ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2014
Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 89 papers, 4 of them syntheses that pooled it.
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Who cites it
89 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Peripheral Neuropathy Instruments for Individuals with Cancer: A COSMIN-Based Systematic Review of Measurement Properties.Current oncology (Toronto, Ont.) · 2024Pooled it
- Patient-Reported Physical Function Measures in Cancer Clinical Trials.Epidemiologic reviews · 2017Pooled it
- The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Pooled it
- The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2015Pooled it
- Longitudinal patient-reported outcomes on genotype-guided irinotecan dosing: feasibility and clinical relevance.The oncologist · 2024Trial
- Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
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- Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Trial
- Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial.JAMA oncology · 2020Trial
- Characterizing patient-clinician chemotherapy-induced peripheral neuropathy assessment and management communication approaches.Patient education and counseling · 2019Trial
- Relationship between physician-adjudicated adverse events and patient-reported health-related quality of life in a phase II clinical trial (NCT01143402) of patients with metastatic uveal melanoma.Journal of cancer research and clinical oncology · 2017Trial
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- Stereotactic radiotherapy using a linear accelerator for arteriovenous malformation and arteriovenous fistula identification using 320-row angiography-computed tomography images, case series and a single-center experience.Fujita medical journal · 2026Article
- Symptoms experienced during the first 4 months of chemotherapy administration: a longitudinal cohort study in an Australian cancer treatment unit.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Adapting mainstreaming genetic education and clinical communication materials for cancer patients of varying backgrounds.Patient education and counseling · 2026Article
- Incorporating patients' input in the development and validation of patient-reported outcome measures in oncology: a comprehensive scoping review.Health and quality of life outcomes · 2026Review
- Review
- Review
29 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
20 authors.
Funding
Abstract
purposeThe National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library.
methodsCognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea), attribute terms (regarding frequency, severity, or interference), response options, and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25% patients.
resultsOne hundred and twenty-seven patients participated (35% ≤high school, 28% non-white, and 59% female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7 days) was improved when the reference period was incorporated.
conclusionsThis study provides evidence confirming comprehension of the US English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps to establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.
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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.