Determining the feasibility of linked claims and vaccination data for a COVID-19 vaccine pharmacoepidemiological study in Germany–RiCO feasibility study protocol

Introduction
In Germany, there has been no population-level pharmacoepidemiological study on the safety of the COVID-19 vaccines. One factor preventing such a study so far relates to challenges combining the different relevant data bodies on vaccination with suitable outcome data, specifically statutory health insurance claims data. Individual identifiers used across these data bodies are of unknown quality and reliability for data linkage.

Methods and analysis
As part of a larger pharmacovigilance study on the COVID-19 vaccines, called RiCO (German ‘Risikoevaluation der COVID-19-Impfstoffe’, Englisch ‘Risk assessment of COVID-19 vaccines’), a feasibility study is being conducted to determine the overall confidence level with which existing data can be analysed in relation to the safety of the COVID-19 vaccine. This RiCO feasibility study will establish a data flow combining claims data and vaccination data for a subsample of the total German population, describe data quality for each dataset from the various sources, estimate the proportion of the different linkage errors and will develop various approaches for linking the data in addition to the simple form of linkage using a common identifier in order to reduce possible linkage errors. These last three points are the core objective of the feasibility study. A secondary objective is to test the viability of the required data flow involving multiple stakeholders from different parts of the healthcare system.

Ethics and dissemination
Results will be published and used to plan the actual pharmacovigilance study on the COVID-19 vaccines for Germany, as well as future research on the role of COVID-19 vaccines as risk or protective factors for long-term COVID-19 effects. In accordance with national legal requirements, permission to use of the statutory health insurance claims data was requested and granted by the national regulatory authority for statutory health insurances. The vaccination data will be used in accordance with the requirements of the national regulation on COVID-19 vaccinations. Ethical approval was not required for this secondary data study and was therefore not sought. The results of the feasibility study will be published in a suitable, peer-reviewed scientific journal. Results will also be presented to stakeholders from German statutory health insurances and government organisations.

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Risk perception among healthcare professionals working in emergency care in remote locations: a scoping review protocol

Introduction
Providing healthcare in emergency services is a multifaceted challenge that demands prompt approaches. Ensuring safety and efficacy becomes even more challenging in ‘remote locations’, referring to geographical areas located far from urban centres or densely populated regions, often characterised by insufficient access to services, infrastructure and communication channels. Despite the pivotal role of healthcare professionals’ skills and knowledge in risk management in these contexts, academic literature has largely overlooked this aspect. Thus, addressing healthcare professionals’ perceptions of risks within remote areas is crucial for informed decision-making and improved service administration.

Methods and analysis
This scoping review protocol adopts the methodology outlined by the Joanna Briggs Institute. The objective is to delineate the current scientific evidence regarding the perception of both direct and indirect risks associated with healthcare practice in remote emergency settings. Employing the Population, Concept, and Context dimensions, inclusion criteria were established for each dimension: Population—nurses or other healthcare professionals with overlapping roles; Concept—perception of risk; Context—remote community or site and emergency care. The search will encompass the Scopus, PubMed, LILACS, Cochrane, CINAHL and Web of Science databases. A specific time frame for the selection of articles was not delimited. Observational, quantitative, qualitative studies and reviews will be eligible for inclusion if they meet the predetermined criteria. Two reviewers will undertake the document review process. Eligible documents may be in English or Portuguese, and only those subjected to peer review will be considered for inclusion.

Ethics and dissemination
Ethical approval will not be necessary for this study as it entails a scoping review based on previously published evidence. The findings from the scoping review will be disseminated through scientific conferences and published in academic journals.

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Frequency, demographics, diagnoses and consultation patterns associated with low-acuity attendances in German emergency departments: a retrospective routine healthcare data analysis from the INDEED project

Objective
Evidence suggests interventions targeting low-acuity attendances have been hampered by insufficient characterisation of potential target groups. This study aimed to estimate the frequency of low-acuity emergency department (ED) attendances and to provide an overview of their demographic, diagnosis and consultation patterns.

Design
Observational analyses of routine healthcare data.

Setting
German EDs.

Participants
Adult patients with statutory health insurance who visited the ED of 16 participating hospitals in 2016.

Main outcome measures
Frequency, demographics, diagnoses and consultation patterns of low-acuity and high-acuity attendees.

Main results
Of the 454 747 ED visits, 370 756 visits (50.1% female) were included for analysis. Four participating hospitals had to be excluded due to the lack of data that were necessary for the stepwise approach to define low and high acuity. We identified 101 337 visits as low acuity (27.3%) and 256 876 as high acuity (69.3%), whereas 12 543 (3.4%) could not be classified. The proportion of attendees classified as low acuity decreased with age (highest at 40.6% in the age group

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Efficacy and safety of individual nutrition support in patients with hepatitis B virus-related acute-on-chronic liver failure at nutrition risk: a study protocol for a randomised controlled clinical trial

Introduction
Malnutrition is a common complication of hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) typically associated with poor prognosis. Despite nutritional treatment, the outcomes for these patients are limited by the symptoms and complications associated with ACLF. So far, the benefits of nutritional interventions in these populations have not been proven. This study aims to explore a new nutritional intervention method for patients with HBV-ACLF and evaluate its safety and efficacy.

Methods and analysis
This study is an investigator-initiated, nonblind, randomised controlled clinical trial. We will recruit 60 patients with HBV-ACLF according to the Chinese Group on the Study of Severe Hepatitis B criteria hospitalised in the Infectious Diseases Department of the Third Affiliated Hospital of Sun Yat-Sen University. Eligible patients will be randomly allocated to the nutrition support group (intervention group) and the control group in a 1:1 ratio. Patients in the nutrition support group will receive 10 days of tailor-made nutrition therapy consisting of oral nutritional supplements and supplementary parenteral nutrition. Patients in the control group will receive standard nutrition with dietary advice. All assessments will be conducted at baseline, 30 days and 90 days. The primary outcome measure is the liver transplant-free mortality rate. The secondary indicators include the incidence of clinical adverse outcomes and changes in indicators such as muscle mass, muscle strength, physical function and quality of life (EQ-5D scale).

Ethics and dissemination
This study has been approved by the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University (approval number: II2023-242-03). The results and conclusions of the clinical trial will be published in academic conferences or journals.

Trial registration number
NCT06128421.

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