Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

NCT07050823/NCT07093021/NCT07134855.

Few artificial intelligence (AI) clinical decision support systems (CDSSs) are ever evaluated in practice. Although some signal of clinical effectiveness may be needed to justify AI deployment and testing, such data are typically unavailable in early-stage research. This conundrum is especially relevant in the intensive care unit (ICU), where conditions like sepsis and acute respiratory distress syndrome (ARDS) require high-stakes decisions. Our group developed the AI ventilator assistant (AVA), a novel AI CDSS for patients with sepsis ARDS receiving invasive mechanical ventilation. But the promising results of predictive performance estimates are not sufficient to assess AVA’s clinical safety and appropriateness prior to future evaluation and deployment. Therefore, we propose a Clinician Turing Test as a novel validation approach to determine whether clinicians can distinguish AVA-generated treatment recommendations from those enacted by real human clinicians. If AVA’s recommendations are consistently indistinguishable from those of real clinicians, thereby ‘passing’ this Turing test, this would provide a strong preclinical signal of safety and appropriateness.

This multisite, randomised, electronic, vignette-based Phase 1b study will use a Clinician Turing Test design. We aim to recruit 350 critical care clinicians, including physicians and advanced practice providers from six US hospitals. Participants will review nine clinical vignettes of patients with sepsis and ARDS derived from the Molecular Epidemiology of Severe Sepsis in the ICU cohort and an associated profile of a suggested treatment plan. For each participant–vignette combination, the source of the treatment profile will be randomly assigned (AI-generated by AVA vs the actually enacted treatment from real human clinicians) in a 1:1 allocation. The primary endpoint is the participants’ accuracy in identifying whether a treatment profile was AI-generated or human-generated, assessed using equivalence testing through a mixed-effects logistic regression model with random effects for participants and vignettes. Secondarily, a fitted binary classifier will assess discrimination ability using the C-statistic. Secondary endpoints include clinicians’ perceptions of the safety and appropriateness of the treatment profiles, confidence in distinguishing AI-generated and human-generated recommendations, interest in AI CDSSs for sepsis and ventilator management and the time to complete the survey. This novel Phase 1b design provides preliminary but essential information about an AI CDSS’s clinical appropriateness without the risk or cost of actual deployment, thereby informing decisions about future clinical implementation and evaluation in real clinical environments.

This protocol was approved by the Institutional Review Board of the University of Pennsylvania (Protocol #858201). Results are expected in 2026 and will be submitted for publication in peer-reviewed journals and presented at scientific conferences.

NCT07025096.

Cardiovascular diseases (CVDs) are the leading cause of death worldwide, making the development of self-management strategies crucial for preventing complications and improving clinical outcomes. This process involves symptom monitoring, treatment adherence, emotional management and a healthy lifestyle, among others. Reliable instruments are necessary to measure self-management, requiring robust psychometric properties. In this way, this COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)-based systematic review aims to assess the quality of specific self-management instruments for adults with CVDs.

This systematic review will follow the COSMIN and be reported according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol. Searches will be conducted in seven databases: MEDLINE, Web of Science, Scopus, PsycINFO, EMBASE and CINAHL. Additionally, a manual search will be performed on PROQOLID, PROMIS and The Medical Outcome Trust websites. Studies on the development and validation of patient-reported instruments measuring specific self-management for individuals with CVDs will be included, without language or date restrictions. The search will be performed in November 2025, with the final version of the review expected to be completed in October 2026. Data extraction will follow COSMIN recommendations. The Modified Grading of Recommendations, Assessment, Development and Evaluation approach will be used to determine the quality of evidence. Instruments will be categorised according to COSMIN recommendations. All steps will be conducted by two independent reviewers, with a third reviewer involved in case of discrepancies. Additionally, the content of the instruments will be analysed and linked to the International Classification of Functioning, Disability and Health, following international recommendations.

This study does not require ethics committee approval as it is a review of published data. The review results will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

CRD42024605969.

To examine how menstruation, contraceptive use and gender-based violence intersect to shape the sexual and reproductive health and autonomy of girls and young women in Kenya.

Qualitative study exploring girls and young women’s experiences with contraceptive use and menstrual management, using in-depth interviews and focus group discussions analysed through a reflexive thematic approach.

Four county-run family planning clinics in Uasin Gishu County, Kenya.

77 girls and young women aged 15–19 years (via 35 in-depth interviews and 7 focus group discussions) and 27 family planning clinic providers (via 5 focus group discussions).

