To identify the drivers of changes in modern contraceptive use (MCU) among women of reproductive age in three selected sub-Saharan African countries.
This is a secondary analysis of cross-sectional Demographic and Health Survey (DHS) data using a multivariable Blinder-Oaxaca decomposition approach.
The sample consisted of 73 777 women aged 15–49 years from the two most recent DHSs conducted in Gabon (2012, 2019–2021), Senegal (2018, 2023), and Tanzania (2015, 2022). Pregnant women were excluded from the sample.
We assessed the change in MCU over the two most recent DHS waves for the three countries.
MCU declined in Gabon from 26.5% to 18.4%, in Senegal from 20.5% to 18.5% and in Tanzania from 29.7% to 27.6%. Across the three countries, the contributions of compositional changes to trends in MCU varied significantly. In Senegal, characteristics explained 181% of the change, driven by reduced exposure to family planning information (157%), high parity (147%) and employment (9%), while education, urbanisation, union type and lower parity mitigated the decline. In Gabon, the overall characteristics included led to an increase in MCU (–44%), rather than a decline, reflecting the effect of favourable changes toward higher education (–19%) and urban residence (–10%). However, the behavioural effect was predominant (144%). This suggests that modifications in individual attitudes, practices and preferences regarding contraception outweighed structural changes, leading to the overall downward trend observed in Gabon. In Tanzania, neither characteristics nor coefficients significantly explained observed changes. Results for Tanzania indicate that none of the factors included in the model made a significant contribution to the change in MCU. Conversely, increases in educational attainment and urbanisation contributed to an increase in MCU in both Senegal and Gabon.
Interventions promoting MCU should consider the role of receiving family planning information at a health facility, parity, work status, educational attainment and urbanisation in informing changes in the use of modern contraceptive methods.
Cancer remains a growing public health challenge in India, impacting not only patients but also their caregivers, often family members who bear the emotional, physical and financial burdens of care. These family caregivers face overwhelming stress, anxiety and depression, particularly in rural areas with limited healthcare access. Cultural expectations often lead them to neglect their own well-being. Many are forced to reduce work or quit jobs, worsening financial strain. Despite their vital role, caregivers are largely overlooked in cancer care discourse. There is an urgent need for India-specific, empathetic research and policies that support caregiver health and recognise caregiving as a public health priority.
This study employs a sequential explanatory mixed-methods design to examine the association between caregiver burden and mental health status among informal caregivers of patients with cancer in central rural India. In the quantitative phase, a cross-sectional survey will be conducted using systematic random sampling. Data will be collected via a semistructured questionnaire and standardised tools: the Copenhagen Burnout Inventory to assess burnout levels, and the Depression, Anxiety and Stress Scale-21 to evaluate psychological distress. Statistical analysis will include descriptive statistics and regression analysis.
The qualitative phase will involve in-depth interviews with purposively selected caregivers to explore lived experiences, coping mechanisms and emotional challenges. Interviews will be transcribed and analysed using thematic content analysis. Integration of quantitative and qualitative findings will provide a comprehensive understanding of caregiver burden and mental health, reflecting both measurable patterns and the human experience of caregiving in a rural setting.
Ethical clearance for this study protocol was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Medical Education and Research, Sawangi (Meghe), Wardha (Approval No. DMIHER(DU)/IEC/2025/436). Permission for data collection was further granted by both the institutional ethics committee and Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha. The findings of this research will be disseminated through publications in peer-reviewed scientific journals and by engaging relevant stakeholders through appropriate channels of communication.
CTRI/2025/08/093357.
To investigate the incidence, prevalence and mortality of anorexia nervosa (AN) among individuals with childhood-onset type 1 diabetes (T1D) compared with matched controls in Sweden.
Retrospective nationwide cohort study using linked registry data.
Nationwide, Sweden; population-based registers (covering the period 1977–2019).
12 202 individuals diagnosed with T1D before age 15 years (5618 females; 6584 males) and 48 484 age-matched, sex-matched and municipality-matched controls without diabetes (23 618 females; 24 866 males).
