Cutaneous T cell lymphoma (CTCL) is a group of non-Hodgkin lymphomas that primarily affects the skin and can mimic inflammatory dermatoses. Unlike many skin diseases, CTCL can lead to disabling symptoms, and advanced CTCL can even be fatal. Early studies investigating health-related quality of life (HRQOL) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), common subtypes of CTCL, demonstrated significant impairment across numerous domains. The aim of this current study is to develop a core domain set (CDS) to identify the essential aspects of MF/SS that influence HRQOL that should be measured in therapeutic clinical trials. In the future, this set of core concepts will be used to identify the best patient- reported outcome measure(s) (PROM) for HRQOL for MF/SS clinical research.

Multiple strategies will be used to generate candidate concepts: systematic review of the literature, qualitative study and a survey study of healthcare providers. A Delphi consensus process including a comprehensive group of stakeholders (patients, caregivers/care partners, a multidisciplinary group of healthcare professionals, patient advocacy groups, pharmaceutical industry representatives, methodologists and government agencies) will be used to achieve consensus. Statistical corrections for multiple significance testing and false positive findings will be undertaken.

The study was submitted for and received institutional review board approval at the University of Washington (IRB# STUDY00018890 and STUDY00019407). Informed consent will be obtained from all participants where necessary. We will disseminate our findings through peer-reviewed, open access publications and presentations at national/international conferences. We will provide a plain language summary in lay terms for patients and families to patient advocacy groups for distribution to their network.

The protocol is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database.

Prior research, mostly from North America, suggests improved clinical outcomes for female patients treated by female physicians. Whether these findings apply in European healthcare systems and how underlying processes of care vary by sex remains unclear. This study aimed to assess whether in-hospital outcomes and processes of care differ by patient sex, physician sex or their interaction, in a European setting.

Retrospective cohort study.

General internal medicine division of a Swiss tertiary teaching hospital.

Adult inpatients (≥18 years) hospitalised between 2014 and 2024 and their primarily responsible physicians, classified by administrative sex (male vs female). The cohort included 20 094 hospitalisations (44.6% female patients) and 216 physicians (48.1% female).

Outcomes included in-hospital mortality, 30-day mortality and 30-day readmission, as well as processes of care (resource use, advance care planning and cardiovascular low-value care). Multilevel mixed-effects regression models adjusted for patient and physician characteristics.

Female patients had lower in-hospital mortality (OR 0.72, 95% CI 0.59 to 0.89) and 30-day mortality (OR 0.75, 95% CI 0.65 to 0.87), lower hospitalisation costs (–4.26%, 95% CI –6.08% to –2.41%), fewer diagnostic and therapeutic procedures (–6.44%, 95% CI –9.76% to –3.01%), fewer blood tests (–8.95%, 95% CI –12.98% to –4.73%) and were less likely to have resuscitation orders (OR 0.64, 95% CI 0.58 to 0.71) or intensive care unit transfer orders (OR 0.64, 95% CI 0.55 to 0.73). They were, however, more likely to receive non-indicated antihypertensive treatment (OR 1.86, 95% CI 1.38 to 2.51). No significant differences were observed by physician sex or patient–physician sex interaction.

In a European tertiary teaching hospital with universal healthcare coverage, in-hospital outcomes and processes of care did not differ by physician sex or patient–physician sex interaction. Nevertheless, disparities by patient sex persisted, underscoring the need for sex-disaggregated quality monitoring and sex-sensitive medical training.

Maternal and child mortality has markedly decreased worldwide over the past few decades. Despite this success, the decline remains unequal across countries and is overall insufficient to meet the Sustainable Development Goals. South Asia and sub-Saharan Africa bear most of the burden of maternal and child morbidity and mortality. Major gaps persist in our understanding of the causes, timing, diagnostic thresholds and risk factors for adverse outcomes in these regions. Addressing these gaps requires new ways to prevent and treat disease, from novel diagnostics to precision public health strategies, all of which rely on high-quality clinical data from diverse populations. The Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study aims to estimate population-level prevalence of morbidities and mortality and to assess biological, clinical and sociodemographic risk among mother–infant pairs in India, Pakistan, Kenya, Ghana and Zambia.

