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Hospital discharge planning in cardiac care: study protocol for a mixed-methods study on the implementation, influencing factors and quality of care in Germany

Por: Imhof · L. · Bartels · R. · Blum · K. · Blume · K. S. · Fleischer · S. · Gottschalk · S. · Heber · R. · Horenkamp-Sonntag · D. · Meyer · G. · Remppis · B. A. · Schneider · U. · Schreyoegg · J. · Winter · V.
Introduction

Discharge planning (DP) is essential to ensure continuity of care during patient transitions between inpatient and outpatient settings. Although DP has been legally required for all hospitals in Germany since 2017, several studies show considerable variation in its implementation, likely due to differences in structural characteristics and organisational processes. Both quality and efficiency-enhancing DP processes are particularly important in the context of cardiovascular disease, which is the leading cause of mortality and a major contributor to healthcare costs in Germany. The ‘Ready to Discharge’ (R2D) project investigates the implementation status, influencing factors and outcomes of DP in cardiac units of German hospitals. By integrating quantitative and qualitative data, we aim to identify best practices and provide actionable recommendations for improving DP processes.

Methods and analysis

A mixed-methods study design will be used. Quantitative analyses will be based on primary data from hospital and patient surveys combined with secondary data from health insurance claims and hospital quality reports. Key outcome measures will include healthcare utilisation outcomes (eg, readmissions, emergency department visits), patient health status outcomes (eg, patient satisfaction, self-rated health) and medication-related outcomes (eg, medication adherence). Qualitative interviews with healthcare professionals will enrich the findings by providing insights into barriers and facilitators to DP.

Ethics and dissemination

This study was approved by the Ethics Committee of Bergische University of Wuppertal and the German Federal Office for Social Security. Informed consent will be obtained for all primary data collections. Hospital managing directors will be informed prior to the hospital survey and will be able to withdraw consent. Patients can withdraw their consent at any time. Secondary data will be analysed in pseudonymised form to ensure patient confidentiality. Results will be disseminated through workshops, regional and international conferences and peer-reviewed publications.

Treatments for Pyoderma Gangrenosum: A Systematic Review and Single‐Arm Meta‐Analysis of Systemic Therapies

ABSTRACT

Pyoderma gangrenosum (PG) is a neutrophilic dermatosis associated with significant morbidity and mortality, with no consensus treatment to date. To review all clinical trials of treatments for PG to synthesise clinical evidence regarding the efficacy and safety of different treatments. After PROSPERO (CRD42023459180) registration, we systematically searched five databases (clinicaltrials.gov, CENTRAL, Embase, PubMed and Scopus) up until 18th May 2024 for PG treatments. Of 10 579 identified articles, 5853 deduplicated abstracts were screened. Twenty studies met the screening criteria after a full text review of 60 articles. We assessed the risk of bias using ROBIN-I for non-randomised and ROB-2 for randomised trials. Two reviewers independently performed article screening and quality assessments. Two reviewers independently extracted and recorded data on study characteristics, participants' demographics, disease characteristics, treatment regimens, and outcomes for the selected studies. A single-arm meta-analysis of available RCTs and non-randomised studies was conducted to analyse the outcomes of different systemic immunomodulators. The primary outcome was the complete healing of PG. Secondary outcomes included rates of recurrence, treatment failure, adverse events and time to complete healing. A total of twenty (20) interventional studies were included in the data synthesis: nine (9) prospective open-label studies, six (6) prospective cohort studies, three (3) open-label clinical trials, and two (2) randomised controlled trials evaluating multiple biological, systemic, and topical interventions. On random effects meta-analysis of systemic therapies including adalimumab, canakinumab, infliximab, chlorambucil, cyclosporine, cyclophosphamide and prednisolone, the pooled proportion of complete healing across 11 studies was 0.59 (95% confidence interval [CI]: 0.41–0.74; Χ 2 = 26.66, p < 0.01; I 2 = 66%); the pooled proportion of PG recurrence across 6 studies was 0.30 (95% CI: 0.20–0.41; Χ 2 = 1.14, p = 0.95; I 2 = 0%); the pooled proportion of serious adverse effects from 4 studies was 0.10 (95% CI: 0.05–0.19; Χ 2 = 5.01, p = 0.17; I 2  = 40%); and the pooled proportion of PG treatment failure across seven studies was 0.36 (95% CI: 0.24–0.49; Χ 2 = 12.78, p = 0.03; I 2 = 61%). The proportion of complete wound healing varies significantly across treatments and recurrence is common even in a limited follow-up period. Heterogeneity of study methods and low numbers hamper disease research. There remains a significant unmet need for better outcome measures than just complete healing as well as better treatment options to improve patient outcomes.

