Despite implementation of the National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD), screening coverage for oral, breast and cervical cancers remains below 2%. Screening quality is inadequately addressed and delays in diagnosis and treatment initiation continue to persist. This multisite implementation research aims to improve district-level coverage and quality of screening, early diagnosis and timeliness of treatment initiation through a model co-developed within the NP-NCD context.

The study will be conducted in three phases across seven districts in diverse regions of India. In phase I (formative), the current status, barriers and facilitators of cancer screening, diagnosis and treatment initiation under NP-NCD will be assessed. In phase II (optimisation), a model (package of implementation strategies) will be co-developed and iteratively optimised with multistakeholder engagement at the subdistrict level to improve screening coverage and quality and strengthen the referral system for early diagnosis and treatment initiation. In phase III (scale-up and evaluation), the model will be implemented at the district level and evaluated for improvements in screening, early diagnosis and treatment initiation. A convergent mixed-methods design will be used, incorporating household surveys, facility assessments and stakeholder interviews. Implementation Research Logic Model will guide planning, execution and evaluation in the present study. Determinants of screening coverage and quality, early diagnosis and treatment initiation will be assessed using the Consolidated Framework for Implementation Research. Implementation strategies for the model will be finalised using the Expert Recommendations for Implementing Change framework. Implementation and service outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework.

Ethical approval has been obtained from all study sites. The study findings will be disseminated at the state, national and global levels through meetings and conferences and submitted to a peer-reviewed journal for publication.

CTRI/2025/08/092672.

To identify subgroups with similar social determinants of health (SDOH) characteristics using latent class analysis (LCA) and examine their associations with physical and mental health, cognitive function and missed workdays at 3 and 6 months post-SARS-CoV-2 infection. We hypothesised that intersecting SDOH factors would differentially influence COVID-19-related health outcomes across subgroups.

Prospective cohort study from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), with longitudinal data collection and cross-sectional analyses at baseline, 3-month and 6-month follow-ups.

Multicentre registry across eight US academic medical centres (Chicago, Dallas, Houston, Los Angeles, New Haven, Philadelphia, San Francisco and Seattle).

Adults aged ≥18 years, fluent in English or Spanish, with self-reported acute COVID-19 symptoms and a confirmed positive SARS-CoV-2 test within 42 days before enrolment (9 December 2020 to 12 August 2022), and access to an internet-connected device. Exclusions included incarceration, inability to provide informed consent, lack of confirmed SARS-CoV-2 infection or no internet access. Of 3791 eligible participants with complete baseline data, 2897 (76.4%) completed the 3-month follow-up and 2666 (70.3%) completed the 6-month follow-up; most were aged 18–49 years (74–75%), female (66–67%), white (86.6–87.5%) and non-Hispanic (86.6–87.5%).

Prespecified primary outcomes were physical and mental health (Patient-Reported Outcomes Measurement Information System (PROMIS)-29 V.2.1 T-scores for depression, anxiety, fatigue, sleep disturbance, pain interference, physical function and social participation), cognitive function (PROMIS Cognitive Function Short Form 8 T-scores) and missed workdays due to illness (binary: >1 week vs ≤1 week, from a single-item survey). All measures were self-reported and collected at baseline, 3 months and 6 months; no changes from protocol.

LCA identified a 4-class model as optimal (lowest Bayesian Information Criterion (BIC) after evaluating 1–7 class models; significant demographic differences (² p

In this US prospective cohort, SDOH-based subgroups showed persistent disparities in health outcomes post-SARS-CoV-2 infection. Findings highlight the urgent need for intersectional approaches to address systemic inequities in post-COVID-19 recovery.

NCT04610515.

In current practice, fluid volumes administered to children following kidney transplant vary widely. Up to 52% of children experience fluid overload-related complications. Current fluid guidelines are not evidence-based and the optimal amount of fluid for children after transplant is not known. The aim of Randomised multiple centre trial of conservative versus LIberal fluid adMInisTration for children receiving a kidney tranSplant (LIMITS) is to determine whether relative limitation of fluid volume administered to children receiving kidney transplants is superior to liberal fluid volume administration.

