Type 2 diabetes is a growing global health challenge that requires effective prevention strategies. Public health and community-based approaches play an essential role in reaching vulnerable populations and addressing broader determinants of health. This protocol outlines a scoping review aimed at systematically mapping the existing evidence on lifestyle-based diabetes prevention interventions implemented in public health and community contexts.

A systematic literature search will be conducted to identify relevant studies published in English or German from 1 January 2014 onwards. The following databases will be searched: PubMed, Web of Science Core Collection, CINAHL (via EBSCO), the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews (via OVID) and ClinicalTrials.gov. Relevant websites and grey literature sources will be searched to identify further eligible studies. (Cluster-)randomised controlled trials, non-randomised controlled trials and clinical trials will be included. These must examine nutrition-based, physical activity-based or lifestyle-based interventions aimed at preventing type 2 diabetes in healthy adults or individuals with pre-diabetes, implemented in public health or community settings. Case reports and studies involving medical therapies or pharmacological interventions will be excluded. The literature search started in May 2025 and is expected to be completed by the end of December 2025.

As this scoping review is based on the secondary analysis of publicly available data, no ethical approval is required. Our dissemination strategy includes publication in peer-reviewed journals, presentations at academic conferences and targeted dissemination to relevant interest holders.

This project has been registered at Open Science Framework (https://osf.io/zafg5/), as PROSPERO does not accept registrations for scoping reviews.

Shared decision-making is widely advocated in policy and practice, but how it is to be applied in a high-stakes clinical decision such as major lower limb amputation due to chronic limb-threatening ischaemia or diabetic foot is unclear. The aim of this study was to explore the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation.

A qualitative study (done as part of a broader mixed-methods study) using semi-structured interviews. Interview transcriptions were analysed using thematic analysis.

Vascular centres in three large National Health Service hospitals in Wales and England, UK, between 1 October 2020 and 30 September 2022.

A purposive sample of 18 patients for whom major lower limb amputation was considered as a treatment option/carried out, with interviews conducted before or within 4 months of amputation and 4–6 months after amputation. A further purposive sample of 20 healthcare professionals (including eight surgeons) involved in supporting or conducting major lower limb amputation decision-making.

Five major categories were identified that highlighted the challenges of ensuring shared decision-making associated with major lower limb amputation: (i) patients’ limited understanding, (ii) variable patient attitudes to decision-making, (iii) healthcare professionals’ perceived challenges to sharing decision-making, (iv) surgeons’ paternalism and (v) patients’ and healthcare professionals’ decisional regret/possible consequences of challenges.

Amputation is a life-changing decision for both patients and healthcare professionals, with huge consequences. Despite being considered the gold standard, our findings highlight several challenges to effective shared decision-making for major lower limb amputation. Shared decision-making training for healthcare professionals is paramount if these limitations are to be addressed and patients are to feel confident in being adequately informed about the treatment decisions that they make.

NCT04903756.

Social prescribing is an approach to addressing non-medical issues affecting people’s health and well-being (eg, loneliness, housing or financial problems). It has gained international traction over recent years as complementary to medical care. A larger research project, comparing social prescribing across European countries, is considering how to tailor provision for the following groups: (a) LGBTIQ+persons, (b) refugees and first-generation immigrants and (c) older adults living alone. As part of this research, a qualitative study will address the question: What are the enabling and limiting factors associated with implementing social prescribing, across different European countries, from the perspective of key stakeholders?

Five European countries (Austria, England, Germany, Poland, Portugal) will be involved. Researchers from each country will conduct approximately 20 semi-structured interviews (total number will be 100). Interviewees will be people receiving, delivering, managing and funding/commissioning social prescribing. Interviews will be audio-recorded and transcribed. A cross-country analysis will be undertaken; framework analysis will support this process, with a chart developed in Excel in which data from across the five countries is summarised by the researchers involved. Summaries will be based on a thematic framework that researchers from the five countries develop together after initially analysing their own data.

Ethical approval was initially secured through the University of Oxford’s Medical Sciences Interdivisional Research Ethics Committee (IDREC 1806086) for data collection in England. This approved application was then used to secure ethics approval in Austria (through Ludwig Boltzmann Gesellschaft), Germany (through Bergische Universität Wuppertal), Poland (through Wroclaw Medical University) and Portugal (through NOVA University of Lisbon). Dissemination will include an academic journal article and presentation at relevant conferences. It will also include short videos, written summaries/policy briefs and an infographic.

