Enhancing Quality of Life for Individuals with Stroke (EQL-stroke) is an international, collaborative multiphase project aiming to strengthen supported self-management for older adults recovering from stroke at home in Sweden, Latvia and the Netherlands. Existing poststroke pathways may provide insufficient support for self-management during the transition from hospital to home, and there is limited evidence on interventions that integrate social networks and everyday environmental context.

EQL-stroke uses a participatory, multimethod design across three phases. Phase I generates knowledge through policy review, qualitative interviews and people–place mapping (~25 participants per country) and includes cross-cultural adaptation of the Collective Efficacy of Networks Scale. Phase II co-designs and specifies a tailored social network-informed supported self-management intervention (the Network-Based Intervention), including core components and principles for local adaptation (~15 participants per country). Phase III will recruit approximately 20–40 stroke survivors for a single-arm pilot feasibility study with an 8-week follow-up and embedded process evaluation to assess feasibility, acceptability and fidelity in routine practice.

Ethical approval has been obtained from the Swedish Ethical Review Authority (reg. no. 2025-00083-01), the Rīgas Stradina Universitāte Research Ethical Committee (reg. no. Rīgas Stradina Universitāte Research Ethical Committee) and the Research Ethics Committee of the Faculty of Spatial Sciences, University of Groningen (reg. no. 2025-07). Findings will be disseminated through peer-reviewed publications, stakeholder engagement activities and patient/public channels.

With a prevalence of around 7.6%, developmental language disorders (DLDs) without comorbidities are among the most common and most frequently treated childhood disorders. Standard DLD therapy in Germany consists of individual therapy sessions once per week within speech–language therapy practices. In reality, these sessions only take place every 10–14 days on average. Online therapy may be beneficial but is not yet standard practice in Germany. Although DLD group therapy has been proven to be effective, it is rarely undertaken in Germany. The aim of this study is to compare the effectiveness of online DLD therapy for small groups of children with standard one-to-one therapy.

The effectiveness of two treatment settings is evaluated in 212 children with moderate-to-severe DLD (ages 3 years to 6 years 11 months) in the multicentre, block randomised controlled trial (RCT) THErapy ONline. Five centres in Germany participate. Children are randomly assigned to the intervention group (online interval-intensive therapy, IG1, n=106) or the control group (extensive standard in-person therapy, IG2, n=106). A speech and language assessment is conducted at baseline (study entry, T0), 12 months (T1) and 18 months (T2) after therapy start. The co-primary outcome parameters are the speech and language test scores of phonological speech sound production, expressive vocabulary, grammar production and language comprehension at T1. The secondary outcome parameters comprise two composite speech and language test scores at T1 and T2, including phonological working memory scores and the individual scores of the aforementioned tests at T2, as well as process evaluation parameters (time expenditure, resource utilisation, such as salary costs of speech–language therapists, additional costs of the online therapy, adherence to appointments and therapy acceptance).

This study has been approved by the Institutional Ethics Review Board of Westphalia-Lippe (2022-282 f-S). Parents provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences.

DRKS00030068

Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

RBR-3dcrj98.

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

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

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

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

NCT04996433.

The interfaces between the fields of communication, education and health have been indicated by international institutions such as the WHO and the European Centre for Disease Prevention and Control. However, hegemonic scientific practices supersede dialogue between the three fields, isolating their practices. This fragmenting tendency is observed in scientific literature, which has created gaps in the dialogue and articulation between communication, education and health. Although health promotion requires both communicative and educational practices, the epistemological, historical, political, cultural and socioeconomic aspects have also engendered tensions between the fields. Communication is often seen as a mere instrument for other practices, rather than a phenomenon that (re)produces meanings and power dynamics. In opposing the reductionist and instrumentalising perspectives of knowledge fields, the primary objective of the scoping review is to map the scientific evidence on the interfaces between communication and education in health to indicate a conceptual framework that articulates communication and education practices within the context of health.

