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Population-based study of pharmacogenetics and pharmacokinetics in Southern African patients with multidrug-resistant tuberculosis (PoPG): a protocol for the Namibian cohort

Por: Boois · L. · Ekandjo · H. · Shavuka · O. · Nepolo · E. · Ndong Sima · C. A. · Oelofse · C. · Uren · C. · Petersen · D. C. · Möller · M. · Wijk · M. · Kellermann · T. · Decloedt · E. · McIlleron · H. · Denti · P. · Claassens · M. M.
Background

Multidrug-resistant tuberculosis (MDR-TB) is an urgent public health challenge in Namibia, with profound socioeconomic consequences. The high burden of both tuberculosis and HIV complicates treatment and underscores the need for optimised drug therapies. Precision medicine, which leverages patient-specific genetic and molecular information, offers promise for improving MDR-TB outcomes. However, its effective application relies on population-specific data, particularly understanding how individuals metabolise tuberculosis drugs and how genetic diversity drives variability in treatment response. Currently, no pharmacokinetic (PK) or pharmacogenetic (PG) data on TB treatment exist for Namibian populations. This gap is particularly concerning, given the country’s genetic diversity, environmental factors and comorbidities that may uniquely influence drug metabolism. This study aims to generate PK and PG data to inform dose optimisation and support personalised treatment strategies for MDR-TB in Namibia. The findings will contribute to improved patient care and inform health system strengthening based on locally relevant evidence.

Methods

This cross-sectional study will consist of 100 Namibian participants with matched human DNA and PK data of MDR-TB cases receiving isoniazid, clofazimine, bedaquiline and the fluoroquinolones (levofloxacin or moxifloxacin). PK sampling will be divided as follows: 30 individuals will undergo intensive PK sampling, while the remaining (n=70) will undergo sparse PK sampling. DNA will be extracted at Stellenbosch University (SU), and samples will be genotyped using the H3Africa microarray. Sequences will be aligned to the human reference genome, hg38 (GRCh38p13), using the freely available Burrows-Wheeler Aligner. A subset of the samples (n=20–30) will undergo whole genome sequencing (WGS) to verify imputation results and identify novel genetic variants potentially affecting PK in this population.

Data analysis

Quality control and variant call format file generation will be performed using the Genome Analysis Toolkit best practices (V.3.5). Intensive and sparse PK data will be pooled for the development of a population PK (popPK) model using a non-linear mixed-effects modelling approach. The popPK model will characterise the relationship between TB drug dose and exposure, including quantifying covariates, including genetic variation, explaining PK variability, providing a foundation for dose optimisation and personalised treatment strategies.

Ethics and dissemination

Ethics approval was obtained from the University of Namibia Human Research Ethics Committee for Health (Ref. SOM18/2024), the Ministry of Health and Social Services (Ref. 22/4/2/3), the SU Health Research Ethics Committee (Ref. N21/11/136) and the University of Cape Town Human Research Ethics Committee (Ref. 500/2022).

Harm reduction and pharmacy practice: a scoping review of services for people who use drugs provided by pharmacy staff

Por: Navarrete · J. · Berg · E. · Hughes · C. · Salokangas · E. · Taylor · M. · Kung · J. Y. · Johnson · J. A. · Hyshka · E.
Objectives

The roles of pharmacy staff have expanded to include public health functions, such as delivering harm reduction services for people who use drugs (PWUD), particularly unregulated substances and non-medical drug use, in response to an ongoing drug overdose crisis. Nonetheless, their involvement across the full spectrum of harm reduction services remains underexplored. This study mapped existing research describing or evaluating the implementation of harm reduction services for PWUD provided by pharmacy staff.

Design

Scoping review.

Data sources

MEDLINE, EMBASE, CINAHL, Web of Science, Scopus and Cochrane Library (inception to July 2025).

Study selection

Studies reporting on the description or evaluation of harm reduction services for PWUD provided by pharmacy staff.

Data extraction

Two team members screened studies for eligibility and extracted the data. The data were analysed primarily to describe harm reduction services and the role of pharmacy staff.

Results

43 articles were included. The most frequently reported harm reduction services were sexually transmitted and blood-borne infection care (33%), needle and syringe programmes (21%), naloxone distribution (19%) and medication treatment for opioid use disorder (19%). Pharmacy staff were integrated into multidisciplinary teams (79%), with their roles varying from education to medication prescribing. Included studies reported harm reduction services for PWUD delivered by pharmacy staff as effective, feasible and safe. However, implementations were not tailored to equity-deserving populations. Services primarily addressed opioid-related harms, while strategies focusing on the use of non-opioid substances were limited.

Conclusion

This scoping review highlights the diverse roles pharmacy staff play in delivering harm reduction services for PWUD. Positioned at the intersection of accessibility and healthcare delivery, pharmacy staff are ideally situated to expand access to equitable care. To fully harness this potential, future research and practice should embed harm reduction as a core philosophy, extending beyond individual interventions to support the creation of person-centred, non-judgmental and low-barrier services.

