GAIA (Germany)

Abstract Background Pacemaker (PM) patients may be at an increased risk of developing heart failure with preserved ejection fraction (HFpEF) due to pacing-induced cardiac remodeling and age-related cardiovascular changes. However, HFpEF remains underdiagnosed and poorly understood in this population. Early detection is crucial for timely intervention, improving outcomes and reducing complications. Purpose Evaluate the impact of a systematic screening program of HFpEF in a large cohort of PM patients. Methods This was a cross-sectional, single-center study of patients with right ventricular apical pacing PMs implanted between January 2018 and December 2022. Each participant underwent a comprehensive assessment, including echocardiography, NT-proBNP measurement, clinical evaluation, PM interrogation and frailty assessment using the Edmonton Frail Scale. HF was classified per the 2023 ESC guidelines, with detailed systolic and diastolic function evaluation, including strain analysis and diastolic stress testing when needed. Results A total of 510 PM patients were screened, revealing a high prevalence of previously unrecognized HF. Of these, 194(38.0%) were diagnosed wth HFpEF, 31(6.1%) HFmrEF and 15(2.9%) previously undiagnosed HFrEF. Notably, only 47(9.2%) of HFpEF patients had a prior diagnosis. HFpEF patients were older (median age 83 years; IQR 78–86; p=0.003), and had a higher proportion of females (50.5% vs 19.4% in HFmrEF and 33.3% in HFrEF; p=0.003). They also had a high-risk CV profile, namely hypertension (84.5%), dyslipidemia (72.2%) and diabetes (43.3%). HFpEF patients had similar PM type distribution and ventricular pacing burden (75.6%±29.4, p =0.135) compared to other HF groups, with significantly higher ventricular pacing compared to non-HF patients (75.6%±29.4 vs 60.7%±43.4, p<0.001). Echocardiography characteristics of HFpEF patients revealed higher left ventricular global longitudinal strain (GLS) (-13.5±4.32%) and left atrial reservoir strain (17.56±9.43%) compared to HFmrEF and HFrEF, but still significantly lower than non-HF patients (GLS:13.5 vs 15.1, p<0.001). Systematic screening led to key interventions: 28% of patients were referred to cardiology (17% for LVEF<40%, 11% for severe valvular disease), 18% were referred to other specialties for additional management and 28.8% of newly diagnosed HFpEF patients for therapeutic reassessment to improve guideline-directed treatment. Conclusion Systematic screening in PM patients revealed a substantial burden of unrecognized HFpEF, highlighting the need for proactive diagnostics in this high-risk group. HFpEF patients had significant cardiovascular risk factors, high ventricular pacing burden, and suboptimal guideline-directed therapy. Structured screening enabled earlier detection, specialist referrals, and therapeutic reassessment. These findings support integrating routine HF screening into PM management to enhance early diagnosis, treatment optimization, and patient outcomes.

In this randomized controlled trial, we investigated the efficacy of the digital cognitive behavioral therapy-based program lancivis in improving quality of life (QoL), cancer-related fatigue, distress symptoms and fear of cancer progression in N = 604 cancer patients and survivors in Germany. Participants in the intervention group (IG; n = 304) used lancivis alongside treatment as usual (TAU) while participants in the control group (CG; n = 300) received TAU only. Intent-to-treat (ITT) analyses revealed significant improvements in fatigue in the IG compared to the CG after 3 months (T1; Cohen's d: 0.29) and 6 months (T2; Cohen's d: 0.31). Participants in the IG reported also significantly lower fear of cancer progression than the CG at T1 and T2 and lower levels of distress symptoms at T2. No between group differences were found for health-related QoL. Results suggest that lancivis may present a beneficial addition to psycho-oncological care services.

Abstract Introduction Interventional cardiology training has a long learning curve and exposes patients and clinicians to undesirable procedural risks. We aim to assess whether mentored simulation-based training with three dimensional (3D) printed models can improve the procedural skills and safety performance of beginners in coronary diagnostic procedures. Methods Twenty-nine final-year medical students from a single centre were lectured in the basic principles of invasive coronary angiography (ICA) for one-hour, and then randomized to conventional training or simulation training. Conventional training (n=15) consisted in watching a 20-minute video demonstrating all ICA steps in a 3D-printed coronary simulator. Simulation training (n=14) offered the same explanations in a hands-on training session with the 3D-printed model, in pairs, for 20 minutes. The co-primary endpoint was efficacy and safety of performing a simulated ICA in the 3D-printed simulator, installed under sterile drapes, in a conventional angiography suite. Efficacy and safety were graded by a blinded investigator using a pre-specified performance checklist, including the identification of procedural "red flags", graded 0-100%. The secondary endpoint was theoretical knowledge, assessed in a 25-question multiple-choice quiz, graded 0-100%. Results All participants completed the training and evaluation phases. Both elements of the co-primary endpoint were superior in the simulation group: efficacy score of 91.5 ± 3.8 vs 64.6 ± 8.3% and safety score 100.0 (100.0-100.0) vs 62.5 (20.8-79.2) %, p<0.001. The median number of "red flags" were 2 (1-4) in conventional and 0 (0-0) in simulation training recipients (p<0.001). Secondary endpoint was higher in simulation training: 85.7 ± 9.0 vs 76.8 ± 12.7% (p=0.039). Conclusion Mentored simulation-based training of medical students in ICA with 3D-printed models resulted in improved performance regarding efficacy, procedural safety, and theoretical knowledge.ResultsSimulation and evaluation setup

