Where are all the veterans? A mixed methods assessment of a systematic strategy to increase veteran registration in UK primary healthcare practices.

OBJECTIVES: To identify effective initiatives to increase veteran registration in UK primary healthcare (PHC) practices. DESIGN: A structured and systematic strategy was designed to improve the number of military veterans correctly coded within PHC. A mixed methods approach was adopted to evaluate the impact. PHC staff provided anonymised patient medical record data that used Read and Systematised Nomenclature of Medicine - Clinical Terms codes to identify the number of veterans within each PHC practice. This included baseline data, then scheduled further information after two phases of internal advertisement and two phases of external advertisement of different initiatives intended to raise veteran registration. Qualitative data was acquired through post-project interviews with PHC staff to ascertain the effectiveness, benefits, problems and means for improvement. A modified Grounded theory was used for the 12 staff interviews. SETTING AND PARTICIPANTS: Twelve PHC practices in Cheshire, England, participated in this research study with a combined total of 138 098 patients. Data was collected between 01 September 2020 until 28 February 2021. RESULTS: Overall, veteran registration increased by 218.1% (N=1311). Estimated coverage of veterans increased from a coverage of 9.3% to a coverage of 29.5%. There was an increased population coverage ranging from 5.0% to 54.1%. The staff interviews revealed improved staff commitment and their taking ownership of the responsibility to improve veteran registration. The primary challenge was the COVID-19 pandemic, in particular the significantly reduced footfall and the communication opportunities and interface with patients. CONCLUSIONS: Managing an advertising campaign and improving veteran registration during a pandemic caused huge problems, but it also presented opportunities. Enabling a significant increase in PHC registration during the harshest and most testing conditions indicates that the accomplished achievements have substantial merit for wider adoption and impact.

JBI systematic review protocol of text/opinions on how to best collect race-based data in healthcare contexts.

INTRODUCTION: Racialized population groups have worse health outcomes across the world compared with non-racialized populations. Evidence suggests that collecting race-based data should be done to mitigate racism as a barrier to health equity, and to amplify community voices, promote transparency, accountability, and shared governance of data. However, limited evidence exists on the best ways to collect race-based data in healthcare contexts. This systematic review aims to synthesize opinions and texts on the best practices for collecting race-based data in healthcare contexts. METHODS AND ANALYSES: We will use the Joanna Briggs Institute (JBI) method for synthesizing text and opinions. JBI is a global leader in evidence-based healthcare and provides guidelines for systematic reviews. The search strategy will locate both published and unpublished papers in English in CINAHL, Medline, PsycINFO, Scopus and Web of Science from 1 January 2013 to 1 January 2023, as well as unpublished studies and grey literature of relevant government and research websites using Google and ProQuest Dissertations and Theses. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement methodology for systematic reviews of text and opinion will be applied, including screening and appraisal of the evidence by two independent reviewers and data extraction using JBI's Narrative, Opinion, Text, Assessment, Review Instrument. This JBI systematic review of opinion and text will address gaps in knowledge about the best ways to collect race-based data in healthcare. Improvements in race-based data collection, may be related to structural policies that address racism in healthcare. Community participation may also be used to increase knowledge about collecting race-based data. ETHICS AND DISSEMINATION: The systematic review does not involve human subjects. Findings will be disseminated through a peer-reviewed publication in JBI evidence synthesis, conferences and media. PROSPERO REGISTRATION NUMBER: CRD42022368270.

Patient-clinician dynamics in remote consultations: a qualitative study of cardiology and rheumatology outpatient clinics in the UK.

