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Optimizing vitamin A supplementation: A comparative cost-effectiveness analysis of routine distribution strategies in northern Côte d’Ivoire

by Melissa M. Baker, Lyonel Nerolin Doffou Assalé, David Doledec, Romance Dissieka, Ahmenan Claude Liliane Konan, Agnes Helen Epse Assagou Mobio, Koffi Landry Kouadio, Oka René Kouamé, Ama Emilienne Yao, Hubert Zirimwabagabo

Background

While recent data on vitamin A deficiency (VAD) prevalence is lacking, the 2004 Côte d’Ivoire Nutrition and Mortality Survey reported that 26.7% of children aged 6–59 months were affected by VAD, and approximately 60% were at risk. Since 2016, the government has transitioned from mass campaigns to routine vitamin A supplementation (VAS) delivery integrated into health services. However, evidence on the cost-effectiveness of the routine distribution approaches is limited. This study evaluated the cost, coverage, and cost-effectiveness of three routine VAS delivery strategies across two health districts in northern Côte d’Ivoire.

Methods

A mixed-methods study evaluated three routine VAS delivery strategies – routine-fixed, advanced community-based, and catch-up – across two health districts, Ferkessédougou and Niakaramadougou, in northern Côte d’Ivoire. The quantitative cost data were collected via a structured tool covering six cost categories: planning, procurement, training, social mobilization, distribution, and supervision. VAS coverage was assessed through a post-event coverage survey (PECS) via a two-stage cluster sampling methodology. A cost-effectiveness analysis determined the cost per child supplemented, the cost per DALY averted, and a sensitivity analysis tested the robustness of the findings under different cost scenarios.

Results

The total program cost for July-December 2023 was 25.5 million FCFA, with personnel costs comprising over 70% of expenditures. In Ferkessédougou, the routine advanced community-based strategy was the most cost-effective, at 458 FCFA per child in rural areas (versus 596 FCFA for the routine-fixed facility-based approach in the same area). In Niakaramadougou, the December catch-up was more cost-effective in rural areas (606 FCFA per child) than the routine-fixed approach (714 FCFA). Across both districts combined, the routine-fixed strategy averaged roughly 651 FCFA per child supplemented, and the cost per DALY averted ranged from 30,093 FCFA (advanced strategy in Ferkessédougou) to 89,550 FCFA (catch-up Jul 2023 in Niakaramadougou) – all below Côte d’Ivoire’s cost-effectiveness threshold (0.5 x GDP per capita; approximately USD 1,265).

Conclusion

All three strategies were cost-effective, though the advanced community-based strategy achieved the best balance of reach and efficiency. Scaling advanced strategies within health system constraints may enhance sustainability and coverage in low-resource settings.

Association between the continuum of maternal healthcare services and child immunisation in East Africa: a propensity score matching analysis

Por: Gebrehana · A. K. · Abrham Asnake · A. · Seifu · B. L. · Fente · B. M. · Bezie · M. M. · Asmare · Z. A. · Tsega · S. S. · Negussie · Y. M. · Asebe · H. A. · Melkam · M.
Objective

To assess the association between the maternal continuum of healthcare and child immunisation in East Africa using propensity score matching (PSM).

Design

Cross-sectional study using Demographic and Health Survey data.

Setting

This study was conducted in East African countries.

Participants

This study included a weighted sample of 13 488 women with children aged 12–23 months.

Outcome measure

Child immunisation was the outcome variable of this study.

Results

The PSM estimates indicate that the average treatment effect on the treated for complete child immunisation was 0.0583, meaning that children of mothers who received a complete maternal continuum of care had a 5.83% higher probability of being fully immunised compared with children of mothers with incomplete care. Expressed relative to the treated group’s mean, this corresponds to a 7.48% increase. Additionally, our results indicated that the population average treatment effect was 0.0629. This means that, on average, a complete continuum of maternal healthcare increases the probability of full child immunisation by approximately 6.29% across the entire population.

Conclusion

The study highlights that children whose mothers receive comprehensive maternal healthcare are more likely to complete their childhood immunisations. This finding underscores the need to integrate immunisation services into maternal healthcare programmes to enhance vaccination coverage and promote better child health. To maximise this connection, improving access to maternal healthcare, especially in underserved regions, is crucial, along with ensuring that immunisation is a regular part of maternal care.

Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial

Por: McDonald · E. G. · Cheng · M. P. · Davis · J. S. · Goodman · A. L. · Lawler · P. R. · Marsh · J. · Mertz · D. · Paul · M. · Rodriguez-Bano · J. · Siegal · D. M. · Tong · S. Y. · Walls · G. · Lee · T. C. · The SNAP Global Trial Steering Committee · Bonten · Daneman · van Hal · Heriot
Introduction

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

Methods and analysis

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

Ethics and dissemination

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

Trial registration number

NCT0665050.

