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Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Sandra A....
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![Page 1: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Sandra A. Mitchell, PhD, CRNP Outcomes Research Branch, DCCPS Ethan.](https://reader035.fdocuments.us/reader035/viewer/2022070414/5697c0091a28abf838cc70c2/html5/thumbnails/1.jpg)
Patient-Reported Outcomes version of the Common
Terminology Criteria for Adverse Events
Sandra A. Mitchell, PhD, CRNPOutcomes Research Branch, DCCPS
Ethan Basch, MD, MScUniversity of North Carolina
September 9, 2013
![Page 2: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Sandra A. Mitchell, PhD, CRNP Outcomes Research Branch, DCCPS Ethan.](https://reader035.fdocuments.us/reader035/viewer/2022070414/5697c0091a28abf838cc70c2/html5/thumbnails/2.jpg)
Taxotere Drug Label
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• Clinicians systematically miss adverse symptoms• Including at baseline in trials
Clinician vs. Patient AE Reporting
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Reliability of Clinician CTCAE Symptom Reports
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Patient vs. Clinician Gr3 Diarrhea
NCCTG 9741: Phase 3 trial in metastatic colon cancer
IFL Arm
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Patient-Reported Gr3 Diarrhea
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Between study arms
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Patients Don’t Over-Report Non-Relevant Symptoms
Symptom (Gr3) Reporter Arm 2 Arm 1 P
Cough Clinician 1% 2% 0.4
PRO 3% 4% 0.2
Dyspnea Clinician 5% 3% 0.1
PRO 3% 2% 0.4
Concentration problems
Clinician n/a n/a n/a
PRO 3% 3% 0.9
![Page 8: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Sandra A. Mitchell, PhD, CRNP Outcomes Research Branch, DCCPS Ethan.](https://reader035.fdocuments.us/reader035/viewer/2022070414/5697c0091a28abf838cc70c2/html5/thumbnails/8.jpg)
Symptom Arm Treatment Worsening from Baseline
P
Nausea Arm 1 43% 35% 0.004
Arm 2 38% 24%
Fatigue Arm 1 90% 47% 0.3
Arm 2 89% 50%
Diarrhea Arm 1 72% 45% <0.001
Arm 2 64% 31%
8
Better Detection of Baseline Symptoms Leads to Better Delineation of Cumulative AEs Between
Arms
![Page 9: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Sandra A. Mitchell, PhD, CRNP Outcomes Research Branch, DCCPS Ethan.](https://reader035.fdocuments.us/reader035/viewer/2022070414/5697c0091a28abf838cc70c2/html5/thumbnails/9.jpg)
Symptom Arm Treatment Worsening from Baseline
P
Nausea Arm 1 43% 35% 67% 0.004
Arm 2 38% 24% 71%
Fatigue Arm 1 90% 47% 58% 0.3
Arm 2 89% 50% 70%
Diarrhea Arm 1 72% 45% 65% <0.001
Arm 2 64% 31% 56%
In label9
Better Detection of Baseline Symptoms Leads to Better Delineation of Cumulative AEs Between
Arms
![Page 10: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Sandra A. Mitchell, PhD, CRNP Outcomes Research Branch, DCCPS Ethan.](https://reader035.fdocuments.us/reader035/viewer/2022070414/5697c0091a28abf838cc70c2/html5/thumbnails/10.jpg)
10
Investigator Agreement with Patient CTCAE
in Phase 2 Trial
8%
8%
2%
14%
6%
2%
4%
85%
87%
96%
85%
93%
94%
95%
7%
5%
2%
2%
1%
4%
1%
0% 20% 40% 60% 80% 100%
KPS
Pain
Nausea
Fatigue
Dyspnea
Cough
Anorexia
![Page 11: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Sandra A. Mitchell, PhD, CRNP Outcomes Research Branch, DCCPS Ethan.](https://reader035.fdocuments.us/reader035/viewer/2022070414/5697c0091a28abf838cc70c2/html5/thumbnails/11.jpg)
PRO-CTCAE Measurement System
1. Symptom Library 2. System for Survey Administration
• 78 symptomatic adverse events drawn from CTCAE
• PRO-CTCAE questions (items) evaluate symptom occurrence, frequency, severity, and interference
• Web-based system to customize surveys and manage survey administration
• Patients respond to surveys using web, tablet or interactive voice response (IVRS) telephone system
• Conditional branching (skip patterns)
• Write-ins with automatic mapping to standardized terminology
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NCI PRO-CTCAE Study GroupNCI PRO-CTCAE Study Group Supported through NCI contracts HHSN261200800043C and HHSN261201000063C
• PRO-CTCAE Team:
• Organizational Affiliations: NCI Community Cancer Centers Program (NCCCP), RTOG, Alliance, FDA
• We gratefully acknowledge our study participants and patient representatives!
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PRO-CTCAE Symptom Library
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CTCAE vs. PRO-CTCAE Item Structures CTCAE
Adverse Event
Grade
1 2 3 4 5
Mucositis oral
Asymptomatic or mild symptoms; intervention not indicated
Moderate pain; not interfering with oral intake; modified diet indicated
Severe pain; interfering with oral intake
Life-threatening consequences; urgent intervention indicated
-
PRO-CTCAEPlease think back over the past 7 days:
What was the severity of your MOUTH OR THROAT SORES at their WORST?None / Mild / Moderate / Severe / Very severe
How much did MOUTH OR THROAT SORES interfere with your usual or daily activities?Not at all / A little bit / Somewhat / Quite a bit / Very much
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Scientifically Rigorous Development
• Extensive cognitive testing in patients• Large U.S. validation study• Software developed and hosted at NCI• Translations underway• Pilot integration into clinical trials
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System for Electronic Data Capture
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Patient Interface
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Write-Ins for Additional Symptoms
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Form Builder
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Questionnaire Scheduling
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Email Alerts
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Reports and Data Export
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Early Adopters
• Early adopters in academia and industry testing PRO-CTCAE in trials and observational studies
• Cooperative group trials
• Collaboration agreements
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1. Identifying best-tolerated dose or schedule
2. Comparing tolerability between products• E.g. Gleevec vs. interferon; pazopanib vs. sunitinib
3. Identifying baseline symptoms and changes from baseline
• General screening of AEs to characterize risk profile
Potential Uses
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Discussion and Path Forward
• Interest to identify early-phase trials to integrate PRO-CTCAE to assess:
• Feasibility of using PRO-CTCAE
• Value in dose-finding and decision rules
• Optimal workflow for adding PRO-CTCAE into trials
• Role of investigators in using PRO-CTCAE data
• Mapping of PRO-CTCAE to CTCAE grades