This study is a prospective, open cohort study with a planned recruitment of about 6000 women annually across six research sites in five countries. Participants are pregnant women enrolled less than 20 weeks gestation, as determined by ultrasound, identified through active house-to-house and facility-based surveillance. Robust clinical data will be collected at 12 scheduled study visits during antenatal care, labour and delivery, and through 1 year postpartum. A total of 34 outcomes will be captured. The primary analysis will estimate the burden of adverse outcomes and examine associated risk factors to inform future intervention strategies. Data will also be used to develop normative values for pregnant and postpartum women, as well as predictive models to assess pregnancy risk.

PRISMA received institutional and national ethical approvals. Findings will be published in peer-reviewed open-access journals and disseminated at national and international forums to inform clinical guidelines and public health practice.

NCT05904145.

Despite advances in maternity care, stillbirth remains a major burden. It disproportionately affects black and Asian mothers, those with obesity and women over the age of 35 years. Induction of labour may benefit these women, but there is no clear evidence to guide recommendations on optimal timing of induction because of variations in the intervention and insufficient power in primary trials for rare outcomes such as stillbirth and perinatal mortality, or to assess whether effects differ by maternal characteristics. We will conduct an individual participant data (IPD) meta-analysis of randomised trials to assess the overall and differential effect of induction of labour, according to timing of induction and maternal characteristics, on adverse perinatal and maternal outcomes. We will also rank induction of labour timing strategies by their effectiveness to inform clinical and policy decision-making.

We will identify randomised trials on induction of labour by searching MEDLINE, CINAHL, EMBASE, BIOSIS, LILACS, Pascal, SCI, CDSR, ClinicalTrials.gov, ICTRP, ISRCTN registry, CENTRAL, DARE and Health Technology Assessment Database, without language restrictions, from inception to June 2025. Primary researchers of identified trials will be invited to join the OPTIMAL Collaboration and share the original trial data. Data integrity and trustworthiness assessment will be performed on all eligible trials. We will check each study’s IPD for consistency with the original authors before standardising and harmonising the data. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool. We will perform a series of one-and-two-stage random-effects meta-analyses to obtain the summary intervention effect on composite adverse perinatal outcome (stillbirth, neonatal death or severe morbidity requiring admission to neonatal unit) with 95% CIs and summary treatment–covariate interactions (maternal age, ethnicity, parity, socioeconomic status, body mass index and method of conception). Heterogeneity will be summarised using tau², I² and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Small study effects (potential publication bias) will be investigated using funnel plots.

The study is registered on PROSPERO (CRD420251066346) and ethics approval is not required. We will disseminate findings widely to women, healthcare professionals and policymakers through academic, professional bodies and social media channels, and in peer-reviewed journals to achieve impact.

CRD420251066346.

To determine the survival rate and prognostic factors associated with tuberculosis (TB) mortality in Medellín between 2018 and 2023.

Quantitative observational analytical study of a retrospective cohort.

Based on notifications made to the Public Health Surveillance System and managed by the Secretary of Health of Medellín—Colombia between 2018 and 2023.

A total of 11 202 individuals diagnosed with TB, aged between 1 and 103 years.

The Kaplan-Meier method was employed to determine survival and risk functions, as well as median survival. Crude HRs and adjusted HRs (aHRs) were estimated using Cox proportional hazards regression models.

A median overall survival of 1410 days (3.86 years) and an adjusted mortality rate of 40 cases per 100 000 population were estimated for the study period (6 years). Factors associated with TB mortality were age (>59 years) (aHR 5.53; 95% CI 3.17 to 9.65), renal disease (aHR 2.98; 95% CI 2.27 to 3.90), HIV infection (aHR 2.82; 95% CI 1.39 to 3.32) and cancer (aHR 2.56; 95% CI 1.95 to 3.34).

TB survival is influenced by age and comorbidities, indicating the need for targeted strategies to protect high-risk groups. Strengthening comprehensive TB control through timely diagnosis, integrated management of chronic conditions and patient-centred care is essential to reduce preventable deaths. Furthermore, improving case notification and follow-up through integrated information platforms will contribute to more effective public health interventions.

