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.

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.

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.

Mapping Processes in the Emergency Department Using the Functional Resonance Analysis Method.

Emergency departments (EDs) are dynamic, complex, and demanding environments. Introducing changes that lead to improvements in EDs can be challenging owing to the high staff turnover and mix, high patient volume with different needs, and being the front door to the hospital for the sickest patients. Quality improvement is a methodology applied routinely in EDs to instigate change to improve several outcomes such as waiting times, time to definitive treatment, and patient safety. Introducing the changes needed to transform the system in this way is seldom straightforward with the risk of "not seeing the forest for the trees" when attempting to change the system. In this article, we demonstrate how the functional resonance analysis method can be used to capture the experiences and perceptions of frontline staff to identify the key functions in the system (the trees), to understand the interactions and dependencies between them to make up the ED ecosystem ("the forest") and to support quality improvement planning, identifying priorities and patient safety risks.

The cost of implementing the COVID-19 shielding policy in Wales.

BACKGROUND: The EVITE Immunity study investigated the effects of shielding Clinically Extremely Vulnerable (CEV) people during the COVID-19 pandemic on health outcomes and healthcare costs in Wales, United Kingdom, to help prepare for future pandemics. Shielding was intended to protect those at highest risk of serious harm from COVID-19. We report the cost of implementing shielding in Wales. METHODS: The number of people shielding was extracted from the Secure Anonymised Information Linkage Databank. Resources supporting shielding between March and June 2020 were mapped using published reports, web pages, freedom of information requests to Welsh Government and personal communications (e.g. with the office of the Chief Medical Officer for Wales). RESULTS: At the beginning of shielding, 117,415 people were on the shielding list. The total additional cost to support those advised to stay home during the initial 14 weeks of the pandemic was £13,307,654 (£113 per person shielded). This included the new resources required to compile the shielding list, inform CEV people of the shielding intervention and provide medicine and food deliveries. The list was adjusted weekly over the 3-month period (130,000 people identified by June 2020). Therefore the cost per person shielded lies between £102 and £113 per person. CONCLUSION: This is the first evaluation of the cost of the measures put in place to support those identified to shield in Wales. However, no data on opportunity cost was available. The true costs of shielding including its budget impact and opportunity costs need to be investigated to decide whether shielding is a worthwhile policy for future health emergencies.

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.

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.

Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial.

