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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.

Azithromycin use in labour to prevent sepsis among pregnant women undergoing vaginal delivery in Nigeria (AZIN-V): a study protocol for a hybrid type 2 effectiveness-implementation trial

Por: Afolabi · B. B. · Makwe · C. C. · Oluwole · E. O. · Obi-Jeff · C. · Mitchell · E. J. · Banke-Thomas · A. · Adeyemo · T. A. · Abioye · A. I. · Eboreime · E. A. · Saidu · A. D. · Okoro · U. A. · Akintan · P. · Osuagwu · C. S. · Chieme · C. F. · Lawanson · T. · Hossain · A. · Walker · K.
Introduction

Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.

Methods and analysis

This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).

For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.

Ethics and dissemination

This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.

Trial registration number

ISRCTN16415327.

Culturally appropriate sexual health interventions for STBBI and HIV among racialised immigrant communities in Western nations: a scoping review protocol

Por: Kwame · A. · Maina · G. · Langman · E. · Ndubuka · N. · Caine · V. · Spence · C. · Maposa · S. · Kamrul · R. · Mason · N. · Etowa · J. · Eaton · A. D. · Caron-Roy · S. · Abdulrasheed · A. · Guliak · D. · Chowdhury · I. · Ahmed · A. · Nyoni · N. · Hanson · J. · Alvarez · A.
Introduction

Racialised immigrant communities in Western nations face disproportionate risks for sexually transmitted and blood-borne infections (STBBIs) due to systemic barriers, including racism, stigma and limited access to culturally appropriate care. While the need is well-established, a comprehensive synthesis of effective, culturally responsive sexual health interventions is lacking. This scoping review aims to map the available evidence on sexual health intervention needs and protective factors of racialised immigrants, and to identify and describe existing culturally appropriate programmes in Western nations.

Methods and analysis

The review will follow the JBI methodology for scoping reviews and be reported as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. A systematic search strategy, developed and peer-reviewed by a health sciences librarian, will be executed in MEDLINE, Embase, CINAHL and Scopus, alongside grey literature sources, with no date limit. Two independent reviewers will screen titles/abstracts and full texts against the inclusion criteria. Data will be extracted using a standardised tool, analysed via narrative synthesis and framed by a socio-ecological model to categorise interventions across individual, interpersonal, community and structural levels.

Ethics and dissemination

Ethical approval is not required for this review. Findings will be disseminated through a peer-reviewed publication, academic presentations and tailored summaries for community organisations and policy-makers to ensure practical application.

Review registration

Open Science Framework (https://osf.io/9qah6).

Implementation strategies for the WHO Safe Childbirth Checklist: a scoping review

Por: Gama · Z. A. d. S. · Semrau · K. E. A. · Rosendo · T. M. S. d. S. · Freitas · M. R. d. · Saraiva · C. O. P. d. O. · Westgard · C. M. · Mita · C. · Tuller · D. E. · Freitas · K. d. M. S. · Molina · R. L.
Background

The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.

Objectives

To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.

Eligibility criteria

We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.

Sources of evidence

We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.

Charting methods

This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).

Results

34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.

Conclusions

SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.

Registration

Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.

Development and validation of a risk prediction model for chronic kidney disease among adult hypertensive patients having follow-up at University of Gondar Comprehensive Specialised Hospital, Ethiopia: a retrospective cohort study

Por: Tilahun · A. D. · Limenih · M. A. · Muluneh · A. G. · Hailu · W. · Anlay · D. Z. · Liyew · B. · Muche · A. A.
Objective

Chronic kidney disease (CKD) arises due to uncontrolled hypertension (HTN). HTN significantly increases the risk of complications in vital organs, mainly the kidneys. If hypertensive individuals receive early intervention, the majority of these complications and deaths from CKD can be avoided. Having a clinically applicable tool to predict the future risk of those complications can prevent early disability and premature mortality. However, to this day, there is a lack of a validated risk prediction model specifically designed for CKD of hypertensive patients in Ethiopia. We aimed to develop a risk prediction model for CKD among hypertensive patients at the University of Gondar Comprehensive Specialised Hospital (UoGCSH), Ethiopia.