AN diagnoses (International Classification of Diseases-10 codes F50.0 and F50.1) identified via the National Patient Register. Outcomes were period prevalence, point prevalence at ages 15 and 20 years, 10-year incidence rates and proportional mortality ratios (PMR), stratified by sex. ORs and incidence rate ratios (IRR) with 95% CIs were estimated using Mantel-Haenszel methods; Kaplan-Meier analysis compared time to AN diagnosis between groups.
The period prevalence of AN among females with T1D was 1.9% compared with 1.1% in controls (OR 1.64, 95% CI 1.31 to 2.06; p
Females with childhood-onset T1D in Sweden have an elevated risk of AN and markedly higher mortality when both conditions are present. Despite the increased relative risk, the absolute risk of AN in females with T1D remained below 2%. These findings support routine screening for eating disorders in the T1D population, particularly among adolescent and young adult females.
To assess the sex-specific status of dietary diversity (DD) and its associated factors among older men and women (aged ≥60 years) in Bangladesh.
A nationally representative cross-sectional survey was conducted in 2018–2019 on food security, nutrition and health of older adults of both sexes.
Data were collected from 82 clusters (rural 57, non-slum urban 15 and slum 10) from all eight administrative divisions of Bangladesh.
A total of 4817 participants aged ≥60 years (2482 men and 2335 women) were enrolled.
A list-based (24-item) recall method was employed, and the items were later aggregated into 10 food groups. The outcome variable was the prevalence of inadequate DD, defined as consumption of less than 5 food groups out of 10.
Men and women had mean DD scores of 4.33±1.6 and 4.13±1.7, respectively. Women had a higher prevalence of inadequate DD than men (61.2% vs 56.3%, p=0.028). Among the food groups, women consumed significantly less fish and eggs than men (fish: 50.96% vs 57.76%, p=0.002; eggs: 17.13% vs 22.10%, p=0.004). Poor education, rural dwellings, living in homes with fewer individuals and living in food-insecure households were associated with inadequate DD in both sexes. Furthermore, among men, older age and not being currently married, and among women, lower age and living in households with middle wealth status were associated with inadequate DD.
The study found that older women consume relatively less diverse diets than men, and several sociodemographic factors influence inadequate DD among older adults of both sexes in Bangladesh. These factors should be considered while developing policies and programmes to promote equitable access to a diversified diet and improve geriatric health and nutritional outcomes.
The timing of a woman’s first birth is significantly associated with maternal and child health outcomes and socioeconomic opportunities. Delaying the first birth is associated with reduced risks of adolescent pregnancy complications, improved birth outcomes and enhanced interpregnancy intervals, all of which contribute to better maternal and child health. In Somaliland, early childbearing is prevalent, necessitating an understanding of its associated factors. Early childbearing, defined as a first birth before age 20, is prevalent in Somaliland, with 47.02% of women having their first birth by this age, significantly higher than the average for sub-Saharan Africa (approximately 30%) and global figures.
This study aimed to identify the sociodemographic factors associated with age at first birth among married women in Somaliland.
The median duration from marriage to first birth was 3 years, with a median age at first birth of 21 years. Women residing in the Sool (adjusted HR: 1.318, 95% CI 1.138 to 1.527) and Sanaag (adjusted HR: 1.265, 95% CI 1.095 to 1.462) regions had a significantly higher hazard of first birth compared with those in Awdal (reference). Conversely, women in the middle (adjusted HR: 0.821, 95% CI 0.685 to 0.985) and highest (Adjusted HR: 0.799, 95% CI 0.663 to 0.964) wealth quintiles had a significantly lower hazard of first birth compared with the lowest wealth quintile. Age at first marriage was a strong factor associated with the outcome; marrying at age 20 or older (adjusted HR: 0.699, 95% CI 0.644 to 0.759) was associated with a significantly lower hazard of first birth compared with those who married before age 20. After adjustment, other factors including residence, media exposure and husband’s employment status were not significantly associated with the timing of first birth.