BACKGROUND: Concomitant administration of COVID-19 and influenza vaccines could reduce burden on health-care systems. We aimed to assess the safety of concomitant administration of ChAdOx1 or BNT162b2 plus an age-appropriate influenza vaccine. METHODS: In this multicentre, randomised, controlled, phase 4 trial, adults in receipt of a single dose of ChAdOx1 or BNT162b2 were enrolled at 12 UK sites and randomly assigned (1:1) to receive concomitant administration of either an age-appropriate influenza vaccine or placebo alongside their second dose of COVID-19 vaccine. 3 weeks later the group who received placebo received the influenza vaccine, and vice versa. Participants were followed up for 6 weeks. The influenza vaccines were three seasonal, inactivated vaccines (trivalent, MF59C adjuvanted or a cellular or recombinant quadrivalent vaccine). Participants and investigators were masked to the allocation. The primary endpoint was one or more participant-reported solicited systemic reactions in the 7 days after first trial vaccination(s), with a difference of less than 25% considered non-inferior. Analyses were done on an intention-to-treat basis. Local and unsolicited systemic reactions and humoral responses were also assessed. The trial is registered with ISRCTN, ISRCTN14391248. FINDINGS: Between April 1 and June 26, 2021, 679 participants were recruited to one of six cohorts, as follows: 129 ChAdOx1 plus cellular quadrivalent influenza vaccine, 139 BNT162b2 plus cellular quadrivalent influenza vaccine, 146 ChAdOx1 plus MF59C adjuvanted, trivalent influenza vaccine, 79 BNT162b2 plus MF59C adjuvanted, trivalent influenza vaccine, 128 ChAdOx1 plus recombinant quadrivalent influenza vaccine, and 58 BNT162b2 plus recombinant quadrivalent influenza vaccine. 340 participants were assigned to concomitant administration of influenza and a second dose of COVID-19 vaccine at day 0 followed by placebo at day 21, and 339 participants were randomly assigned to concomitant administration of placebo and a second dose of COVID-19 vaccine at day 0 followed by influenza vaccine at day 21. Non-inferiority was indicated in four cohorts, as follows: ChAdOx1 plus cellular quadrivalent influenza vaccine (risk difference for influenza vaccine minus placebos -1·29%, 95% CI -14·7 to 12·1), BNT162b2 plus cellular quadrivalent influenza vaccine (6·17%, -6·27 to 18·6), BNT162b2 plus MF59C adjuvanted, trivalent influenza vaccine (-12·9%, -34·2 to 8·37), and ChAdOx1 plus recombinant quadrivalent influenza vaccine (2·53%, -13·3 to 18·3). In the other two cohorts, the upper limit of the 95% CI exceeded the 0·25 non-inferiority margin (ChAdOx1 plus MF59C adjuvanted, trivalent influenza vaccine 10·3%, -5·44 to 26·0; BNT162b2 plus recombinant quadrivalent influenza vaccine 6·75%, -11·8 to 25·3). Most systemic reactions to vaccination were mild or moderate. Rates of local and unsolicited systemic reactions were similar between the randomly assigned groups. One serious adverse event, hospitalisation with severe headache, was considered related to the trial intervention. Immune responses were not adversely affected. INTERPRETATION: Concomitant vaccination with ChAdOx1 or BNT162b2 plus an age-appropriate influenza vaccine raises no safety concerns and preserves antibody responses to both vaccines. Concomitant vaccination with both COVID-19 and influenza vaccines over the next immunisation season should reduce the burden on health-care services for vaccine delivery, allowing for timely vaccine administration and protection from COVID-19 and influenza for those in need. FUNDING: National Institute for Health Research Policy Research Programme.

Implementing public involvement throughout the research process-Experience and learning from the GPs in EDs study.

BACKGROUND: Public involvement in health services research is encouraged. Descriptions of public involvement across the whole research cycle of a major study are uncommon and its effects on research conduct are poorly understood. AIM: This study aimed to describe how we implemented public involvement, reflect on process and effects in a large-scale multi-site research study and present learning for future involvement practice. METHOD: We recorded public involvement roles and activities throughout the study and compared these to our original public involvement plan included in our project proposal. We held a group interview with study co-applicants to explore their experiences, transcribed the recorded discussion and conducted thematic analysis. We synthesized the findings to develop recommendations for future practice. RESULTS: Public contributors' activities went beyond strategic study planning and management to include active involvement in data collection, analysis and dissemination. They attended management, scrutiny, planning and task meetings. They also facilitated public involvement through annual planning and review sessions, conducted a Public Involvement audit and coordinated public and patient input to stakeholder discussions at key study stages. Group interview respondents said that involvement exceeded their expectations. They identified effects such as changes to patient recruitment, terminology clarification and extra dissemination activities. They identified factors enabling effective involvement including team and leader commitment, named support contact, building relationships and demonstrating equality and public contributors being confident to challenge and flexible to meet researchers' timescales and work patterns. There were challenges matching resources to roles and questions about the risk of over-professionalizing public contributors. CONCLUSION: We extended our planned approach to public involvement and identified benefits to the research process that were both specific and general. We identified good practice to support effective public involvement in health services research that study teams should consider in planning and undertaking research. PUBLIC CONTRIBUTION: This paper was co-conceived, co-planned and co-authored by public contributors to contribute research evidence, based on their experiences of active involvement in the design, implementation and dissemination of a major health services research study.

A mixed-methods characterisation of patient safety incidents by primary eye care practitioners.

