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 -