A transdisciplinary team developed this protocol based on the 2024 Joanna Briggs Institute Manual for Evidence Synthesis. The procedures required to conduct the review were guided by the frameworks proposed by Arksey and O'Malley, Levac et al and Peters et al. The study eligibility criteria were established based on the Problem, Concept and Context outlined in the research questions. Primary and secondary studies will be retrieved from nine sources, covering both conventional and grey literature. These sources include Embase, ERIC, LILACS, PubMed/MEDLINE, ScienceDirect, Scopus, Web of Science, the Brazilian Digital Library of Theses and Dissertations, and the Networked Digital Library of Theses and Dissertations. A categorised form will be used for data collection and subsequent analysis. The reporting of the review findings will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

The nature of the research and the use of secondary data sources do not require informed consent forms or approval from ethics committees in Brazil. The scientific findings from the review will be disseminated through peer-reviewed journals, academic conferences and other scientific communication channels.

The protocol was registered on the Open Science Framework (OSF) and is available at https://doi.org/10.17605/OSF.IO/Z3CX7.

Obtaining clean-catch urine (CCU) samples from non-continent infants is a common clinical challenge due to low urine volume and irregular urination. Non-invasive stimulation techniques, such as the bladder stimulation technique (BST) and the Quick-Wee method, have been proposed to improve success rates and reduce contamination. However, the supporting evidence remains inconsistent, and no multicentre randomised trials have directly compared the effectiveness and safety of Quick-Wee, BST and standard CCU.

The study will enrol 342 infants aged 1–12 months requiring urinalysis, recruited from paediatric wards across three tertiary hospitals in China. Eligible participants will be randomly assigned in a 1:1:1 ratio to one of three intervention groups: BST, Quick-Wee or standard CCU. The primary endpoint is the success rate of urine collection within 5 min of intervention. Secondary endpoints include time to urination, 5 min urination rate, infant discomfort scores, parental and clinician satisfaction, and urine contamination rates. Safety will be evaluated by monitoring the incidence of adverse events.

This study was approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University (No. 114/2025). Written informed consent will be obtained from all participants’ parents prior to enrolment. Study findings will be published in peer-reviewed journals and presented at relevant conferences. Individual participant data will be kept strictly confidential and securely stored in compliance with data protection regulations.

ChiCTR2500098691.

Hand osteoarthritis (OA) is a prevalent and debilitating joint disorder that impairs daily functioning and quality of life. Current treatments are often inadequate in managing the symptoms and progression of the disease. The cytokine interleukin (IL)-17 has been implicated in the inflammatory processes associated with OA, making it a potential target for therapeutic intervention. This trial aims to evaluate the efficacy of vunakizumab, an IL-17A inhibitor, in reducing pain and improving functional outcomes in patients with erosive hand OA.

This multicentre, randomised, placebo-controlled, double-blind trial will enrol 150 participants aged 30–80 years with symptomatic erosive hand OA. Participants will be randomised in a 1:1 ratio to receive either vunakizumab 120 mg or placebo subcutaneously every 4 weeks for 24 weeks, with a loading dose injection period during the first 4 weeks. The primary outcome is the change in hand pain assessed by the Visual Analogue Scale at 28 weeks. Secondary outcomes include changes in physical function measured by the Functional Index for Hand Osteoarthritis, the Quick Disabilities of the Arm, Shoulder and Hand questionnaire and the Health Assessment Questionnaire, as well as changes in grip strength and radiographic and MRI evaluations of the hands.

Written informed consent will be obtained from all participants. The study was approved by the Ethics Committee of Shanghai Sixth People’s Hospital (2024–217) and will adhere to the Declaration of Helsinki. Research results will be published in peer-reviewed journals.

ChiCTR2500101031; https://www.chictr.org.cn/showproj.html?proj=264789.

To determine how people with post-COVID syndrome in Germany experience medical care and what healthcare problems they see in relation to post-COVID.