OBJECTIVE: Explore the experiences of patients and clinicians in rheumatology and cardiology outpatient clinics during the first year of the COVID-19 pandemic, focusing on the impact of remote consultations on interpersonal dynamics. DESIGN: Qualitative study using semistructured interviews, conducted between February and June 2021. SETTING: The rheumatology and cardiology departments of a general hospital in England, UK. PARTICIPANTS: All clinicians and a convenience sample of 100 patients in each department who had taken part in a remote consultation in the past month were invited to take part. Twenty-five interviews were conducted (13 with patients, 12 with clinicians). RESULTS: Three themes were developed through the analysis: adapting to the dynamics of remote consultations, impact on the patient's experience and impact on the clinician's experience. The majority of remote consultations experienced by both patients and clinicians had been via telephone. Both clinicians and patients found remote consultations to be more business-like and focused, with the absence of pauses restricting time for reflection. For patients with stable, well-managed conditions, remote consultations were felt to be appropriate and could be more convenient than in-person consultations. However, the loss of visual cues meant some patients felt they could not give a holistic view of their condition and limited clinicians' ability to gather and convey information. Clinicians adjusted their approach by asking more questions, checking understanding more frequently and expressing empathy verbally, but felt patients still shared fewer concerns remotely than in person; a perception with which patients concurred. CONCLUSIONS: These findings highlight the importance of ensuring, for each patient, that remote care is appropriate. Future research should focus on developing ways to support both clinicians and patients to gather and provide all information necessary during remote consultations, to enhance communication and trust.

Perceived organisational support and work engagement among health sector workers during the COVID-19 pandemic: a multicentre, time-lagged, cross-sectional study among clinical hospital staff in Pakistan.

OBJECTIVE: Workplace engagement is associated with several significant positive organisational outcomes. The COVID-19 pandemic has emphasised the importance of workplace engagement, particularly for front-line healthcare workers. Drawing on the conservation of resources theory, this study examines the impact of personal and job resources in a workplace that help in resource conservation for work engagement. In view of the high burnout rates reported among health professionals during the COVID-19 pandemic, this study aims to investigate the impact of perceived organisational support (POS) on work engagement through the mediating effect of well-being and the moderating role of employees' resilience. DESIGN: Time-lagged, cross-sectional, split questionnaire-based survey study. SETTING: Data were gathered from 68 hospitals in Pakistan, of which 45 were public and 23 were private hospitals. PARTICIPANTS AND ANALYSIS: Simple random sampling techniques were used and data were collected from 345 healthcare professionals (ie, doctors, nurses and allied health professionals) using split questionnaires, in two waves with a 3-week interval, with a response rate of 80%. For analysis of data, the study used the PROCESS macro by Hayes. RESULTS: Engagement at work was positively correlated with POS, well-being and resilience. POS significantly predicted work engagement through well-being (ß=0.06, SE=0.02, 95% bias-corrected CI 0.021, 0.10). Further analysis of the strong effect of resilience on subjective well-being shows the significant value of the mediated moderation index (ß=0.06, SE=0.02, 95% bias-corrected CI 0.03, 0.11). CONCLUSION: The findings suggest that well-being may be an important pathway through which healthcare workers' POS may influence work engagement, particularly when their resilience capability is high. To maintain engagement at the workplace, hospital administrators should consider strengthening organisational and individual resources that build a supportive environment to meet the demands of challenging times.

Royal Society of Medicine, Colt Foundation Research & Clinical Innovation Meeting 2022

Correspondence to Wg Cdr Robert M Barker-Davies, Academic Department of Military Rehabilitation, Defence Medical Rehabilitation Centre Stanford Hall, Loughborough, LE12 5BR, UK;Robert.barker-davies@nhs.net The Royal Society of Medicine (RSM–Military Medicine Section), Colt Foundation Research & Clinical Innovation Meeting has been at the core of Defence Medical Services (DMS) academic activity since its inception in 2007. Initially, the meeting sought submissions from medical officers, typically undertaking higher degrees, but in recent years the scope of the meeting has been broadened to include all healthcare professional disciplines.1 2 This reflects the strategic directions of both UK Healthcare and the DMS towards greater interdisciplinary healthcare delivery models and integrated research3 in which shared role understanding and supportive team structures have been identified as themes that promote collaborative success in military medical teams.4 The top six s for the Colt Research prize, published here in BMJ Military Health, reflect this diversity as they span several disciplines and both academic and Defence institutions. [...]we heard from Captain Kat Matthews, army physiotherapist and professional triathlete.