Region, wealth quintile and age at first marriage are critical factors associated with first birth timing in Somaliland. Interventions should focus on addressing regional disparities and promoting delayed marriage to improve maternal and child health outcomes. Further research is needed to explore the complex social and cultural drivers of these findings.
Case reports (CRs) are essential in physiotherapy, yet reporting remains heterogeneous and insufficiently standardised. The 2013 CAse REport (CARE) guideline improves transparency but lacks physiotherapy-specific detail. This study aimed to develop a consensus-driven extension of the CARE reporting guideline to support structured reporting of physiotherapy CRs, encompassing physiotherapy-specific assessments and interventions.
An e-Delphi consensus process study following the ACcurate COnsensus Reporting Document (ACCORD) guidelines.
Online.
Forty-four international experts in physiotherapy practice, research and education, along with six core committee members.
Experts objectively scored items for relevance (5-point Likert scale) and provided open-ended responses for each item of the drafts. Scores and responses were analysed to facilitate iterative refinement of the Physiotherapy CAse REport (PhyCARE) reporting guidelines. Consensus was predetermined at over 70% agreement.
Round 1 had the majority of items achieving ≥70% agreement, except two items that did not meet the threshold were revised and replaced with an alternative. Five new items addressing physiotherapy-specific reporting needs were added, and 10 items were relocated. In round 2, all 35 items across 13 domains achieved 84%–100% agreement. The nomenclature of one domain was revised to ‘Outcomes and Follow-up’. Following two e-Delphi rounds, consensus was achieved, and suggestions from online meeting, piloting led to item rephrasing, after which the PhyCARE guidelines were finalised.
The PhyCARE guidelines have the potential to provide a physiotherapy-specific extension of CARE to support structured, transparent and reproducible reporting of physiotherapy CRs.
Global discussions surrounding the medical use of marijuana have gained momentum; yet in Malaysia, cannabis remains strictly prohibited under the Dangerous Drugs Act 1952. Despite its legal status, there is growing public discourse on its potential therapeutic benefits. Understanding public acceptance is critical for informing future health policies and public education efforts.
This study used a cross-sectional design, web-based survey among Malaysians aged 18 years and above using convenience and snowball sampling methods. The survey collected data on sociodemographic characteristics, lifestyle factors (eg, smoking and drug use), awareness of medical marijuana and perceived risk. Multivariable logistic regression analysis was performed to identify factors associated with acceptance of medical marijuana decriminalisation.
Out of 2047 respondents, 88.4% supported medical marijuana decriminalisation based on clinical evidence. Key predictors of acceptance included male gender (adjusted OR (AOR) 1.71; 95% CI 1.29 to 2.26), higher education (Bachelor’s degree AOR 1.56; 95% CI 1.09 to 2.23 and Master’s/PhD AOR 2.04; 95% CI 1.34 to 3.10), self-employment (AOR 1.84; 95% CI 1.22 to 2.77) and private sector employment (AOR 1.40; 95% CI 1.03 to 1.89). Behavioural factors, such as smoking (AOR 1.58; 95% CI 1.10 to 2.27), prior drug use (AOR 1.86; 95% CI 1.30 to 2.67) and low perceived risk (AOR 5.82; 95% CI 3.48 to 9.73), were also significantly associated with acceptance.
A large proportion of Malaysian adults supported the clinical use of medical marijuana. Acceptance was strongly associated with demographic and behavioural factors, particularly gender, education and perceived risk. These findings may guide the development of targeted public health education and inform future discussions on regulatory approaches in Malaysia.
To test the agreement and usability of a novel quality appraisal tool: A MeaSurement Tool to Assess systematic Reviews of Prognostic Factor studies (AMSTAR-PF).
Observational study.
14 appraisers of varied experience levels and backgrounds, including undergraduate, master’s and PhD students, postgraduate researchers, research fellows and clinicians.
Eight systematic reviews were rated by all reviewers using AMSTAR-PF.
Planned measures included intrapair and inter-pair agreement using Cohen’s and Fleiss’ kappa, time of use and time to reach consensus. Interrater agreement was an added measure, and Gwet’s agreement coefficient was calculated and presented due to its greater stability across agreement levels. The percentage of intrapair agreements identical or one category apart was also presented.