This project has received funding from the European Union’s Horizon Europe Research and Innovation Programme under grant agreement No 101155873. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.

While paediatric cardiac arrest is a rare event, consequences for the patients are significant with a considerable risk of morbidity, disability and mortality. The risk of cardiac arrest is substantially increased in children with congenital heart disease. Nevertheless, there is a lack of data concerning this population. To close this knowledge gap, this multicentre, prospective, open registry aims to implement a standardised structure for data collection and follow-up of paediatric cardiac arrests associated with heart diseases in Germany.

All paediatric patients who experience a cardiac arrest and receive at least 2 minutes of cardiopulmonary resuscitation are invited to participate in this registry. The dataset comprises demographical, clinical, resuscitation and outcome data, collected in accordance with the Utstein guidelines. Neurological assessments, cognitive and motor tests are conducted at fixed intervals. Additionally, patient-reported outcome measures will be surveyed. Primary outcomes are survival to discharge and neurodevelopmental outcome after discharge and 2 years. The data are pseudonymised prior to submission to an online REDCap database, which is centrally hosted on a server located in Leipzig, Germany.

This study follows the Declaration of Helsinki and received ethical approval from the Ethics Committee in Leipzig. Registry results will allow us to understand the epidemiology, guideline adherence, risk factors and will be presented at conferences and submitted to a peer-reviewed journal for publication.

NCT05373498.

Mental disorders affect nearly one billion people worldwide, posing major challenges to public health. While conventional treatments like psychotherapy and pharmacotherapy are effective for many patients, they are often associated with adverse effects and high non-response rates, underscoring the need for alternative approaches. Non-invasive brain stimulation techniques such as transcranial magnetic stimulation, transcranial electric stimulation and transcranial focused ultrasound stimulation are increasingly used to treat psychiatric conditions. Although these methods show promising efficacy, data on their adverse effects remain fragmented and inconsistently reported. This meta-analysis aims to systematically compare the type and frequency of adverse effects, tolerability, and acceptability across different brain stimulation techniques and mental disorders. The findings will help improve safety monitoring and support more personalised, well-tolerated treatment strategies.

A systematic literature search of the Embase, MEDLINE(R), AMED (Allied and Complementary Medicine) and APA PsycINFO via OVID will be performed. Eligible studies include randomised controlled trials (RCTs) that compare active treatments or an active treatment with sham control, including both parallel group and cross-over studies, as well as prospective non-randomised studies such as case–control studies and pre–post studies investigating adverse effects of non-invasive brain stimulation in psychiatric populations. Included studies report on the frequency of adverse effects in a standardised manner. Primary outcomes comprise the incidence of specific adverse effects, dropout rates due to adverse effects (tolerability) and overall dropout rates (acceptability). Risk of bias will be assessed using the Cochrane RoB 2.0 tool for RCTs and the NHLBI quality assessment tool for pre–post studies. The quality of case–control studies will be assessed using the Newcastle-Ottawa scale. Provided that sufficient data are available and the network of comparisons is adequately connected, a network meta-analysis will be conducted to compare adverse effects and tolerability across interventions.

No ethical approval is needed to conduct this work. The findings will be submitted for publication in peer-reviewed journals and presented at scientific meetings.

CRD420251164554

To develop and validate the Internalised Stigma Scale for Gestational Diabetes Mellitus (ISS-GDM), a questionnaire measuring self-reported internalised stigma among women with prior gestational diabetes mellitus (GDM). We hypothesised that internalised GDM stigma could be reliably and validly assessed through a short psychometric instrument.

Cross-sectional validation study.

Follow-up data from the Danish, multicentre Face-it trial for women with prior GDM and their families.

In total, 248 women completed the ISS-GDM approximately 1 year after their GDM affected pregnancy.

The primary outcome was psychometric properties of the ISS-GDM, assessed using Cronbach’s alpha, confirmatory factor analysis (CFA) and Rasch analysis (RA). Secondary outcomes included identification of item anomalies (local response dependence, differential item functioning).