Bridging the stroke care gap: development and validation of CaknaStrok Education Package (CEP) for caregivers of stroke survivors in Malaysia

Por: Sidek · N. N. · Kamalakannan · S. · Musa · K. I. · Long Tuan Kechik · T. S. M. · Hamzah · N. · Abd Hamid · R. I. · Darus · D. · Ibrahim · K. A. · Seman · N. · Ahamad Fouzi · L. · Abdul Hamid · F. · Ismail · T. A. T.
Background

Stroke is one of the top causes of disability in Malaysia, yet caregivers have limited access to structured, culturally tailored education to support poststroke care.

Objectives

To develop and validate the CaknaStrok Education Package (CEP), a blended learning intervention comprising a printed guidebook and a trilingual mobile health application for informal stroke caregivers in Malaysia.

Design

Methodological study involving the development and validation of a caregiver education programme guided by the Analyse, Design, Develop, Implement, Evaluate (ADDIE) instructional design framework.

Setting

Development and validation were conducted in Malaysia between January 2022 and December 2023. Both experts and caregivers were recruited from two tertiary hospitals on the East Coast of Malaysia, with caregivers identified from inpatient wards and outpatient clinics at these hospitals.

Participants

Content validation involved 10 multidisciplinary experts. Face validation involved 14 informal stroke caregivers who met eligibility criteria, and all completed the study.

Methods

CEP was developed based on prior needs assessment and expert input. Content validation was undertaken using the Content Validity Index (CVI) and face validation using the Face Validity Index (FVI), both assessed on a four-point Likert scale. Qualitative feedback was also obtained from the participants.

Results

CEP consists of six modules delivered via a printed guidebook and a trilingual app with videos, assessment tools and local resources. Experts rated the content highly valid (Scale-level (S)-CVI/the average method (Ave): 0.97–0.99 across domains). Caregivers reported strong acceptability (S-FVI/Ave: 0.95–0.99). Qualitative feedback from experts and caregivers informed refinements to content clarity, usability and presentation, including improved navigation, consistent language use and enhanced visual design. Suggestions requiring substantial structural changes were documented for future iterations.

Conclusions

The CEP shows strong content and face validity as a blended caregiver education tool. By combining printed and digital formats, CEP addresses cultural and access challenges and provides a scalable model for stroke caregiver education in Malaysia. Further pilot or feasibility studies are warranted to evaluate usability, engagement and implementation in real-world settings prior to effectiveness evaluation.

Enhancing communication with bereaved relatives about emergency and critical care trials (ENHANCE): a mixed-methods study

Por: Doughty · H. · Deja · E. · Young · B. · Welters · I. · Shepherd · V. · Milosevic · S. · OHara · K. · Carman · J. · Sankar · V. · Thomas-Jones · E. · Euden · J. · Woolfall · K.
Objectives

Clinical research in emergency and critical care is vital, but recruitment and consent are complex. Research may be conducted without prior consent when patients are critically ill, and interventions are time critical. Some patients may die before research participation can be discussed with relatives, leaving the bereaved unaware of their involvement. This study explored potential communication strategies for informing bereaved relatives when a patient has died following enrolment into an emergency or critical care study without prior consent.

Design and setting

A mixed-methods study using a telephone survey and semi-structured interviews conducted simultaneously. The survey was conducted within a National Health Service Trust in North West England with relatives of deceased study participants. Semi-structured interviews were conducted with bereaved relatives and research and clinical staff across the UK, and medical examiner (ME)/ME officers based in England and Wales. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis. Data were synthesised using a constant comparison approach.

Participants

11 bereaved relatives completed the survey. 53 individuals (21 research and clinical staff, 18 relatives and 14 MEs/officers) participated in semi-structured interviews.

Results

Although many trials do not include a process for notifying bereaved relatives about research participation, most relatives valued the opportunity to learn about their family member’s participation, emphasising the importance of transparency and trust. However, some raised concerns over the potential burden of automatic disclosure by the ME service. Offering bereaved relatives the option to receive sensitively worded information about research involvement at an appropriate time, soon after death, was recommended.

Conclusion

Bereaved relatives should have the choice to be informed about research participation without prior consent. Our findings support the need for transparent and sensitive communication and will contribute to future guidance for the design and conduct of adult emergency and critical care studies.

Mechanisms of SGLT inhibitor action and physiological mediators: systematic review and protocol for the MOSAIC collaborative meta-analysis

Por: Kugathasan · L. · Nardone · M. · Muskiet · M. · Diaz Martinez · J. P. · Lovblom · L. E. · Orchanian-Cheff · A. · Nielsen · S. · Rotbain · V. · Kazup · A. · Cersosimo · E. · Gullaksen · S. · Vernstrom · L. · van Baar · M. J. B. · van Bommel · E. · Kannenkeril · D. · Scholtes · R. · Hesp
Introduction

Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Methods and analysis

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics and dissemination

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

PROSPERO registration number

CRD420251001413.