LIMITS is a pragmatic, open-label, UK-based, multicentre randomised controlled trial, with an internal pilot phase and integrated economic evaluation. A total of 140 children receiving kidney transplants will be randomised to receive either conservative postoperative fluid administration (maximum of 150 mL/m²/hour for no longer than 18 hours, followed by a fixed daily target of maximum 1.5 L/m²/day thereafter) versus the comparator of liberal postoperative fluid administration (fluid volume administered to replace urine output and insensible losses for at least 48 hours with target urine output >2 mL/kg/hour). The primary outcome is mean days at home in the first 30 days after kidney transplant. The primary outcome will be analysed using a mixed linear regression model adjusted for donor type (living vs deceased donor) and participant weight (

The trial received Health Research Authority approval on 20 August 2025 (REC reference: 25/EE/0161, IRAS project ID: 354370). Findings will be presented to academic groups via national and international conferences and peer-reviewed journals. The patient and public involvement group will play an important part in disseminating the study findings to the public domain.

ISRCTN21516608.

Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is a promising respiratory support method for avoiding invasive mechanical ventilation in neonatal intensive care units (NICUs). However, its effectiveness and safety have not been widely established through clinical evidence. In this study, we aim to evaluate the feasibility of NIV-NAVA as a primary respiratory support method after birth and its effects on short-term clinical outcomes and long-term neurodevelopment in preterm infants.

In this prospective multicentre observational study, 230 preterm infants will be recruited after birth. This study will include preterm infants born between 27⁺⁰ and 31⁺⁶ weeks of gestation who require respiratory support within the first 48 hours after birth. NIV-NAVA will be initiated as primary respiratory support either immediately after birth or during the early NICU stay, with settings adjusted according to each infant’s clinical condition. Discontinuation of NIV-NAVA or transition to continuous positive airway pressure or high-flow nasal cannula will be performed based on clinical stability. A less invasive surfactant administration method will be used for infants with respiratory distress syndrome to avoid intubation whenever possible. Infants intubated at birth will be extubated to NIV-NAVA as early as is clinically feasible. Invasive ventilation may be applied if clinical deterioration occurs. The rate of NIV-NAVA failure, duration of non-invasive and invasive ventilation, rate of bronchopulmonary dysplasia and clinical outcomes, such as air leak, patent ductus arteriosus, intraventricular haemorrhage and retinopathy of prematurity, will be measured. The neurodevelopmental outcomes of infants will be assessed for up to 3 years.

The Institutional Review Board (IRB) of Korea University Anam Hospital (2024AN0554) and Seoul National University Bundang Hospital (IRB No. B-2507-984-304) approved this study. The results will be disseminated through scientific conferences and publications.

NCT06786039 registered on 14 January 2025.

Asthma is one of the most prevalent long-term health conditions affecting pregnant women. Poorly controlled asthma during pregnancy is associated with adverse maternal and fetal outcomes and may predispose offspring to long-term respiratory morbidity. The current ‘one size fits all’ approach to asthma management during pregnancy is not optimally effective for approximately half of the pregnant women with asthma. A personalised medicine approach to managing airways disease is required. The treatable traits approach focuses on the identification and treatment of traits in the pulmonary, extra-pulmonary and behavioural domains, which are identifiable, measurable, clinically relevant (linked to exacerbation risk or poor asthma control) and treatable. This manuscript outlines the protocol for the Treatable Traits for Asthma Management in Pregnancy (TTAP) study. The purpose of the TTAP study is to prospectively determine the prevalence of a range of treatable traits from these three domains in pregnant women with asthma and determine which traits are associated with exacerbation risk, poor asthma control and poor asthma-related quality of life. Additionally, this study will assess differences in trait prevalence and clinical relevance in pregnant women from regional versus metropolitan hospitals in Australia and in different antenatal models of care.