A large proportion of respondents endorsed statements reflecting self-disappointment, self-blame and an altered self-perception. Less endorsed statements included feeling inferior to other mothers or guilt towards family members due to GDM. The ISS-GDM demonstrated satisfactory psychometric properties. CFA indicated that item 2 assessing self-perceived capabilities as a mother did not load onto the main factor, while CFA and RA identified local response dependence and differential item functioning by body mass index. After adjustments, a two-factor solution supported calculating a sum score of items 1 and 3–11, with item 2 retained as a stand-alone indicator of perceived parenting capabilities. The 10-item scale demonstrated acceptable reliability (Cronbach’s alpha=0.78).

The ISS-GDM is a reliable and valid tool for assessing internalised stigma among women with prior GDM. Our findings further suggest that a substantial proportion of women with prior GDM experience self-blame and an altered self-perception due to their diagnosis. The ISS-GDM scale enables research into its prevalence, severity and consequences.

Self-efficacy is a major factor in enabling individuals to follow behavioural goals. This applies to health behaviours including physical activity and exercise behaviour, a health topic especially important for persons suffering from health conditions. In subjects with already existing conditions, self-efficacy in exercise behaviour is a research field with a high volume of published articles, yet it has never been charted in its entirety. This systematic evidence map (SEM) provides a comprehensive overview of the current state in published empirical research.

Collecting, categorising and visualising the breadth of evidence via SEM following the Methods of Evidence Mapping by Schmucker et al.

Medline (via PubMed) and PsycINFO (via EbscoHost).

We searched for the terms ‘self-efficacy’ and any of the search terms ‘sport’ and ‘exercise’ in titles and abstracts. We included all empirical research studies published until 2022 that measured self-efficacy in relation to exercise. This SEM includes all studies on humans with a pre-existing condition. We extracted the data points authors, title, year, sample size (N), age groups, pre-existing condition(s), surveyed sport and method of measuring self-efficacy.

We extracted the data points from the full text (if available). In addition to a data table, we created a freely accessible evidence map in the form of graphs in this article.

The number of publications grew over time from single publications per year in the 1980s to over 100 per year in the beginning of the 2020s, adding up to 1342 included studies. Most research focuses on middle-aged and older adults. Research covers a wide variety of conditions, with endocrine, nutritional and metabolic diseases (22%) as well as diseases of the circulatory system (19%) being the most common disease groups. Most included studies (71%) do not specify a sport. Most (55%) papers used validated scales to measure self-efficacy, and we discovered 235 individually named scales among them.

This paper offers the first ever comprehensive list of empirical publications on self-efficacy in exercise behaviour in persons with pre-existing conditions in the form of a SEM. The research field was as wide as anticipated concerning total numbers, number of individual scales for measuring self-efficacy, as well as range in diagnosed conditions. Most research focusing on advanced age may be due to many diseases only manifesting later in life, and the lack of specification in types of sport points to the choice of sport being less important than getting enough exercise in general. Future research should examine the strength of evidence and the robustness and comparability of self-efficacy scales as well as underrepresented disease groups for public health considerations.

Since no primary data was collected, an ethics approval is not required for the presented work. In addition to the result being disseminated via the publication at hand, the data is being shared in detail via the Open Science Framework platform.

Acute lower limb ischaemia (ALI) is a life- and limb-threatening vascular emergency requiring urgent intervention. Despite advancements in therapeutic strategies, outcome reporting for ALI remains inconsistent, limiting evidence synthesis and guideline development. The CORE-ALI study aims to develop a Core Outcome Set (COS) to standardise outcome reporting and ensure the inclusion of both clinical and patient-centred metrics.

CORE-ALI will use a structured, multi-phase methodology guided by the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Core Outcome Set-STAndards for Reporting (COS-STAR) guidelines. Phase 1 involves stakeholder engagement through semi-structured interviews with patients, clinicians and policymakers from diverse European healthcare systems. Qualitative data will be analysed using thematic analysis to generate a preliminary list of outcomes. In Phase 2, a multi-round Delphi survey (anticipated two to three rounds) will prioritise and refine outcomes through consensus building, with quantitative data analysed using descriptive and non-parametric statistical methods. Phase 3 will culminate in a consensus meeting to finalise the COS. Multilingual accommodations will ensure inclusivity, and General Data Protection Regulation (GDPR)-compliant platforms will secure data handling.

