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Factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 in primary healthcare settings in Nepal: a cross-sectional study

Por: Timalsena · D. · Nakarmi · C. S. · Mali · S. · Dhakal · A. · Bharati · A. · Bishwokarma · A. · Adhikari · A. · Poudel · B. · Rai · B. K. · Baral · P. P. · Bhattarai · S. · Dixit · L. · Pokharel · Y. · Rhodes · E. · Xu · D. R. · Spiegelman · D. · Shrestha · A.
Objective

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.

Design

Cross-sectional study.

Setting

PHC facilities across various provinces in Nepal.

Participants

A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.

Main outcome measures

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.

Results

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).

Conclusion

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.

Potential drug-drug interactions among hospitalised cardiac patients in Nepal: a prospective observational study

Por: Sah · B. K. · Karna · A. K. · Subedi · S. · Sah · R. K. · Shrestha · S. · Dangi · N. B.
Background

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.

Objectives

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.

Methods

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.

Results

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.

Conclusions

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.

Effectiveness and cost-effectiveness of community-based TB screening algorithms using computer-aided detection (CAD) technology alone compared with CAD combined with point-of-care C reactive protein testing in Lesotho and South Africa: protocol for a pair

Por: Signorell · A. · van Heerden · A. · Ayakaka · I. · Jacobs · B. K. · Antillon · M. · Tediosi · F. · Verjans · A. · Brugger · C. · Harkare · H. V. · Labhardt · N. D. · Bosman · S. · Kamele · M. · Keitseng · M. · Madonsela · T. · Kurscheid · J. · Muhairwe · J. · Keter · A. K. · Murphy · K.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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/).

Trial registration

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

Evaluating impacts of improved flooring on enteric and parasitic infections in rural households in Kenya: study protocol for a cluster-randomised controlled trial

Por: Halliday · K. E. · Kepha · S. · Legge · H. · Allen · E. · Dreibelbis · R. · Elson · L. · Kakoi · B. K. · Mcharo · C. · Muli · S. · Mwongeli · J. · Njomo · D. · Njoroge · M. M. · Ochwal · V. · Oswald · W. E. · Rono · M. · Safari · T. K. · Filinger · U. · Kaluli · J. W. · Mwandawiro · C. S.
Introduction

Earthen floors are often damp or dusty and difficult to clean, providing an ideal environment for faecal pathogens and parasites. Observational studies have revealed associations between household flooring and health outcomes, but robust experimental evidence is scant. This study will evaluate the impact of an improved household flooring intervention on enteric infections, soil-transmitted helminth (STH) infections and tungiasis through implementation of a cluster-randomised trial in two rural settings in Kwale and Bungoma Counties, Kenya.

Methods and analyses

440 clusters (households) across both sites are allocated to control or intervention group, in which a low-cost, sealed, washable, cement-based floor is installed in eligible buildings of the dwelling, alongside a floor-care guide provided during an induction meeting. Following baseline assessments in both groups, all individuals over 1 year receive albendazole and those infected with tungiasis receive benzyl benzoate. Primary outcomes are as follows: prevalence of enteric infections in children under 5 years assessed via stool surveys and PCR; prevalence of tungiasis infection in children 1–14 years based on clinical exam; and prevalence of STH infection in all household members over 1 year assessed via Kato-Katz. Secondary outcomes include the following: intensity of STH and tungiasis infections; prevalence of caregiver-reported gastrointestinal illness in children under 5; quality of life and well-being measures; and environmental contamination. A process evaluation investigates intervention acceptability, durability, practicality and cost.

Ethics and dissemination

The protocol has been approved by ethics committees of The Kenya Medical Research Institute, The Kenya National Commission for Science Technology and Innovation, and The London School of Hygiene & Tropical Medicine. Following the 12-month implementation period and final assessments, control households are offered improved floors. Results will be disseminated within Kenya, to the Ministries of Health and of Lands, Public Works, Housing and Urban Development, and to subnational leadership and communities. Dissemination will also occur through publications and conference presentations.

Trial registration number

NCT05914363.

Investigating the combined effects of statins and exercise on skeletal muscle mitochondrial content and function, cardiorespiratory fitness and quality of life in individuals with dyslipidaemia: protocol for a randomised placebo-controlled trial

Por: Sjurtharson · T. · Larsen · S. · Jensen · S. B. K. · Bejder · J. · Rasmussen · J. · a Borg · S. · Kristiansen · J. · Meinhardsson · J. M. · Olsen · H. W. · Ellingsgaard · H. · Vigh-Larsen · J. F. · Nordsborg · N. B. · Mohr · M.
Introduction

Dyslipidaemia, affecting approximately 39% of adults worldwide, is a major risk factor for cardiovascular disease. Individuals with dyslipidaemia are often prescribed statins, which effectively lower plasma low-density lipoprotein cholesterol (LDL-C), thereby reducing the risk of cardiovascular events and mortality. Although statins lower LDL-C, emerging evidence suggests that they may counteract the beneficial adaptations to exercise in skeletal muscle mitochondria and whole-body aerobic capacity. The underlying mechanisms remain unclear, and there is a need for studies investigating how statins influence molecular adaptations to exercise. The primary objective of this study is to investigate the combined effects of statin therapy and focused exercise training on mitochondrial function and whole-body aerobic capacity in people with dyslipidaemia. The untargeted proteomic analysis will be incorporated to provide detailed insights into how statins may affect mitochondrial proteins and other muscle metabolic traits, offering molecular explanations for altered functional readouts at both the muscle and whole-body levels.

