Participation Requirements for a Guideline Panel PGIN Representative

Background These slides are intended to clarify the guideline development process and illustrate expectations of PGIN Representative for participation in an ASCO guideline panel. Guideline development is 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.

ASCO’s 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 the conducted. If evidence identified is not considered appropriate, limited, inconsistent, indirect, or of poor quality, then the formal consensus-based methodology may be considered. While the decision to move incorporate consensus recommendation(s) may vary, the common thread is lack of sufficient evidence. ASCO utilizes the Modifed 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

ASCO’s Guidance Products Guideline Endorsement: ASCO can be approached by the other organization to endorse a guideline or ASCO can initiate the process. The topic should be relevant and appropriate to the mission and interests of ASCO and its membership and not be duplicative of existing ASCO guidelines. Endorsing other organizations’ guidelines decreases duplication of efforts and allows ASCO to expand our library of recommendations available to members. Guideline Adaptation: Similar to the endorsement process, ASCO has a process for adapting other organizations’ guidelines. Guidelines can be adapted if new information is published that changes a recommendation or ASCO interprets the evidence in a different matter, which could alter the original recommendations. Adapting other organizations’ guidelines decreases duplication of efforts and allows ASCO to expand our 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

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.

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 Panel’s 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 Panel’s 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

GLIDES What is GLIDES? It stands for GuideLines Into DEcision Support. Why does ASCO Guidelines use GLIDES? It standardizes the drafting of clear, implementable, and translatable guideline recommendations. It also helps develop guideline recommendations that clinical decision support can use. When does ASCO Guidelines use GLIDES? During the development of the statements that form guideline recommendations. What are the most important things Panel members should do before Panel meetings? Panelists should come to meetings prepared to discuss the potential benefits and harms of the interventions, the benefit-harms balance, and the quality of the body of evidence found in the systematic review. For additional information on GLIDES, please visit

General Responsibilities of a PGIN Representative Encourage the Panel to discuss practice issues that could impact the application of recommendations Focus on the implementation aspects of the guideline Contribute to implementation content for guideline in collaboration with others Help produce implementation guides for end- users

Responsibilities for Developing Recommendations PGIN Representatives should consider the following for interpretation of the evidence and development of recommendations: Review guideline drafts and provide commentary from the community oncology perspective Application of Recommendations: – decidability (precisely under what circumstances to do something) – executability (exactly what to do under the circumstances defined) Effect on process of care and potential financial impact (the degree to which the recommendation impacts upon the usual workflow in a typical care setting) Novelty/innovation (the degree to which the recommendation proposes behaviors considered unconventional by clinicians or patients) Flexibility (the degree to which a recommendation permits interpretation and allows for alternatives in its execution) Remind panel of the GLiDES approach for drafting recommendations

Thank you for participating in the guideline development process. If you have any questions or concerns, please contact X