Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

ClinicalTrials.gov, NCT06619223.

The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.

QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.

QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.

Most clinical practice guidelines (CPGs) for assessing and managing people’s chronic pain focus on specific pain conditions, body sites or life course stages. This creates complexity for clinicians making care choices in the absence of a diagnosis and/or where a person experiences more than one pain condition. Specific to this context is the ICD-11 classification of chronic primary pain where an experience of pain cannot be better accounted for by another condition. CPGs for chronic primary pain, agnostic to condition or body part, may support clinicians towards best pain care since many of the principles of person-centred chronic pain care are transdiagnostic. The two aims of this systematic review are to (1) identify and appraise CPGs for chronic primary pain, relevant across the life course and (2) map the CPG content against a pain care priority framework to evaluate the extent to which the CPG content aligns with the priorities of people with lived chronic pain experience.

We will systematically search nine scholarly databases, the Epistemonikos database and international and national guidelines clearinghouses. CPGs published within 2015–2025, in any language, that offer recommendations about assessment and/or management of chronic primary pain for people of any age, excluding hospitalised inpatients or institutionalised populations, will be included. Pairs of reviewers will independently screen citations for eligibility and appraise CPG quality and implementation potential using the Appraisal of Guidelines for Research and Evaluation (AGREE)-II and the AGREE-Recommendations Excellence tools, respectively. Data extraction will include the citation and scope characteristics of each CPG, methods used to develop recommendations, verbatim recommendations, guiding principles or practice information and narrative excerpts related to the GRADE Evidence-to-Decision (EtD) considerations (or equivalent). We will use the PROGRESS-PLUS framework as a checklist to identify whether determinants of health equity were considered by guideline developers. CPG recommendations will be organised according to common topics and categorised in a matrix according to strength and direction. Qualitative content analysis will be used to synthesise excerpts relating to GRADE EtD considerations (or equivalent), and we will map extracted data against an established chronic pain care priority framework to determine the extent to which the CPGs align with values and preferences of people with lived experience. Interpretation will be informed by an interdisciplinary Advisory Group, including lived experience partners.

Ethical approval is not required for this systematic review. Results will be disseminated through publication in an open-access peer-reviewed journal, through professional societies, and integrated into education curricula and public-facing resources. Reporting will be consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.

CRD420251000482.

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

Gambling is of public health importance due to the potential impacts of gambling on individuals and their communities.

This review draws on evidence to address: ‘What is known about gambling in lesbian, gay, bisexual, trans and queer+ (LGBTQ+) communities?’ including (i) the prevalence of gambling harm; (ii) the lived experience of gambling harms; (iii) the interventions and service barriers and (iv) the risk and protective factors against gambling harms.

The identified peer-reviewed and grey literature papers were screened against inclusion and exclusion criteria by two reviewers prior to extracting data. Eligibility for inclusion was assessed via the Critical Appraisal Skills Programme (CASP) framework and a Weight of Evidence approach.

PubMed, Web of Science, ProQuest, Google Scholar and Cochrane were searched for peer reviewed and grey literature published from June 2000 to June 2023.

Data extraction tables were developed to include the characteristics, methods, sample and key findings for each study.

19 papers were included, which showed mixed prevalence of problems with gambling among lesbian, gay and bisexual populations. There is more consistent evidence that trans and gender diverse people experience higher levels of problems with gambling compared with cisgender (not trans) people. Limited research focused on the lived experience or the wider impact of gambling harm among LGBTQ+communities. Risk factors for gambling harm included minority stress, societal stigma, discrimination and isolation. Protective factors against gambling harm included higher levels of support, positive social interaction and mainstream community connectedness. No studies were identified with gambling interventions specific to LGBTQ+people. General health service barriers included professionals’ use of pathologising language or a lack of cultural competency and education around LGBTQ+issues.

Research on LGBTQ+ gambling harm remains distinctly limited. Further, population-based surveys as well as in-depth qualitative research are needed to develop a comprehensive understanding of gambling in LGBTQ+communities. Research should be undertaken in collaboration with LGBTQ+peers. A better understanding of gambling could inform a whole systems approach with targeted interventions to protect against gambling harm and to promote greater health equity. Open Science Framework registration number (http://osf.io/jf85y/).

Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide, associated with significant morbidity, mortality and healthcare utilisation. AF rhythm control strategies demonstrate attrition with time. A number of modifiable AF risk factors contribute to an atrial cardiomyopathy culminating in incident AF but importantly also recurrence. We propose that a novel multidisciplinary lifestyle intervention (Super Rehab, SR) may improve symptoms and AF burden.

