Comparison of EORTC QLQ-C30 and PRO-CTCAE™ Questionnaires on Six Symptom Items

Taarnhøj, Gry Assam; Kennedy, Fiona; Absolom, Kate; Bæksted, Christina; Vogelius, I.R.; Johansen, Christoffer; Velikova, Galina; Pappot, Helle

doi:10.1016/j.jpainsymman.2018.05.017

Cited by 16 publications

(12 citation statements)

References 34 publications

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“…The authors proposed several reasons why this may have occurred, including that the QLQ-C30 items assess frequency, and not severity. 10 In this current analysis, we showed that there is little difference between instruments when measuring symptoms. Avoiding duplicate items (e.g.…”

Section: Discussionmentioning

confidence: 58%

Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events

et al. 2022

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Objective Although patient-reported symptoms and side effects are increasingly measured in cancer clinical trials, an appropriate assessment frequency has not yet been established. To determine whether differences in assessment frequency affect the apparent incidence and severity of patient-reported symptoms using two well-established patient-reported outcome measures used within the same clinical trial. Methods We examined patient-reported outcome results from AURA3 (NCT02151981), a randomized open-label study comparing Tagrisso (osimertinib) with platinum-based chemotherapy in patients with previously treated estimated glomerular filtration rate/T790M mutation-positive metastatic non-small cell lung cancer. The outcome of interest was the proportion of patients in each arm that reported worsening of nausea, vomiting, fatigue, diarrhea, constipation, and appetite loss from baseline measured using the patient-reported outcome—common terminology criteria for adverse event (weekly) or European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (every 6 weeks). Results Similar trends were observed for all six symptoms investigated. Using nausea in the chemotherapy arm as an example, 76% of patients reported any worsening from baseline based on weekly patient-reported outcome—common terminology criteria for adverse event assessments. When using an every 6-week assessment of Quality of Life Questionnaire Core 30 nausea and restricting analysis to an every 6-week assessment for patient-reported outcome—common terminology criteria for adverse event nausea, the proportion of chemotherapy arm patients reporting any worsening of nausea was 40% for both measures. Across the six patient-reported symptomatic adverse events, we observed differential proportions when comparing frequent versus sparse assessment. Conclusion This analysis demonstrates that more frequent assessment of patient-reported symptomatic adverse events will lead to improved detection, and therefore a more complete understanding of the tolerability of experimental anti-cancer therapies.

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Section: Discussionmentioning

confidence: 58%

Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events

et al. 2022

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“…In cancer treatment, the combination of PRO as an intervention and as an outcome measure is becoming more frequent. In a study by our group, Taarnhj et al demonstrated that there is a high correlation between PRO-CTCAE and QLQ-C30 for the six overlapping symptoms: pain, nausea, vomiting, constipation, diarrhea and fatigue, when applying equal level scales and that for some symptoms, use of questions from one questionnaire can be sufficient [43]. This also indicates that questions from a questionnaire developed for measuring outcome can be used in the setting where PRO is the intervention.…”

Section: Discussionmentioning

confidence: 97%

Comparing the patients’ subjective experiences of acute side effects during radiotherapy for head and neck cancer with four different patient-reported outcomes questionnaires

Holländer-Mieritz

Johansen

et al. 2019

Acta Oncologica

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“…The benefit of using an item set specifically developed for this purpose is that it captures the acute symptomatic AEs to RT with a 7 days recall period. In addition, using a simple item set for weekly PRO covering the most common symptomatic AEs rather than using several standardized questionnaires minimizes patient burden [ 51 ]. It ensures symptom coverage and relevance for this specific population in pelvic radiotherapy.…”

Section: Discussionmentioning

confidence: 99%

Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

Møller

Pappot

Bernchou

et al. 2021

J Patient Rep Outcomes

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Background A new technology in cancer treatment, the MR-linac, provides online magnetic resonance-guided radiotherapy (MRgRT) that combines real-time visualization of the tumor and surrounding tissue with radiation therapy to deliver treatment more accurately. Online MRgRT makes it possible to minimize treatment volume, potentially reducing acute treatment toxicity. Patient-reported outcomes (PRO) add the patient perspective to evaluating treatment toxicity related to new technology. The objective of this mixed-methods study was to develop and explore the content validity of a set of PRO items to evaluate acute pelvic toxicity to radiotherapy including online MRgRT. Methods A literature review and chart audit were conducted to identify symptomatic adverse events (AEs) to be selected from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) library and European Organisation for Research and Treatment of Cancer (EORTC) item library. To validate the content, the item set was applied in a prospective pilot cohort of patients referred for primary pelvic RT with curative intent. Patients reported symptoms weekly during RT (4–8 weeks) and the subsequent 4 weeks. Follow-up reports were collected at 8, 12, and 24 weeks after RT. To ensure symptom coverage clinician-reported toxicity and individual patient interviews were conducted. The symptomatic AEs were included in the final item set if ≥20% of patients reported them. Results Eighteen acute symptomatic AEs were selected for the initial item set. Forty patients (32 prostate cancer, 8 cervical cancer) were included in the pilot study. Patients with prostate cancer and those with cervical cancer both reported all 18 acute AEs. However, vomiting was not reported by > 20% of patients thus excluded from the item set. Adding a few diagnosis-specific AEs to the final item set was required for both prostate and cervical cancer patients. Conclusions A PRO item set for patients with pelvic cancer treated with radiotherapy with a curative intent was developed and content validity explored. In the pilot study, the item set captured the most common acute symptomatic AEs for patients with prostate and cervical cancer related to pelvic RT including online MRgRT. Further validation of the content in broader disease sites would be needed in future studies.

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Comparison of EORTC QLQ-C30 and PRO-CTCAE™ Questionnaires on Six Symptom Items

Abstract: The good reliability and consistency between the QLQ-C30 and PRO-CTCAE support future attempts to minimize patient burden by shortening health-related quality of life questionnaires.

Cited by 16 publications

References 34 publications

Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events

Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events

Comparing the patients’ subjective experiences of acute side effects during radiotherapy for head and neck cancer with four different patient-reported outcomes questionnaires

Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

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