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.

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.

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.

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.

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.

Unsafe care in residential settings for older adults: a content analysis of accreditation reports.

Residents of aged care services can experience safety incidents resulting in preventable serious harm. Accreditation is a commonly used strategy to improve the quality of care; however, narrative information within accreditation reports is not generally analysed as a source of safety information to inform learning. In Australia, the Aged Care Quality and Safety Commission (ACQSC), the sector regulator, undertakes over 500 accreditation assessments of residential aged care services against eight national standards every year. From these assessments, the Aged Care Quality and Safety Commission generates detailed Site Audit Reports. In over one-third (37%) of Site Audit Reports, standards relating to Personal and Clinical Care (Standard 3) are not being met. The aim of this study was to identify the types of resident Safety Risks that relate to Personal and Clinical Care Standards not being met during accreditation or re-accreditation. These data could inform priority setting at policy, regulatory, and service levels. An analytical framework was developed based on the World Health Organization's International Classification for Patient Safety and other fields including Clinical Issue (the issue related to the incident impacting the resident, e.g. wound/skin or pain). Information relating to safety incidents in the Site Audit Reports was extracted, and a content analysis undertaken using the analytical framework. Clinical Issue and the International Classification for Patient Safety-based classification were combined to describe a clinically intuitive category ('Safety Risks') to describe ways in which residents could experience unsafe care, e.g. diagnosis/assessment of pain. The resulting data were descriptively analysed. The analysis included 65 Site Audit Reports that were undertaken between September 2020 and March 2021. There were 2267 incidents identified and classified into 274 types of resident Safety Risks. The 12 most frequently occurring Safety Risks account for only 32.3% of all incidents. Relatively frequently occurring Safety Risks were organisation management of infection control; diagnosis/assessment of pain, restraint, resident behaviours, and falls; and multiple stages of wounds/skin management, e.g. diagnosis/assessment, documentation, treatment, and deterioration. The analysis has shown that accreditation reports contain valuable data that may inform prioritization of resident Safety Risks in the Australian residential aged care sector. A large number of low-frequency resident Safety Risks were detected in the accreditation reports. To address these, organizations may use implementation science approaches to facilitate evidence-based strategies to improve the quality of care delivered to residents. Improving the aged care workforces' clinical skills base may address some of the Safety Risks associated with diagnosis/assessment and wound management.

Comparing rates of adverse events detected in incident reporting and the Global Trigger Tool: a systematic review.

Many hospitals continue to use incident reporting systems (IRSs) as their primary patient safety data source. The information IRSs collect on the frequency of harm to patients [adverse events (AEs)] is generally of poor quality, and some incident types (e.g. diagnostic errors) are under-reported. Other methods of collecting patient safety information using medical record review, such as the Global Trigger Tool (GTT), have been developed. The aim of this study was to undertake a systematic review to empirically quantify the gap between the percentage of AEs detected using the GTT to those that are also detected via IRSs. The review was conducted in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies published in English, which collected AE data using the GTT and IRSs, were included. In total, 14 studies met the inclusion criteria. All studies were undertaken in hospitals and were published between 2006 and 2022. The studies were conducted in six countries, mainly in the USA (nine studies). Studies reviewed 22 589 medical records using the GTT across 107 institutions finding 7166 AEs. The percentage of AEs detected using the GTT that were also detected in corresponding IRSs ranged from 0% to 37.4% with an average of 7.0% (SD 9.1; median 3.9 and IQR 5.2). Twelve of the fourteen studies found <10% of the AEs detected using the GTT were also found in corresponding IRSs. The >10-fold gap between the detection rates of the GTT and IRSs is strong evidence that the rate of AEs collected in IRSs in hospitals should not be used to measure or as a proxy for the level of safety of a hospital. IRSs should be recognized for their strengths which are to detect rare, serious, and new incident types and to enable analysis of contributing and contextual factors to develop preventive and corrective strategies. Health systems should use multiple patient safety data sources to prioritize interventions and promote a cycle of action and improvement based on data rather than merely just collecting and analysing information.

Experience-based codesign approach to improve care in Australian emergency departments for complex consumer cohorts: the MyED project protocol, Stages 1.1-1.3.