PURPOSE: Patient safety in eye health care is an underdeveloped field of research. A patient safety incident occurs when an unintended incident happens that could have (or did) lead to harm. To enable learning from patient safety incidents in optometry, a characterisation of commonly experienced safety incidents is needed to identify options to improve the quality of care. This study aimed to characterise eye health-related patient safety incidents from the perspective of eye care practitioners. METHODS: At a national conference in Wales, 56 eye care practitioners participated in a stakeholder workshop on eye care-related patient safety incidents. Participants were asked to suggest patient safety incidents that have occurred, or based on their experience, could occur in optometric practice. Using the nominal group technique, participants voted on the incident they perceived could cause the most harm and the incident observed most frequently in practice. Framework analysis supported identification of themes about the nature and outcomes of incidents in eye care. RESULTS: Diagnostic incidents were perceived to be the most severe (highest number of 'severity votes', n = 38), whilst administration-related incidents were most frequent (highest number of 'frequency votes' n = 39). Four themes were identified which are as follows: inappropriate clinical decision-making; delayed or missed referral of patients to general medical practitioners or ophthalmologists; compromised communication with other practitioners or patients and delays in receiving eye care. The results suggest that incidents relating to inappropriate clinical decision-making could result in the most severe harm to patients but may not occur frequently. CONCLUSIONS: Diagnostic- and administrative-related incidents pose clear challenges for improvement in quality and safety of care. The breadth of themes reflecting the nature and outcomes from unsafe eye care highlights the complexity underpinning incidents and the burden to patients. This work has informed the content of an all-Wales incident report form for primary eye care practitioners.

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.

Patients' experiences of attending emergency departments where primary care services are located: qualitative findings from patient and clinician interviews from a realist evaluation.

BACKGROUND: Patient experience is an important outcome and indicator of healthcare quality, and patient reported experiences are key to improving quality of care. While patient experience in emergency departments (EDs) has been reported in research, there is limited evidence about patients' specific experiences with primary care services located in or alongside EDs. We aim to identify theories about patient experience and acceptability of being streamed to a primary care clinician in an ED. METHODS: Using theories from a rapid realist review as a basis, we interviewed 24 patients and 106 staff members to generate updated theories about patient experience and acceptability of streaming to primary care services in EDs. Feedback from 56 stakeholders, including clinicians, policymakers and patient and public members, as well as observations at 13 EDs, also contributed to the development of these theories, which we present as a programme theory. RESULTS: We found that patients had no expectations or preferences for which type of clinician they were seen by, and generally found being streamed to a primary care clinician in the ED acceptable. Clinicians and patients reported that patients generally found primary care streaming acceptable if they felt their complaint was dealt with suitably, in a timely manner, and when clinicians clearly communicated the need for investigations, and how these contributed to decision-making and treatment plans. CONCLUSIONS: From our findings, we have developed a programme theory to demonstrate that service providers can expect that patients will be generally satisfied with their experience of being streamed to, and seen by, primary care clinicians working in these services. Service providers should consider the potential advantages and disadvantages of implementing primary care services at their ED. If primary care services are implemented, clear communication is needed between staff and patients, and patient feedback should be sought.

Learning from diagnostic errors to improve patient safety when GPs work in or alongside emergency departments: incorporating realist methodology into patient safety incident report analysis.