The TTAP study is a multicentre, prospective observational cohort study. Study participants are pregnant women with asthma attending antenatal clinics at 10 metropolitan and regional hospitals (public and private) in NSW and Victoria, Australia. Assessment of traits from the pulmonary, extrapulmonary and behavioural domains as well as asthma outcomes is conducted at three gestational timepoints: 12–16 weeks, 22–26 weeks and 32–36 weeks of pregnancy. A follow-up assessment of asthma outcomes is conducted at 2–4 weeks postpartum. The outcomes assessed are asthma exacerbations requiring medical intervention (primary outcome), asthma symptom control and asthma-related quality of life. Traits and outcomes will be assessed using questionnaires, direct questioning, measurement of biomarkers, physical measurements and assessment of routinely collected data from medical records.

The Hunter New England Human Ethics Committee (2024/ETH01289) has approved the TTAP study protocol. Outcomes will be published in peer-reviewed journals, presented at scientific conferences and disseminated online to participants, clinicians and other pregnant women with asthma and their families via the Asthma in Pregnancy Toolkit website https://asthmapregnancytoolkit.org.au/.

Women residing in rural areas or belonging to lower socioeconomic status (SES) strata experience disproportionately low rates of breast cancer screening, contributing to delayed diagnoses and poorer prognoses. In addition, their participation in clinical trials remains markedly limited, reducing opportunities to access preventive and screening interventions. Promoting research preparedness among women before disease onset may empower them to make informed decisions regarding their health and willingness to participate in clinical research with fewer emotional and logistical barriers.

This project applies a community-based participatory research approach to develop and refine the WeCARE (Women’s Engagement for Cancer Awareness, Resources and Education) intervention for women aged 50–74 years who have either never undergone breast cancer screening or have not received screening in the past 5 years and who reside in rural areas or belong to low SES groups. The intervention consists of two components. Component 1 is a single-day, in-person community forum that includes (a) an educational seminar led by an oncologist to address breast cancer risk and screening guidelines, (b) survivor storytelling to enhance emotional engagement and cultural resonance and (c) facilitated navigation to breast cancer screening and future research participation. Component 2 involves structured post-forum follow-up through multiple touchpoints (phone calls and mailed boosters) to reinforce knowledge, address barriers and support screening completion and research enrolment. Quantitative data (eg, screening completion, satisfaction and follow-up engagement) will be summarised using descriptive statistics to assess feasibility and reach on 50 participants. Qualitative feedback from participants will undergo thematic analysis to identify barriers, facilitators and perceived cultural relevance. Integrated mixed-method interpretation will inform iterative refinement of the WeCARE intervention and guide design of subsequent larger trials.

Approved by the Mayo Clinic Institutional Review Board (IRB #25–008934). All participants will provide informed consent. Procedures ensure confidentiality, cultural sensitivity and participant safety. Data will be stored in REDCap and disseminated through publications, conferences, local town halls and community reports.

Loneliness and social isolation are increasingly recognised as determinants of cardiovascular and brain health, particularly among older adults. Evidence from high-income settings links social disconnection to higher risk of coronary heart disease, stroke, cognitive decline and mortality, yet few interventions have been adapted for rural, resource-limited environments. In rural coastal Ecuador, demographic stability, low migration and strong community engagement provide a unique context to evaluate a culturally grounded intervention. This study aims to determine whether a multi-component social connection intervention programme (SCIP), informed by the Social Cognitive Theory, can reduce loneliness and social isolation and improve cardiovascular, cognitive and psychosocial outcomes among older adults living in three rural villages participating in a population-based cohort.

This quasi-experimental matched-control study will be conducted in Atahualpa (intervention site) and the neighbouring villages of El Tambo and Prosperidad (control sites). Eligible participants are adults aged ≥60 years without disability, dementia or major psychiatric illness. Intervention participants will be matched to controls using variable-ratio propensity score methods. The 12-month SCIP includes monthly community educational activities, peer-support group sessions and individualised coaching (two times per month) focused on skill-building, goal-setting and cognitive-behavioural strategies. Participants in the control villages will receive usual community and primary care services without exposure to SCIP activities. Baseline and 12-month assessments will measure social isolation, loneliness, cardiovascular health, sleep quality, cognitive performance, depressive symptoms and quality of life. Incident stroke, cardiovascular disease and mortality will be monitored quarterly. Analyses will use mixed-effects models for continuous and categorical outcomes and Cox proportional hazards models for incident events, adjusting for relevant confounders.

