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As a companion to the CTCAE, NCI has developed a Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [8].
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Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events.
The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients' self-reported symptomatic adverse events in cancer clinical trials.
In order to improve the accuracy and efficiency of collecting and grading adverse event data, the NCI has established the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system [4, 5, 6, 7].
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute as an adverse event assessment system to evaluate patients' symptoms, which tend to be underestimated in cancer clinical trials.
The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials.
The aim was to examine the feasibility, acceptability and clinical utility of electronic symptom surveillance with clinician feedback using a subset of items drawn from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a cancer treatment setting.
There is growing awareness of collecting symptom data using PRO; therefore, the NCI developed the "Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)" instrument to assess adverse symptomatic events that occur in clinical trials directly from patients' responses.
The fact that electronic symptom surveillance with clinician feedback using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Danish prostate cancer patients was shown to be feasible in this study makes us hypothesize that the model is applicable to future research.
Patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE): A specific subset from the US NCI CTCAE project taxonomy; work is in progress.
The National Cancer Institute (NCI) in the USA is also developing a methodology for collecting PRO-AEs in oncology trials based on a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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