This is a single-centre, randomised controlled study. Patients aged ≥18 years with a body mass index ≥27 kg/m² with paroxysmal or persistent AF will be randomised 1:1 to National Health Service (NHS) usual care (UC) or to SR (together with NHS UC). SR incorporates high-intensity exercise, personalised dietary advice and AF risk factor modification. SR will be undertaken over 12 months. In addition to baseline assessments, follow-up assessments will occur at the 6, 12 and 15-month time points. The primary outcome will be the difference in AF symptom burden at 12 months between groups. Secondary outcomes include AF burden (assessed by an implantable cardiac monitor), changes to cardiac structure and function and computed tomography-based assessment of epicardial adipose tissue.

Ethics approval was granted by London-Chelsea Research Ethics Committee (reference: 22/LO/0479 22/08/2022). All participants will provide written informed consent prior to enrolment. Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. A summary will also be communicated to the participants.

ClinicalTrials.gov ID NCT05596175.

Preterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting.

Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints.

Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219).

NCT04685356.

Stroke is the second leading cause of death worldwide, with the greatest burden in low- and middle-income countries (LMICs). Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the highest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. The Planetary Outcomes after Intracranial Haemorrhage study aims to provide a global snapshot of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings. It will also describe variation seen in care processes and available resources and time delays to receiving care. A greater understanding of the current state of sICH care is essential to identify possible interventions and targets for improved standards of care in all settings.

We describe a planned prospective, multicentre, international observational cohort study of patients admitted to hospital for management of sICH. We will include patients of all ages presenting to hospital with imaging evidence of sICH (IPH, intraventricular haemorrhage and/or SAH). The study will collect patient, care process and short-term outcome data, following patients for up to 30 days (or until discharge or death, whichever occurs first). Any centre globally where patients with sICH are admitted and managed can participate, targeting a sample size of 712 patients. The study will recruit centres worldwide through pre-existing research networks and by dissemination through neurosurgical and stroke conferences and courses. Each participating centre will complete a site questionnaire alongside patient data collection.

The study has received ethical approval by the University of Cambridge (PRE.2024.070). Participating centres will also confirm that they have undergone all necessary local governance procedures prior to starting local data collection. The findings will be disseminated via open access peer-reviewed journals, relevant conferences and other professional networks and lay channels, including the study website (https://plotich.org/) and social media channels (@plotichstudy).

NCT06731751.

Selecting an optimal initial dosage of opioid agonist treatment (OAT) balances effectiveness and safety, as initial doses that are too low may be insufficient, potentially prompting clients to seek unregulated drugs to alleviate withdrawal symptoms, which may increase the likelihood of treatment discontinuation. Conversely, initial doses that are too high carry a risk of overdose. As opioid tolerance levels have risen in the fentanyl era, linked population-level data capturing initial doses in the real world provide a valuable opportunity to refine existing guidance on optimal OAT dosing at treatment initiation. Our objective is to determine the comparative effectiveness of alternative initial doses of methadone, buprenorphine-naloxone and slow-release oral morphine at OAT initiation, as observed in clinical practice in British Columbia (BC), Canada.

We propose a population-level retrospective observational study with a linkage of nine provincial health administrative databases in BC, Canada (1 January 2010 to 31 December 2022). Our study includes two time-to-event primary outcomes: OAT discontinuation and all-cause mortality during follow-up. We propose ‘initiator’ target trial analyses for each medication using both propensity score weighting and instrumental variable analyses to compare the effect of different initial OAT doses on the hazard of time-to-OAT discontinuation and all-cause mortality. A range of sensitivity analyses will be used to assess the robustness of the results.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.

The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.

This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.

ISRCTN61751241.

Health coaching is the process of working with a trained coach, peer, or healthcare professional towards self-determined health and wellness goals. Health coaching is being increasingly adopted in multiple healthcare settings and has been shown to improve overall health outcomes and long-term maintenance of chronic conditions in multiple countries and healthcare settings. Research surrounding the costs of implementing health coaching and its effects on healthcare costs, particularly long-term costs, has been limited. Although analysis of healthcare costs has become an important priority in recent years, the available literature looking at the cost impacts of health coaching is small and inconclusive, finding mixed results with a variety of methodologies. This scoping review aims to identify gaps in the literature and help set a research agenda regarding the costs of health coaching implementation and its impacts.

