PRO CTCAE - sporedata/researchdesigneR GitHub Wiki

General description

The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a patient-reported outcome (PRO) outcome measurement system developed by the National Cancer Institute to evaluate and capture symptomatic adverse events and toxicity in patients in cancer clinical trials.

PRO-CTCAE has been linguistically validated in over 30 languages and was designed to be a companion to the CTCAE, the standard lexicon for adverse event reporting in cancer clinical trials.

A pediatric module (includes 130 items representing 62 symptomatic toxicities drawn from the CTCAE) permits self-reporting by children and adolescents aged 7-17 years or caregiver-reporting for minors aged 7-17 who are unable to self-report (Ped-PRO-CTCAE - includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE).

Related publications

• Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research
• Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer
• Translation Into Simplified Chinese and Cultural Validation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Using Cognitive Interviewing
• Reliability and Validity of the Korean Language Version of the U.S. National Cancer Institute's Patient-Reported Outcomes Common Terminology Criteria for Adverse Events
• Electronic versus paper-pencil methods for assessing chemotherapy-induced peripheral neuropathy
• National Cancer Institute PRO-CTCAE Study Group. Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
• Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
• Linguistic Validation of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Korean
• Japanese translation and linguistic validation of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
• Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
• Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop
• Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections
• Improving attribution of adverse events in oncology clinical trials
• Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
• News from the NIH: Person-centered outcomes measurement: NIH-supported measurement systems to evaluate self-assessed health, functional performance, and symptomatic toxicity
• Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Data access

More information about PRO-CTCAE can be found at https://healthcaredelivery.cancer.gov/pro-ctcae/