Cognitive behavioral therapy improves psychosocial outcomes in rheumatoid arthritis (RA), but access is limited. We conducted a randomized controlled trial to evaluate the efficacy of a cognitive-behavioral digital therapeutic, reclarit, on psychosocial outcomes in adult RA patients with impaired health-related quality of life. Participants were randomized to reclarit plus treatment as usual (TAU) or TAU plus educational and informational material (active control). The primary outcome was SF-36 mental (MCS) and physical (PCS) component summary scores at 3 months, with additional assessments at 6 months. reclarit significantly improved SF-36 MCS scores compared to control (mean difference 3.3 [95% CI 0.7, 5.9]; p = 0.014), with high user satisfaction and sustained improvements at 6 months. Depression, anxiety, fatigue, and social/work functioning also improved significantly, while SF-36 PCS, pain, and disability scores did not differ. In conclusion, reclarit offers immediate, effective, evidence-based and personalized psychological support for RA patients.

PurposeCultivated meat (CM) is attracting increased attention as an environmentally sustainable and animal-friendly alternative to conventional meat. As the technology matures, more data are becoming available and uncertainties decline. The goal of this ex-ante life cycle assessment (LCA) was to provide an outlook of the environmental performance of commercial-scale CM production in 2030 and to compare this to conventional animal production in 2030, using recent and often primary data, combined with scenario analysis.MethodsThis comparative attributional ex-ante LCA used the ReCiPe Midpoint impact assessment method. System boundaries were cradle-to-gate, and the functional unit was 1 kg of meat. Data were collected from over 15 companies active in CM production and its supply chain. Source data include lab-scale primary data from five CM producers, full-scale primary data from processes in comparable manufacturing fields, data from computational models, and data from published literature. Important data have been cross-checked with additional experts. Scenarios were used to represent the variation in data and to assess the influence of important choices such as energy mix. Ambitious benchmarks were made for conventional beef, pork, and chicken production systems, which include efficient intensive European animal agriculture and incorporate potential improvements for 2030.Results and discussionCM is almost three times more efficient in turning crops into meat than chicken, the most efficient animal, and therefore agricultural land use is low. Nitrogen-related and air pollution emissions of CM are also lower because of this efficiency and because CM is produced in a contained system without manure. CM production is energy-intensive, and therefore the energy mix used for production and in its supply chain is important. Using renewable energy, the carbon footprint is lower than beef and pork and comparable to the ambitious benchmark of chicken. Greenhouse gas profiles are different, being mostly CO2 for CM and more CH4 and N2O for conventional meats. Climate hotspots are energy used for maintaining temperature in reactors and for biotechnological production of culture medium ingredients.ConclusionsCM has the potential to have a lower environmental impact than ambitious conventional meat benchmarks, for most environmental indicators, most clearly agricultural land use, air pollution, and nitrogen-related emissions. The carbon footprint is substantially lower than that of beef. How it compares to chicken and pork depends on energy mixes. While CM production and its upstream supply chain are energy-intensive, using renewable energy can ensure that it is a sustainable alternative to all conventional meats.RecommendationsCM producers should optimize energy efficiency and source additional renewable energy, leverage supply chain collaborations to ensure sustainable feedstocks, and search for the environmental optimum of culture medium through combining low-impact ingredients and high-performance medium formulation. Governments should consider this emerging industry’s increased renewable energy demand and the sustainability potential of freed-up agricultural land. Consumers should consider CM not as an extra option on the menu, but as a substitute to higher-impact products.