The scoping review will be structured according to Levac et al’s enhancement to Arksey and O’Malley’s framework for conducting scoping reviews. PubMed, Embase, and the Health and Medicine Collection will be searched for peer-reviewed research that includes health and wellness coaching and some measurement of cost. Details about the type of study, cost analysis, methodology and results from the included articles will be extracted and summarised. Full-text publications, excluding editorials and opinion pieces, included in this scoping review will be published in 2017 or later, will be written in English, will align with the definition of health coaching as described by the National Board for Health and Wellness Coaching, and will include cost measurement. This review will include publications not captured in the previous integrative literature review looking at the cost-effectiveness of health coaching.

Findings will be disseminated through a peer-reviewed publication and through presentations to both health system and community-based entities currently using or considering adopting health coaching. Ethics approval is not a requirement for this review as no human research participants will be involved. All data will be obtained from publicly available literature, with no primary data generated.

To investigate discrepancies in perceptions regarding the accessibility and availability of rest and relaxation (R&R) spaces between hospital doctors in Scotland and NHS Scotland regional health boards (HBs), with the intention of informing best practices for organisational policy on the provision of R&R spaces both now and in the future.

A qualitative study, through an inhabited institutionalism (II) lens, of semi-structured interviews of hospital doctors across the career continuum in Scotland and all NHS regional HBs in Scotland providing written information relating to R&R space provision.

NHS Scotland during the COVID-19 pandemic and beyond.

Hospital doctors (n=30) who had participated in a larger qualitative study and provided specific insights on R&R spaces. All NHS Scotland regional HBs (n=14).

Although HBs reported the provision of R&R spaces, numerous doctors reported R&R spaces had been removed, relocated or were inaccessible. Furthermore, limited awareness of their availability attributed to inadequate communication, compounded the issue. This divergence between institutional reporting and front-line experience can be interpreted through the lens of II, which posits that institutional polices are often interpreted and implemented differently.

This study emphasises how crucial R&R spaces are to promoting doctors’ well-being especially during the time of high stress. HBs must not only guarantee the accessibility and physical availability of R&R spaces but also enhance their communication regarding the provision.

Endovascular therapy is the main treatment for chronic limb-threatening ischaemia in the UK. Despite a restenosis risk of 50% over 2 years, reintervention rates are low, potentially resulting in preventable amputations. European guidelines recommend ultrasound surveillance to facilitate early treatment of restenosis. This study will investigate the use of duplex ultrasound after endo revascularisation (DUSTER). The aim is to assess the feasibility, acceptability and impact on clinical decision-making of a 1-year integrated ultrasound surveillance programme after lower limb endovascular therapy.

DUSTER is a mixed-methods study. Phase I is a three-site, feasibility, open-label, randomised controlled trial. The standard of care, the control arm, is standard clinical surveillance by a vascular specialist at 1, 6 and 12 months. The intervention arm will receive integrated ultrasound (ankle-brachial pressure index, toe pressure and duplex) plus standard clinical surveillance. Primary outcomes are rates of attendance and completion of ultrasound surveillance tests, as well as the percentage of participants undergoing reintervention for restenosis. Secondary outcomes are limb salvage, amputation-free survival, reasons for amputation, complications, serious adverse events and mortality.

Phase II comprises independent semistructured interviews with intervention arm participants. The interviews will explore barriers and facilitators to ultrasound surveillance and the effect of ultrasound surveillance on patients’ lives.

Phase III has two separate focus groups for participants and clinical stakeholders to identify which outcomes matter most in any subsequent large-scale effectiveness trials.

This research has been approved by a UK (West Midlands, Black Country) Research Ethics Committee (reference 24/WM/0232) and the Health Research Authority (IRAS 349192). Dissemination of results will be by the DUSTER co-investigators in peer-reviewed journals, to the National Institute for Health and Care Research and to a lay audience via the Mid and South Essex NHS Foundations Trust website.

NCT06702306.

People identified as higher risk by a machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation [FIND-AF]) are at increased risk of cardio-renal-metabolic-pulmonary disease and cardiovascular death. The OPTIMISE-1 randomised controlled trial aims to test the effect of community-based specialist-led identification and management of cardio-renal-metabolic-pulmonary (CRMP) disease and risk factors compared with usual care on the use of therapeutic interventions over a follow-up of 6 months among high FIND-AF risk community-dwelling individuals.