Establishing a non-viral transfection system for fibroblasts using branched polyethylenimine

by Tim Lukas Lübbersmeyer, Kirsten Wissel, Andrea Hoffmann, Lisa Kötter, Thomas Lenarz, Gerrit Paasche

Enhanced survival of spiral ganglion neurons (SGN) could improve hearing in patients with cochlear implants. Supplying these cells with growth factors like brain-derived neurotropic factor (BDNF) has been shown to improve cell survival and vitality. Direct applications of BDNF, e.g., via integrated drug-delivering cannula, elevate the surgical risks, as well as the probability of infections. Therefore, in vivo production of BDNF by on-site transfection of cells with plasmid DNA coding for BDNF might be an option. Polyethylenimine (PEI) was chosen as a non-viral transfection reagent, due to its comparatively low cytotoxicity, ease of preparation and use. NIH/3T3 fibroblasts were used as model cells for fibroblast transfection that could be transferred to cochlear implants. Branched 25 kDa PEI was diluted in PBS and mixed in different ratios with two different plasmids coding for BDNF and tdTomato simultaneously. Particle size and zeta potential were determined, and cell metabolic activity was measured using MTT. Transfection efficiency was determined by counting cells with and without transfection-induced fluorescence. Complexes of DNA and PEI were mostly larger than DNA and PEI molecules alone. In addition, complexation of DNA with PEI altered the surface charge of the particles. The cell metabolic activity test confirmed cytocompatibility for almost all tested complexes of DNA and PEI. Plasmid A, which was based on a lentiviral vector backbone, resulted in a very low transfection efficiency of 0.4%, whereas with plasmid B, which was based on pUC19, a transfection efficiency of about 9% was achieved. Size and zeta potential indicate the formation of complexes with both plasmids. Transfection efficacy appears to be dependent on the size of the DNA molecule used. With successful transformation of nearly 10% efficiency and a comparatively low cytotoxicity, the proposed transfection system using plasmid B may be used for further experiments.

What motivates GPs to vaccinate against influenza? Protocol for a mixed-methods study

Por: Bussmann · A. · Plath · E. · Minor · M. · Meyer · A. C. · Hagemann · C. · Damm · O. · Wasem · J. · Speckemeier · C.
Introduction

In Germany, influenza vaccination rates in at-risk groups are well below the 75% coverage recommended by the WHO. Although it has been shown that general practitioners (GPs) can play a key role in increasing their patients’ willingness to be vaccinated, this potential does not seem to have been fully used. This study aims to uncover factors that motivate GPs to vaccinate their patients against influenza, investigate the role of financial incentives in achieving higher vaccination rates and determine how the daily practice of GPs can be made more vaccination friendly.

Methods and analysis

A mixed-methods approach is employed to reach the research aims. Literature reviews will be conducted to identify factors that motivate GPs to vaccinate against influenza and to identify studies in which preferences are elicited. This is followed by semistructured interviews with GPs (n=6–10). The scoping reviews and interviews serve as a basis for the development of a quantitative survey directed at GPs which includes a discrete choice experiment. The quantitative survey will be sent to a total of 3760 GPs.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki. A positive vote has been received from the Ethics Committee of the Medical Association North Rhine (2024259). Study participants will only be included in the study after being given informed consent. Manuscripts will be prepared for the scoping review on motivating factors and after completion of the quantitative survey, which will be submitted to peer-reviewed journals. Interim results and final results of the project will be presented at conferences.