Preoperative anaemia and its impact on immediate surgical outcomes in elderly patients: a multicentre prospective cohort study in Ethiopia

Por: Wubet · H. B. · Gobezie · N. Z. · Deress · G. M. · Mekuriaw · B. Y. · Abuhay · A. G. · Afework · W. A. · Siyoum · T. M. · Gedefaw · G. D. · Abate · A. T. · Demissie · B. · Demtie · D. G. · Asmare · T. B.
Objective

To assess how preoperative anaemia affects surgical outcomes in elderly patients within a resource-limited setting.

Design

Prospective cohort study.

Setting

Two comprehensive specialised hospitals in Ethiopia.

Participants

Participants consisted of 224 patients aged 65 years and older who underwent surgery between 1 December 2024 and 29 March 2025.

Primary and secondary outcome measures

Perioperative blood transfusions were the primary outcome. Secondary outcomes included intensive care unit (ICU) admission, risk of postoperative complications, prolonged hospitalisation, poor recovery quality and in-hospital mortality.

Results

The anaemic group required transfusions of three or more units more frequently than the non-anaemic group (10.5% vs 2.6%; absolute risk difference 8.0%). Their perioperative transfusion rates were significantly higher (42.3% vs 18.4%; p

Conclusion and recommendation

Preoperative anaemia significantly increases the risk of transfusion, poor recovery, ICU admission, prolonged hospitalisation and in-hospital mortality in older patients who underwent surgery. In resource-limited settings, improving perioperative outcomes should prioritise the early detection and treatment of anaemia.

Prevalence and determinants of precancerous cervical lesions among women screened for cervical cancer in Africa: A systematic review and meta-analysis

by Berihun Agegn Mengistie, Getie Mihret Aragaw, Tazeb Alemu Anteneh, Kindu Yinges Wondie, Alemneh Tadesse Kassie, Alemken Eyayu Abuhay, Wondimnew Mersha Biset, Gebrye Gizaw Mulatu, Nuhamin Tesfa Tsega

Background

Precancerous cervical lesions, or cervical intraepithelial neoplasia (CIN), represent a significant precursor to cervical cancer, posing a considerable threat to women’s health globally, particularly in developing countries. In Africa, the burden of premalignant cervical lesions is not well studied. Therefore, the main purpose of this systematic review and meta-analysis was to determine the overall prevalence of precancerous cervical lesions and identifying determinants among women who underwent cervical cancer screening in Africa.

Methods

This study followed the Preferred Reporting Item Review and Meta-analysis (PRISMA) guidelines. The protocol for this systematic review and meta-analysis was registered on the International Prospective Register of Systematic Reviews (PROSPERO) (ID: CRD42025645427). We carried out a systematic and comprehensive search on electronic databases such as PubMed and Hinari. In addition, Google Scholar and ScienceDirect were utilized to find relevant studies related to precancerous cervical lesions. Data from the included studies were extracted using an Excel spreadsheet and analyzed using STATA version 17. The methodological quality of the eligible studies was examined using the Joanna Briggs Institute (JBI) assessment tool. Publication bias was checked by using the funnel plot and Egger’s tests. A random-effects model using the Der Simonian Laird method was used to estimate the pooled prevalence of pre-cancerous cervical lesions in Africa. The I-squared and Cochrane Q statistics were used to assess the level of statistical heterogeneity among the included studies.

Results

A total of 112 eligible articles conducted in Africa, encompassing 212,984 study participants, were included in the quantitative meta-analysis. Thus, the pooled prevalence of pre-cancerous cervical lesions in Africa was 17.06% (95% confidence interval: 15.47%−18.68%). In this review, having no formal education (AOR = 4.07, 95% CI: 1.74, 9.53), being rural dweller(AOR = 2.38, 95% CI: 1.64, 3.46), history of STIs (AOR = 3.94, 95% CI: 2.97, 5.23), history of having multiple partners (AOR = 2.73, 95% CI: 2.28, 3.28), early initiation of coitus (AOR = 2.77, 95% CI: 2.11, 3.62), being HIV-seropositive women (AOR = 3.33, 95% CI: 2.32, 4.78), a CD4 count Conclusions

In Africa, the overall prevalence of pre-cancerous cervical lesions is high (17%). The findings of this review highlight that health professionals, health administrators, and all other concerned bodies need to work in collaboration to expand comprehensive cervical cancer screening methods in healthcare facilities for early detection and treatment of cervical lesions. In addition, increasing community awareness and health education, expanding visual inspection of the cervix with acetic acid in rural areas, offering special attention to high-risk groups (HIV-positive women), encouraging adherence to antiretroviral therapy for HIV-positive women, overcoming risky sexual behaviors and practices, and advocating early detection and treatment of precancerous cervical lesions.

