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CTEP Program MeetingPatient-Reported Outcomes (PROs)
in Cancer Treatment Trials
Ethan Basch, MD, MScMemorial Sloan-Kettering Cancer Center
PROs for Adverse Event Reporting
March 18, 2008
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Overview
1. Background2. Rationale for using PROs for AE Reporting3. Prior and ongoing research
(outside scope of PRO-CTCAE contract)• Questionnaire and platform development• Feasibility• Patient vs. clinician reporting
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Essential activity in treatment trials• To ensure patient safety • To provide data about drug effects
– Trialists, regulators, clinicians, patients
Core activity in routine cancer care• To guide therapy and supportive care
Adverse Event Monitoring
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NCI-sponsored treatment trials: CTCAE v3 ~1000 individual items
Standard Approach to AE Monitoring
CATEGORY EXAMPLE DATA SOURCE
Laboratory Anemia (hemoglobin) Laboratory report
“Objective” Blood Pressure Clinical staff
“Subjective” Nausea Clinical staff and patients
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Patient Experiences
Symptom
Clinician Interprets Symptom
Clinician interviews patient at visit
Chart Representation
of SymptomClinician writes in chart
Data ManagerInterpretation of SymptomData manager
abstracts chart
ResearchDatabase
Manualdata entry
Current Model for Adverse Symptom Reporting in Oncology Trials
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Patient Experiences
Symptom
ResearchDatabase
Patient direct reporting of symptoms (1)
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Patient Experiences
Symptom
ResearchDatabase
Clinician
Patient direct reporting of symptoms (2)
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Rationales for Patient-Reported Outcomes Approach to Adverse Symptom Reporting
• Improve efficiency of data collection– Eliminating data collection steps, reducing errors
• Provide more direct account of patient experience– Eliminating filtering of patient reports by others
• Engage patients as active participants in trials • Enable real-time data capture (ePROs)
– Automated alerts, between-visit reporting
• Provide subsequent patients with AE information reported by their peers, not clinical staff
• Harmonize CTCAE with current standards for symptom measurement using PROs– Eg, FDA guidance
Trotti, Colevas, Setser, Basch: JCO, 2007
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Research Prior to PRO-CTCAE Contract
• Created initial adaptations of CTCAE symptom items for pilot testing
• “STAR” items
Basch: JCO, 2005
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EXAMPLE: DIARRHEA
Basch: JCO, 2005
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Items Loaded to Web Platform
• Online interface– Patient self-reporting– Longitudinal report– Automated alerts
• Administration– Touchscreen kiosks and wireless tablet computers in
clinic waiting areas– Home computers between visits
Basch: J Am Med Informatics Assoc, 2007
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STAR Lung Page
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STAR Report Page--Patient Name--
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Symptom Reported Page
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Feasibility Studies
• Outpatients with lung, gynecologic, and genitourinary malignancies receiving chemotherapy
• Intervention: – Selected CTCAE symptoms– 10-minute training– Encouraged to login at follow-up visits– Access to website from home (voluntary)– Reports printed for clinicians at visits– Alerts nurses for grades 3-4
Basch, JCO, 2007
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Results
Feasible• Most patients are willing and able to self-
report CTCAE symptoms at clinic visits– Including non-web avid, elderly, and
end-stage with high symptom burdens – No attrition in login rates after up to 2 years
or up to 40 clinic visits
Basch, JCO, 2007
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Satisfaction
• High patient satisfaction– Wish to continue using– Would recommend to others
• High clinician satisfaction– Accurate portrayal of patient status– Useful as basis for clinical decisions
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57 email alerts(25 different patients)
15 from clinic-based computers
42 from home
computers
Patient’s location
4chemotherapy
holds
7 tel contacts 3 med changes 3 appts made
Clinician actions
Basch, JCO, 2005
Toxicity Alerts for Grade 3-4 (n=80)
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Conclusions
• Most patients receiving chemotherapy are willing and able to self-report adverse symptom information at clinic visits
• Clinicians find information valuable and will use it to guide treatment decisions
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Real-World Question
• If PROs became a standard approach for reporting adverse symptoms in oncology, how might this alter the frequency or severity of documented toxicities?– Do patients report adverse symptoms
differently from clinicians?
