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Efficacy, moderators and mediators of cognitive behavioural analysis system of psychotherapy (CBASP) versus behavioural activation (BA) in persistently depressed treatment-resistant inpatients: study protocol for the multicentre, randomised controlled cha

Por: Brakemeier · E.-L. · Klein · J. P. · Zimmermann · J. · Hollandt · M. · Reinhard · M. A. · Boger · S. · Daldrup · L. · Eldem · L. · Gebhardt · P. · Heinrich · S. · Hirsmueller · M. · Millerowski · J. · Richter · M. · Ridderbusch · I. C. · Suerig · S. · Schroeter · L. · Velten-Schurian
Introduction

Up to 30% of individuals with depression develop persistent depressive disorder (PDD), an often disabling and difficult to treat condition. The Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is the only psychotherapy developed specifically for treating individuals with PDD. While several randomised controlled trials (RCTs) have demonstrated its efficacy in outpatient settings, evidence for its use in inpatient settings remains limited. Pilot studies of CBASP inpatient programmes in Germany have shown promising feasibility and effectiveness; however, no RCTs to date have systematically evaluated their outcomes. This study represents the first RCT to compare the short- and long-term efficacy and safety of CBASP with Behavioural Activation (BA), a first-line psychotherapy for depression, within an intensive multimodal inpatient setting.

Methods and analysis

In this prospective, multicentre, rater-blinded RCT with an active control group, we aim to recruit 396 adults (aged 18–70 years) with treatment-resistant PDD at eight German university hospitals. Participants will be randomly assigned to receive either (1) CBASP or (2) BA within an intensive treatment programme consisting of 10 weeks acute treatment in an inpatient and/or day clinic setting, followed by 6 weeks of outpatient continuation treatment. Primary and secondary outcome assessments will be conducted at multiple time points: baseline (T0), treatment onset (T1), after 5 and 10 weeks of acute treatment (T2, T3), at the end of continuation treatment (T4, week 16) and every 2 months up to week 64 (T5, naturalistic follow-up).

The primary outcome measure will be the change in depression severity, as assessed by the Hamilton Depression Rating Scale (24-item version), after 16 weeks of treatment (from T0 to T4). Secondary outcomes will include response, remission, deterioration and relapse rates, self-reported depression and anxiety symptoms and additional psychological variables. A cost-benefit analysis will evaluate the health-economic benefits of both interventions. Additionally, this RCT will explore personalised treatment selection and mechanisms of change, including potential moderators and mediators of treatment effects. The findings from this trial are expected to provide clinicians with evidence-based guidance on choosing CBASP versus BA for inpatients with treatment-resistant PDD.

Ethics and dissemination

This study has received ethical approval from the ethics committees of all participating university hospitals. All participants will provide written informed consent before enrolment. Study findings will be published in peer-reviewed journals and presented at national and international conferences. We have involved people with lived experience from the earliest pilots onward, using their feedback to refine our study design. Ongoing consultation at conferences and public events has further ensured that our research remains grounded in patient perspectives.

Trial registration number

NCT04996433.

Mental health status and associated factors among rural adult women: findings of a community-based cross-sectional study in Bangladesh

Por: Islam · M. Z. · Sharf-Ul-Alam · S. M. · Rahman · M. F. · Mahmood · F. · Farhana · N. · Akter · S. · Parveen · T. · Alam · Z. · Azim · A. · Khan · M. A. S.
Objectives

To assess the mental health status and identify associated factors among rural adult women in Bangladesh.

Design

Cross-sectional study using face-to-face interviews with a semistructured questionnaire.

Methods

Data were collected between January and February 2025 in three rural upazilas (Dhamrai, Nawabganj and Sreepur) using multistage systematic sampling. The semistructured questionnaire included sociodemographic characteristics, household assets and the Depression Anxiety Stress Scale-21 (DASS-21). The wealth index was calculated using principal component analysis. Cases with mild to extreme levels of depression, anxiety and stress were grouped together to indicate the presence of any level of the three mental health problems. Statistical analyses included descriptive statistics, bivariate analyses using ², Fisher’s exact test and Welch two-sample t-test, and multivariable binary logistic regression to identify predictive factors of mental problems. A Venn diagram was generated to display the proportion of patients with anxiety, depression and stress. Data analysis was performed using SPSS (V.26) and R Studio (V.2025.05) with a significance level of p

Participants

A total of 1350 women aged 18 years or older who were available at home during the data collection period and gave consent to participate. Women who were unable to participate due to illness were excluded.

Results

Participants had a mean (±SD) age of 36.35 (±12.58) years. The prevalence of depression, anxiety and stress was 47.7%, 60.7% and 23.2%, respectively. Moderate severity was most common among patients with depression (20.34%), anxiety (24.20%) and stress (8.03%). 20% of participants experienced all three conditions simultaneously, with 22% having both depression and anxiety. Multivariable analysis revealed that factors associated with an increased odds of depression, anxiety and stress were chronic diseases (ORs (95% CIs): 2.02 (1.50 to 2.73), 1.44 (1.05 to 1.99) and 1.91 (1.35 to 2.71), respectively) and history of abuse (1.84 (1.28 to 2.66); 3.15 (2.06 to 4.93) and 1.91 (1.28 to 2.83), respectively). Family history of mental illness was associated with an increased odds of anxiety (1.71 (95% CI 1.12 to 2.87)) and stress (1.61 (95% CI 1.01 to 2.52)). So was the presence of a caregiving role (1.68 (95% CI 1.18 to 2.42) and 1.50 (95% CI 1.02 to 2.19) for anxiety and stress, respectively). Having a financial problem was associated with an increased odds of anxiety (1.52 (95% CI 1.16 to 2.00)). A happy family relationship was associated with decreased odds of depression (0.28 (95% CI 0.20 to 0.93)), anxiety (0.22 (95% CI 0.06 to 0.60)) and stress (0.50 (95% CI 0.25 to 1.00)). Conjugal satisfaction was protective against anxiety (0.42 (95% CI 0.18 to 0.80) and stress (0.32 (95% CI 0.17 to 0.59)). Unexpectedly, higher wealth status (being rich) increased depression (1.56 (95% CI 1.04 to 2.34) and anxiety (1.57 (95% CI 1.03 to 2.41) risk.