The protocol was approved by the Ethics Committee of Hospital-Clinica Kennedy, Guayaquil. All participants will provide written informed consent. Findings will be disseminated through peer-reviewed publications, conference presentations and community reports. Results may inform scalable strategies to enhance psychosocial well-being and reduce cardiovascular and cognitive risk in underserved rural populations.

NCT07319663.

Prolonged weaning from invasive mechanical ventilation is a major challenge in critically ill patients failing a spontaneous breathing trial. Levosimendan, a calcium sensitiser, has been shown to improve respiratory muscle function. However, its effect on clinically relevant endpoints in difficult to wean patients has not yet been investigated. We aim to assess whether levosimendan shortens the weaning process in invasively ventilated intensive care unit (ICU) patients who fail a separation attempt. The objective is to assess the effect of levosimendan on the number of ventilator-free days and alive at day 28.

The WEANing with LEvoSimendan Study (WEANLESS) is an investigator-initiated, multicentre, double-blind, parallel-group, randomised clinical superiority trial. Adult invasively ventilated patients who failed a separation attempt are randomly assigned to receive either intravenous levosimendan (intervention) or placebo (control). The primary outcome is the number of ventilator-free days and alive at day 28 from randomisation. WEANLESS also evaluates the effects of levosimendan on patient-reported outcomes, measured through daily dyspnoea scores and uses an EQ-5D-5L questionnaire. Additionally, we will evaluate healthcare resource utilisation and intensive care capacity, assessed through reintubation rates, ICU readmissions within 90 days, the need for non-invasive respiratory support and ICU length of stay. WEANLESS includes a pharmacokinetic analysis of levosimendan and its metabolites.

WEANLESS is the first clinical study that is sufficiently powered to determine the effect of intravenous levosimendan in difficult to wean patients on the duration of weaning from invasive ventilation.

WEANLESS is registered before the inclusion of the first patient at clinicaltrials.gov; the study protocol has been approved by the relevant ethics committee. Its findings will be disseminated through presentations at scientific conferences and publications in a peer-reviewed journal.

NCT07105202.

Aboriginal women in the remote Northern Territory (NT) experience high rates of adverse pregnancy outcomes related to hyperglycaemia in pregnancy. Oral glucose tolerance test (OGTT) screening was recommended in early pregnancy but barriers to uptake exist.

To examine uptake of screening for hyperglycaemia in pregnancy among Aboriginal women in remote NT communities and explore adverse pregnancy outcome rates among women who did not have early OGTT screening compared with women who did undergo screening in early pregnancy and those with pre-existing diabetes.

Retrospective observational cohort study of pregnancies among Aboriginal women in remote NT clinics from January 2017 to December 2019. Screening for hyperglycaemia in pregnancy included having an early OGTT (

Among 1191 pregnancies in 52 remote communities, pre-existing type 2 diabetes (T2D) was diagnosed in 6.4% (n=76) and gestational diabetes mellitus (GDM) was diagnosed in 13% (154/1191). Excluding women with pre-existing diabetes, 226 (20%) had an early OGTT. Guideline-directed screening (with either (a) an early OGTT diagnosing GDM or (b) a negative early OGTT followed by a routine OGTT) occurred in 14% of pregnancies (n=158). Compared with women who had an early pregnancy OGTT, the combined adverse pregnancy outcome was more common among women with pre-existing T2D (89% vs 54%, adjusted OR 6.06 (95% CI 2.75 to 13.35)) and similar among women who did not undergo early OGTT (50%, adjusted OR 0.97 (95% CI 0.71 to 1.32)).

