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Developing Clinical Recommendations for Breast, Colorectal, and Lung Cancer Adjuvant Treatments Using the GRADE System: A Study From the Programma Ricerca e Innovazione Emilia Romagna Oncology Research Group

Rossana De Palma, Alessandro Liberati, Giovannino Ciccone, Elena Bandieri, Maurizio Belfiglio, Manuela Ceccarelli, Maurizio Leoni, Giuseppe Longo, Nicola Magrini, Maurizio Marangolo, Fausto Roila

From the Agenzia Sanitaria Regionale Regione Emilia Romagna, Bologna; Università degli Studi di Modena e Reggio Emilia; Centro Valutazione Efficacia Assistenza Sanitaria, AUSL Modena; Centro Prevenzione Oncologica, Azienda Ospedaliera Molinette, Torino; Consorzio Mario Negri Sud, Santa Maria Inbaro, Chieti, Italy; Azienda Sanitaria Locale Ravenna; and the Azienda Ospedaliero Policlinico, Perugia, Italy

Corresponding author: Rossana De Palma, MD, PRI-ER Oncology Research Group, Agenzia Sanitaria Regionale, Viale Aldo Moro 21, Bologna, Italy; e-mail: rdepalma{at}regione.emilia-romagna.it

Purpose: In the area of anticancer drugs, the legitimate search for effective interventions can be jeopardized by the strong pressure for accelerated approval, which may hinder the full assessment of their benefit-risk profile. We aimed to produce drug-specific recommendations using an explicit approach that separates the judgments on quality of evidence from the judgment about strength of recommendations.

Materials and Methods: We used the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system to develop recommendations for the use of specific anticancer drugs/regimens; 12 clinical questions relevant to adjuvant treatment of breast (three), colorectal (four) and lung (five) cancer have been assessed by multidisciplinary panels supported by a group of methodologists.

Results: For nine of 12 questions, recommendations were produced (one strong and six weak in favor and one weak and one strong against the index treatment); for the remaining three questions no specific course of action could be recommended. The perceived benefits to risk balance of the treatment was the most important and statistically significant (P < .01) predictor of panels’ recommendations and of their strength, whereas panelists’ personal (age, sex) and professional (specialty) characteristics were not statistically associated.

Conclusion: Because the GRADE system sets out an explicit process going from evaluation of the quality of evidence and benefit-risk profile to the judgment of the strength of recommendations, in this experience, it proved very useful to combine methodologic rigor with the interdisciplinary participation that is important in the definition of evidence based clinical policies.

Supported by Contratto No. 249, Bando Nazionale Ricerca Finalizzata 2005, Ministero della Salute, Italia. Supported in part by the Fondo per l’Innovazione, an unrestricted grant provided by the following companies: AstraZeneca, Chiesi, Cordis Glaxo Smith Kline, Lilly, Pfizer Novartis, Siemens, and Takeda.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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