People with disabilities are underrepresented in clinical trials, which impacts generalisability and ethical integrity of results. Despite international mandates to diversify participants, there is a lack of guidance on how to make trials disability-inclusive. This scoping review identifies and synthesises guidance, practices and recommendations supporting the inclusion of people with disabilities in clinical trials.

We conducted a scoping review following the Arksey and O'Malley framework and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses for scoping reviews.

Medline (OVID) and Public Affairs Information System Index (October 2024) searches identified peer-reviewed articles. Grey literature was identified through targeted advanced Google searches and website reviews (February–March 2025). Google Scholar was searched to identify recently published documents between March and April 2025.

Documents with guidance or policies related to inclusion of people with disabilities in clinical trials published in English from 2019 to 2025 were included.

Two independent reviewers screened titles, abstracts and full texts and extracted data, with adjudication by a third reviewer.

A total of 69 documents met inclusion criteria. Thematic synthesis identified eight recommendation domains: (1) inclusive and universal trial design, (2) accessible recruitment, (3) inclusive data collection, (4) equitable data analysis, (5) accessible reporting and dissemination, (6) ethical oversight and institutional review board inclusion, (7) supported and accessible consent processes and (8) the inclusion of people with disabilities as researchers and stakeholders. Themes cutting across all domains included guidance emphasising universal design, anti-ableist frameworks, supported decision-making, flexible protocols and engagement with disability communities.

Disability-inclusive clinical trials are essential to ensure the validity of clinical trial results, uphold ethical responsibilities and advance health equity. While emerging frameworks offer direction on how to include people with disabilities in trials, current implementation remains inconsistent and largely voluntary. Clear, enforceable standards are needed to support governments, ethics boards, institutions and funders in making clinical trials more disability-inclusive.

The timing of a woman’s first birth is significantly associated with maternal and child health outcomes and socioeconomic opportunities. Delaying the first birth is associated with reduced risks of adolescent pregnancy complications, improved birth outcomes and enhanced interpregnancy intervals, all of which contribute to better maternal and child health. In Somaliland, early childbearing is prevalent, necessitating an understanding of its associated factors. Early childbearing, defined as a first birth before age 20, is prevalent in Somaliland, with 47.02% of women having their first birth by this age, significantly higher than the average for sub-Saharan Africa (approximately 30%) and global figures.

This study aimed to identify the sociodemographic factors associated with age at first birth among married women in Somaliland.

The median duration from marriage to first birth was 3 years, with a median age at first birth of 21 years. Women residing in the Sool (adjusted HR: 1.318, 95% CI 1.138 to 1.527) and Sanaag (adjusted HR: 1.265, 95% CI 1.095 to 1.462) regions had a significantly higher hazard of first birth compared with those in Awdal (reference). Conversely, women in the middle (adjusted HR: 0.821, 95% CI 0.685 to 0.985) and highest (Adjusted HR: 0.799, 95% CI 0.663 to 0.964) wealth quintiles had a significantly lower hazard of first birth compared with the lowest wealth quintile. Age at first marriage was a strong factor associated with the outcome; marrying at age 20 or older (adjusted HR: 0.699, 95% CI 0.644 to 0.759) was associated with a significantly lower hazard of first birth compared with those who married before age 20. After adjustment, other factors including residence, media exposure and husband’s employment status were not significantly associated with the timing of first birth.

Region, wealth quintile and age at first marriage are critical factors associated with first birth timing in Somaliland. Interventions should focus on addressing regional disparities and promoting delayed marriage to improve maternal and child health outcomes. Further research is needed to explore the complex social and cultural drivers of these findings.

The roles and functions of traditional birth attendants in the community and in relation to the formal healthcare system have to the best of our knowledge, not previously been explored in Somaliland. This study aimed to explore the past and current roles and practices of traditional birth attendants from the traditional birth attendants’ perspective.

An exploratory study was conducted using purposive sampling technique first followed by snowballing technique from January to December 2023.

Somaliland rural communities in the six regions of the country.

Traditional birth attendants from all six regions of Somaliland were interviewed. Thematic analysis inspired by Braun and Clarke was used to analyse the data.

Traditional birth attendants were historically involved in pregnancy care, childbirth and the practice of female genital mutilation/cutting. Their role has undergone a significant shift in recent years. Traditional birth attendants are increasingly acting as vital links between the community and the formal healthcare system. They report that they have maintained strong trust within their communities, which positions them as effective mediators in promoting access to professional maternal and reproductive health services.

Traditional birth attendants are becoming trusted intermediaries between the community and the formal healthcare system. In the pursuit of universal health coverage and the goal of delivering high-quality, equitable care for all, leveraging traditional birth attendants as part of a broader midwifery-led care model offers a cost-effective strategy in the Somaliland context.

To evaluate the association between metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic-associated steatohepatitis (MASH), and the risk of colorectal cancer (CRC) and benign colorectal neoplasms (BCN), and to explore whether liver fibrosis/cirrhosis modifies these associations.

Retrospective cohort study with 1:1 propensity score matching.

Global, multicentre real-world analysis using deidentified electronic health records from over 130 healthcare organisations in the TriNetX Global Collaborative Network.