Interrater agreement averaged 0.59 (range 0.21–0.90), inter-pair agreement 0.61 (range 0.24–0.91) and intrapair agreement 0.75 (range 0.45–0.95) across the domains, with agreement for the overall rating 0.46 (95% CI 0.30 to 0.62) for interrater agreement, 0.46 (95% CI 0.17 to 0.74) for inter-pair agreement and 0.68 (range of averages 0.22–1.00) for intrapair agreement. The majority (60.7%) of intrapair ratings were identical, with 94.6% of final ratings either identical or only one category different for the overall appraisal. The time taken to appraise a study with AMSTAR-PF improved with use and averaged around 34 min after the first two appraisals.
Despite some variance in agreement for different domains and between different appraisers, the testing results suggest that AMSTAR-PF has clear utility for appraising the quality of systematic reviews of prognostic factor studies.
Viral hepatitis B (HBV) and C (HCV) infections remain major public health threats in Ghana, with prevalence rates significantly higher in prison populations than in the general population. Despite this, incarcerated individuals are frequently excluded from national testing and treatment programmes. Overcrowding, poor sanitation and limited access to healthcare create a high transmission risk. There is an urgent need for targeted, evidence-based interventions to address this health inequity and support Ghana’s progress towards viral hepatitis elimination.
This protocol describes a study designed to evaluate the effectiveness of a multicomponent targeted educational intervention in increasing knowledge, intention to test, testing uptake and treatment initiation for HBV and HCV among adult prison inmates in the Greater Accra and Eastern Regions of Ghana.
A cluster randomised controlled trial (RCT) with a 1:1 parallel design will be conducted in eight prisons stratified by gender (six male, two female) with 208 inmates per arm. The intervention group will receive the Prison Education for Prevention of Hepatitis Intervention, comprising an education programme (posters, infographics, film screenings, peer-led discussions and structured health education) alongside HBV and HCV testing, treatment and care linkage. The control group will receive standard health education and basic printed materials. Testing intentions, uptake, prevalence and treatment outcomes will be measured. Cost-effectiveness analysis will inform sustainability and scale-up. The primary endpoint is uptake of hepatitis B and C testing. Secondary outcomes include changes in hepatitis knowledge and testing intentions, prevalence of hepatitis B and C, treatment uptake among diagnosed inmates, linkage to hepatitis care services and cost-effectiveness of the intervention.
Data will be analysed, accounting for prison clustering, using mixed-effects models and regression methods. Outcomes include testing uptake, knowledge, intentions, prevalence, treatment initiation and sustained virologic response, adjusted for key covariates. Baseline characteristics and intervention reach will be summarised descriptively. Analyses will follow intention-to-treat and Consolidated Standards of Reporting Trials guidelines. Cost-effectiveness will estimate Incremental Cost Effectiveness Ratio (ICERs) per inmate tested, infection detected and treatment initiated.
The RCT was approved by the College of Health Sciences ethics and protocol review committee (no. CHS-E/M.1-P 4.7/2025–2026). Results will be presented at relevant national and international meetings and conferences and will be published in international peer-reviewed journals. Furthermore, we plan to communicate the results to relevant stakeholders in the Ghanaian Prisons and Healthcare systems.
PACTR202512558588684.
The Latarjet procedure is the mainstay treatment in high-demand patients with substantial glenoid bone loss or after failed capsulolabral repairs. Patients typically return to sport (RTS) within 6 months postoperatively, requiring intensive rehabilitation. Current rehabilitation protocols focus on mobility, strength and stability. Yet, psychological factors, such as fear of reinjury, are the main reason not to RTS. Therefore, this study aims to determine whether integrating psychological interventions into postoperative rehabilitation improves patient-reported shoulder function compared with physical therapy alone.
