Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

NCT04897516.

This study aims to assess the feasibility of respondent-driven sampling (RDS) to recruit participants with recent abortion experiences in humanitarian contexts, and describe the composition of the study sample generated with this sampling method.

This was a three-phase mixed-methods community-engaged research study employing an exploratory and explanatory sequential approach. We conducted in-depth interviews, focus group discussions, an interviewer-administered questionnaire on abortion experiences and a health facility assessment.

Bidibidi Refugee Settlement, Uganda and Kakuma Refugee Camp, Kenya from November 2021 to December 2022.

Using RDS, we recruited 600 participants in Kakuma and 601 participants in Bidibidi with recent abortion experiences. In Kakuma, participants were primarily from Burundi, the Democratic Republic of the Congo and South Sudan; participants in Bidibidi were primarily from South Sudan. Most participants in both sites had completed at least some primary school and were not employed.

RDS recruitment dynamics: convergence and bottlenecks on key sociodemographic variables, recruitment and population homophily, reciprocity of social ties, success and experiences recruiting.

There were minor violations of RDS assumptions, particularly regarding assumptions of reciprocity of ties and seed composition independent of sample. In addition, there was a strong tendency of participants to recruit those from the same home country and living within the same camp zone. However, sample proportions for age, home country, marital status, zone of residence and student status reached equilibrium (stabilised) by around 500 participants at each site, and we were able to quickly attain the study sample size.

While the true representativeness of our sample remains unknown, RDS is a practical and effective recruitment method in humanitarian contexts for sensitive topics, particularly for research questions in which no data or sampling frames exist. However, attention to representativeness and community engagement is essential to optimising its application and ensuring success.

To explore how pre-existing conditions affect the diagnostic process for potential cancer in primary care patients.

Qualitative interview study using thematic analysis underpinned by a critical realist approach.

Primary care practices recruited through four Clinical Research Networks and UK health charities across England.

Interviews were conducted with 75 patients with one or more pre-existing conditions (anxiety/depression, diabetes, obesity, chronic obstructive pulmonary disease, Parkinson’s disease or multiple long-term conditions (four or more)) and 28 primary care professionals (general practitioners and nurses).

The study identified legitimacy as a central theme influencing patient trajectories in the health system while trying to receive a diagnosis for symptoms with which they presented to primary care. Patients engaged in self-triage to determine whether symptoms were ‘legitimate’ enough to seek care. Subsequent triaging steps (by receptionists, nurses and online systems) acted as gatekeepers, with decisions influenced by effectiveness of describing the symptom and subjective impressions. During consultations, clinicians relied on a mix of symptom narrative clarity, medical history and objective ‘metrics’ (eg, blood results, family history) to determine legitimacy for further investigations. Pre-existing conditions could either lower the threshold for referrals or obscure potential cancer symptoms. The stigma associated with mental health diagnoses often undermined perceived legitimacy and contributed to delays.

Legitimacy is continuously negotiated throughout the diagnostic pathway. It is shaped by social, moral and biomedical judgements. To promote early cancer diagnosis for patients with pre-existing conditions, clinicians must make legitimacy assessments explicit, reduce stigma especially around mental health and standardise triage processes.

Multiple sclerosis (MS) is a chronic neurological condition that affects approximately 150 000 people in the UK and presents a significant healthcare burden, including the high costs of disease-modifying treatments (DMTs). DMTs have substantially reduced the risk of relapse and moderately reduced disability progression. Patients exhibit a wide range of responses to available DMTs. The Predicting Optimal INdividualised Treatment response in MS (POINT-MS) cohort was established to predict the individual treatment response by integrating comprehensive clinical phenotyping with imaging, serum and genetic biomarkers of disease activity and progression. Here, we present the baseline characteristics of the cohort and provide an overview of the study design, laying the groundwork for future analyses.

POINT-MS is a prospective, observational research cohort and biobank of 781 adult participants with a diagnosis of MS who consented to study enrolment on initiation of a DMT at the Queen Square MS Centre (National Hospital of Neurology and Neurosurgery, University College London Hospital NHS Trust, London) between 01/07/2019 and 31/07/2024. All patients were invited for clinical assessments, including the expanded disability status scale (EDSS) score, brief international cognitive assessment for MS and various patient-reported outcome measures (PROMs). They additionally underwent MRI at 3T, optical coherence tomography and blood tests (for genotyping and serum biomarkers quantification), at baseline (i.e., within 3 months from commencing a DMT), and between 6–12 (re-baseline), 18–24, 30–36, 42–48 and 54–60 months after DMT initiation.