Conclusions

A major segment of rural adult women of Bangladesh experiences mental health problems. The findings recommend community-based comprehensive mental health screening programmes, interventions and integration of mental healthcare into primary health systems to address this critical public health challenge.

What factors influence patient participation in an artificial intelligence-based initiative to optimise referrals from primary to specialist haematology care? A multicentre retrospective observational study in four Spanish hospitals

Objectives

Increasing demand for haematological specialist care makes the optimisation of referrals and outpatient workflow a priority. Automated placing of standardised test orders prior to the first appointment may provide haematologists with necessary information to reach diagnoses and initiate treatment at the first patient encounter, reducing low-value follow-up appointments. We aimed to evaluate rates of patient participation in an initiative using artificial intelligence to place standardised test orders as well as reasons for non-participation, differences in the number of participants and non-participants discharged back to primary care with a diagnosis or appropriate treatment plan, and potentially avoidable referrals.

Design

A retrospective, multicentric cohort study.

Setting

Four academic hospitals in Madrid, Spain.

Participants

18 190 patients referred for a first haematologist appointment for 11 included presenting complaints.

Intervention

Referral notes from primary care were classified using natural language processing and automated placement of standardised test order sets was carried out prior to first appointment for participating patients.

Outcome measures

We compared demographic differences between participants and non-participants, the main motives for not participating, and the number of patients discharged back to primary care at first appointment with a diagnosis and treatment plan. Most frequent International Classification of Diseases, tenth revision codes for each of the included presenting complaints were described.

Results

During the study period, 18 190 (41%) patients were referred for a first haematologist appointment for presenting complaints included in the intervention (‘eligible patients’), of which 612 (3.3%) patients agreed to participate in the intervention. Participants were significantly younger than non-participants. Most common motives for not participating were administrative reasons (6268, 76.9%). Only 122 (1.5%) patients expressed explicit unwillingness to participate. A significant increase in the number of patients discharged upon first appointment was observed for participants (146 (23.9%) vs 3375 (19.36%); p=0.041), signifying a 22% relative reduction in avoidable follow-up. The diagnosis ‘haematological disorders ruled out’ was constantly observed as one of the ten most common diagnoses made by the haematology specialist for all but one of the included presenting complaints.

Conclusion

Natural language processing of referrals from primary to specialist haematology care with automated placing of standardised test orders can decrease low-value follow-up appointments. Explicit refusal to participate was low. Participants tended to be younger than non-participants, underlining the importance of designing strategies to target the older population in order to improve participation.

Identifying common mental disorders among perinatal and non-perinatal women in northern India: a cross-sectional validation study of the diagnostic accuracy of six self-report measures

Por: Fellmeth · G. · Sharma · D. · Kanwar · P. · Chawla · K. · Gupta · V. · Thakur · A. · Harrison · S. · Quigley · M. A. · Bharti · O. · Chandra · P. S. · Desai · G. · Thippeswamy · H. · Singh · S. · Nair · M. · Kishore · M. T. · Alderdice · F. · Verma · A. · Perinatal Mental Health Study (P
Objectives

To translate and culturally adapt six self-report measures for depression, anxiety, post-traumatic stress disorder (PTSD) and somatic symptom disorder into Hindi and determine their diagnostic accuracy against a diagnostic clinical interview.

Design

Cross-sectional validation study.

Setting

Rural Kangra, Himachal Pradesh, northern India.

Participants

480 perinatal (pregnant or within 12 months postpartum) and non-perinatal (not currently pregnant and not given birth within 12 months) women at one tertiary hospital and district-level Anganwadi (community health) centres.

Primary and secondary outcome measures

Symptom endorsement; and discriminant validity, sensitivity, specificity, positive and negative predictive values and area under the receiver operating characteristic curve (AUROC) of the Kessler Scale of Psychological Distress (K10), Patient Health Questionnaire (PHQ9), Edinburgh Postnatal Depression Scale (EPDS), Generalised Anxiety Disorder Scale (GAD7), Perinatal Anxiety Screening Scale (PASS), PTSD Checklist (PCL-5) and Scale for the Assessment of Somatic Symptoms (SASS).

Results

Complete data were available for 443 participants. Tiredness and body weakness were the most commonly endorsed symptoms among participants with common mental disorders. Among perinatal participants, the AUROC was highest for the GAD7 (0.88, 95% CI 0.79 to 0.96) and SASS (0.84, 95% CI 0.71 to 0.96). Among non-perinatal participants, the AUROC was highest for the SASS (0.92, 95% CI 0.88 to 0.97) and PHQ9 (0.91, 95% CI 0.86 to 0.96).

