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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
Standard Approach to AE Monitoring

NCI-sponsored treatment trials: CTCAE v4

  • 790 individual items

vs. patients


Nci contract hhsn261200800043c
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


Mission
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


Scope
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


Pro ctcae network
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



Survey highlights 729 stakeholders in cooperative groups
Survey Highlights*729 Stakeholders in Cooperative Groups

* Full survey results and White Paper available on project Wiki (https://wiki.nci.nih.gov/x/cKul)


Item development
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


Item development1
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



Item refinement
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


Software platform
Software Platform

Hosted on NCI servers



Integrated study calendar
Integrated Study Calendar

Planned future integration with Patient Study Calendar (PSC)


Simple Patient Interface

Secondary conditional item




Software usability testing
Software “Usability” Testing

  • 3 cancer centers

    • 120 patients, 60 staff members


Validation study
“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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