Hospitalised adults aged 45–75 years between October 2019 and October 2024. Patients with prior diagnoses of colorectal neoplasia or other chronic liver diseases were excluded. Final matched cohorts included 138 902 MASLD and non-MASLD patients, 3715 MASH and non-MASH patients, and 1312 MASH patients with and without fibrosis.

Primary outcomes: Incidence of CRC and BCN. Secondary outcome: Combined incidence of CRC and BCN. Outcomes were assessed with and without controlling for metabolic risk factors using Cox proportional hazards models.

MASLD was associated with increased risks of CRC (HR 2.71, 95% CI 2.29 to 3.20) and BCN (HR 2.50, 95% CI 2.38 to 2.63), both p

MASLD and MASH are independent risk factors for CRC and BCN, irrespective of metabolic comorbidities. Fibrosis/cirrhosis does not significantly influence CRC risk. These findings support the need to revisit CRC screening guidelines for patients with MASLD/MASH. Further prospective studies are warranted to explore underlying mechanisms and evaluate preventative interventions.

Pneumonia and diarrhoea are two of the major causes of child mortality globally. Countries affected by conflict and other humanitarian emergencies, such as Somalia, have a particularly high burden of these diseases. Published reports from UNICEF and WHO have shown that various factors, including social, economic and environmental factors, are all associated with the occurrence of childhood pneumonia and diarrhoea. The objective of this study was to determine the prevalence, burden and associated sociodemographic determinants of pneumonia and diarrhoea among children younger than 5 years (under-5 children) in Somalia.

A community-based survey using an interviewer-administered questionnaire was conducted employing a modified WHO Expanded Program on Immunization (EPI) 30-Cluster sampling technique to identify households and respondents in nine selected districts across six member states in Somalia. The interviewers began selecting households starting from house number 1 and continued until 75 households were surveyed in each cluster.

We considered the catchment areas of 12 target maternal and child health (MCH) centres as our study areas. Villages were considered as primary sampling units (PSU) while households within villages were considered as secondary sampling units, where women (with under-5 children) within households were the respondents.

A total of 36 clusters (villages) were selected from the catchment areas of 12 target MCH centres. All households within the selected villages’ PSUs were listed. The interviewer started interviewing from house number 1 and continued till 75 households were covered to conduct interviews with mothers of under-5 children. Data collection took place between October and December 2023.

The prevalence and burden of childhood pneumonia and diarrhoea were estimated. A logistic regression model was employed to examine the determinants of childhood pneumonia and diarrhoea.

A total of 2483 under-5 morbidities were reported, 1712 probable pneumonia cases and 825 diarrhoea cases. Our calculations suggest that the prevalence of overall under-5 morbidity was 458.4 per 1000 children (95% CI 444.3 to 472.6) in the last 90 days. The prevalence of pneumonia and diarrhoea was 316.0 (95% CI 303.5 to 328.8) and 152.3 (95% CI 142.2 to 162.8) per 1000 under-5 children, respectively. A total of 70 under-5 deaths occurred in the past year, of which 37 were infants. Our exploration depicts an under-5 mortality rate of 39.3 deaths per 1000 live births per year (95% CI 30.6 to 49.7), and the infant mortality rate was 20.8 per 1000 live births per year (95% CI 14.8 to 28.6) in the study area, which is much lower than earlier estimates. The crude birth rate was 106.6 per 1000 population, and the stillbirth rate was 149.8 per 1000 births (95% CI 134.9 to 165.7), which is very high. We explored probable causes of 70 under-5 deaths and found that the highest proportion of under-5 deaths (22.9%) was due to acute respiratory infections (ARI), and about 15.7% were due to diarrhoea. Among other probable causes, congenital diseases (12.9%), accidents (11.4%) and measles (8.6%) were noteworthy.

This study revealed a high burden of pneumonia and diarrhoea among the studied population in Somalia. The study also identified important sociodemographic and environmental determinants that tend to increase the risk of pneumonia and diarrhoea among under-5 children.

Cardiovascular events (CVEs), in particular acute coronary syndrome (ACS), complicate the course of a significant number of patients hospitalised for community-acquired pneumonia (CAP) or influenza. Emerging evidence suggests that this increased risk of CVEs could be mitigated by the use of acetylsalicylic acid (aspirin). The ASCAP study investigates whether the addition of aspirin to standard therapy in hospitalised patients with moderate-to-severe CAP or influenza can reduce the incidence of CVEs.

The ASCAP study is a multicentre, double-blind, placebo-controlled randomised trial in 16 university and general hospitals in the Netherlands, in which patients are randomised to acetylsalicylic acid or matching placebo for 90 days. Eligible patients are adults hospitalised for moderate-to-severe CAP or influenza. Patients with antithrombotic or anticoagulant drugs, or those with contraindications for aspirin, are excluded. The primary outcome is the incidence of ACS up to day 180. Secondary outcomes include the incidence of 4-point major adverse cardiovascular events up to day 180, as well as the incidence of major bleeding and clinically relevant non-major bleeding events up to day 90, all-cause mortality up to day 180 and quality of life and societal costs up to day 180. Survival time will be analysed by the log-rank test, stratified for CAP and influenza, with a two-sided alpha of 0.05. Assuming an average baseline ACS risk of 7.5% over 180 days with up to 30% variation across strata, and a 60% hazard reduction due to aspirin, the required sample size to achieve 80% power is 760 patients. Currently, 114 patients are enrolled in the study.