Semistructured interviews with a topic guide; audio-recording, transcription and analysis in terms of content.

13 digital interviews and one face-to-face meeting between April and June 2024.

14 German people with post-COVID syndrome (10 female; 4 male).

The experiences of the study participants in the care of their post-COVID symptoms were heterogeneous and suggested the continued, at least partially persisting, presence of problems in Germany that have already been addressed in the past. While other studies focus primarily on structural hurdles, our study provides indications that the interactions between healthcare professionals and patients may be important for their satisfaction with care. In particular, physician initiative, education and communication appear to play central roles. In addition, respondents often felt inadequately informed and reported problems with obtaining information. The level of knowledge about the disease in society as a whole has also been frequently criticised.

Doctor–patient interaction may be a critical factor in improving the care of post-COVID patients, with both supportive and problematic experiences indicating that empathic communication and transparent education can play an important role in reducing miscommunication and perceived stigma. In addition, people with post-COVID syndrome appear to need easier access to disease-specific information, which might be facilitated by expanded digital resources and additional dedicated support information services.

Urgent and emergency care in Germany is delivered across multiple, loosely connected sectors. In the absence of coherent, time-resolved data on patient movements between emergency medical services (EMS), out-of-hours ambulatory care, emergency departments (EDs) and inpatient care, inefficiencies and coordination gaps remain difficult to quantify. A process-centric, trans-sectoral analysis is required to characterise real-world patient pathways and identify actionable levers for improvement. The study aims to reconstruct, model and analyse patient pathways for urgent health complaints across all relevant sectors of the healthcare system in a German model region.

We will employ a mixed-methods observational study design. Routine data from EMS, out-of-hours ambulatory care, EDs and subsequent inpatient care will be pseudonymised at source, linked via a trusted third party and analysed within a trusted research environment. Time-stamped event logs will support process mining for discovery, conformance and performance analysis alongside descriptive statistics with stratification by context, such as setting, time of day, urgency and patient cohorts. Anonymous cross-sectional surveys of patients and front-line professionals, complemented by quarterly snapshot surveys in out-of-hours ambulatory care and interviews, will provide convergent evidence on the motives, barriers and coordination of utilisation behaviour. Enrolment for surveys is anticipated from the fourth quarter of 2025; routine data capture covers 1 January–31 December 2026; analyses and dissemination run until 31 December 2027.

The study received ethical approval from the Ethics Committee of the Medical Faculty at RWTH Aachen University (EK 25-351). Survey modules are conducted anonymously with voluntary participation and without collection of direct identifiers; routine care data are processed in pseudonymised form and analysed within a trusted research environment. Stakeholder interviews will be conducted with informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and summary reports for participating institutions and stakeholders, complemented by plain-language materials to support patient-centred navigation.

DRKS00035916.

Alcohol consumption is an increasingly recognised modifiable risk factor for dementia, yet whether it has differential impacts on dementia subtypes and its role in disease progression remains unclear. This study aims to: (1) quantify the association between alcohol intake and incidence of dementia subtypes and (2) examine whether individuals who drink heavily and develop dementia referred to hereafter as ‘alcohol-related’—have poorer post-diagnosis outcomes compared with other dementia cases. Clarifying these relationships will determine whether alcohol selectively increases risk for specific dementia phenotypes or broadly heightens neurodegenerative vulnerability, with implications for prevention, clinical counselling and therapeutic targeting.