Study design

A retrospective follow-up study was conducted from 1 January 2012 to 30 December 2021. The Least Absolute Shrinkage and Selection Operator regression methods were used to select predictors. The performance of the models was assessed using the Area Under the Curve and calibration plots. The internal validity of the model was evaluated using bootstrapping methods, and the model was presented as a nomogram. Decision curve analysis was conducted to assess the net benefit of the prediction model in clinical and public health contexts.

Setting

Data from patients’ medical records were collected via the Kobo Toolbox in the UoGCSH.

Participant

We followed a total of 1120 Patients diagnosed with HTN.

Results

The incidence of CKD among adult hypertensive patients was 19.82% (95% CI 17.59% to 22.26%). In the multivariable logistic regression analysis, age, residency, baseline blood pressure status, type of HTN, family history of HTN, baseline serum creatinine levels, proteinuria at baseline and dyslipidaemia were identified as statistically significant predictors of CKD. The nomogram demonstrated a discriminatory power of 91.98% (95% CI 90.09% to 93.88%) and a calibration p value of 0.327. The sensitivity and specificity of the prediction model were 80.63% (95% CI 74.81% to 85.61%) and 87.97% (95% CI 85.66% to 90.03%), respectively. The developed nomogram has a greater net benefit than using the treat-all or treat-none strategies when the threshold probability of the patient is increased.

Conclusion

The nomogram demonstrated excellent discrimination and calibration in identifying hypertensive patients at high risk of CKD. This predictive model offers clinicians a valuable tool for early identification of high-risk individuals, enabling timely interventions, personalised counselling and optimised management through close monitoring to prevent disease progression.

A pilot randomised controlled trial of a critical time intervention for people leaving prison: findings from an integrated process evaluation

Por: Williams · A. D. N. · Jacob · N. · Moriarty · Y. · Madoc-Jones · I. · Fitzpatrick · S. · Mackie · P. · Thomas · I. · Grozeva · D. · Lloyd · B. · Deidda · M. · Achiaw · S. O. · Lewis · K. · Cannings-John · R. · Katikireddi · S. V. · White · J. · Lewsey · J.
Background

We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

Objective

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

Design

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Setting

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

Participants

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

Intervention

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

Results

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

Conclusions

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

Trial registration number

ISRCTN46969988.

Critical time intervention for people leaving prison at risk of homelessness in England and Wales (PHaCT trial): a pilot feasibility randomised controlled trial

Por: Williams · A. D. N. · Jacob · N. · Grozeva · D. · Lloyd · B. · Moriarty · Y. · Deidda · M. · Achiaw · S. O. · Thomas · I. · Lewis · K. · Cannings-John · R. · Madoc-Jones · I. · Fitzpatrick · S. · Katikireddi · S. V. · Mackie · P. · White · J. · Lewsey · J.
Objective

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Design

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Setting

Four prisons for men across England and Wales, UK.

Participants

Men leaving prison at risk of homelessness and intervention delivery staff.

Intervention

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Outcome measures

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

Results

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

Conclusion

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

Trial registration number

ISRCTN46969988.

Duffy-null variant and practical implications for patient care: a scoping review

Por: Asiimwe · E. · Ngo · T. P. · Ziv · E. · Leavitt · A. D.
Objective

To evaluate and map research examining clinical associations with the Duffy-null variant.

Design

Scoping review of the existing literature.

Data sources

We conducted a systematic search of PubMed, Embase, CINAHL and Web of Science for studies published in English between 1 January 2000 and 25 June 2024.

Eligibility

Studies were eligible for inclusion if they examined associations relevant to current standard clinical practice and met our protocol’s inclusion criteria.

Data extraction

We extracted the following information from included studies: study year(s), patient population, sample size, study design, primary outcome and primary findings. Studies were grouped by outcome and synthesised in tabular and qualitative formats.