Interviewees’ contributions suggest that covert contraceptive use, when discovered through menstrual monitoring, provoked intimate partner violence. Heavy menstrual bleeding, whether related to contraceptive use or not, was viewed as a sexual restriction and also fuelled intimate partner violence. Furthermore, the inability to afford sanitary pads, combined with the stigma surrounding menstruation, drove some girls and young women into exploitative sexual relationships, often resulting in unwanted or unintended pregnancies.

Menstrual bleeding and contraceptive use, both independently and in combination, affect girls and young women’s reproductive autonomy and overall health and well-being, particularly in relation to gender-based violence. Improving menstrual hygiene management, challenging the stigma and harmful norms tied to menstruation and contraception and ensuring safe contraceptive use are integral to improving sexual and reproductive health and autonomy and are requisite for preventing and eradicating gender-based violence.

Individuals with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA) due to craniofacial features (eg, midface hypoplasia, glossoptosis) and studies have shown that the prevalence of OSA in this population is markedly increased compared with that of typically developing children. Adenotonsillectomy is considered the first-line treatment for childhood OSA. However, persistent OSA is common, thus many children with DS are referred for positive airway pressure (PAP) therapy initiation; PAP appears to be an important aspect of living with DS. PAP has been shown to be highly effective in the general population for treating OSA and improving OSA-associated neurobehavioural symptoms, such as quality of life, behaviour, mood, daytime sleepiness and school performance. However, PAP as a treatment for OSA has not been well-studied in children with DS. Therefore, we designed a multicentre randomised controlled trial recruiting children with DS and OSA at three academic institutions, aged 6–18 years, referred for PAP initiation to treat OSA.

86 participants will be randomised to a 6-month intensive behavioural intervention (INT) to improve PAP adherence versus standard clinical care and underwent standardised evaluations of quality of life, behaviour, attention, PAP adherence and healthcare utilisation at baseline, 6 months and 12 months.

This study has been approved by the institutional review board at Children’s Hospital of Philadelphia (IRB of record, IRB # 20–0 17 512). Cincinnati Children’s Medical Center and University of Miami delegated IRB review and approval responsibility to Children’s Hospital of Philadelphia through reliance agreements as mandated by National Institutes of Health (NIH). All participants will be minors; consent will be obtained from parents and assent from participants will be obtained when possible. The intervention tested in this trial is considered not greater than minimal risk, and no identifiable data will be reported. As required by the NIH, a data safety monitoring board (DSMB) has been formed, who will review and approve the protocol and any protocol changes prior to implementation. The study team will send biannual reports and hold a biannual meeting with the DSMB to review any safety and protocol concerns. Findings will be presented at national conferences pertinent to this topic and published in peer-reviewed medical journals. In addition, findings will be shared in the lay format with DS associations around the world and used for training of healthcare providers and trainees (R25HD118212). Further, data collected will be deposited in a repository (National Sleep Research Resource; sleepdata.org) after completion of the study to maximise use by scientific community.

NCT04132999.

Health systems’ (HS) adaptations to climate change (CC) cover two major, and interrelated dimensions: (1) Environmental sustainability—actions aimed at limiting the negative impact of HS on the environment (eg, by reducing greenhouse gas emissions) and (2) Climate resilience—adaptations focused on improving HS’ ability to cope with the impact of CC (eg, by improving HS preparedness to climate-induced natural disasters). Within both dimensions, a diversity of actions, at different HS levels, can take place. The general objective is to provide health policy makers with a comprehensive evidence-based set of recommendations on the scope and effectiveness of HS adaptations to CC.

An umbrella review will be conducted. Systematic reviews will be included if: (1) They focus on HS adaptations to CC (including both environmental sustainability and climate resilience strategies/actions), (2) Were published since 2015 and (3) Report a quality appraisal of included studies. Five databases were searched: (1) MEDLINE via PubMed, (2) Scopus, (3) Web of science core collection, (4) ProQuest Central and (5) The Cochrane Database of Systematic Reviews. Two reviewers will independently assess studies’ eligibility, conduct quality appraisal and perform data extraction. Data will be synthesised using both quantitative and qualitative methods. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses will guide the reporting of results.

Ethical approval is not required, as this study involves the collection and analysis of secondary data only. The results will be submitted for publication in a peer-reviewed journal and disseminated via dedicated research channels and social media platforms.

CRD420251052647.