Conclusions

Measures which assess for fatigue, tiredness and somatic symptoms may help to identify women experiencing common mental disorders in this setting. Small numbers of participants with clinically diagnosed mental disorders in our sample mean results must be interpreted cautiously.

Trial registration number

NCT05485701.

Co-STARS: a feasibility evaluation of a co-produced mental health literacy training package to reduce mental health inequities for Black young people in underserved communities - study protocol for a randomised controlled trial with an external pilot, pro

Por: Kumarendran · B. · Cherrington · E. · Bandyopadhyay · S. · Crowe · F. · Machaczek · K. K. · Brown · L. · Campbell · N. · Jordan · G. · Pope · M. A. · Antonovic · M. · Taylor · M. · W · N. · Mahamud · A. · Chandan · J. S. · Griffiths · S. L. · on behalf of the Co-STARS youth co-produc
Introduction

Severe mental illness such as psychosis is among the most disabling illnesses worldwide, disproportionately affecting minoritised ethnic groups and those in socioeconomic disadvantage. In the UK, people from Black ethnic backgrounds are more likely to experience a first episode of psychosis and to be detained under the Mental Health Act than White British people. There is a clear need for mental health services to improve cultural awareness and understanding of the broader social needs of minoritised groups, as well as the need to improve mental health literacy (MHL) within Black communities to empower individuals to seek timely mental health support. This protocol describes our programme of work which aims to assess the feasibility, acceptability and cost-effectiveness of Co-STARS, which is a co-produced, culturally appropriate tiered training package.

Methods and analysis

We co-produced a culturally appropriate, place-based, tiered MHL training package (Co-STARS) to deliver within underserved Black communities and via an e-learning package implemented among staff within mental health trusts. The training will be evaluated in stages. First, a pilot cluster randomised controlled trial will assess the feasibility and acceptability (defined as participants’ perceptions of the training’s relevance, usefulness and delivery) of a lived experience-led MHL training package delivered by Black young people with experience of mental ill health, to underserved communities in Birmingham, UK. Acceptability will be quantified through participation and completion rates and explored qualitatively via focus groups and interviews. Second, a stepped-wedge cluster randomised trial will evaluate the feasibility of an e-learning training programme for mental health professionals. We will embed a process evaluation to explore change mechanisms and identify barriers and enablers for future implementation. Third, we will use realist-informed participatory systems mapping and novel epidemiological analyses to explore downstream effects (ie, improved care access for Black ethno-racial groups within the intervention areas). Last, a cost-effectiveness framework will be developed to assess whether the intervention is good value for money in future efficacy trials. In the cluster trial, eight clusters will be randomised to the intervention arm (face-to-face training in the community) and control arm (display of MHL materials) with pre- and post-assessments in 120 participants from 8 clusters, 3 weeks apart. In the stepped wedge trial, six clusters (clinical teams within NHS mental health trusts) including 120 NHS staff in total, will move from control phase to intervention phase in a stepped wedge manner, with pre-assessments and post-assessments.

Ethics and dissemination

This proposal was reviewed by the Research Governance of the University of Birmingham and UK Research and Innovation (UKRI) grant reviewers. Ethics approval was granted by East of Scotland Research Ethics Service. The findings will be communicated in research conferences, stakeholder meetings, via social media, through publication in peer-reviewed journals and as a policy document.

Trial registration number

ISRCTN10517405.

Stimulating amyloid-{beta} clearance in cerebral amyloid angiopathy with low-sodium oxybate and/or non-invasive vagus nerve stimulation (Clear-Brain): study protocol for a randomised pre-post trial

Por: Schriemer · S. E. · Hirschler · L. · van Etten · E. S. · van Zwet · E. W. · Lammers · G. J. · Liebler · E. J. · van Walderveen · M. A. A. · Slats · A. M. · van Es · A. C. G. M. · Verbeek · M. M. · van Osch · M. J. P. · Wermer · M. J. H. · Fronczek · R.
Introduction

Cerebral amyloid angiopathy (CAA) is caused by the accumulation of amyloid-beta (Aβ) in the cerebrovasculature. The glymphatic system is thought to be involved in the clearance of cerebral waste products, including Aβ. Stimulation of the glymphatic system through enhancing deep sleep with low-sodium oxybate (LXB) or inhibition of cortical spreading depolarisations via non-invasive vagus nerve stimulation (nVNS) could potentially increase clearance of Aβ and hence improve disease course.

Methods and analysis

We will perform a pre-post trial to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 participants, 30 with sporadic CAA and 30 with Dutch-type CAA, will be randomly assigned to receive either LXB, nVNS or both interventions, resulting in three groups (20 in each group: LXB, nVNS and both). The study spans 6 months, comprising a 3-month observational phase and a 3-month intervention phase. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. We will assess possible disease progression with (non-)haemorrhagic imaging markers on 7-Tesla MRI at baseline, before and after intervention, as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed with CSF-Selective T2-weighted Readout with Acceleration and Mobility encoding (CSF-STREAM) on 7-Tesla MRI.

Ethics and dissemination

The study was reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft (P23.100) on 8 April 2024. The first participant was enrolled on 27 March 2025. Study results will be published in peer-reviewed journals and presented at scientific conferences. Additionally, study updates and results will be shared with participants via our newsletter twice a year.

Trial registration

EU CT number 2023–5 06 128-10-00, Universal Trial Number U1111-1295-1113, ClinicalTrials.gov NCT06421532.