Gender- and sex-sensitive psychopharmacotherapy of alcohol use disorder: a systematic review and meta-analysis protocol

Por: Hiss · I. C. · Hoffmann · S. · Reinhard · I. · Siegmann · E.-M. · Bach · P. · Kiefer · F. · Fischer · R. · Jäger · K. · Lenz · B.
Introduction

Alcohol use disorder (AUD) is a prevalent, chronic condition generating considerable global morbidity, mortality and socioeconomic burden. Despite the availability of established pharmacotherapies, overall treatment uptake remains low and effect sizes are moderate at best. Emerging evidence highlights substantial differences in treatment response between sexes and genders, yet these factors are rarely systematically considered in clinical trials or routine care. Existing reviews have limited scope and often exclude gender-diverse populations. This project aims to (1) Synthesise evidence on gender- and sex-specific efficacy, safety and adherence in AUD pharmacotherapies, (2) Evaluate the consideration of sex and gender beyond binary classifications in existing research and (3) Develop recommendations for gender- and sex-sensitive treatment strategies.

Methods and analysis

A systematic review and meta-analysis will be conducted using (PubMed, Web of Science, Scopus, Google Scholar, German Clinical Trials Register and ClinicalTrials.gov). We will include randomised controlled trials of pharmacotherapies for AUD with a minimum treatment duration of 4 weeks, reporting gender-specific and/or sex-specific results. The literature search will cover studies published up to October 2025, with inclusion restricted to articles published in English or German, regardless of setting. Two reviewers will independently screen records and assess risk of bias (Cochrane RoB), with evidence certainty evaluated using Grading of Recommendations Assessment, Development and Evaluation and aligned to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 and Sex and Gender Equity in Research guidelines.

Ethics and dissemination

Ethics approval is not required as only data from already completed studies and supplementary information directly provided by study authors are used. Findings and recommendations will be disseminated in peer-reviewed journals and presented at conferences and workshops.

PROSPERO registration number

CRD420251079160.

How do musculoskeletal disorders impact on quality of life in Tanzania? Results from a community-based survey

Por: Grieve · E. · Deidda · M. · Krauth · S. J. · Biswaro · S. M. · Halliday · J. E. B. · Hsieh · P.-H. · Kelly · C. · Kilonzo · K. · Kiula · K. P. · Kolimba · R. · Msoka · E. F. · Siebert · S. · Walker · R. · Yongolo · N. M. · Mmbaga · B. · McIntosh · E. · NIHR Global Health Group · Biswaro
Objectives

There are little available data on the prevalence, economic and quality of life impacts of musculoskeletal disorders in sub-Saharan Africa. This lack of evidence is wholly disproportionate to the significant disability burden of musculoskeletal disorders as reported in high-income countries. Our research aimed to undertake an adequately powered study to identify, measure and value the health impact of musculoskeletal conditions in the Kilimanjaro region, Tanzania.

Design

A community-based cross-sectional survey was undertaken between January 2021 and September 2021. A two-stage cluster sampling with replacement and probability proportional to size was used to select a representative sample of the population.

Setting

The survey was conducted in 15 villages in the Hai District, Kilimanjaro region, Tanzania.

Participants

Economic and health-related quality of life (HRQOL) questionnaires were administered to a sample of residents (aged over 5 years old) in selected households (N=1050). There were a total of 594 respondents, of whom 153 had a confirmed musculoskeletal disorder and 441 matched controls. Almost three-quarters of those identified as having a musculoskeletal disorder were female and had an average age of 66 years.

Primary and secondary outcome measures

Questions on healthcare resource use, expenditure and quality of life were administered to all participants, with additional more detailed economic and quality of life questions administered to those who screened positive, indicating probable arthritis.

Results

There is a statistically significant reduction in HRQOL, on average 25% from a utility score of 0.862 (0.837, 0.886) to 0.636 (0.580, 0.692) for those identified as having a musculoskeletal disorder compared with those without. The attributes ‘pain’ and ‘discomfort’ were the major contributors to this reduction in HRQOL.

Conclusions

This research has revealed a significant impact of musculoskeletal conditions on HRQOL in the Hai district in Tanzania. The evidence will be used to guide clinical health practices, interventions design, service provisions and health promotion and awareness activities at institutional, regional and national levels.

Birth prevalence and parental stress associated with neural tube defects in Amhara’s public comprehensive specialized hospitals, Ethiopia, 2024

by Hailemariam Gezie, Endalk Birrie Wondifraw, Muluken Amare Wudu, Habtam Gelaye, Fekadeselassie Belege Getaneh

Background

Neural tube defects (NTDs) are severe congenital anomalies resulting from the incomplete closure of the embryonic neural tube, affecting around 300,000 newborns globally each year and leading to significant mortality and disability. While high-income countries have seen a reduction in NTD prevalence, developing nations like Ethiopia continue to face high rates. Families impacted by NTDs often endure emotional challenges, including grief, anxiety, and social isolation. This study aims to investigate the birth prevalence of NTDs and the associated parental stress, emphasizing the wider effects on families.