748 participants provided baseline data. They were mostly female (68%) and White (75%) participants, with relapsing–remitting MS (94.3%), and with an average age of 40.8 (±10.9) years and a mean disease duration of 7.9 (±7.4) years since symptom onset. Despite low disability (median EDSS 2.0), cognitive impairment was observed in 40% of participants. Most patients (98.4%) had at least one comorbidity. At study entry, 59.2% were treatment naïve, and 83.2% initiated a high-efficacy DMT. Most patients (76.4%) were in either full- or part-time employment. PROMs indicated heterogeneous impairments in physical and mental health, with a greater psychological than physical impact and with low levels of fatigue. When baseline MRI scans were compared with previous scans (available in 668 (89%) patients; mean time since last scan 9±8 months), 26% and 8.5% of patients had at least one new brain or spinal cord lesion at study entry, respectively. Patients showed a median volume of brain lesions of 6.14 cm³, with significant variability among patients (CI 1.1 to 34.1). When brain tissue volumes z-scores were obtained using healthy subjects (N=113, (mean age 42.3 (± 11.8) years, 61.9% female)) from a local MRI database, patients showed a slight reduction in the volumes of the whole grey matter (–0.16 (–0.22 to –0.09)), driven by the deep grey matter (–0.47 (–0.55 to –0.40)), and of the whole white matter (–0.18 (–0.28 to –0.09)), but normal cortical grey matter volumes (0.10 (0.05 to 0.15)). The mean upper cervical spinal cord cross-sectional area (CSA), as measured from volumetric brain scans, was 62.3 (SD 7.5) mm². When CSA z-scores were obtained from the same healthy subjects used for brain measures, patients showed a slight reduction in CSA (–0.15 (–0.24 to –0.10)).

Modelling with both standard statistics and machine learning approaches is currently planned to predict individualised treatment response by integrating all the demographic, socioeconomic, clinical data with imaging, genetic and serum biomarkers. The long-term output of this research is a stratification tool that will guide the selection of DMTs in clinical practice on the basis of the individual prognostic profile. We will complete long-term follow-up data in 4 years (January 2029). The biobank and MRI repository will be used for collaborative research on the mechanisms of disability in MS.

Adolescents living with HIV are at a high nutritional risk. Ensuring optimal nutrition and food security is fundamental for promoting the health of adolescents and youth living with HIV/AIDS (AYLHIV), preventing HIV disease progression and improving quality of life. The objective of this scoping review is to map and identify the current literature concerning nutrition and food-related interventions addressing AYLHIV.

The study will follow the Joanna Briggs Institute methodology for scoping reviews. We will search for relevant studies in the following databases: MEDLINE, EMBASE, Web of Science and Google Scholar. We will perform additional searches of the grey literature using snowball search and citation tracking and manual searches of institutional websites. Titles and abstracts will then be screened by two independent reviewers for assessment against the inclusion criteria. Disagreements will be resolved through discussion. A data extraction form will be used to guide the data extraction.

This review will involve the collection and analysis of secondary sources that have been published and/or are publicly available. Therefore, ethics approval is not required. The results will be published in an international peer-reviewed journal, presented at scientific conferences and disseminated through digital science communication platforms.

The protocol is registered in the Open Science Framework: https://doi.org/10.17605/OSF.IO/HGBKV.

Maternal respiratory syncytial virus (RSV) vaccination has been introduced to protect infants from severe respiratory infections. However, its uptake and impact on perinatal outcomes are unknown in the UK.

To evaluate uptake of RSV vaccine during pregnancy in a UK population.

This cross-sectional study was conducted at a tertiary maternity hospital in London. The participants included pregnant women who delivered between 1 September and 17 December 2024 (n=1157). For the analysis of vaccine uptake, the cohort included women eligible for vaccination who delivered beyond 28 weeks’ gestation and were at 36 weeks or less on 1 September 2024 (n=911). The main outcome measures were RSV vaccine uptake and its association with sociodemographic factors, perinatal outcomes including preterm birth (PTB), hypertensive disorders of pregnancy and stillbirth.

Of 911 eligible women, 19% (n=173) received the RSV vaccine during pregnancy. Uptake increased significantly from 4% in September to 32% in December (p

RSV vaccine uptake shows significant increases over time, with disparities in uptake by ethnicity and socioeconomic status. Further research is needed to increase vaccination rates, particularly in disadvantaged groups, and evaluate perinatal outcomes.

Among the emergency services, firefighters have the highest percentage of mortality (45%) due to sudden cardiac death, with the majority related to underlying cardiovascular disease. This necessitates that firefighters stay in good physical condition and maintain adequate cardiovascular fitness to cope with these stressors and perform their duties with minimal health risks. Therefore, this study aims to determine the association between metabolic syndrome and physical fitness in firefighters.

