Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms.

We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients’ hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions.

The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings.

NCT05913700.

Buddhist novices reside in Buddhist temples, which are legally designated as smoke-free areas. Nevertheless, similar to other men in their age group, they are susceptible to various risk factors that lead to smoking. This digital survey aimed to examine tobacco smoking and its associated factors among Buddhist novices in Thailand.

A cross-sectional digital survey.

88 temple-based schools in Thailand.

A stratified two-stage cluster sampling method was employed to select 5371 novices. Data were collected between June and August 2022 using self-administered electronic questionnaires.

Descriptive statistics and multivariable logistic regression analysis were used to identify the associated factors.

Overall, 32.8% of the respondents reported they had tried smoking, and the average age of initiation was 12.4 years. In the past 30 days, 25.7% had smoked any tobacco product. Multiple factors following the ecological model of health behaviour were found to be statistically associated with smoking by 37.3%. Among these were intrapersonal-level factors, such as age, living in the southern region and attempted smoking. Two were interpersonal-level factors: the smoking behaviour of close relatives, specifically parents, and their respected monks. Two were institutional-level factors: perceiving that temple-based schools are smoke-free areas and exposure to secondhand smoke. Three factors at the community and policy levels were noticed tobacco advertising at the point of sale, social media and tobacco promotion.

The findings of this study support the development of comprehensive intervention programmes that address the multiple factors to prevent Buddhist novices from smoking.

Perimenopause is a critical transitional period in reproductive ageing. A set of physiological and psychological changes can affect perimenopausal women’s quality of life and further threaten their older adult health conditions. In China, less than one-third of midlife women with menopausal symptoms have actively sought professional healthcare. Regarding the public health significance of comprehensive menopause management, the current study aims to investigate the effects of a therapeutic lifestyle modification (TLM) intervention on cardiometabolic health, sexual functioning and health-related quality of life among perimenopausal Chinese women.

A randomised controlled trial with two parallel arms will be conducted at the gynaecology outpatient department of Yunnan Provincial Hospital of Traditional Chinese Medicine in China. 94 eligible perimenopausal women aged between 40 and 55 years will be recruited for the study. The TLM intervention consists of four elements: menopause-related health education, dietary guidance, pelvic floor muscle training and Bafa Wubu Tai Chi exercise. Participants will be randomly assigned (1:1) to receive either the 12-week TLM intervention or routine care via stratified blocked randomisation. The primary outcome is quality of life; secondary outcomes of interest include sexual functioning and cardiometabolic health. The outcome measures will be assessed at baseline and post-intervention. To explore the effects of the intervention, linear mixed models will be applied to test the changes between the two groups over time in each outcome based on an intention-to-treat analysis.

The Research Ethics Review Committee of Chulalongkorn University (COA No 178/66) and the Medical Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (IRB-AF-027-2022/02-02) approved the study protocol. Written informed consent will be obtained from all participants. Results will be published in peer-reviewed journals and disseminated through conferences.

ChiCTR2300070648.

Metabolic dysfunction-associated fatty liver disease (MASLD) is the hepatic manifestation of metabolic syndrome and the leading cause of chronic liver disease worldwide. Given that there is no pharmacological treatment for MASLD, it is imperative to understand whether lifestyle modifications may improve biochemical and pathological outcomes. One commonly proposed dietary modification is the Mediterranean diet; however, vegetarianism may also be a promising intervention. Vegetarianism has been shown to be associated with reduced morbidity and mortality in metabolic syndrome outcomes in coronary artery disease and diabetes; however, the relationship between vegetarian diet and MASLD is less clear. In this scoping review, we will provide a comprehensive overview of the current body of evidence related to a vegetarian diet and MASLD.

The aim of this scoping review is to describe and summarise the current body of evidence related to MASLD and a vegetarian diet. This review will be conducted using Arksey and O’Malley’s framework. The literature review will be conducted using the following databases: SCOPUS, Web of Science, CINAHL-Plus, Cochrane Library and Medline. No restriction will be made on publication date. Included studies will encompass clinical trials and observational designs that examine effects or association of vegetarian diet in adults (≥16 years) and report on the incidence, prevalence or progression of MASLD. Grey literature, non-human studies and articles focusing on changes in a specific food or nutraceutical will be excluded. Articles must have an English-language abstract available to be considered for inclusion. Screening and data extraction will be conducted by two independent reviewers. The findings will be summarised with descriptive statistics.

Approval from a medical ethics committee is not required for this review. Once the review is complete, the findings will be submitted to a peer-reviewed journal.

Nationwide lifestyle intervention—specific health guidance (SHG) in Japan—employs counselling and education to change unhealthy behaviours that contribute to metabolic syndrome, especially obesity or abdominal obesity. We aimed to perform a model-based economic evaluation of SHG in a low participation rate setting.