Results

A total of 2737 studies were screened, and 44 met our inclusion criteria. Most studies were observational, and the most common research question examined was the association with resistance to Plasmodium vivax malaria (9/44). Overall, we observed that the association between the Duffy-null variant and asymptomatic lower absolute neutrophil count (ANC) is demonstrated in large prospective cohort studies. The association with resistance to P. vivax malaria is primarily supported by large cross-sectional studies. There were no studies examining the practical applications of these findings, for example, optimal Duffy-genotype adjusted ANC thresholds for clinical decision-making in patients receiving chemotherapy. Finally, we observed that 19 different associations with this trait have been explored, several in conditions with no clear link to the Duffy trait, for example, progression rates in HIV/AIDS, risk of diabetes, etc.

Conclusions

We found established associations between the Duffy-null variant and asymptomatic lower ANC and with resistance to P. vivax malaria but a lack of data for the practical utilisation of these findings in clinical care. Future studies, such as those examining safe ANC values for entry into clinical trials and for ANC nadir for Duffy-null patients receiving medications associated with increased risk of neutropenia, for example, clozapine, are needed. We observed numerous reported associations of unclear clinical utility. Studies investigating associations with the Duffy trait should be guided by biologic plausibility and clinical utility of positive findings.

Three infections, one fight: an implementation study to map needle prevalence and evaluate HIV, syphilis and hepatitis C prevention interventions in Regina, Saskatchewan - a protocol

Por: Eaton · A. D. · Rowe · M. W. · Varghese · S. M. · House · H. · Pang · N. · Kwan · S. · Ford · P. · Reddy · V. D. · Acoose · T. · Littleford · J. · Lang · K. · Foreman · E. S. · Sasakamoose · J. · Pandey · M. · Medeiros · P. · Loutfy · M. R. · Grace · D. · Brennan · D. J. · Zhao · K. · Shuper
Introduction

Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.

Methods and analysis

This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.

Ethics and dissemination

Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.

Registration

Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B

Implementing timeliness metrics for household contact tracing and TB preventive treatment through TB champions in the public sector, India: an explanatory mixed-methods study

Por: Nair · D. · Thekkur · P. · Thiagesan · R. · Vyas · A. · Paul · S. · Mishra · B. K. · Hota · P. K. · Khogali · M. · Zachariah · R. · Berger · S. D. · Satyanarayana · S. · Kumar · A. M. V. · Bochner · A. F. · Ananthakrishnan · R. · Harries · A. D.
Objectives

A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.

Design

This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).

Setting

The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.

Participants

In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.

Primary outcome measures

The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.

Results

In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.

Conclusions

TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.

Participants experiences of potential adverse effects of an intervention to improve critical thinking about health choices: a qualitative cross-trial process evaluation in Kenya, Rwanda and Uganda

Por: Oxman · M. · Chesire · F. · Mugisha · M. · Ssenyonga · R. · Nsangi · A. · Oxman · A. D. · Fretheim · A. · Rosenbaum · S. · Kaseje · M. · Sewankambo · N. · Melby-Lervag · M. · Lewin · S.
Objectives

To explore participants’ experiences of potential adverse effects of the Informed Health Choices secondary school intervention across three trial sites and to revise a framework of potential adverse effects of interventions to improve critical thinking about health choices.

Design

This was a qualitative study. We extracted and analysed relevant data from separate process evaluations in each country. Data came from surveying teachers, observing lessons and group and individual interviews with students, teachers and other stakeholders. We modified and applied framework analysis, including five stages: (1) development of an initial framework of potential adverse effects, (2) familiarisation with the data, (3) indexing, (4) abstraction and synthesis and (5) revising the framework. We applied reflexive strategies individually and as a team.

Setting

Lower secondary school in five randomly sampled subcounties of Kisumu County in Kenya, districts representing all five provinces in Rwanda, and six districts in the central region of Uganda, between 2022 and 2024.