Equity, Diversity, Inclusion and Accessibility in pharmacy education: a scoping review protocol

Por: Kan · I. · Vander Kloet · M. A. · Lein · R. K. · Koehler · T. · Blokzijl · M.-R. · Mantel-Teeuwisse · A. K. · Alfarah · M.
Introduction

Equity, Diversity, Inclusion and Accessibility (EDIA) are recognised as core principles in higher education, yet their practical integration into pharmacy education remains underexplored. This review aims to identify the scope of existing research, highlight knowledge gaps and provide valuable insights for pharmacy educators, researchers and policymakers seeking to enhance EDIA integration within pharmacy education.

Methods and analyses

This protocol describes the methodology for a scoping review to systematically map the existing peer-reviewed literature on EDIA in pharmacy education, focusing on three critical areas: faculty development, curriculum content and teaching strategies. Using the Population, Concept and Context framework, the review will include studies examining faculty members, students and administrators within formal pharmacy education contexts worldwide. The scoping review will adhere to the Joanna Briggs Institute methodology and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. The search will include peer-reviewed academic studies, accessed through databases such as MEDLINE, Embase, CINAHL, APA PsycINFO, ERIC and Web of Science. Backward snowballing will also be employed. Data will be charted using a predefined extraction tool, and findings will be synthesised and presented in tabular and narrative formats. A pilot search took place in March 2025, and the final search, study selection and data extraction will be conducted from May to December 2025. The subsequent analysis, presentation and interpretation of results are planned thereafter.

Ethics and dissemination

Ethics approval is not required. We plan to share findings through a variety of means including professional networks, peer-reviewed journal publications, conference presentations, invited workshops and webinars, on the FPD-Include project website and on our research groups’ university websites.

Prevalence of potentially inappropriate medication prescribing, inappropriate medication use, prescription omission and drug interactions among older adults in Ethiopia: a systematic review and meta-analysis

Por: Yazie · T. S. · Alemu · M. A. · Zewdu · W. S. · Asmare Emiru · Z. · Tarekegn · G. Y. · Meharie · B. G. · Belete · A. M. · Debasu Addisu · Z.
Objective

To determine the prevalence of potentially inappropriate prescribing (PIP), potentially inappropriate medication (PIM), potential prescription omission (PPO), potentially harmful drug–drug interactions (PDDI) and identify associated factors among older Ethiopians.

Design

Systematic review and meta-analysis

Data source

We searched PubMed, HINARI, Scopus and Web of Science databases to identify eligible studies published up to 31 October 2025.

Study selection

Observational studies reported the prevalence of PIP, PIM, PPO and PDDI among older adults from any healthcare settings were screened.

Data extraction and synthesis

Two independent reviewers selected studies, extracted data and assessed the risk of bias. The quality and risk of bias of the studies were assessed using the Newcastle-Ottawa scale and Hoy risk of bias tool, respectively, while the certainty of evidence of outcomes was assessed using Grading of Recommendations, Assessment, Development and Evaluation based on Cochrane recommendations. We used a random-effects model for analyses to estimate the pooled prevalence and associated factors. All data analyses were done using Stata V.17 software.

Main outcomes and measures

The national prevalence of PIP, PIM, PPO and PDDI was estimated as main outcomes. Variations were estimated based on regions, age groups, outcome evaluation tool, disease type and healthcare setting.

Results

The review included 25 studies (n=5662 participants) for PIP or PIM, 14 studies (n=2706 participants) for PDDI and 6 studies (n=1342 participants) for PPO. The pooled prevalence estimate was 41% (95% CI 33% to 48%), I2=96.87% for PIP, 37% (95% CI 31% to 44%), I2=96.33% for PIM, 55% (95% CI 36% to 73%), I2=99.00% for PDDI and 14% (95% CI 6% to 24%), I2=95.07% for PPO. The majority of the studies have very good quality (very good=13, good=1, satisfactory=11 for PIP and PIM; very good=11, satisfactory=3 for PDDI; very good=6 for PPO) and low risk of bias (low risk=18, moderate risk=7 for PIP and PIM; low risk=12, moderate risk=2 for PDDI and low risk=6 for PPO), while all studies for each outcome have low certainty of evidence. Subgroup analyses revealed significant regional and contextual variations. Polypharmacy was significantly associated with PIP (OR=3.72, 95% CI 2.53 to 5.46, p2=69.56%), PIM (OR=4.20, 95% CI 2.91 to 6.06, p2=57.83%) and PDDI (OR=4.51, 95% CI 3.05 to 6.69, p2=0.00%), while hypertension (OR=2.46, 95% CI 1.38 to 4.36, p2=0.00%) was associated with PIP.

Conclusions and relevance

This review found a high prevalence of PIP, PIM, PDDI and PPO among older adults in Ethiopia, with notable heterogeneity across regions. Polypharmacy was associated with PIP, PIM and PDDI, while hypertension showed association with PIP. Despite generally good study quality, the certainty of evidence was low for the included studies due to the cross-sectional design nature, with high heterogeneity. Therefore, these findings should be interpreted cautiously. This study indicates a high burden of inappropriate medication prescribing and its associated factors, underscoring the importance of further robust studies to clarify prescribing practices and associated factors.

PROSPERO registration number

CRD42024556744.