The study has received ethics approval from the Ethics Committee of the Medical University of Innsbruck (EK Nr: 1082/2025) on 20/05/2025. Additional local ethics approvals are required and will be obtained at all participating sites prior to the initiation of recruitment. The final Core outcome set will be disseminated through peer-reviewed publications, presentations at international conferences and engagement with professional societies and patient organisations.

COMET initiative (Registration No. 3346).

The analgesic and antipyretic paracetamol (acetaminophen) is generally considered safe in therapeutic doses. The most important toxic effect is hepatotoxicity after supratherapeutic doses or in the presence of risk factors (eg, malnutrition, alcoholism). According to the WHO analgesic ladder, a combination of a non-opioid analgesic such as paracetamol with a strong opioid is recommended as step III treatment of patients with chronic pain, despite limited evidence for this approach. The main aim of this study is to test the hypothesis that paracetamol does not provide clinically relevant benefits when added to strong opioids in patients with chronic pain.

Investigator-initiated, randomised, double-blind, placebo-controlled, non-inferiority trial at two Swiss hospitals. A total of 140 patients with chronic pain requiring strong opioids and paracetamol ≥1.5 g/day for at least 7 days will be enrolled and randomised to either continued combination treatment or strong opioid plus placebo. In the first study phase (days 1–7), patients receive identically looking capsules containing either paracetamol at the exact dose previously used or a placebo. During a second study phase (days 7–14), all patients stop the blinded study medication (paracetamol and placebo) with follow-up to day 14. Adherence will be assessed by pill count and measurement of paracetamol and opioid serum concentrations. Patients are instructed to use a pain diary daily during the whole study. The primary outcome is the average pain score on day 7 using a 10 cm visual analogue scale (VAS). A difference between groups of ≤8 mm will be considered clinically irrelevant. Secondary outcomes will include VAS pain score on day 14, number of opioid rescue doses used, subjective ratings of overall feeling of well-being, quality of life, nausea/vomiting, drowsiness and constipation, and other adverse events, and potential effects of study drug concentrations and opioid receptor and cytochrome P450 (CYP) genotypes on the observed differences.

The study was approved by the Ethics Committee (Ethikkommission Bern, reference number 2021-01518) and the Swiss Agency for Therapeutic Products (Swissmedic, reference number 701286). Results will be published in open-access policy peer-reviewed journals. The study is funded by the Swiss National Science Foundation (grant number 32 003B_201072).

NCT05088876.

To understand how key relational factors lead to observed outcomes in mental health peer support.

This realist-informed qualitative review synthesised findings from 18 studies to develop programme theory relating to interpersonal contexts, linked outcomes and underlying mechanisms of change of mental health peer support.

Four databases were searched: PsycINFO, Embase, Medline, CINAHL.

All studies were evaluated for relevance and rigour for development of programme theory.

Qualitative data were extracted from 20 studies. A realist-informed synthesis identified repeating themes with context-mechanism-outcome configurations.

This identified five key contextual factors that together form the APPEAR framework (Accepting, Personalised Practice, Empowering, Available and Reciprocal). These contextual factors were found to interact to create the conditions for improved personal recovery outcomes in the domains of (1) self-acceptance, (2) confidence, (3) hopefulness, (4) self-expression, (5) relationships and (6) knowledge and skills.

The APPEAR framework offers an operational foundation for understanding interpersonal mental health peer support interventions.

Cardiopulmonary bypass has been used to perform complex cardiac surgery for over 70 years. Advances in bypass techniques and perioperative medicine have increased the safety of cardiac procedures, leading to reduced morbidity and mortality. Nevertheless, cardiopulmonary bypass still carries risks, including systemic inflammation and dysfunction of various organs. To date, optimal blood pressure management during cardiopulmonary bypass remains a subject of ongoing debate. Conflicting evidence exists regarding negative outcomes associated with both low and high mean arterial pressures. Current clinical guidelines recommend a broad target range for mean arterial pressure during cardiopulmonary bypass, which underscores the existing gap in knowledge. In non-cardiac surgery, the time-weighted average of mean arterial pressure has been used to determine minimum safe thresholds, with greater deviation from 65 mm Hg associated with an increased risk of adverse outcomes. However, the definition and reporting of low blood pressure during cardiopulmonary bypass varies between studies, and the use of time-weighted averages below the threshold is still uncommon. Details on pump flow during extracorporeal circulation are seldom reported.