This population-based cohort study of alcohol and dementia will use linked UK electronic health records from Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics (ONS). Participants will be eligible if they have available linked data from January 1998, when ONS death registrations became available, until the end of follow-up. Alcohol exposure will be defined through self-reported recorded weekly alcohol units and diagnostic codes for harmful or dependent alcohol use. Primary outcomes including incident all-cause and subtype-specific dementia (eg, Alzheimer’s, vascular, Lewy body, Parkinson’s, frontotemporal) as well as secondary outcomes (ie, mortality, care-home entry and neuropsychiatric symptoms). Key covariates encompassing socio-demographic factors, smoking and relevant comorbidities will be adjusted for. Multivariable Cox proportional hazards and Fine-Gray competing risk models will estimate associations with dementia incidence. Post-diagnosis prognosis will be compared for dementia in individuals with a history of heavy alcohol use (‘alcohol-related’) and dementia in individuals with minimal alcohol exposure (‘non-alcohol-related’) cases using survival and logistic regression models. Multiple testing correction will be applied across dementia subtype comparisons. Alcohol exposure will be modelled continuously and non-linearly using restricted cubic splines and categorically using binary indicators of harmful/dependent use. Missing covariate data will be assessed and addressed using appropriate methods, including multiple imputation and complete-case analysis. Data extraction and analysis are scheduled from October 2025 to October 2026.

Use of de-identified routine data will proceed under existing Research Ethics Committee and data governance approvals. Findings will be disseminated via open-access peer-reviewed journals, academic conferences and summaries targeted at patient, public and policy audiences. The results of this study will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) guidelines.

Childhood overweight and obesity pose a growing public health problem with increasing prevalence both in Europe and globally. Reasons can be found in behavioural factors such as a sedentary lifestyle, eating habits or low exercise levels and to a lesser extent in a genetic predisposition or a metabolic disorder. Preventing children with obesity and overweight to grow into obese teenagers is therefore of high importance. However, there are currently no established care and prevention programmes in Germany for the early reduction of overweight and prevention of obesity in children aged 3–6 years. fruehstArt aims to close this gap with a cross-sector outreach and family-centred personal counselling approach, where parents receive support from paediatricians and trained coaches who conduct consultations in the home of the family. The main research question is whether the fruehstArt programme reduces overweight and obesity in children aged 3–6 years within 12 months, as measured by the body mass index-standard deviation score (BMI-SDS).

fruehstArt has been developed as a new form of care, which includes a family intervention with motivational interviews provided by paediatricians and individual home-based counselling provided by a trained coach on eating behaviour, exercising, sleeping behaviour and age-appropriate use of electronic devices. fruehstArt will be accompanied by an efficacy study (summative evaluation of change in BMI-SDS). In addition to German, the project is also offered in Turkish in order to reach families with a migration background and language barriers. 812 children with overweight or obesity and their families in the region North Rhine will be included and observed over 12 months. Recruitment of children occurred from December 2023 to April 2025 with the final visits scheduled for April 2026. The study is conducted as a randomised controlled trial with a social-ecological intervention approach, considering children in their living environment and conditions. Moreover, a formative evaluation at the process level, and the system level will be carried out and complemented by a health economic analysis. Those are carried out to provide information about the intervention’s success and relevant costs. Thus, fruehstArt is realised in the form of an effectiveness–implementation hybrid design that combines the analysis of effectiveness with an evaluation of the implementation process.

The study received ethics approval in a coordinated procedure from the ethics committee of the Medical Faculty University hospital of Cologne and the ethics committee of the North Rhine Medical Association. For all collected data, the relevant national and European data protection regulations will be considered. All personal data (contact details) will be removed for the data analysis in order to ensure pseudonymisation. Dissemination strategies include reports and quality workshops for organisations, peer-reviewed publications and the presentation of results at conferences.

The aim of the unique form of care fruehstArt is to improve the care of preschool children with overweight or obesity through innovative home-based counselling, cross-sectoral service integration and to address the cultural needs of Turkish families.

DRKS00030749 (29-09-2023)

The digital transformation of healthcare has created an urgent need for primary care physicians (PCPs) to acquire competencies in digital health. However, the structure and scope of postgraduate training programmes remain poorly defined and unevenly implemented worldwide, and no scoping review has yet synthesised the evidence. This review aims to map existing postgraduate digital health training programmes for PCPs, including their content, structure and delivery approaches.

