Dossier n. 172/2009 [Abstract] The production of clinical recommendations using the GRADE method

This report is devoted to the presentation of the scientific background and results of the AFO (an acronym standing for Appropriateness of Oncologic Drugs) project developed by the Health Care and Social Agency of Emilia-Romagna region in the framework of the Research and Innovation program (PRI E-R).

From the methodological standpoint the novelty of the project stems from the utilisation of the GRADE method (Grading of Recommendation, Assessment, Development and Evaluation) for the production and grading of clinical recommendations on the effects of health care interventions.

The GRADE method originated from the work of an international working group that, starting 2001, was convened to go beyond the variations in the existing methods for producing and grading clinical recommendations. These variations were mostly due to conceptual inconsistencies that, if not properly recognised and addressed, would jeopardise the credibility of the entire guidelines movement.

From the subject matter standpoint the AFO project - which was also partially supported by a research grant from the Italian Ministry of Welfare, Health and Social Affairs - was conceived to test the feasibility of a working methodology where multidisciplinary panels of clinicians would be convened to produce clinical recommendations on newly registered drugs as well as those already in widespread use but whose indications change over time.

In the first part of the report, after a brief introduction on the working hypotheses and objectives of the PRI ER program and the AFO project, the GRADE method is presented and discussed.

In the second part the results of the activities of the three panels that produced a total of 32 recommendations for the adjuvant and advanced treatment of breast, colorectal and lung cancer are reported.

The final session of the report addresses some open issues relative to the application of the GRADE method to the production of clinical recommendations construed with the explicit aim of improving quality and appropriateness of care in oncology.

In the Appendix, two examples of the recommendations produced though this project are presented: they refer to Trastuzumab in the treatment of early breast cancer and Fluoropirimide in the adjuvant therapy of colon cancer.