The European Multidisciplinary Evidence-Based Guideline on Pancreatic Cancer: Methodological Protocol.

Background: Pancreatic cancer remains one of the most lethal cancers despite extensive efforts and research conducted over the past decades. To effectuate groundbreaking improvements in pancreatic cancer treatment, interdisciplinary and international collaboration is essential. Evidence-based guidelines, including state-of-the-art evidence and expert opinion, are crucial to guide medical specialists, researchers, and patients, especially on issues where consensus is still lacking. This article describes the methodological protocol for the development of the European Multidisciplinary Evidence-Based Guideline on Pancreatic Cancer. The guideline aims to identify current knowledge gaps on pancreatic cancer management, develop questions based on these knowledge gaps, and answer these questions with evidence-based recommendations supplemented, when evidence is lacking, with expert advice for treatment and future research. Methods: This guideline development protocol is developed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. The process is structured into six stages: First, 13 theme-based multidisciplinary working groups are established, comprising representatives from 30 European medical and patient societies. Second, these working groups identify the most relevant current knowledge gaps on pancreatic cancer within their theme and formulate key questions. Third, the available evidence to answer these key questions is obtained through systematic reviews and the certainty of evidence is assessed using the GRADE approach. Fourth, recommendations are developed based on the available evidence. Fifth, all participants reach consensus on the recommendations through a modified Delphi process. Sixth, the recommendations are discussed during an open conference, including an external validation committee. Discussion: This methodological protocol of the European Multidisciplinary Evidence-Based Guideline on Pancreatic Cancer is designed to identify key knowledge gaps across 13 themes and formulate evidence-based recommendations. This guideline initiative unites 30 European medical and patient societies for pancreatic cancer.