We plan to conduct a retrospective, single-centre data analysis to investigate the effects of both arterial blood pressure and extracorporeal pump flow, including their time-weighted averages and areas under defined thresholds, during cardiopulmonary bypass on neurological outcomes in adult patients undergoing cardiac surgery between 2014 and 2023. The study will include both elective and emergency procedures, with separate analyses conducted based on the urgency and complexity of the operations. Digitally recorded anaesthesia and perfusion records will be imported and validated to extract information on haemodynamic parameters, neurological monitoring and extracorporeal circulation. Ischaemic and haemorrhagic strokes will be identified by screening postoperative brain imaging records for keywords indicating neurological events. Diagnostic data and additional patient and procedural information will be extracted from the local cardiac surgery database and hospital information system. Information about incidence and course of postoperative delirium will be extracted from the patient data management system used in intensive care. We expect to include approximately 500–700 cases per year in the final analysis.

The local ethics committee approved our study (Ethics Committee of the Medical University of Graz, IRB00002556, 36-296 ex 23/24). We aim to publish the results of our study preferably in an open access format.

The study protocol was registered at the Center for Open Science (https://doi.org/10.17605/OSF.IO/FAMV3).

Atrial fibrillation (AF) is a growing public health concern associated with significant morbidity, mortality and impaired quality of life. Despite evidence supporting cardiac rehabilitation (CR) as part of secondary prevention in AF care, referral rates remain low, and the extent of CR needs in this population is unknown. This protocol outlines a nationwide survey-based and registry-based study aiming to: i) describe CR needs among individuals with AF and ii) assess eligibility and acceptance of referral to specific CR components based on individual patient preferences and their overlap with identified needs.

This cross-sectional study includes three phases: 1) identification of the study population using Danish national registries; 2) electronic survey distribution to individuals with a first-time AF diagnosis in 2023–2024 and 3) registry data enrichment of the entire population. The survey includes validated patient-reported outcome measures aligned with a newly developed Needs Assessment Model, supplemented by items on patient preferences for CR components. Data are analysed descriptively and using correlation analysis.

Participants are informed of the study purpose, data protection and their rights before providing informed consent through survey participation. The study follows the Declaration of Helsinki and Danish ethical standards. Findings are disseminated via scientific journals, conferences, a cross-sectoral stakeholder workshop and public outreach activities.

NCT06772207.

Although individuals with dementia who reside in nursing homes are particularly susceptible to developing delirium, this condition is rarely recognised in these settings. Detection of delirium requires validated and reliable tools for this setting that can be applied by nursing staff. The primary objective of the study is to assess the comprehensibility, practicality and inter-rater reliability of two delirium detection tools (4 A’s test (4AT) and 4-item delirium superimposed on dementia (4-DSD)) and one tool for assessing both the diagnosis and severity of delirium (Delirium Rating Scale-Revised-98 (DRS-R-98)) in people with dementia who reside in nursing homes when used by nurses.

The comprehensibility and practicality of the German versions of the 4AT, 4-DSD and DRS-R-98 will be evaluated using cognitive interviews in accordance with the consensus-based standards for the selection of health measurement instruments framework. On the basis of the results of the cognitive interviews, a manual for each of the three tools will be developed and finalised by an expert panel. Finally, the inter-rater reliability and measurement error of the three tools will be determined using the manuals. For this purpose, a total of 70 residents from six nursing homes will be assessed by at least two nurses. The data analysis will include descriptive statistics and inter-rater reliability assessment for individual items (kappa value) and total scores (Intraclass correlation coefficients).

This study will assess the comprehensibility, practicality and inter-rater reliability of the 4AT, 4-DSD and DRS-R-98 for use in residents with dementia in nursing homes. The project was approved by the medical ethics committee of the University of Oldenburg (reference number: 2025-093).

The inter-rater reliability study was registered in the German Clinical Trials Register. Registration number: DRKS00037458 (https://www.drks.de/search/de/trial/DRKS00037458/details).