Uptake of guideline-directed screening in Aboriginal women in remote NT was low, although there was no difference in pregnancy outcomes for women who were and were not screened with an early OGTT. Rates of adverse pregnancy outcomes were concerningly high in women with pre-existing T2D, highlighting a need to strengthen diabetes care for these women.

Frostbite is a common reason for emergency department (ED) presentations in Canada. Iloprost, a prostacyclin analogue, has been investigated to reduce the risk of amputation with its use expanding. Two Canadian cities implemented iloprost over different times leading to a practice variation that allowed for treatment comparison. Our objective is to evaluate the effectiveness of iloprost compared with non-iloprost treatment. Secondary objectives include assessing the impact of iloprost dosage and homelessness.

A retrospective cohort study was conducted on adult severe frostbite cases presenting to EDs in Calgary and Edmonton between November 2021 and April 2024. Data were abstracted from clinical databases and analysed for demographic and injury characteristics, treatment and amputation outcomes.

Of 1812 total ED encounters for frostbite, 257 patients with grades 2–4 extremity frostbite were included for analysis. Logistic regression found that overall patients receiving iloprost were associated with reduced likelihood of any amputation (OR=0.49, 95% CI 0.25 to 0.96) and fewer digit amputations (p

Iloprost infusion was associated with a reduction in amputation rates in grade 3 and 4 frostbite with the greatest association seen in grade 3 cases. Greater iloprost dosage was associated with improved digit salvage. Homelessness was associated with delayed ED presentation.

To estimate the relative effectiveness of vaccination (0, 1, 2, ≥3 doses) and prior infection, in combination, on risk of SARS-CoV-2 infection/reinfection.

Prospective cohort study.

We recruited participants for the Aegis Study from nine clinics across five US states. Participants must have been 18 years or older, had a history of a positive PCR for SARS-CoV-2, SARS-CoV-2 antigen or antibody test for SARS-CoV-2 with documentation or had no suspected or documented prior SARS-CoV-2 infection, intended to remain in study area for the next 12 months, and had elevated risk of future SARS-CoV-2 exposure. Exclusion criteria included acute illness, contraindication to phlebotomy, use of immunosuppressants or receipt of systemic immunoglobulins.

We used extended Cox regression with robust standard errors to estimate the association between time-varying number of vaccine doses and baseline prior infection on risk of infection/reinfection among a prospective cohort of US adults between February 2021 and January 2023, accounting for censoring using inverse probability of censoring weights. Additionally, to quantify possible exposure misclassification of prior infection by comparing prior infection operationalised as (1) documented/self-reported prior infection and (2) documented/self-reported prior infection plus nucleocapsid antibody indication of prior infection.

Of n=2178 who completed enrolment, n=1887 adults (63% female; 65% non-Latino White) contributed 366 905 days of observation. Participants contributed an average of 7.2 months of follow-up between February 2021 and January 2023. 28% (n=533) of individuals were infected or reinfected during the study period. Similar relative effectiveness was observed between the two different operationalisations of prior infection. After correction for prior infection status in the nearly 16% of those without study documentation of prior infection who had nucleocapsid antibody levels comparable to documented cases, relative to the unvaccinated with no prior infection, estimated effectiveness generally increased with increasing vaccine doses and prior infection (without prior infection: one (17%, 95% CI –31% to 47%), two (49%, 95% CI 31% to 63%), ≥three (71%, 95% CI 58% to 80%) vaccine doses; with prior infection: none (56%, 95% CI 30% to 72%), one (71%, 95% CI 42% to 86%), two (65%, 95% CI 49% to 76%), ≥three (80%, 95% CI 68% to 88%) vaccine doses). Pairwise comparisons at each vaccine dose (ref: no prior infection) revealed that prior infection provided additional protection, with stronger relationships for no and one dose (none: 56% (95% CI 30% to 72%), one: 66% (95% CI 28% to 84%), two: 31% (95% CI 7% to 49%), ≥three 31% (95% CI 0% to 53%)). There was a marked decrease in the protection offered by vaccination, prior infection, or both in the Omicron period versus pre-Omicron period.