INTRODUCTION: Emergency department (ED) care must adapt to meet current and future demands. In Australia, ED quality measures (eg, prolonged length of stay, re-presentations or patient experience) are worse for older adults with multiple comorbidities, people who have a disability, those who present with a mental health condition, Indigenous Australians, and those with a culturally and linguistically diverse (CALD) background. Strengthened ED performance relies on understanding the social and systemic barriers and preferences for care of these different cohorts, and identifying viable solutions that may result in sustained improvement by service providers. A collaborative 5-year project (MyED) aims to codesign, with ED users and providers, new or adapted models of care that improve ED performance, improve patient outcomes and improve patient experience for these five cohorts. METHODS AND ANALYSIS: Experience-based codesign using mixed methods, set in three hospitals in one health district in Australia. This protocol introduces the staged and incremental approach to the whole project, and details the first research elements: ethnographic observations at the ED care interface, interviews with providers and interviews with two patient cohorts-older adults and adults with a CALD background. We aim to sample a diverse range of participants, carefully tailoring recruitment and support. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Western Sydney Local Health District Human Research Ethics Committee (2022/PID02749-2022/ETH02447). Prior informed written consent will be obtained from all research participants. Findings from each stage of the project will be submitted for peer-reviewed publication. Project outputs will be disseminated for implementation more widely across New South Wales, Australia.

Implementation of consensus-based perioperative care pathways to reduce clinical variation for elective surgery in an Australian private hospital: a mixed-methods pre-post study protocol.

INTRODUCTION: Addressing clinical variation in elective surgery is challenging. A key issue is how to gain consensus between largely autonomous clinicians. Understanding how the consensus process works to develop and implement perioperative pathways and the impact of these pathways on reducing clinical variation can provide important insights into the effectiveness of the consensus process. The primary objective of this study is to understand the implementation of an organisationally supported, consensus approach to implement perioperative care pathways in a private healthcare facility and to determine its impact. METHODS: A mixed-methods Effectiveness-Implementation Hybrid (type III) pre-post study will be conducted in one Australian private hospital. Five new consensus-based perioperative care pathways will be developed and implemented for specific patient cohorts: spinal surgery, radical prostatectomy, cardiac surgery, bariatric surgery and total hip and knee replacement. The individual components of these pathways will be confirmed as part of a consensus-building approach and will follow a four-stage implementation process using the Exploration, Preparation, Implementation and Sustainment framework. The process of implementation, as well as barriers and facilitators, will be evaluated through semistructured interviews and focus groups with key clinical and non-clinical staff, and participant observation. We anticipate completing 30 interviews and 15-20 meeting observations. Administrative and clinical end-points for at least 152 participants will be analysed to assess the effectiveness of the pathways. ETHICS AND DISSEMINATION: This study received ethical approval from Macquarie University Human Research Ethics Medical Sciences Committee (Reference No: 520221219542374). The findings of this study will be disseminated through peer-reviewed publications, conference presentations and reports for key stakeholders.

Guiding principles for effective collaborative implementation strategies for multisite hospital improvement initiatives: a mixed-method realist evaluation of collaborative strategies used in four multisite initiatives at public hospitals in New South Wales, Australia.

OBJECTIVE: Large-scale, multisite hospital improvement initiatives can advance high-quality care for patients. Implementation support is key to adoption of change in this context. Strategies that foster collaboration within local teams, across sites and between initiative developers and users are important. However not all implementation strategies are successful in all settings, sometimes realising poor or unintended outcomes. Our objective here is to develop guiding principles for effective collaborative implementation strategies for multi-site hospital initiatives. DESIGN: Mixed-method realist evaluation. Realist studies aim to examine the underlying theories that explain differing outcomes, identifying mechanisms and contextual factors that may trigger them. SETTING: We report on collaborative strategies used in four multi-site initiatives conducted in all public hospitals in New South Wales, Australia (n>100). PARTICIPANTS: Using an iterative process, information was gathered on collaborative implementation strategies used, then initial programme theories hypothesised to underlie the strategies' outcomes were surfaced using a realist dialogic approach. A realist interview schedule was developed to elicit evidence for the posited initial programme theories. Fourteen participants from 20 key informants invited participated. Interviews were conducted via Zoom, transcribed and analysed. From these data, guiding principles of fostering collaboration were developed. RESULTS: Six guiding principles were distilled: (1) structure opportunities for collaboration across sites; (2) facilitate meetings to foster learning and problem-solving across sites; (3) broker useful long-term relationships; (4) enable support agencies to assist implementers by giving legitimacy to their efforts in the eyes of senior management; (5) consider investment in collaboration as effective well beyond the current projects; (6) promote a shared vision and build momentum for change by ensuring inclusive networks where everyone has a voice. CONCLUSION: Structuring and supporting collaboration in large-scale initiatives is a powerful implementation strategy if contexts described in the guiding principles are present.