Cause-specific excess mortality in rural India during the COVID-19 pandemic 2020-2023: longitudinal analyses of deaths in 0.2 million rural health facilities

Por: Kumar · P. · Suraweera · W. · Karlinsky · A. · Jha · P.
Objective

India had an estimated three to five million excess deaths from causes attributable to SARS-CoV-2 during 2020–2021, far exceeding official government statistics. Most deaths in India occur in rural areas, where medical certification of deaths is limited. Yet, the effects of the pandemic in rural settings remain largely undocumented. We estimated the cause-specific excess mortality in rural areas of selected states of India.

Design

Longitudinal analyses of hospital mortality data.

Settings

India’s Health Management Information System (HMIS) reports the number of deaths by cause for adolescents or adults aged 10 years or more. We examined eight states with high coverage of the expected number of deaths in rural areas.

Participants

We analysed monthly death reports from the HMIS, which covered approximately 0.2 million health facilities during 2018–2023. We compared excess deaths during the peak COVID-19 months in rural health facilities to pre-COVID-19 and non-peak periods of 2021, and categorised reported causes by their probable association with COVID-19.

Primary outcome measure

Excesses of cause-specific and total mortality.

Results

During the April–June 2021 SARS-CoV-2 wave, predominantly driven by the Delta variant, monthly deaths in rural health facilities across India surged from approximately 200 000 to 500 000. In eight states with high-quality reporting, rural facility deaths increased by 270% (95% CI 267% to 272%) compared with the same months in 2018–2019, prior to the COVID-19 pandemic. Notably, this surge occurred despite a sharp decline in hospital admissions following the national lockdown in March 2020. The largest relative increase was for fever-related and respiratory diseases, and these deaths were markedly elevated even when compared to non-peak months of 2021. Generalising these findings from eight states to all of rural India yields an estimate of approximately 2.6 million excess rural deaths in April–June 2021. In contrast, there were few excess deaths during the Omicron viral waves in 2022–2023.

Conclusion

COVID-19 substantially increased deaths in rural India during April–June 2021, but reassuringly, no significant excess mortality was observed in subsequent years. The HMIS provides an important opportunity to strengthen routine mortality surveillance in rural India.

Development and evaluation of a mobile health (mHealth) application for smoking cessation among adolescents in Indonesia: a mixed methods randomised controlled trial study protocol

Por: Ilmaskal · R. · Prabandari · Y. S. · Oktaria · V.
Introduction

Adolescent smoking poses a critical public health challenge in Indonesia, where approximately 7.4% of adolescents are current smokers. This issue is compounded by the tobacco industry’s aggressive marketing strategies, particularly targeting youth. Mobile health (mHealth) interventions offer promising alternatives for smoking cessation because of their accessibility and adaptability. However, while mHealth applications have shown potential in promoting smoking cessation, their efficacy remains inconsistent, particularly among adolescent populations in low- and middle-income countries. This study aims to develop an innovative mHealth intervention model designed explicitly for adolescent users.

Methods and analysis

This study used a mixed-methods, sequential, exploratory approach, including a randomised controlled trial. The research will be conducted in three phases: (1) a qualitative study to inform the app’s design; (2) a development phase using the Rapid Application Development model; and (3) a single-blind, two-arm randomised controlled trial to evaluate the app’s efficacy. Participants will be randomised into either the mHealth intervention group or a paper-based control group using block randomisation to ensure balanced allocation and minimise bias. The protocol is compliant with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for transparency and reporting. The study population will consist of adolescent smokers aged 13–15 years who reside in Padang City. A total of 110 participants will be recruited, with 55 adolescents in the intervention group and 55 in the control group. The primary outcome is smoking abstinence at 1-, 3- and 6-month follow-ups, which will be assessed through a self-report questionnaire. Secondary outcomes include changes in self-efficacy, motivation, social support, nicotine dependence and user engagement with the intervention.

Ethics and dissemination

The study complies with protocols, the Helsinki Declaration, the principles of Good Health Research Practice and regulatory requirements. The protocol was approved by the Medical and Health Research Ethics Committee, Faculty of Medicine, Public Health and Nursing, Gadjah Mada University (Ref No: KE-FK-0864-EC-2025). Informed consent will be obtained from both adolescents and their parents/guardians, ensuring confidentiality and voluntary participation. The results of this study will be published in peer-reviewed journals.

Trial registration number

NCT07198828.

