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Clinicians have always graded side effects themselves, and they systematically under-record them. PRO-CTCAE is the matching set of questions asked of the patient instead, in plain language, about how often a symptom happened, how bad it was and how much it got in the way.
The standard way of recording side effects in a cancer trial is the Common Terminology Criteria for Adverse Events, filled in by the investigator. The reason the National Cancer Institute built a patient-reported version is stated in the development paper: "Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE."
What was built. "A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items." The items were refined by cognitive interviewing with patients on active treatment of varied educational, racial and geographic backgrounds, and a platform was built to administer them over the internet or by automated telephone.
Validation. The psychometric study enrolled 975 adults on outpatient chemotherapy or radiotherapy at nine US cancer centres and community practices, with 940 completing at visit one and 852 at visit two. Of those, "at least 1 symptom was reported by 938 of 940 (99.8%) participants". A third of the sample had a high school education or less, and 17.1 per cent had an Eastern Cooperative Oncology Group performance status of 2 to 4, so this was not a sample of well, highly educated volunteers. The National Cancer Institute states that PRO-CTCAE is available "in more than 60 validated languages".
Why it matters outside trials. PRO-CTCAE items are the symptom questions inside most of the electronic symptom monitoring systems whose randomised evidence is on the next record, including the PRO-TECT trial.
What it misses and what it is not. It is a symptom measure, not a quality-of-life measure: it gives a profile of individual side effects, not a summary score, and deliberately so. It covers symptomatic adverse events only, so it says nothing about laboratory toxicity, nothing about late effects that are not symptoms (a drop in bone density, a rising clonal haematopoiesis clone), and nothing about function beyond the interference questions. There is also an unresolved question about how to analyse and report it: a trial can report every item at every cycle, which nobody reads, or a composite, which loses the point. Guidance on that is still being worked out, and the development paper acknowledged it at the time.
Each of 78 symptomatic adverse events drawn from the clinician-graded CTCAE is asked of the patient in plain language with up to three attributes, frequency, severity and interference with usual activities, on five-point verbal scales with a seven-day recall, so that the patient's account can be set beside the clinician's grade for the same event.
Query for this technology: (TITLE:"PRO-CTCAE: side effects graded by the person having them" OR ABSTRACT:"PRO-CTCAE: side effects graded by the person having them") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about PRO-CTCAE: side effects graded by the person having them, not a curated reading list.
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Shares How recovery is measured: the questionnaires behind the numbers, Patients lack understanding, navigation and agency, Quality of life, HR-positive / HER2-negative breast cancer and the tags rejuvenation, survivorship, measurement, instruments.
Shares How recovery is measured: the questionnaires behind the numbers, Quality of life, Toxicity and quality of life are undervalued, HR-positive / HER2-negative breast cancer and the tags rejuvenation, survivorship, measurement, instruments.
Shares EORTC QLQ-C30: the questionnaire most cancer trials use, How recovery is measured: the questionnaires behind the numbers, Patients lack understanding, navigation and agency, Quality of life and the tags rejuvenation, survivorship, measurement, instruments.
Shares How recovery is measured: the questionnaires behind the numbers, Patients lack understanding, navigation and agency, Quality of life, HR-positive / HER2-negative breast cancer and the tags rejuvenation, survivorship, measurement, instruments.
Shares The questionnaires that were never returned, and the people never asked, Asking people how they are, every week, as a treatment in its own right, Patients lack understanding, navigation and agency, Quality of life and the tags rejuvenation, survivorship, measurement.