Birang Daruganora: a protocol for a qualitative study to elicit Aboriginal and Torres Strait Islander community views about cultural needs and experiences for a new Australian health facility.

INTRODUCTION: To address challenges regarding the delivery of healthcare, governments and health services are focusing on the implementation of models that are flexible, person-centred, cost-effective and integrate hospital services more closely with primary healthcare and social services. Such models increasingly embed consumer codesign, multidisciplinary teams and leverage digital technologies, such as telehealth, attempting to deliver care more seamlessly and to continually improve services. This paper provides a study protocol to describe a method to explore Aboriginal and/or Torres Strait Islander consumer and healthcare provider needs and expectations for the design and development of a new healthcare facility in Australia. METHODS AND ANALYSIS: A qualitative study of consumer members' and health providers' needs and expectations. Data collection includes a short consumer-specific and provider-specific, demographic questionnaire and culturally appropriate facilitator-coordinated consultation workshops. Data will be analysed thematically (qualitatively). ETHICS AND DISSEMINATION: The results will be actively disseminated through peer-reviewed journals, conference presentations, reports to stakeholders and community meetings. This study was reviewed and approved by a health service-based Ethics Committee in New South Wales, Australia and the Aboriginal Health and Medical Research Committee.

Innovative models of healthcare delivery: an umbrella review of reviews.

OBJECTIVE: To undertake a synthesis of evidence-based research for seven innovative models of care to inform the development of new hospitals. DESIGN: Umbrella review. SETTING: Interventions delivered inside and outside of acute care settings. PARTICIPANTS: Children and adults with one or more identified acute or chronic health conditions. DATA SOURCES: PsycINFO, Ovid MEDLINE and CINAHL. PRIMARY AND SECONDARY OUTCOME MEASURES: Clinical indicators and mortality, healthcare utilisation, quality of life, self-management and self-care and patient knowledge. RESULTS: A total of 66 reviews were included, synthesising evidence from 1272 primary studies across the 7 models of care. Virtual care was the most common model studied, addressed by 47 (73%) of the reviews. Common outcomes evaluated across reviews were clinical indicators and mortality, healthcare utilisation, self-care and self-management, patient knowledge, quality of life and cost-effectiveness. The findings indicate that the innovative models of healthcare we identified in this review may be effective in managing patients with a range of acute and chronic conditions. Most of the included reviews reported evidence of comparable or improved care. CONCLUSIONS: A consideration of local infrastructure and individual patient characteristics, such as health literacy, may be critical in determining the suitability of models of care for patients and their implementation in local health systems. TRIAL REGISTRATION NUMBER: 10.17605/OSF.IO/PS6ZU.

Innovative models of care for the health facility of the future: a protocol for a mixed-methods study to elicit consumer and provider views.

INTRODUCTION: To address the challenges of rapidly changing healthcare, governments and health services are increasingly emphasising healthcare delivery models that are flexible, person centred, cost-effective and integrate hospital services more closely with primary healthcare and social services. In addition, such models increasingly embed consumer codesign, integration of services, and leverage digital technologies such as telehealth and sophisticated medical records systems. OBJECTIVES: This paper provides a study protocol to describe a method to elicit consumer and healthcare provider needs and expectations for the development of innovative care models. METHODS AND ANALYSIS: A literature review identified six key models of care, supported by a common theme of consumer-focused care, along with the international evidence supporting the efficacy of these models. A mixed-methods study of the needs and expectations of consumer members and health providers who reside or work in the area of a new hospital catchment will be undertaken. They will complete a community-specific and provider-specific, short demographic questionnaire (delivered during the recruitment process) and be assigned to facilitator-coordinated online workshops comprising small focus groups. Follow-up interviews will be offered. Culturally and linguistically diverse members and Aboriginal and Torres Strait Islander Elders and their communities will also be consulted. Data will be analysed thematically (qualitative) and statistically (quantitative), and findings synthesised using a triangulated approach. ETHICS AND DISSEMINATION: The results will be actively disseminated through peer-reviewed journals, conference presentations and in a report to stakeholders. This study was reviewed and approved by the relevant Ethics Committee in New South Wales, Australia.