Physical activity advice from general practitioners in Germany: findings from a cross-sectional population survey of individuals with chronic ischaemic heart disease (OptiCor study)

Por: Hoppe · S. · Prinz · A. · Kotz · D. · Mons · U. · Kuss · O. · Crutzen · R. · Kastaun · S.
Objectives

The current German treatment guideline for chronic ischaemic heart disease (IHD) recommends that general practitioners (GPs) deliver brief advice on physical activity (PA) to patients with IHD. Such advice consists of at least three elements (ie, 3As): (1) assessing the PA level, (2) advising on PA and (3) assisting with recommendations. This study examined the extent to which individuals with self-reported IHD in Germany reported the receipt of such advice.

Design

Cross-sectional population-based face-to-face survey (from June 2023 to August 2024).

Setting

Households across Germany.

Participants

1004 individuals aged 35+ years with self-reported IHD and GP contact.

Outcome measures

Primary outcome: self-reported proportions of receipt of GP-delivered PA advice according to the 3As. Main secondary outcome: associations between person characteristics and the likelihood of receiving PA advice.

Results

Among individuals with self-reported IHD, 36.4% (95% CI 33.4% to 39.4%) received all 3As of PA advice, 42.1% (95% CI 39.1% to 45.2%) received one or two elements, 9.9% (95% CI 8.1% to 11.8%) received no advice at all and 3.8% (95% CI 2.7% to 5.1%) were advised to avoid PA (7.9% did not remember/refused to answer). Women (vs men) were more likely to receive no advice (OR=1.74, 95% CI 1.11% to 2.72%), while middle (vs younger) aged individuals (OR=0.46, 95% CI 0.22% to 0.99%), those with PA levels of 1–149 min/week (vs no PA; OR=0.16, 95% CI 0.08% to 0.31%) and of 150+ min/week (vs no PA; OR=0.13, 95% CI 0.07% to 0.23%) and those with higher (vs lower) education (OR=0.39, 95% CI 0.20% to 0.76%) were less likely to receive no advice. Individuals living in urban (vs rural) areas (OR=0.65, 95% CI 0.46% to 0.88%) and those with PA levels of 1–149 min/week (vs no PA; OR=0.59, 95% CI 0.37% to 0.95%) and of 150+ min/week (vs no PA; OR=0.55, 95% CI 0.36% to 0.84%) were less likely to receive only one or two (vs all) of the 3As. Of those who received at least one element of advice (n=788), 72.5% reported they were more active afterwards, with a higher proportion when all 3As (vs only some elements) were provided (86.8% vs 59.6%).

Conclusions

Only one-third of individuals with self-reported IHD in Germany received comprehensive PA advice. Specific person characteristics, such as female gender and lower education, were associated with lower proportions of received PA advice. Efforts are needed to improve GP-led PA guidance, particularly for underserved groups.

Trial registration number

German Clinical Trials Register (DRKS00031304).

Blood pressure control rates among hypertensive patients managed in community health centres in Shenzhen, China: a megacity population-based observational study

Por: He · J. · Zhang · N. · Kang · L. · Yan · W. · Zeng · H. · Wu · L. · Zhu · Z. · Liu · M. · Liang · W.
Background

Hypertension represents a major public health challenge globally, with a rising prevalence in China. This study aims to explore the factors shaping blood pressure (BP) control among hypertensive patients managed in community health centres (CHCs), with a particular emphasis on the association with age.

Methods

This was a population-based, observational study that used healthcare records from CHC in Shenzhen, covering the period from 1 January 2000 to 8 October 2024. Univariate and multivariate logistic regression analyses were employed to assess the independent associations of various factors with BP control rate. Additionally, the study evaluated the relationship between age and BP control across six distinct age subgroups.

Results

The study included 1 073 914 participants who met the eligibility criteria, with 955 415 (88.97%) patients achieving BP control. The median baseline age was 55.9 (IQR 18–109) years. Individuals aged 45 years and above demonstrated better BP control rates (46–55, OR 1.053, 95% CI 1.020 to 1.087; 56–65, OR 1.246, 95% CI 1.205 to 1.289; 66–75, OR 2.183, 95% CI 2.103 to 2.265; >75, OR 2.159, 95% CI 2.060 to 2.262). Among young adults aged 18–35 years, increasing age was consistently associated with poorer BP control across most subgroups. For the middle-aged groups (36–45 and 46–65 years), age had little impact on BP control. In the 66–75 years age range, older age was linked to better BP control in some groups.

Conclusion

The association between age and BP control varied across age groups. Hypertension management strategies should be tailored to address the unique needs of different age groups, geographical regions and targeted populations.

Detecting undiagnosed hypertension using repeated blood pressure measurements: a cross-sectional study in rural Sidama Region, Ethiopia

Por: Birhanu · B. E. · Likka · M. H. · Areru · H. A. · Hibstu · D. T. · Lindtjorn · B.
Objective

To determine the prevalence of undiagnosed hypertension and its risk factors among adults in rural Sidama Region, Ethiopia, using a two-step diagnostic method.

