes in Australia.

What are the experiences of team members involved in root cause analysis? A qualitative study.

BACKGROUND: Conducting root cause analysis (RCA) is complex and challenging. The aim of this study was to better understand the experiences of RCA team members and how they value their involvement in the RCA to inform future recruitment, conduct and implementation of RCA findings into clinical practice. METHODS: The study was set in a health network in Adelaide, South Australia. A qualitative exploratory descriptive approach was undertaken to provide an in-depth understanding of team member's experience in participating in an RCA. Eight of 27 RCA team members who conducted RCAs in the preceding 3-year period were included in one of three semi-structured focus groups. Thematic analysis was used to synthesise the transcribed data into themes. RESULTS: We derived four major themes: Experiences and perceptions of the RCA team, Limitations of RCA recommendations, Facilitators and barriers to conducting an RCA, and Supporting colleagues involved in the adverse event. Participants' mixed experience of RCAs ranged from enjoyment and the perception of worth and value to concerns about workload and lack of impact. Legislative privilege protecting RCAs from disclosure was both a facilitator and a barrier. Concern and a desire to better support their colleagues was widely reported. CONCLUSIONS: Clinicians perceived value in reviewing significant adverse events. Improvements can be made in sharing learnings to make effective improvements in health care. We have proposed a process to better support interviewees and strengthen post interview follow up.

Analysis of applying a patient safety taxonomy to patient and clinician-reported incident reports during the COVID-19 pandemic: a mixed methods study.

BACKGROUND: The COVID-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. We aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context. METHODS: We conducted a mixed-methods study integrating two phases in an exploratory, sequential design. This included a comparative secondary analysis of patient safety incident reports from two studies conducted during the first wave of the pandemic, where we coded patient-reported incidents from the UK and clinician-reported incidents from France. The findings were presented to a focus group of experts in classification systems and patient safety, and a thematic analysis was conducted on the resultant transcript. RESULTS: We identified five key themes derived from the data analysis and expert group discussion. These included capitalising on the unique perspective of safety concerns from different groups, that existing frameworks do identify priority areas to investigate further, the objectives of a study shape the data interpretation, the pandemic spotlighted long-standing patient concerns, and the time period in which data are collected offers valuable context to aid explanation. The group consensus was that no COVID-19-specific codes were warranted, and the PISA classification system was fit for purpose. CONCLUSIONS: We have scrutinised the meaningful use of the PISA classification system's application during a period of systemic healthcare constraint, the COVID-19 pandemic. Despite these constraints, we found the framework can be successfully applied to incident reports to enable deductive analysis, identify areas for further enquiry and thus support organisational learning. No new or amended codes were warranted. Organisations and investigators can use our findings when reviewing their own classification systems.