(1) Analyse in depth an exemplar safety-critical task required of newly qualified doctors (prescribing insulin) and (2) Provide transferable insights into how undergraduate education could better educate medical students to meet the demands of practice when they become postgraduate trainees.

Document analysis of doctors’ reported experiences of insulin prescribing, an everyday task that has an emergent logic of practice and harms not just patients but (psychologically) new doctors. Application of third-generation (social emergence) complexity theory to explore why practice can be ‘mutually unsafe’.

A system of care comprising all five Northern Irish (UK) Health and Social Care Trusts, which together provide healthcare to a population of nearly two million people.

68 postgraduate year 1 and year 2 trainees (PGY1/2s), mainly PGY1s.

Thick description of new doctors’ contexts of action, reasons for acting and specific actions. We present this as a narrative compiling all 68 stories, 13 detailed exemplar stories and a diagram summarising how multiple factors interacted to make practice complex.

Situations that required PGY1/2s to act had interacting layers of complexity: (1) disease trajectories; (2) social dynamics between stakeholders and (3) contextual influences on stakeholders’ interactions. Out-of-hours working and unsuitable wards intensified troublesome contextual influences. All three individually complex layers ‘crystallised’ briefly to create ‘moments of action’. At best, PGY1/2s responded proactively, ‘stretched time’ and checked the results of their actions. At worst, PGY1/2s ‘played safe’ in unsafe ways (eg, took no action), acted on unsafe advice or defaulted to actions protecting them from criticism. Informal, pervasive rules emerged from, and perpetuated, unsafe practice.

New doctors’ work includes acting on indeterminate, emergent situations whose complexity defies rules that are determinate enough to be taught off the job. If new doctors are to perform capably in moments of action, medical students need ample, supervised, situated experience of what it is like to take responsibility in such moments.

To explore the challenges experienced by people with intellectual disability, their carers and health and social care professionals when using and managing medication.

A synthesis of qualitative research using meta-ethnography.

We searched seven databases: MEDLINE, Embase, CINAHL, Science, Social Science and Conference Proceedings Citation Indices (Web of Science), Cochrane Library, PsycINFO and Proquest Dissertations and Theses from inception to September 2022 (updated in July 2023).

We included studies exploring the challenges and perceptions of people with intellectual disability, their carers and health and social care professionals regarding medication management and use.

We reviewed 7593 abstracts and 475 full texts, resulting in 45 included papers. Four major themes were identified: (1) Medication-related issues, (2) navigating autonomy and relationships, (3) knowledge and training needs and (4) inequalities in the healthcare system. We formulated a conceptual framework centred around people with intellectual disability and described the interconnectedness between them, their carers and health and social care professionals in the process of managing and using medication. We identified challenges that could be associated with the person, the medication and/or the context, along with a lack of understanding of these challenges and a lack of capability or resources to tackle them. We developed an overarching concept of ‘collective collaboration’ as a potential solution to prevent or mitigate problems related to medication use in people with intellectual disability.

The effective management of medication for people with intellectual disability requires a collaborative and holistic approach. By fostering person-centred care and shared decision-making, providing educational and practical support, and nurturing strong relationships between all partners involved to form a collective collaboration surrounding people with intellectual disability, improved medication adherence and optimised therapeutic outcomes can be achieved.

CRD42022362903.

Preterm infants, particularly those born before 29 weeks of gestation, are at increased risk of developing bronchopulmonary dysplasia (BPD) and other complications of prematurity. Substantial evidence suggests that respiratory tract colonisation with Ureaplasma species significantly contributes to pulmonary inflammation, impaired lung function and subsequent lung disease especially in very immature infants. Moreover, Ureaplasma exposure has been implicated in the pathogenesis of other inflammation-related sequelae of prematurity. Although representing a potentially actionable risk factor for adverse short-term and long-term neonatal outcome, controversies on Ureaplasma-associated morbidity remain and recommendations for screening practices in preterm infants are missing. The NEO-CONSCIOUS (Neonatal Colonisation and Infection with Ureaplasma in very immature preterm infants born Ureaplasma colonisation and infection in very preterm infants at high risk of adverse outcome, the extent of potentially accompanying inflammation and the impact on short-term and long-term morbidity.