BACKGROUND: Increasing demand on emergency healthcare systems has prompted introduction of new healthcare service models including the provision of GP services in or alongside emergency departments. In England this led to a policy proposal and £100million (US$130million) of funding for all emergency departments to have co-located GP services. However, there is a lack of evidence for whether such service models are effective and safe. We examined diagnostic errors reported in patient safety incident reports to develop theories to explain how and why they occurred to inform potential priority areas for improvement and inform qualitative data collection at case study sites to further refine the theories. METHODS: We used a mixed-methods design using exploratory descriptive analysis to identify the most frequent and harmful sources of diagnostic error and thematic analysis, incorporating realist methodology to refine theories from an earlier rapid realist review, to describe how and why the events occurred and could be mitigated, to inform improvement recommendations. We used two UK data sources: Coroners' reports to prevent future deaths (30.7.13-14.08.18) and National Reporting and Learning System (NRLS) patient safety incident reports (03.01.05-30.11.15). RESULTS: Nine Coroners' reports (from 1347 community and hospital reports, 2013-2018) and 217 NRLS reports (from 13 million, 2005-2015) were identified describing diagnostic error related to GP services in or alongside emergency departments. Initial theories to describe potential priority areas for improvement included: difficulty identifying appropriate patients for the GP service; under-investigation and misinterpretation of diagnostic tests; and inadequate communication and referral pathways between the emergency and GP services. High-risk presentations included: musculoskeletal injury, chest pain, headache, calf pain and sick children. CONCLUSION: Initial theories include the following topics as potential priority areas for improvement interventions and evaluation to minimise the risk of diagnostic errors when GPs work in or alongside emergency departments: a standardised initial assessment with streaming guidance based on local service provision; clinical decision support for high-risk conditions; and standardised computer systems, communication and referral pathways between emergency and GP services. These theories require refinement and testing with qualitative data collection from case study (hospital) sites.

Challenges of recruiting emergency department patients to a qualitative study: a thematic analysis of researchers' experiences.

BACKGROUND: At times of increasing pressure on emergency departments, and the need for research into different models of service delivery, little is known about how to recruit patients for qualitative research in emergency departments. We report from one study which aimed to collect evidence on patients' experiences of attending emergency departments with different models of using general practitioners, but faced challenges in recruiting patients. This paper aims to identify and reflect on the challenges faced at all stages of patient recruitment, from identifying and inviting eligible patients, consenting them for participation and finally to engaging them in interviews, and make recommendations based on our learning. METHODS: A thematic analysis was carried out on field-notes taken during research visits and meeting minutes of discussions to review and improve patient recruitment throughout the study. RESULTS: The following factors influenced the success of patient recruitment in the emergency department setting: complicated or time-consuming electronic health record systems for identifying patients; narrow participant eligibility criteria; limited research nurse support; and lack of face-to-face communication between researchers and eligible patients. CONCLUSIONS: This paper adds to the methodological evidence for improving patient recruitment in different settings, with a focus on qualitative research in emergency departments. Our findings have implications for future studies attempting to recruit patients in similar settings.

A qualitative content analysis of retained surgical items: learning from root cause analysis investigations.

OBJECTIVE: To describe incidents of retained surgical items, including their characteristics and the circumstances in which they occur. DESIGN: A qualitative content analysis of root cause analysis investigation reports. SETTING: Public health services in Victoria, Australia, 2010-2015. PARTICIPANTS: Incidents of retained surgical items as described by 31 root cause analysis investigation reports. MAIN OUTCOME MEASURE(S): The type of retained surgical item, the length of time between the item being retained and detected and qualitative descriptors of the contributing factors and the circumstances in which the retained surgical items occurred. RESULTS: Surgical packs, drain tubes and vascular devices comprised 68% (21/31) of the retained surgical items. Nearly one-quarter of the retained surgical items were detected either immediately in the post-operative period or on the day of the procedure (7/31). However, about one-sixth (5/31) were only detected after 6 months, with the longest period being 18 months. Contributing factors included complex or multistage surgery; the use of packs not specific to the purpose of the surgery; and design features of the surgical items. CONCLUSION: Retained drains occurred in the post-operative phase where surgical counts are not applicable and clinician situational awareness may not be as great. Root cause analysis investigation reports can be a valuable means of characterizing infrequently occurring adverse events such as retained surgical items. They may detect incidents that are not detected by other data collections and can inform the design enhancements and development of technologies to reduce the impact of retained surgical items.

Emergency department clinical leads' experiences of implementing primary care services where GPs work in or alongside emergency departments in the UK: a qualitative study.

