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☐ ☆ ✇ BMJ Open

How do new doctors prescribe insulin? Qualitative exploration of the complexity of everyday practice and implications for medical education

Por: Dornan · T. · Lee · C. · Hancock · J. · Mattick · K. · Gillespie · H. · Findlay-White · F. · Conn · R. — Septiembre 19th 2025 at 06:54
Objectives

(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.

Design

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’.

Settings

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.

Participants

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

Main outcome measures

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.

Results

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.

Conclusions

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.

☐ ☆ ✇ BMJ Open

Challenges of using and managing medication: a meta-ethnography of the experiences and perceptions of people with intellectual disability and people who support them

Por: Ghosh · I. · Adams · D. · Auguste · P. · Brown · A. · Chaplin · E. · Flynn · S. · Gauly · J. · Gill · P. · Langdon · P. E. · Mahon · D. · Martin · K. · Patterson · S. · Sutherland · D. · Tromans · S. J. · Chen · Y.-F. · Seers · K. · Supporting Medication use In people with a LEarning d — Septiembre 19th 2025 at 06:54
Objective

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

Design

A synthesis of qualitative research using meta-ethnography.

Data source

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).

Eligibility criteria for selecting studies

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.

Results

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.

Conclusions

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.

PROSPERO registration number

CRD42022362903.

☐ ☆ ✇ BMJ Open

Study protocol: neonatal colonisation and infection with Ureaplasma in very immature preterm infants born <29 weeks of gestation (NEO-CONSCIOUS) - a prospective multicentre study assessing early life colonisation rates and potentially associated advers

Por: Glaser · K. · Rittenschober-Böhm · J. · Humberg · A. · Stichtenoth · G. · Butzer · S. · Mehler · K. · Kipfmüller · F. · Köstlin-Gille · N. · Gille · C. · Kick · A. · Dornis · D. · Henrich · B. · Farr · A. · Härtel · C. · Silwedel · C. — Septiembre 2nd 2025 at 15:14
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

German Clinical Trials Register (DRKS00033001).

☐ ☆ ✇ BMJ Open

Association of childhood health and socioeconomic status with dementia risk in older age: a cross-sectional study using the Indonesia Family Life Survey 2014-2015

Por: Le · T. · Lee · A. · Gilleen · J. · Maharani · A. — Agosto 17th 2025 at 08:12
Objectives

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.

Design

Cross-sectional study.

Setting

Indonesia.

Participants

6693 aged 50+.

Results

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.

Conclusion

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.

☐ ☆ ✇ BMJ Open

VR READY: a protocol for a non-randomised, single-arm, mixed methods, feasibility trial of a coproduced ViRtual REality intervention to AiD recoverY in people recently admitted to intensive care

Por: Drew · C. J. G. · Smallman · K. · Gill · S. · Greenstock · C. · Cullen · K. · Irving · A. · Twose · P. · Battle · C. · White · D. · Smalley · M. · Lynch · C. — Agosto 13th 2025 at 05:11
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ISRCTN88854487.

☐ ☆ ✇ BMJ Open

TRIAGE-GS: protocol for a randomised controlled trial of a genomics-first approach to rare disease diagnosis for patients awaiting assessment by a clinical geneticist

Por: Stanley · K. J. · Chisholm · C. · Gillespie · M. K. · Caluseriu · O. · del Signore · N. · Elango · S. · Hartley · T. · Hewson · S. · Kim · R. H. · McSheffrey · G. · Mendoza-Londono · R. · Sawyer · S. L. · Somerville · M. · Venkataramanan · V. · White-Brown · A. · Telesca · S. · Shickh — Agosto 11th 2025 at 03:13
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT06935019.

☐ ☆ ✇ BMJ Open

Releasing time to deliver care: a mixed methods evaluation of the implementation of enhanced midwifery continuity of carer

Por: Gillibrand · S. · Parkyn · K. · Hall · C. · Kletter · M. · Harkness · E. · Munford · L. A. · Wilson · P. · Dumville · J. — Julio 29th 2025 at 06:15
Objectives

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.

Design

Rapid evaluation using mixed-methods.

Setting

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.

Participants

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.

Results

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’.

Conclusions

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.

