scholarly journals Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shan-Shan Yang ◽  
Lei Chen ◽  
Ying Liu ◽  
Hai-Jun Lu ◽  
Bo-Jie Huang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Chinese Version ◽  
Life Questionnaire ◽  
European Organization ◽  
Retest Reliability ◽  
Simplified Chinese ◽  
Patient Reported ◽  
The Common ◽  
Test Retest Reliability

Abstract Background The psychometric properties of the simplified Chinese version of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) have not been assessed. Therefore, we aimed to assess its validity, reliability, and responsiveness. Patients and methods A Chinese version of the PRO-CTCAE and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) were distributed to 1580 patients from four cancer hospitals in China. Validity assessments included construct validity, measured by Pearson’s correlations and confirmatory factor analysis (CFA), and known-groups validity, measured by t-tests. The assessment of reliability included internal consistency, measured by Cronbach’s ɑ, and test-retest reliability, measured by the intraclass correlation (ICC). Responsiveness was assessed by standardized response means (SRMs). Results Data from 1555 patients who completed the instruments were analyzed. The correlations were high between PRO-CTCAE items and parallel QLQ-C30 symptom scales (r > 0.60, p < 0.001), except for fatigue (severity: r = 0.49). Moreover, CFA showed the PRO-CTCAE structure was a good fit with the data (Root Mean Square Error of Approximation = 0.046). Known-groups validity was also confirmed. Cronbach’s ɑ of all item clusters were greater than 0.9 and the median test-retest reliability coefficients of the 38 items were 0.85 (range = 0.71–0.91). In addition, the SRMs of PRO-CTCAE items were greater than 0.8, indicating strong responsiveness. Conclusion The simplified Chinese version of the PRO-CTCAE showed good reliability, validity, and responsiveness.

scholarly journals Linguistic validation of the simplified Chinese version of the US National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Cheng KKF ◽  
S. A. Mitchell ◽  
N. Chan ◽  
E. Ang ◽  
W. Tam ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
A Priori ◽  
Cognitive Interviews ◽  
Simplified Chinese ◽  
Patient Reported ◽  
The Us ◽  
The Common ◽  
Response Choices

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.

Validity and reliability of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9047-9047 ◽  
Author(s):  
Amylou C. Dueck ◽  
Tito R. Mendoza ◽  
Sandra A. Mitchell ◽  
Bryce B. Reeve ◽  
Kathleen M. Castro ◽  
...  
Keyword(s):  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Performance Status ◽  
Intraclass Correlation ◽  
Validity And Reliability ◽  
Retest Reliability ◽  
Cancer Centers ◽  
Patient Reported ◽  
Ecog Ps ◽  
Test Retest Reliability

9047 Background: Symptomatic adverse events (AE) in cancer trials are reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective into AE reporting, NCI contracted (HHSN261201000043C) to create a patient-reported outcomes companion tool (PRO-CTCAE). We report the validity and reliability of PRO-CTCAE’s 124 items reflecting 78 symptomatic AEs. Methods: English-speaking subjects (n=869; 44% male; median [mdn] age 59; 32% racial/ethnic minority; 34% high school or less; 17% ECOG Performance Status [PS] 2-4) receiving treatment for a range of cancers at 4 NCI-designated cancer centers and 5 sites in NCI's Community Cancer Centers Program completed a web-based survey in clinic including PRO-CTCAE and EORTC QLQ-C30. Pearson correlations were computed between PRO-CTCAE items and QLQ-C30 scales. Differences in PRO-CTCAE item scores between clinician-reported ECOG PS (0-1 vs 2-4) groups were computed. Test-retest reliability of 48 prespecified items was evaluated in a subset (n=79). Results: Correlations in the expected direction were observed for 116/124 PRO-CTCAE items with the QLQ-C30 global health scale (mdn r=-.21; range .08 to -.57). Stronger correlations were seen for PRO-CTCAE items with conceptually related QLQ-C30 domains: fatigue with physical, role and social functioning (-.54 to -.66); anxiety and depression with emotional functioning (-.54 to -.70); and concentration and memory problems with cognitive functioning (-.62 to -.72) [all p <0.001]. Fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea items strongly correlated with corresponding QLQ-C30 symptom scales (.69 to .79, all p <0.001). Scores for 98/124 PRO-CTCAE items were higher in the ECOG PS 2-4 vs 0-1 group (mdn effect size .3). Test-retest reliability was observed across all tested items (mdn intraclass correlation coeff .77; range .53 to .96). Conclusions: Results demonstrate favorable validity and reliability of PRO-CTCAE in a large, heterogeneous sample of patients undergoing cancer treatment. Further testing in multicenter treatment trials is underway.

scholarly journals 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)

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.