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Patient vs. Clinician Reporting
• Paper survey
• 400 patient-clinician pairs– Cancer outpatient clinics
• Patients and clinicians answered the same CTCAE items
Basch, Lancet Oncol, 2006
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Basch, Lancet Oncol, 2006
Comparison of Paired Observations
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Cumulative Incidence of Symptoms
Patient-reporting
Clinician-reporting
CTCAE Grade-2 (Moderate) CTCAE Grade-3 (Severe)
Patient-reporting
Clinician-reporting
Basch, ASCO, 2008
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Which Perspective Should Be Standard?
• Treatment trials/drug labeling– Choosing one approach vs. the other could impact how
toxic drugs look on paper
“Clinician knows best”
TOXICITY “Patient knows best”
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Which Perspective in Trials and Labels?
• If continue clinician reports as standard– Will appear to systematically under-report and under-rate
severity of symptoms compared to patient reports
• If adopt patient reports as standard– Frequency and severity of AE reports on labels will likely
increase
• Or report both?– Might they be reflecting different phenomena?
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Longitudinal Study
Design• Patients and clinicians reported the same CTCAE symptoms at
each clinic visit for up to 1.5 years• Analyzed associations of patient vs. clinician CTCAE reports with
risk of death, hospitalization, and daily health status
Findings• Clinician CTCAE symptom reporting predicts death and
hospitalization, while patient reporting does not• Patient CTCAE reporting correlates more highly with daily
health status than clinician reporting
Basch, ASCO, 2008
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Conclusion
• Clinicians and patients provide complementary information– Capture different aspects of the experience with
disease and treatment
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Drug Labels
• Would inclusion of both patient-based and clinician-based adverse symptom data in drug labels cause confusion?
– Instructive to look at examples of ratings reporting approaches outside of healthcare
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Metacritic.com
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CNET Reviews
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Tripadvisor
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Docetaxel Drug Label
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Ongoing Research
• Multi-center cooperative group study (CALGB)– Feasibility of patient CTCAE reporting, nested in 5
treatment trials– Cancer centers/CCOPs
• PRO study nested in Phase II trial– Patients self-report CTCAE symptoms via computer– Clinicians review patient reports on computer, then
agree or disagree/reassign grades– Clinicians assign attribution
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CTCAE Patient Level Report (1)
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CTCAE Patient Level Report (2)
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• Patients are willing and able to report CTCAE symptoms via computer
• Patient reporting is discrepant from clinician reporting – PROs more reflective of day-to-day experience
• Clinicians will accept patient-reported AEs for treatment decisions and documentation
• Reporting of both patient and clinician AE grades is reasonable in treatment trial results and labels– Would provide additional information about toxicity
Summary
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• What are the barriers to widely implementing such a system?
• What AEs are appropriate for patient reporting?• How should this work operationally?
– Should clinicians use PROs to inform their own grades?– How often should patients self-report
• Only at visits?• Between visits (eg, weekly)?