BACKGROUND: To manage increasing demand for emergency and unscheduled care NHS England policy has promoted services in which patients presenting to Emergency Departments (EDs) with non-urgent problems are directed to general practitioners (GPs) and other primary care clinicians working within or alongside emergency departments. However, the ways that hospitals have implemented primary care services in EDs are varied. The aim of this study was to describe ED clinical leads' experiences of implementing and delivering 'primary care services' and 'emergency medicine services' where GPs were integrated into the ED team. METHODS: We conducted interviews with ED clinical leads in England (n = 19) and Wales (n = 2). We used framework analysis to analyse interview transcripts and explore differences across 'primary care services', 'emergency medicine services' and emergency departments without primary care services. RESULTS: In EDs with separate primary care services, success was reported when having a distinct workforce of primary care clinicians, who improved waiting times and flow by seeing primary care-type patients in a timely way, using fewer investigations, and enabling ED doctors to focus on more acutely unwell patients. Some challenges were: trying to align their service with the policy guidance, inconsistent demand for primary care, accessible community primary care services, difficulties in recruiting GPs, lack of funding, difficulties in agreeing governance protocols and establishing effective streaming pathways. Where GPs were integrated into an ED workforce success was reported as managing the demand for both emergency and primary care and reducing admissions. CONCLUSIONS: Introducing a policy advocating a preferred model of service to address primary care demand was not useful for all emergency departments. To support successful and sustainable primary care services in or alongside EDs, policy makers and commissioners should consider varied ways that GPs can be employed to manage variation in local demand and also local contextual factors such as the ability to recruit and retain GPs, sustainable funding, clear governance frameworks, training, support and guidance for all staff. Whether or not streaming to a separate primary care service is useful also depended on the level of primary care demand.

Identifying 'avoidable harm' in family practice: a RAND/UCLA Appropriateness Method consensus study.

BACKGROUND: Health care-related harm is an internationally recognized threat to public health. The United Kingdom's national health services demonstrate that upwards of 90% of health care encounters can be delivered in ambulatory settings. Other countries are transitioning to more family practice-based health care systems, and efforts to understand avoidable harm in these settings is needed. METHODS: We developed 100 scenarios reflecting a range of diseases and informed by the World Health Organization definition of 'significant harm'. Scenarios included different types of patient safety incidents occurring by commission and omission, demonstrated variation in timeliness of intervention, and conditions where evidence-based guidelines are available or absent. We conducted a two-round RAND / UCLA Appropriateness Method consensus study with a panel of family practitioners in England to define "avoidable harm" within family practice. Panelists rated their perceptions of avoidability for each scenario. We ran a k-means cluster analysis of avoidability ratings. RESULTS: Panelists reached consensus for 95 out of 100 scenarios. The panel agreed avoidable harm occurs when a patient safety incident could have been probably, or totally, avoided by the timely intervention of a health care professional in family practice (e.g. investigations, treatment) and / or an administrative process (e.g. referrals, alerts in electronic health records, procedures for following up results) in accordance with accepted evidence-based practice and clinical governance. Fifty-four scenarios were deemed avoidable, whilst 31 scenarios were rated unavoidable and reflected outcomes deemed inevitable regardless of family practice intervention. Scenarios with low avoidability ratings (1 s or 2 s) were not represented by the categories that were used to generate scenarios, whereas scenarios with high avoidability ratings (7 s 8 s or 9 s) were represented by these a priori categories. DISCUSSION: The findings from this RAND/UCLA Appropriateness Method study define the characteristics and conditions that can be used to standardize measurement of outcomes for primary care patient safety. CONCLUSION: We have developed a definition of avoidable harm that has potential for researchers and practitioners to apply across primary care settings, and bolster international efforts to design interventions to target avoidable patient safety incidents that cause the most significant harm to patients.

Taxonomy of the form and function of primary care services in or alongside emergency departments: concepts paper.

