General statements that vaccinations are among the most important preventive measures in medicine are common in public health guidance. While the efficacy of individual vaccines is well established through randomised controlled trials and observational studies, ecological studies at the population level can provide complementary insights into the relative historical contributions of different childhood vaccinations to reductions in morbidity and mortality. To date, there has been a lack of systematic reviews of such comparative studies, especially with a focus on Germany. The aim of this scoping review is to map the state of research on ecological studies that compare the relative contribution of different childhood vaccinations to reducing morbidity and mortality, with a focus on reported data from Germany in an international comparison. A more precise scientific and public communication about vaccinations strengthens confidence in evidence-based vaccination recommendations.
This scoping review follows the Joanna Briggs Institute methodology for scoping reviews. Reporting will be in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews (PRISMA-ScR). A comprehensive search will be conducted in MEDLINE via PubMed, Embase via Elsevier, Web of Science, Scopus via Elsevier and Google Scholar, supplemented by grey literature sources. Studies will be selected and data charted by at least two independent reviewers using the Population/Concept/Context (PCC) framework. Results will be synthesised descriptively and presented thematically.
No ethical approval is required as this is a secondary analysis of published data. The findings will be disseminated through publication in a peer-reviewed journal and as part of the first author’s doctoral thesis. The protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/4FH3X).
Anastomotic leak is a major complication after anterior resection for rectal cancer, with reported rates of 10–15%. Recent evidence implicates the gut microbiome, where specific bacteria colonise the anastomotic site and secrete collagenase that weakens healing tissue. Preclinical studies demonstrate that tranexamic acid can inhibit this process when delivered rectally into the bowel lumen. This protocol outlines a feasibility trial of rectally administered tranexamic acid delivered via rectal catheter to the anastomotic site after anterior resection, accompanied by embedded microbiome and qualitative substudies.
This is an open-label, single-centre, randomised controlled feasibility trial. 45 patients undergoing anterior resection for rectal or sigmoid cancer will be randomised 2:1 to receive tranexamic acid or sterile water, administered intraoperatively and on postoperative days 1–3 via a rectal catheter. Feasibility outcomes include assessment of recruitment, intervention adherence, protocol compliance and safety. Exploratory clinical outcomes include anastomotic leak and other postoperative complications. A mandatory microbiome substudy will characterise changes in microbial composition and bacterial collagenase activity, providing mechanistic insight into treatment response. An optional qualitative substudy will explore acceptability of the intervention from the perspectives of patients and healthcare professionals.
The protocol was approved by the North West Liverpool Central Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency on 30 October 2024 (24/NW/0254). Recruitment commenced on 7 January 2025 following receipt of site-specific approvals. Feasibility, mechanistic and qualitative findings will be disseminated through peer-reviewed publications, academic conferences and stakeholder engagement activities. The results will inform progression to a definitive phase III trial and shape key elements of study design.
To preserve the validity and reliability of health instruments like patient-reported outcome measures across linguistic and cultural contexts, translation, cross-cultural adaptation and psychometric validation must be conducted using standardised, rigorous methodologies. Although international standards proposed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) are available, adherence to these guidelines in Bangla-language instrument studies has not been systematically evaluated. This systematic review aims to identify, synthesise and critically appraise Bangla-language translation, cross-cultural adaptation and psychometric validation studies of health instruments for adherence to recommended methodological approaches, translation and cross-cultural adaptation guidelines and psychometric properties.
In this study, we will search three databases, including Ovid MEDLINE, PubMed and EMBASE via Ovid, from 1 February 2026 to 1 March 2026 to retrieve published articles on translation, adaptation and psychometric validation of health-related instruments into Bangla. Two reviewers will independently conduct title and abstract screening, full-text eligibility assessment, data extraction, evaluation of translation and cross-cultural adaptation quality and assessment of psychometric properties. The certainty of evidence will be graded. Disagreements will be resolved by consensus, with the consultation of a third reviewer when necessary. Methodological quality and psychometric properties will be assessed based on the COSMIN Risk of Bias (RoB) checklist and COSMIN standards. Evaluation of translation and cross-cultural adaptation will be based on the extended ISPOR guideline. COSMIN-Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used to rate the certainty of evidence.
This study is a systematic review protocol, exclusively on published literature and publicly available data, and does not involve direct interaction with human participants or the collection of individual participant-level data. Therefore, ethical approval is not applicable. We expect to share our findings through national and/or international platforms. Moreover, the results will be published in a peer-reviewed journal. We anticipate that the result of this study will contribute to recommending a standardised roadmap for researchers, especially for conducting translation, validation and cross-cultural adaptation studies of health-related instruments in Bangla.
CRD420251250949.
To examine the prevalence and sociodemographic factors associated with tobacco smoking, smokeless tobacco and dual use among adults in Ghana using the 2022 Demographic and Health Survey (GDHS).
Ghana, nationwide sample of males and females aged ≥15 years.
This was a cross-sectional secondary analysis of the 2022 GDHS.