In our real-world observational sample, vaccination (with two and ≥three vaccine doses of any Food and Drug Administration Emergency Use Authorization approved vaccine) and prior infection conferred benefits for protection against infection/reinfection. Re-classification of prior infection status based on antibody levels had little effect on results.

Active patient involvement is a core principle of patient-centred care, yet public experiences of medical decision-making in non-Western settings remain underexamined. In South Korea, nationwide evidence on how adults experience, perceive and prefer medical decision-making is limited. This study, therefore, examined Korean adults’ experiences, perceptions and preferences regarding medical decision-making.

A cross-sectional study was conducted between March and April 2025 using online data collection for adults aged 19–59 years and face-to-face interviews for those aged 60 years or older.

This nationwide survey was conducted in South Korea.

A total of 1081 Korean adults were recruited using proportional quotas for sex, age group and region. After excluding withdrawals and invalid responses, 1000 were included (response rate 92.5%).

Overall, 70.4% of respondents reported at least one significant health-related decision in the past 2 years. Although 34.1% reported making their most recent decision independently, a larger proportion preferred collaborative decision-making involving clinicians and/or family members. The clinician’s explanation was the most influential factor (77.4%). Preferences for primary decision-maker varied by clinical context: patient-led decisions were favoured for low-risk interventions such as vaccination (78.5%), whereas physician involvement was preferred for life-threatening illness (86.2%). Communication ratings were highest for presentation of treatment options (mean score 3.56±0.79 on a 5-point scale) and lowest for explanation of potential treatment risks (mean score 3.20±0.89). Participants satisfied with decision outcomes reported higher communication quality (p

Medical decision-making was common, but respondents’ experiences did not always match their preference for collaborative involvement. The findings suggest that strengthening patient-centred care in South Korea will require not only improvements in patient–clinician communication, but also attention to family involvement and structural conditions such as limited consultation time and current reimbursement arrangements.

Despite growing interest in the therapeutic potential of 3,4-methylenedioxymethamphetamine (MDMA), no targeted measure to systematically assess side effects of MDMA-assisted psychotherapy (MDMA-AP) exists.

Our aim was to develop an MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to capture side effects over the course of MDMA-AP.

Informed by a systematic review and a review of other relevant questionnaires, we drafted a list of potential side effects. Face and content validation were obtained via a modified two-round online Delphi process involving experts in MDMA-AP and the neuropsychopharmacology of MDMA.

Twelve experts consented to participate over two rounds of Delphi panel deliberations (response rate: Round 1 = 83–92%, Round 2 = 75%). The Delphi panellists were asked to keep, discard, modify or suggest additional items. The final version of the M-SET consists of 165 items across four questionnaires that collect information at screening, baseline, the day of medication sessions and longer term follow-up.

The use of a modified Delphi technique proved a successful method to generate content for the first structured tool designed to evaluate side effects specifically associated with MDMA-AP.

The M-SET is recommended for use in both research and clinical settings. Its implementation has the potential to improve the safety of delivering MDMA-AP as well as support the development of a more systematic and robust evidence base on its safety and tolerability.

The interaction between the gut microbiota and the host immune system is implicated in the pathogenesis of inflammatory bowel disease, including ulcerative colitis (UC). Targeting the gut microbiota with faecal microbiota transplantation (FMT) from a healthy donor has shown promise in inducing remission in patients with active UC. However, mixed results and protocol heterogeneity have limited its practical application. Our previous Transfer of Faeces in Ulcerative Colitis; Restoring Homeostasis (TURN) trial found a correlation of clinical response with specific strains and butyrate production. Since most gut microbes, including many butyrate producers, are anaerobes, anoxic processing of donor stool may be essential to increase efficacy of FMT in UC. This trial aims to enhance FMT efficacy by applying strict anoxic processing, selecting donors based on microbial composition and using repetitive dual-route administration.

