Addressing methodological challenges in evaluating diagnostic tests: Combining the GRADE approach and the RAND/UCLA Appropriateness Method to produce clinical recommendations

Article type
Authors
Ballini L1, Vignatelli L1, Negro A1, Maltoni S1, Grilli R1
1Agenzia Sanitaria e Sociale Regionale Emilia-Romagna - Italy
Abstract
Background: Developing recommendations for appropriate use of diagnostic tests presents serious challenges from defining the clinical rationale for the new test and its position in the current diagnostic-therapeutic pathways to dealing with the lack of evidence on impact of test on patient-important outcomes. Recent methodological breakthroughs (1,2) provide valuable insights to address these challenges.

Objectives: develop a new methodology (transparent and encompassing clinical reasoning) which combines the GRADE approach for grading quality of evidence and strength of recommendations with the RAND method of consensus; test the methodology to produce recommendations on the use of Positron Emission Tomography (PET) in oncology.

Methods: two multidisciplinary panels of experts were convened to produce recommendations on PETás use in four types of cancer (breast, esophageal, lung, and colo-rectal cancer). Answerable research questions were developed by positioning and comparing PET against existing diagnostic tests (replacement, add-on, triage). Clinical rationale was based on capacity of new test to modify initial diagnosis, subsequent change in therapeutic approach and resulting clinical benefits for patients. Results from the systematic review of literature on PETás diagnostic accuracy were analysed and presented using GRADEás levels of evidence. Lack of direct evidence on patient-important outcomes was bypassed using GRADEás logic for eliciting expertsá judgement on clinical consequences of testing positive and testing negative. Results of two rounds of votes on level of appropriateness were analysed using the RAND/UCLA Appropriateness Method.

Results: a total of 34 a voting forms for each clinical question was generated via the above described methodology; recommendations for each cancer were produced by the panels in just two meetings; levels of agreement and disagreement were registered and reported.

Conclusions: 37 experts engaged in producing clinical recommendations managed to work through the GRADEás approach and delivered 34 recommendations in a very short period of time.

References
1. Bossuyt PM, Irwig L, Craig J, Glasziou P. Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ. 2006; 332(7549):1089-92.
2. Sch"unemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, Williams JW Jr, Kunz R, Craig J, Montori VM, Bossuyt P, Guyatt GH; GRADE Working Group. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106-10.