PRO-CTCAE : PATIENT-REPORTED OUTCOMES VERSION OF CTCAE. Lori Minasian, MD Deputy Director, Division of Cancer Prevention, NCI
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1 1 RO-CTCAE : ATIENT-REORTED OUTCOME VERION OF CTCAE Lori Minasian, MD Deputy Director, Division of Cancer revention, NCI
2 2 Disclosures I work for the UA Federal Government I have no financial conflicts to disclose resenting on behalf of the NCI RO-CTCAE cientific Leadership Team
3 3 Outline of Talk sychometric development for RO-CTCAE Describe initial principles for use Identify differences between HRQOL tools and toxicity reporting
4 4 What is RO-CTCAE? RO-CTCAE is designed for patient reporting of symptomatic adverse events RO-CTCAE is an item bank of questions Derived from the CTCAE adverse event items Complimentary to CTCAE (and to be used with) RO-CTCAE is ONLY for descriptive reporting Not ready for clinical and protocol specific decisionmaking based upon individual RO-CTCAE scores
5 RO-CTCAE Measurement ystem 1. ymptom Library 2. ystem for urvey Administration 78 symptomatic adverse events drawn from CTCAE RO-CTCAE questions evaluate symptom occurrence, frequency, severity, and interference Web-based system to customize surveys and manage survey administration atient responds to surveys using web, tablet or interactive voice response (IVR) telephone system Conditional branching (skip patterns) Write-ins with automatic mapping to standardized terminology For more information, visit:
6 sychometrically robust library of items Electronic system fits data collection smoothly into trials workflow and offers favorable user-experience Accommodate patients with limited English proficiency/digital literacy upply meaningful data to improve understanding of symptomatic AEs Electronic system for survey mgmt Usability testing Implement telephone reporting (IVR) panish Validation Feasibility, Acceptabili ty & Cost and beyond Develop Items Cognitive Testing Validation tudy Evaluate utility for decisionmaking Funded by NCI contracts HHN C, HHN C, and
7 7 RO-CTCAE Content Validity 78 symptomatic AEs identified from ~800 CTCAE terms for patient self-reporting lain-language AE terms identified Each symptomatic AE has 1 to 3 items 1 Frequency, severity, interference w/ activities Content validity established during three interview rounds with semi-structured interview using structured and open-ended probes (N=127) 2 63/80 symptom terms generated no cognitive difficulties; 17 modified and re-tested without further difficulties 1 Basch et al., (2014). Development of the National Cancer Institute s atient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (RO-CTCAE). Journal of the National Cancer Institute, 106(9). pii: dju244 2 Hay et al. (2014). Cognitive interviewing of the atient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (RO-CTCAE) to support content validity. Quality of Life Research, 23(1):
8 ATIENT-REORTED OUTCOME VERION OF THE COMMON TERMINOLOGY CRITERIA FOR ADVERE EVENT (RO-CTCAE ) ITEM LIBRARY (Version 1.0) Gastrointestinal Taste changes Decreased appetite Nausea Vomiting Heartburn Gas Bloating Hiccups Constipation Diarrhea Oral Dry mouth Difficulty swallowing Mouth/throat sores Cracking at the corners of the mouth (cheilosis/cheilitis) Voice quality changes Hoarseness Abdominal pain Fecal incontinence I I F F F F F F FI FI Cardio/Circulatory welling Heart palpitations Cutaneous Rash kin dryness Acne Hair loss Itching Hives Hand-foot syndrome Nail loss Nail ridging Nail discoloration ensitivity to sunlight Bed/pressure sores Radiation skin reaction kin darkening tretch marks FI F Neurological Numbness & tingling Dizziness Visual/erceptual Blurred vision Flashing lights Visual floaters Watery eyes Ringing in ears Attention/Memory Concentration Memory ain General pain Headache Muscle pain Joint pain I I I I I I FI FI FI FI leep/wake Insomnia Fatigue Anxious Mood Discouraged ad I I Gynecologic/Urinary Irregular periods/vaginal bleeding Missed expected menstrual period Vaginal discharge Vaginal dryness ainful urination Urinary urgency Urinary frequency Change in usual urine color Urinary incontinence FI FI FI FI I FI exual Achieve and maintain erection Ejaculation Decreased libido Delayed orgasm Unable to have orgasm ain w/sexual intercourse Miscellaneous Breast swelling and tenderness Bruising Chills Increased sweating Decreased sweating Hot flashes Nosebleed ain and swelling at injection site Body odor F F F F F Respiratory hortness of breath Cough Wheezing I I Dimensions F: Frequency I: Interference : everity : resence/absence /Amount
9 RO-CTCAE Validity and Reliability Results demonstrate favorable validity, reliability, and responsiveness of RO-CTCAE in a large, heterogeneous sample of patients undergoing cancer treatment (n=940) 1 Most RO-CTCAE items (119/124) reached a statistically significant (p<0.05) and meaningful effect size on one or more validity criteria Majority of the items tested (n=27 items) exhibited acceptable testretest reliability All tested items (n=27 items) were sensitive to differences between groups 1 Dueck AC, et al. (2015). Validity and reliability of the U.. National Cancer Institute s atient-reported Outcomes version of the Common Terminology Criteria for Adverse Events (RO-CTCAE). JAMA Oncology, Epub ahead of print.