Identification of core outcomes for quality in routine care provided to people living with dementia in Australia: a multilevel modified Delphi consensus study

Por: Kenny · D. · Welch · A. · Dao-Tran · T.-H. · Lendich · K. · Brittain · D. · Thompson · J. · Parkin · B. · Nunn · J. · OKeefe · F. · Semler · R. · Davies · B. · Comans · T. · COM-IC project team · Welch · Kearney · Meyer · Cunningham · Kenny · Trepel · Petrie · Nunn · Quinn · Lowthian · Ng
Objective

To co-design a core outcome set with people living with dementia and other stakeholders that can be used to measure the quality of dementia care in home care and residential settings.

Design

Multilevel modified Delphi consensus study. A priori consensus threshold of 70% was used to include or exclude outcomes.

Setting

Routine dementia care provided through home care and residential aged care facilities in Australia.

Participants

A stakeholder panel comprising people living with dementia, formal and family/informal carers of people living with dementia, advocates, policy experts, allied-health professionals, nurses and professionals working in the aged care industry. Round 1 included 10 panellists; subsequent rounds extended the number of participants to 24.

Results

Seven outcome domains (Death, Physiological and clinical, Functional, Life impact, Resources, Adverse events and Education), encompassing 105 individual outcomes were considered by the panel over four rounds.

The 105 outcomes were distilled to 16 outcomes identified as important in home care and 15 in residential aged care. In both settings, nine outcomes (Dignity, Advanced care planning, Meaningful activities, Feeling safe and secure, Emotional wellbeing, Quality of Life, Resource utilisation, Safety incidents and Dementia-specific qualifications for care staff) were considered important.

Additionally, seven outcomes in the home care setting (Behavioural symptoms of dementia, Diagnosis of dementia, Hygiene, Importance of Relationships, Quality of carer and family lives, Dementia care navigation and Opportunities for unpaid carers) and six outcomes in the residential aged care setting (Neuropsychiatric symptoms of dementia, Pain, Hygiene and comfort, Medication safety, Staff carer morale and Adverse effects) were classified as important.

Conclusions

The outcomes identified during this modified Delphi consensus study provide a promising basis for the development of a meaningful, practical and measurable core outcome set that could be used in dementia care settings to improve the quality of routine care provided to people living with dementia.

Risk factors for neuroendocrine neoplasms: protocol for a case-control study based on a record linkage of registry and claims data

Por: Voigtländer · S. · Gerlach · R. · Grundmann · N. · Donnachie · E. · Berger · U. · Hakimhashemi · A. · Meyer · M. · Tauscher · M. · Müller-Nordhorn · J.
Background

Recent studies showed an increase in neuroendocrine neoplasms, especially for the digestive tract. Several risk factors have been suggested to explain this increase, including a family history of cancer, tobacco smoking, alcohol consumption and metabolic disorders such as diabetes and obesity. Another risk factor may be depressive disorders, which could increase the risk of neuroendocrine neoplasms either directly or mediated through associated risk behaviours and/or antidepressant medication. Here, we outline the design of our study to identify the risk factors for neuroendocrine neoplasms in Germany.

Methods and analysis

A case–control study of the resident population of Bavaria, the second most populous federal state in Germany, based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. Cases have a diagnosis of a malignant neuroendocrine neoplasm, either of the bronchopulmonary system or the gastroenteropancreatic system, in the period from 2021 to 2023. Controls are sampled from the non-cases and matched on sex, birth year (in 5-year intervals) and time of diagnosis (by calendar quarter). Risk factor prevalence of cases and controls is assessed on the basis of assured outpatient diagnoses, that is, diagnoses documented in at least 2 out of 4 consecutive quarters in the 16 quarters preceding the diagnosis of a neuroendocrine neoplasm. The analysis uses conditional logistic regression to estimate ORs and 95% CIs.

Ethics and dissemination

This study protocol was approved by the Ethics Committee of the Bavarian State Chamber of Physicians (reference number: 24008). Approval by the supervisory authority has been obtained from the Bavarian State Ministry of Health, Care, and Prevention (reference number: G35h-A1080-2023/20-2) and also the Bavarian Data Protection Commissioner stated to have no concerns after presentation of the study protocol (reference number: DSB/7-692/1-275). The results of the case–control study will be presented at national as well as international conferences and be published in the form of scientific articles in peer-reviewed journals.