Determinants of barriers to accessing healthcare services among married women in Somalia: a multilevel analysis of nationwide survey data

Por: Ali · A. S. · Hassan · Y. S. A. · Ahmed · M. M. · Omar · M. A.
Objectives

To identify the individual and community-level factors associated with barriers to accessing healthcare services among currently married women in Somalia.

Design

A cross-sectional analysis using data from the 2020 Somalia Demographic and Health Survey.

Setting

Somalia.

Participants

A nationally representative sample of 30 311 currently married women aged 15–49 years with complete data on outcome and explanatory variables.

Primary outcome measures

The primary outcome was ‘reporting at least one barrier to accessing healthcare’, a composite binary variable based on four specific problems: obtaining permission to go for treatment, getting money for treatment, distance to the health facility and not wanting to go alone.

Results

A substantial majority (77.06%) of married women reported experiencing at least one barrier to accessing healthcare. Financial cost was the most common barrier (69.91%), followed by distance to health facilities (65.95%), reluctance to go alone (49.64%) and the requirement for permission (46.03%). Multilevel analysis confirmed that higher household wealth was strongly protective (richest vs poorest: adjusted OR (aOR)=0.27, 95% CI 0.24 to 0.32). Paradoxically, factors typically considered protective were associated with increased barriers: women with secondary education (aOR=1.19, 95% CI 1.00 to 1.41) and those with educated husbands (aOR=1.23, 95% CI 1.14 to 1.33) reported more obstacles. Similarly, urban residents faced higher odds of barriers than their nomadic counterparts (aOR=1.40, 95% CI 1.27 to 1.55). Significant regional disparities were evident, with community-level context explaining 26.30% of the total variance in reporting barriers.

Conclusion

Access to healthcare for married women in Somalia is predominantly hindered by economic, educational and community-level constraints. Targeted interventions addressing socioeconomic disparities, infrastructural deficits and specific community contexts are essential to alleviate these barriers.

ALARUM: Active One Health surveillance in LMICs to monitor and predict Antimicrobial Resistance Using Metagenomics - a cross-sectional study protocol

Por: van der Sande · M. A. B. · Valia · D. · Tigoi · C. · Stoesser · N. · Stamm · L. · Marten · A. · Riems · B. · Musyimi · R. · Sibidou · Y. · Schurch · A. C. · Tiendrebeogo · E. W. · Mwaringa · S. · Kohns Vasconcelos · M. · Ingelbeen · B. · Tinto · H. · Bielicki · J. A. · Cooper · B. S. · B
Background

In rural sub-Saharan Africa (sSA), the burden of antimicrobial resistance (AMR) remains high. As AMR continues to rise, there is a strong need for practical, implementable surveillance to monitor and mitigate risks, as well as inform timely, evidence-based clinical decision-making. Emerging evidence points to possible community-level drivers, such as transmission between human, animal and environmental reservoirs as contributing factors, yet microbiological surveillance or opportunities for wastewater-based surveillance are often limited and insufficient in these settings. Therefore, alternative sustainable and affordable approaches are needed. We intend to build on the demonstrated potential of metagenomic profiling of pooled faecal material, which accurately predicted population-level AMR prevalence in invasive Enterobacterales infections.

Methods and analysis

We aim to validate this metagenomic pooled approach on additional populations, and to evaluate whether AMR patterns could be similarly predicted from surveillance of community One Health reservoirs. We will assemble existing data from hospital-based microbiology diagnostic laboratories in rural Burkina Faso and Kenya, and determine to what extent community-level metagenomic data, and/or faecal material of patients on hospital admission, can predict AMR in clinical isolates. We will perform community-level surveys in eight clusters per country, randomly selecting 15 households per cluster. We will systematically sample suspected environmental AMR exposure sites in and around households (soil, drinking water, latrines, chicken faeces) and collect data on community-level antibiotic use, hygiene practices, contact with domestic animals and sanitary facilities. Samples and data will be collected twice: during the dry and during the rainy season.

In addition to evaluating the accuracy of predicting resistance in clinical isolates, we will quantify community-level exposure risks. We will conduct metagenomic profiling on pooled DNA extracts from human stool samples (hospital and community-level) and from household environments. Bayesian statistical models will quantify relationships between AMR gene abundance in the environment and in human stool, and invasive bacteria identified among clinical patients, accounting for geography and seasonality. A cost-utility analysis will determine under what circumstances the use of pooled metagenomic data to inform empirical antibiotic policies would represent an efficient use of resources.

Ethics and dissemination

The proposed surveillance protocol is developed in partnership with local communities and local and international researchers and has received ethical approval in Kenya and Burkina Faso. It will assess whether intermittent, pooled-sample metagenomics provides a viable, low-cost and practical approach for population-level AMR surveillance in settings that—like many in rural sSA—lack systematic microbiological diagnostics and where sewage systems for wastewater-based surveillance are absent. By providing an alternative to routine microbiological-based surveillance where this proves challenging to implement, this approach may help improve treatment outcomes, contribute to equity and public health. Findings will be disseminated through peer-reviewed publications and academic conferences and will contribute to the recently proposed WHO AMR surveillance strategy, which combines survey-based approaches with routine AMR surveillance.

Association between angiotensin receptor-neprilysin inhibitor use and clinical outcomes in patients with heart failure: a 1-year prospective cohort study from Jordan

Por: Odeh · R. S. · Abdel Jalil · M. · Qudah · M. A. · Al-Makhamreh · H. K. · Saleh · A. · Awwad · O.
Objectives

Heart failure (HF) is associated with complex symptoms and frequent hospitalisation that reduce patients’ quality of life (QoL). This study aims to assess the association between angiotensin receptor-neprilysin inhibitor (ARNI) use and changes in QoL and disease-related outcomes among patients with HF in Jordan.

