ArticleJournal of the American Medical Informatics Association : JAMIA2019
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).
Article in Journal of the American Medical Informatics Association : JAMIA, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
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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
43 citing papers in PubMed.
- Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial.Nature medicine · 2025Trial
- Patient-Reported Outcomes During and After Treatment for Locally Advanced Rectal Cancer in the PROSPECT Trial (Alliance N1048).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Comparing Paclitaxel-Carboplatin with Paclitaxel-Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer.International journal of environmental research and public health · 2020Trial
- A qualitative study of cancer clinical trial network consumers' acceptability of the modular approach to patient-reported outcome measurement: how much of it is "common sense"?Journal of patient-reported outcomes · 2026Article
- Characterizing persistent Post-COVID-19 vaccination symptoms using MedDRA system organ class and preferred term classifications.Scientific reports · 2026Article
- Review
- Review
- Use of patient-reported outcomes version of the common terminology criteria for adverse events in oncology clinical trials.Contemporary clinical trials communications · 2025Article
- Hepatic arterial infusion chemotherapy combined with lenvatinib and immune checkpoint inhibitor versus lenvatinib for advanced hepatocellular carcinoma: a multicenter study with propensity score and coarsened exact matching.La Radiologia medica · 2025Article
- Using GPT-4o to interpret patient-reported outcomes without training.Journal of the National Cancer Institute · 2025Article
- Article
- Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials - insights from an expert virtual roundtable.EClinicalMedicine · 2024Review
- Acceptability and usefulness of the EORTC 'Write In three Symptoms/Problems' (WISP): a brief open-ended instrument for symptom assessment in cancer patients.Health and quality of life outcomes · 2024Article
- Addition of Immune Checkpoint Inhibitor Showed Better Efficacy for Infiltrative Hepatocellular Carcinoma Receiving Hepatic Arterial Infusion Chemotherapy and Lenvatinib: A Multicenter Retrospective Study.ImmunoTargets and therapy · 2024Article
- The Necessity of Interoperability to Uncover the Full Potential of Digital Health Devices.JMIR medical informatics · 2023Article
- A tailored phase I-specific patient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events.British journal of cancer · 2023Article
- Exploring differences in symptomatic adverse events assessment between nurses and physicians in the clinical trial setting.Scientific reports · 2023Article
- What Patients Say: Large-Scale Analyses of Replies to the Parkinson's Disease Patient Report of Problems (PD-PROP).Journal of Parkinson's disease · 2023Article
- Patient-Reported Outcomes in Early Phase Clinical Trials: An Opportunity to Actively Promote Patient-Centered Care.The oncologist · 2022Article
- Efficacy and Risk Factors of Pyrrotinib in Second- and Third-Line Treatments for HER2-Positive Advanced Breast Cancer.Computational and mathematical methods in medicine · 2022Article
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
objectiveThe study sought to describe patient-entered supplemental information on symptomatic adverse events (AEs) in cancer clinical research reported via a National Cancer Institute software system and examine the feasibility of mapping these entries to established terminologies. MATERIALS AND
methodsPatients in 3 multicenter trials electronically completed surveys during cancer treatment. Each survey included a prespecified subset of items from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Upon completion of the survey items, patients could add supplemental symptomatic AE information in a free text box. As patients typed into the box, structured dropdown terms could be selected from the PRO-CTCAE item library or Medical Dictionary for Regulatory Activities (MedDRA), or patients could type unstructured free text for submission.
resultsData were pooled from 1760 participants (48% women; 78% White) who completed 8892 surveys, of which 2387 (26.8%) included supplemental symptomatic AE information. Overall, 1024 (58%) patients entered supplemental information at least once, with an average of 2.3 per patient per study. This encompassed 1474 of 8892 (16.6%) dropdowns and 913 of 8892 (10.3%) unstructured free text entries. One-third of the unstructured free text entries (32%) could be mapped post hoc to a PRO-CTCAE term and 68% to a MedDRA term. DISCUSSION: Participants frequently added supplemental information beyond study-specific survey items. Almost half selected a structured dropdown term, although many opted to submit unstructured free text entries. Most free text entries could be mapped post hoc to PRO-CTCAE or MedDRA terms, suggesting opportunities to enhance the system to perform real-time mapping for AE reporting.
conclusionsPatient reporting of symptomatic AEs using a text box functionality with mapping to existing terminologies is both feasible and informative.
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Registered trials
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.