A representative sample of 22 058 individuals (females, 15 014 aged 15–49; males, 7044 aged 15–59)
Current tobacco smoking, smokeless tobacco use and dual use.
Prevalence for smoking, smokeless tobacco and dual use was 4.7 (4.1–5.4), 1.6 (1.3–2.0) and 0.6 (0.4–0.9) among males and 1.0 (0.8–1.3), 0.08 (0.05–0.1) and 0.1 (0.05–0.1) among females, respectively. Among males, smoking was associated with higher age (30–44 years: AOR: 2.3, 95% CI 1.7 to 3.1; 45–59 years: AOR: 2.6, 95% CI 1.8 to 3.7). Higher education was protective for both sexes [(males: AOR: 0.4, 95% CI 0.2 to 0.8) and (females: AOR: 0.4, 95% CI 0.2 to 0.8)] compared with their counterparts who had no education. Males in the Coastal zone had higher odds of use (AOR: 1.8, 95% CI 1.3 to 2.3) compared with males in the Middle zone, while females in the Northern/Savanna zone had lower odds of tobacco use (AOR: 0.5, 95% CI 0.3 to 0.8) compared with the Middle zone. Being Christian was associated with lower odds of smoking among males (AOR: 0.3, 95% CI 0.2 to 0.5) compared with others, while being Mole-Dagbani ethnic is associated with higher odds of smoking among females (AOR: 3.0, 95% CI 1.7 to 5.4).
The study provides the first national analysis across Ghana’s 16 regions and investigates patterns of smoking, smokeless tobacco and dual tobacco use. While tobacco use in Ghana remains predominantly smoked and male-driven, the divergent patterns of use across educational, regional and ethnic groups, especially the emerging risk among females, represent a significant public health shift that demands focused gender-sensitive tobacco control interventions.
Management of cryptoglandular anal fistula is characterised by wide variation in diagnostic strategies, surgical techniques and outcome reporting, limiting comparison between studies and hindering evidence-based guideline development. This study aims to implement a standardised core outcome measurement set within a large international observational framework and to evaluate the feasibility of a scalable digitally supported model for global collaborative surgical research.
Cryptoglandular anal fistula treatment is a prospective, international, multicentre observational study comprising two components: a short-term audit capturing clinician-reported outcomes at 3 months and a long-term cohort capturing clinician- and patient-reported outcomes over twelve months. Adults undergoing surgery for primary or recurrent cryptoglandular anal fistula are eligible, excluding non-cryptoglandular aetiologies. Data are collected using secure electronic case report forms and digitally administered patient-reported outcome measures, with paper alternatives available where required. Outcomes are defined according to the Anal Fistula Core Outcome Measurement Set and include clinical and radiological healing, recurrence, complications, reintervention, development of additional fistulas, symptoms, psychological impact of treatment, continence, quality of life and additionally work productivity. The study was designed around a predefined nine-step framework, including multidisciplinary coordination, central ethical approval to support local submissions, artificial intelligence-assisted translation of study materials with native review and implementation of secure digital data capture systems. Based on previous European Society of Coloproctology studies and expected centre volumes, the audit arm aims to include approximately 1000 patients and the cohort arm 500 to 750 patients.
Central ethical approval has been obtained from the Medical Ethics Review Committee of the Maastricht University Medical Centre+ under METC 2024-0374 (audit arm) and METC 2024-0361 (cohort arm) with local approvals or waivers secured in participating countries according to national regulations. Written informed consent is obtained for cohort participation. Results will be disseminated through peer-reviewed publications and international conferences, with the aim of informing future guideline development and supporting patient-centred care in cryptoglandular anal fistula management.
Burn injuries constitute a significant health concern, requiring immediate first aid to mitigate further tissue damage and complications. Most countries worldwide recommend application of 20 min of cool running water (20CRW) within 3 hours of the burn as the cornerstone in burn first aid management. Despite its widespread acceptance and proven benefits in reducing the severity of burns and subsequent interventions, concerns regarding the risk of hypothermia following this intervention persist, representing at least a perceived barrier to the delivery of 20CRW. When it does occur, hypothermia in patients with burns has been associated with higher mortality rates, even after controlling for burn injury severity. Developing an understanding of the incidence of post-burn hypothermia following 20CRW, with a specific focus on potential predictive and/or causative factors, is quintessential.
A retrospective cohort study of all adult and paediatric patients with thermal burn injuries presenting to one of 11 participating Australian or New Zealand hospitals between 1 January 2024 and 31 December 2024 will be conducted. The primary outcome is the incidence of hypothermia in patients with burns following their arrival at the emergency department (ED). Secondary outcomes include influence of burn first aid cooling, risk factors influencing hypothermia, impact of hypothermia on clinical patient outcomes and incidence of hypothermia in patients with burns in non-ED settings.
Ethical approval was granted by the Children’s Health Queensland Human Research Ethics Committee (CHQHREC; HREC Ref No: HREC/25/QCHQ/114285) as well as Health and Disability Ethics Committees, New Zealand (HDEC; Ref No: 2026 EXP 23892). The study findings will be formally disseminated through peer-reviewed journals and conference presentations.