Trial registration number

NCT06282016.

Frameworks, models and theories for prevention of child maltreatment: protocol for a scoping review from a population health perspective

Por: Rasch · L. · Alayli · A. · Ballmeyer · C. · Franco · J. V. A. · De Bock · F.
Introduction

Child maltreatment (CM) is a major public health issue with lifelong consequences on mental health, quality of life, educational and economic prospects of children who experienced CM. Early identification of maltreated children is important to prevent further CM and ensure that children’s basic needs are met, as well as to address and avoid further consequences. However, above and beyond early identification, it is crucial to avoid the occurrence of CM. This may include the reduction of risk factors at the family and community level as well as creating supportive environments for growing up safely. Therefore, we need to understand the prevention of CM conceptually and view it not only from a medical perspective, but also from a population health perspective. The aim of this scoping review is to identify and describe theories, models or frameworks on the prevention of CM from a broad population health perspective, considering primary, secondary and tertiary prevention strategies.

Methods and analysis

A broad search in four databases (PubMed (NIH NLM), PsycInfo (Ovid), CINAHL Plus (EBSCOhost) and Web of Science (Clarivate)) will be conducted from 2009 to current. Additionally, the grey literature on websites from key public health organisations will be considered. Results will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews: Checklist and Explanation (2018). The review will include articles describing a theory, model or framework on prevention strategies for CM. Studies focussing on single interventions that do not describe prevention strategies conceptually, will be excluded. General characteristics of the frameworks, theories and models and information on types of prevention strategies they describe will be extracted. Findings will be presented in a structured table format as well as narratively.

Ethics and dissemination

As we will not collect any personal, confidential or sensitive data, ethical approval is not required. We will publish our results in a scientific journal, present them at conferences and use them for further knowledge translation activities. The scoping review is registered with the Open Science framework: https://osf.io/49g7z/.

Iron deficiency in patients with cardiogenic shock: protocol for a scoping review

Por: Germinario · L. · Catena · D. · Ott · S. · Roeschl · T. · Ghamri · Y. · Meyer · A. · OBrien · B. · Schoenrath · F.
Introduction

Cardiogenic shock (CS) is a severe condition characterised by low cardiac output and often hypotension, which results in organ hypoperfusion due to cardiac failure. As a form of acute heart failure, this condition seems to share similar underlying pathological mechanisms. It is well established that iron deficiency is correlated with chronic and acute heart failure, causing worsening of the symptoms, reduction of quality of life and survival and simultaneously increasing the rehospitalisation rates for all causes in these patients. It remains unclear whether there is an association between iron deficiency and CS. The objective of this scoping review will be to determine the actual state of the art regarding the significance of iron deficiency in patients affected by CS.

Methods and analysis

We will conduct a systematic review of the literature using MEDLINE and EMBASE via ‘Ovid’ (Elsevier) and Web of Science (2024 Clarivate). The goal is to analyse the incidence and clinical significance of iron deficiency in patients affected by cardiogenic shock. To gain a deeper insight into the underlying pathophysiological mechanisms, the review will include basic research conducted on both human subjects and on animal models as well as observational, randomised controlled studies and systematic reviews and meta-analysis. To maximise the identification of relevant reports and reduce loss of information, a systematic search of the literature will be performed from inception until January 2025 using the terms "iron deficiency" as well as "iron", "ferritin", "transferrin", "transferrin saturation", "hepcidin" and "soluble transferrin receptor" matching these terms with the keywords "cardiogenic shock", "acute heart failure", "advanced heart failure", "decompensated heart failure", "lvad", "left ventricular assist device", "mechanical circulatory support", "VA-ECMO" and "Extracorporeal Life Support". We will also use the corresponding MeSH and Emtree terms. In order to find grey literature, we will use the OADT.org internet-based database.