Methods and analysis

A total of 100 women and men (aged 40–65 years) diagnosed with dyslipidaemia without atherosclerotic cardiovascular disease will be enrolled in this 12-week, double-blinded, randomised, placebo-controlled trial. Participants will be randomised into one of four groups using a block randomisation approach to ensure an allocation ratio of 60:40 for exercise and non-exercise conditions, respectively. The four groups will be: (1) exercise+placebo, (2) exercise+atorvastatin (80 mg/day), (3) atorvastatin (80 mg/day) and (4) placebo. The primary outcome is mitochondrial function, measured by changes in skeletal muscle citrate synthase activity from baseline to post-intervention. Secondary outcomes include whole-body aerobic capacity (VO2peak) and proteomic analyses. Genetic analysis will be conducted to assess the role of genetic polymorphisms in individual responses to statins and exercise.

Ethics and dissemination

The trial has received ethical approval from the Faroe Islands Ethical Committee (2024-10) and adheres to the Declaration of Helsinki and General Data Protection Regulation (GDPR). Results will be published in peer-reviewed international journals.

Trial registration number

NCT06841536.

The CHILL BONES (combining high-intensity impact loading and lifting with mind-body exercise for optimisation of nervous system and skeletal health) trial: protocol for a parallel-group, semi-randomised controlled trial

Por: Collier · J. · Beck · B. R. · Sabapathy · S. · Weeks · B. K.
Introduction

Animal studies suggest that elevated sympathetic nervous system (SNS) activity can accelerate bone loss. However, this area has not been well researched in humans. High-intensity Resistance and Impact Training (HiRIT) is recognised as an effective treatment for osteoporosis and osteopenia. Alternate forms of exercise such as mind-body exercise may be used to modulate sympathetic activity, which could have an additive benefit for skeletal adaptation when used in conjunction with HiRIT. The aim of this study is to investigate whether the combination of mind-body exercise (Tai Chi) and HiRIT can be used to concurrently modulate SNS activity and improve skeletal health.

Methods and analysis

The CHILL BONES trial is a semi-randomised controlled trial where consenting adults over 60 years, who have low bone mass (total hip, femoral neck and/or lumbar spine T-score

Ethics and dissemination

Ethical approval was granted by the Griffith University Human Research Ethics Committee (GUHREC; GU Ref No: 2023/448). Trial findings will be disseminated to participants via a plain-language summary upon completion. Results will be formally reported through peer-reviewed journals and conference presentations.

Trial registration number

ACTRN12623001209684; Australian New Zealand Clinical Trials Registry.

Post-market quality assessment of antibiotics: findings from a cross-sectional study using standardised patients in Tabalong and Bekasi districts, Indonesia

Por: Mashuri · Y. A. · Hasanah · M. · Rahayu · I. D. · Liverani · M. · Probandari · A. · Batura · N. · Schierhout · G. · Ferdiana · A. · Wulandari · L. P. L. · Dewi · B. K. · Jan · S. · Yeung · S. · Wiseman · V. · Day · R. · Wibawa · T.
Objectives

In Indonesia, antibiotics are often purchased without a prescription at community pharmacies, contrary to current regulations. This practice may increase the risk of out-of-specification (OOS) medicines being dispensed, potentially contributing to treatment failure and antibiotic resistance. To address this concern, we assessed the quality of antibiotics purchased without a prescription at private drug retail outlets (PDROs) in Indonesia.

Design and setting

We conducted a cross-sectional study in Tabalong and Bekasi, Indonesia, using standardised patients (SPs) who purchased antibiotics without a prescription for three clinical scenarios: upper respiratory tract infection (URTI), tuberculosis (TB) and child diarrhoea. The pharmacies and drug stores were randomly selected from each subdistrict based on the probability proportional method. We measured the active pharmaceutical ingredient (API) content of the antibiotic samples using high-performance liquid chromatography (HPLC).

Samples and analysis

The quality of 183 antibiotics including amoxicillin tablets (148/183, 80.9%, 95% CI 74.7% to 86.1%), amoxicillin dry syrup (12/183, 6.6%, 95% CI 3.6% to 10.8%), ampicillin tablets (5/183, 2.7%, 95% CI 1.1% to 5.9%) and ciprofloxacin tablets (18/183, 9.8%, 95% CI 6.2% to 14.8%) obtained from 117/166 (70.5%, 95% CI 62.8 to 77.2) PDROs were tested. Descriptive statistics were used to describe the characteristics of the purchased antibiotics, and the API content of each antibiotic was compared against the United States Pharmacopeia 43-National Formulary 38 (USP 43-NF 38) standards in absolute values and percentages.

Results

Almost all samples produced in Indonesia (182/183, 99.5%, 95% CI 97.5% to 99.9%) were unbranded (123/183, 67.2%, 95% CI 60.2% to 73.7%) or branded generic (60/183, 32.8%, 95% CI 26.3% to 39.8%) and packaged in strips (165/183, 90.2%, 95% CI 85.2% to 93.8%). Around 12/183 (6.6%, 95% CI 3.6% to 10.8%) antibiotics were found to be OOS; these were mostly amoxicillin 125 mg dry syrup (6/12, 50%, 95% CI 24.3% to 75.7%) and ciprofloxacin 500 mg tablet (5/18, 27.8%, 95% CI 11.5% to 50.6%). Around 33% (4/12, 95% CI 12.5% to 61.2%) of amoxicillin 125 mg dry syrup samples had an API content above the label claim, the highest being 187%, whereas 16.7% (2/12, 95% CI 3.6% to 43.6%) were below the label claim, the lowest being 64%. About 27.8% (5/18, 95% CI 11.5% to 50.6%) of ciprofloxacin samples tested had an API content above the label claim; the highest was 120%.

Conclusion

While the proportion of OOS antibiotics identified was relatively small, at a population level, it represents a significant proportion of sub-optimally treated infections.

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