Design

Prospective observational cohort study.

Setting and participants

The study was conducted among patients with HF attending the outpatient cardiology clinics at Jordan University Hospital, a tertiary care centre in Amman, Jordan. Patients either initiated on ARNI or receiving angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB) were included in the study at a 1:2 ratio. All participants were followed up for up to 1 year after recruitment. The study period was from 4 February 2024 to 29 May 2025.

Primary and secondary outcome measures

Data on QoL, New York Heart Association (NYHA) functional class and left ventricular ejection fraction (LVEF) were collected at baseline and after 3 months of treatment. Hospitalisation data were collected for the preceding year and the year following participants’ recruitment. Medication adherence and ARNI side effects were assessed after 3-month of follow-up period.

Results

A total of 227 patients with HF were included; 74 were initiated on ARNI, and 153 were receiving ACEIs/ARBs. At baseline, significantly lower QoL scores and LVEF were observed in the ARNI group compared with the ACEIs/ARBs group. After 3-month, the ARNI group showed improvements in all QoL scores, NYHA functional class and LVEF (p

Conclusions

ARNI use was associated with favourable QoL, NYHA class, and LVEF as well as lower hospitalisation rates among patients with HF in Jordan. The safety profile was consistent with previous studies.

Establishing patient perceptions and preferences for a journal transparency tool to support health literacy: a mixed-methods online survey and focus group study of Canada-based patients

Por: Ricketts · A. · Lalu · M. M. · Proulx · L. · Halas · M. · Castillo · G. · Almoli · E. · Albert · M. A. · Grudniewicz · A. · Bryson · G. L. · Moher · D. · Cobey · K.
Objectives

To determine how patients use the internet to get health information and to identify their needs and preferences for a journal transparency tool which would highlight journal transparency practices.

Design

A mixed-methods study comprising a cross-sectional online survey followed by virtual focus groups to further explore the survey responses.

Setting

Canada.

Participants

A total of 183 adult patients and caregivers completed our online survey. 29 survey respondents participated in the subsequent focus groups.

Primary and secondary outcome measures

We report descriptive statistics (counts and percentages) for all quantitative survey items. We used thematic content analysis for text-based survey responses. The focus groups asked patients about four key topics: (1) the content they would like to see in a journal transparency tool, (2) how they would like the content visually displayed, (3) how to best share the tool with patients and (4) how to determine whether the tool was successful over time. We conducted a thematic content analysis to identify core themes discussed. Focus group participants then rank-ordered the themes identified by their perceived importance.

Results

Of the 183 survey respondents, 146 (82%) indicated they use the internet most often when looking for health information, 66 (37%) indicated they sometimes read original research articles when searching for health information and 92 (52%) indicated they sometimes have difficulty knowing if the information they read online is reliable. Approximately half (86; 49%) of the survey respondents had never heard of predatory journals. We identified 32 themes across the four key topic areas that were discussed in the focus groups.

Conclusions

Patients have expressed a need for a journal transparency tool. This study will inform the tool’s development to ensure that it meets the needs and preferences of patients.

Epidemiological investigation of perinatal depression among pregnant and postpartum women: findings from a cross-sectional survey in the Philippines

Por: Filoteo · J. A. · Maravilla · J. C. · Mamaat · J. E. · Flores · A. D. · Jumamil · A. N. · Cardenas · R. L. · Quijencio · W. · Bayani · M. A. · Santos · N. · Acena · J. L. · Alfonso · A. L. · Rivera · M. · Guarino · R. · Sarmiento · R. · Flenady · V. · Boyle · F. M. · Loughnan · S. A. · T
Objective

This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

Design

Cross-sectional survey.

Setting

The Philippines.

Participants

Participants were recruited online and face-to-face from maternal care facilities.

Primary outcome measure

Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

Results

A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

Conclusions

At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

STRATUM-OS: first step in the development and validation of the STRATUM tool based on multimodal data processing to assist surgery in patients affected by intra-axial brain tumours - observational study protocol

Por: Fabelo · H. · Ramallo-Farina · Y. · Morera · J. · Pineiro · J. F. · Lagares · A. · Jimenez-Roldan · L. · Burström · G. · Garcia-Bello · M. A. · Garcia-Perez · L. · Falero · R. · Gonzalez · M. · Duque · S. · Rodriguez-Jimenez · C. · Hernandez · M. · Delgado-Sanchez · J. J. · Paredes
Introduction

Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.

Methods and analysis

This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.

Ethics and dissemination

The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.

Trial registration number

NCT07036783.

Prevalence of texting thumb among medical students and its association with behavioural patterns during digital device usage: a cross-sectional study

Por: Salameh · M. A. · Odeh · H. · Boyajian · S. D. · Amaireh · E. A. · Jaradat · E. · Bawardi · S. S. · AlTaamreh · B. · Al Haj Ali · N. S. · Madi · A.
Background

Teenagers widely use digital devices for information sharing and other daily activities. Their heavy reliance on smartphones and tablets may contribute to repetitive-use injuries of the thumb.

Objectives

This study aimed to investigate the prevalence of texting thumb (TT) among medical students and to identify the potential associations between TT and behavioural patterns during digital device use.