This study is approved by the Medical Ethics Committee Amsterdam UMC (Amsterdam, The Netherlands) under reference number 2023.0741 and registered under EU trial number 2023-504553-12-01 in the EU portal CTIS (Clinical Trials Information System). Results of the study will be published in a peer-reviewed journal.

EU CTIS: 2023-504553-12-01.

Tuberculosis (TB) remains the leading cause of infectious disease deaths, particularly among people living with HIV (PWH). Despite being preventable, TB preventive therapy (TPT) uptake is low in high-burden regions like South Africa, where new guidelines have expanded TPT eligibility and introduced shorter, more effective regimens like 3 months of weekly rifapentine and isoniazid (3HP). As differentiated service delivery models for HIV care have proven effective, there is increasing recognition that decentralising TPT delivery may improve coverage and completion. This study explores whether a community-based TPT delivery strategy can enhance uptake and completion of TPT compared with traditional clinic-based services.

We will conduct a household-randomised, non-blinded, controlled trial. Persons eligible for TPT will be recruited from the TB TRIAGE+Trial study, a community-based household TB screening study. Households containing at least one person eligible for TPT will be randomised 1:1 to either community-based TPT or standard-of-care clinic referral for TPT. At enrolment, all participants will be provided with a 2-week supply of TPT in the community. Participants randomised to the community arm will receive the entire course of TPT in a single dispense (12 weeks of 3HP or 6 months of isoniazid, if 3HP is contraindicated). Clinic-arm participants will be referred to their local clinic for the remainder of their course of TPT and will collect TPT refills on the clinic-determined schedule. Our primary outcome is the proportion of participants who complete a course of TPT. Secondary outcomes include overall adherence to TPT, predictors of adherence with TPT, participant satisfaction with the assigned TPT delivery method and adverse events.

The study and its tools were approved by the Human Sciences Research Councils Research Ethics Committee (approval number: 2/25/10/23), based in Pretoria, Gauteng, South Africa, as well as the University of Washington Institutional Review Board (Study 00018448). Study findings will be shared through the community advisory group and local stakeholder meetings, relevant international and local meetings/conferences and peer-reviewed publications.

NCT06214910. Date and version: 3.0, 30 July 2024.

Tuberculosis (TB) remains a significant public health challenge in many African communities, where underreporting and underdiagnosis are prevalent due to barriers in accessing care and inadequate diagnostic tools. This is particularly concerning in hard-to-reach areas with a high burden of TB/HIV co-infection, where missed or delayed diagnoses exacerbate disease transmission, increase mortality and lead to severe economic and health consequences. To address these challenges, it is crucial to evaluate innovative, cost-effective, community-based screening strategies that can improve early detection and linkage to care.

We conduct a prospective, community-based, diagnostic, pragmatic trial in communities of the Butha Buthe District in Lesotho and the Greater Edendale area of Msunduzi Municipality, KwaZulu-Natal in South Africa to compare two strategies for population-based TB screening: computer-aided detection (CAD) technology alone (CAD4TBv7 approach) versus CAD combined with point-of-care C reactive protein (CRP) testing (CAD4TBv7-CRP approach). Following a chest X-ray, CAD produces an abnormality score, which indicates the likelihood of TB. Score thresholds informing the screening logic for both approaches were determined based on the WHO’s target product profile for a TB screening test. CAD scores above a threshold prespecified for the CAD4TBv7 approach indicate confirmatory testing for TB (Xpert MTB/RIF Ultra). For the CAD4TBv7-CRP approach, a CAD score within a predefined window requires the conduct of the second screening test, CRP, while a score above the respective upper threshold is followed by Xpert MTB/RIF Ultra. A CRP result above the selected cut-off also requires a confirmatory TB test. Participants with CAD scores below the (lower) threshold and those with CRP levels below the cut-off are considered screen-negative. The trial aims to compare the yield of detected TB cases and cost-effectiveness between two screening approaches by applying a paired screen-positive design. 20 000 adult participants will be enrolled and will receive a posterior anterior digital chest X-ray which is analysed by CAD software.

The protocol was approved by National Health Research Ethics Committee in Lesotho (NH-REC, ID52-2022), the Human Sciences Research Council Research Ethics Committee (HSRC REC, REC 2/23/09/20) and the Provincial Health Research Committee of the Department of Health of KwaZulu-Natal (KZ_202209_022) in South Africa and from the Swiss Ethics Committee Northwest and Central Switzerland (EKNZ, AO_2022–00044). This manuscript is based on protocol V.4.0, 19 January 2024. Trial findings will be disseminated through peer-reviewed publications, conference presentations and through communication offices of the consortium partners and the project’s website (https://tbtriage.com/).

ClinicalTrials.gov (NCT05526885), South African National Clinical Trials Register (SANCTR; DOH-27-092022-8096).