Multiple well-considered but siloed initiatives and programmes exist in Australia to support ear and hearing screening and assessment for Indigenous children. However, the lack of coordination of these programmes leads to inefficiencies in resource allocation and disrupts opportunities to implement a cost-effective, efficient, and easily navigable system of care. Indigenous children experience high prevalence rates of middle ear disease, as well as earlier onset, increased severity and longer infections compared with non-Indigenous children. The aims of this study are to: (1) Understand current ear and hearing screening programmes in three New South Wales communities and evaluate their strengths and limitations, (2) Strengthen, implement and evaluate ear and hearing screening programmes and (3) Identify the barriers and facilitators for scaling strengthened ear and hearing screening programmes nationally and the importance and feasibility of each factor.

A series of desktop searches and co-design workshops will be completed to achieve aim (1) and (2) and the results will be mapped into work-as-done and work-as-imagined using the Functional Resonance Analysis Method. Strengthened screening programmes will be implemented in communities using the criteria from national and international guidance documents and the Practical, Robust, Implementation and Sustainability Model and evaluated. Finally, workshops will be conducted with key stakeholders to identify the barriers and facilitators for scaling strengthened ear and hearing screening programmes nationally and the importance and feasibility of each factor.

This project has received ethics approval from the Aboriginal Health and Medical Research Council Human Research Ethics Committee (Ref: 2350/24). Results will be disseminated to the community through the CEOs of the Aboriginal Community Controlled Health Organisations as well as published in peer-reviewed journals and presented at conferences. The findings from data collected will be used to inform the co-production of an enhanced system for ear and hearing care.

Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.

To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.

This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.

Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.

ACTRN12624000576527.

Tobacco use is the most significant modifiable risk factor for adverse health outcomes, and early research indicates there are also significant harms associated with vaping. National targets aim to reduce smoking and vaping during pregnancy for Aboriginal and Torres Strait Islander people. While most Aboriginal and Torres Strait Islander people want to quit, cessation is frequently attempted without support, increasing the chance of relapse. Group-based smoking cessation programmes increase quit success by 50%–130% in the general population; however, they have never been evaluated in Aboriginal and/or Torres Strait Islander communities.

The Gulibaa study is an Indigenous-led and community-embedded project that will co-design, implement and evaluate a group-based model of care to support Aboriginal and Torres Strait Islander women to be smoke- and vape-free. Staff of Health Services in New South Wales, Australia, will receive training to deliver a face-to-face group-based smoking and vaping cessation intervention. Aboriginal and/or Torres Strait Islander people who identify as a woman or non-binary, are pregnant or of reproductive age (16 to 49 years), currently smoke or vape at least once per day and are willing to attend the programme are eligible to participate. Up to 500 participants will be recruited. A mixed method evaluation approach will be implemented guided by the RE-AIM framework. Outcomes will include intervention reach, intervention effectiveness (determined primarily by self-reported 7-day point prevalence abstinence at 6 months follow-up), acceptability and feasibility of the intervention, programme fidelity and maintenance and cost effectiveness.

Embedding culturally safe support to quit during pregnancy can result in improved outcomes for both mother and child and immediately improve intergenerational health and well-being. Ethics approval has been provided by the Aboriginal Health and Medical Research Council and the University of Newcastle. Study findings will be disseminated to Aboriginal and Torres Strait Islander communities in ways that are meaningful to them, as well as through Aboriginal health services, key national bodies, relevant state and federal government departments.

ACTRN12625001050448.

Despite efforts to implement lesbian, gay, bisexual, transgender, queer or questioning, and other sexual and gender diverse (LGBTQ+) inclusive practices to address health disparities faced by LGBTQ+ individuals, factors that facilitate the uptake of these practices remain underexplored. Informed by the Consolidated Framework for Implementation Research (CFIR), this study explores nurse leaders’ perspectives across diverse US healthcare systems regarding the facilitators and barriers to implementing LGBTQ+ inclusive practices.

We used a qualitative descriptive design. Semistructured interviews guided by the CFIR framework were conducted from October to December 2023. The data were analysed using thematic analysis.

