Incretin-based drugs, including glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RAs, are increasingly used in the management of type 2 diabetes mellitus and obesity. While these agents have shown cardiovascular benefits, their effects on both cardiovascular outcomes and cardiac structure and function remain uncertain—particularly in patients with and without a history of heart failure (HF).

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S)), as well as clinical trial registries from their inception and onwards to identify relevant randomised trials. The literature search is scheduled for July 2025. Two review authors will independently extract data and assess risk of bias. We will include randomised controlled trials assessing the effects of cagrilintide/semaglutide, liraglutide, semaglutide and tirzepatide in patients with and without a history of HF. The primary outcome will be cardiovascular mortality. Secondary outcomes will include HF hospitalisation, myocardial infarction, stroke, heart rate, systolic blood pressure, N-terminal pro B-type natriuretic peptide, left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume. Data will be synthesised by aggregate data meta-analyses and trial sequential analysis. Risk of bias will be assessed with the Cochrane Risk of Bias tool, version 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

As this study is a systematic review based on secondary analysis of published data, ethical approval is not required. Findings will be published in international peer-reviewed scientific journals.

CRD420251003374.

Parkinson’s disease (PD) is a neurodegenerative, progressive disorder known for motor and non-motor symptoms. The vestibular system, via the vestibulo-ocular reflex (VOR), is crucial for maintaining dynamic gaze stability, and its role in PD is raising interest among researchers. Indeed, vestibular dysfunction in PD may exacerbate postural instability and gait disturbances; however, the prevalence of vestibular dysfunctions remains unclear. This study aims to objectively investigate the VOR function in people with PD using the video head impulse test.

This is a cross-sectional study conducted in a neurorehabilitation hospital. People with PD were included if they had no cognitive impairment and the ability to walk without physical assistance. The video head impulse test was used to assess the VOR function across all six semicircular canals, using both the Head Impulse Paradigm (HIMP) and the Suppression Head Impulse Paradigm (SHIMP) paradigms.

35 people with PD (mean age: 69.9±8.4; 11 females) with moderate motor symptoms (MDS-UPDRS-part III: 27.7±6.8) were included. Using normative cut-offs, 69% of the participants had at least one dysfunctional canal (60% hypo-gain, 9% hyper-gain). The prevalence reached 83% when both the HIMP and SHIMP paradigms were considered.

There is a high prevalence of vestibular dysfunction in people with PD. The instrumental assessment of VOR gains could reveal undiagnosed vestibular dysfunctions and, in the future, lead to more specific rehabilitation management of people with PD.

Pre-eclampsia (PE) remains a major contributor to maternal morbidity and mortality globally. Early identification of risk factors and evaluation of prognostic models for severe adverse maternal outcomes are essential for improving management and reducing complications. While numerous studies have explored potential risk markers, there is still no consensus on the most reliable factors and models to use in clinical practice. This systematic review aims to consolidate research on both individual predictors and prognostic models of severe adverse maternal outcomes in PE, providing a comprehensive overview to support better clinical decision-making and patient care.

This review follows the Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol 2015 checklist. A systematic search will be performed using a detailed strategy across Medline, Embase, Cochrane, ProQuest dissertations, and grey literature from inception to 2 April 2024. Eligible studies will include those investigating clinical, laboratory-based, and sociodemographic predictors of severe adverse maternal outcomes in PE. Two reviewers will independently assess titles, abstracts, full texts, and extract data and assess study quality using the Quality In Prognostic Studies (QUIPS) tool for studies on risk predictors and the Prediction model Risk of Bias Assessment Tool (PROBAST) for prognostic models. The inclusion criteria will encompass cohort, case-control, and cross-sectional studies published in English and French involving women diagnosed with PE and reporting on the risk prediction for adverse maternal outcomes. The main outcomes of interest will include severe maternal morbidity and mortality during pregnancy, delivery, or within the postpartum period. Analyses will include both narrative synthesis and, where appropriate, meta-analysis using random-effects models. Pooled estimates will be calculated, with publication bias assessed through funnel plots and statistical tests (eg, Begg’s and Egger’s). Heterogeneity will be primarily assessed through visual inspection of forest plots, supported by statistical measures, such as the I² test, with further exploration through sensitivity, subgroup, and meta-regression analyses.

This systematic review will be based on published data and will not require ethics approval. Results will be disseminated through peer-reviewed publications and presentations at academic conferences.

CRD42024517097.

Polypharmacy is associated with an increased risk of adverse patient outcomes across various settings, including inpatient care. To enhance the appropriateness of medication therapy management for patients during hospital stays, computerised interventions have shown promise with regard to patient safety. This study assesses whether the implementation of a clinical decision support system will optimise the process of inpatient medication therapy to prevent inappropriate medication use and thus promote patient safety.

The intervention will be evaluated in a prospective, cluster-randomised controlled trial using a stepped-wedge design. The study will be conducted in 12 hospitals across Germany over a total period of 33 months. Patients will be treated according to the group status of the hospital and receive either standard care or the Transsektorale Optimierung der Patientensicherheit or trans-sectoral optimisation of patient safety intervention. The primary outcome is the combined endpoint of all-cause mortality and all-cause hospitalisation. Secondary endpoints are, for example, inappropriate prescriptions, utilisation of different health services, cost-effectiveness, as well as patient-reported outcome measures. Parameters describing the attitudes of patients and healthcare professionals towards the intervention and organisational change processes will be collected as part of the process evaluation. The primary endpoint will be evaluated using hospital and outpatient claims data from participating statutory health insurances at the population level. There are multiple secondary endpoints with data linkage of primary and secondary data at study participant level. Statistical analysis will make use of (generalised) linear mixed models or generalised estimating equations, taking account of independent covariables. All data analyses of the process evaluation will be descriptive and explorative.

Data collection, storage and evaluation meet all applicable data protection regulations. The trial has been approved by the Ethics Committees of the University of Wuppertal and the Medical Association of Saarland, Germany. Results will be disseminated through workshops, peer-reviewed publications and local and international conferences.

DRKS00025485.

Cardiovascular diseases remain the leading cause of mortality worldwide. Tirzepatide is approved for the treatment of type 2 diabetes mellitus and overweight and is increasingly used. The adverse effects with tirzepatide may not be disease-specific and have not been assessed previously.

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED), Conference Proceedings Citation Index—Science (CPCI-S)) and clinical trial registries from their inception and onwards to identify relevant randomised clinical trials. We expect to conduct the literature search in January 2025. Two review authors will independently extract data and perform risk of bias assessments. We will include randomised clinical trials comparing tirzepatide versus placebo or no intervention in all patient groups with an increased risk of cardiovascular events. Primary outcomes will be all-cause mortality and serious adverse events. Secondary outcomes will be myocardial infarction, stroke, all-cause hospitalisation and non-serious adverse events. Data will be synthesised by meta-analyses and Trial Sequential Analysis, risk of bias will be assessed with the Cochrane Risk of Bias tool—version 2. We will systematically assess if the thresholds for statistical and clinical significance are crossed, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations.

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

CRD42024599035.