Clinical study reports published by the European Medicines Agency 2016-2018: a cross-sectional analysis.

OBJECTIVES: To describe the characteristics of clinical study report (CSR) documents published by the European Medicines Agency (EMA), and for included pivotal trials, to quantify the timeliness of access to trial results from CSRs compared with conventional published sources. DESIGN: Cross-sectional analysis of CSR documents published by the EMA from 2016 to 2018. METHODS: CSR files and medication summary information were downloaded from the EMA. Individual trials in each submission were identified using document filenames. Number and length of documents and trials were determined. For pivotal trials, trial phase, dates of EMA document publication and matched journal and registry publications were obtained. RESULTS: The EMA published documents on 142 medications that were submitted for regulatory drug approval. Submissions were for initial marketing authorisations in 64.1%. There was a median of 15 (IQR 5-46) documents, 5 (IQR 2-14) trials and 9629 (IQR 2711-26,673) pages per submission, and a median of 1 (IQR 1-4) document and 336 (IQR 21-1192) pages per trial. Of all identified pivotal trials, 60.9% were phase 3 and 18.5% were phase 1. Of 119 unique submissions to the EMA, 46.2% were supported by a single pivotal trial, with 13.4% based on a single pivotal phase 1 trial. No trial registry results were identified for 26.1% trials, no journal publications for 16.7% and 13.5% of trials had neither. EMA publication was the earliest information source for 5.8% of pivotal trials, available a median 523 days (IQR 363-882 days) before the earliest publication. CONCLUSIONS: The EMA Clinical Data website contains lengthy clinical trial documents. Almost half of submissions to the EMA were based on single pivotal trials, many of which were phase 1 trials. CSRs were the only source and a timelier source of information for many trials. Access to unpublished trial information should be open and timely to support decision-making for patients.

Factors associated with recognition at work among nurses and the impact of recognition at work on health-related quality of life, job satisfaction and psychological health: a single-centre, cross-sectional study in Morocco.

OBJECTIVES: To describe the sociodemographic, occupational and health factors that influence nurses' recognition at work and to examine a recognition pathway model to assess the relationship between recognition at work and health-related quality of life (HRQOL), job satisfaction, anxiety and depression. DESIGN: This is a cross-sectional observational study with prospective data collection based on a self-report questionnaire. SETTING: University hospital centre in Morocco. PARTICIPANTS: The study included 223 nurses with at least 1 year of practice at the bedside in care units. MEASURES: We included the sociodemographic, occupational and health characteristics of each participant. The Fall Amar instrument was used to measure job recognition. HRQOL was measured using the Medical Outcome Study Short Form 12. The Hospital Anxiety and Depression Scale was used to assess anxiety and depression. Job satisfaction was measured using a rating scale (ranging from 0 to 10). Path analysis was used to examine the nurse recognition pathway model to assess the relationship between nurse recognition at work and key variables. RESULTS: The participation rate in this study was 79.3%. Institutional recognition was significantly correlated with gender, midwifery specialty and normal work schedule: ß=-5.10 (-8.06, -2.14), ß=-5.13 (-8.66, -1.60) and ß=-4.28 (-6.85, -1.71), respectively. Significant correlations were found between recognition from superiors and gender, mental health specialisation and normal work schedule: ß=-5.71 (-9.39, -2.03), ß=-5.96 (-11.17, -0.75) and ß=-4.04(-7.23, -0.85), respectively. Recognition from coworkers was significantly associated with mental health specialisation: ß=-5.09 (-9.16, -1.01). The trajectory analysis model found that supervisor recognition had the best impact on anxiety, job satisfaction and HRQOL. CONCLUSIONS: Recognition from superiors is important in maintaining nurses' psychological health, HRQOL and job satisfaction. Therefore, managers in hospitals should address the issue of recognition at work as a potential personal, professional and organisational lever.