Participants

Students and teachers in the intervention arms of the trials, parents of students in the intervention arms and administrators at intervention schools, as well as curriculum developers and policy-makers.

Intervention

The intervention involved providing teachers with a 2–3-day training workshop, and digital classroom resources, including lesson plans for 10 lessons to be delivered over the course of one semester.

Results

We generated findings about potential increases in adverse misunderstandings, anxiety related to transfer of learning, adversely experienced cognitive dissonance, work or schoolwork-related stress, inequity, conflicts and waste. The revised framework includes the same categories of potential adverse effects as our initial framework: decision-making harms, psychological harms, equity harms, group and social harms, waste and other harms. We revised other elements of the framework, including definitions of the categories and its structure.

Conclusions

This study provides insight into the potential adverse effects of interventions to improve critical thinking about health choices. The findings complement those of the trials and country-level process evaluations.

Emergency department-initiated palliative care screening among older adults: a systematic review and meta-analysis protocol

Por: Lin · D. E. · Gunaga · S. · Mowbray · F. I. · Isaacs · E. D. · Markwalter · D. · George · N. · Hay · A. E. · Manfredi · R. · Westlake · E. · Akhter · M. · Bowman · J. K. · Rebollo-Lee · N. · Gacioch · B. · Ginsburg · A. D. · Brooten · J. K. · Pajka · S. · Selman · K. · Bain · P. · Davis · J
Introduction

The rapidly growing population of older adults (individuals aged 65 years and older) presents a new set of challenges for healthcare providers in the emergency department (ED), given the prevalence of severe and life-threatening conditions among this group, such as chronic cancer, Alzheimer’s disease/dementia and congestive heart failure. ED encounters often represent a critical point in an older patient’s trajectory of care and can thus be an important opportunity for various interventions such as palliative care consultation. Therefore, identifying those who will benefit most from palliative care is of high importance, especially in determining the course of future treatment. Thus, we aim to conduct a systematic review assessing the efficacy of palliative care screening in the ED by assessing inpatient length of stay as the primary outcome and quality of life, percentage of hospitalisation and cost of care as secondary outcomes.

Methods

This study will use Ovid MEDLINE, Embase, EBSCO CINAHL, Web of Science and Cochrane as databases. The study population comprises adults aged 60 years and older, with no focus on any specific clinical specialty or disease. Patients who have not received palliative care screening will serve as the comparator. Only studies with an applicable comparator will be considered. Studies published from 1 January 2000 to 1 July 2025 will be included.

All articles will be reviewed independently and in duplicate, and every author will participate in the review, data abstraction and conflict resolution process.

Ethics and dissemination

Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42024562389.

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.

Time to first optimal glycaemic control and associated factors among adult patients with diabetes at the University of Gondar Comprehensive Specialized Hospital, northwest Ethiopia: a retrospective cohort study

Por: Getahun · A. D. · Ayele · E. M. · Tsega · T. D. · Anberbr · S. S. · Geremew · G. W. · Biyazin · A. A. · Taye · B. M. · Mekonnen · G. A.
Objective

To assess the time to first optimal glycaemic control and its predictors among adult patients with type 1 and type 2 diabetes at the University of Gondar Comprehensive Specialized Hospital in Ethiopia.

Design

A retrospective cohort study.

Setting

University of Gondar Comprehensive Specialized Hospital, northwest, Ethiopia.

Participants

We recruited 423 adult diabetic patients who were diagnosed between 1 January 2018 and 30 December 2022 at the University of Gondar Comprehensive Specialized Hospital.

Outcome measures

The primary outcome was the time from diagnosis to the achievement of the first optimal glycaemic control, measured in months. A Cox proportional hazards regression model was fitted to identify predictors of time to first optimal glycaemic control. Data were collected with KoboToolbox from patient medical charts and exported to Stata V.17. The log-rank test was used to determine the survival difference between subgroups of participants.