Protocol for the implementation evaluation of an integrated paediatric and primary care model: Strengthening Care for Children (SC4C).

INTRODUCTION: Implementation evaluations provide insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines a detailed protocol of an implementation evaluation embedded in a stepped-wedge cluster randomised controlled trial of a model of care, Strengthening Care for Children (SC4C), that integrates paediatric care in general practice. The purpose of this manuscript is to describe the pragmatic methods that will be used to capture implementation evaluation process and outcome data within this trial. METHODS AND ANALYSIS: Our implementation evaluation will use a mixed methods design, with data collected in the intervention arm of the SC4C trial guided by a logic model developed using the Consolidated Framework for Implementation Research (CFIR) and Proctor and colleague's taxonomy of implementation outcomes. Data collection will be via questionnaires and semistructured interviews with general practitioners, paediatricians, general practice administrative staff and children and families. Each of the 21 general practices recruited into the study will be described in terms of staffing, patient throughput and location, in addition to the nuanced inner and outer contexts, use of the intervention and its acceptability. We will quantify implementation effectiveness in each general practice clinic using the CFIR validated scoring system. Importantly, we have embedded data collection post intervention to enable assessment of the sustainable adoption of the intervention. An inductive approach to the analysis of qualitative data will identify additional emerging themes that may not be covered by the formal frameworks underpinning our analysis. ETHICS AND DISSEMINATION: Ethical approval was granted by the Royal Children's Hospital Ethics Committee in August 2020 (HREC: 65955). Results will be submitted for publication in peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER: Australia New Zealand Clinical Trials Registry 12620001299998 on 1 December 2020.

Designing clinical indicators for common residential aged care conditions and processes of care: the CareTrack Aged development and validation study.

BACKGROUND: People who live in aged care homes have high rates of illness and frailty. Providing evidence-based care to this population is vital to ensure the highest possible quality of life. OBJECTIVE: In this study (CareTrack Aged, CT Aged), we aimed to develop a comprehensive set of clinical indicators for guideline-adherent, appropriate care of commonly managed conditions and processes in aged care. METHODS: Indicators were formulated from recommendations found through systematic searches of Australian and international clinical practice guidelines (CPGs). Experts reviewed the indicators using a multiround modified Delphi process to develop a consensus on what constitutes appropriate care. RESULTS: From 139 CPGs, 5609 recommendations were used to draft 630 indicators. Clinical experts (n = 41) reviewed the indicators over two rounds. A final set of 236 indicators resulted, mapped to 16 conditions and processes of care. The conditions and processes were admission assessment; bladder and bowel problems; cognitive impairment; depression; dysphagia and aspiration; end of life/palliative care; hearing and vision; infection; medication; mobility and falls; nutrition and hydration; oral and dental care; pain; restraint use; skin integrity and sleep. CONCLUSIONS: The suite of CT Aged clinical indicators can be used for research and assessment of the quality of care in individual facilities and across organizations to guide improvement and to supplement regulation or accreditation of the aged care sector. They are a step forward for Australian and international aged care sectors, helping to improve transparency so that the level of care delivered to aged care consumers can be rigorously monitored and continuously improved.

What Constitutes "Appropriate Care" for Low Back Pain?: Point-of-Care Clinical Indicators From Guideline Evidence and Experts (the STANDING Collaboration Project).