A hypothetical population, comprised 50 000 Japanese aged 40 years who met the criteria of the SHG, used a microsimulation using the Markov model to evaluate SHG’s cost-effectiveness compared with non-SHG. This hypothetical population was simulated over a 35-year time horizon.

SHG is conducted annually by all Japanese insurers.

Model parameters, such as costs and health outcomes (including quality-adjusted life-years, QALYs), were based on existing literature. Incremental cost-effectiveness ratios were estimated from the healthcare payer’s perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to evaluate the uncertainty around the model input parameters.

The simulation revealed that the total costs per person in the SHG group decreased by JPY53 014 (US$480) compared with that in the non-SHG group, and the QALYs increased by 0.044, wherein SHG was considered the dominant strategy despite the low participation rates. PSA indicated that the credibility intervals (2.5th–97.5th percentile) of the incremental costs and the incremental QALYs with the SHG group compared with the non-SHG group were –JPY687 376 to JPY85 197 (–US$6226 to US$772) and –0.009 to 0.350 QALYs, respectively. Each scenario analysis indicated that programmes for improving both blood pressure and blood glucose levels among other risk factors for metabolic syndrome are essential for improving cost-effectiveness.

This study suggests that even small effects of counselling and education on behavioural modification may lead to the prevention of acute life-threatening events and chronic diseases, in addition to the reduction of medication resulting from metabolic syndrome, which results in cost savings.

Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.

This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.

The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.

ISRCTN15319595.

Lockdowns and border closures impacted medicine availability during the COVID-19 pandemic. This study aimed to assess the availability of essential, generic medicines for chronic diseases at public pharmaceutical supply agencies in Ethiopia.

Comparative cross-sectional study.

The availability of essential, generic medicines for chronic diseases was assessed at two public pharmaceutical supply agency hubs.

The current study included public supply agency hub managers, warehouse managers and forecasting officers at the study setting.

The assessment encompassed the availability of chronic medicines on the day of data collection, as well as records spanning 8 months before the outbreak and 1 year during the pandemic. A total of 22 medicines were selected based on their inclusion in the national essential drug list for public health facilities, including 17 medicines for cardiovascular disease and 5 for diabetes mellitus.

The results of the study indicate that the mean availability of the selected basket medicines was 43.3% (95% CI: 37.1 to 49.5) during COVID-19, which was significantly lower than the availability of 67.4% (95% CI: 62.2 to 72.6) before the outbreak (p

The COVID-19 pandemic worsened the availability of essential chronic medicines, including higher rates of stockouts and unit price hikes for some products in the study setting. The study’s findings imply that the COVID-19 pandemic has aggravated already-existing medicine availability issues. Efforts should be made to develop contingency plans and establish mechanisms to monitor medicine availability and pricing during such crises.

To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.

Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews.

From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda.

The outcome measures were the proportion of parents with voluntary consent, factors affecting voluntariness and the sources of external influence. Parents rated the voluntariness of their consent on a voluntariness ladder. Indepth interviews described participants’ lived experiences and were aimed at adding context.

All 151 parents randomly sampled for the survey participated (84% female, median age 40 years). Most (67%) gave a fully voluntary decision, with a score of 10 on the voluntariness ladder, whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 2.7% scored 4. Trust in medical researchers (adjusted OR 9.90, 95% CI 1.01 to 97.20, p=0.049) and male sex of the parent (adjusted OR 3.66, 95% CI 1.00 to 13.38, p=0.05) were positively associated with voluntariness of consent. Prior research experience (adjusted OR 0.31, 95% CI 0.12 to 0.78, p=0.014) and consulting (adjusted OR 0.25. 95% CI 0.10 to 0.60, p=0.002) were negatively associated with voluntariness. Consultation and advice came from referring health workers (36%), spouses (29%), other family members (27%), friends (15%) and researchers (7%). The indepth interviews (n=14) identified the health condition of the child, advice from referring health workers and the opportunity to access better care as factors affecting the voluntariness of consent.

This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents’ trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents’ consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.

No whole-school interventions which seek to reduce physical, sexual and emotional violence from peers, intimate partners and teachers have been trialled with adolescents. Here, we report a protocol for a pilot trial of the Good School Toolkit-Secondary Schools intervention, to be tested in Ugandan secondary schools. Our main objectives are to (1) refine the intervention, (2) to understand feasibility of delivery of the intervention and (3) to explore design parameters for a subsequent phase III trial.