This scoping review will follow the Joanna Briggs Institute methodology and adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A systematic search will be conducted across five databases (PubMed, Scopus, Cochrane Library, ScienceDirect and Web of Science) and relevant grey literature, covering publications from January 2019 to June 2025. Studies describing postgraduate digital health training programmes for PCPs will be eligible for inclusion. Data will be extracted and synthesised descriptively and thematically using an inductive approach.

As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through a peer-reviewed publication and conference presentations and will inform future curriculum development and policy in digital health education for PCPs. The results may also inform national curriculum reforms and accreditation standards, supporting more consistent and competency-based digital health education globally.

This scoping review protocol has been registered with the Open Science Framework.

To assess the impact of the non-reimbursement policy on vitamin D therapy discontinuation in patients from the general and rheumatic populations.

A cross-sectional study.

Research institute specialised in health research and two outpatient pharmacies in the Netherlands.

Patients from the general and rheumatic population with an active prescription for vitamin D supplementation therapy were included.

Data were collected between April and May 2023 through self-reported questionnaires. Descriptive statistics and logistic regression were performed using STATA V. 17. P value

The primary outcome was the proportion of patients who discontinued vitamin D supplementation therapy following the implementation of the non-reimbursement policy. Secondary outcomes included patient-reported reasons for therapy discontinuation and the association between patient-related characteristics and the risk of therapy discontinuation. In addition, the proportion of patients who switched to an alternative supplement and whether this switch had been made in consultation with a healthcare provider was examined.

Of the 4800 patients, 302 (6.4%) patients discontinued their vitamin D therapy. The three most frequently reported reasons for therapy discontinuation were the inability to afford supplements without reimbursement, not willing to pay for supplements without reimbursement and being unaware of the alternative vitamin D supplements to switch to. Younger age, financial constraints and limited health literacy were significantly associated with vitamin D therapy discontinuation (p

The implementation of the non-reimbursement policy resulted in a small proportion of patients discontinuing their vitamin D therapy. Elevated discontinuation rates were associated with specific patient-related characteristics including patients aged

Lesbian, gay, bisexual, trans, intersex, queer/questioning and other sexual and gender minorities (LGBTIQ+) face systemic barriers and discrimination in healthcare settings, leading to significant health disparities. These challenges persist in palliative and end-of-life care (PEOLC), where older LGBTIQ+ people often lack family support and experience social isolation. Despite the increasing ageing of the LGBTIQ+ population in Switzerland, there is limited evidence on their specific PEOLC needs. Additionally, healthcare providers’ knowledge and practices regarding LGBTIQ+ inclusivity in these settings remain understudied. This study aims to address these gaps by co-creating knowledge and developing best practice recommendations for inclusive PEOLC in Switzerland.

This study employs a mixed-methods participatory action research approach across three work packages (WPs). WP0 ensures participatory engagement through advisory boards, workshops and co-design processes across Switzerland’s four linguistic regions. WP1 investigates the palliative and PEOLC needs of LGBTIQ+ people and their (chosen) families through qualitative interviews (n30) and a quantitative survey embedded in the Swiss LGBTIQ+ Panel. WP2 explores healthcare providers’ perceptions and practices regarding LGBTIQ+ patients through qualitative interviews (n30) and a nationwide quantitative survey among palliative and PEOLC professionals. Data will be analysed using reflexive thematic analysis for qualitative data and multivariate regression models for quantitative data. Findings will be synthesised through a specific data integration framework, integrating community and healthcare perspectives.

This study has received ethical approval from the relevant Swiss Ethics Committees. The participatory approach promotes inclusivity, empowering LGBTIQ+ people and healthcare providers in shaping recommendations. Findings will be disseminated via peer-reviewed publications, policy briefs, stakeholder workshops and the co-created Rainbow Book, a best-practice guide for LGBTIQ+ inclusive palliative and PEOLC in Switzerland.