This is a prospective observational multicentre study being conducted in level III neonatal intensive care units in Germany and Austria. In total, 400 infants born before 29 weeks of gestation are screened for Ureaplasma colonisation immediately after birth. In addition, biomarkers of systemic inflammation are determined on day 1 and day 28. The study infants are followed up until discharge and at 2 years corrected age. The primary outcome BPD and/or death is assessed at 36 weeks postmenstrual age. Secondary outcomes include systemic inflammation, secondary infections, intraventricular haemorrhage, periventricular leukomalacia, necrotising enterocolitis, retinopathy of prematurity and neurodevelopmental outcome at 24 months corrected age.

The study has been approved by the ethics committees in Würzburg and Leipzig and the local ethics committees of all participating centres. Results will be disseminated through peer-reviewed international publications and conferences. The study is registered with the German Clinical Trials Register, ID DRKS00033001.

German Clinical Trials Register (DRKS00033001).

This study aims to investigate the associations between childhood health, childhood socioeconomic status and dementia risk in later life, and to assess the potential modifying effects of their interaction. The study also accounted for key confounders to better clarify these relationships within the Indonesian population.

Cross-sectional study.

Indonesia.

6693 aged 50+.

Individuals in the ‘unhealthy’ childhood health cluster had 1.17 times higher odds of dementia risk compared with the ‘healthy’ cluster (95% CI: 1.00 to 1.38), a borderline association, while those in the ‘poor socioeconomic status’ cluster had 1.39 times higher odds compared with the ‘non-poor’ cluster (95% CI: 1.15 to 1.68). No significant interaction was found between childhood health and socioeconomic status on either the multiplicative (OR=0.88, 95% CI: 0.30 to 2.57) or additive scale (all relative excess risk due to interaction, attributable proportion and synergy index measures non-significant). Older age, lower education, lower wealth, lower social capital and higher depression scores are significantly associated with increased dementia risk.

This study finds that both childhood health and socioeconomic status independently influence dementia risk in later life. No significant interaction between these two early-life factors was found, suggesting that their effects on dementia risk operate independently rather than synergistically. Using nationally representative Indonesian data, the findings highlight the importance of addressing early-life adversity in dementia prevention and call for standardised definitions to improve research comparability, particularly in low-income and middle-income countries contexts.

Post-intensive care syndrome (PICS) describes a cluster of ongoing symptoms experienced by a large proportion of patients previously admitted to critical care. Despite a large rise in survival following critical care, interventions to support recovery and combat PICS are lacking. It has been suggested that the use of digital tools such as virtual reality (VR) may play a useful role in the development of recovery-supporting interventions. We engaged with people with lived experience of critical care admission to coproduce a VR intervention (ViRtual REality to AiD recoverY post ICU (VR READY)). Here, we present a protocol for the initial feasibility and acceptability testing of this intervention.

This is a single-arm, single-site, non-randomised feasibility trial of VR READY. Up to 25 participants recently admitted to critical care will be recruited to use the VR READY intervention for at least 5 min per day for a period of 14 days. Participants must have capacity to consent and be free from ongoing delirium in order to participate. Outcomes relating to sleep and well-being will be measured at baseline and at day 14 after intervention delivery. The primary outcome is feasibility, which will be assessed according to prespecified criteria. Participants will complete a qualitative interview to assess acceptability of the intervention, trial design and outcomes approximately 1 month after completing the intervention period. No formal statistical analysis of outcomes will be conducted, but these will be summarised descriptively. Interviews will be subjected to reflexive thematic analysis.

This study received a favourable ethical opinion by North-East York Research Ethics Committee (Ref 23/NE/0113) in June 2024. Study results will be disseminated through the peer review literature, ISRCTN registry and directly to participants, which will be facilitated by the study public and patient involvement steering group.

ISRCTN88854487.