☐ ☆ ✇ BMJ Open

Evaluation of optical sensor technology for the early detection of peripheral intravenous infiltration in neonates: a retrospective cohort study

Por: van Rens · M. F. P. T. · Hugill · K. · van der Lee · R. · Francia · A. L. V. · van Loon · F. H. J. v. · Bayoumi · M. A. A. — Julio 5th 2025 at 14:21
Objective

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.

Design

Single-centre, retrospective, observational cohort study.

Setting

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.

Participants

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.

Interventions

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.

Outcome measurements

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.

Results

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

Conclusions

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.

☐ ☆ ✇ BMJ Open

AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers - comparing facial versus intranasal administration via pharmacometric modelling

Por: Follet · C. · Dumont · A. · Roussel · M. · Gillibert · A. · Boedard · C. · Quillard · M. · Ruault · S. · Vallin · F. · Donnadieu · N. · Nunes Ferreira · D. · Pereira · T. · Joly · L.-M. · Lvovschi · V. · Duflot · T. — Julio 4th 2025 at 04:45
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

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

☐ ☆ ✇ BMJ Open

Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study

Por: Salam · A. · Laba · T. · Dhurjati · R. · Josyula · L. K. · de Silva · A. · Godamunne · P. · Guggilla · R. · Jan · S. · Maulik · P. K. · Naik · N. · Patel · A. · Pathmeswaran · A. · Prabhakaran · D. · Rodgers · A. · Selak · V. · Webster (Griffiths) · R. — Junio 27th 2025 at 19:17
Background

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.

Methods

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.

Results

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.

Conclusions

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.

Trial registration number

ACTRN12612001120864, SLCTR/2015/020.

☐ ☆ ✇ BMJ Open

How did staffing strategies change amid COVID-19 and post pandemic? A qualitative study

Por: Jeffs · L. · Limoges · J. · Das Gupta · T. · Di Prospero · L. · Harris · A. · Merkley · J. · Rosen · B. · Reid · M. · Rao · M. · Black · A. · Zeng · R. L. · McGillis Hall · L. — Junio 27th 2025 at 02:27
Objectives and design

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.

Setting

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

Results

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.

Conclusions

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.

☐ ☆ ✇ BMJ Open

Longitudinal observational research study: establishing the Australasian Congenital Cytomegalovirus Register (ACMVR)

Por: Chandrasekaran · P. · Bowen · A. · Jones · C. A. · Sung · V. · Clark · J. E. · Britton · P. N. · Palasanthiran · P. · Waight · E. · Gillespie · A. N. · Smithers Sheedy · H. · ACMVR Group · ACMVR · Jones · Bowen · Smithers-Sheedy · Sung · Clark · Britton · Palasanthiran · Waight · Cha — Junio 25th 2025 at 18:45
Purpose

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.

Participants

Children

Findings to date

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

Future plans

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.

☐ ☆ ✇ BMJ Open

Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice

Por: Tahsin · F. · Doody · P. · Clyne · B. · Kiely · B. · Moriarty · F. · Gillespie · P. · Kenny · E. · Boland · F. · Byrne · M. · OConnor · L. · Murphy · A. W. · Smith · S. M. — Junio 20th 2025 at 17:34
Background

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.

Methods

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.

Ethics and dissemination

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.

Trial registration number

ISRCTN11585238.

☐ ☆ ✇ BMJ Open

Globally applicable solution to hearing loss screening: a diagnostic accuracy study of tablet-based audiometry

Por: Cheong · J. · Lowe · E. · Lee · C. W. · Barbosa · C. · Gillen · L. · King · E. · Premachandra · P. · Shah · A. · Drobniewski · F. — Mayo 22nd 2025 at 09:59
Objectives

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).

Design

Diagnostic accuracy study.

Setting

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

Participants

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

Interventions

TA, hearing-related questionnaires and patient usability questionnaires.

Outcome measures

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

Results

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

Conclusions

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.

Trial registration number

NCT05847556.

☐ ☆ ✇ BMJ Open

Improved Medication communication and Patient involvement At Care Transitions (IMPACT-care): study protocol for a pre-post intervention trial in older hospitalised patients

Por: Cam · H. · Franzon · K. · Östman · V. · Kälvemark Sporrong · S. · Kempen · T. G. H. · Nielsen · E. I. · Lindner · K.-J. · Ekelo · B. · Bernsten · C. · Ehlin · U. · Lindmark · S. · Hadziosmanovic · N. · Gillespie · U. — Mayo 2nd 2025 at 12:04
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT06610214.

