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ClinGen Actionability Community Curation Module

Date of Release: August 1, 2024

Expiration Date: August 31, 2025

Credits offered: CME, NSGC Category 2 (Self-report)

Estimated time for completion: 1 hour per curation (up to 30 a year)

Course must be completed by the expiration date

Overview

The Clinical Genome Resource (ClinGen) is an NIH-funded resource dedicated to building an authoritative central resource that defines the clinical relevance of genes and variants for use in precision medicine and research.

In 2016, ClinGen published A Standardized, Evidence-based Protocol to Assess Clinical Actionability of Genetic Disorders Associated with Genomic Variation. The protocol centers around gene-condition topics, which incorporate information about genes, associated diseases or conditions, specific outcomes, and interventions to address these outcomes. The process involves identifying available evidence for these topics, producing qualitative summary reports of clinical actionability, applying a semi-quantitative metric (SQM) to generate a score of actionability, and applying a rubric to make an overall assertion on the level of actionability.

The ClinGen Actionability Work Group (AWG) designed a module for geneticists and genetic counselors to participate in the literature review and completion of the early rule-out assessments to ensure gene-condition topics meet minimal criteria for actionability. ClinGen early rule-out assessments of actionability are made publicly available as a resource for the community.

The ClinGen Actionability protocol:

• Defines the criteria needed to assess clinical actionability in the context of a secondary finding from genome-scale sequencing
• Describes the evidence supporting clinical actionability in a semi-quantitative manner
• Allows Actionability community curators to use this information to perform a standardized and transparent assessment of actionability of a given gene-condition topic

Module Steps:

1. The learner will be assigned gene-condition topics which need early rule-out assessments
2. Conduct literature searches per protocol to identify relevant publications
3. Complete early rule-out assessment to determine whether gene-condition topic meets minimum criteria for actionability
4. Enter these assessments into the Actionability Curation Interface (ACI)

Target Audience:

Geneticists and genetic counselors participating in ClinGen AWG community curation activities

Learning Objectives:

At the conclusion of this session, participants should be able to:

• Perform literature searches to identify relevant publications as part of early rule-out assessment
• Utilize the early rule-out process to evaluate whether a gene-condition topic meets the minimum criteria for actionability
• Utilize the ACI to enter assessments

For the purpose of this module, learning objectives will be demonstrated by the learner by submitting early rule-out assessments in the ACI.

• • • Adam Buchanan, MS, MPH, CGC - Genomic Medicine Institute, Geisinger Health System, Danville, Pennsylvania
    • Joanna Bulkley, PhD - Department of Translational and Applied Genomics, Kaiser Permanente Center for Health Research, Portland, Oregon
    • Mari Gilmore, MS, CGC – Department of Translational and Applied Genomics, Kaiser Permanente Center for Health Research, Portland, Oregon
    • Jessica Hunter, MS, PhD - Genomics, Ethics, and Translational Research Program, RTI International, Research Triangle Park, North Carolina
    • Kristy Lee, MS, CGC - Department of Genetics, University of North Carolina, Chapel Hill, North Carolina, USA
    • Kandamurugu Manickam, MD, MPH, FACMG - Division of Genetic and Genomic Medicine, Nationwide Children’s Hospital, The Ohio State University College of Medicine, Columbus, Ohio.
    • Christine Pak, PhD - Department of Translational and Applied Genomics, Kaiser Permanente Center for Health Research, Portland, Oregon
    • Bradford Powell MD, PhD, FACMG - Department of Genetics, University of North Carolina, Chapel Hill, North Carolina

Continuing Medical Education (CME AMA & CME Other)

Accreditation

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The American College of Medical Genetics and ClinGen - Clinical Genome Resource Genomics and is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation
The American College of Medical Genetics and Genomics designates this enduring activity for a maximum of 30 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

NSGC Category 2 CEUs/Genetic Counselors (self-report)

This activity meets requirements to apply for Category 2 CEUs from the National Society of Genetic Counselors (NSGC). Please complete the module and submit your certificate to NSGC, using the instructions for “How Do I Get Category 2 CEUs?” on How to Submit a Category 2 CEU Application in the NSGC CEU Portal. ACMG is the accredited sponsor. You must apply within three months (90 days) of the activity date. NSGC charges a $50 fee for processing and a certificate.

Learner Data Consent

ACMG Education reports learner data to respective agency boards and you will be asked for consent during the evaluation process. Your compliance with deadlines and completing evaluations are part of the process in meeting learner needs and ACMG’s education mission.

Claiming your Educational Credits

• Invitation code
• Provide a record of a ClinGen Actionability early rule-out assessment, including:

• Gene Name
• Disease Name
• Early-rule out assessment in the ACI

• Evaluation (required for self-reporting)

Please note: In the Self-Report section, you will be asked how many CMEs are requested. 1 CME is the equivalent of one hour. Please use that field to document the number of hours (maximum of 1) you spent performing the literature review, utilizing the early rule-out process, and entering the early rule-out assessment in the ACI.

Accredited Continuing Education Financial Disclosure

The American College of Medical Genetics and Genomics (ACMG) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Accredited Continuing Education (ACE) for physicians. ACMG is an organization committed to improvement of patient care and general health by the incorporation of genetics and genomics into clinical practice.

ACMG has implemented the following procedures to ensure the independence of ACE activities from commercial influence/promotional bias, the Accreditation Council for Continuing Medical Education (ACCME) requires that providers (ACMG) must be able to demonstrate that: 1) everyone in a position to control the content of an ACE activity has disclosed all financial relationships that they have had in the past 24 months with ineligible* companies; 2) ACMG has implemented a mechanism to mitigate relevant financial relationships; and 3) all relevant financial relationships with ineligible companies are disclosed to the learners before the beginning of the educational activity. The learners must also be informed if no relevant financial relationships exist.
*Ineligible companies are defined as those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

ACMG Education Policies

Please review the policies below regarding the ACMG Education program

• Financial Disclosures and Mitigation Procedure
• ACMG Content Validation Policy
• ACMG Content Branding Policy

All of the relevant financial relationships listed for these individuals have been mitigated.

Disclaimer

ACMG educational programs are designed primarily as an educational tool for health care providers who wish to increase their understanding of the application of genomic technologies to patient care. The ACMG does not endorse or recommend the use of this educational program to make patient diagnoses, particularly by individuals not trained in medical genetics. Adherence to the information provided in these programs does not necessarily ensure a successful diagnostic outcome. The program should not be considered inclusive of all proper procedures and or exclusive of other procedures and that are reasonably directed at obtaining the same results. In determining the propriety of any specific procedure or, a healthcare provider should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen.

Questions regarding CE credit should be directed to education@acmg.net