Developing GRADE outcome-based recommendations about diagnostic tests: a key role in laboratory medicine policies

Abstract

Harmonisation and risk management policies represent key-issues in modern laboratory medicine as they focus on a more patient-centred delivery of laboratory information based on the recognition of the importance of all steps of the total testing process (TTP) for assuring quality and patient safety. However, a further essential step in project aiming to improve the value of laboratory medicine becomes the assessment of the impact of testing on patient-important outcomes. The grading of recommendations assessment, development and evaluation (GRADE) evidence to decision (EtD) frameworks may provide a systematic and transparent approach for translating the best clinical evidence available into healthcare decisions and recommendations. GRADE is a tool appropriate not only for evaluating test accuracy but also for clinical impact, such as mortality, morbidity, symptoms, and quality of life and therefore it should be applied to the outcome research in laboratory medicine. The application of GRADE requires the recognition that a recommendation about the use of test results should result from a balance between the desirable and the undesirable consequences, including non-health related consequences such as resource utilisation, feasibility, acceptability, equity and other factors. GRADE EtDs, represents a fundamental step in projects designed to improve care quality. Patient-physician-laboratory feedback can be assured through the GRADE process, where the team developing the recommendations should include the "three-parties" representatives; clinicians, laboratorians and patient/ consumers. This ensures that the laboratory-patient interaction should not be a one-way process only (information from laboratory to patient) but a two-way process, incorporating patient expectations and feedback.

Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia

“…To our knowledge, this work is new in its detailing the specific way each item of evidence quality was used for the specific field of diagnostic studies for neurodegenerative diseases. Previous analogous papers, even those addressing the need to adapt traditional methods of evidence assessment to the less sound field of diagnostic studies, did not treat with this detail each specific item of evidence quality, and never related specifically to FDG-PET nor other biomarker specific to neuroimaging nor to dementia (10,11,34,35). Moreover, our effort is new in detailing the methodological strengths and weaknesses of current FDG-PET diagnostic studies, with the aim to concretely address methodological improvement of next studies.…”

“…Besides the high costs and the likely lack of potential sponsors for FDG-PET, sharing a similar destiny as the "orphan drugs", proper completion of RCTs requires rather univocal treatment courses downstream to diagnosis, and possibly the availability of disease modifiers. Methodological adaptations have been proposed that may allow deriving decisions from data lacking RCT-derived evidence for diagnostic tests in evolving fields like those of dementia (10,11,34,35); however, the basic methodological requirements outlined in this paper as short term priorities can be complied with and should no longer be disregarded, in order for these adaptations to be properly adopted.…”

Full method validation in clinical chemistry

“…Furthermore, monitoring and treatment practices risk being implemented erroneously due to the bias, since clinical practice guidelines [19][20][21] that inform about proper actions for diagnosis and treatment are optimally based on unbiased test results (Fig. 4).…”

“…Clinical practice guidelines [19][20][21] and the use of reference measurement procedures [22][23][24][25][26]. Standardisation is accomplished when equivalent results are obtained by different clinical laboratory tests conducted by different laboratories using valid traceability chains established between the measurement results and a stable endpoint, be it the SI, the value of internationally agreed reference material (RM) or a value obtained with a reference method.…”

The principles of Health Technology Assessment in laboratory medicine

“…HTA and HS must be considered the elements that more than any other confer multiple values to innovation, especially in laboratory medicine, which is the link between clinical and therapeutic effectiveness [43].…”