1. Participation Requirements for a Guideline Panel Member

2. Background These slides are intended to clarify the guideline development process and illustrate expectations of member for participation in an ASCO guideline panel. Guideline development can be time-consuming, but the end- products are especially valued by members. We recognize that participation in development in an ASCO guideline involves significant commitment of time and energy. We hope that the material that follows provides some clarification regarding the expectations and scope of the undertaking.

3. ASCOs Guidance Products Clinical Practice Guideline: Addresses specific clinical situations (disease- oriented) or use of approved medical products, procedures, or tests (modality-oriented). Systematic reviews serve as the evidentiary basis for drafting principles of clinical care. Interpretation and extrapolation of evidence are often necessary. Consensus Guideline: A systematic review is conducted. If evidence identified is limited, inconsistent, indirect, or of poor quality, then the formal consensus-based methodology may be considered. While the decision to incorporate consensus recommendation(s) may vary, the common thread is lack of sufficient evidence. ASCO utilizes a modified Delphi process for creating consensus guideline recommendations. Additional information on the methodology can be found on the ASCO Guidelines Wiki Guideline Development page.ASCO Guidelines Wiki Guideline Development page

4. ASCOs Guidance Products Guideline Endorsement: ASCO can be approached by other organizations to endorse a guideline or ASCO can initiate the process. The topic should be relevant and appropriate to the mission and interests of ASCO. Endorsing other organizations guidelines decreases duplication of effort and allows ASCO to expand the library of recommendations available to members. Guideline Adaptation: ASCO follows a process for adapting guidelines from other organizations. Guideline recommendations can be adapted from one or multiple relevant guidelines with the intent of producing a guideline relevant to the ASCO membership. Adapting other organizations guidelines decreases duplication of efforts and allows ASCO to expand the library of recommendations available to members. Provisional Clinical Opinion (PCO): is intended to offer timely clinical direction to the ASCO membership following the publication or presentation of potentially practice-changing data from major studies. The PCO may serve in some cases as interim direction to the membership pending the development or updating of an ASCO clinical practice guideline. The PCO enables ASCO to provide a rapid response to key data from clinical cancer research. Additional information on the methodology can be found on the ASCO Guidelines Wiki Guideline Development page.ASCO Guidelines Wiki Guideline Development page

5. Steps in Creating an ASCO Guideline 1.Systematic review conducted by ASCO Staff (searches, abstract review, full text review, data extraction, evidence table development) 2.Panel meets, reviews evidence, develops recommendations 3.Draft manuscript assembled by the Co-Chairs or Steering Committee and ASCO Staff Co-chairs 4.Panel reviews and approves the first draft 5.Draft submitted for JCO review and sent concurrently for external review 6.Reviews incorporated into revised draft 7.Panel reviews and approves revised draft 8.Draft submitted to CPGC for review and approval 9.Panel revises draft based on CPGC review 10.Panel reviews and approves final draft. 11.Draft returned to CPGC reviewers for review and approval (if required) 12.Draft resubmitted to JCO.

6. Guideline Steps

7. Appraising the Evidence and Rating the Evidence and Recommendations Quality appraisal. It is proposed that evidence informing guideline recommendations be formally appraised to evaluate the reliability and validity of the evidence. These assessments of quality will be made for individual sources of evidence (i.e., individual trials, systematic reviews, etc.) using pre-specified criteria, which are based primarily on elements of quality related to study design, methodology, and risk of bias. A sample of the study quality appraisal checklist developed/adapted for randomized controlled trials is provided in Appendix 3. Strength of evidence. The quality of the total body of evidence used to inform a given recommendation will be assessed to evaluate its validity, reliability, and consistency. This assessment will consider the individual study quality ratings, the overall risk of bias, and the overall validity and reliability of the total body of evidence. The summary rating will be an indication of the Panels confidence in the available evidence. Strength of recommendations. The Panel provides a rating of the strength of each recommendation. This assessment is primarily based on the strength of the available evidence for each recommendation and it is an indication of the Panels confidence in its guidance or recommendation. However, where evidence is lacking, it also affords panels the opportunity to comment on the strength of their conviction and uniformity of their agreement that the recommendation represents the best possible current guidance. Additional information on can be found on the ASCO Guidelines Wiki Guideline Development page.ASCO Guidelines Wiki Guideline Development page

9. General Responsibilities Panel members are expected to substantively contribute to interpretation of the evidence in formulating guideline recommendations. Panel members are asked to attend and participate in webinars/teleconferences to synthesize the results of the systematic review, discuss the structure of the guideline, and to formulate recommendations. Members may also be asked to attend a face-to-face meeting (at ASCO headquarters). All Panel members are expected to critically edit and review drafts of the document. Panel members are asked to meet deadlines. Members who are unable for whatever reason to adhere to the project timeline/work schedule are asked to notify ASCO staff and Panel Chairs. Panel members are required to observe a strict policy of confidentiality of guideline documents, draft and final, pending guideline publication; and are required to keep content of panel deliberations confidential. Panel members are required to disclose any potential conflicts of interest, including commitments that might be perceived as conflicts prior to initiating work on the guideline; and are asked to apprise ASCO staff of any changes that arise over the course of the project.

10. Additional Responsibilities Panel members may be asked to provide feedback or input into the development of Clinical Tools and Resources (CT&Rs), such as, decision aids, algorithms, or flow charts that are designed to facilitate adherence to the guideline. Panel members may be asked to interface with the media at the time of publication and to assist ASCO in the development of press releases, and of materials suitable for use with patients and for publication on the cancer.net website. Panel members are not expected to draft these documents, but to critically review them to ensure that the content is accurate and clear. Panel members may be asked to participate in the development of quality measures from the guideline recommendations. These statements are considered by the Quality of Care Committee for use as quality measures in QOPI.

11. Thank you for participating in the guideline development process. If you have any questions or concerns, please contact guidelines@asco.org. guidelines@asco.org