Design, setting and participants

This cross-sectional study employed an online, self-developed questionnaire to assess demographic and behavioural patterns associated with smartphone use. Data on thumb pain and its features were evaluated for diagnostic purposes. This study comprised medical students from six medical schools in Jordan. Data were collected from 482 medical students, excluding those who did not meet the inclusion criteria.

Results

The prevalence of TT was 34%, predominantly on the right side (53%) and at the thumb base (69%). The findings suggest that TT was significantly associated with specific behavioural patterns, including supporting the forearm (p=0.026, adjusted OR: 1.611; 95% CI 1.059 to 2.449), number of texting per day (p=0.005, adjusted OR: 1.319; 95% CI 1.086 to 1.603) and studying hours per day using a digital device (p=0.002, adjusted OR: 1.586; 95% CI 1.193 to 2.109). Also, students’ attitudes toward thumb pain were significantly associated with the TT (p=0.005, adjusted OR: 1.351; 95% CI 1.094 to 1.668).

Conclusion

Students’ attention to behavioural patterns is crucial when using digital devices. Supporting the forearm, limiting text message use, avoiding prolonged use of digital devices, never ignoring hand pain and resting the hand significantly reduce the risk of thumb overuse injury.

Effectiveness of online supportive counselling on quality of life in women with high-risk human papillomavirus in Iran: study protocol for a randomised controlled trial

Por: Mikaeil · A. · Nasiri-Amiri · F. · Shafizadeh · F. · Behmanesh · F. · Hamzehpour · R. · Bijani · A. · Delavar · M. A. · Afshar · Z. M.
Introduction

Human papillomavirus (HPV) is one of the most common sexually transmitted diseases and affects the quality of life (QoL) of individuals, necessitating interventions beyond physical treatments. The aim of this study is to determine the effectiveness of individual supportive counselling on the QoL in women with high-risk HPV.

Methods and analysis

This randomised clinical trial will include 80 women with HPV who will be selected from 2025 to 2026 in Babol, Iran. Following selection based on inclusion criteria, samples will be randomly allocated to intervention and control groups. Then, they will complete demographic–social questionnaires, QoL in HPV patients and general health questionnaires. Individuals in the intervention group will receive 4 weekly online supportive counselling sessions in addition to routine care. The control group will receive routine care. Both groups will complete the questionnaires again at 6 weeks and 4 months postbaseline. Data will be analysed using SPSS V.26 software and statistical tests including ², t-test and repeated measures analysis of variance, and regression models if necessary. A significance level of 5% will be used for the tests.

Ethics and dissemination

This study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.082). The trial will adhere to the ethical principles of the Declaration of Helsinki. Findings will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.

Trial registration number

IRCT20180218038783N11, 14 September 2025.

Mental Health First Aid training for Chile and Argentina: protocol for a cluster randomised controlled trial

Por: Agrest · M. · Encina-Zuniga · E. · Ardila-Gomez · S. · Fernandez · M. A. · Gabriel · R. · Bargamian · J. · Alvarado · R. · Morgan · A. J. · Kelly · C. M. · Reavley · N.
Introduction

Community support for individuals with mental health problems is a global public health issue. Poor mental health literacy and high levels of stigmatising attitudes among the general population can hinder both help-seeking behaviours and limit the capacity of community members to provide support to people experiencing mental health challenges. The Mental Health First Aid (MHFA) training course was created to educate community members to provide initial help towards a person developing a mental health problem. MHFA training has spread to high-income countries, but there is relatively little research on cultural adaptation to lower-resource settings. This study aims to fill that gap and is the first cluster randomised controlled trial (cRCT) assessing the effectiveness of MHFA training in Chile and Argentina.

Methods and analysis

The study involves a two-arm wait-list cRCT with 240 participants (120 in each country). The study will be conducted in three settings in each of Chile and Argentina (eg, universities, health services and workplaces). Two clusters per setting in each country will be paired and randomly allocated to the intervention (the MHFA training for Chile and Argentina) or the wait-list control group. Participants in the intervention arm will be asked to complete questionnaires at baseline (T1), after training completion (T2) and 6 months after completion (T3), with control arm participants completing data collection at corresponding time points. The primary outcome will be intended support towards someone experiencing a mental health problem or experiencing a mental health crisis. Secondary outcome measures will include the ability to recognise depression and psychosis in vignettes; beliefs about the helpfulness of different types of interventions and helping actions, confidence in providing MHFA and stigmatising attitudes towards a person with depression or psychosis. Findings will demonstrate whether the culturally adapted MHFA training for Chile and Argentina can effectively enhance intended support, knowledge, attitudes and supportive actions towards other individuals within the community.

Ethics and dissemination

Ethics approval has been granted by the Human Research Ethics Committee at the University of Melbourne (Australia), Proyecto Suma (Argentina) and the University of Chile (Chile). Dissemination will be via academic publications and conference presentations. These will also be made available to participants and other interested parties on request.

Trial registration number

ISRCTN63724445.

Adolescent community reinforcement approach in secure care for adolescents with substance use and serious norm-violating behaviour: a randomised feasibility trial

Por: Mälarstig · I. · Tyrberg · M. · Spännargard · A. · Garke · M. A. · Lundgren · T. · Alfonsson · S.
Background

Adolescents placed in state-run secure youth homes (by the Swedish National Board of Institutional Care) due to substance misuse and serious norm-violating behaviour (including offending) are in pressing need of effective help, yet available treatments lack scientific support. The treatment Adolescent Community Reinforcement Approach (A-CRA) supports abstinence and improves social functioning in outpatient settings, but has not been evaluated in secure youth homes.