This randomised, double-blind, placebo-controlled, multicentre study evaluates the efficacy of strictly anoxic prepared donor FMT compared with anoxic prepared autologous FMT in patients with mild to moderate active UC. An open-label extension option is available for non-responders in the autologous arm. Included patients will receive 4 weekly FMTs, comprising two double-route administrations (nasoduodenal administration combined with enema) and two single enemas. Donors are selected based on their microbiota profile, informed by our previous TURN trial and literature. A total of 76 patients evaluable for the primary endpoint will be included. The primary endpoint is steroid-free clinical and endoscopic remission at week 8, assessed by the adapted Mayo score. An interim analysis will be conducted midway through the study by a Data Safety Monitoring Board to monitor efficacy and safety. Other outcomes of this study include the evaluation of clinical, endoscopic and histological response. In addition to clinical results, this study aims to provide valuable insights into specific microbial strains, metabolites and mechanisms correlated with response, aiding in the development of future microbial therapies.

Ethics approval was obtained from the medical ethics committee of the Amsterdam University Medical Centre in the Netherlands (reference number 2018_057). All participants will provide written informed consent. The results of the trial will be disseminated through publication in a peer-reviewed journal and presentations at (inter)national conferences.

Prospectively registered in May 2018 in the Dutch Trial Register (NTR/LTR) as NL7770. Assigned NL-OMON52507 following the transition of the Dutch Trial Register to the Overview of Medical Research in the Netherlands. Also registered at ClinicalTrials.gov (NCT05998213).

To examine HIV care attrition patterns and risk factors among adolescent girls and young women (AGYW) enrolled in prevention of mother-to-child transmission of HIV (PMTCT) services in Tanzania.

Prospective cohort study.

The study was conducted in three regions of Tanzania: Kagera, Tabora and Dar es Salaam across 543 public and private health facilities.

A total of 10 147 pregnant and postpartum AGYW living with HIV attending PMTCT services between 1 January 2018 and 31 December 2020 were included in this study and followed prospectively until they were censored at the last appointment date or 31 December 2023, whichever was earlier.

The primary outcome was time to HIV care attrition, defined as death, discontinuation of antiretroviral treatment (ART) or loss to follow-up (LTFU). LTFU was defined as failure to attend a scheduled clinic appointment and being absent from care for ≥90 consecutive days following a missed appointment among non-transfers. Kaplan-Meier analyses were used to estimate time to first attrition. The Anderson-Gill proportional hazard model estimated the risk factors for repeated care interruptions, adjusted for baseline characteristics and stratified by ART status at PMTCT enrolment.

A total of 3259 attrition events were observed, of which 79% occurred within the first year, with the median time to first attrition of 4 months (IQR: 1–8), 96.3% were due to LTFU. Over two-thirds of first-year attrition occurred among AGYW newly started on ART at PMTCT enrolment, who had more than twice the attrition rate of those already on ART (28.6 vs 11.2 per 100-person-years). Of AGYW lost to follow-up, 44.8% returned to care and 20.9% experienced subsequent attrition. Among AGYW new on ART, attrition was higher in those enrolled late in their third trimester (adjusted HR (aHR) 1.20; 95% CI 1.01 to 1.42) versus those in the first trimester and lower during the postpartum period (aHR 0.58; 95% CI 0.43 to 0.79). In AGYW already on ART, attrition rate was higher among adolescents 18–19 years (aHR 1.37; 95% CI 1.13 to 1.66) and those enrolled late; during the second (aHR 1.41; 95% CI 1.16 to 1.72) and third trimesters (aHR 1.57; 95% CI 1.23 to 2.00) or post partum (aHR 1.36; 95% CI 1.09 to 1.70) compared with the first trimester. AGYW with early-stage HIV, on second-line regimens and attending facilities with fewer AGYW, had a lower attrition rate in contrast to comparison groups.

AGYW newly started on ART at PMTCT enrolment are more likely to have early and recurring dropout. Given the cyclical nature of HIV care engagement, tailored and repeated interventions are needed to support continuous retention and re-engagement for pregnant and postpartum AGYW with HIV.