Results

Median time to first optimal glycaemic control was 10.6 months. Among 423 adult diabetic patients, 301 (71.16%) achieved the first optimal glycaemic control during the study period. Age category (middle age (adjusted HR (AHR)=0.56, 95% CI 0.41 to 0.76), older age (AHR=0.52, 95% CI 0.33 to 0.82)), comorbidity (AHR=0.52, 95% CI 0.35 to 0.76), therapeutic inertia (AHR=0.20, 95% CI 0.13 to 0.30) and medication non-compliance (AHR=0.49, 95% CI 0.27 to 0.89) were significant predictors of time to optimal glycaemic control.

Conclusion

The median time to first optimal glycaemic control was prolonged. Diabetic care should focus on controlling the identified predictors to achieve optimal glycaemic control early after diagnosis.

Healthcare utilisation and barriers to healthcare after violence and rape in the Norwegian population: a cross-sectional, multimethod study

Por: Skauge · A. D. · Aakvaag · H. F. · Strom · I. F. · Nissen · A. · Seifert · L. C. · Överlien · C. · Dale · M. T. G.
Objectives

Despite the important role of healthcare services in trauma recovery, many survivors of violence do not seek help. This study aims to examine rates of healthcare utilisation, including differences for physical violence versus rape, gender and physical injury (vs no injury) and obstacles to seeking care within 6 months following incidents of physical violence and rape.

Design and setting

The participants were randomly chosen from the National Population Registry in Norway and invited to participate in a telephone survey on violence exposure and health between June 2021 and June 2022 (N=4299, 49% women).

Participants

The sample included 1768 violence-exposed individuals. Of the women (n=749), 82.1% had experienced physical violence and 40.3% had experienced forcible rape. Of the men, most had experienced physical violence (98.6%) and a small percentage had experienced rape (3.5%).

Outcome measures

Logistic regression models were used to investigate whether healthcare seeking differed by gender, type of violence (rape vs physical violence) and severity (physical injury). Barriers to accessing healthcare were also investigated using descriptive statistics and content analysis.

Results

Healthcare seeking rates were low after rape (16.9%) and physical violence (24.2%), with somewhat higher rates among individuals experiencing both types of violence (39.9%). There were no statistically significant differences in the odds of healthcare utilisation between the three types of violence exposures when we controlled for gender, physical injury, violence characteristics and sociodemographic factors. Men were more likely than women to have sought healthcare (adjusted OR (aOR): 1.37, 95% CI: 1.02 to 1.85, p=0.042). Physical injury was strongly associated with greater healthcare utilisation (aOR: 6.39, 95% CI: 4.85 to 8.41, p

Conclusions

Few victims seek healthcare shortly after experiencing rape or physical violence. Quantitative and qualitative findings indicate that many seek healthcare exclusively for severe physical injury. These results emphasise the need to improve health services’ outreach to victims of violence, who are at heightened risk of mental health issues and chronic illnesses.

Protocol for a systematic review and meta-analysis on utilisation of palliative care service and predictors among adult cancer patients in Ethiopia

Por: Demeke · A. D. · Yeshiwas · A. · Gebrie · H. · Ayehu Akele · M. · Gashaw · A. · Dessie Gesssess · A. · Melkie · T. T. · Bogale · N. · Eba · W. W.
Introduction

Palliative cancer care is comprehensive, specialised medical care of patients that aims to alleviate physical, mental and emotional distress based on patients’ needs rather than on prognosis. In Ethiopia, the federal ministry of health started palliative care (PC) in 2016. Since then, services have been developed and integrated as important components of the Health Sector Transformation Plan II. However, there is a scarcity of nationally summarised data regarding PC service utilisation in Ethiopia. Therefore, this protocol describes a planned systematic review and meta-analysis that will evaluate utilisation of PC services and its predictors among adult cancer patients in Ethiopia.

