ArticleThe oncologist2019
Feasibility Assessment of Using the Complete Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library.
Article in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed.
- Longitudinal patient-reported outcomes on genotype-guided irinotecan dosing: feasibility and clinical relevance.The oncologist · 2024Trial
- International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study.Clinical trials (London, England) · 2026Article
- Review
- Cancer Clinical Trial Patients' Perceptions of Reporting Adverse Events Via an Electronic Platform.Therapeutic innovation & regulatory science · 2025Article
- Understanding the Role of Patient-Reported Outcomes for Decision-Making in Early-Phase Dose-Finding Clinical Trials.Current oncology (Toronto, Ont.) · 2025Article
- Transarterial chemoembolization versus hepatic arterial infusion chemotherapy as first treatment for hepatocellular carcinoma with macrovascular invasion.International journal of medical sciences · 2025Article
- Impact of immigration background on feasibility of electronic patient-reported outcomes in advanced urothelial cancer patients.Health and quality of life outcomes · 2024Article
- Unleashing patient voices: empowering adverse event assessment with complete patient-reported outcomes.The oncologist · 2024Article
- Adverse Event Reporting in Cancer Clinical Trials: Incorporating Patient-Reported Methods. A Systematic Scoping Review.The patient · 2024Article
- Recommendations to address respondent burden associated with patient-reported outcome assessment.Nature medicine · 2024Review
- A tailored phase I-specific patient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events.British journal of cancer · 2023Article
- International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection.Nature communications · 2022Review
- Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events.Pediatric blood & cancer · 2022Article
- Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.The Lancet. Haematology · 2022Review
- Efficacy and safety of endovascular brachytherapy combined with transarterial chemoembolization for the treatment of hepatocellular carcinoma patients with type III or IV portal vein tumor thrombosis.World journal of surgical oncology · 2022Article
- The value of patient-reported outcomes in early-phase clinical trials.Nature medicine · 2022Article
- Clinician and Patient Reporting of Symptomatic Adverse Events in Cancer Clinical Trials: Using CTCAE and PRO-CTCAEPatient related outcome measures · 2022Review
- Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov.Cancer medicine · 2021Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) complements capture of symptomatic adverse events (AEs) by clinicians. Previous trials have typically used a limited subset of relevant symptomatic AEs to reduce patient burden. We aimed to determine the feasibility of administering all 80 AEs included in the PRO-CTCAE library by approaching consecutive patients enrolled in a large academic phase I program at three points in time. Here, we report a preplanned analysis after enrolling the first 20 patients. All items were answered on 51 of 56 potential visits (adherence 91%). Three (5%) additional PRO-CTCAE assessments were partially completed, and two (4%) were missed because of conflicting appointments. No patient withdrew consent or chose not to complete the assessments once enrolled on study. Future trials of experimental drugs that incorporate the PRO-CTCAE should consider using this unselected approach to identify adverse events more completely.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.