Methodology

An institution-based cross-sectional study was conducted in Dessie and Deber Berhan comprehensive specialized hospitals from July 24, 2023, to July 24, 2024, to evaluate the birth prevalence of NTDs and the associated parental stress among parents of children aged 1 month to 12 years diagnosed with NTDs. A total of 308 parent-child pairs participated in the study. Data were gathered using a pretested questionnaire and an 18-item Parenting Stress Scale. Statistical analysis was performed using Stata version 17, where linear regression was utilized to identify significant predictors after verifying the necessary assumptions. The findings were presented in multiple formats for clarity and comprehensibility.

Results

The overall birth prevalence of neural tube defects was found to be 0.0052 (95% CI: 0.0038, 0.0067), which translates to 52 cases per 10,000 deliveries. Key factors associated with increased parental stress included being a mother (β = 2.51), older parental age (β = 0.18), the child’s age (β = 0.81), a prior history of having children with NTDs (β = 7.88), and the presence of a ventriculoperitoneal shunt in the child (β = 4.66).

Conclusion

The findings of this study indicate that the birth prevalence of NTDs is becoming a significant public health concern. Additionally, several factors contributing to increased parental stress were identified, including older parental age, the child’s age, a previous history of NTDs in siblings, and the presence of a ventriculoperitoneal shunt. These results highlight the urgent need for targeted support and resources for affected families to help mitigate the psychological impact associated with these conditions.

Treatment outcome of acute coronary syndrome and associated factors among patients admitted to public hospitals in Harari Regional State, Eastern Ethiopia: a retrospective cross-sectional study

Por: Tessema · T. B. · Ahmed · A. · Adem · H. A. · Firdisa · D. · Abebe · T. · Mossie · Y. · Wondimneh · F.
Background

Acute coronary syndrome (ACS) is the leading cause of morbidity and mortality among individuals with cardiovascular disease, accounting for half of all global cardiovascular-related deaths. No prior research has examined ACS treatment outcomes and associated factors in the study area. This study aimed to evaluate the risk factors and treatment outcome of ACS patients admitted to public hospitals in Harari Regional State, Eastern Ethiopia.

Methods

A retrospective hospital-based cross-sectional study was conducted among 308 ACS patients. Patient records from admissions between 1 November 2018 and 31 October 2023 were reviewed, with data collected between 10 January and 10 February 2024 using a structured checklist adapted from previous research. Statistical analysis was performed using SPSS V.25.0, with bivariable and multivariable logistic regression identifying significant associations at a p value

Results

The mean patient age was 56.4±16 years, with males comprising 77.3% of participants. Half (51.6%) resided in rural areas, and only 16.2% presented within 12 hours of symptom onset. Overall, 81 patients (26.3%) experienced a poor treatment outcome for ACS, including 39 (12.7%) in-hospital deaths, 24 (7.8%) referrals to higher-level facilities and 18 (5.8%) who left against medical advice. Factors significantly associated with poor outcome included hospital presentation more than 72 hours after symptom onset (AOR 2.734 (95% CI 1.006 to 7.435)), left ventricular ejection fraction (LVEF)

Conclusion

Poor treatment outcome was independently predicted by the presence of ischaemia features on the echocardiography, LVEF (

Study protocol for a randomised controlled trial to determine the efficacy of lisdexamfetamine for the treatment of acute methamphetamine withdrawal in inpatient settings

Por: Acheson · L. S. · Siefried · K. J. · Lintzeris · N. · Dunlop · A. J. · Haber · P. S. · Arunogiri · S. · Christmass · M. · Doyle · M. · Donoghoe · M. · Nagle · J. · Clifford · B. · McKetin · R. · Lubman · D. I. · Brett · J. · Taylor · N. · Carr · A. · Levin · F. R. · Shoptaw · S. · Ezard · N
Introduction

Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.

Methods and analysis

We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.

Ethics and dissemination

This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.

Trial registration number

ACTRN12624001061527.

A Comprehensive Assessment of the Environmental Impact of Different Infant Feeding Types: The Observational Study GREEN MOTHER

ABSTRACT

Aim(s)

To observe and compare the environmental impacts of different types of infant feeding, considering the use of formula, infant feeding accessories, potentially increased maternal dietary intake during breastfeeding (BF) and food consumption habits.

Design

An observational cross-sectional multicentre study conducted in the Barcelona Metropolitan Area of the Catalan Institute of Health.

Methods

Data were collected from 419 postpartum women on infant feeding type (formula milk and accessories), maternal dietary intake (24-h register) and food consumption habits from November 2022 to April 2023. The environmental impacts (climate change (CC), water consumption and water scarcity) of the infant feeding types and maternal diet were calculated using the IPCC, ReCiPE and AWARE indicators, respectively. The differences in impacts were calculated by Kruskal–Wallis test.

