S The European Up-Front Risk Assessment Tool (EUFRAT) The European Up-Front Risk Assessment Tool...

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The European Up-Front Risk Assessment Tool

(EUFRAT)

The European Up-Front The European Up-Front Risk Assessment ToolRisk Assessment Tool

(EUFRAT)(EUFRAT)

Presentation overview

1. Dynamics in blood transfusion chain

2. Risk model scheme

3. Outputs of the risk model

4. Modules in the risk assessment tool:– Tool functionality:

• Specification questions• Risk calculator • Options panel

– User manual

Blood transfusion chain

General population

Donors

Infected

Plasma / components

Processingproducts

Final blood

products

Recipient

Probability of infection

Contaminationprobability & amount of infectious material

Risk reduction

Risk of infection

Donor selection / screening

Product risk

Risk Model Scheme

• Entities • Modulating factors (input)

Infected

Outputs of the risk model

Module: Tool functionality

• Specification questions• Risk calculator • Options panel: Additional settings/functions/documentation

Specification questions

Specify the risk to be estimated and the data the users have available.1. Do you want to estimate the risk of transfusion transmission from a donor who

has visited an outbreak-affected region?

2. Is the number of infected donors available?

2.1. Are the infected donors identified by testing the donation?

2.2. Is the test performance (sensitivity & specificity) available?

3. Is information on various donation types and frequencies available?

4. Are there questions in the donor health questionnaire that potentially screen out the infected donors before donation?

5. Is the donated blood screened for the infection using a diagnostic test?

6. Is pathogen removal/inactivation or blood processing implemented to minimize the risk of contamination?

6.1. Is detail of infectivity level available?

Specification questions (continued)

Entities

Questions

Risk calculator

Interface options:•Disease selection•Expand/collapse of five entities•Constant/random variables•Variable info and chart•Editable fields

Risk calculator (continued)

Disease selection:• Select one from the eighteen emerging infections provided in dropdown

menu OR select “Not specified” for calculating other diseases.

Risk calculator (continued)

Expand/collapse: • To show/hide the details of five entities

Collapsed

Expanded

Risk calculator (continued)

Input/output variables:• Constant: point estimate • Random: estimate distributed in a range • Validation text: inputs are valid for calculation

ConstantRandom

Validation text

Risk calculator (continued)

Variable info and chart•Info: help text of the variable.•Chart: provided when the input/output is in range

Info Chart

Risk calculator (continued)

Adjustable inputs• Add or delete • Re-name

Re-name

Add/delete

Options panel: Additional settings/functions/documentation

Simulation:•Generate number of samples•With or without replacement•(Automatic) calculation

Generate samples

(Automatic) calculation

Options panel (continued)

Tool additional functions:•Save inputs and outputs •Load them for reuse, and•Print results

Additional functions

Options panel (continued)

Documentation: • Worked examples of emerging infections outbreaks with their risk

estimates calculated using EUFRAT

Presentation slides: summary of all tool functionalities.

User manual

Contents:• Introduction• Step-by-step guidance• List of definitions• Infection data• Risk model flowchart• Modelling assumptions• Formulas for calculation• List of symbols• Reference list