Primary care services in or alongside emergency departments look and function differently and are described using inconsistent terminology. Research to determine effectiveness of these models is hampered by outdated classification systems, limiting the opportunity for data synthesis to draw conclusions and inform decision-making and policy. We used findings from a literature review, a national survey of Type 1 emergency departments in England and Wales, staff interviews, other routine data sources and discussions from two stakeholder events to inform the taxonomy. We categorised the forms inside or outside the emergency department: inside primary care services may be integrated with emergency department patient flow or may run parallel to that activity; outside services may be offered on site or off site. We then describe a conceptual spectrum of integration: identifying constructs that influence how the services function-from being closer to an emergency medicine service or to usual primary care. This taxonomy provides a basis for future evaluation of service models that will comprise the evidence base to inform policy-making in this domain. Commissioners and service providers can consider these constructs in characterising and designing services depending on local circumstances and context.

Diagnostic error in the emergency department: learning from national patient safety incident report analysis.

BACKGROUND: Diagnostic error occurs more frequently in the emergency department than in regular in-patient hospital care. We sought to characterise the nature of reported diagnostic error in hospital emergency departments in England and Wales from 2013 to 2015 and to identify the priority areas for intervention to reduce their occurrence. METHODS: A cross-sectional mixed-methods design using an exploratory descriptive analysis and thematic analysis of patient safety incident reports. Primary data were extracted from a national database of patient safety incidents. Reports were filtered for emergency department settings, diagnostic error (as classified by the reporter), from 2013 to 2015. These were analysed for the chain of events, contributory factors and harm outcomes. RESULTS: There were 2288 cases of confirmed diagnostic error: 1973 (86%) delayed and 315 (14%) wrong diagnoses. One in seven incidents were reported to have severe harm or death. Fractures were the most common condition (44%), with cervical-spine and neck of femur the most frequent types. Other common conditions included myocardial infarctions (7%) and intracranial bleeds (6%). Incidents involving both delayed and wrong diagnoses were associated with insufficient assessment, misinterpretation of diagnostic investigations and failure to order investigations. Contributory factors were predominantly human factors, including staff mistakes, healthcare professionals' inadequate skillset or knowledge and not following protocols. CONCLUSIONS: Systems modifications are needed that provide clinicians with better support in performing patient assessment and investigation interpretation. Interventions to reduce diagnostic error need to be evaluated in the emergency department setting, and could include standardised checklists, structured reporting and technological investigation improvements.

Participatory design of an improvement intervention for the primary care management of possible sepsis using the Functional Resonance Analysis Method.

BACKGROUND: Ensuring effective identification and management of sepsis is a healthcare priority in many countries. Recommendations for sepsis management in primary care have been produced, but in complex healthcare systems, an in-depth understanding of current system interactions and functioning is often essential before improvement interventions can be successfully designed and implemented. A structured participatory design approach to model a primary care system was employed to hypothesise gaps between work as intended and work delivered to inform improvement and implementation priorities for sepsis management. METHODS: In a Scottish regional health authority, multiple stakeholders were interviewed and the records of patients admitted from primary care to hospital with possible sepsis analysed. This identified the key work functions required to manage these patients successfully, the influence of system conditions (such as resource availability) and the resulting variability of function output. This information was used to model the system using the Functional Resonance Analysis Method (FRAM). The multiple stakeholder interviews also explored perspectives on system improvement needs which were subsequently themed. The FRAM model directed an expert group to reconcile improvement suggestions with current work systems and design an intervention to improve clinical management of sepsis. RESULTS: Fourteen key system functions were identified, and a FRAM model was created. Variability was found in the output of all functions. The overall system purpose and improvement priorities were agreed. Improvement interventions were reconciled with the FRAM model of current work to understand how best to implement change, and a multi-component improvement intervention was designed. CONCLUSIONS: Traditional improvement approaches often focus on individual performance or a specific care process, rather than seeking to understand and improve overall performance in a complex system. The construction of the FRAM model facilitated an understanding of the complexity of interactions within the current system, how system conditions influence everyday sepsis management and how proposed interventions would work within the context of the current system. This directed the design of a multi-component improvement intervention that organisations could locally adapt and implement with the aim of improving overall system functioning and performance to improve sepsis management.