INTEGRATING THE CHILD'S VOICE IN ADVERSE EVENT REPORTING IN ONCOLOGY TRIALS- INITIAL STEPS IN THE PEDIATRIC PRO-CTCAE INITIATIVE

Author(s)

Reeve BB1, Withycombe J2, Tomlinson D3, Sung L3, Mowbray C4, Martens C1, Mack JW5, Lyons JC1, Kohler RK1, Keller S4, Jacobs SS4, Gold SH1, Freyer DR6, Baker JN7, Hinds PS4
1University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 2Palmetto Health Children's Hospital, Columbia, SC, USA, 3The Hospital for Sick Children, Toronto, ON, Canada, 4Children's National Medical Center, Washington, DC, USA, 5Harvard Medical School, Boston, MA, USA, 6University of Southern California, Los Angeles, CA, USA, 7St Jude Children's Research Hospital, Memphis, TN, USA

OBJECTIVES: Over 60% of children with cancer will participate in a clinical trial. Collection of Adverse Events (AE) in trials is required by law and the current standard is that AEs are reported only by clinicians even when many AEs are subjective (e.g., fatigue, pain). Our overarching goal is to design a child self-report measure of subjective AEs that will inform AE reporting for the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), the standard lexicon for grading AEs in oncology trials world-wide. This study’s objectives are to review the CTCAE to identify which AEs are amenable to self-report by children ages 7 or older and to design a self-report questionnaire to measure the selected AEs. METHODS: The CTCAE contains 790 AEs described in medical terms. Through two online surveys, we sought consensus among 184 experienced pediatric oncologists and nurses, from 7 diverse Children’s Oncology Group treatment centers. To inform draft of the questionnaire, a search of PubMED was conducted for self-report symptom measures appropriate for children younger than 21 years. RESULTS: The response rates for the clinician surveys were 78% and 67%. A final 63 CTCAE terms were selected as being subjective, relevant for measuring in pediatric cancer trials, and amenable to self-report. The PubMED search yielded 28 self-report symptom measures for use in children with cancer. The measures varied in symptoms measured, characteristics (e.g., reference period, response options), and level of psychometric evidence. CONCLUSIONS: The 63 CTCAE terms were translated through this process into child friendly terms (e.g., “fatigue” to “tired”) and a 129-item measure was drafted in English to capture a symptom’s severity, frequency, and/or interference. Follow-up steps include cognitive interviews and a longitudinal validation study. Ultimately, systematic collection of these data in trials will enhance the validity of AE reporting and improve care for children with cancer.

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PRM94

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Oncology

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×