We will conduct a pilot cluster randomised controlled trial, with two arms and parallel assignment. Eight schools will be randomly selected from a stratified list of all eligible schools in Kampala and Wakiso Districts. We will conduct a baseline survey and endline survey 18 months after the baseline, with 960 adolescents and 200 teachers. Qualitative data and mixed methods process data collection will be conducted throughout the intervention. Proportion of staff and students reporting acceptability, understanding and implementing with fidelity will be tabulated at endline for intervention schools. Proportions of schools consenting to participation, randomisation and proportions of schools and individual participants completing the baseline and endline surveys will be described in a Consolidated Standards of Reporting Trials diagram.

The ethical requirements of our project are complex. Full approvals have been received from the Mildmay Ethics Committee (0407-2019), the Uganda National Council for Science and Technology (SS 6020) and the London School of Hygiene & Tropical Medicine (16212). Results of this study will be published in peer-reviewed academic journals, and shared with public bodies, policy makers, study participants and the general public in Uganda.

PACTR202009826515511.

Coexisting multiple health conditions is common among older people, a population that is increasing globally. The potential for polypharmacy, adverse events, drug interactions and development of additional health conditions complicates prescribing decisions for these patients. Artificial intelligence (AI)-generated decision-making tools may help guide clinical decisions in the context of multiple health conditions, by determining which of the multiple medication options is best. This study aims to explore the perceptions of healthcare professionals (HCPs) and patients on the use of AI in the management of multiple health conditions.

A qualitative study will be conducted using semistructured interviews. Adults (≥18 years) with multiple health conditions living in the West Midlands of England and HCPs with experience in caring for patients with multiple health conditions will be eligible and purposively sampled. Patients will be identified from Clinical Practice Research Datalink (CPRD) Aurum; CPRD will contact general practitioners who will in turn, send a letter to patients inviting them to take part. Eligible HCPs will be recruited through British HCP bodies and known contacts. Up to 30 patients and 30 HCPs will be recruited, until data saturation is achieved. Interviews will be in-person or virtual, audio recorded and transcribed verbatim. The topic guide is designed to explore participants’ attitudes towards AI-informed clinical decision-making to augment clinician-directed decision-making, the perceived advantages and disadvantages of both methods and attitudes towards risk management. Case vignettes comprising a common decision pathway for patients with multiple health conditions will be presented during each interview to invite participants’ opinions on how their experiences compare. Data will be analysed thematically using the Framework Method.

This study has been approved by the National Health Service Research Ethics Committee (Reference: 22/SC/0210). Written informed consent or verbal consent will be obtained prior to each interview. The findings from this study will be disseminated through peer-reviewed publications, conferences and lay summaries.

This study examined whether the US President’s Emergency Plan for AIDS Relief (PEPFAR) funding had effects beyond HIV, specifically on several measures of maternal and child health in low-income and middle-income countries (LMICs). The results of previous research on the question of PEPFAR health spillovers have been inconsistent. This study, using a large, multicountry panel data set of 157 LMICs including 90 recipient countries, adds to the literature.

Seven indicators including child and maternal mortality, several child vaccination rates and anaemia among childbearing-age women are important population health indicators. Panel data and difference-in-differences estimators (DID) were used to estimate the impact of the PEPFAR programme from inception in 2004 to 2018 using a comparison group of 67 LMICs. Several different models of baseline (2004) covariates were used to help balance the comparison and treatment groups. Staggered DID was used to estimate impacts since all countries did not start receiving aid at PEPFAR’s inception.

All 157 LMICs from 1990 to 2018.

90 LMICs receiving PEPFAR aid and cohorts of those countries, including those required to submit annual country operational plans (COP), other recipient countries (non-COP), and three groupings of countries based on cumulative amount of per capita aid received (high, medium, low).

PEPFAR aid to combat the HIV epidemic.

Maternal mortality and child mortality rates, vaccination rates to protect children for diphtheria, whooping cough and tetanus, measles, HepB3, and tetanus, and prevalence of anaemia in women of childbearing age.

Across PEPFAR recipient countries, large, favourable PEPFAR health effects were found for rates of childhood immunisation, child mortality and maternal mortality. These beneficial health effects were large and significant in all segments of PEPFAR recipient countries studied. We also found significant and favourable programme effects on the prevalence of anaemia in women of childbearing age in PEPFAR recipient countries receiving the most intensive financial support from the PEPFAR programme. Other recipient countries did not demonstrate significant effects on anaemia.

This study demonstrated that important health indicators, beyond HIV, have been consistently and favourably influenced by PEPFAR presence. Child and maternal mortality have been substantially reduced, and childhood immunisation rates increased. We also found no evidence of ‘crowding out’ or negative spillovers in these resource-poor countries. These findings add to the body of evidence that PEPFAR has had favourable health effects beyond HIV. The implications of these findings are that foreign aid for health in one area may have favourable health effects in other areas in recipient countries. More research is needed on the influence of the mechanisms at work that create these spillover health effects of PEPFAR.