This monocentric randomised controlled trial will enrol 52 patients undergoing a Latarjet procedure for anterior shoulder instability. Participants will be equally and randomly assigned to either postoperative physical therapy combined with cognitive behavioural therapy or physical therapy alone. Eligibility criteria include patients aged 18–67 years undergoing an open or arthroscopic Latarjet procedure at our institution. Exclusion criteria include posterior or multidirectional instability, rotator cuff tear, prior shoulder surgery, anxiety disorder, using anxiolytics, neurological disorder, systemic disease, previous hospitalisation for shoulder pain and proximal humerus fractures.
The primary outcome is the Western Ontario Shoulder Index at 6 months postoperatively. Secondary outcomes include incidence of recurrent dislocations, RTS and return-to-work rates, Tampa Scale of Kinesiophobia for Shoulder Instability, subjective shoulder value and visual analogue score for pain at 6 months postoperatively as well as the Shoulder Instability Return to Sport after Injury scale at 4.5 months postoperatively.
This study was approved by the French Committee of Person Protection West I. The national registration number is 2023-A02057-38. The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. Patients are not financially compensated for participation and are allowed to withdraw from the study at any time without any preconditions. The final results of the study will be submitted for publication in a peer-reviewed journal and an abstract of the study will be submitted to international scientific meetings by the end of 2026. Data will be made available by the corresponding author on reasonable request.
The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. The trial sponsor is Vivalto Santé.
Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.
Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.
The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).
The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.
Trial registration number: COMET registration number 3485
Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.
This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.
This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.
To identify stakeholder perceived challenges and facilitators for implementing a clean fuel and clean stove intervention to reduce household air pollution and hypertension in Lagos, Nigeria.
Qualitative study guided by the Exploration and Preparation phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, using focus group discussions and in-depth semi-structured interviews with inductive and deductive thematic analysis.
Peri-urban communities across the five administrative divisions of Lagos State, Nigeria.
128 stakeholders from 32 communities, including community, religious, market and youth leaders, primary healthcare staff, and household decision makers. Approximately half were female.
This was a pre-implementation needs assessment that included demonstrations of the clean stove and fuel.
Thematic domains describing barriers and enablers to adoption and implementation, mapped to EPIS inner, outer, and bridging factors.
Stakeholders reported barriers that included stove stacking, upfront stove cost, concerns about long-term fuel price and availability, equipment durability and maintenance, safety, mistrust of new technology, and uncertainty about stove performance for dishes requiring high heat and long cooking times. Reported facilitators included payment flexibility and subsidies, opportunities to test the stove, perceived benefits of cleaner and faster cooking with less soot, endorsement by community leaders, and interest in local retail and distribution to improve access.
Implementation planning for clean fuel and clean stove programmes should address affordability, reliable fuel supply chains, durability and service, culturally relevant cooking needs, and trust building through community leadership. These findings inform adaptation strategies for scale-up in similar low-resource settings.
This scoping review aims to map evidence or literature on improvement strategies used by health leaders and professionals to strengthen the safety climate in the operating room.
A scoping review was performed on the basis of the method proposed by the Joanna Briggs Institute and applied to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) extension.
16 academic and grey literature data sources were searched using search terms on 17 January 2025, namely, Medical Literature Analysis and Retrieval System Online via Pubmed, Latin American and Caribbean Literature on Health Sciences via the Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Embase, PsycINFO, Cochrane Library, WorldCat, Digital Library of Theses and Dissertations, Brazilian Association of Surgical Center Nurses, Center for Material and Sterilization and Anesthetic Recovery, Association of Portuguese Operating Room Nurses, Association of PeriOperative Registered Nurses, Institute for Healthcare Improvement, WHO and Agency for Healthcare Research and Quality.
Study selection, data extraction and synthesis were based on the following eligibility criteria based on the acronym PCC (participants, concept, context): participants (health leaders and professionals), concept (strategies to improve the safety climate) and context (operating room). This scoping review considered studies published from 2009 onwards.
Information on the objective, method and findings addressing improvement strategies employed to strengthen the safety climate in the surgical centre was retrieved. The findings are presented in tables and in a qualitative thematic summary.
