The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events

Abstract Background The aim of this study was to translate and linguistically validate the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) into Simplified Chinese for use in Singapore. Methods All 124 items of the English source PRO-CTCAE item library were translated into Simplified Chinese using internationally established translation procedures. Two rounds of cognitive interviews were conducted with 96 cancer patients undergoing adjuvant treatment to determine if the translations adequately captured the PRO-CTCAE source concepts, and to evaluate comprehension, clarity and ease of judgement. Interview probes addressed the 78 PRO-CTCAE symptom terms (e.g. fatigue), as well as the attributes (e.g. severity), response choices, and phrasing of ‘at its worst’. Items that met the a priori threshold of ≥20% of participants with comprehension difficulties were considered for rephrasing and retesting. Items where < 20% of the sample experienced comprehension difficulties were also considered for rephrasing if better phrasing options were available. Results A majority of PRO-CTCAE-Simplified Chinese items were well comprehended by participants in Round 1. One item posed difficulties in ≥20% and was revised. Two items presented difficulties in < 20% but were revised as there were preferred alternative phrasings. Twenty-four items presented difficulties in < 10% of respondents. Of these, eleven items were revised to an alternative preferred phrasing, four items were revised to include synonyms. Revised items were tested in Round 2 and demonstrated satisfactory comprehension. Conclusions PRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.

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Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Health and Quality of Life Outcomes ◽

10.1186/s12955-016-0426-6 ◽

2016 ◽

Vol 14 (1) ◽

Cited By ~ 47

Author(s):

Antonia V. Bennett ◽

◽

Amylou C. Dueck ◽

Sandra A. Mitchell ◽

Tito R. Mendoza ◽

...

Keyword(s):

Adverse Events ◽

Patient Reported Outcomes ◽

Interactive Voice Response ◽

Interactive Voice Response System ◽

Tablet Computer ◽

Response System ◽

Patient Reported ◽

The Common ◽

The U.S ◽

Voice Response

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Establishing a common metric for patient-reported outcomes in cancer patients: linking patient reported outcomes measurement information system (PROMIS), numerical rating scale, and patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-020-00271-0 ◽

2020 ◽

Vol 4 (1) ◽

Author(s):

Minji K. Lee ◽

Benjamin D. Schalet ◽

David Cella ◽

Kathleen J. Yost ◽

Amy C. Dueck ◽

...

Keyword(s):

Information System ◽

Adverse Events ◽

Patient Reported Outcomes ◽

Rating Scale ◽

Measurement Information ◽

Outcomes Measurement ◽

T Score ◽

Patient Reported ◽

Measurement Information System ◽

The Common

Abstract Background Researchers and clinicians studying symptoms experienced by people with cancer must choose from various scales. It would be useful to know how the scores on one measure translate to another. Methods Using item response theory (IRT) with the single-group design, in which the same sample answers all measures, we produced crosswalk tables linking five 0–10 numeric rating scale (NRS) and 15 items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, scored on a 1–5 scale) to the T-Score metric of six different scales from the NIH Patient reported Outcomes Measurement Information System (PROMIS®). The constructs, for which we conducted linking, include emotional distress-anxiety, emotional distress-depression, fatigue, sleep disturbance, pain intensity, and pain interference. We tested the IRT linking assumption of construct similarity between measures by comparing item content and testing unidimensionality of item sets comprising each construct. We also investigated the correlation of the measures to be linked and, by inspecting standardized mean differences, whether the linkage is invariant across age and gender subgroups. For measures that satisfied the assumptions, we conducted linking. Results In general, an NRS score of 0 corresponded to about 38.2 on the PROMIS T-Score scale (mean = 50; SD = 10); whereas an NRS score of 10 corresponded to a PROMIS T-Score of approximately 72.7. Similarly, the lowest/best score of 1 on PRO-CTCAE corresponded to 39.8 on T-score scale and the highest/worst score of 5 corresponded to 72.0. Conclusion We produced robust linking between single item symptom measures and PROMIS short forms.

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Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

American Society of Clinical Oncology Educational Book ◽

10.1200/edbk_159514 ◽

2016 ◽

pp. 67-73 ◽

Cited By ~ 44

Author(s):

Paul G. Kluetz ◽

Diana T. Chingos ◽

Ethan M. Basch ◽

Sandra A. Mitchell

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Patient Reported Outcomes ◽

Patient Perspective ◽

Cancer Clinical Trials ◽

Cancer Therapies ◽

Systematic Assessment ◽

Promising Tool ◽

Patient Reported ◽

The Common

Systematic capture of the patient perspective can inform the development of new cancer therapies. Patient-reported outcomes (PROs) are commonly included in cancer clinical trials; however, there is heterogeneity in the constructs, measures, and analytic approaches that have been used making these endpoints challenging to interpret. There is renewed effort to identify rigorous methods to obtain high-quality and informative PRO data from cancer clinical trials. In this setting, PROs are used to address specific research objectives, and an important objective that spans the product development life cycle is the assessment of safety and tolerability. The U.S. Food and Drug Administration’s (FDA) Office of Hematology and Oncology Products (OHOP) has identified symptomatic adverse events (AEs) as a central PRO concept, and a systematic assessment of patient-reported symptomatic AEs can provide data to complement clinician reporting. The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being evaluated by multiple stakeholders, including the FDA, and is considered a promising tool to provide a standard yet flexible method to assess symptomatic AEs from the patient perspective. In this article, we briefly review the FDA OHOP’s perspective on PROs in cancer trials submitted to the FDA and focus on the assessment of symptomatic AEs using PRO-CTCAE. We conclude by discussing further work that must be done to broaden the use of PRO-CTCAE as a method to provide patient-centered data that can complement existing safety and tolerability assessments across cancer clinical trials.

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Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-017-0012-7 ◽

2017 ◽

Vol 1 (1) ◽

Cited By ~ 6

Author(s):

Tempei Miyaji ◽

Yukiko Iioka ◽

Yujiro Kuroda ◽

Daigo Yamamoto ◽

Satoru Iwase ◽

...

Keyword(s):

Adverse Events ◽

Patient Reported Outcomes ◽

Linguistic Validation ◽

Patient Reported ◽

The Us ◽

The Common ◽

Japanese Translation

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Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials

Clinical Trials ◽

10.1177/1740774518799985 ◽

2018 ◽

Vol 15 (6) ◽

pp. 616-623 ◽

Cited By ~ 7

Author(s):

Peter C Trask ◽

Amylou C Dueck ◽

Elisabeth Piault ◽

Alicyn Campbell

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Patient Reported Outcomes ◽

Selection Process ◽

Late Phase ◽

Relevant Information ◽

Specific Patient ◽

Patient Reported ◽

Oncology Clinical Trials ◽

The Common

As new cancer treatment regimens demonstrate increased potential to improve patients’ survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment’s tolerability. The U.S. Food and Drug Administration has recommended using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in clinical trials. A practical guideline is needed to inform a priori selection of specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items for use in any given industry-sponsored oncology clinical trial. Standardizing this selection process will foster systematic and consistent data collection as part of drug development and enhance our knowledge on how to use patient-relevant information as part of a treatment’s risk/benefit assessment. This article presents methods and consensus recommendations for selecting specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items to include in early-phase and late-phase oncology clinical trials.

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