Design

A community-based cross-sectional study was conducted from 1 April to 31 July 2024. Data were collected among adults aged 45 years and above using the World Health Organization STEPwise Approach to Surveillance questionnaire. The Demographic and Health Survey questionnaire was also used to collect data on household characteristics.

Setting

Selected rural kebeles of Shebedino district, Sidama, Ethiopia.

Participants

2875 adults aged ≥45 years identified via census.

Outcome measures

Undiagnosed hypertension was defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, in individuals with no history of the condition.

Results

The prevalence of undiagnosed hypertension ranged from 7.7% (95% CI: 6.7% to 8.7%) to 14.3% (95% CI: 13.0% to 15.6%). The previously diagnosed hypertensive cases were found in 3.3% (95% CI: 2.7% to 4.1%). Female sex (AOR 2.02; 95% CI: 1.44 to 2.82), age ≥ 65 years (AOR 1.48; 95%CI: 1.01 to 2.15), and history of alcohol drinking and khat chewing (AOR 2.94; 95%CI: 1.52 to 5.66) were significantly associated with undiagnosed hypertension. Lack of awareness of salt-related health risks (AOR 3.14; 95% CI: 2.30 to 4.30) and no prior blood pressure measurement (AOR 5.60; 95% CI: 1.73 to 18.07) were also associated with undiagnosed hypertension.

Conclusions

Undiagnosed hypertension is common among adults aged ≥45 years in the rural Sidama Region. Female sex, older age, substance use, limited awareness of salt-related health risks, and lack of prior blood pressure measurement were the identified risk factors. Regular screening should be implemented to detect cases at an early stage.

Enhancement of the capacity of a healthcare team through real-time information-sharing using a wireless intercom system: a prospective simulation study

Por: Sato · H. · Kuwabara · D. · Minoguchi · K. · Masubuchi · T. · Matsumoto · M. · Okuyama · Y. · Kawakami · H. · Abe · T. · Nakamura · K. · Goto · T. · Nakajima · K.
Objectives

Rising patient numbers and limited resources are creating a challenging environment for healthcare providers recently. Anaesthesiologists are also increasingly faced with complex situations, requiring high adaptability in the operating room. To enhance team adaptability during emergencies, effective communication methods are essential. This study aimed to compare the impact of mobile phones and intercoms on the response time and effectiveness of anaesthesiologist teams in emergency situations.

Design

Prospective, observational and simulation study.

Setting

Anaesthesiology and Critical Care, Yokohama City University Medical Center, Yokohama, Japan.

Participants and methods

This study, conducted at Yokohama City University Medical Center (Yokohama, Japan), evaluated how communication methods (intercoms vs mobile phones) impact the efficiency of anaesthesiologists in the simulation setting. Two scenarios were tested: (1) retrieving a video laryngoscope during a difficult intubation and (2) gathering support during cardiac arrest.

Primary and secondary outcome measures

Outcomes measured included time to secure equipment, time for assistance to arrive and staff numbers gathered. The Wilcoxon signed-rank test was used to compare the outcomes between the intercom and mobile phone groups.

Results

In scenario 1, the time to secure the video laryngoscope was significantly shorter with intercom use compared with mobile phones (intercom vs mobile phone, median (IQR): 29 (25–33) s vs 50 (39–62) s; p=0.013, effect size 20 (95% CI 7 to 31)). In scenario 2, the time from the request for assistance until the first supporting staff member reached the operating room was significantly shorter in using the intercoms (intercom vs mobile phone, median (IQR): 16 (14–18) s vs 35 (31–38) s; p=0.04, effect size 17 (95% CI 6 to 24)), and more personnel were available in the intercom group (intercom vs mobile phone, median (IQR): 3 (3–3.5) persons vs 2 (1–2) persons; p=0.04, effect size 1.5 (95% CI 1 to 3)).

Conclusion

Real-time information sharing through intercoms improved the ability of the anaesthesiologist team to respond more rapidly and effectively in emergency situations, enhancing overall team adaptability. This approach may improve patients’ outcomes by shortening response times and increasing team coordination.

Anaesthesia workforce distribution, practices and essential resources in Sierra Leone: a nationwide, cross-sectional, facility-based study

Por: Ovreas · E. · Vreede · E. · van Duinen · A. J. · Svengaard · M. · Furre · M. E. · Kamara · A. K. · Sesay · D. A. · Lonnee · H. · Nathani · P. · Kabba · M. S. · Bolkan · H. A.
Objectives

To assess anaesthesia capacity and practice in Sierra Leone by enumerating the anaesthesia workforce by volume, training level and distribution across urban and rural areas and facility ownership; estimating the prevalence of anaesthesia methods used for common surgical procedures by provider category; and evaluating hospital infrastructure and the availability of essential anaesthesia-related medications and equipment.

Design

A nationwide, cross-sectional, facility-based study combining structured questionnaires administered through face-to-face interviews with facility leads and retrospective review of surgical and anaesthesia logbooks.