Results

Significant differences for the three environmental impacts were observed. The CC impact of formula milk and feeding accessories was 0.01 kg CO2eq for exclusive BF, 1.55 kg CO2eq for mixed feeding and 4.98 kg CO2eq for formula feeding. While BF mothers consumed an extra 238 kcal, no significant differences were found related to maternal diet across feeding types.

Conclusion

Exclusive BF was the most sustainable type of infant feeding, considering formula and infant feeding accessories. In our study, the difference between the impacts of BF and non-BF mothers' diet was insignificant.

Implications for the Profession and/or Patient Care

Offer informative and educational support for midwives and other healthcare professionals on BF and a healthy, sustainable diet to transfer this knowledge to the general public.

Impact

Raise the general public's awareness about BF and a healthy, sustainable diet. To reduce environmental impacts through behavioural changes.

Reporting Method

STROBE.

Patient or Public Contribution

Patients of the Catalan Health Service reviewed the content of the data collection tools.

Trial Registration: (for the whole GREEN MOTHER project): NCT05729581 (https://clinicaltrials.gov)

LSTA1-GBM-2A: study protocol for an exploratory phase 2a randomised controlled trial evaluating tumour-homing peptide certepetide with temozolomide in glioblastoma multiforme

Por: Truusalu · J. P. · Oselin · K. · Lass · J. · Buck · K. K. · Sietsema · W. · Soeorg · H. · Toome · K. · Kaarna · K. · Teesalu · T. · Korgvee · L.-T.
Introduction

Glioblastoma multiforme (GBM) is an aggressive primary brain tumour associated with a poor prognosis despite standard-of-care treatment, including surgical resection, radiotherapy and temozolomide (TMZ) chemotherapy. Certepetide (also known as LSTA1, CEND-1) is an investigational tumour-penetrating peptide that facilitates the extravascular delivery and intratumoural penetration of co-administered immune/chemotherapeutics; however, it has not yet been evaluated in clinical trials for the treatment of intracranial malignancies.

Methods and analysis

LSTA1-GBM-2A is an exploratory phase 2a, double-blind, placebo-controlled, randomised, proof-of-concept investigator-initiated trial assessing the safety, tolerability and preliminary efficacy of certepetide in combination with standard-of-care TMZ, compared with TMZ with a matching placebo, in subjects with newly diagnosed GBM.

The trial is funded by Lisata Therapeutics, sponsored by Tartu University Hospital and conducted at hospitals in Estonia and Latvia. Subjects are randomised in a 2:1 ratio. Following initial surgery and radiotherapy with concurrent TMZ, the subjects receive intravenous certepetide or placebo alongside six cycles of adjuvant TMZ treatment. The primary endpoint is overall survival. The target number of subjects is 30. The first subject was recruited in January 2024, and accrual is ongoing.

Ethics and dissemination

This study was approved by the Republic of Estonia State Agency of Medicines (17 October 2023) and the State Agency of Medicines of the Republic of Latvia (1 February 2024). The results of this study will be published in peer-reviewed journals and reported at academic conferences.

Trial registration number

2023-506813-23-00.

VReeze: an open-source virtual reality for the examination of freezing of gait in Parkinsons disease - a study design of a crossover repeated measures study for validation

Por: Siragy · T. · Russo · Y. · Hirschbichler · S. · Nantel · J. · Wegscheider · P. · Schweiger · H. · Simonlehner · M. · Kisiel · M. · Horsak · B.
Introduction

Parkinson’s disease is the second most prevalent neurodegenerative disease worldwide, with up to 70% of patients exhibiting freezing of gait (FOG). FOG is defined as transient episodes when one is unable to effectively engage in the stepping process (despite the intention to walk), which decreases or completely ceases forward movement. Although several FOG triggers have been identified, eliciting FOG remains challenging in research, hindering progress in research and therapy. Virtual reality (VR) offers a promising approach to evoke FOG during overground walking by combining environmental and neuropsychological triggers. This project aims to validate an existing open-source VR-FOG toolbox that integrates multiple triggers.

Methods

A within-subject repeated measures crossover study design with a 1-hour washout period will be used for this project to validate the VR-FOG toolbox. This will consist of three blocks (baseline non-VR, VR non-FOG and VR-FOG). All participants will first complete a baseline walking trial without VR, then be randomised to either the VR non-FOG environment—a virtual replica of the laboratory—or the VR-FOG environment containing multiple virtual FOG triggers. After a 1-hour washout period, they will complete the remaining VR condition. A crossover design will minimise ordering effects of VR conditions on FOG frequency and duration. Twenty participants with Parkinson’s disease with FOG will be tested at St. Pölten University of Applied Sciences (Austria) and 20 at the University of Exeter (UK) and will be recruited from local communities. Multisite testing will verify that the VR-FOG environment triggers FOG regardless of testing location.

Ethics and dissemination

Ethical approval was obtained from the Lower Austrian Ethics Commission and the University of Exeter review boards. All data will be anonymised, used solely for this project and securely stored in General Data Protection Regulation-compliant repositories. Study results will be presented at scientific conferences and published in peer-reviewed journals.