Applying dyadic digital psychological interventions for reducing caregiver burden in the illness context: a systematic review and a meta-analysis protocol.

INTRODUCTION: Providing informal care to one's romantic partner who is ill may become a highly distressing and demanding task. Based on the innovative dyadic coping model, several support interventions have been developed to alleviate informal caregivers' burden, including both caregivers' and care receivers' needs. Considering the unique challenges characterising the caregiving phenomenon, such as geographical barriers and time restrictions, digital solutions should be considered. However, there is a lack of research examining the effectiveness of dyadic digital solutions. Thus, this review aims to examine the existing literature on the efficacy of dyadic digital psychological interventions designed for caregivers and their care-receivers couples within the illness context. METHODS AND ANALYSIS: Randomised controlled trials targeting caregivers' burden among dyads of informal caregivers and care receivers will be identified via an electronic search of the following databases: PubMed, Embase, the Cochrane Library, Cinhal, Scopus, PsycINFO, MEDLINE and supplemented by hand searching of previous systematic reviews. The search will be undertaken following the PICO (population, intervention, comparison and outcome) elements. If possible, a meta-analysis will be conducted to examine: (1) the effectiveness of dyadic digital psychological interventions for reducing caregivers' burden (primary outcome) among caregivers who are in a romantic relationship with the care receivers; (2) the effectiveness of dyadic digital psychological interventions on secondary outcomes such as anxiety, depression, stress, quality of life, well-being and self-efficacy among caregivers and care receivers; and (3) moderating effects of clinical and methodological factors on caregivers' burden. Prior to inclusion in the review, retrieved papers will be critically appraised by two independent reviewers. The Cochrane Risk of Bias tool will assess the risk of bias for randomised controlled trials. ETHICS AND DISSEMINATION: Ethical approval is not required as no primary data will be collected. Findings will be disseminated through peer-reviewed publications, presentations at academic conferences and lay summaries for various stakeholders. PROSPERO REGISTRATION NUMBER: CRD42022299125.

Clinical emergency care quality indicators in Africa: a scoping review and data summary.

OBJECTIVES: Emergency care services are rapidly expanding in Africa; however, development must focus on quality. The African Federation of Emergency Medicine consensus conference (AFEM-CC)-based quality indicators were published in 2018. This study sought to increase knowledge of quality through identifying all publications from Africa containing data relevant to the AFEM-CC process clinical and outcome quality indicators. DESIGN: We conducted searches for general quality of emergency care in Africa and for each of 28 AFEM-CC process clinical and five outcome clinical quality indicators individually in the medical and grey literature. DATA SOURCES: PubMed (1964-2 January 2022), Embase (1947-2 January 2022) and CINAHL (1982-3 January 2022) and various forms of grey literature were queried. ELIGIBILITY CRITERIA: Studies published in English, addressing the African emergency care population as a whole or large subsegment of this population (eg, trauma, paediatrics), and matching AFEM-CC process quality indicator parameters exactly were included. Studies with similar, but not exact match, data were collected separately as 'AFEM-CC quality indicators near match'. DATA EXTRACTION AND SYNTHESIS: Document screening was done in duplicate by two authors, using Covidence, and conflicts were adjudicated by a third. Simple descriptive statistics were calculated. RESULTS: One thousand three hundred and fourteen documents were reviewed, 314 in full text. 41 studies met a priori criteria and were included, yielding 59 unique quality indicator data points. Documentation and assessment quality indicators accounted for 64% of data points identified, clinical care for 25% and outcomes for 10%. An additional 53 'AFEM-CC quality indicators near match' publications were identified (38 new publications and 15 previously identified studies that contained additional 'near match' data), yielding 87 data points. CONCLUSIONS: Data relevant to African emergency care facility-based quality indicators are highly limited. Future publications on emergency care in Africa should be aware of, and conform with, AFEM-CC quality indicators to strengthen understanding of quality.