10 Comparison of Recall eriods N=110 patients completed 27 RO-CTCAE items (14 symptomatic A/Es) Comparison of 28 daily ratings to 1-, 2-, 3-, and 4-week recalled ratings 1-week recall corresponds well to daily reporting. Differences between daily and longer recall periods widen with 2, 3, and 4 week recall Recall eriod Effect ize of the Difference (compared to max. daily score within that period) 7 day day day ast month Mendoza et al. Evaluation of different recall periods for the U National Cancer Institute s atient-reported Outcomes version of the Common Terminology Criteria for Adverse Events (RO-CTCAE). Manuscript in preparation for Clinical Trials.
11 11 Timeframe for Assessments Recall period is 7 days Anticipate weekly reporting Currently, data to demonstrate ~ 90% compliance for weekly reporting up to 20 weeks with reminders. Baseline and off-study assessment are essential Balance number of items asked and frequency of time for assessments with data quality If asking questions with an interval of longer than one week, the recall period remains the last 7 days
12 Mode Equivalence N=112 patients completed 28 RO-CTCAE items (14 symptomatic AEs) by each of the three modes of administration at a single clinic visit Average time to complete an item: Web: 11.1 seconds (D = ±8.4) Interactive Voice Response (IVR): 16.3 seconds (D = ±6.3) aper: 10.3 seconds (D = ±5.8) Median ICC (Range) Between modes, item-level mean differences were very small, and the corresponding effect sizes were all less than 0.20 Bennett et al. (2016). Health and Quality of Life Outcomes. E ub ahead of print.
13 Technology May Improve Data Collection Electronic administration reduces the number of items that must be asked of patients Conditional branching Computer adaptive testing Technology has enabled data collection to be more efficient, customized, mobile, and responsive mart phone/hand-held devices/interactive Voice Response (IVR) for data collection Customize time of day for assessment, text size on screen, and mode of administration Reminders to patients and staff for missed surveys Eliminate need for data entry Mobile devices may improve engagement
14 % of atients elf-reporting Example from Actual Trial: Compliance over Time Weekly reporting from home via Web or IVR (patient choice), with central monitoring and backup human telephone calls % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Active Therapy Complete d upported by NCI contract HHN C
15
16 16 Toxicity Reporting & RO-CTCAE Toxicity Reporting Clinician assesses adverse events and grade events Action is taken based upon protocol specific instructions for the purpose of preventing or reducing harm Events reviewed in real time and study design may be modified Each event is reported and analyzed independently RO-CTCAE atient answers separate questions about occurrence of event If event occurs, answer questions about frequency, severity or interference No protocol directed modifications based only on patient reports Each event evaluated individually (No summary score)
17 CTCAE Use Within Clinical Trials rotocol parameters atient Eligibility Dose Limiting Toxicity (DLT) Maximum Tolerated Dose (MTD) determination Dose Modification Recommended hase 2 dose Reporting of both routine adverse events and serious adverse events (AE) Monitor safety data and regulatory reporting 17
18 CTCAE vs. RO-CTCAE Item tructures Adverse Event Mucositis oral CTCAE Grade Asymptomatic or mild symptoms; intervention not indicated Moderate pain; not interfering with oral intake; modified diet indicated evere pain; interfering with oral intake Life-threatening consequences; urgent intervention indicated - lease think back over the past 7 days: RO-CTCAE What was the severity of your MOUTH OR THROAT ORE at their WORT? None / Mild / Moderate / evere / Very severe How much did MOUTH OR THROAT ORE interfere with your usual or daily activities? Not at all / A little bit / omewhat / Quite a bit / Very much
19 RO-CTCAE core vs. CTCAE Grade RO-CTCAE responses are scored from 0 to 4 Up to three questions per AE Item Frequency, everity, Interference Clinician CTCAE Grade Bundles the constructs of severity, frequency and interference Grading dependent upon clinician judgement of medical significance Clinician Grade RO-CTCAE core One grade by clinician Up to three patient reported scores per Item CTCAE Grade 4 does not exist for most of the RO-CTCAE items
20 20 HRQOL Toxicity Reporting HRQOL Questions designed to address overall effects of cancer and its treatment atient answers questions in real time Responses evaluated by study at the completion of the study Tools are designed to provide a summary score Toxicity Reporting Clinician assesses adverse events for patient safety Action is taken specifically to reducing further harm Events reviewed in real time and study design may be modified Each event is reported independently
21 21 Key oints Different tools used for different purposes HRQOL provides an assessment for multiple different domains on how a patient experiences the combination of cancer, its treatment and related effects. Toxicity reporting is specific to safety and patients may not be aware of what is treatment related or cancer related.
22 22 Key oints RO-CTCAE is a new tool: Derived from clinician rated CTCAE for the purpose of refining the understanding of adverse events as a consequence of treatment. Clinician graded CTCAE remains standard for protocol directed action specific individual adverse events RO-CTCAE provides descriptive information to compliment clinician reporting Much more work is needed to understand how best to use RO-CTCAE data.
23 23 Ongoing Work Responsiveness, minimal clinically important difference, cut-points, relationship among the attributes everal languages in development/validation, including Chinese, Korean, Italian, French, wedish, Dutch, and Danish Evaluate different approaches to patient-investigator grade reconciliation and to analyzing and representing RO-CTCAE data
24 NCI RO-CTCAE tudy Group upported through NCI contracts HHN C and HHN C Organizational Affiliations: NCI Community Cancer Centers rogram (NCCC), RTOG, Alliance, FDA We gratefully acknowledge our study participants and patient representatives! NCI Community Cancer Centers rogram (NCCC), RTOG, Alliance, FDA We gratefully acknowledge our study participants and patient representatives!
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