A total of 26 studies were analysed, published between 2009 and 2024, with the USA as the country of origin of the publications with the highest number (11 studies). As for the methodological approach, intervention and quasi-experimental studies stand out. When the studies in this review were mapped, strategies that strengthened the safety climate in the operating room were identified and grouped into two main axes that are interrelated: communication tools and training programmes.
It is evident that the implementation of tools that promote communication and training programmes enhances safe surgical care, as they contribute substantially to the domains of the safety culture. The use of communication protocols in the operating room is recommended as a perioperative safety tool.
This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/zg8nu/).
To assess diagnostic concordance and reclassification following an India-led, multinational virtual multidisciplinary discussion (V-MDD) platform for interstitial lung disease (ILD).
Prospective, multicentre service-evaluation study.
Twenty-four Indian referral centres connected through a secure virtual platform, with international faculty participation from the UK, Greece and Sri Lanka.
A total of 127 anonymised ILD cases discussed across 29 V-MDD sessions (February 2024–February 2025). Each panel included ≥4 pulmonologists, two pulmonary pathologists, one of three rotating thoracic radiologists and one of two rheumatologists, along with international experts.
The cohort (mean age 52.6±16.1 years; 53.5% female (68/127)) most frequently presented with dyspnoea (82.6%) and cough (73.2%). Pre-V-MDD diagnoses included hypersensitivity pneumonitis (HP) and sarcoidosis as distinct disease entities, and usual interstitial pneumonia (UIP) and non-specific interstitial pneumonia (NSIP) as radiological patterns, along with connective tissue disease (CTD)-ILD and other ILDs. Concordance between pre- and post-V-MDD CT diagnoses was substantial (=0.658; 95% CI 0.562 to 0.754; p
The India-led, multinational V-MDD model demonstrated substantial diagnostic concordance and refined nearly one-quarter of ILD diagnoses. This virtual, scalable framework expands access to subspecialty expertise and offers a practical blueprint for standardising ILD care in resource-limited and cross-border settings.
Effect size and event rate estimation is necessary for sample size calculation in randomised clinical trials. Overestimation of the effect size and event rate can lead to inadequately powered studies and increased probability of false negative results. This is common in trials involving critically ill patients. However, such overestimation has not been systematically evaluated in trials involving neurocritical care. We aimed to conduct a systematic review of published randomised clinical trials involving critically ill neurological patients, to determine the accuracy of effect size and event rate estimation.
We will review randomised clinical trials involving adult critically ill neurological patients that were published from 2015 onwards in selected clinically useful and high-impact journals. We will include randomised clinical trials reporting a binary or time to event outcome, using two study groups, and a superiority design testing the efficacy of diagnostic, monitoring, therapeutic or process interventions. All eligible studies must report an estimated event rate in the control group and estimated effect size. All relevant studies will be identified through database searches. All study selection and data extraction will be conducted by two independent reviewers. We will use a random-effects model for pooling data. This review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Accuracy of effect size and event rate estimation will be evaluated by comparing the estimated and observed values. The association between the accuracy of the individual randomised clinical trial effect size and event rate estimation and rejection of the null hypothesis will be evaluated using logistic regression analysis. Multivariable linear regression analysis will be used to explore the factors associated with accuracy of effect size and event rate estimation. In addition, we will perform subgroup analysis by impact factor of the published journals, sample size of the studies and risk of bias.
As this systematic review will use data from previously published studies, it does not require ethics approval. Findings of this systematic review will be published in a peer-reviewed journal and will be presented at specialty-based conferences. The study will be included in the higher degree research thesis of the primary author.
CRD420251106394.
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.
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.
Data from patients’ medical records were collected via the Kobo Toolbox in the UoGCSH.
We followed a total of 1120 Patients diagnosed with HTN.
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.
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.
