TY - JOUR

T1 - Guidance on protocol development for EFSA generic scientific assessments

AU - EFSA Scientific Committee, null

AU - More, Simon

AU - Bampidis, Vasileios

AU - Benford, Diane

AU - Bragard, Claude

AU - Hernández-Jerez, Antonio

AU - Bennekou, Susanne Hougaard

AU - Koutsoumanis, Konstantinos Panagiotis

AU - Lambré, Claude

AU - Machera, Kyriaki

AU - Mullins, Ewen

AU - Nielsen, Søren Saxmose

AU - Schlatter, Josef

AU - Schrenk, Dieter

AU - Turck, Dominique

AU - Younes, Maged

AU - Kraft, Andrew

AU - Naegeli, Hanspeter

AU - Tsaioun, Katya

AU - Aiassa, Elisa

AU - Arcella, Davide

AU - Barizzone, Fulvio

AU - Cushen, Maeve

AU - Georgiadis, Marios

AU - Gervelmeyer, Andrea

AU - Lanzoni, Anna

AU - Lenzi, Paolo

AU - Lodi, Federica

AU - Martino, Laura

AU - Messens, Winy

AU - Ramos Bordajandi, Luisa

AU - Rizzi, Valentina

AU - Stancanelli, Giuseppe

AU - Supej, Špela

AU - Halldorsson, Thorhallur Ingi

N1 - Publisher Copyright: © 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.

PY - 2023

Y1 - 2023

N2 - EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the ?Draft framework for protocol development for EFSA's scientific assessments? published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the ?APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and ? not covered in this guidance ? generating empirical evidence ex novo. The guidance is complemented by a standalone ?template? for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment.

AB - EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the ?Draft framework for protocol development for EFSA's scientific assessments? published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the ?APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and ? not covered in this guidance ? generating empirical evidence ex novo. The guidance is complemented by a standalone ?template? for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment.

KW - APRIO

KW - generic scientific assessments

KW - guidance

KW - methods

KW - PECO

KW - PICO

KW - planning

KW - problem formulation

KW - protocol development

U2 - 10.2903/j.efsa.2023.8312

DO - 10.2903/j.efsa.2023.8312

M3 - Journal article

C2 - 37908452

VL - 21

SP - 1

EP - 68

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 10

M1 - e08312

ER -