Diverse healthcare settings (eg, acute care hospitals and public health centres) across the USA.

We purposively recruited 21 nurse leaders, such as chief nursing officers or chief nurse executives, who oversee nursing strategy, staffing and quality across their organisations.

Consistent with prior frontline-focused studies, nurse leaders confirmed key inner setting and individuals facilitators (eg, LGBTQ+ specific training, electronic health record adaptation, visible executive engagement). Our findings add system-level detail from an executive perspective. Leaders identified actionable levers such as establishing LGBTQ+ clinical and social services, allocating protected time and budgets, and deploying dedicated implementation teams. We also identified a cross-cutting barrier: a reactive, crisis-driven organisational culture that hinders proactive inclusion efforts. Beyond the organisation, sociopolitical and legal climates shaped readiness and resourcing, with anti-LGBTQ+ laws influencing inclusion initiatives. Finally, nurse leaders highlighted the need for rigorous multilevel evaluation (eg, patient, staff, institution) and noted that common surveys inadequately capture LGBTQ+ inclusion, revealing measurement gaps that impede continuous improvement.

Implementing LGBTQ+ inclusive practices in healthcare is essential for optimal health outcomes and social justice. Understanding the context of implementation at multiple levels is crucial. Future research should focus on testing implementation strategies, developing inclusive healthcare surveys, and supporting the role of organisational culture and leadership in promoting LGBTQ+ inclusivity.

To understand the regulatory landscape in the UK and globally before the introduction of the Medicines and Healthcare Products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP). This paper aims to inform on the IRP’s potential impact on access to innovative medicines, by comparing medicines approval in the UK with other international regulatory agencies.

A retrospective analysis of 154 technologies (medicine(s) + studied indication(s)) was conducted based on the National Institute for Health and Care Research Innovation Observatory technology briefings submitted to the National Institute for Health and Care Excellence (NICE) in 2020. These briefings serve as the trigger for the NICE Technology Assessment process. Data on the medicines’ submission and approval dates were extracted across five IRP reference regulators, which are the regulators from the US (Food and Drug Administration (FDA)), European Union (EU) (European Medicines Agency (EMA)), Japan (Pharmaceuticals and Medical Devices Agency (PMDA)), Australia (Therapeutic Goods Administration (TGA)) and Singapore (Health Science Authority (HSA)). The dates were compared with data from the UK (MHRA).

95 (62%) medicines were approved by at least one regulatory agency, while 59 (38%) medicines were not approved by any regulatory agency. The number of medicines approved by the following regulatory agencies is FDA (n=84, 55%), EMA (n=80, 52%), MHRA (n=71, 46%), TGA (n=51, 33%), HSA (n=41, 27%) and PMDA (n=38, 25%). The first submissions were primarily to the FDA (n=64) or the EMA (n=24). The FDA had the highest number of first approvals (n=70), followed by the EMA (n=17), PMDA (n=5) and the MHRA (n=1). The FDA used more expedited pathways than other regulators (n=61). Compared with the MHRA, FDA approvals were on average 360 days faster and EMA approvals 86 days faster.

There were significant differences in market access timelines across the five reference regulators, with the FDA and EMA having the highest number of approved medicines, first submissions and first approvals. IRP applications with the FDA or EMA as reference regulators may expedite access to innovative medicines in the UK by reducing the approval dates gap between the FDA/EMA and the MHRA. This understanding of the regulatory landscape will help inform future planning to accommodate the disruption that the IRP may cause.

Physical activity improves physical and psychosocial outcomes in healthy children and in children with a range of chronic health conditions. Unfortunately, children with chronic health conditions have lower levels of physical activity compared to their healthy peers due to multiple restrictions in physical activities and therefore tend to have lower levels of physical activity compared with their peers. This paper describes the protocol for Move to Improve, a pragmatic trial of an individualised physical activity intervention for children with chronic health conditions.