Primary aldosteronism (PA) is a highly prevalent but underdiagnosed cause of hypertension, characterised by renin-independent aldosterone production. PA is associated with a higher incidence of cardiovascular and kidney complications, independent of blood pressure. Although mineralocorticoid receptor antagonists (MRAs) are the standard treatment when surgical adrenalectomy is not clinically indicated or possible, response is typically monitored using indirect clinical markers such as blood pressure and potassium. Emerging evidence suggests that achieving renin unsuppression may result in better outcomes, yet this hypothesis has not been tested in a randomised controlled trial. The objective of this trial is to evaluate whether a renin-guided MRA titration strategy improves biochemical efficacy compared with standard titration in patients with PA.
This is a multicentre, open-label, pragmatic randomised controlled trial in four academic centres in Canada. 58 adults with confirmed PA, suppressed renin at baseline, and an indication for long-term MRA therapy will be enrolled. Key exclusion criteria include prior MRA use, estimated glomerular filtration rate 4.8 mmol/L and pregnancy. The primary endpoint is the proportion of participants with unsuppressed renin at 12 months. Secondary outcomes include blood pressure, left ventricular mass, kidney function, MRA dose, quality of life and various safety outcomes. Participants will be randomised 1:1 to a renin-guided titration strategy or standard care. In the intervention arm, MRAs will be titrated to achieve unsuppressed renin (>10 ng/L, >15 mIU/L or >1.0 ng/mL/hour). The control arm follows usual clinical practice, without serial renin measurements during dose titration. All participants will be followed for 12 months, with visits at 1, 3, 6, 9 and 12 months. Analysis will follow the intention-to-treat principle and use Fisher’s exact test for proportions, mixed-effects models for continuous outcomes and Kaplan-Meier estimates for time-to-event data. The trial is powered to detect a 42% absolute difference in the primary outcome (40% in the control groups vs 82% in the experimental group; alpha 0.05, 80% power, 15% loss to follow-up). This trial will be the first to prospectively assess the biochemical efficacy of a renin-guided MRA titration strategy in PA. If successful, the next phase will be to assess the efficacy of this strategy on important surrogate outcomes and patient-reported outcome measures.
This study was approved by the Research and Ethics Board of the Centre intégré universitaire de santé et de services sociaux du Nord-de-l’Île-de-Montréal (project number 2024-2727). All the participating sites have received the ethics approval. The findings will be disseminated through national and international presentations and peer-reviewed publications.
To examine how socioeconomic deprivation influences referral pathways to emergency departments (EDs) and to assess how these pathways affect subsequent hospital outcomes.
Retrospective observational study.
Emergency department of a large teaching hospital in the East of England, providing secondary and tertiary care.
482 787 ED attendances by patients aged 16 years and over, recorded between January 2019 and December 2023. Patients were assigned Index of Multiple Deprivation (IMD) deciles based on residential postcode.
Referral source (general practitioner (GP), National Health Service (NHS) 111, ambulance, self-referral, other), total ED time, 4-hour breach, hospital admission and unplanned return within 72 hours.
Substantial socioeconomic inequalities were observed in referral pathways. Patients from the most deprived areas were significantly less likely to be referred by a GP (4.7%) than those from the least deprived areas (14.7%) and more likely to arrive via ambulance (32% vs 24%). These differences persisted after adjusting for demographic, clinical and contextual variables. Ambulance referrals showed the longest ED stays, ranging from 347 to 351 min across IMD deciles (overall 95% CI 343 to 363) and the highest probability of 4-hour breaches (51%; 95% CI 50% to 53%). Self-referrals had the greatest rates of unplanned returns within 7 days (up to 7.1%; 95% CI 5.5% to 8.7%). In contrast, NHS 111 and GP referrals were associated with shorter stays, lower breach rates and fewer reattendances. Minimal variation in outcomes was observed across deprivation levels once referral source was accounted for.
Inequalities in how patients access emergency care, particularly reduced GP and NHS 111 referrals among more deprived groups, appear to underpin disparities in ED outcomes. Referral source captures important clinical and system-level factors that influence patient experience and resource use. Interventions to improve equitable access to structured referral pathways, particularly in more deprived areas, may enhance both the efficiency and fairness of emergency care delivery. Further research using national data is needed to assess broader policy implications and economic costs associated with differential access.
About 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.
Systematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.
The results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.
CRD42022332039.