Prevalence, determinants and consequences of delayed treatment intensification among type 2 diabetes mellitus patients at the University of Gondar Comprehensive Specialised Hospital, Northwest Ethiopia, 2024: a mixed-methods study

Por: Mussie · D. A. · Zerihun · T. E. · Kassaw · A. T. · Muche · E. A.
Objective

To ascertain the clinical impact, prevalence and associated determinants of delayed treatment intensification, defined as delaying the escalation of treatment plans for individuals with type 2 diabetes mellitus who fail to attain ideal glycaemic control, at the University of Gondar Comprehensive Specialised Hospital in Northwest Ethiopia.

Design

A mixed-methods study.

Setting

University of Gondar Comprehensive Specialised Hospital.

Participants

420 patients with type 2 diabetes mellitus with poor glycaemic control after the index date were included in this study. A simple random sampling technique was employed to select the required sample size. Data were collected retrospectively and entered into EpiData V.4.6 and exported to Stata V.14.2 for analysis.

Method

Multivariable logistic regression was used to identify factors associated with delayed treatment intensification. A p value of 0.05 in the multivariable analysis was considered statistically significant. Qualitative data were collected through in-depth interviews with eight selected healthcare providers, and thematic analysis was undertaken to identify the underlying barriers to timely treatment intensification.

Primary outcome

Delayed treatment intensification.

Results

The prevalence of delayed treatment intensification was 51.4% (95% CI 46.6% to 56.2%), with a median delay of 14 months (IQR: 7.5–42 months) from the index date. Among those experiencing delayed treatment intensification, 43.1% developed new chronic diabetic complications, including retinopathy (18.1%), neuropathy (14.4%) and nephropathy (6.0%). Other complications (hypertension, stroke, heart failure and diabetic foot ulcer) accounted for 4.64% of the cases. Significant predictors of delayed treatment intensification included longer duration of diabetes (adjusted ORs (AOR) 1.68; 95% CI 1.13 to 2.5), presence of comorbidities (AOR 1.83; 95% CI 1.04 to 3.2) and use of cardioprotective medications (AOR 1.59; 95% CI: 1.04 to 2.43). The qualitative findings revealed additional barriers contributing to delayed treatment intensification, including financial limitations, insufficient patient awareness and non-adherence among patients. Additionally, healthcare provider-related factors, including professional fatigue and knowledge gaps, as well as health institution-related factors such as inadequate healthcare infrastructure.

Conclusions

This study found a high prevalence of delayed treatment intensification (51.4%), associated with comorbidities, longer disease duration, low patient awareness, cardioprotective drug use and barriers related to the system and providers. To address these gaps, priorities should include strengthening patient education, scheduling regular reviews for high-risk patients and improving clinical decision support tools for timely treatment intensification. Enhancing healthcare infrastructure, such as medication supply and diagnostic services, and offering refresher training to reduce provider fatigue, are also crucial for improving the delivery of diabetes care.

Measuring the continuation of antidepressant exposure prior to, during, and after pregnancy: A scoping review protocol

by Lauren S. Tailor, Hilary K. Brown, Jessie Cunningham, Simone N. Vigod, Erzsébet Horváth-Puhó, Sonia M. Grandi

Objective

The goal of this scoping review is to summarize how prior studies have measured antidepressant continuation/discontinuation prior to, during, and after pregnancy.

Introduction

Pregnant individuals and healthcare providers are faced with difficult decisions about whether to continue antidepressants in pregnancy due to the historical exclusion of pregnant women from clinical trials and the lack of rigorous evidence to support these decisions. Prior studies examining the effects of pre- and perinatal antidepressant use on perinatal outcomes using observational data have been inconsistent, primarily due to the binary (ever/never) categorization of exposure, which may not accurately reflect real-world use.

Inclusion criteria

The population for this review consists of pregnant individuals. The concept is the measurement of continued preconception, prenatal, and postpartum antidepressant use. We will include human studies (no restrictions on language or geographic location) with the following study designs: cohort studies, cross-sectional studies, case-control studies, and descriptive analyses or spontaneous reports that reference antidepressant use over time.

Methods

We will conduct a scoping review using the JBI (formerly Joanna Briggs Institute) manual for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist (PRISMA-ScR). The search strategy will be performed using database-specific nomenclature in MEDLINE, EMBASE, PsycINFO, Cochrane, Web of Science, and Canada’s Drug Agency Grey Matters Guide for grey literature, limiting the final search to publications since 2022 to include contemporary data. Two independent reviewers will 1) screen titles/abstracts/full-texts and 2) extract data. Findings will summarize measurements of antidepressant continuation during the perinatal period, categorizing studies based on the descriptions of timing, duration, adherence, and exposure ascertainment.