Psychometric properties of patient reported outcome (PRO) instruments in patients with small cell lung cancer (SCLC) in RESILIENT part 1.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24027-e24027
Author(s):  
Jaba Kokhreidze ◽  
Veleka Allen ◽  
Cristina Ivanescu ◽  
Xiaopan Valerie Yao ◽  
Bin Zhang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Construct Validity ◽  
Psychometric Properties ◽  
Internal Consistency ◽  
Life Questionnaire ◽  
Retest Reliability ◽  
Patient Reported ◽  
Eortc Qlq ◽  
Test Retest Reliability ◽  
Pro Instruments

e24027 Background: The ongoing two-part phase 2/3 RESILIENT study (NCT03088813) is investigating the efficacy and safety of liposomal irinotecan monotherapy in patients with SCLC who have progressed on or after first line platinum-based chemotherapy. This exploratory analysis from RESILIENT part 1 was conducted to confirm the psychometric properties of established PRO instruments that had not previously been validated in patients with SCLC. Methods: Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (C30) and the EORTC QLQ Lung Cancer 13 (LC13) before treatment assignment (baseline), every 6 weeks thereafter, at treatment discontinuation and at the 30-day follow-up visit. Psychometric methods included descriptive statistics (items and scales), correlations (item-to-item and item-to-total), internal consistency (Cronbach’s α), test-retest reliability (intraclass correlation coefficient [ICC], two-way random effects model), construct validity and sensitivity to change. The analysis included patients who received at least one dose of study drug and completed at least one PRO assessment. Results: Thirty patients were enrolled in RESILIENT part 1 and included in the analysis. At baseline, 68% of patients reported ‘not severe’ or ‘mild’ symptoms. Floor effects (i.e. more than 25% of responses of ‘not at all’) were observed for several of the functioning/impact and symptom scales of the EORTC QLQ C30 and LC13. Moderate to strong correlations were found among most questionnaire items within their respective scales. Acceptable evidence for internal consistency and good test-retest reliability were observed. Selected results for the EORTC QLQ LC13, including dyspnea scales, are shown in the Table. The magnitude of correlations among PRO instruments supported evidence for convergent validity in this sample. Conclusions: In RESILIENT part 1, patients experienced low and tolerable symptoms at enrollment, limiting the potential for further improvement. Overall, these PRO instruments had acceptable psychometric properties (e.g. construct validity, reliability and ability to detect change) in this sample. However, these analyses should be repeated in a larger sample using data from RESILIENT part 2. Clinical trial information: NCT03088813. [Table: see text]

Test/retest study of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire.

1995 ◽  
Vol 13 (5) ◽  
pp. 1249-1254 ◽  
Author(s):  
M J Hjermstad ◽  
S D Fossa ◽  
K Bjordal ◽  
S Kaasa
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Reliability And Validity ◽  
Life Questionnaire ◽  
European Organization ◽  
Retest Reliability ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Test Retest Reliability