STUDY DESIGN: Multiround wiki-based Delphi expert panel survey. OBJECTIVE: To provide proof of concept for an alternative method for creating sets of nationally-agreed point-of-care clinical indicators, and obtain consensus among end-user groups on "appropriate care" for the assessment, diagnosis, acute, and ongoing care of people with low back pain (LBP). SUMMARY OF BACKGROUND DATA: The provision of inappropri ate and low value care for LBP is a significant healthcare and societal burden. Vague clinical practice guideline (CPG) recom mendations can be difficult to apply and measure in real world clinical practice, and a likely barrier to "appropriate care." METHODS: Draft "appropriate care" clinical indicators for LBP were derived from CPG recommendations published between 2011 and 2017. Included CPGs were independently appraised by two reviewers using the Appraisal of Guidelines for Research and Evaluation instrument. Headed by a Clinical Champion, a 20-member Expert Panel reviewed and commented on the draft indicators over a three-round modified e-Delphi process using a collaborative online wiki. At the conclusion of each review round, the research team and the Clinical Champion synthesized and responded to experts' comments and incorporated feedback into the next iteration of the draft indicators. RESULTS: From seven CPGs and six qualitative meta-syntheses, 299 recommendations and themes were used to draft 42 "appropriateness" indicators. In total, 17 experts reviewed these indicators over 18 months. A final set of 27 indicators compris ing screening and diagnostic processes (n = 8), assessment (n = 3), acute (n = 5), and ongoing care (n = 9), and two which crossed the acute-ongoing care continuum. Most indicators were geared toward recommended care (n = 21, 78%), with the remainder focused on care to be avoided. CONCLUSION: These 27 LBP clinical indicators can be used by healthcare consumers, clinicians, researchers, policy makers/ funders, and insurers to guide and monitor the provision of "appropriate care" for LBP.Level of Evidence: 4.

Systematic review of the factors and the key indicators that identify doctors at risk of complaints, malpractice claims or impaired performance.

OBJECTIVE: To identify the risk factors associated with complaints, malpractice claims and impaired performance in medical practitioners. DESIGN: Systematic review. DATA SOURCES: Ovid-Medline, Ovid Embase, Scopus and Cochrane Central Register of Controlled Trials were searched from 2011 until March 2020. Reference lists and Google were also handsearched. RESULTS: Sixty-seven peer-reviewed papers and three grey literature publications from 2011 to March 2020 were reviewed by pairs of independent reviewers. Twenty-three key factors identified, which were categorised as demographic or workplace related. Gender, age, years spent in practice and greater number of patient lists were associated with higher risk of malpractice claim or complaint. Risk factors associated with physician impaired performance included substance abuse and burn-out. CONCLUSIONS: It is likely that risk factors are interdependent with no single factor as a strong predictor of a doctor's risk to the public. Risk factors for malpractice claim or complaint are likely to be country specific due to differences in governance structures, processes and funding. Risk factors for impaired performance are likely to be specialty specific due to differences in work culture and access to substances. New ways of supporting doctors might be developed, using risk factor data to reduce adverse events and patient harm. PROSPERO REGISTRATION NUMBER: PROSPERO registration number: CRD42020182045.

How to sustainably build capacity in quality improvement within a healthcare organisation: a deep-dive, focused qualitative analysis.

BACKGROUND: A key characteristic of healthcare systems that deliver high quality and cost performance in a sustainable way is a systematic approach to capacity and capability building for quality improvement. The aim of this research was to explore the factors that lead to successful implementation of a program of quality improvement projects and a capacity and capability building program that facilitates or support these. METHODS: Between July 2018 and February 2020, the Southern Adelaide Local Health Network (SALHN), a network of health services in Adelaide, South Australia, conducted three capability-oriented capacity building programs that incorporated 82 longstanding individual quality improvement projects. Qualitative analysis of data collected from interviews of 19 project participants and four SALHN Improvement Faculty members and ethnographic observations of seven project team meetings were conducted. RESULTS: We found four interacting components that lead to successful implementation of quality improvement projects and the overall program that facilitates or support these: an agreed and robust quality improvement methodology, a skilled faculty to assist improvement teams, active involvement of leadership and management, and a deep understanding that teams matter. A strong safety culture is not necessarily a pre-requisite for quality improvement gains to be made; indeed, undertaking quality improvement activities can contribute to an improved safety culture. For most project participants in the program, the time commitment for projects was significant and, at times, maintaining momentum was a challenge. CONCLUSIONS: Healthcare systems that wish to deliver high quality and cost performance in a sustainable way should consider embedding the four identified components into their quality improvement capacity and capability building strategy.