☐ ☆ ✇ BMJ Open

Applying co-design health literacy development in Australian prisons: protocol for system-wide application of the Optimising Health Literacy and Access (Ophelia) process

Por: Gill · S. W. · Bowman · J. · Cheng · C. · Shaw · C. · Hampton · S. · Hoey · W. · Osborne · R. H. — Abril 8th 2025 at 02:16
Introduction

Prisons present both unique opportunities and challenges for delivering healthcare to individuals who often experience significant vulnerabilities and often have poor health outcomes. Actions and solutions informed by the health literacy strengths and challenges (ie, health literacy-informed interventions) of people in prison offer an opportunity to build fit-for-purpose and effective interventions in this unique context. This study aims to adapt and apply the three-phase Optimising Health Literacy and Access (Ophelia) process in a state-wide prison context to generate codesigned improvements in information, resources and services for people in prison.

Methods and analysis

Health Literacy Questionnaire data from 471 people in prison will be analysed using descriptive and cluster analyses (Ophelia Phase 1). Clusters, with qualitative interview data, will then inform vignette development for use in ideas generation workshops and yarning circles with stakeholders to develop health literacy-informed interventions. Selection, prioritisation and testing of identified interventions will be undertaken (Phase 2), followed by implementation and evaluation (Phase 3). This project will advance intervention development in the prison context, enabling the voice of people in prison and service providers to be heard through codesign. The protocol will inform the development and implementation of interventions to systematically improve the delivery of information, services and resources for people in prison, which may be relevant to prison healthcare authorities globally.

Ethics and dissemination

Ethical approval to undertake Phase 1 of the Ophelia process has been granted from the following Human Research Ethics Committees: Swinburne University of Technology (Ref: 20236977–15461), Justice Health NSW (Ref: 2022/ETH01433), Aboriginal Health and Medical Research Council (Ref: 2007/22) and the Corrective Services Ethics Committee (Ref: D2022/1452326). Dissemination of the study findings will be the Justice Health NSW codesign process and ownership of the project through authentic engagement with people with lived experience and health and corrective staff. It will also be disseminated through publication in a PhD thesis, peer-reviewed research papers and conference presentations.

☐ ☆ ✇ BMJ Open

Another gap on the rota: a scoping review of attrition from specialty training in secondary care

Por: Gillespie · H. · Brown · M. E. L. · Brennan · N. · Burford · B. · Vance · G. — Abril 3rd 2025 at 06:39
Background

The healthcare workforce is in crisis. Despite a competitive selection process, a substantial number of doctors leave specialty training (ST) programmes prematurely. This attrition causes increased costs for the National Health Service, exacerbates workforce shortages and threatens quality and safety of care. It also increases pressure on trainees who remain, further compounding the risk of attrition. There is an urgent need to understand why doctors leave ST in order to find ways to maintain the training pipeline from ST to consultant.

Objectives

We aimed to understand what is known about why doctors choose to leave ST programmes in secondary care, to map current knowledge and identify avenues for future research.

Eligibility criteria

All studies which investigated why doctors leave ST programmes in secondary care were included.

Sources of evidence

Ovid Medline, Web of Science, SCOPUS and EMBASE were searched until January 2024. Descriptive codes were assigned to the findings of each study. These descriptive codes were reviewed and grouped together in broader categories.

Charting methods

Data was extracted and charted, and a qualitative content approach was used to synthesise data.

Results

A total of 6079 potentially relevant abstracts were retrieved, of which 23 were included in the final analysis. This included the experience of 1896 doctors who have left training and 454 programme directors. Doctors chose to leave training programmes because (1) they felt unsupported and underappreciated, (2) training was associated with unacceptable personal costs and (3) career prospects were unattractive.

Conclusion

There is a mismatch between trainees’ expectations of ST and the reality of being a trainee in ST. Understanding the issues which drive attrition and developing evidence-based solutions, has the potential to both reduce attrition, and improve the training experience for doctors in training more widely.

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