BackgroundLiving Labs are user-centered, open innovation ecosystems based on a systematic user cocreation approach, which integrates research and innovation processes in real-life communities and settings. The Horizon 2020 Project VITALISE (Virtual Health and Wellbeing Living Lab Infrastructure) unites 19 partners across 11 countries. The project aims to harmonize Living Lab procedures and enable effective and convenient transnational and virtual access to key European health and well-being research infrastructures, which are governed by Living Labs. The VITALISE consortium will conduct joint research activities in the fields included in the care pathway of patients: rehabilitation, transitional care, and everyday living environments for older adults. This protocol focuses on health and well-being research in everyday living environments.ObjectiveThe main aim of this study is to cocreate and test a harmonized research protocol for developing big data–driven hybrid persona, which are hypothetical user archetypes created to represent a user community. In addition, the use and applicability of innovative technologies will be investigated in the context of various everyday living and Living Lab environments.MethodsIn phase 1, surveys and structured interviews will be used to identify the most suitable Living Lab methods, tools, and instruments for health-related research among VITALISE project Living Labs (N=10). A series of web-based cocreation workshops and iterative cowriting processes will be applied to define the initial protocols. In phase 2, five small-scale case studies will be conducted to test the cocreated research protocols in various real-life everyday living settings and Living Lab infrastructures. In phase 3, a cross-case analysis grounded on semistructured interviews will be conducted to identify the challenges and benefits of using the proposed research protocols. Furthermore, a series of cocreation workshops and the consensus seeking Delphi study process will be conducted in parallel to cocreate and validate the acceptance of the defined harmonized research protocols among wider Living Lab communities.ResultsAs of September 30, 2021, project deliverables Ethics and safety manual and Living lab standard version 1 have been submitted to the European Commission review process. The study will be finished by March 2024.ConclusionsThe outcome of this research will lead to harmonized procedures and protocols in the context of big data–driven hybrid persona development among health and well-being Living Labs in Europe and beyond. Harmonized protocols enable Living Labs to exploit similar research protocols, devices, hardware, and software for interventions and complex data collection purposes. Economies of scale and improved use of resources will speed up and improve research quality and offer novel possibilities for open data sharing, multidisciplinary research, and comparative studies beyond current practices. Case studies will also provide novel insights for implementing innovative technologies in the context of everyday Living Lab research.International Registered Report Identifier (IRRID)DERR1-10.2196/34567

The document presents the collection of practical guidelines and technical manuals on principles, tools and technologies to improve WUE and NUE.

<p>The document presents the collection of practical guidelines and technical manuals on principles, tools and technologies to improve WUE and NUE.</p>

eHealth programs have been found to be effective in treating many psychological conditions. Regarding Borderline Personality Disorder (BPD), few programs have been tested; nevertheless, results are promising. The therapeutic alliance is an important factor predicting treatment outcome in BPD. However, we do not know yet to what extent BPD patients form a therapeutic alliance with an eHealth tool and how this relationship differs from the relationship with their human therapist. This study aims to address this question using priovi, an interactive schema therapy-based eHealth tool for BPD. Semi-structured interviews were conducted to explore how patients perceived the therapeutic alliance with priovi and its differences compared to the alliance with their human therapist (N = 9). Interview data were analyzed following the procedures of qualitative content analysis. Additionally, the Working Alliance Inventory (WAI-SR) was administered in two versions (regarding the human therapist and priovi, N = 16) every three months during the treatment phase of one year. Results indicate that patients were able to form a good therapeutic relationship with priovi, but it differed from the relationship to their human therapist. Important categories were “priovi is helpful, supportive and always there” and “priovi is less flexible”. WAI ratings for the task subscale were high in both relationships but significantly higher in WAItherapist compared to WAIpriovi in two measurements (nine-months measurement: t = 2.76, df = 15, p = 0.015; twelve-months measurement: t = 3.44, df = 15, p = 0.004). These results indicate that BPD patients can form a functioning alliance with an eHealth program and that eHealth programs may be especially useful for psychoeducation and cognitive exercises.

This study analyses the psychometric properties of the Working Alliance Inventory adapted for guided Internet interventions (WAI-I). We drew on the data set from a multicenter trial that examined a guided Internet intervention (deprexis) for patients with mild to moderate depression. Two hundred twenty-three patients completed the WAI-I and the Patient Satisfaction Questionnaire (ZUF-8) at posttreatment, and the Attitudes toward Psychological Online-Interventions Questionnaire (APOI) at baseline. We ran confirmatory factor analyses (CFA) testing two- and three-factor solutions and calculated Cronbach's α, item-total correlations, and correlations of the WAI-I with APOI and ZUF-8. The results suggested a two-factor solution, with a very good model fit and evidence of factor independency, adequate internal consistency, and external validity for the complete scale and the sub-scales. The WAI-I showed as a reliable and valid instrument to capture alliance in guided Internet interventions, which might facilitate process-outcome research and treatment development efforts.