Issues addressed in PRO-CTCAE contract
Remaining Questions
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CTEP Program MeetingPatient-Reported Outcomes (PROs)
in Cancer Treatment Trials
Ethan Basch, MD, MScMemorial Sloan-Kettering Cancer Center
Overview of PRO-CTCAE Contract
March 18, 2008
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• 2-Year Contract– Started on 10/1/08
NCI Contract HHSN261200800043C
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Overall Mission of Project
• 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 systems
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SOW
• Generate White Paper identifying barriers, ideal conditions, and solutions to implement PRO-CTCAE
• Create PRO-CTCAE items• Build/evaluate electronic PRO-CTCAE platform• Evaluate measurement properties of items• Develop training materials• Design cooperative group study
YEAR 1
YEAR 2
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Task-Based Framework for Project
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Expert Investigative Team and Subcontracts
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How the Work is Done
• Committee for each Task– Under direction of each task leader– Regular teleconferences for each– Vigorous work between calls– Documentation archived on wiki
• https://wiki.nci.nih.gov/x/cKul
• Timelines– Oriented around RFP-specified deliverables
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Progress to DateTask 1: Create White Paper
• Survey of 729 stakeholdersRole N*
NCI Representative 41
FDA Representative 26
Cooperative Group Leadership 52
Cooperative Group Member 130
Lead PI 84
Investigator 103
CRA 161
Research Nurse 185
Patient Advocate 121
Industry 30*Not mutually exclusive
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Progress to DateTask 1: Create White Paper
• Survey resultsQUESTION AGREE NEUTRAL DISAGREESystems to collect PROs in clinical trials should be developed 89% 5% 6%
In clinical trials, AEs should be reported by clinicians and patients 88% 8% 4%
Both patient and clinician reported AEs should be reported in clinical trial results and in drug labels
76% 15% 9%
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Progress to DateTask 1: Create White Paper
• Potential barriers to CTCAE PROsQUESTION AGREE NEUTRAL DISAGREESevere illness/debilitation of patients 88% 6% 6%
Caregiver/proxy reporting should be permitted 70% 12% 18%
Lack of computers 69% 15% 16%
Limited time 58% 19% 23%
Limited personnel 57% 18% 25%
Limited clinic space 48% 21% 29%
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Progress to DateTask 1: Create White Paper
• Solutions: funds and new computersQUESTION AGREE NEUTRAL DISAGREEThese barriers could be overcome with adequate funding 79% 13% 8%
My site has clinic staff who could assist patients to self-report 66% 18% 16%
My site has clinic areas that could be used for patient reporting 47% 28% 25%
My site has computers that could be used for patient reporting 24% 25% 51%
My site would need new computers 72% 21% 7%
Wireless computers are feasible at my site 58% 12% 19%
Paper-based reporting is feasible at my site 86% 14% 4%
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Progress to DateTask 2: Develop Items
• 77 CTCAE symptoms identified amendable to patient self-reporting
• PRO-CTCAE items created– Different in format from CTCAE– Can be viewed on Wiki
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PRO-CTCAE Item ListAbdominal pain Depression Edema – Limb Hot flashes Myalgia Rash Urticaria
Acne Dermatitis (Radiation)
Ejaculatory dysfunction
Hyper-pigmentation
Nail changes Rash: Hand-Foot
Vaginal discharge
Alopecia/hair loss Diarrhea Epistaxis (Nosebleeds)
Hypohidrosis Nausea Rigors/chills Vaginal dryness
Amenorrhea Distension/bloating, abdominal
Erectile dysfunction
Incontinence, anal Neuropathy-sensory
Skin Breakdown
Vision – blurred
Anorexia Dizziness Fatigue Incontinence, urinary
Odor Striae Voice changes
Anxiety Dry mouth/ xerostomia Flashing lights Injection site reaction/
extravasation
Orgasmic dysfunction
Sweating (diaphoresis)
Vomiting
Arthralgia (joint pain)
Dry skin Flatulence Insomnia Pain Taste alteration
Watery eye
Bronchospasm, wheezing Dyspareunia Floaters Irregular menses Painful urination
Tinnitus Decreased concentration
Chelilitis Dysphagia Gynecomastia Libido Palpitations Tremor Depression 2Constipation Dyspnea Heartburn/
dyspepsiaMemory
impairmentPhoto-
sensitivityUrinary
frequencyNail changes 2
(color)
Cough Easy bruising Hiccoughs Mucositis/stomatitis
Pruritus/ Itching Urine color change
Nail changes 3(shape)
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Progress to DateTask 4: Cognitive Interviews
• A protocol has been developed to interview patients to assure comprehension of the new items– Undergoing IRB review at NCI and four cancer
centers
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Progress to DateTask 5: Platform Development
• A computer platform is in development with SemanticBits– Developer of other caBIG software including
caAERS
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Form Builder
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Patient Interface
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Study Calendar
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Summary
• Other tasks in startup phases• Future work beyond the contract
– Assess patient reporting between visits– Translation into non-English – Site-by-site feasibility assessment– Evaluate this approach outside of clinical trial setting for post-
market surveillance– Measure impact of this approach on quality of care