An abnormal composition of gut bacteria along with alterations in microbial metabolites and reduced gut barrier integrity has been associated with the pathogenesis of chronic autoimmune and inflammatory rheumatic diseases (AIRDs). The aim of the systematic review, for which this protocol is presented, is to evaluate the clinical benefits and potential harms of therapies targeting the intestinal microbiota and/or gut barrier function in AIRDs to inform clinical practice and future research.
This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.
No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.
CRD42025644244.
Depressed mood is a psychological state characterised by sadness or loss of interest in activities, is a common symptom that accompanies most major mental disorders. It is therefore reasonable to consider it as a transdiagnostic target, which when addressed, may improve the functioning and quality of life of persons with lived experience of mental disorders. However, there is limited understanding of the depressed mood as a transdiagnostic target across major mental disorders. Therefore, this scoping review aims to synthesise knowledge on depressed mood, its measurement and interventions among persons with anxiety and/or psychosis.
This scoping review followed Arksey and O'Malley’s framework. Peer-reviewed articles and grey literature published from January 1988 to April 2024 were searched in the following databases: Medline/PubMed, Scopus, Web of Science, Africa-Wide Information, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, SocINDEX, Humanities International Complete, Sabinet, Open Grey and Google Scholar. Articles were screened at title, abstract and full article levels. Data extracted were analysed using thematic analysis and reported following Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. We also consulted stakeholders such as lived experience experts, clinicians and researchers to contextualise our findings.
We screened 245 full articles out of the 4039 hits and included 28 articles in this review. Although depressed mood is conceptually different from clinical depression, the terms are used interchangeably in the literature. The prevalence of depressed mood in psychosis was 7.3–33.3%, with no prevalence studies specific to anxiety disorders. Commonly used outcome measures included Beck’s Depression Inventory (n=6) and Patient Health Questionnaire-9 (n=5). Psychosocial conservative interventions such as cognitive–behavioural therapy were the most common interventions. Other interventions, including yoga, pharmacotherapy and Ecology Momentary Interventions, were also reported. All interventions were reported to improve depressed mood, and most were implemented in high-income settings. Stakeholders, including lived experience experts, concurred on the importance of using depressed mood as a transdiagnostic target, viewing it as a ‘window’ for early identification and management of many common mental disorders.
There is a need to clarify the definition and diagnostic cut-off points on common outcome measures of depressed mood. There is also a need for increased research on depressed mood as a viable transdiagnostic target in anxiety and/or psychosis with a special focus on low-to-middle income countries.
Depressed mood is an important and prevalent transdiagnostic target with great promise for early management in anxiety and/or psychosis. Valid diagnostic and measurement tools are developing, and so are the targeted interventions in the context of anxiety and/or psychosis.
To assess the pooled prevalence of self-reported sexually transmitted infections (STIs) and their associated factors among adults in South and Southeast Asia, using the Demographic and Health Survey data collected between 2015 and 2023.
A community-based cross-sectional study design was conducted using a multistage cluster sampling approach. Multilevel multivariable logistic regression analysis was employed to identify predictors of self-reported sexually transmitted infections (STIs). Model selection was guided by Akaike’s information criterion, and adjusted odds ratios (AORs) with 95% CIs were estimated to determine statistically significant associations.
South and Southeast Asia.
This analysis included a weighted sample of 791 019 adults aged 15–49 who reported ever having had sexual intercourse. The majority of the participants were female (n=6 87 880; 87%), and most were from Southeast Asia (n=7 00 539; 89%).
The pooled prevalence of self-reported STIs among adults in South and Southeast Asia was 12.94% (95% CI 7.73% to 18.14%). At the individual level, higher odds of reporting STIs were associated with being female (AOR 1.84; 95% CI1.68 to 2.02), having middle (AOR 1.11; 95% CI 1.04 to 1.19) or high wealth status (AOR 1.15; 95% CI 1.07 to 1.24]), being employed (AOR 1.14; 95% CI 1.07 to 1.22), having multiple sexual partners (AOR 2.79; 95% CI 2.22 to 3.52) and having undergone HIV testing (AOR 1.10; 95% CI: 1.02 to 1.20). Conversely, lower odds of self-reported STIs were observed among individuals aged 35–39 years (AOR 0.78; 95% CI 0.66 to 0.92), 40–44 years (AOR 0.68; 95% CI 0.58 to 0.82) and 45–49 years (AOR 0.61; 95% CI 0.52 to 0.73); those who had ever been in a union (AOR 0.71; 95% CI 0.62 to 0.83); individuals with higher education (AOR 0.84; 95% CI 0.76 to 0.93); and those with comprehensive HIV knowledge (AOR 0.82; 95% CI 0.77 to 0.87). At the community level, high illiteracy rates (AOR 1.25; 95% CI 1.15 to 1.35) and high media non-exposure (AOR 1.11; 95% CI 1.02 to 1.20) were positively associated with STIs, while rural residence (AOR 0.81; 95% CI 0.74 to 0.89) and living in Southeast Asia (AOR: 0.47; 95% CI 0.42 to 0.53) were linked to lower odds of self-reported STIs.
