Non-communicable diseases cause 74% of global deaths, with cardiovascular diseases as the major contributor. Hypertension, a primary risk factor for cardiovascular disease, is highly prevalent in Africa. Diagnosis, treatment and control rates are notably limited in rural areas. This limitation results in increased risks of premature mortality and complications such as stroke due to socioeconomic, cultural and geographical challenges. Progress in African countries enhancing hypertension services through primary health care interventions exists. However, a comprehensive review of all primary health care interventions addressing undiagnosed and uncontrolled hypertension in rural African settings is lacking. This scoping review aims to categorise primary health care interventions targeting undiagnosed and uncontrolled hypertension in rural African adults. Intervention components will be mapped to the four stages outlined in the hypertension care cascade to develop a pilot intervention logic model for rural African adults with hypertension.

The scoping review protocol will adhere to the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Studies considered for inclusion will include any intervention delivered by any healthcare provider in a rural African primary care setting targeting any stage of hypertension care. Eight databases will be searched without date restrictions, supplemented by grey literature and reference list searches. A two-stage screening process (title/abstract and full text) will determine evidence source eligibility. All eligible sources of evidence will be extracted, charted and evaluated using the Template for Intervention Description and Replication checklist. A pilot logic model categorising and mapping interventions to the four stages of the hypertension care cascade will be visually presented and analysed using narrative synthesis.

No primary data will be collected; therefore, ethics approval is not required. Findings will be disseminated to local health authorities in Ghana and other African Regions and through national and international conferences and publications in peer-reviewed journals.

Delivery of virtual care increased throughout the COVID-19 pandemic and persisted after physical distancing measures ended. However, little is known about how to measure the quality of virtual care, as current measures focus on in-person care and may not apply to a virtual context. This scoping review aims to understand the connections between virtual care modalities used with ambulatory patient populations and quality measures across the Quintuple Aim (provider experience, patient experience, per capita cost, population health and health equity).

Virtual care was considered any interaction between patients and/or their circle of care occurring remotely using any form of information technology. Five databases (MEDLINE, Embase, PsycInfo, Cochrane Library, JBI) and grey literature sources (11 websites, 3 search engines) were searched from 2015 to June 2021 and again in August 2022 for publications that analysed virtual care in ambulatory settings. Indicators were extracted, double-coded into the Quintuple Aim framework; patient and provider experience indicators were further categorised based on the National Academy of Medicine quality framework (safety, effectiveness, patient-centredness, timeliness, efficiency and equity). Sustainability was added to capture the potential for continued use of virtual care.

13 504 citations were double-screened resulting in 631 full-text articles, 66 of which were included. Common modalities included video or audio visits (n=43), remote monitoring (n=11) and mobile applications (n=11). The most common quality indicators were related to patient experience (n=58 articles), followed by provider experience (n=25 articles), population health outcomes (n=23 articles) and health system costs (n=19 articles).

The connections between virtual care modalities and quality domains identified here can inform clinicians, administrators and other decision-makers how to monitor the quality of virtual care and provide insights into gaps in current quality measures. The next steps include the development of a balanced scorecard of virtual care quality indicators for ambulatory settings to inform quality improvement.

To assess the return on investment (ROI) of the New York Tobacco Control Programme (NY TCP).

New York and other states of the USA.

NY TCP.

Smoking prevalence, smoking-attributable healthcare expenditures (SAEs), smoking-attributable mortality, years of life lost (YLL), the dollar value of YLL and the ROI for healthcare expenditures and mortality.

We used a synthetic control method to estimate the effectiveness of NY TCP funding on smoking prevalence. The synthetic control method created a comparison group that best matched the adult smoking prevalence trend in New York state in the period prior to implementation of the NY TCP and compared smoking prevalence in the state to smoking prevalence in the synthetic control in the period after treatment (2001–2019). The synthetic control group represents what the trend in smoking prevalence in New York would have been had there been no tobacco control expenditures. The ROI was calculated as net savings for each outcome divided by net programme expenditures.

Cumulative savings in SAE in New York from 2001 to 2019 amounted to US$13.2 billion. An estimated 41 771 smoking-attributable deaths (SADs) were averted in New York from 2001 to 2019, and an estimated 672 141 YLL averted as a result of NY TCP funding in the same period. From 2001 to 2019, the ROI for SAE in New York was approximately 14, the economic value ROI of the YLL due to SAD was nearly 145 and the combined ROI was almost 160.

In this study, we found relatively large ROIs for the NY TCP, which suggests that the programme—which lowers SAE and saves lives—is an efficient use of public funds.