Rare diseases (RD) are collectively common and often genetic. Families value and can benefit from precise molecular diagnoses. Prolonged diagnostic odysseys exacerbate the burden of RD on patients, families and the healthcare system. Genome sequencing (GS) is a near-comprehensive test for genetic RD, but existing care models—where consultation with a medical geneticist is a prerequisite for testing—predate GS and may limit access or delay diagnosis. Evidence is needed to guide the optimal positioning of GS in care pathways. While initiating GS prior to geneticist consultation has been trialled in acute care settings, there are no data to inform the utility of this approach in outpatient care, where most patients with RD seek genetics services. We aim to evaluate the diagnostic yield, time to diagnosis, clinical and personal utility and incremental cost-effectiveness of GS initiated at the time of referral triage (pre-geneticist evaluation) compared with standard of care.

200 paediatric patients referred to one of two large genetics centres in Ontario, Canada, for suspected genetic RD will be randomised into a 1:1 ratio to the intervention (GS first) or standard of care (geneticist first) arm. An unblinded, permuted block randomisation design will be used, stratified within each recruitment site by phenotype and prior genetic testing. The primary outcome measure is time to genetic diagnosis or to cessation of active follow-up. Survival analysis will be used to analyse time-to-event data. Additional measures will include patient-reported and family-reported measures of satisfaction, understanding and perceived test utility, clinician-reported measures of perceived test utility and management impact, and healthcare system utilisation and costs.

This study was approved by Clinical Trials Ontario. Results will be disseminated, at minimum, via peer-reviewed journals, professional conferences and internal reports to funding bodies. Efforts will be made to share aggregated study results with participants and their families.

NCT06935019.

The enhanced midwifery continuity of carer (eMCoC) pilot programme provided additional resource (funding) to midwifery teams operating in the 10% most deprived areas in England. The eMCoC programme aims to provide additional support to those at greatest risk of poor maternal health outcomes. We conducted a rapid formative evaluation aiming to explore the implementation of the pilot programme to (1) generate timely insights to inform ongoing service delivery; (2) generate a logical framework of the eMCoC service and; (3) inform the design of a longer-term summative evaluation.

Rapid evaluation using mixed-methods.

We explored implementation of the eMCoC service in 58 funded local midwifery teams across 23 Local Maternity and Neonatal Systems (LMNS). We undertook qualitative data collection in 10 case study sites across England, focusing on the implementation in 17 teams.

We purposively sampled 34 service users who received care from enhanced teams, and 38 staff working in enhanced teams. Inclusion criteria for the service user interviews included women who had received care from enhanced teams during our evaluation period and were more than 28 weeks pregnant. Exclusion criteria included women who had not received care from our target teams. We undertook descriptive analysis using the Maternity Services Dataset to compare the characteristics of service users in enhanced teams with service users receiving other midwifery service models.

Many of the 58 teams funded were unable to implement eMCoC during the evaluation period because of institutional and organisational barriers. The barriers identified here are indicative of the barriers associated with implementing midwifery continuity of carer. Largely, the eMCoC service successfully targeted women living in the most deprived areas and a focus on reaching women living in these areas was valued by enhanced teams. Equally, enhanced teams strived to broaden the targeted characteristics (i.e. more broadly than on the basis of deprivation) to include a wider and more diverse set of social risk factors and vulnerabilities, based on local needs and priorities. Service users reported being well supported by the enhanced teams, including receiving relational and well-being support and personalised one-to-one public health education, information and support. Service users emphasised that enhanced teams went ‘above and beyond in their care’.

Funding for eMCoC has been well received by both staff and service users. The implementation of the enhanced roles was perceived to have supported delivery of team-based care, facilitating successful release of midwifery capacity and the delivery of additional public health activities. Supporting a team-focused ethos seems an important feature of eMCoC services. This was consistent across sites and from both staff and service user perspectives. There appears to be many routes (i.e. different service delivery types) to delivering enhanced care, and the multiplicity of service delivery types found in this evaluation suggests no tightly prescribed way of meeting eMCoC’s objectives. The flexibility of the initial funding specification guidance from NHS England has been a key driver of local ownership and permitted eMCoC services to be organically built ‘from the ground up’. Our conclusions point to the value of autonomy afforded to local areas to use eMCoC funding as they deem necessary to best suit the needs of their staff and specific service user groups. Attention should be placed on the barriers to implementation and sustainability issues which can be addressed, namely: delays in releasing funding from LMNS and Integrated Care Boards to providers, and protecting maternity support worker and midwifery time to their allocated teams.