Objective

To evaluate the feasibility, acceptability and preliminary effects of A-CRA in Swedish secure youth homes, and assess the feasibility of study procedures before a multicentre randomised controlled trial (RCT).

Methods

In a randomised feasibility trial, 42 adolescents (16–20 years) at four secure youth homes were allocated to A-CRA plus treatment as usual (A-CRA+TAU; n=22) or TAU alone (n=20). Substance use was measured with self-reports and registry data at baseline, post-treatment and up to 24 months after treatment; participants were also interviewed about acceptability and satisfaction.

Results

Feasibility was demonstrated: 77% reached the predefined exposure threshold (≥12 A-CRA procedures). Adolescents found the intervention acceptable and helpful in secure care. Study procedures were largely workable, though questionnaire data showed substantial missingness. Preliminary effects were favourable, with no evidence of harm.

Conclusions

A-CRA appears feasible in secure youth care, with minor adjustments, and is perceived as helpful and acceptable by adolescents. Treatment effects will be evaluated in an upcoming multicentre RCT.

Trial registration number

NCT05081934.

Applying the socioecological model to examine the beliefs, perceptions and attitudes surrounding preterm birth in Ethiopia: a qualitative study

Por: Estifanos · A. S. · Gelaw · M. A. · Getachew · H. · Ireso · B. R. · Dimtse · A. · Metaferia · G. · Woldehawariat · T. D. · Walelegn · M. · Magge · H. · Roro · M. A. · Gobena · R. G. · Nigatu · Y. D. · Mengistu · Y. · Shikur · B. · Demissew · R. · Beyene · S. A. · Tumilowicz · A.
Background

Premature birth is the leading cause of neonatal morbidity and mortality. Understanding perceptions, beliefs and attitudes towards preterm births, and how these factors influence care provision at health facilities and at home is crucial for improving preterm newborns’ health outcomes.

Methods

We conducted an exploratory qualitative study at Batu and Meki communities in the East Shewa Zone of Oromia Region, Ethiopia. We conducted in-depth interviews (n=81) and focus group discussions (n=8) using semistructured guides. The study participants included women who had preterm births, family members, community members, healthcare workers and expert stakeholders. We audio-recorded, transcribed the interviews and coded the transcripts. We employed the socioecological model to present perceptions, beliefs and attitudes towards preterm birth at individual, interpersonal, organisational and societal levels.

Findings

Giving birth to a preterm newborn is often associated with fear, stress, unhappiness, concern and worry. At the individual level, preterm newborns’ mothers often feel guilt and self-blame. Families tend to keep preterm birth a secret due to perceptions of ‘incompleteness’. At the interpersonal level, preterm newborns are often stigmatised and families are disappointed by mothers who give birth prematurely. However, some believe that preterm newborns are accepted within the community. At the organisational level, healthcare providers find the causes of preterm birth unpredictable, they do not consider preterm births prevalent, and consider some of them as abortion. There is also a common belief that preterm infants have a low survival rate, leading to the deprioritisation of their care. At the societal level, some believe preterm births are caused by divine will as punishment for sins committed by the mother, while others think they occur naturally. Preterm newborn’s death is often not acknowledged as true loss and families are discouraged from grieving.

Conclusions

Our study found that the beliefs, perceptions and attitudes surrounding preterm birth, held by families, communities, healthcare providers and society at large, influence the care that preterm newborn–mother dyads receive both at home and within health facilities. Addressing these requires a multifaceted approach targeted at deeply ingrained attitudes and perceptions.

Malaria service readiness and associated factors among health facilities that provide antenatal care services in Ethiopia: a cross-sectional study using generalised estimating equation analysis

Por: Bogale · K. A. · Asemahagn · M. A. · Gelaye · K. A. · Muchie · K. F. · Engedaw · H. A. · Azage · M.
Objective

To assess malaria service readiness and its associated factors among health facilities that provide antenatal care (ANC) services in Ethiopia.

Design

Nationally representative cross-sectional facility-based study.

Participants

A total of 1156 public and private health facilities that reported providing ANC services at the time of the survey.

Setting

Health facilities across nine regions and two city administrations of Ethiopia based on data from the 2021/2022 Ethiopia Service Provision Assessment survey.

Results

Only 15.7% (95% CI 13.8 to 18.0) of facilities demonstrated full malaria service readiness, while 14.3% had none of the key components. Substantial regional variation was observed: facilities in Somali region were more likely to be ready (adjusted OR (AOR)=1.53; 95% CI 1.19 to 1.95), whereas readiness was significantly lower in several regions, including Amhara, Oromia, Gambella, Harari, Addis Ababa, Dire Dawa and Sidama, compared with Southern Nations, Nationalities and Peoples’ Region. Governance-related factors were strong predictors of readiness—the presence of a client suggestion box (AOR=1.60; 95% CI 1.12 to 2.29), recent report submission (AOR=2.79; 95% CI 1.15 to 6.76) and monthly staff meetings (AOR=1.64; 95% CI 1.26 to 2.14) were associated with higher readiness.

Conclusion

Malaria service readiness in Ethiopian health facilities providing ANC services is low and unevenly distributed across regions. Strengthening supply chains, staff training and governance systems may improve facility preparedness and support more effective malaria service delivery for pregnant women.

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