A substantial prevalence of self-reported STIs was observed among adults in South and Southeast Asia. Both individual- and community-level factors influence STI risk. The individual-level determinants include socio-demographic characteristics, sexual behaviours, HIV-related knowledge and testing history, while community-level factors reflect disparities in geographic location, educational attainment and media exposure.
A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.
This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).
The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.
In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.
The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.
In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.
TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.
Despite global efforts to improve nutrition, young women aged 15–24 years in low-income and middle-income countries (LMICs) face persistent dual burdens of malnutrition, marked by high rates of underweight and emerging issues of overnutrition, such as overweight and obesity. Current research often emphasises individual-level factors, potentially overlooking broader regional influences.
To examine the burden of abnormal nutritional indices among women aged 15–24 years in 40 LMICs using the most recent Demographic and Health Survey conducted between 2015 and 2023.
Cross-sectional study design.
40 LMICs.
357 587 young women aged 15–24 years.
A multilevel mixed-effect multinomial analysis was conducted to identify determinants of underweight, overweight and obesity. The adjusted relative risk ratio with 95% CI was used to declare the statistical significance of the association.
Our analysis found that among young women aged 15–24 years in LMICs, the pooled prevalence of underweight was 25.7% (95% CI 25.6% to 25.8%), with substantial country-level variation. The highest prevalence was in Timor-Leste (35.4%) and India (31.6%), while Jordan (2.9%) and Zambia (5.5%) had the lowest rates. Overweight and obesity prevalence was 17.7% (95% CI 15.7% to 19.7%), with the highest rates in Jordan (48.9%) and Zambia (40.9%) and the lowest in Timor-Leste (3.9%) and Ethiopia (4.5%). Furthermore, factors such as household wealth, age at marriage, age, education status, access to media, employment status, parity, contraceptive use, toilet facility, region and place of residence were statistically associated with being underweight, overweight and obese.
Our study highlights significant variations in nutritional status among young women aged 15–24 years in LMICs, with a notable prevalence of underweight and emerging challenges of overweight and obesity. Country-specific strategies addressing socioeconomic disparities and regional differences are crucial for effective public health interventions to improve nutritional outcomes among this vulnerable population.
To assess factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 at primary healthcare (PHC) facilities in Nepal after healthcare workers received training.
Cross-sectional study.
PHC facilities across various provinces in Nepal.
A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.
The adoption of PEN Protocol 1 components: blood pressure measurement, blood glucose screening, 10-year cardiovascular disease (CVD) risk assessment using WHO/International Society of Hypertension risk charts and body mass index (BMI) assessment. Factors associated with protocol adoption were assessed using generalised estimating equations for ORs.
Among participants, 100% reported measuring blood pressure, while 56% measured blood sugar, 28% assessed CVD risk and 27% assessed BMI. The adoption of the CVD risk prediction chart was positively associated with the availability of amlodipine (adjusted OR (aOR) 3.00; 95% CI 1.09 to 8.27). The adoption of BMI assessment was positively associated with access to a stadiometer (aOR 3.23; 95% CI 1.26 to 8.30) and a glucometer (aOR 3.07; 95% CI 1.12 to 8.40), and negatively associated with lack of motivation/inertia of previous practice (aOR 0.60; 95% CI 0.42 to 0.87) and environmental factors such as lack of time and resources (aOR 0.57; 95% CI 0.37 to 0.89). Blood glucose level measurements were positively associated with being at a PHC centre (aOR 7.34; 95% CI 2.79 to 19.3) and the availability of metformin (OR 2.40; 95% CI 1.08 to 5.29).
Adoption of PEN Protocol 1 varied by component and was influenced by resource availability, provider motivation and system barriers. Addressing these factors is key to optimising implementation in low-resource settings.
Drug–drug interactions (DDIs) are a significant concern for patients on complex therapeutic regimens, especially involving cardiovascular medications, which are frequently implicated in these interactions.
This study used a standardised interaction database to determine the frequency, severity and risk factors associated with potential DDIs (pDDIs) among cardiovascular disease (CVD) in-patients.
The prospective cross-sectional study was conducted at a tertiary care hospital in Nepal from April 2024 to October 2024. A total of 106 eligible CVD in-patients were evaluated for pDDIs using the Lexicomp DDI checker database, and the interactions were categorised based on severity and risk rating. Binary logistic regression identified factors associated with pDDIs.
The study identified 621 pDDIs using the Lexicomp database, with median values of 8 pDDIs per patient. Patients with at least one pDDI comprised 64.2% of the sample. Most pDDIs were of moderate severity (77.3%) with risk ratings of C (65.7%). The most common cardiovascular medications involved in the detected DDI pairs were diuretics (31.2%), antiplatelets and anticoagulants (23.8%) and calcium channel blockers (12.2%). Multivariate binary logistic regression revealed that patients who stayed longer (adjusted OR (AOR) 9.08, 95% CI 1.027 to 80.216, p=0.047), those receiving more medications (AOR 18.85, 95% CI 2.975 to 119.370, p=0.002) and those who were admitted to the intensive cardiac care unit (AOR 16.31, 95% CI 2.728 to 97.461, p=0.002) were significantly more likely to experience pDDIs.
This study found a higher prevalence of pDDIs. It is advisable to incorporate medication reviews into routine cardiac care and use a drug interaction checker to identify pDDIs.
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).