Trial reportThe Lancet. Oncology2026
Inter-rater reliability of CTCAE assessments with or without EORTC patient-reported outcome data in a mixed cancer population: a multinational, open-label, randomised controlled trial.
Trial report in The Lancet. Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04066868 (Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings), which is not on this map. Cited by 4 papers.
What it found
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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.
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
Who cites it
4 citing papers in PubMed.
- Trial
- Measuring toxicity better: patient-reported outcome-informed calibration for CTCAE assessment.Translational cancer research · 2026Article
- Health-related quality of life among working-age women with breast cancer in Croatia: a population-referenced cross-sectional study.BMC women's health · 2026Article
- Locked-Window EQ-5D-5L (Index and VAS) Benchmarking in Sarcoma Care: Rule-Based Traffic-Light Classification Across Two Institutions.Diseases (Basel, Switzerland) · 2026Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Common Terminology Criteria for Adverse Events (CTCAE) is the standard for provider-based rating of adverse events in oncology, but its reliability for symptomatic adverse events is low. Patient-reported outcome (PRO) data might improve the inter-rater reliability of CTCAE assessments. We investigated whether providers' access to PRO data enhances the inter-rater reliability of CTCAE ratings and the detection of symptomatic adverse events.
methodsThis multinational, open-label, randomised controlled trial was done in 11 hospitals in ten countries. Adults (aged ≥18 years) with any cancer diagnosis receiving chemotherapy, immunotherapy, or radiotherapy of curative or palliative intent were eligible. Patients were randomly assigned (1:1) to the intervention group (in which providers saw patients' PRO data as they were doing CTCAE assessments) or the control group (in which providers did not have access to PRO data) within each centre through a minimisation algorithm and a weighted cutoff; no additional stratification factors were applied. Patients completed the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 16 additional items from the EORTC Item Library, covering 17 symptomatic adverse events. Two independent providers (oncologists or trained nurses) did CTCAE ratings. The primary endpoint was the inter-rater reliability of CTCAE ratings, expressed as intraclass correlation coefficients (ICCs), for all patients with complete assessments. The trial was registered at ClinicalTrials.gov (NCT04066868) and is now closed.
findingsBetween Feb 10, 2020, and Dec 6, 2024, a total of 1067 patients were enrolled (538 in the control group and 529 in the intervention group), with full data from 512 patients in the control group and 501 in the intervention group included in the analysis. Median age was 59 years (IQR 46-68); 558 (55·1%) of 1013 were female and 455 (44·9%) were male. Most had good functional status (403 [79%] of 512 had ECOG 0-1 in the control group and 371 [74%] of 501 in the intervention group). The most common cancer types were haematological (control group: 137 [27%] of 512; intervention group: 131 [26%] of 501), breast (control group: 118 [23%]; intervention group: 107 [21%]), and gastrointestinal (control group: 98 [19%]; intervention group: 89 [18%]). Inter-rater reliability was significantly higher in the intervention group for 13 of 17 symptomatic adverse events, with the largest differences for memory impairment (ICC 0·176; p<0·0001), irritability (0·161; p<0·0001), concentration impairment (0·157; p<0·0001), depression (0·126; p=0·0012), and anxiety (0·109; p=0·0018). There was no significant difference for pain, rash, and peripheral sensory neuropathy and the reliability was significantly higher in the control group than the intervention group for diarrhoea (ICC -0·066; p=0·013).
interpretationAvailability of PRO data to providers for CTCAE rating improves the consistency of provider-based symptomatic adverse event detection in patients with cancer. PRO data supports reliable assessment of treatment-related toxicity, highlighting the value of integrating PRO data into clinical evaluations within cancer trials.
fundingEORTC Quality of Life Group.
Indexed as
Identifiers
41570841What Socratic holds
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 Socratic graph.