The authors will search the following electronic databases: PubMed/Medline, SCOPUS and Web of Science, with no limitations to publication year. For data extraction, the two principal reviewers will use a general data extraction form to retrieve the key characteristics of each study. The Rayyan intelligent systematic review tool will be used to screen and select studies for inclusion. Thereafter, information from the included studies will be captured on the researcher-generated data extraction form. The Joanna Briggs Institute (JBI) Critical Appraisal Tools for quantitative studies will be used to conduct the methodological assessment of each study included. Data will be analysed using Review Manager 5.3 to determine the exposure effects and MedCalc statistical software Ltd and will be used to determine the pooled correlation effects. The results will be presented using figures, graphs and tables.

Details for this systematic review protocol can be accessed on PROSPERO (CRD42024535088). The authors will disseminate this protocol and the findings of the systematic review and meta-analysis in peer-reviewed journals and in national and international conferences. In addition, this review will add significantly to the body of knowledge in the scientific community worldwide and assist academics in exploring research gaps on this topic.

CRD42024535088.

Treatment expectations are a key mechanism of placebo effects in clinical trials. In a previous study (PSY-HEART-I), preoperative expectation optimisation improved quality of life 6 months postcardiac surgery. However, barriers such as travel distance, staffing shortages and COVID-19 limited participation. This study evaluates the feasibility and acceptability of iEXPECT, a brief internet-based intervention designed to optimise expectations before heart surgery.

In this three-arm, multicentre randomised controlled trial, 160 patients undergoing elective coronary artery bypass graft surgery are randomised to: (a) standard of care (SOC); (b) SOC plus iEXPECT with phone-based guidance (iEXPECT enhanced) or (c) SOC plus iEXPECT with email-based guidance (iEXPECT limited). The intervention includes four 20 min online modules addressing surgical benefits, side effects and coping strategies. Modules are accompanied by personalised guidance provided through feedback on each module via email or telephone (three before surgery, three booster sessions at 6, 12 and 18 weeks postsurgery). Assessments occur at baseline (5–21 days before surgery), preoperatively (day before surgery), 7 days postsurgery and 6 months later. Primary feasibility outcomes include recruitment (≥1 participant/week/centre), retention (≥49% completing 6-month follow-up including biomarkers) and engagement (≥75% completing ≥1 presurgery module). Acceptability is measured by self-reported enjoyment, usefulness and impact, with acceptance defined as mean scores >3.4 (5-point Likert scale) and CSQ-I ratings. Secondary outcomes include psychological measures, inflammatory markers and heart rate variability.

Ethical approval was granted by the Ethics Committees of Philipps University Marburg (AZ 229/23 BO) and the University of Giessen (AZ 186/23). All participants provide written informed consent. Results will be shared via publications, conferences and public outreach with relevant consumer advocacy groups.

DRKS00033284.

To evaluate the effects of diabetes mellitus (DM) and body mass index (BMI) on long-term all-cause mortality in chronic total occlusion (CTO) patients.

Retrospective, nationwide cohort study.

Swedish Coronary Angiography and Angioplasty Registry, between June 2015 and December 2021.

24 284 patients with angiographically confirmed CTO. Prior coronary artery bypass graft surgery excluded. Subgroups were defined by DM status and BMI categories (underweight, healthy weight, overweight, obesity).

Long-term all-cause mortality, assessed by Kaplan-Meier analysis and multivariable Cox proportional hazards regression.

DM was present in 30.3% of patients and conferred a 31% higher risk of mortality (HR: 1.31, 95% CI: 1.20 to 1.42; p2, lowest risk (nadir) at 32 kg/m² and modest rise above 35 kg/m².

In this nationwide CTO cohort, DM independently predicted higher long-term mortality, accompanied by more severe comorbidities and greater CTO complexity, and insulin therapy further elevated hazard. Overweight and obese patients had better survival, while underweight individuals had the poorest prognosis. These findings underscore the importance of individualised risk assessment and management strategies in CTO patients, particularly those with DM or low BMI.

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m² and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

ISRCTN68786622.

The increasing prevalence of overweight and obesity among individuals with type 1 diabetes (T1D) complicates glycaemic management and escalates insulin resistance, necessitating innovative therapeutic strategies. Tirzepatide, a dual agonist for glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors, shows promise in managing weight and glycaemic control in type 2 diabetes but is unexplored in the context of T1D. This double-blind, placebo-controlled randomised trial will evaluate the efficacy of tirzepatide in adults with T1D and overweight/obesity over 32 weeks.

