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Volume:
Biochimica Clinica 2019; 43(1) 076-089
Pubblicato on-line:
Febbraio 4, 2019
DOI:
10.19186/BC_2019.004
Il Grading of Recommendations Assessment Development and Evaluation(GRADE) quale metodologia sistematica e trasparente per valutare l’esame di laboratorio nella formulazione di raccomandazioni e linee guida
AUTORI
1Dipartimento Interaziendale ad Attività Integrata Medicina di Laboratorio e Anatomia Patologica, Ospedale Civile S. AgostinoEstense, Modena
2Centro Regionale di Riferimento, Struttura Organizzativa Dipartimentale Sicurezza e Qualità in Laboratorio, AziendaOspedaliero-Universitaria Careggi, Firenze
3Laboratorio Analisi Chimico-Cliniche, Istituto Fiorentino di Cura e Assistenza, Firenze
ABSTRACT
The Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology assystematic and transparent framework to evaluate diagnostic test value in supporting guide lines andrecommendations issuing.
A multidimensional pathway based on GRADE Evidence to Decision (EtD) frameworkis presented. The aim of the document is to define a valid process to assess the adoption of a diagnostic test and theconsequences of the decision. The framework includes three sections reflecting the main steps of GRADE EtD:formulating the relevant question, making an assessment of the evidence, and drawing conclusions. As a matter ofexample, the EtD framework is used to present the evidence concerning the molecular diagnosis of sepsis inneonates including seven dimensions: (1) formulating the question; (2) assessment of diagnostic test accuracy; (3)certainty of the evidence; (4) effects of test on the main patient outcome; (5) balance between the desirable andundesirable effects; (6) resource use; (7) equity, acceptability and feasibility. The example is used to better elucidatethe concepts and to show how reviewers may complete each dimension with the relevant information avaiable.Several factors could influence the final decisions: the relevance of the problem, the values of diagnostic accuracy,the effects of the test on main patient outcome; other issues may play a role. The framework consists of acomprehensive decision aid model to ensure that all important criteria are considered to explain a judgment. Thisapproach could help health professionals to use the best available research evidence in a structured and transparentway to inform decisions in the context of laboratory medicine.