The Needs Assessment Tool-Cancer (NAT-C) is a consultation guide to identify, triage and reduce unmet patient needs.

We aimed to assess NAT-C fidelity, mechanisms of action and implementation issues in UK primary care as part of a clinical and cost-effectiveness cluster randomised controlled trial of the NAT-C for people with cancer compared with usual care (registration: ISRCTN15497400).

Design: a mixed-methods process evaluation informed by normalisation process theory (NPT). Setting: 21 participating general practices in England were randomised to be trained to conduct an NAT-C guided consultation with people with cancer (excluding those in remission). General practitioner fidelity of intervention and clinical action resulting from the NAT-C consultation was noted. Two Normalisation MeAsure Development Questionnaire surveys were distributed to trained clinicians before (Survey 1) and after delivery of ≥2 NAT-C consultations (Survey 2). Semi-structured interviews were conducted with clinicians (post delivery ≥2 NAT-C consultations) and key stakeholders in primary and cancer care. Fidelity, action and paired before/after survey data were analysed using descriptive statistics. Interview data were analysed using a deductive thematic framework approach (NPT-informed). Data were narratively synthesised with cross-tabulated key findings.

Of the 360/376 (96%) NAT-C consultations delivered, 258/360 (72%) resulted in clinical action, including 50 (13%) external referrals. 14 paired before (Survey 1, n=53) and after (Survey 2, n=29) responses. Survey 1 showed positive responses across all NPT domains, but while continuing to see relevance, usefulness and legitimacy, Survey 2 highlighted concerns about insufficient resources and management support. 16 clinician participants (eight GPs, eight key stakeholders; 50% male) completed interviews. Following synthesis, we identified five themes: (1) the perceived value of the NAT-C; (2) ‘champions’ are important at all levels (practice, regionally and nationally); (3) research evidence is seen as important, but influences implementation indirectly through policy, clinical guidelines and resourced initiatives; (4) adequate resources are fundamental for implementation beyond practice level and (5) NAT-C practicalities; training is adequate, but robust functional information technology systems are needed.

Implementation requires champions and clinicians ‘buy-in’ to the patient value to legitimise use. In the context of current primary care pressures, resources were seen as essential to embed the NAT-C, but financial incentives were viewed with mixed feelings.

ISRCTN15497400.

To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.

Mixed-methods study describing the development of a patient decision aid.

A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.

Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.

We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).

Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

Well-being of healthcare professionals (HCPs) is vital for care quality, staff retention and overall healthcare system effectiveness. This study aims to identify the organisational and workplace variables associated with sick leave and measures of engagement of HCPs on department level within a single Dutch academic hospital.

Cross-sectional study using routinely collected organisational data.

A tertiary-care academic hospital in the Netherlands.

25 clinical departments were included. Department level variables were derived from routinely collected hospital databases. Availability of data varied across variables. Analysis included information on patient population, human resources, care processes, quality of care and employee and patient experiences to assess differences, correlations and predictors for sick leave and engagement.

Primary outcome measures were (1) sick leave (%) and (2) engagement, assessed through two staff-survey items (vitality and connectedness; 0–10 Numeric Rating Scale). Both outcomes were analysed at department level.

Employee population data showed the most consistent patterns across analyses. Departments with higher staffing capacity had higher sick leave and lower engagement in group comparisons (p=0.009, p=0.030, respectively). In multivariable models, higher staffing capacity remained associated with increased sick leave (B=1.38, 95% CI 0.53 to 2.23, p=0.003). Engagement was positively associated with higher inflow (B=0.92, 95% CI 0.06 to 1.77, p=0.037) and negatively associated with outflow (B = –1.36, 95% CI –2.08 to –0.63, p=0.001). No consistent associations were found with patient population and patient experience measures.

Workforce-related factors, particularly staffing capacity and inflow and outflow, are strongly linked to sick leave and engagement. Routinely collected hospital data can be used to identify at-risk departments and inform targeted strategies for improving workforce sustainability. Future studies should explore more granular, team-level data to better support staff well-being and care quality.

Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.