ESMO Clinical Practice Guidelines: Consensus Conference (CC) SOP Edited by EDC-SC September 2013

2 Consensus Conference Membership Proposal and rationale for Consensus Conference (CC) by Subject Editor (SE) to ESMO Guidelines Working Group (GLWG), approved by ESMO Educational Steering Committee (EDC-SC) One chair nominated by SE, the SE being the co-chair. Validation by GLWG & EDC-SC Up to 30 members providing pan-European representation, priority to ESMO Faculty members. Maximum of 4 non-Europeans if they bring scientific expertise. Acknowledged experts in the field Multidisciplinary experts as individual professionals. Declarations of conflict of interest (COI) must be obtained from all invited contributors before confirmation of their involvement (Responsibility of the chairs)

3 Basic Methodology: Pre-conference CC Chairs break the Guideline Topic into several subtopics, each containing specific Questions to be addressed within each subtopic. The target audience is physicians practicing in the field of oncology. Each subtopic is assigned to a Working Group (3-10 members of the CC). For each Working Group (WG) a WG Coordinator will be appointed by the CC Chairs. A pre-meeting (1 day) must be organized between CC Chairs and the WG Coordinators to work on the Questions of each subtopic. This meeting must take place preferably 6 months prior and at least 3 months prior to the consensus conference.

4 Basic Methodology: Pre-conference PREPARATION MEETING: During the preparation meeting the Chairs & WG Coordinators will select the participants to be invited to the Consensus Conference. At this meeting Questions will be defined to be addressed by each WG. Following the preparation meeting participants will be invited to join a specific WG and contribute to the preparatory work of the CC. WGs organize preparatory workshops/meetings in order to work on the subtopic assigned and the developed Questions: via exchange of e- mails, e-meetings, e-processing of a document (MyESMO, Skype, etc). It is likely that no funding for formal physical meetings will be available.

5 CGC Structure

6 Basic Methodology: Pre-conference Working Group (WG) responsibilities : Identification of available evidence via a narrative review of the evidence. The WG Coordinators will decide how the group will work and may assign specific tasks to each WG member. Study of relevant evidence (e.g. assign Questions to WG members who perform narrative review of the evidence). Writing up of a report on the Questions & evidence review including a list of important references. Forwarding of report to Chairs prior to the Consensus Conference.

7 Basic Methodology: Conference The Chairs are responsible for and have authority over the conference. Suggested general outline (2 day conference): INTRODUCTION with all participants. WG DISCUSSION PHASE: Each WG to convene and discuss the subtopic. JOINT PRESENTATION PHASE: All members meet for presentation of all WG SoERs, to be critically analyzed & discussed by all. CONCLUSION PHASE: The CC Chairs conclude what has been discussed, agreed upon or disagreed. SUMMARY & PLANNING MEETING: The CC Chairs and WG Chairs may spend some additional time at the end of the conference to discuss decisions and next steps. It is advisable to record areas of dissent. Following the Consensus Conference, all WGs should send their draft subtopic manuscripts (with Questions, Recommendations and Levels of Evidence) to the Chairs within 1 month.

8 Basic Methodology: Post-Conference Chairs incorporate all draft subtopic manuscripts (with Questions, Recommendations and Levels of Evidence) in a pre-final manuscript. Areas of controversy and dissent are included and acknowledged in the final text. Levels of Evidence and references are provided for every formulated recommendation throughout the document. The grading system must be consistent across guidelines and the basis for the class of recommendation & levels of evidence documented. The pre-final manuscript is circulated to all members of the CC for a final check and comments/suggestions. The Chairs finalize the document and forward it to the GLWG and EDC-SC for approval.

9

Levels of Evidence 10

Grades of Recommendation 11

12 Publication Authorship includes all members of the CC. All participants will be listed as authors on the manuscript (Appendix at the end) with the following being listed before the abstract in this order: Chair, Working Group chairs (alphabetical), Subject Editor (co-chair). Only those participating at the consensus conference can be included as authors, though the Chair has the final decision.

13 Organisation / funding / update No funding should originate from the industry in order to safeguard the integrity of the guidelines (only ESMO or professional networks). No involvement of industry or patient representatives in guideline development. A yearly minor update may be performed by Chairs & CC members on a case by case basis, by exchange of s, e-meetings or e- processing of the document. These small updates can be included in the CPGs. A major update of the CPG will take place via a reiteration of the Consensus Conference cycle every 5 years or when GLWG/CC Chairs/EDC-SC feel that it is mandated by new scientific developments.

14 CGC Flowchart