Conclusion

This scoping review will establish the extent to which prior studies have been able to measure continued use to inform a clear definition of continued antidepressant exposure to be used in future studies. Review registration: Open Science Framework https://osf.io/2ewpq

Adverse pregnancy outcomes and associated factors among mothers who had operative vaginal delivery in Amhara Region Comprehensive Specialized Hospitals: multicentre cross-sectional study

Por: Misker · A. D. · Melesew · A. A. · Gobezie · N. Z. · Wubet · H. B. · Diress · G. M. · Abuhay · A. G. · Demite · D. G. · Tadesse · M. A. · Mihretie · G. N. · Abate · A. T. · Asmare · T. B. · Goshu · Y. A. · Siyoum · T. M. · Mekuriaw · B. Y. · Gedefaw · G. D. · Kebede · S. D. · Demissie
Objective

Assess the magnitude of adverse pregnancy outcomes and associated factors among mothers who had operative vaginal delivery in Amhara Region Comprehensive Specialized Hospitals, 2024.

Study design

A cross-sectional study was conducted from 1 November 2024 to 20 February 2025.

Study setting

Seven comprehensive specialised hospitals were included in the study.

Participants

The study was employed on 389 mothers who had operative vaginal delivery.

Methods

Systematic sampling was used. Data were collected via questionnaires, chart reviews and observation. Data were entered into Epi Data V.4.6 and analysed using V.25 statistical package of social sciences. Variables with p

Outcome

Adverse pregnancy outcomes of operative vaginal delivery.

Results

Adverse pregnancy outcomes of operative vaginal delivery were 42.2%. Among them, 46 (11.8%) had only maternal complications, 55 (14.1%) had only neonatal complications and 63 (16.2%) had both maternal and neonatal complications. Perineal tear 29 (7.5%) and episiotomy extension 31 (8%) were the most common maternal complications, while caput succedaneum 45 (11.6%) was the most neonatal complication. The most common indication of operative vaginal delivery was prolonged second stage 203 (52.2%). Vacuum-assisted delivery (AOR 0.53; 95% CI 0.29 to 0.96), two tractions (AOR 2.19; 95% CI 1.23 to 3.90), birth weight less than 2.5 kg (AOR 1.85; 95% CI 1.21 to 2.83) and mid fetal station (AOR 2.9; 95% CI 1.49 to 5.64) were significantly associated with adverse pregnancy outcomes.

Conclusions

Adverse pregnancy outcomes following operative vaginal delivery were high. Type of instrumental vaginal delivery, number of tractions, fetal birth weight and fetal station were significantly increased risks. Therefore, operators should minimise traction attempts during operative vaginal delivery to reduce adverse outcomes.

Adolescent Chlamydia Screening in Pediatric Primary Care: A Quality Improvement Project

ABSTRACT

Aim

To increase Chlamydia trachomatis screening in adolescents 15–19 years of age from 7.8% to 15% following a 6-week implementation of universal chlamydia screening at three paediatric primary care (PPC) sites.

Methods

Pre-implementation (1 January 2022–19 October 2022) and post-implementation (20 October 2022–1 June 2023) screening rates were tracked through run charts and compared via Chi-square testing. Universal opt-out chlamydia screening with universal urine collection for 15- to 19-year-old was implemented at well visits, along with patient and staff education, and sexually transmitted infection treatment protocols.

Results

Chlamydia trachomatis screening increased from 7.8% to 34.1% with implementation of universal opt-out chlamydia screening. Proportions of patients screened increased significantly among White individuals, males and privately insured individuals.

Conclusions

A universal C. trachomatis screening project can be feasibly implemented in pediatric primary care and successfully increase adolescent chlamydia screening rates.

Implications for the Profession

Implementing a universal opt-out C. trachomatis screening project is feasible in PPC and can help achieve the public health goal of chlamydia identification and treatment.

Impact

These findings will be impactful for both paediatric primary care and adolescent patients. The universal, opt-out C. trachomatis screening approach facilitated screening increases, improved equity in screening and led to increased case detection and treatment which has vast significance for those patients.

Reporting Method

This manuscript is submitted using the SQUIRE 2.0 guidelines for quality improvement reporting.

Patient Contribution

Patient contribution included de-identified data collection of chlamydia screening rates of eligible adolescents 15–19 years old who attended routine well visits at the three PPC locations. The data were reviewed on a dashboard, then stratified by race, ethnicity, payor and sex assigned at birth.