This study aimed to evaluate the utility of optical sensor-based technology in mitigating the frequency and severity of peripheral intravenous infiltration and/or extravasation (PIVIE) in neonates.

Single-centre, retrospective, observational cohort study.

Tertiary-level neonatal intensive care unit (NICU) (112 cots) at the Women’s Wellness and Research Centre (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar, January 2019–December 2022.

All neonates admitted to the NICU requiring intravenous therapy via a neonatal short peripheral intravenous catheter (n-SPC) were included. Participants were excluded if the insertion was unsuccessful, if they had incomplete data, or if they received intravenous therapy exclusively through alternative vascular access devices.

The study analysed two cohorts representing different clinical practices over two distinct periods. In the conventional cohort (Phase 1, 2019–2020), PIVIE detection relied solely on periodic ‘Touch Look Compare (TLC)’ assessments. In the ivWatch cohort (Phase 2, 2021–2022), continuous optical sensor-based monitoring using the ivWatch system was implemented alongside TLC assessments. This sequential design allowed for a comparison of outcomes between the two phases.

The primary outcomes were the occurrence and severity of PIVIE. Secondary outcomes included the influence of patient demographics, vascular access characteristics, and management details on PIVIE incidence and severity.

Over the 4-year data collection period, 32 713 peripheral intravenous catheters were analysed across two cohorts. PIVIE was the most common reason for unplanned device removal. In the conventional cohort (Phase 1, 2019–2020), 4941 infiltration events were reported (29.9%), compared with 4872 events (30.1%) in the ivWatch cohort (Phase 2, 2021–2022). However, severity measures using the Intravenous Extravasation Grading Scale (IEGS) revealed a marked reduction in severe PIVIE cases, with severe events decreasing from 243 (4.9%) in the conventional cohort to 54 (1.1%) in the ivWatch cohort (p

PIVIE remains a frequent complication in neonatal vascular access. Continuous site monitoring with optical sensor technology was associated with earlier detection of PIVIE events and reduced IEGS severity scores. These findings highlight the potential of integrating sensor-based monitoring with traditional observational methods to improve patient outcomes in neonatal care.

Pain accounts for approximately 80% of emergency department admissions. While intravenous morphine titration is commonly used for severe pain, non-invasive alternatives that bypass intravenous access are needed. Nebulised fentanyl, combined with pupillometry for objective monitoring of opioid impregnation, may offer a rapid and safe alternative for pain management.

This phase I, open-label, randomised, exploratory, crossover, single-centre prospective controlled trial will employ pharmacokinetic–pharmacodynamic (PK–PD) modelling to assess the variability in bioavailability of nebulised fentanyl administered via intranasal route versus facial aerosol. 20 healthy volunteers will receive three repeated administrations of fentanyl over two visits. At each visit, blood samples (n=11) will be collected for fentanyl quantification by liquid chromatography–tandem mass spectrometry, and pupillary unrest in ambient light (PUAL) measurements (n=9) will be recorded. The resulting data will be analysed using Monolix 2024R1 to model PK–PD relationships, perform Monte Carlo simulations and determine the optimal dosing and timing required to achieve a reduction of more than 30% in PUAL, while also evaluating safety, comfort and tolerance.

The study has been approved by the Ethic Committee Île-de-France VII (approval reference number: 000216, February 2024) and will be conducted in accordance with the Declaration of Helsinki. Informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed publications, conference presentations and appropriate data-sharing platforms to support further research and clinical application.

This trial is registered at ClinicalTrials.gov (Identifier: NCT06281951).