How does work environment relate to diagnostic quality? A prospective, mixed methods study in primary care.

OBJECTIVES: The quest to measure and improve diagnosis has proven challenging; new approaches are needed to better understand and measure key elements of the diagnostic process in clinical encounters. The aim of this study was to develop a tool assessing key elements of the diagnostic assessment process and apply it to a series of diagnostic encounters examining clinical notes and encounters' recorded transcripts. Additionally, we aimed to correlate and contextualise these findings with measures of encounter time and physician burnout. DESIGN: We audio-recorded encounters, reviewed their transcripts and associated them with their clinical notes and findings were correlated with concurrent Mini Z Worklife measures and physician burnout. SETTING: Three primary urgent-care settings. PARTICIPANTS: We conducted in-depth evaluations of 28 clinical encounters delivered by seven physicians. RESULTS: Comparing encounter transcripts with clinical notes, in 24 of 28 (86%) there was high note/transcript concordance for the diagnostic elements on our tool. Reliably included elements were red flags (92% of notes/encounters), aetiologies (88%), likelihood/uncertainties (71%) and follow-up contingencies (71%), whereas psychosocial/contextual information (35%) and mentioning common pitfalls (7%) were often missing. In 22% of encounters, follow-up contingencies were in the note, but absent from the recorded encounter. There was a trend for higher burnout scores being associated with physicians less likely to address key diagnosis items, such as psychosocial history/context. CONCLUSIONS: A new tool shows promise as a means of assessing key elements of diagnostic quality in clinical encounters. Work conditions and physician reactions appear to correlate with diagnostic behaviours. Future research should continue to assess relationships between time pressure and diagnostic quality.

Physical performance testing in post-COVID-19 patients: protocol for a systematic review of psychometric measurement properties.

INTRODUCTION: COVID-19 is an infectious disease that causes severe acute respiratory syndrome. A large variety of exercise capacity tests are used for the evaluation of post-COVID-19 patients, but the psychometric properties of these exercise tests remain undetermined in this population. This study aims to critically appraise, compare and summarise the psychometric properties (validity, reliability and responsiveness) of all physical performance tests that are used to assess exercise capacity in post-COVID-19 patients. METHODS AND ANALYSIS: This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. We will include studies with hospitalised adult post-COVID-19 patients (aged 18 years or older and with a confirmed diagnosis of COVID-19). The research will cover randomised controlled trials (RCTs), quasi-RCTs and observational studies published in English and performed in the following settings: hospital, rehabilitation centre, outpatient clinic. We will search the following databases with no date restrictions: PubMed/MEDLINE, EMBASE, SciELO, Cochrane Library, CINAHL and Web of Science. Two authors will independently assess the risk of bias (using the Consensus-Based Standards for the Selection of Health Measurement Instruments Risk of bias checklist) and the certainty of evidence (using the Grading of Recommendations, Assessment, Development and Evaluations). According to the results obtained, data will be meta-analysed or reported narratively. ETHICS AND DISSEMINATION: No ethical approval is required for this publication since it will be based on published data. Results of this review will be disseminated via peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42021242334.

Consultation skills development in general practice: findings from a qualitative study of newly recruited and more experienced clinical pharmacists during the COVID-19 pandemic.