60 participants (aged 18–70 years) with a body mass index ≥27 kg/m² and HbA1c≤10% will be randomised 1:1 to receive either tirzepatide or a placebo, alongside standard insulin therapy. The primary outcome is the change in body weight (%). Secondary measures include change in HbA1c (%), proportion of body weight lost (>5%, >10%, >15% and >20%), changes in insulin dosage, time in range by continuous glucose monitoring (CGM) criteria and severity of comorbidities. Compliance, adverse events and medication interactions will be closely monitored, with adjustments made for tolerability. Patient-reported outcomes and experiences will be measured to capture the benefits of glycaemic management, weight management and quality of life. To compare the means of body weight reduction (%) between the tirzepatide and control groups, an independent samples t-test will be employed under the assumption that data are normally distributed. Secondary outcome measures will be analysed by Student’s t-test. All data will be reported as group means with confidence intervals, with default statistical significance assumed at p

Ethical approval has been obtained from the Northern Sydney Local Health District’s Human Research Ethics Committee (approval ID #2024/ETH00180).

NCT06180616.

The COVID-19 pandemic disrupted maternal healthcare access globally, leading many women to give birth outside of healthcare facilities, often assisted by traditional birth attendants (TBAs). This study explored the experiences of Kenyan women who gave birth outside of healthcare facilities during the COVID-19 pandemic based on the Person-Centered Maternity Care (PCMC) framework.

This study used data from descriptive qualitative indepth interviews with Kenyan women who gave birth outside of healthcare facilities between March and November 2020. Participants lived within the catchment areas of six health facilities in Kiambu and Nairobi counties and were recruited by community leaders and community health workers. Interviews were conducted in 2020 via phone and inductively coded and analysed by a team of researchers.

A total of 28 Kenyan women who gave birth outside of healthcare facilities between March and November 2020 completed indepth interviews.

In this sample, approximately one-third of women were assisted by TBAs, while the majority were supported by friends and family members. Women generally described salient aspects of their care pertaining to the PCMC domain of supportive care. During labour, birth and the immediate postpartum, women received emotional support, basic medical assistance and instrumental support such as preparing food and baths. However, women also described concerns about giving birth outside of healthcare facilities, including poor hygiene and lack of privacy in birthing spaces as well as instances of verbal and physical harassment by TBAs. Overall, women worried about potential complications during birth, and many women delayed seeking postpartum and postnatal care.

Women who were unable to access healthcare facilities during the COVID-19 pandemic relied on TBAs and/or friends and family for support during labour and birth. These women faced gaps in PCMC, specifically related to supportive care. Given that birthing outside of healthcare facilities remains common globally, particularly during emergencies such as pandemics, TBAs should be supported to provide more person-centred care to women giving birth outside of healthcare facilities.

Despite low sensitivity and implementation challenges, the tuberculin skin test (TST) remains the standard-of-care tuberculosis (TB) infection test in Mexico. Interferon gamma release assays (IGRA) may overcome TST-related challenges. Within the confines of the local programmatic setting, this cross-sectional study evaluated the prevalence of TB infection (TBI) and concordance of TST and IGRA in three high-risk populations in Mexicali, Baja California, Mexico.

Household contacts (HHC) of individuals with TB, people who use drugs (PWUD), people deprived of liberty (PDL) and prison employees underwent evaluation for TBI using TST and QIAreach, a novel IGRA. Prevalence of infection, concordance of test results and reactivity trends of time-to-results (TTR) by TST-induration size were assessed.

In total, 214 of 411 (52.07%) people who had TST and 269 of 460 (58.48%) people who had IGRA tested positive for TBI. Frequency of infection varied across risk groups (HHC 29 (29.6%); PWUD 67 (70.53%); PDL 111 (56.06%) and prison employees 7 (35.0%), p20 mm, p=0.05).

All risk groups had a high frequency of TBI, necessitating locally tailored guidelines for screening, treatment and management of TBI to optimise care for vulnerable populations.

In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

NCT06849245.

The ageing population in Europe is experiencing a significant rise in urinary incontinence (UI), which affects millions and incurs substantial healthcare costs. While conservative treatment (eg, behavioural strategies, pelvic floor exercises) can help manage UI, there is a need for evidence-based eHealth solutions to improve adherence and treatment outcomes. The KOKU Bladder project aims to co-create, develop and test an eHealth intervention to improve bladder health (BH) and UI in adults aged 50 and over.