Heavy alcohol use and alcohol use disorder (AUD) continues to rise as a public health problem and increases the risk for disease. Elevated rates of anxiety, depression, sleep disruption and stress are associated with alcohol use. Symptoms may progress to diagnosed neurophysiological conditions and increase risk for relapse if abstinence is attempted. Research on mechanisms connecting the gastrointestinal microbiome to neuropsychological disorders through the gut-brain axis is well-established. Less is known how the oral microbiome and oral microbial-associated biomarkers may signal to the brain. Therefore, a synthesis of research studying relationships between alcohol intake, alcohol-associated neurophysiological symptoms and the oral microbiome is needed to understand the state of the current science. In this paper, we outline our protocol to collect, evaluate and synthesise research focused on associations between alcohol intake and AUD-related neuropsychological disorders with the oral microbiome.

The search strategy was developed and will be executed in collaboration with a medical research librarian. Studies will be screened by two independent investigators according to the aim of the scoping review, along with the outlined exclusion and inclusion criteria. After screening, data will be extracted and synthesised from the included papers according to predefined demographic, clinical and microbiome methodology metrics.

A scoping review of primary sources is needed to synthesise the data on relationships between alcohol use, neuropsychological conditions associated with AUD and the oral microbiome. The proposed scoping review is based on the data from publicly available databases and does not require ethical approval. We expect the results of this synthesis will identify gaps in the growing literature and highlight potential mechanisms linking the oral-brain axis to addiction and other associated neuropsychological conditions. The study findings and results will be disseminated through journals and conferences related to psychology, neuroscience, dentistry and the microbiome.

Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

ACTRN12622000584730.

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.

Obesity increases the risk of morbidity and mortality. A major driver has been the increased availability of ultra-processed food (UPF), now the main UK dietary energy source. The UK Eatwell Guide (EWG) provides public guidance for a healthy balanced diet but offers no UPF guidance. Whether a healthy diet can largely consist of UPFs is unclear. No study has assessed whether the health impact of adhering to dietary guidelines depends on food processing. Furthermore, our study will assess the impact of a 6-month behavioural support programme aimed at reducing UPF intake in people with overweight/obesity and high UPF intakes.

UPDATE is a 2x2 cross-over randomised controlled trial with a 6-month behavioural intervention. Fifty-five adults aged ≥18, with overweight/obesity (≥25 to 2), and ≥50% of habitual energy intake from UPFs will receive an 8-week UPF diet and an 8-week minimally processed food (MPF) diet delivered to their home, both following EWG recommendations, in a random order, with a 4-week washout period. All food/drink will be provided. Participants will then receive 6 months of behavioural support to reduce UPF intake. The primary outcome is the difference in weight change between UPF and MPF diets from baseline to week 8. Secondary outcomes include changes in diet, waist circumference, body composition, heart rate, blood pressure, cardiometabolic risk factors, appetite regulation, sleep quality, physical activity levels, physical function/strength, well-being and aspects of behaviour change/eating behaviour at 8 weeks between UPF/MPF diets, and at 6-month follow-up. Quantitative assessment of changes in brain MRI functional resting-state connectivity between UPF/MPF diets, and qualitative analysis of the behavioural intervention for feasibility and acceptability will be undertaken.

Sheffield Research Ethics Committee approved the trial (22/YH/0281). Peer-reviewed journals, conferences, PhD thesis and lay media will report results.

NCT05627570

Restorative sleep is critical in preventing hypertension and other chronic diseases. Limited research has explored the relationship between sleep quality and hypertension in Africa. This study investigated the association between sleep quality and blood pressure control among hypertensive patients in Southern Nigeria.

Cross-sectional study.

A rural tertiary hospital in Southern Nigeria, April to June 2023.

250 systematically selected hypertensive adults. Participants completed a validated semistructured interviewer-administered questionnaire to assess their sleep patterns, including sleep duration, self-reported trouble sleeping and a history of clinical diagnosis of sleep disorders. Sleep patterns were categorised as restorative (healthy) or non-restorative (unhealthy). The blood pressure of respondents was checked and categorised as controlled (

Quality of sleep and blood pressure control.

Respondents had a mean age of 51.5±10.0 years, with the majority being female (156, 62.4%), married (135, 54.0%) and belonging to the Esan tribe (125, 50.0%). The prevalence of restorative sleep was 36%, while the blood pressure control rate was 23.6%. An association was found between restorative sleep and blood pressure control (adjusted OR =4.38; 95% CI=2.37–8.10; p

The study found an association between poor quality sleep and poor blood pressure control. Incorporating sleep assessments and interventions into comprehensive hypertension management strategies could be explored as a possible approach to improve sleep quality and enhance blood pressure control.

PACTR202301917477205.

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.