Ambulatory care is defined as the provision of medical treatment by healthcare professionals outside an inpatient hospital setting. While well-established in acute medicine, uptake of ambulatory pathways in emergency general surgery (EGS) is variable and optimal design and delivery is unclear in this context. This systematic review sought to (1) appraise current EGS ambulatory pathway literature and (2) ascertain the constituent components across the identified pathways, guiding the development of comprehensive templates for future EGS ambulatory pathways.

Systematic review.

PubMed, Embase, Medline and Cochrane Library, from 5 December 2018 to 5 December 2023 inclusive.

All primary observational studies (ie, case–control, cohort studies and randomised controlled trials (RCTs)) were included. Case series and conference abstracts were excluded due to the high likelihood of incomplete data. Studies reporting paediatric or non-surgical populations, or ambulatory surgical care within a primary care setting, were also excluded.

General study characteristics (year and journal of publication, country of origin, study design, disease area, number of patients receiving ambulatory management and use of control groups) were recorded. To identify the constituent components of EGS ambulatory pathways, an initial subset of five papers was reviewed, from which four categories were identified (decision-making processes, scoring/classification systems, investigations and care escalation and discharge criteria). An additional fifth component (‘follow-up’) was identified during data extraction. Reporting of the constituent components of ambulatory pathways was also extracted, as well as outcomes including readmission, complications and mortality.

Of 43 included studies, there were 8 RCTs, 31 cohort studies and 4 studies using other methods. Reporting of all aspects of EGS ambulatory pathways was heterogeneous. 24 (56%) papers reported the specialty and grade of clinician acting as senior decision-maker. 17 different scoring/classification systems were used. 32 (74%) papers described using investigations to select ambulatory patients, including blood tests (n=12) and imaging (n=16). Eight studies (19%) specified both care escalation and discharge criteria. Information about follow-up was described in 29 papers, with location (n=29), time points (n=26), personnel (n=16) and the form of the follow-up (n=23) all reported variably. Readmission rates were recorded in 34 studies and ranged from 0% to 13%. Most studies (n=32) reported 30-day readmission, although 48 hours (n=1) and 90 days (n=1) were also used. Mortality was recorded in 24 papers, with 21 reporting a mortality rate of 0 and the remaining 3 reporting rates of

Key components of published EGS ambulatory pathways include decision-making processes, scoring/classification systems, investigations, care escalation and discharge criteria, and follow-up. However, this information is currently inconsistently reported. Future work to identify and agree on guidelines for the ‘core’ components of ambulatory EGS pathways is needed, to facilitate cross-study comparisons, and crucially, provide a ‘gold-standard’ framework for developing future ambulatory pathways.

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.

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

Chronic inflammatory skin diseases, despite low mortality, significantly impair quality of life (QoL). Up to 80% of patients with dermatological conditions experience severe itch and poor sleep, as well as related mental health challenges such as anxiety and depression. The relationship between skin diseases and mental health highlights the challenges that doctors face in treating these conditions. Existing psychotherapeutics, such as mindfulness training, cognitive behavioural therapy and acceptance and commitment therapy, are widely used and effective in the treatment of mental health illnesses. However, there is limited evidence on the application of such interventions in dermatology, and most mental health apps lack robust clinical evaluation. We report the design of a randomised controlled trial to evaluate the efficacy and implementation of a mobile app containing dermatology-specified psychotherapeutic strategies in reducing QoL burden.

English-speaking patients aged 16 years and older with psoriasis, eczema or chronic urticaria will be recruited and randomised into the intervention arm (psychotherapeutic application) or active control group (Healthy365 app, a general wellness application managed by the Singapore Health Promotion Board). This allows a comparative assessment of app-usage-specific outcomes while preserving the blinding of all participants. The primary outcome is the change in the Dermatology Life Quality Index (DLQI) score from baseline to week 8. Secondary outcomes include physician-assessed disease severity at weeks 8 and 16 relative to baseline, differences in other patient-reported measures at weeks 8, 16 and 32, self-reported treatment adherence and initiation/escalation of systemic medications. To understand how patients engage with the app, we will evaluate the implementation process, focusing on key measures such as engagement, satisfaction and willingness to pay. Statistical analysis will be carried out on an intention-to-treat basis, and missing data will be analysed using last observation carried forward.

All participants will receive both verbal and written study information that aligns with Good Clinical Practice guidelines. Ethical approval has been obtained from the National Healthcare Group’s Domain Specific Review Board (reference number: 2022/00751). Results will be disseminated via publication in a relevant journal. Data will be available from the corresponding author on reasonable request.

NCT06702293.