PURPOSE The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated instrument that assesses health-related quality of life (HRQOL) in cancer patients. It is used in cancer clinical trials in Europe, Canada, and the United States, and has demonstrated high reliability and validity in different groups of cancer patients. Despite thorough testing of reliability and validity, we have not identified any reports on its test/retest reliability; thus, a test/retest study was performed at the Norwegian Radium Hospital (NRH). MATERIALS AND METHODS Cancer patients from the outpatient clinic who were off treatment for > or = 3 months were eligible for the study. The EORTC QLQ-C30 was given to the patients when they presented for their visit. The second questionnaire was received by the patients 4 days later. Of 291 eligible patients, 270 (93%) agreed to participate and 190 (73%) completed both questionnaires. RESULTS The test/retest reliability measured by Pearson's correlation coefficient was high for all functional scales, with a range from .82 for cognitive and role function to .91 for physical function. The r value for global HRQOL was .85. For the symptom scales--nausea/vomiting, fatigue, and pain--the coefficients were .63, .83, and .86, respectively. The single-item coefficients ranged from .72 for diarrhea to .84 for financial impact. The Spearman rank correlation was in the same range for all dimensions. CONCLUSION The EORTC QLQ-C30 seems to yield high test/retest reliability in patients with various cancer diagnoses whose condition is not expected to change during the time of measurement.

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)

2016 ◽  
pp. 67-73 ◽  
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.

scholarly journals Patient-Reported Outcomes Measurement Information System (PROMIS) in Femoroacetabular Impingement (FAI)

2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0026
Author(s):  
Anas Minkara ◽  
Michaela O’Connor ◽  
Robert W. Westermann ◽  
James T. Rosneck ◽  
Thomas Sean Lynch
Keyword(s):  
Hip Arthroscopy ◽  
Patient Reported Outcomes ◽  
Pain Interference ◽  
Measurement Information ◽  
Retest Reliability ◽  
Pearson Coefficient ◽  
Patient Reported ◽  
Ceiling Effects ◽  
Measurement Information System ◽  
Test Retest Reliability

Objectives: Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded computerized adaptive test (CAT) developed to effectively assess patient outcomes in multiple domains, including physical function (PF), pain severity, and quality of life while minimizing patient burden. The purpose of this study is to validate PROMIS in patients undergoing hip arthroscopy for Femoroacetabular Impingement (FAI), including test-retest reliability and correlation with validated hip outcome measures. Methods: Patients undergoing elective hip arthroscopy for FAI were consecutively enrolled at a major academic center. Patients with chronic comorbidities, bilateral FAI with a staged approach, and lack of postoperative follow-up were excluded. Eligible patients completed the modified Hip Harris Score (mHHS), Hip Outcome Score Activities of Daily Living (HOS-ADL), International Hip Outcome Tool (iHOT-12), and PROMIS including PF, pain interference, and activity satisfaction. Questionnaires were completed preoperatively, two, and six weeks postoperatively. Ceiling effects were determined to be present if greater than 15% of patients scored the highest possible score on one of the patient reported outcome measurement tools in this study. The correlation of preoperative values with postoperative function were assessed utilizing the Pearson coefficient. Normality was evaluated using the Shapiro-Wilk test. Dependent sample t-tests were utilized to compare means in test-retest reliability. Results: There were 38 patients with a mean age of 29.3 ± 8.9 years (54% female) identified for the study. PROMIS demonstrated excellent correlation with HOS-ADL (Pearson coefficient of 0.81, Figure 1), as well as mHHS (0.80) and iHOT-12 (0.73). Patients with higher PROMIS-pain interference and pain intensity scores demonstrated a negative linear correlation with mHHS (r=-0.86, p<0.05), HOS-ADL (r=-0.71, p<0.05), and iHOT-12 (-0.71, p<0.01). PROMIS scores exhibited significant responsiveness to hip arthroscopy. Patients with higher activity satisfaction demonstrated excellent-good correlation with mHHS scores (r=0.66, p<0.05) and HOS-ADL (0.66, p<0.05). PROMIS also demonstrated excellent test-retest reliability with no variability in scores, including PF (55.5 ± 8.6 vs. 54.2 ± 10.5, p=0.74). No floor or ceiling effects were exhibited by PROMIS including the physical function, pain interference, pain intensity, social participation, and role satisfaction domain scores. Conclusion: PROMIS is a valid and efficient PRO in hip arthroscopy for FAI demonstrating excellent test-retest reliability and correlation with established hip outcome measures. No floor or ceiling effects were demonstrated by PROMIS. Subdomains also exhibit excellent prognostic ability in the clinical setting.

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

2018 ◽  
Vol 15 (6) ◽  
pp. 616-623 ◽  
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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