Methods and materials

The online databases of PubMed, Hinari, EMBASE, CINHAL, Science Direct, Scopus and Google Scholar will be comprehensively searched from inception to 31 February 2025. To assess the quality of included studies, the Joanna Briggs Institute critical appraisal tools will be used. The statistical software STATA V.17 will be used for data analyses. To examine the heterogeneity between studies, inverse variance (I2) will be used. To calculate the pooled prevalence of PC service utilisation, a fixed or random effects meta-analyses model will be used with a 95% CI, depending on the presence or absence of heterogeneity between included studies. To look for publication bias, a visual inspection of the funnel plot and Egger and Begg’s regression test and a 5% level of significance will be used.

Ethics and dissemination

Ethical approval is not applicable. The results will be disseminated to academic beneficiaries and the public.

Validation of a standardised approach to collect sociodemographic and social needs data in Canadian primary care: cross-sectional study of the SPARK tool

Por: Kosowan · L. · Katz · A. · Howse · D. · Adekoya · I. · Delahunty-Pike · A. · Seshie · A. Z. · Marshall · E. G. · Aubrey-Bassler · K. · Abaga · E. · Cooney · J. · Robinson · M. · Senior · D. · Zsager · A. · ORourke · J. J. · Neudorf · C. · Irwin · M. · Muhajarine · N. · Pinto · A. D.
Objective

This study validates the previously tested Screening for Poverty And Related social determinants to improve Knowledge of and access to resources (‘SPARK Tool’) against comparison questions from well-established national surveys (Post Survey Questionnaire (PSQ)) to inform the development of a standardised tool to collect patients’ demographic and social needs data in healthcare.

Design

Cross-sectional study.

Setting

Pan-Canadian study of participants from four Canadian provinces (SK, MB, ON and NL).

Participants

192 participants were interviewed concurrently, completing both the SPARK tool and PSQ survey.

Main outcomes

Survey topics included demographics: language, immigration, race, disability, sex, gender identity, sexual orientation; and social needs: education, income, medication access, transportation, housing, social support and employment status. Concurrent validity was performed to assess agreement and correlation between SPARK and comparison questions at an individual level as well as within domain clusters. We report on Cohen’s kappa measure of inter-rater reliability, Pearson correlation coefficient and Cramer’s V to assess overall capture of needs in the SPARK and PSQ as well as within each domain. Agreement between the surveys was described using correct (true positive and true negative) and incorrect (false positive and false negative) classification.

Results

There was a moderate correlation between SPARK and PSQ (0.44, p60), SPARK correctly classified 90.5% (n=176/191).

Conclusions

SPARK provides a brief 15 min screening tool for primary care clinics to capture social and access needs. SPARK was able to correctly classify most participants within each domain. Related ongoing research is needed to further validate SPARK in a large representative sample and explore primary care implementation strategies to support integration.

Transcranial direct current stimulation combined with physical exercise in knee osteoarthritis: a protocol for a randomised controlled clinical trial

Por: Lima · V. B. · Silva · C. A. M. · Silva · S. G. D. d. · Macedo · L. d. B. · de Souza · M. C. · Lins · C. A. d. A. · de Souza · C. G.
Introduction

Osteoarthritis (OA) is a degenerative and progressive joint condition causing pain and disability. Physical exercise is recognised as the most effective intervention since individuals with this condition often experience muscle weakness, balance deficits and chronic pain. Additionally, knee osteoarthritis (KOA) is associated with central sensitisation, contributing to chronic pain conditions. Transcranial Direct Current Stimulation (tDCS), a non-invasive neuromodulation technique, has been employed to induce changes in pain perception by altering cortical excitability, potentially reducing chronic pain.

Methods and analysis

This is a protocol for a randomised controlled trial. Participants will be allocated to two groups: G1 (active tDCS combined with exercise) and G2 (sham tDCS combined with exercise). The intervention protocol will last for 5 weeks, with two sessions per week on non-consecutive days. Pain intensity will be assessed as the primary outcome using the Numeric Rating Scale (NRS). The sample size was calculated based on a minimum clinically important difference of 3 points on the NRS between groups, with a statistical power of 80% and a significance level of 5%. Secondary outcomes will include physical function and global perceived change.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Trairi School of Health Sciences, Federal University of Rio Grande do Norte (Approval Number: 6.801.827), and it is in accordance with the Declaration of Helsinki for human research. Results will be published in peer-reviewed journals and presented at scientific events. This trial is registered in the Brazilian Clinical Trials Registry.