Phase 1 will consist of the co-creation and technological development of the eHealth solution. First, a rapid review will be undertaken to identify eHealth solutions (ie, technologies and websites), including behaviour change techniques (BCTs) and elements of gamification for self-management of BH and UI in adults aged 50 and over. Also, a consultation with eight experts on BH/UI and/or BCTs will be conducted to explore recommendations for the new eHealth solution. The PROSECO framework will facilitate an assessment of the co-creation process. Phase 1 will additionally include the conduction of at least six focus groups, to be held in Kaunas (Lithuania), Catalonia (Spain) and Manchester (UK) to co-create the contents of the digital solution. Each focus group will include 10–12 community-dwelling adults aged 50+, with different physical conditions and continence status, as well as health professionals and other stakeholders. The information collected will be analysed thematically. First, we will hold three focus groups, one in each country, to find out the opinion of the participants. Once the focus groups are finished and the first version of the technological solution is created, participants will test it and provide feedback in three additional focus groups. Participants’ opinions will be taken into account to make modifications to the solution and co-create the final version. Gamification methods and the Honeycomb model for user experience will be followed in order to achieve a technological solution that is adequate for its target population.

Phase 2 will consist of a multicentre pilot study with a mixed method (quantitative and qualitative) approach to assess the feasibility and acceptability of the newly developed technological solution. At least 120 participants (40 per country) will be recruited and randomised into two groups: intervention (KOKU Bladder) and control (indirect health education). The primary outcome will be the severity of UI, according to the International Consultation on Incontinence Questionnaire-UI short form. Secondary outcomes will include quality of life (EuroQol 5-Dimension, 5-Level), life-impact related to UI (Incontinence Impact Questionnaire-7), lower urinary tract symptoms (Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10)), International Consultation Questionnaire on Incontinence Bowel Score, Patient Global Impression of Improvement; levels of physical activity and sedentary behaviour (accelerometer), as well as satisfaction with treatment (Client Satisfaction Questionnaire (CSQ-8)). The latter, together with recruitment, adherence, retention, attrition and data loss, will be used for measuring intervention feasibility and acceptability. Statistical and clinical significance, as well as effect size, will be calculated.

The project is approved by the Research Ethics Committee of IRIS-CC approved the project on 9 January 2025 (code 24/095), the Research Ethics Committee of Hospital Universitari Arnau de Vilanova of Lleida on 27 January 2025 (CEIC-3201), the Commission on Research Ethics of Lithuania on 3 March 2025 (SMTEK-31) and the Research Ethics Committee 3 of the University of Manchester on 13 August 2025 (2025-23619-43258). Participation and withdrawal will be voluntary. Informed consent will be obtained from candidates willing to join the project. Study results will be disseminated via publication of scientific articles, presentations at professional workshops, webinars and congresses, as well as through social media and lay summaries for participants and the general public.

NCT06583733.

CRD42024597624.

Multimorbidity contributes significantly to poor population health outcomes while straining healthcare systems. Although some multimorbid patients experience an accelerated health decline (a decline in well-being or functional status that cannot be attributed to the natural ageing-related health deterioration), others can remain stable for years. Identifying risk factors for accelerated health decline in persons with multimorbidity could help prevent complications and reduce unnecessary interventions. Our review, therefore, aims to map the evidence on the clinical, biographical and healthcare-related factors associated with an accelerated health decline in multimorbid individuals.

We will use the evidence-mapping review methodology. We will perform a systematic comprehensive literature search in Medline via Pubmed, Cochrane Library, EMBASE, Web of Science and Google Scholar using two broad concepts: ‘multimorbidity’ and ‘longitudinal studies’. We will search with MeSH terms (eg, ‘Multimorbidity’ (Majr), ‘Longitudinal Studies’ (Majr)) and free text words (eg, multimorbidity, multiple chronic condition*, longitudinal), from inception to date of the final search. All original quantitative studies involving participants in primary care and related healthcare settings will be included. Abstract/titles and full-text screening and data extraction will be performed independently by two or more researchers to minimise selection and reporting bias, with conflicts resolved by consensus. The data will be analysed qualitatively, and topics will be extracted to create evidence clusters. Risk factors will be classified in groups and cross-referenced against the outcomes from respective studies into combinations of exposure-outcome clusters. The resulting evidence clusters will be described narratively and presented as bubble plots. The search, initiated in January 2023, will be updated following this protocol review to reflect the most current evidence; exact dates will be reported in the results manuscript.

Due to the nature of the proposed evidence map, ethics approval will not be required. Results from our research will be disseminated through publications in peer-reviewed journals and presentations at local, national and international conferences.

https://osf.io/q72xa/