OPTIMISE-1 is a multicentre, pragmatic, prospective, randomised, open-label, blinded-endpoint strategy trial that will recruit 138 participants aged 30 years or older, with a high FIND-AF risk score and previously enrolled in the FIND-AF pilot study (NCT05898165), to be randomised 1:1 to a specialist-led care intervention or usual care. The primary endpoint is a composite of initiation or increase of guideline-directed CRMP therapies. The secondary endpoints are the components of the primary endpoint, time to primary endpoint, diagnosis of new CRMP diseases or risk factors, time to diagnosis of new CRMP diseases or risk factors, initiation or increase of guideline-directed CRMP therapies for participants with recorded CRMP disease, initiation or increase of guideline-directed CRMP therapies for participants with newly diagnosed CRMP disease and change in participant-reported quality of life.

The study has ethical approval (the North East & North Tyneside 2 Research Ethics Committee reference 24/NE/0188). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder’s open access policy.

Clinicaltrials.gov NCT06444711.

Sleep is a biological necessity with vital effects on all tissues and organs of the body. Preoperative sleep disturbance is associated with increased postoperative pain intensity and opioid consumption. Given that insomnia is a potentially modifiable risk factor, interventions targeting sleep prior to surgery may improve postoperative pain control and enhance key outcomes of recovery.

Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) is a randomised, parallel group, two arm, controlled trial evaluating the effects of preoperative sleep-promotion on postoperative pain control, brain health and physical recovery. The main objective is to investigate whether preoperative insomnia treatment in patients scheduled to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA) may improve acute postoperative pain control. 100 adults with insomnia disorder (Insomnia Severity Index score >10 and confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for persistent insomnia disorder), scheduled to undergo primary TKA or THA, will be randomised to preoperative cognitive behavioural therapy for insomnia (CBT-I) or an active comparator control intervention, sleep education therapy (SET). Both interventions will be delivered over 4 weeks in hybrid format through a digital self-guided platform in combination with weekly telehealth video sessions with a psychologist (CBT-I) or research nurse (SET). A video-assisted booster session will be provided 1–2 weeks postoperatively. The primary outcome measure is acute postoperative pain intensity, averaged over the first 7 postoperative days (POD). Secondary outcome measures include long-term postoperative pain control, changes in quantitative sensory testing variables (eg, temporal summation, conditioned pain modulation), sleep, cognition (eg, attention, memory, processing speed, executive function), mental health, health-related function, physical activity, quality of life and blood biomarkers. Participants will undergo on-site evaluation preoperative (preintervention and postintervention) and 6 months postoperative. Additional remote assessments will take place during POD1–7, 3 and 12 months postoperative.

The Swedish Ethical Review Authority has approved the PROSAP-A trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.

NCT06145516.

Diagnosing pulmonary tuberculosis (PTB) in children is challenging owing to paucibacillary disease, non-specific symptoms and signs and challenges in microbiological confirmation. Chest X-ray (CXR) interpretation is fundamental for diagnosis and classifying disease as severe or non-severe. In adults with PTB, there is substantial evidence showing the usefulness of artificial intelligence (AI) in CXR interpretation, but very limited data exist in children.

A prospective two-stage study of children with presumed PTB in three sites (one in South Africa and two in Pakistan) will be conducted. In stage I, eligible children will be enrolled and comprehensively investigated for PTB. A CXR radiological reference standard (RRS) will be established by an expert panel of blinded radiologists. CXRs will be classified into those with findings consistent with PTB or not based on RRS. Cases will be classified as confirmed, unconfirmed or unlikely PTB according to National Institutes of Health definitions. Data from 300 confirmed and unconfirmed PTB cases and 250 unlikely PTB cases will be collected. An AI-CXR algorithm (qXR) will be used to process CXRs. The primary endpoint will be sensitivity and specificity of AI to detect confirmed and unconfirmed PTB cases (composite reference standard); a secondary endpoint will be evaluated for confirmed PTB cases (microbiological reference standard). In stage II, a multi-reader multi-case study using a cross-over design will be conducted with 16 readers and 350 CXRs to assess the usefulness of AI-assisted CXR interpretation for readers (clinicians and radiologists). The primary endpoint will be the difference in the area under the receiver operating characteristic curve of readers with and without AI assistance in correctly classifying CXRs as per RRS.

The study has been approved by a local institutional ethics committee at each site. Results will be published in academic journals and presented at conferences. Data will be made available as an open-source database.

PACTR202502517486411

Micronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.

This will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B₁₂). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.

The study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.

All data will be made publicly available (deidentified) after the publication of the main impact paper.

NCT06810440.