High blood pressure (BP) is a significant global health issue, with many treated patients failing to achieve BP control. The Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial evaluated the effectiveness, cost-effectiveness and acceptability of early use of low-dose triple fixed-dose combination of BP-lowering drugs (‘triple pill’) compared with usual care in the management of hypertension. The TRIUMPH trial showed superior BP control with the triple pill strategy compared with usual care. This process evaluation of the TRIUMPH trial aimed to explore the contextual factors that influenced the trial outcomes, implementation of the triple pill strategy, mechanisms of its effects and potential barriers and facilitators for implementing the triple pill strategy in routine practice.

Guided by the UK Medical Research Council’s framework, semistructured interviews were conducted with 23 patients and 13 healthcare providers involved in the TRIUMPH trial. Data were analysed using the framework analysis method in NVivo.

Hypertension care in Sri Lanka was hindered by the absence of systematic screening and overcrowded public clinics. Despite free medication provision at public clinics, long waiting times and occasional stock-outs posed challenges. In the TRIUMPH trial, both intervention and usual care were delivered in the context of ‘better than usual’ care, including team-based management, reduced waiting times, monetary assistance for travel, routine adherence monitoring and intensive follow-up. The triple pill strategy provided a simplified regimen, better access to BP-lowering medications and better BP-lowering efficacy. Key barriers to implementation in routine practice included the triple pill’s large size, therapeutic inertia and restrictive regulatory policies regarding fixed-dose combinations.

Implementation of the triple pill strategy into routine practice requires health system strengthening, provider training and supportive policy measures to replicate its effectiveness seen in the trial.

ACTRN12612001120864, SLCTR/2015/020.

A qualitative study was undertaken to explore the nature of staffing strategies from the perspectives of nursing, medicine and health disciplines employed in a hospital setting.

Interviews were conducted in six hospitals in Canada between November 2022 and September 2023.

118 healthcare professionals and leaders who experienced changes in staffing strategies participated in this study. Three themes emerged to describe new or adaptive staffing strategies: (1) valuing new roles and teams; (2) being redeployed; and (3) enhancing coverage.

Our study elucidates the staffing strategies that were employed during the COVID-19 pandemic that included creating new and adapting existing roles and teams; redeploying healthcare professionals; and enhancing coverage. Study findings can be used to guide leaders to use a proactive systematic approach to staffing models that includes adaptable and flexible staffing models within local contexts.

Congenital cytomegalovirus (cCMV) is an important cause of long-term childhood disability. In Australia, the identification and treatment practices and the long-term clinical and neurodevelopmental outcomes of children with cCMV are unknown. The Australasian cCMV Register (ACMVR) is a longitudinal register and resource for research that aims to describe and explore, in Australian children with cCMV: (1) their clinical characteristics over time, (2) antiviral therapy use/prescribing up to 1 year of age and (3) risk factors and potential avenues for prevention of adverse sequelae of the virus.

Children

Ethics and governance approvals, study database and a steering group have been established. Data collection is active in five sites across Australia.

The ACMVR will inform our understanding of the long-term outcomes for children with cCMV in Australia and provide a sampling frame and resource for recruitment in future clinical and epidemiological research to inform practice and policy. New opportunities for the establishment of additional study sites and collaborations with Australian maternity and fetal medicine researchers and with cCMV registries in other countries are currently being explored.

There is increasing awareness of the impact of living with multiple long-term conditions (referred to as multimorbidity) on patients and health systems. Managing multimorbidity remains a challenge for primary care providers; necessitating tailored interventions that are both clinically and cost effective. In the Irish health system, two pilot trials have demonstrated promising results for patients living with multimorbidity. The first, MultimorbiditY COllaborative Medication Review And DEcision making (MyComrade), involved pharmacists supporting the management of polypharmacy, and the second, Link MultiMorbidity (LinkMM), involved link workers delivering social prescribing. This definitive trial aims to evaluate the clinical and cost effectiveness of both these interventions, as well as conduct a process evaluation.