Using the RE-AIM framework, this study aims to test the feasibility of Move to Improve, an 8-week hospital-based individualised physical activity intervention. We will recruit 100 children aged 5–17 years who are diagnosed with type 1 diabetes, cancer, postburn injuries and cerebral palsy to a single-arm, pragmatic feasibility trial. The primary outcomes (objective moderate to vigorous physical activity, quality of life and goal attainment) and secondary outcomes (including aerobic capacity, body composition, motor function, grip strength and psychosocial outcomes) will be assessed at baseline, post intervention and at 6-month and 12-month follow-ups. We will conduct semistructured interviews with participants and their primary caregiver at a 2-month follow-up to capture aspects of feasibility. Quantitative data will be reported descriptively, and qualitative data will be analysed using thematic analysis. Data gathered from this study will inform service decision-making and future trials.

The study has received ethics approval from the Government of Western Australia Child and Adolescent Health Service Human Research Ethics Committee (RGS6677). Findings of this research will be communicated to the public through peer-reviewed publications, conference presentations, reports, infographics and information sheets. Modifications to the protocol will be outlined in the trial registry and journal publications. Authorship will be in accordance with the International Committee of Medical Journal Editors.

Australian and New Zealand Clinical Trials Registry Number: ACTRN12624000836538.

Type 2 diabetes is a prevalent chronic disease, associated with health complications, premature morbidity and significant healthcare costs. Optimal lifestyle behaviour control and patient self-management are crucial for improving diabetes control; however, they are difficult to achieve in primary care. There is limited research on the use of information from wearable devices to encourage behaviour change. This study will examine the effectiveness and cost-effectiveness of a multi-component health behaviour intervention in achieving clinically significant reductions in haemoglobin A1c (HbA1c) among general practice patients with type 2 diabetes.

The study uses a cluster-randomised controlled design, with general practices randomly assigned to either the Wearables Integrated Technology (WEAR-IT) intervention (n=15) or usual care (n=15). To achieve a sample size of 375 participants, 12–13 patients per practice will be recruited. Patients diagnosed with type 2 diabetes will be eligible to participate if they are aged 18–75 years; have had poorly controlled diabetes (HbA1c≥7.5%), with the cognitive capacity and ability to access the intervention application via an iOS or Android smart device. The WEAR-IT self-management intervention combines information from wearable devices (physical activity, blood glucose and blood pressure) and the electronic medical record, with goal setting and coaching support. The intervention will be primarily delivered by the general practice nurse, with review and confirmation of goals by the general practitioner. Participants attending the usual care practices will receive standard care. Outcome measures, including HbA1c, lipids, blood pressure, quality of life, dietary and exercise behaviours and cost-effectiveness, will be collected at baseline, 6-month (primary endpoint) and 12-month post-randomisation. The primary analysis will compare the change in HbA1c between the intervention and control groups at 6-month follow-up, with long-term outcomes assessed at 12-month post-randomisation.

The study was approved by Bond University (BH00137). Results will be disseminated through peer-reviewed journal publications, conference presentations and summaries to participating sites and patients.

Australian New Zealand Clinical Trials Registry (ACTRN12624000957594).

The study aims to assess the associated influencing oncology nurses’ perceptions of managers’ empowering leadership style and to examine the influence of sex, work experience, shift work, membership of an oncology nursing association or a scientific society, nursing educational level and specialised nursing training in oncology on oncology nurses’ perceptions of managers’ empowering leadership style and its subdimensions.

Descriptive cross-sectional study.

In March 2024, oncology nurses employed in oncology settings were invited to participate.

All Italian oncology nurses who were currently employed were eligible to participate.

The Italian version of the Empowering Leadership Questionnaire was used to assess nurses’ perceptions of managers’ performance in leading by example, participative decision-making, coaching, informing and demonstrating concern/interacting with the team.

A total of 298 nurses agreed to participate. The associated factors for an empowered leadership style across all subdimensions were sex (p=0.006) and the educational level in nursing (p=0.004). Participative decision-making, coaching, informing and demonstrating concern/interacting with the team subdimensions were associated with shift work. Participation in scientific associations (p=0.005) was also influential.

Exploring the data according to the nursing specialisation appeared intriguing, since it could be a more indicative suggestion for future interventions to implement an empowering leadership style in clinical nursing practice and better inform health policymakers to achieve the right solution in their health organisations.

