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Standard Approach to AE Monitoring

Standard Approach to AE Monitoring. NCI-sponsored treatment trials: CTCAE v4 790 individual items. vs. patients. NCI Contract HHSN261200800043C. Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

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Standard Approach to AE Monitoring

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  1. Standard Approach to AE Monitoring NCI-sponsored treatment trials: CTCAE v4 • 790 individual items vs. patients

  2. NCI Contract HHSN261200800043C Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) • Contract initiated October 2008 • Project Officer: Bryce Reeve • Awarded to MSKCC

  3. Mission Employ rigorous scientific methods to create a system for patient self-reporting of adverse symptoms in cancer trials, which is widely accepted and used; generates useful data for investigators, regulators, clinicians and patients; and is compatible with existing adverse event reporting software systems

  4. Scope • Produce a White Paper • Conduct stakeholder survey identifying barriers and potential solutions for implementing patient AE reporting in cooperative group trials • Create patient adaptations of CTCAE symptom items (“PRO-CTCAE items”) • Build software platform • Conduct a “validation” study

  5. PRO-CTCAE Network CBIIT DCCPS DCP DCTD Dana-Farber Christiana N E T W O R K N C C C P NCI MD Anderson Hartford Mayo OLOL MSKCC Coordinating Center Duke Spartanburg Penn St. Joseph - Orange SemanticBits ADVISORS T E C H Cooperative Groups FDA Industry Patient Advocates Perceptive

  6. Progress to Date

  7. Survey Highlights*729 Stakeholders in Cooperative Groups * Full survey results and White Paper available on project Wiki (https://wiki.nci.nih.gov/x/cKul)

  8. Item Development • 78 CTCAE adverse event items identified as amendable to patient self-reporting • To develop patient versions of these items, generic question structures were created based on existing questionnaires • Simple grading scales • Clear to patients from diverse backgrounds • Amenable to translation

  9. Item Development • Lay terms for each symptom identified • Removed medical jargon • Mapped to CTCAE v4 and MedDRA • Identified which “attributes” are appropriate to characterize each symptom • Frequency, severity, interference • Up to 3 attribute items per symptom

  10. Example: Mucositis

  11. Item Refinement • Multicenter “cognitive interviewing” study to assure comprehension across diverse patient populations • N=150 • Focus on lower education and regional diversity • Status: Final interviews being completed now

  12. Software Platform Hosted on NCI servers

  13. Form Builder

  14. Integrated Study Calendar Planned future integration with Patient Study Calendar (PSC)

  15. Simple Patient Interface Secondary conditional item

  16. Reports

  17. Real-Time Alerts

  18. Software “Usability” Testing • 3 cancer centers • 120 patients, 60 staff members

  19. “Validation” Study • Assessment of validity, reliability, sensitivity, and appropriate recall period for items • 900 patients • 5 cancer centers • 5 NCCCP sites • Status: Accrual starting in May

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