Retroperitoneal sarcomas (RPS) are rare and often large malignancies that frequently require extensive surgery for complete tumour removal. Resections of the colorectum are part of the standard resection, this way contributing to complication rates, including anastomotic leakage or obstruction. Surgical strategies for stoma formation and colorectal reconstruction remain poorly defined. The Colorectal Resections and Postoperative Quality of Life in Retroperitoneal Sarcoma Patients Across German-Speaking Sarcoma Centres (COLOSARC-Q) study aims to explore surgical procedures and health-related quality of life (HRQoL) in patients undergoing colorectal procedures during RPS surgery.

COLOSARC-Q is a prospective, multicentre, non-interventional study and will recruit 120 patients with primary RPS who undergo colorectal resection as part of sarcoma surgery in a sarcoma referral centre in Germany or Switzerland. HRQoL is assessed using standardised questionnaires (EORTC QLQ-C30, QLQ-CR29) as well as semi-structured interviews by psycho-oncology services and patient advocates. Data will be collected via an electronic Case Report Form, encompassing demographic, clinical, surgical and outcome-related information. All data will be centrally analysed. For the assessment of quality of life, a qualitative analysis with content and context analysis, as well as evaluation of the questionnaires according to a standardised scoring system, is planned. The primary aim is to evaluate surgical techniques for bowel resection and reconstruction and their influence on the further course of disease. Secondary endpoints assess postoperative complications as well as tumour-, patient- and treatment-related factors.

Ethical approval was granted by the Ethics Committee II of the University of Heidelberg (approval number 2024-562; 13 June 2024). The data protection review was approved by the data protection officer of the University of Heidelberg. Participation of other centres in the study requires local ethical approval. All patients will be required to sign an informed consent form. Results of primary and secondary endpoints will be published.

NCT06943612; German Clinical Trials Registry (DRKS00034135).

Atrial fibrillation (AF) is the leading cause of cardioembolic stroke and is associated with increased stroke severity and fatality. Early identification of AF is essential for adequate secondary prevention but remains challenging due to its often asymptomatic or paroxysmal occurrence. Artificial intelligence (AI) offers new possibilities by integrating biomarkers, clinical phenotypes, established risk factors and imaging features to define a personalised ‘digital twin’ model. The TAILOR study aims to (1) examine prospective detection of AF using monitoring devices, (2) investigate novel prognostic MRI markers in patients with an AF-related stroke (AFRS) and (3) validate AI-based models for outcome prediction in AFRS.

This prospective multicentre observational cohort study includes patients aged 40 years and above, with neuroimaging-confirmed diagnosis of ischaemic stroke, recruited from two sites: Hospital del Mar Barcelona (Spain) and Radboud University Medical Centre (The Netherlands). For the first sub-study (n=300), patients will undergo clinical assessment at baseline, 3 months and 12 months, and patch-based or Holter cardiac monitoring. The second sub-study (n=200) involves repeated brain MRI and cognitive examination after AFRS. Finally, AI-driven ‘digital twin’ models developed on retrospective TARGET datasets will be prospectively evaluated in TAILOR using temporal and centre-stratified analyses for advanced predictive tools for AF and AFRS outcomes.

The TAILOR study was approved by local ethics boards in Barcelona (CPMP/ICH/135/95) and Medical Research Ethics Committee Oost-Nederland (NL86346.091.24). Patients will be included after providing informed consent. Study results will be presented in peer-reviewed journals and at global conferences.

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

The Research Domain Criteria (RDoC) approach initiated by the National Institute of Mental Health provides a comprehensive framework for guiding research on mental illness and health. Since retrospective studies have indicated associations between RDoC characteristics and clinically relevant as well as care-relevant outcomes, there is a need for prospective, theory-driven investigations that systematically link a priori defined assessments of RDoC constructs to clinically and care-relevant outcomes in a transdiagnostic psychiatric sample.