Setting

Public and private hospitals and clinics in Sierra Leone providing surgical care with general, regional or local anaesthesia within an operating theatre.

Participants

69 of 78 eligible surgical facilities nationwide were included. Facilities providing surgical services between September 2022 and August 2023 were eligible; facilities without registries or declining participation were excluded.

Results

Across participating facilities, the anaesthesia workforce comprised 198 full-time positions, predominantly non-physician providers, with only 40.4% (80/198) trained to administer anaesthesia independently. Ketamine-based and spinal anaesthesia were most common, while general anaesthesia with a protected airway accounted for just 5.0% (415/8339) of procedures. Anaesthesia practices varied by provider training level. Essential infrastructure, equipment and medications fell below international minimum standards, with shortages most pronounced in rural facilities.

Conclusions

Severe shortages of certified anaesthesia providers, limited anaesthesia techniques and inadequate material resources remain major barriers to safe anaesthesia and surgical care in Sierra Leone. Targeted investments in workforce development, infrastructure and resource allocation—particularly in rural areas—are required to improve the safety, quality and equity of anaesthesia care nationwide.

Cohort profile: Sub-cohort study on the second phase of the Chiba Study of Mother and Child Health (C-MACH), Japan

Purpose

The second phase of the Chiba Study of Mother and Child Health (C-MACH) was initiated to investigate how environmental exposures from the fetal period to early childhood influence maternal and child health outcomes. The sub-cohort focuses specifically on detailed assessments of indoor environmental factors and neighbourhood-built and social environments. By integrating environmental metrics with biological, behavioural and sociodemographic data, the study aims to elucidate their role in the development of allergies, neurodevelopmental disorders and other non-communicable diseases in early life.

Participants

Between June 2021 and April 2023, 505 pregnant women were enrolled in the second phase of the C-MACH main study. Of these, 298 participants consented to join the sub-cohort study, including 258 in the sleep and physical activity monitoring option (Option 1) and 148 in the indoor allergen exposure sub-study (Option 2). The study includes biological sampling, environmental monitoring and repeated questionnaire surveys. At baseline, 253 live births were recorded from 251 pregnancies.

Findings to date

Of the 298 women, 272 completed early pregnancy questionnaires. The mean maternal age was 33.1 years (SD 4.6); 97.8% were married. University-level education was reported by 51.0% of mothers and 53.7% of fathers. Most households had an annual income of 6 to

Future plans

Longitudinal follow-up will continue until the children reach age 15. Future analyses will examine associations between environmental exposures and allergic, developmental, endocrine/metabolic and obesity-related outcomes.

Optimising internet-based cognitive-behavioural therapy programme to prevent perinatal depression: a unified protocol for two harmonised randomised controlled trials

Por: Toyomoto · R. · Furukawa · T. A. · Noma · H. · Tajika · A. · Watanabe · M. · Honda · Y. · Banno · C. · Ogasawara · S. · Kitaori · T. · Sugiura-Ogasawara · M. · Goto · S.
Introduction

Perinatal depression poses substantial risks to both mothers and their offspring. Given its chronic and recurrent nature, developing effective prevention strategies is crucial. Internet-based cognitive–behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear.

Methods and analysis

This protocol describes two harmonised multicentre, open-label, six-arm randomised controlled trials. Across both trials, a total of 2400 pregnant women between 10 and 20 weeks of gestation will be enrolled. After completing psychoeducation (PE), participants will be randomised to either the control condition (PE only) or one of five CBT programmes: behavioural activation (BA), assertion training, BA+cognitive restructuring, BA + problem solving or BA + behaviour therapy for insomnia. The objectives of the study are: (1) to ascertain that the iCBT approach is effective in perinatal depression, (2) to identify active CBT skills for perinatal women and (3) to examine interactions between these CBT skills and individuals’ baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1 month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale.

Ethics and dissemination

The study has been approved by the Kyoto University Graduate School of Medicine Ethics Committee (C1710) and Nagoya City University Certified Review Board (2024A007). Anonymised study results will be presented at conferences and published by the investigators in peer-reviewed journals.

Trial registration number

jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).

Trends and predictors of caesarean section in Thailand before and during the COVID-19 pandemic: a retrospective analysis of national hospitalisation data under the Universal Coverage Scheme

Por: Karunayawong · P. · Sukmanee · J. · Butchon · R. · Saeraneesopon · T. · Boonma · C. · Kunanusont · C. · Lumbiganon · P. · Morton · A. · Teerawattananon · Y. · Isaranuwatchai · W.
Objectives

Since 1985, the international healthcare community has recommended the ideal rate of caesarean section (CS) to be 10%–15% at the national level. The literature has reported that overused CS without necessary medical indications can be harmful to both maternal and child health. To generate evidence to support policy on CS, this study evaluated the trend over time of CS in Thailand during January 2016 to October 2021 (which included the COVID-19 pandemic period) and explored predictors of CS use.