OBJECTIVE: The new structured medication review (SMR) service was introduced into the National Health Service in England during the COVID-19 pandemic, following a major expansion of clinical pharmacists within new formations known as primary care networks (PCNs). The aim of the SMR is to tackle problematic polypharmacy through comprehensive, personalised medication reviews involving shared decision-making. Investigation of clinical pharmacists' perceptions of training needs and skills acquisition issues for person-centred consultation practice will help better understand their readiness for these new roles. DESIGN: A longitudinal interview and observational study in general practice. SETTING AND PARTICIPANTS: A longitudinal study of 10 newly recruited clinical pharmacists interviewed three times, plus a single interview with 10 pharmacists recruited earlier and already established in general practice, across 20 newly forming PCNs in England. Observation of a compulsory 2-day history taking and consultation skills workshop. ANALYSIS: A modified framework method supported a constructionist thematic analysis. RESULTS: Remote working during the pandemic limited opportunities for patient-facing contact. Pharmacists new to their role in general practice were predominantly concerned with improving clinical knowledge and competence. Most said they already practiced person-centred care, using this terminology to describe transactional medicines-focused practice. Pharmacists rarely received direct feedback on consultation practice to calibrate perceptions of their own competence in person-centred communication, including shared decision-making skills. Training thus provided knowledge delivery with limited opportunities for actual skills acquisition. Pharmacists had difficulty translating abstract consultation principles into specific consultation practices. CONCLUSION: SMRs were introduced when the dedicated workforce was largely new and being trained. Addressing problematic polypharmacy requires structural and organisational interventions to enhance the communication skills of clinical pharmacists (and other health professionals), and their use in practice. The development of person-centred consultation skills requires much more substantial support than has so far been provided for clinical pharmacists.

Country learning on maintaining quality essential health services during COVID-19 in Timor-Leste: a qualitative analysis.

OBJECTIVE: This case study examines the enabling factors, strengths, challenges and lessons learnt from Timor-Leste (TLS) as it sought to maintain quality essential health services (EHS) during the COVID-19 pandemic. DESIGN: A qualitative case study triangulated information from 22 documents, 44 key informant interviews and 6 focus group discussions. The framework method was used to thematically examine the factors impacting quality EHS in TLS. SETTING: National, municipal, facility levels in Baucau, Dili and Ermera municipalities in TLS. RESULTS: Based on the TLS National Health Statistics Reports, a reduction in outpatient, emergency department and primary care service delivery visits was observed in 2020 when compared with 2019. However, in contrast, maternal child health services simultaneously improved in the areas of skilled birth attendants, prenatal coverage and vitamin A distribution, for example. From the thematic analysis, five themes emerged as contributing to or impeding the maintenance of quality EHS including (1) high-level strategy for maintaining quality EHS, (2) measurement for quality and factors affecting service utilisation, (3) challenges in implementation of quality activities across the three levels of the health system, (4) the impact of quality improvement leadership in health facilities during COVID-19 and (5) learning systems for maintaining quality EHS now and for the future. CONCLUSION: The maintenance of quality EHS is critical to mitigate adverse health effects from the COVID-19 pandemic. When quality health services are delivered prior to and maintained during public health emergencies, they build trust within the health system and promote healthcare-seeking behaviour. Planning for quality as part of emergency preparedness can facilitate a high standard of care by ensuring health services continue to provide a safe environment, reduce harm, improve clinical care and engage patients, facilities and communities.

Value of improving patient safety: health economic considerations for rapid response systems-a rapid review of the literature and expert round table.

OBJECTIVES: Failure to rescue deteriorating patients in hospital is a well-researched topic. We aimed to explore the impact of safer care on health economic considerations for clinicians, providers and policymakers. DESIGN: We undertook a rapid review of the available literature and convened a round table of international specialists in the field including experts on health economics and value-based healthcare to better understand health economics of clinical deterioration and impact of systems to reduce failure to rescue. RESULTS: Only a limited number of publications have examined the health economic impact of failure to rescue. Literature examining this topic lacked detail and we identified no publications on long-term cost outside the hospital following a deterioration event. The recent pandemic has added limited literature on prevention of deterioration in the patients' home.Cost-effectiveness and cost-efficiency are dependent on broader system effects of adverse events. We suggest including the care needs beyond the hospital and loss of income of patients and/or their informal carers as well as sickness of healthcare staff exposed to serious adverse events in the analysis of adverse events. They are likely to have a larger health economic impact than the direct attributable cost of the hospital admission of the patient suffering the adverse event. Premorbid status of a patient is a major confounder for health economic considerations. CONCLUSION: In order to optimise health at the population level, we must limit long-term effects of adverse events through improvement of our ability to rapidly recognise and respond to acute illness and worsening chronic illness both in the home and the hospital.

Personalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial.

INTRODUCTION: Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients. METHODS AND ANALYSIS: KAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid-base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8-51.5) min. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion. TRIAL REGISTRATION NUMBER: NCT04040296.

Gaining consensus on clinical quality outcomes for eating disorders: Framework for the development of an Australian national minimum dataset.

OBJECTIVES: Eating disorders (EDs) are complex psychiatric illnesses requiring multidisciplinary care across both mental and medical healthcare settings. Currently, no nationally comprehensive, consistent, agreed on or mandated data set or data collection strategy exists for EDs in Australia: thus, little is known about the outcomes of care nor treatment pathways taken by individuals with EDs. InsideOut Institute was contracted by the Australian Government Department of Health to develop a minimum dataset (MDS) for the illness group with consideration given to data capture mechanisms and the scoping of a national registry. DESIGN: A four-step modified Delphi methodology was used, including national consultations followed by three rounds of quantitative feedback by an expert panel. SETTING: Due to social distancing protocols throughout the global SARS-CoV-2 pandemic, the study was conducted online using video conferencing (Zoom and Microsoft Teams) (Step 1), email communication and the REDCap secure web-based survey platform (Steps 2-4). PARTICIPANTS: 14 data management organisations, 5 state and territory government departments of health, 2 Aboriginal and Torres Strait Islander advising organisations and 28 stakeholders representing public and private health sectors across Australia participated in consultations. 123 ED experts (including lived experience) participated in the first quantitative round of the Delphi survey. Retention was high, with 80% of experts continuing to the second round and 73% to the third. MAIN OUTCOME MEASURES: Items and categories endorsed by the expert panel (defined a priori as >85% rating an item or category 'very important' or 'imperative'). RESULTS: High consensus across dataset items and categories led to the stratification of an identified MDS. Medical status and quality of life were rated the most important outcomes to collect in an MDS. Other items meeting high levels of consensus included anxiety disorders, depression and suicidality; type of treatment being received; body mass index and recent weight change. CONCLUSIONS: Understanding presentation to and outcomes from ED treatment is vital to drive improvements in healthcare delivery. A nationally agreed MDS has been defined to facilitate this understanding and support improvements.

Quality of care in the course of subcutaneous versus intravenous trastuzumab administration in patients with breast cancer: an integrated time-motion study with mixed-methods research.

OBJECTIVES: This study aimed to compare the time required and concerns raised by various perspectives of participants regarding administering subcutaneous and intravenous trastuzumab for patients with breast cancer (BC). DESIGN: This observational time-motion study design with mixed-methods research (cross-sectional surveys and semistructured interviews) was conducted. The time spent on preparing or administering trastuzumab by different healthcare professionals (HCPs) was recorded. The data were analysed by descriptive/inferential statistical analyses, followed by thematic analyses. SETTING: Outpatient and inpatient administration units of a single medical centre in Taiwan. PARTICIPANTS: The study included patients with early-stage BC who received subcutaneous or intravenous trastuzumab (n=93), and HCPs including two attending physicians, a nurse practitioner, two pharmacists and two nurses. RESULT: Based on the perspectives of patients and HCPs, the subcutaneous form of trastuzumab was more efficient, less expensive and produced less discomfort in outpatient units than inpatient units. More participants preferred the subcutaneous form over the intravenous form in both outpatient and inpatient units. Pharmacists and nurse practitioners spent threefold more time on patients when preparing and administering the intravenous form in both outpatient and inpatient units. The concerns raised by patients and HCPs varied in certain aspects, including the injection skills, speed, mental distress (eg, needle phobia) and pain associated with the subcutaneous form. Almost all patients preferred receiving the subcutaneous form in outpatient units after the initial COVID-19 outbreak. CONCLUSION: Patients with early-stage BC preferred receiving subcutaneous trastuzumab in outpatient units rather than inpatient units or the intravenous form before and after the COVID-19 outbreak. Such findings may serve as real-world evidence to facilitate better quality of care regarding administration of subcutaneous or intravenous trastuzumab in medical settings, and its feasible resolutions to balance the quality, concerns and efficiency of anticancer administration during the COVID-19 pandemic.