This prospective observational study assesses six domains—Positive Valence Systems, Negative Valence Systems, Cognitive Systems, Social Processes, Arousal and Regulatory Systems and Sensorimotor Systems—employing a comprehensive set of self-report and additional paradigms to assess cognitive functioning developed a priori in alignment with the RDoC framework while also assessing clinically and care-relevant variables (eg, length of hospital stay). A total of 300 adult participants will be recruited among in- and outpatients of two psychiatric hospitals in Germany (patient group) as well as from the general population (healthy control group). Including healthy individuals will allow for the investigation of continuous variations in psychological functioning rather than categorical distinctions between health and disease. Data collection includes self-reports, clinician ratings, file review and behavioural assessments. Electroencephalography is recorded in a subgroup of participants. A confirmatory factor analysis will be conducted to reproduce the factor structure and regression models will be used to investigate associations between RDoC domains and clinically relevant as well as care-related variables.

Ethics approval was obtained from the local ethics committee of the Brandenburg Medical School—Theodor Fontane (E-01-20220822). Results will be disseminated through peer-reviewed journals and academic conferences.

Cardiovascular diseases, overweight, type 2 diabetes and chronic kidney disease increase the risk of cardiovascular events.

Glucagon-like peptide-1 analogues are recommended by the European Society of Cardiology and the American College of Cardiology to lower the risk of death and progression of cardiovascular disease in patients with cardiovascular disease and type 2 diabetes. Semaglutide, tirzepatide and liraglutide are approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of type 2 diabetes mellitus and overweight. CagriSema is currently not approved, but several phase III trials are ongoing.

No previous systematic review has investigated the effects of semaglutide, tirzepatide, CagriSema and liraglutide, which may not be disease-specific, on hard binary outcomes for all trial populations at increased risk of cardiovascular events.

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index—Science) and clinical trial registries from their inception and onwards to identify relevant randomised trials. We expect to perform the literature search in December 2025. Two review authors will independently extract data and assess the risk of bias. We will include randomised trials assessing the effects of semaglutide, tirzepatide, CagriSema and/or liraglutide in participants with an increased risk of cardiovascular events. The primary outcome will be all-cause mortality. Secondary outcomes will be myocardial infarction, stroke and all-cause hospitalisation. Data will be synthesised by aggregate data meta-analyses, Trial Sequential Analyses and network meta-analysis, risk of bias will be assessed with Cochrane Risk of Bias tool V. 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations and the Confidence in Network Meta-Analysis approach.

This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.

CRD42024623312.

Cardiovascular diseases (CVDs) are the leading cause of death worldwide, making the development of self-management strategies crucial for preventing complications and improving clinical outcomes. This process involves symptom monitoring, treatment adherence, emotional management and a healthy lifestyle, among others. Reliable instruments are necessary to measure self-management, requiring robust psychometric properties. In this way, this COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)-based systematic review aims to assess the quality of specific self-management instruments for adults with CVDs.

This systematic review will follow the COSMIN and be reported according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol. Searches will be conducted in seven databases: MEDLINE, Web of Science, Scopus, PsycINFO, EMBASE and CINAHL. Additionally, a manual search will be performed on PROQOLID, PROMIS and The Medical Outcome Trust websites. Studies on the development and validation of patient-reported instruments measuring specific self-management for individuals with CVDs will be included, without language or date restrictions. The search will be performed in November 2025, with the final version of the review expected to be completed in October 2026. Data extraction will follow COSMIN recommendations. The Modified Grading of Recommendations, Assessment, Development and Evaluation approach will be used to determine the quality of evidence. Instruments will be categorised according to COSMIN recommendations. All steps will be conducted by two independent reviewers, with a third reviewer involved in case of discrepancies. Additionally, the content of the instruments will be analysed and linked to the International Classification of Functioning, Disability and Health, following international recommendations.

This study does not require ethics committee approval as it is a review of published data. The review results will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

CRD42024605969.