Design and setting

This study was a retrospective secondary data analysis of de-identified hospitalisation data under the Universal Coverage Scheme (UCS) from the National Health Security Office’s e-Claims database. Descriptive analyses were conducted to explore the number and rate of CS over time and across different characteristics (ie, age, hospital type, COVID-19 status and delivery day) including a multivariable logistic analysis to explore predictors of CS. Interrupted time series analysis was adopted to investigate the effect of the COVID-19 pandemic on CS rate.

Participants

569 321 CS cases under UCS from 2016 to 2021.

Results

The results showed an increasing trend of CS rate, from 30% in January 2016 to 35% in October 2021. Both clinical (eg, medical indication and age) and non-clinical (eg, region and day of delivery) factors were significantly associated with CS. Furthermore, the COVID-19 pandemic had no significant effect on CS rate (level: –0.0016, 95% CI –0.0085 to 0.0053, p=0.66).

Conclusion

This study highlighted an increasing trend of CS in Thailand and could present supportive evidence that Thailand might have been facing an overuse of CS. More awareness and actions are warranted to ensure the movement towards reduction of unnecessary CS in Thailand.

Genetic, lifestyle and environmental influences on health: a Finnish biobank recall study protocol (BioRecall)

Por: Sillanpää · E. · Föhr · T. · Kurtti · E. · Aittola · K. · Mäkelä · J. · Southerington · T. · Lakka · T. A. · Jokela · T. · Ahtiainen · M. · Laakkonen · E. · Rantakokko · M. · Ravi · S.
Introduction

Non-communicable diseases are the leading causes of premature mortality worldwide. Both genetic predispositions and environmental exposures affect disease risk. While biobanks have increased understanding of genetic predictors of these diseases, environmental influences are expected to have a greater impact on disease development. Individuals also create their own environments and lifestyles based on genetically regulated preferences, leading to gene–environment interactions that require large datasets to study. Finnish biobanks typically lack sufficient lifestyle and environmental data, which limits their use. We present a protocol for a biobank-recall study (BioRecall) to collect data on lifestyle and environmental exposures and combine these findings with genotypes, biological samples and clinical outcomes.

Methods and analysis

All previously genotyped donors from the Central Finland Biobank who have been diagnosed with type 2 diabetes and have consented to recall will be invited to participate in the pilot study. The preliminary feasibility assessment reveals that there are 1580 suitable candidates. Participants will complete an electronic questionnaire on a secure online platform. The questionnaire includes validated questions on lifestyles, anthropometrics, weight loss history, health, symptoms, work characteristics, emotional states and residential environments. Postcode information will facilitate the addition of spatial environmental data. Genotype and related clinical data will be provided in the study in accordance with the Finnish Biobank Act and combined with questionnaire data.

Ethics and dissemination

The Human Sciences Ethics Committee of the University of Jyväskylä delivered a favourable statement regarding the study protocol (1671/13.00.04.00/2023). Central Finland Biobank approved the research plan (no: BB24-0333-A01). The data collected will be returned to the Central Finland Biobank for research purposes with the participants’ consent. Permission for data usage can then be applied through standard protocols of the Fingenious service (https://site.fingenious.fi/en/). If successful, the study will be expanded to other donors and Finnish biobanks.

Long-term habitual physical activity and risk of mortality and long-term care insurance certification in cancer survivors: a prospective cohort study in the LIFE study, Japan

Por: Nakatsuka · K. · Ono · R. · Maeda · M. · Murata · F. · Nishimura · K. · Fukuda · H.
Objectives

This study aimed to investigate the effects of long-term and habitual physical activity on mortality and long-term care insurance (LTCI) certification among cancer survivors using a population database.

Design

5-year retrospective study.

Setting

13 Japanese municipalities participated in the Longevity Improvement & Fair Evidence study.

Participants

Among 471 511 participants who underwent health check-ups, 39 435 met the following eligible criteria: documented in the cancer claims database without a suspected diagnosis and participated in a health check-up at least once in a 12-month period, had no missing exercise data and had already been certified for LTCI.

Main outcome measures

Outcomes were new LTCI certification and all-cause mortality. LTCI certification was assigned by a trained local government official through a systematic process (involving various items—physical function, daily activity function, cognitive function, behavioural disorders, adjustment to social life and daily use of medical services—as well as overall consideration of computer-based and specialist team assessments), and the LTCI severity level correlates with the Barthel index. LTCI certification reflects some impairment in activities of daily living. All-cause mortality was defined based on claims data.