Ethics and dissemination

No additional ethics approval is required, as this review is based on existing research without new data collection. Only studies with ethics approval will be included. We plan to publish our findings in a peer-reviewed journal and present them at international conferences on cardiology, intensive and acute cardiovascular care, cardiac surgery and cardioanaesthesiology.

Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study)

Por: Meyer · S. · Söling · S. · Lampe · D. · Poppe · A. · Bartels · R. · Grandt · D. · Klaas · C. · Dumröse · A. · Reber · K. C. · Greiner · W. · Ihle · P. · Meyer · I. · Köberlein-Neu · J. · TOP study group · Beckmann · Düvel · Dolfen · Sinnen · Reber · Polte · Resch · Faulenbach · Br
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

DRKS00025485.

Impact of antibiotics, iron oxide, and sodium sulfate on microbial community composition in laboratory-built municipal solid waste microcosms

by Judy Malas, Sarah C. Khoury, Michael Tanzillo, Gracie A. Fischer, Jean E. Bogner, D’Arcy R. Meyer-Dombard

Municipal solid waste (MSW) landfills represent underexplored microbial ecosystems. Landfills contain variable amounts of antibiotic and construction and demolition (C&D) wastes, which have the potential to alter microbial metabolism due to biocidal or redox active components, and these effects are largely underexplored. To circumvent the challenge of MSW heterogeneity, we conducted a 65-day time series study on simulated MSW microcosms to assess microbiome changes using 16S rRNA sequencing in response to 1) Fe(OH)3 and 2) Na2SO4 to represent redox active components of C&D waste as well as 3) antibiotics. The addition of Fe(OH)3 altered the overall community composition and increased Shannon diversity and Chao1 richness. The addition of a mixture of seven antibiotics (1000 ng/L each) altered the community composition without affecting diversity metrics. Sulfate addition had little effect on microbial community composition or diversity. These results suggest that the microbial community composition in fresh MSW may be significantly impacted by influxes of iron waste and a single application of antibiotics.

Molecular characterization of chronic cutaneous wounds reveals subregion‐ and wound type‐specific differential gene expression

Abstract

A limited understanding of the pathology underlying chronic wounds has hindered the development of effective diagnostic markers and pharmaceutical interventions. This study aimed to elucidate the molecular composition of various common chronic ulcer types to facilitate drug discovery strategies. We conducted a comprehensive analysis of leg ulcers (LUs), encompassing venous and arterial ulcers, foot ulcers (FUs), pressure ulcers (PUs), and compared them with surgical wound healing complications (WHCs). To explore the pathophysiological mechanisms and identify similarities or differences within wounds, we dissected wounds into distinct subregions, including the wound bed, border, and peri-wound areas, and compared them against intact skin. By correlating histopathology, RNA sequencing (RNA-Seq), and immunohistochemistry (IHC), we identified unique genes, pathways, and cell type abundance patterns in each wound type and subregion. These correlations aim to aid clinicians in selecting targeted treatment options and informing the design of future preclinical and clinical studies in wound healing. Notably, specific genes, such as PITX1 and UPP1, exhibited exclusive upregulation in LUs and FUs, potentially offering significant benefits to specialists in limb preservation and clinical treatment decisions. In contrast, comparisons between different wound subregions, regardless of wound type, revealed distinct expression profiles. The pleiotropic chemokine-like ligand GPR15L (C10orf99) and transmembrane serine proteases TMPRSS11A/D were significantly upregulated in wound border subregions. Interestingly, WHCs exhibited a nearly identical transcriptome to PUs, indicating clinical relevance. Histological examination revealed blood vessel occlusions with impaired angiogenesis in chronic wounds, alongside elevated expression of genes and immunoreactive markers related to blood vessel and lymphatic epithelial cells in wound bed subregions. Additionally, inflammatory and epithelial markers indicated heightened inflammatory responses in wound bed and border subregions and reduced wound bed epithelialization. In summary, chronic wounds from diverse anatomical sites share common aspects of wound pathophysiology but also exhibit distinct molecular differences. These unique molecular characteristics present promising opportunities for drug discovery and treatment, particularly for patients suffering from chronic wounds. The identified diagnostic markers hold the potential to enhance preclinical and clinical trials in the field of wound healing.

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