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Impact of fibrinogen-to-erythrocyte suspension ratio on mortality and functional outcomes in major perioperative bleeding (Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) study): protocol for a prospective observational study

Por: Demir · Z. A. · Kavak Akelma · F. · Akca · O. · Koltka · K. · Dincer · B. · Kocyigit · M. · Tuna · A. T. · Sayın · J. · Yıldırım Ar · A. · Kuvaki · B. · Aykut · A. · Sahin · A. S. · Aydın Güzey · N. · ADEFES Investigators · Yigit · Akyol · Akel · Argun · Aydın · Saracoglu · Canb
Introduction

Early and balanced replacement of blood products appears to be the key factor in improving outcomes of major bleeding patients including acute trauma, cardiac, obstetric and transplant surgery patients. Definitive clinical guidance regarding the optimal ratio of blood products, including those containing fibrinogen, is still lacking. Therefore, we tested the hypothesis that increasing the fibrinogen content to erythrocyte suspension ratio improves the mortality and functional outcomes of patients undergoing surgeries with expected major bleeding.

Methods and analysis

The Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) ratio is a multicentre, prospective, observational, cohort study of patients undergoing major surgical procedures with expected major perioperative bleeding (ie, requiring packed red blood cells (PRBC)>4U/24 hours). For 5U of cryoprecipitate and 1.5 U of fresh frozen plasma (FFP), the approximate dose-equivalent for fibrinogen is considered as 1 gram of fibrinogen. Association of the ADEFES ratio at 24 hours will be assessed on the primary objective, which will consist of the composite of 30-day all-cause mortality, 30-day bleeding-specific mortality and the ‘highly-dependent scores’ of Katz index of independence in activities of daily living.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of Ankara Bilkent City Hospital (approval no. E2-23-4265, dated 07 June 2023; Chair: Prof. Dr. F.E. Canpolat) and by the institutional review boards of all participating centres. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines, as well as in compliance with national regulations on data protection and Good Clinical Practice standards. Written informed consent will be obtained from all participants prior to inclusion in the study.

The results of this study will be disseminated through peer-reviewed scientific journals, presentations at national and international conferences, and communication with relevant stakeholders including clinical practitioners and healthcare institutions. If applicable, study outcomes will also be shared via institutional newsletters and digital platforms to reach a broader audience in the medical community.

Trial registration number

NCT06021184.

Implementation Outcomes and Their Determinants for Hospital‐Led Care Coordination Interventions Targeting Patients With Complex Care Needs: A Qualitative Systematic Review

ABSTRACT

Aim

To describe the implementation determinants for care coordination interventions in a hospital context.

Design

Systematic review.

Methods

This review was guided by the Consolidated Framework of Implementation Research (CFIR), assessed for quality using the Mixed Methods Appraisal Tool and reported with the PRISMA guidelines.

Data Sources

CINHAL Complete, EMBASE, MEDLINE Complete, PsychINFO (between January 1, 2013, and December 31, 2022, and updated May 09, 2024) and a manual reference list search of all included studies.

Results

The search returned 5614 articles after duplicates were removed. After title and abstract screening, 264 articles underwent full-text review. Sixteen studies (15 care coordination models) met the inclusion criteria. The CFIR inner setting domain and the implementation process domain were the most prominent domains and ‘Partnerships & Connections’, ‘Work Infrastructure’, ‘Capability’ and ‘Reflecting and Evaluating’ subdomains emerged as important determinants across the included studies.

Conclusion

Inconsistent findings relating to care coordination outcomes are likely to be substantially influenced by the complexity and heterogeneity of the interventions and variations in implementation and contextual factors. Intra- and inter-organisational relationships were important to connect previously disconnected parts of the health system and were facilitated by experienced care coordinators. Continual improvement was also important to increase fit with contextual factors. More high-quality studies are needed to identify commonalities and provide generalisable principles and characteristics associated with high-performance implementation.

Implications for the Profession and/or Patient Care

Review findings will provide practitioners, policymakers, and researchers with a comprehensive synthesis of evidence underpinning implementation of effective community care coordination from hospital settings.

Impact

These review findings will inform the effective implementation of care coordination interventions in a hospital context for patients with complex multimorbidity.

Reporting Methods

Preferred Reporting Items for Systematic reviews and Meta-Analysis.

Trial and Registration

PROSPERO Registration: CRD42022376642.

Patient or Public Contribution

No patient or public Contribution.

Protocol for a systematic review and meta-analysis on utilisation of palliative care service and predictors among adult cancer patients in Ethiopia

Por: Demeke · A. D. · Yeshiwas · A. · Gebrie · H. · Ayehu Akele · M. · Gashaw · A. · Dessie Gesssess · A. · Melkie · T. T. · Bogale · N. · Eba · W. W.
Introduction

Palliative cancer care is comprehensive, specialised medical care of patients that aims to alleviate physical, mental and emotional distress based on patients’ needs rather than on prognosis. In Ethiopia, the federal ministry of health started palliative care (PC) in 2016. Since then, services have been developed and integrated as important components of the Health Sector Transformation Plan II. However, there is a scarcity of nationally summarised data regarding PC service utilisation in Ethiopia. Therefore, this protocol describes a planned systematic review and meta-analysis that will evaluate utilisation of PC services and its predictors among adult cancer patients in Ethiopia.

Methods and materials

The online databases of PubMed, Hinari, EMBASE, CINHAL, Science Direct, Scopus and Google Scholar will be comprehensively searched from inception to 31 February 2025. To assess the quality of included studies, the Joanna Briggs Institute critical appraisal tools will be used. The statistical software STATA V.17 will be used for data analyses. To examine the heterogeneity between studies, inverse variance (I2) will be used. To calculate the pooled prevalence of PC service utilisation, a fixed or random effects meta-analyses model will be used with a 95% CI, depending on the presence or absence of heterogeneity between included studies. To look for publication bias, a visual inspection of the funnel plot and Egger and Begg’s regression test and a 5% level of significance will be used.

Ethics and dissemination

Ethical approval is not applicable. The results will be disseminated to academic beneficiaries and the public.

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