Trends in the availability of community-based home visiting services for oldest-old in China, 2005-2018.

OBJECTIVES: This study aims to examine trends in neighbourhood availability of community-based home visiting services (CHVS) (ie, coverage by local primary healthcare providers) over time and disparities in service availability according to individual characteristics using nationwide data of oldest-old individuals (age >80) in China. DESIGN: Repeated, cross-sectional study. SETTING: This study derived nationally representative data from the 2005-2018 Chinese Longitudinal Health Longevity Survey. PARTICIPANTS: A final analytical sample of 38 032 oldest-old individuals. PRIMARY OUTCOME MEASURES: Availability of CHVS was defined as having home visiting services in one's neighbourhood. Cochran-Armitage tests were used to test linear trends in the proportions of oldest-old with service availability. Weighted logistic regression models were used to examine variations in service availability across individual characteristics. RESULTS: Of 38 032 oldest-old individuals, availability of CHVS decreased from 9.7% in 2005 to 7.8% in 2008/2009, followed by continual increases to 33.7% in 2017/2018. These changes were similar between rural and urban oldest-old. After accounting for individual characteristics, in 2017/2018, compared with their counterparts, urban residents who had white-collar jobs before retirement and those residing in Western and Northeast China were less likely to have service availability. Oldest-old with disabilities, those living alone and those with low incomes did not report having greater availability of CHVS in either 2005 or 2017/2018. CONCLUSIONS: Despite the increasing service availability over the past 13 years, persistent geographical disparities in the availability of CHVS remain. As of 2017/2018, only one in three oldest-old in China reported having service availability, which raises concerns regarding continuity of care across different settings of services for those most in need, especially those living alone or with disabilities. National policies and targeting efforts are necessary to improve the availability of CHVS and reduce inequity in service availability for optimal long-term care to the oldest-old population in China.

Health visiting in the UK in light of the COVID-19 pandemic experience (RReHOPE): a realist review protocol.

INTRODUCTION: Health visiting services, providing support to under 5s and their families, are organised and delivered in very different ways in different parts of the UK. While there has been attention to the key components of health visiting practice and what works well and how, there is little research on how health visiting services are organised and delivered and how that affects their ability to meet their objectives. The COVID-19 pandemic rapidly disrupted service delivery from March 2020. This realist review aims to synthesise the evidence on changes during the pandemic to identify the potential for improving health visiting services and their delivery. METHODS AND ANALYSIS: This review will follow the RAMESES (Realist And Meta-narrative Evidence Syntheses: Evolving Standards) quality standards and Pawson's five iterative stages to locate existing theories, search for evidence, select literature, extract data, synthesise evidence and draw conclusions. It will be guided by stakeholder engagement with practitioners, commissioners, policymakers, policy advocates and people with lived experience. This approach will consider the emerging strategies and evolving contexts in which the services are delivered, and the varied outcomes for different groups. A realist logic of analysis will be used to make sense of what was happening to health visiting services during and following the pandemic response through the identification and testing of programme theories. Our refined programme theory will then be used to develop recommendations for improving the organisation, delivery and ongoing postpandemic recovery of health visiting services. ETHICS AND DISSEMINATION: General University Ethics Panel approval has been obtained from University of Stirling (reference 7662). Dissemination will build on links to policymakers, commissioners, providers, policy advocates and the public. A range of audiences will be targeted using outputs tailored to each. A final stakeholder event focused on knowledge mobilisation will aid development of recommendations. PROSPERO REGISTRATION NUMBER: CRD42022343117.