Authors' recommendations: Aim: The criteria reported in this document, are to be intended as guidance for programs of clinical governance aimed at: supporting clinicians on the use of FDG-PET; post hoc analyses of appropriate use of FDG-PET; contributing to the planning of the regional health service. Method: A panel of 23 experts, comprising methodologists, nuclear physicians, radiologists, radiotherapists, surgeons, oncologists, ENT specialists, hematologists and health directors working in Health Trusts and Teaching Hospitals of Emilia-Romagna was convened to discuss and agree on the methodology for a research program aimed at defining the criteria for appropriate use of FDG-PET in oncology. For each indication a systematic review was performed. The GRADE approach was applied to assess the quality of included studies, the level of confidence in the overall evidence for each outcome of interest. The GRADE approach for diagnostic recommendations was also used to elicit judgement from the panel members on benefit and harms trade-off for patient-important outcomes. The RAND method was used to vote and reach an agreement on the appropriateness criteria. Results: The panel examined and assessed the role of FDG-PET for the following 7 clinical indications: Diagnosis of primary breast cancer; N staging of primary breast cancer; M staging of locally advanced breast cancer; Evaluation of early response to neo-adjuvant therapy; Evaluation of response to neo-adjuvant therapy at the end of treatment; Follow up in patients with no suspicion of recurrence; Diagnosis and staging of suspect distant recurrence. Thirty-five studies were included. Recommendations: Criteria for appropriate use of FDG-PET in breast cancer: diagnosis of primary breast cancer - Inappropriate for lack of diagnostic role of FDGPET; N staging of primary breast cancer - Inappropriate (level of evidence: very low); M staging of locally advanced breast cancer - Uncertain (level of evidence: low); Evaluation of early response to neo-adjuvant therapy – Uncertain (level of evidence: low); Evaluation of response to neo-adjuvant therapy at the end of treatment - Inappropriate (no diagnostic role of FDG-PET) ; Follow up in patients with no suspicion of recurrence – Inappropriate (level of evidence: very low) ; Diagnosis and staging of suspect distant recurrence – Uncertain (level of evidence: moderate).

Project Status: Completed

Year Published: 2011

URL for published report: http://assr.regione.emilia-romagna.it/it/servizi/pubblicazioni/dossier/doss207

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Italy

Organisation Name: Agenzia Sanitaria e Sociale Regionale (Regional Agency for Health and Social Care)

Contact Address: Viale Aldo Moro 21, 40127 Bologna, Italia tel. +39 051 5277177 fax +39 051 5277049

Contact Name: Ballini_Lu@regione.emilia-romagna.it

Contact Email: Ballini_Lu@regione.emilia-romagna.it

Copyright: Agenzia sanitaria e sociale regionale, Regione Emilia-Romagna