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
Valentina Pecoraro1, Paola Pezzati2, Fiamma Balboni3, Tommaso Trenti1 per il Gruppo di Studio SIBioC Evidence
Based Laboratory Medicine 1Dipartimento Interaziendale ad Attività Integrata Medicina di Laboratorio e Anatomia Patologica, Ospedale Civile S. Agostino
Estense, Modena 2Centro Regionale di Riferimento, Struttura Organizzativa Dipartimentale Sicurezza e Qualità in Laboratorio, Azienda
Ospedaliero-Universitaria Careggi, Firenze 3Laboratorio Analisi Chimico-Cliniche, Istituto Fiorentino di Cura e Assistenza, Firenze
The Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology as systematic and transparent framework to evaluate diagnostic test value in supporting guide lines and recommendations issuing.
A multidimensional pathway based on GRADE Evidence to Decision (EtD) framework is presented. The aim of the document is to define a valid process to assess the adoption of a diagnostic test and the consequences 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 of example, the EtD framework is used to present the evidence concerning the molecular diagnosis of sepsis in neonates 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 and undesirable effects; (6) resource use; (7) equity, acceptability and feasibility. The example is used to better elucidate the 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 a comprehensive decision aid model to ensure that all important criteria are considered to explain a judgment. This approach could help health professionals to use the best available research evidence in a structured and transparent way to inform decisions in the context of laboratory medicine.