A systematic and transparent process to support informed decisions for diagnostic tests in laboratory settings

Article type
Authors
Pecoraro V1
1Department of Laboratory Medicine, NOCSAE, Azienda USL of Modena
Abstract
Background:
Decision-makers sometimes neglect important criteria regarding the adoption of diagnostic tests that could benefit patients. A transparent and explicit approach based on evidence criteria is an efficient tool to guide decision-making processes.

Objectives:
We applied a multidimensional pathway based on the GRADE Evidence to Decision (EtD) frameworks for tests to lead the adoption of molecular methods for the diagnosis of sepsis in neonates.

Methods:
The process includes three steps: formulating a relevant question, making an assessment of the evidence and drawing conclusions. We systematically searched bibliographic databases and websites of scientific societies and regulatory agencies. We included systematic reviews, guidelines and health technology assessment (HTA) reports assessing the diagnostic accuracy of various molecular methods for the diagnosis of sepsis in neonates. We collected data about purpose, eligibility criteria, essential results and authors' conclusions, and qualitatively summarised the main information.

Results:
We included four systematic reviews, seven guidelines and one HTA. The dimensions considered were: 1) question formulation; 2) diagnostic test accuracy assessment; 3) certainty of the evidence; 4) effects of test on main patient outcome; 5) balance between desirable and undesirable effects; 6) resource use; 7) equity, acceptability and feasibility. Authors completed the report regarding the molecular diagnosis of sepsis in neonates, with relevant extracted information. Several factors identified as potentially influencing the final decision were the importance of the problem, diagnostic accuracy values and the effects of the test on main patient outcome.

Conclusions:
The multidimensional pathway based on GRADE EtD frameworks is comprehensive and ensures that all important criteria are considered to assist in judgement creation. This approach could help health professionals to use the best available research evidence in a structured, transparent and reproducible way to inform decisions in the context of laboratory medicine.

Patient or healthcare consumer involvement:
We involved healthcare consumers in the evaluation and interpretation of documents included in the multidimensional pathway.