Comparative effectiveness of take-home dosing schedules for opioid agonist treatment in British Columbia, Canada: a target trial emulation protocol using a population-based observational study

Por: Kurz · M. · Guerra-Alejos · B. C. · Hossain · M. B. · Min · J. E. · Yan · R. · Bruneau · J. · Catherine · N. L. A. · Greenland · S. · Gustafson · P. · Hedden · L. · Karim · E. · McCandless · L. · Nolan · S. · Platt · R. W. · Bach · P. · Seaman · S. · Siebert · U. · Socias · M. E. · Nosyk
Introduction

The introduction of fentanyl and its analogues in the illicit drug supply has prompted greater emphasis on refining clinical treatment protocols to ensure sustained retention in opioid agonist treatment (OAT). Take-home dosing may lessen the treatment burden on clients and thus reduce the risk of treatment discontinuation. The evidence base supporting the use of take-home dosing, including the optimal duration of dispensations, is, however, limited. The objective of this study is to determine the comparative effectiveness of alternative take-home dosing schedules, as observed in clinical practice in British Columbia, Canada from 2010 to 2022.

Methods and analysis

We propose to emulate a target trial with a population-level retrospective study of individuals initiating methadone or buprenorphine/naloxone between 1 January 2010 and 31 December 2022 who are 18 years of age or older and not currently incarcerated or pregnant with no history of cancer or palliative care. Our study will draw on nine linked health administrative databases from British Columbia and will evaluate take-home doses of 2–5 days, 6 days or >6 days compared with continuous daily dosing. The primary outcomes include OAT discontinuation and all-cause mortality on treatment. A causal per-protocol analysis is proposed with longitudinal matching and inverse probability of censoring weighting approaches to adjust for time-fixed and time-varying confounding. A range of sensitivity analyses will be executed to determine the robustness of results.

Ethics and dissemination

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated and shared with local advocacy groups and decision-makers, developers of national and international clinical guidelines, presented at national and international conferences and published in peer-reviewed journals electronically and in print.

Impact of CMV-specific immune reconstitution at the end of letermovir prophylaxis on the development of late cytomegalovirus infection in haematopoietic stem cell transplant recipients (INMUNOEND): a protocol for a prospective, observational, multicentre

Por: Caston · J. J. · Aparicio · C. · Paez-Vega · A. · Pozo Lopez · L. · Garcia · E. · Martin · C. · Ruiz-Arabi · E. · Cuesta-Casas · M. A. · Bermudez-Rodriguez · M. A. · Cerezo-Martin · J. M. · Gonzalez-Sierra · P. A. · Machuca · I. · Martin Dominguez · F. M. · Saldana-Moreno · R. · He
Introduction

Cytomegalovirus (CMV) infection is a common complication in patients undergoing haematopoietic stem cell transplantation (SCT). Letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, a study is needed to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualisation of CMV prophylaxis duration in these patients.

Methods and analysis

INMUNOEND is a multicentre, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post SCT. Immunological and virological monitoring will be conducted until day+200 post-SCT. The primary outcome is the percentage of patients who develop clinically significant CMV infection up to day+200 post-SCT after completing LTV prophylaxis. Data collected will include baseline characteristics of the haematological diseases and comorbidities, variables related to SCT (ie, engrafment, graft-versus-host disease, use of LTV and CMV replication) and variables related to CMV-specific immune reconstitution.

Ethics and dissemination

Ethical approval has been obtained from the institutional review board (Comité de Ética de la Investigación de Córdoba; SICEIA-2024–0 01 762). The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.

Trial registration number

NCT06814301.

Nurse Roles Implementing the Choice for Self‐Collection Cervical Screening in Rural Settings: A Qualitative Study Following National Policy Change

ABSTRACT

Aim

To explore the key factors influencing nurses' capability, opportunity and motivation to offer the choice for self-collection for cervical screening within rural primary care services, following a national policy change in Australia.

Design

A qualitative study informed by implementation and behavioural change frameworks.

Methods

Primary health nurses working in Victoria were invited to participate in semi-structured interviews via video or telephone between December 2022 and March 2023. Eighteen nurses from 18 clinics participated. Interview data were analysed following a Framework analysis approach, and themes were mapped to the COM-B model.

Results

Nurses were highly motivated to offer the choice for self-collection due to perceived advantages for their patients and potential opportunities for reaching people hesitant to screen. There was variation in how nurses offered this choice, and to whom. Some nurses were concerned about lost opportunities to visualise the vulval area or cervix, or to have broader health and wellbeing conversations with patients. Views were mixed about how self-collection would impact nurse roles, and several external factors were impacting their opportunities as cervical screening providers.

Conclusions

Appropriately trained nurses have the capability and motivation to incorporate the choice for self-collection within their screening practice; however, their opportunity to maximise equity and increase participation is impacted by funding models and structures that limit their autonomy.

Impact

People living outside major cities experience greater healthcare inequities. Australia introduced access to the choice for self-collection for all eligible individuals in 2022, in part to achieve greater equity in the national screening program. Nurses can play a key role in program delivery. Understanding how they incorporate self-collection into their practice, and the key factors influencing implementation in rural primary care settings, can inform future program implementation and improve outcomes for patients.

Reporting Method

We have adhered to COREQ reporting guidelines.

Patient or Public Involvement

This study did not include patient or public involvement in its design, conduct or reporting.

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