Results

Three physical activity categories, ‘exercise and walking’, ‘exercise or walking’ and ‘no physical activity’, were used. Among survivors aged 65–74 years, the ‘no physical activity’ group had a higher risk of mortality and LTCI certification than the ‘exercise and walking’ group (adjusted model HR: 1.72, 95% CI 1.52 to 1.94). Among survivors aged ≥75 years, the low physical activity groups had a higher risk of mortality and LTCI certification than the ‘exercise and walking’ group (adjusted model: ‘exercise or walking’, HR: 1.51, 95% CI 1.29 to 1.85; ‘no physical activity’, HR: 1.66, 95% CI 1.43 to 1.92). The effects of physical activity differed according to cancer type.

Conclusions

Habitual physical activity had positive effects on cancer survivors. These effects differed according to age and cancer type.

Impact of treatment-induced thrombosis on the prognosis of acute lymphoblastic leukaemia: a protocol for a systematic review and meta-analysis

Por: Mkhwanazi · Z. A. · Fabunmi · O. A. · Nkambule · B. B.
Introduction

Therapy-associated thrombosis remains a challenge in the management of patients with acute lymphoblastic leukaemia (ALL). Thrombosis associated with asparaginase-containing chemotherapy complicates patient management strategies, prompting the need for effective prophylaxis. Assessing the relationship between chemotherapy-induced thrombosis and patient outcomes is crucial for optimising ALL management strategies. The aim of this systematic review is to provide a synthesis on whether the development of thrombosis during asparaginase-containing chemotherapy regimens impacts the overall and event-free survival of patients with ALL.

Methods and analysis

Data sources: to identify relevant studies, a comprehensive search will be conducted on the major electronic databases, including MEDLINE (PubMed), Web of Science (Clarivate), Academic Search Complete (EBSCOhost), clinicaltrial.gov and the Cochrane Central Register of Controlled Trials from inception to 30 January 2026.

Inclusion criteria for selecting studies: randomised and non-randomised clinical studies evaluating the impact of asparaginase-containing chemotherapy-associated thrombosis on survival outcomes in patients with ALL will be included. Two reviewers will independently screen the retrieved studies, extract data and assess study quality using a predefined criteria. A narrative synthesis will be undertaken, and if feasible, meta-analyses will be conducted. A subgroup and sensitivity analysis will be performed to explain the sources of heterogeneity. The quality of cumulative evidence will be assessed using the grading of recommendations assessment, development and evaluation tool. The findings from this systematic review will inform evidence-based clinical guidelines for thrombosis risk assessment and management in patients with ALL, potentially improving treatment outcomes and reducing thrombosis-related morbidity.

Ethics and dissemination

No ethical approval will be required and the findings of this meta-analysis will be published in a peer-reviewed journal.

Trial registration number

CRD42024532665.

Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial-the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 tr

Por: Shimomura · M. · Ishikawa · S. · Miguchi · M. · Shinozaki · K. · Ikeda · S. · Kobayashi · H. · Nakahara · M. · Sumitani · D. · Shimizu · W. · Kohyama · M. · Saito · Y. · Mukai · S. · Hirata · Y. · Kochi · M. · Shimizu · Y. · Takakura · Y. · Yoshimitsu · M. · Kodama · S. · Uegami · S. · Yano
Background

Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN.

Methods

This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026.

Ethics and dissemination

This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.

Trial registration number

jRCTs062240066

A cultural lens on decision-making in treatment decisions about inflammatory bowel disease: a qualitative analysis with South Asian patients, caregivers and clinicians in Canada

Por: Suryaprakash · N. · Ruzycki · S. M. · Raman · M. · Singh · S. · Nasser · Y. · Rai · P. P. K. · Sidhu · K. · Sidhu · S. · Marshall · D. A.
Objective

There are limited data about how South Asian (SA) patients, their caregivers and their physicians make decisions about treatment, in particular advanced therapies. The study aimed to explore how SA people with inflammatory bowel disease (IBD), their family members and clinicians experience and perceive treatment-related decision-making with the aim of identifying strategies to improve treatment decision-making in Canada.

Design

A descriptive qualitative study with in-depth semi-structured interviews.

Setting

Canada.

Participants

Adults residing in Canada, who self-identified as SA, had received treatment or cared for someone who received treatment for IBD from a gastroenterologist in Canada, and who spoke and understood English, Hindi and/or Punjabi were eligible to participate in the study. Clinician participants (eg, nurses, gastroenterologists, colorectal surgeons) were eligible if they had experience treating SA patients with IBD.

Interventions

Data from 1:1, semi-structured interviews were analysed using deductive and inductive thematic analysis.

Results

The length of time spent in Canada played a central role in patient perspectives on decision-making around IBD treatment. First or second-generation SA people, residency status, family and community involvement, universal factors like stigma, medication costs and preferences for non-pharmacological treatments influenced decision-making. Patient and caregiver participants reported high satisfaction with treatment-related decision-making processes, while clinician participants self-reported lesser satisfaction.

Conclusions

Clinicians and researchers working with SA patients in chronic disease specialties can use these findings to meet the healthcare needs and reduce disparities in optimal treatment for this patient population.

Trial registration

N/A.

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