1. Participation Requirements for a Patient Representative

2. Background These slides are intended to clarify the guideline development process and illustrate expectations of a Patient Representative 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. 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 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. ASCO’s 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 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

9. General Responsibilities of a Patient Representative Present perspective of people affected by a particular cancer or treatment-related issue (e.g. febrile neutropenia) being addressed in the guideline. Assist in drafting the Clinician-Patient Communications section of the guideline Communicate actively with other panel members and ASCO staff

10. Additional Responsibilities Patient Representatives may be asked to provide feedback or input into the development of Clinical Tools and Resources (CT&Rs), specifically, patient-related tools like Decision Aids or Discussion Guides. Patient Representatives may be asked input on materials suitable for use with patients and for publication on the cancer.net website.

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