Post on 23-Jan-2016
description
NCI-sponsored treatment trials: CTCAE v4• 790 individual items
Standard Approach to AE Monitoring
CATEGORY EXAMPLE DATA SOURCE
Laboratory Neutropenia Laboratory report
Observable Retinal tear Clinical staff
Symptoms Nausea Clinical staff vs. patients
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
NCI Contract HHSN261200800043C
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
1. Produce a White Paper2. Conduct stakeholder survey identifying
barriers and potential solutions for implementing patient AE reporting in cooperative group trials
3. Create patient adaptations of CTCAE symptom items (“PRO-CTCAE items”)
4. Build software platform5. Conduct a “validation” study
NCI
ADVISORS TECH
NETWORK
NCCCP
PRO-CTCAE Network
MSKCCCoordinating
Center
Dana-Farber
MD Anderson
Mayo
Duke
Penn
FDACooperative Groups Industry
Christiana
Hartford
OLOL
Spartanburg
St. Joseph - Orange
SemanticBits
PerceptivePatient
Advocates
DCPDCCPS DCTD CBIIT
Progress to Date
Survey Highlights*729 Stakeholders in Cooperative Groups
QUESTION AGREE NEUTRAL DISAGREESystems to collect PROs in clinical trials should be developed 89% 5% 6%
In clinical trials, adverse events should be reported by patients 88% 8% 4%
POTENTIAL BARRIERS AGREE NEUTRAL DISAGREELack of computers 69% 15% 16%
Limited personnel 57% 18% 25%
SOLUTIONS TO OVERCOME BARRIERS AGREE NEUTRAL DISAGREEFunding (for personnel, dedicated space, training) 79% 13% 8%
Computers 72% 21% 7%
* Full survey results and White Paper available on project Wiki (https://wiki.nci.nih.gov/x/cKul)
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 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
Example: Mucositis
CTCAE v4 Term Grade 1 Grade 2 Grade 3 Grade 4
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
Two PRO-CTCAE v1 Items Responses
What was the severity of your MOUTH OR THROAT SORES at their worst?
NoneMildModerate SevereVery Severe
How much did MOUTH OR THROAT SORES interfere with your usual activities?
Not at allA little bitSomewhatQuite a bitVery much
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
Hosted on NCI servers
Form Builder
Integrated Study Calendar
Planned future integration with Patient Study Calendar (PSC)
Simple Patient Interface
Secondary conditional
item
Reports
Real-Time Alerts
Software “Usability” Testing
• 3 cancer centers– 120 patients, 60 staff members
“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