This is a pragmatic, multi-arm, definitive, cluster randomised controlled trial in Irish general practices. The trial will include three arms: (1) MyComrade; (2) LinkMM and (3) usual care, acting as an efficient shared control arm for both interventions. For this trial, 672 patients will be recruited from 48 general practices. The eligibility criteria for the patients will be: (1) over 18 years of age; (2) has two or more chronic conditions; (3) taking 10 or more regular medicines and (4) attending their general practice team for chronic disease management. Outcome data will be collected for all participants, across all trial arms at baseline and 6 months. Primary outcomes include the number of medicines (reflecting the MyComrade intervention) and patient capability (reflecting the LinkMM intervention). Secondary outcomes include proportions and types of potentially inappropriate medications, patient experience of care, patient activation, self-rated health, health-related quality of life, mortality and healthcare utilisation. Quantitative and qualitative data will be collected to inform the process evaluation. Additionally, an economic evaluation will be conducted to evaluate the cost-effectiveness of both interventions compared with the control arm.

The trial protocol was approved by the Irish College of General Practice (ICGP) Ethical Review Board (ref: ICGP_Rec_2023_016). A formal knowledge dissemination plan has been developed for the trial, which includes peer-reviewed publications, conference presentations and reports to healthcare professionals, commissioners and policymakers.

ISRCTN11585238.

Hearing loss (HL) affects 20% of the world’s population, with shortages of audiologists and audiometric sound booths unable to meet demand for hearing care services. We aimed to assess the accuracy of tablet-based audiometry (TA) to screen for HL at standard (0.25–8 kHz) and extended high frequencies (>8 kHz).

Diagnostic accuracy study.

Two secondary care audiology and ear, nose and throat outpatient clinics in the UK between April 2022 and September 2023.

Adults aged≥16 years undergoing sound booth audiometry (SBA).

TA, hearing-related questionnaires and patient usability questionnaires.

Sensitivity, specificity and accuracy of TA compared with SBA for detecting HL. Patient usability assessment of TA and SBA.

129 patients were enrolled with 127 patients (254 ears) included in the final analysis. Median age was 43 years (IQR 33–56), 55% (70/127) were women. 76% (96/127) and 68% (86/127) of patients had HL defined by British Society of Audiology (BSA) and American Speech–Language–Hearing Association (ASHA) criteria. Age was significantly associated with HL (p85%, respectively, between 0.25 and 12.5 kHz. In terms of patient usability, TA showed significantly higher scores in attractiveness (p

TA demonstrated good sensitivity with high specificity for detecting HL at frequencies 0.25–12.5 kHz and would be an acceptable accurate alternative to SBA. This would increase the accessibility of HL screening and has the potential to be used as a diagnostic test in those without tinnitus where resources are limited.

NCT05847556.

Care transitions, particularly hospital discharge, present significant risks to patient safety. Deficient medication-related discharge communication is a major contributor, posing substantial risk of harm to older patients. This protocol outlines the Improved Medication communication and Patient involvement At Care Transitions (IMPACT-care) intervention study, designed to evaluate the effects of a multifaceted intervention for older hospitalised patients on medication-related discharge communication compared with usual hospital care.

A pre–post intervention study will be conducted in two surgical and one geriatric ward of a university hospital in Sweden. The study will begin with a control period delivering usual care, followed by a training period and then an intervention period. The intervention comprises four components performed by clinical pharmacists: (1) information package provided to patients and/or informal caregivers, (2) preparation of medication-related discharge documentation, (3) facilitation of discharge communication and (4) follow-up call to patients or their informal caregiver. Eligible participants are aged ≥65 years, manage their own medications independently or with informal caregiver support, and are admitted to the study wards. Each study period (control and intervention) will last until 115 patients have been included. The primary outcome is the quality of medication-related discharge documentation, assessed using the Complete Medication Documentation at Discharge Measure (CMDD-M). Secondary outcomes include patients’ perceptions of knowledge and involvement in discharge medication communication, and their sense of security in managing medication post-discharge; adherence to medication changes from hospitalisation that persist after discharge; and unplanned healthcare visits following discharge. A process evaluation is planned to explore how the intervention was implemented. Patient inclusion began in September 2024.

The study protocol has been approved by the Swedish Ethical Review Authority (registration no.: 2023-03518-01 and 2024-04079-02). Results will be published in open-access international peer-reviewed journals, and presented at national and international conferences.

NCT06610214.