Trial registration number

Brazilian Clinical Trials Registry (RBR-5pb2g33).

Transporting trial results to synthetic real-world populations in order to estimate real-world effectiveness of newly marketed medicines

Por: Leiva-Escobar · I. · Scherkl · C. · Haefeli · W. E. · Meid · A. D.
Introduction

Real-world effectiveness of a new treatment is relevant information for patients, healthcare professionals and payers, especially when patients encountered in routine clinical care differ significantly from those recruited in the randomised controlled trials (RCTs) that led to approval. However, obtaining effect estimates can be challenging when a new drug has only recently been marketed and real-world data (RWD) are not yet available. For new breast cancer (BC) therapies, we illustrate how RCT inferences can be transported to a target population and how a synthetic population can be generated to mimic a target population for which no RWD is yet available.

Methods and analysis

In our framework, we defined the data-generating process for the RCT population and the real-world (target) population with confounders, effect-modulating covariates and survival times as outcomes. First, we conducted generalisability and transportability (G&T) analyses to transport the RCT results to the simulated target population, applying the inverse probability of sampling weighting and outcome model-based estimator approach. We then used Synthea to generate a synthetic target population based on German BC survival rates and combined both approaches into a coherent strategy.

Results

Effect estimates (HRs with 95% CIs) transported from the RCT to our defined target population closely matched the expected real-world effect (RCT: 0.68 (0.65; 0.71); real-world: 0.75 (0.71; 0.79); transported from RCT: 0.76 (0.71; 0.81)). BC survival rates were very similar between observed and synthetic data (prediction error in absolute survival rates: 1.62%).

Conclusion

Combining G&T with synthetic data may inform decision-making in situations where RWD are not (yet) available.

Developing a screening tool and intervention strategy for elder neglect in persons with dementia in primary care: protocol to use a multistep process

Por: Rosen · T. · Shaw · A. · Elman · A. · Baek · D. · Gottesman · E. · Park · S. · Costantini · H. · Cury Hincapie · M. · Moxley · J. · Ceruso · M. · Chang · E.-S. · Hancock · D. · Jaret · A. D. · Lees Haggerty · K. · Burnes · D. · Lachs · M. S. · Pillemer · K. · Czaja · S.
Introduction

Elder neglect by both informal and formal caregivers is common, particularly among persons with dementia, and has serious health consequences but is under-recognised and under-reported. Persons with dementia are often unable to report neglect due to memory and language impairments, increasing their vulnerability. Screening for elder mistreatment and initiation of intervention in primary care clinics may be helpful, but few evidence-based tools or strategies exist. We plan to: (1) develop a novel primary care screening tool to identify elder neglect in persons with dementia, (2) develop an innovative technology-driven intervention for caregivers and (3) pilot both for feasibility and acceptability in primary care.

Methods and analysis

We will use a multistep process to develop a screening tool, including a modified Delphi approach with experts, and multivariable analysis comparing confirmed cases of neglect in patients with dementia from the existing data registry to non-neglected controls. We will develop an evidence-based, technology-driven caregiving intervention for neglect with an expert panel and iterative beta testing. Following the development of the protocol for implementation of the tool and intervention with associated training, we will pilot test both the tool and intervention in older adult patients and caregivers. We will conduct provider focus groups and interviews with patients and caregivers to assess usability and will modify the tool and intervention. These studies are in preparation for a future randomised trial.

Ethics and dissemination

Initial phases of this project have been reviewed and approved by the Weill Cornell Medicine Institutional Review Board, protocol #22-06024967, with initial approval on 1 July 2022. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.

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