Documenting evidence on global health strategies and programmes that provide safeguards for vulnerable populations and strengthen overall pandemic preparedness is essential. This study aimed to identify factors associated with adherence to COVID-19 mitigation measures, COVID-19-related symptoms and testing, as well as pandemic-related income loss among internally displaced persons (IDPs) in urban and remote areas of Burkina Faso, Niger and Mali.

This cross-sectional study used fixed-site respondent-driven sampling (RDS).

Primary care settings across six urban and remote locations in Burkina Faso, Mali and Niger.

4144 internally displaced adults, who had been forced from their homes within 5 years of the survey, participated in the study. The survey was conducted between August and October 2021 in two selected locations in three countries: Kaya (n=700) and Ouahigouya (n=715) in Burkina Faso; Bamako (n=707) and Ménaka (n=700) in Mali; and Niamey (n=733), and Diffa (n=589) in Niger. Participants were included if they were born in the study countries, displaced due to conflict, violence or disaster, aged 18 years or older, and living or working in the study site for at least 1 month.

The primary outcomes measured were adherence to COVID-19 mitigation measures, presence of COVID-19 symptoms, COVID-19 testing and vaccination rates and pandemic-related income loss.

Among 4144 IDPs surveyed across 6 sites in Burkina Faso, Mali and Niger, over half (52%) reported experiencing at least one COVID-19 symptom in the preceding 2 weeks. However, 8% had ever been tested for COVID-19, and fewer than 5% had received a vaccine in all sites except Diffa, where 54% reported vaccination. While willingness to be vaccinated was high (ranging from 56.6% in Bamako to 89.5% in Niamey), access remained limited. Compliance with public health measures varied; for example, 41.7% of IDPs were able to maintain physical distance from non-household members, and just 60.2% reported wearing a mask. Chronic health conditions were consistently associated with higher odds of COVID-19 symptoms (Ménaka OR: 14.65; 95% CI: 7.36 to 29.17). Economic vulnerability was widespread, with more than half of IDPs in Bamako (58.1%) and Niamey (66.4%) reporting income loss due to the pandemic, and average monthly income declining by over 50% in most sites. IDPs in urban areas generally reported greater exposure to COVID-19 risk factors, while those in remote settings reported lower adherence and poorer access to basic preventive measures.

This is the first known RDS study to explore the impact of the COVID-19 pandemic on IDPs. Findings suggest that IDPs in urban areas may face heightened risks of exposure and infection, underscoring the need to prioritise them in public health efforts. Low testing and vaccination rates and significant income loss call for advocacy and economic relief to address these vulnerabilities. Future pandemic responses should integrate health interventions with targeted support, especially mitigating income loss to bolster IDPs’ resilience.

Physicians are increasingly interested in part-time employment. However, the impact of part-time work on efficiency and quality of care of inpatients is unknown.

To investigate the association between part-time clinical work of hospitalists in General Internal Medicine (GIM) and resource utilisation and short-term patient outcomes.

Retrospective study.

GIM wards of 3 Swiss teaching hospitals.

Each inpatient was categorised as having received care mainly (>50%) by part-time or full-time hospitalists. Part-time clinical work was defined as employment of

Primary outcome was length of hospital stay, secondary outcomes included 30-day readmission, in-hospital mortality, hospitalisation cost and time to completion of the discharge letter. We assessed the association between both groups and outcomes using generalised estimating equations, clustering for individual patients and adjusting for patient and hospitalist characteristics.

There was no statistically relevant difference in length of stay in cases cared for mainly by part-time (mean 7.3 days, 95% CI 7.1 to 7.6) compared with full-time hospitalists (mean 7.6 days, 95% CI 7.3 to 7.8; p=0.18). Time to completion of the discharge letter was longer in the part-time (mean 11.4 days, 95% CI 11.0 to 11.8) versus full-time group (mean 10.9 days, 95% CI 10.6 to 11.2, p=0.049). There was no statistically significant difference between groups for the other outcomes.

We found no evidence that part-time clinical work of hospitalists negatively affects resource utilisation and short-term patient outcomes compared with full-time work.

Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.

A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).

This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.

Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).