scholarly journals Composite grading algorithm for the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

2020 ◽  
pp. 174077452097512
Author(s):  
Ethan Basch ◽  
Claus Becker ◽  
Lauren J Rogak ◽  
Deborah Schrag ◽  
Bryce B Reeve ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Phase Iii ◽  
National Study ◽  
Two Phase ◽  
Patient Reported ◽  
The Common ◽  
Majority Consensus

Background: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library designed for eliciting patient-reported adverse events in oncology. For each adverse event, up to three individual items are scored for frequency, severity, and interference with daily activities. To align the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events with other standardized tools for adverse event assessment including the Common Terminology Criteria for Adverse Events, an algorithm for mapping individual items for any given adverse event to a single composite numerical grade was developed and tested. Methods: A five-step process was used: (1) All 179 possible Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events score combinations were presented to 20 clinical investigators to subjectively map combinations to single numerical grades ranging from 0 to 3. (2) Combinations with <75% agreement were presented to investigator committees at a National Clinical Trials Network cooperative group meeting to gain majority consensus via anonymous voting. (3) The resulting algorithm was refined via graphical and tabular approaches to assure directional consistency. (4) Validity, reliability, and sensitivity were assessed in a national study dataset. (5) Accuracy for delineating adverse events between study arms was measured in two Phase III clinical trials (NCT02066181 and NCT01522443). Results: In Step 1, 12/179 score combinations had <75% initial agreement. In Step 2, majority consensus was reached for all combinations. In Step 3, five grades were adjusted to assure directional consistency. In Steps 4 and 5, composite grades performed well and comparably to individual item scores on validity, reliability, sensitivity, and between-arm delineation. Conclusion: A composite grading algorithm has been developed and yields single numerical grades for adverse events assessed via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, and can be useful in analyses and reporting.

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.

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.

scholarly journals Software for Administering the National Cancer Institute�s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study (Preprint)

2018 ◽  
Author(s):  
Martin W Schoen ◽  
Ethan Basch ◽  
Lori L Hudson ◽  
Arlene E Chung ◽  
Tito R Mendoza ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
National Cancer Institute ◽  
Patient Reported Outcomes ◽  
Task Completion ◽  
Heuristic Evaluation ◽  
Web Based ◽  
System Usability Scale ◽  
Patient Reported ◽  
The Common

BACKGROUND The US National Cancer Institute (NCI) developed software to gather symptomatic adverse events directly from patients participating in clinical trials. The software administers surveys to patients using items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) through Web-based or automated telephone interfaces and facilitates the management of survey administration and the resultant data by professionals (clinicians and research associates). OBJECTIVE The purpose of this study was to iteratively evaluate and improve the usability of the PRO-CTCAE software. METHODS Heuristic evaluation of the software functionality was followed by semiscripted, think-aloud protocols in two consecutive rounds of usability testing among patients with cancer, clinicians, and research associates at 3 cancer centers. We conducted testing with patients both in clinics and at home (remotely) for both Web-based and telephone interfaces. Furthermore, we refined the software between rounds and retested. RESULTS Heuristic evaluation identified deviations from the best practices across 10 standardized categories, which informed initial software improvement. Subsequently, we conducted user-based testing among 169 patients and 47 professionals. Software modifications between rounds addressed identified issues, including difficulty using radio buttons, absence of survey progress indicators, and login problems (for patients) as well as scheduling of patient surveys (for professionals). The initial System Usability Scale (SUS) score for the patient Web-based interface was 86 and 82 (P=.22) before and after modifications, respectively, whereas the task completion score was 4.47, which improved to 4.58 (P=.39) after modifications. Following modifications for professional users, the SUS scores improved from 71 to 75 (P=.47), and the mean task performance improved significantly (4.40 vs 4.02; P=.001). CONCLUSIONS Software modifications, informed by rigorous assessment, rendered a usable system, which is currently used in multiple NCI-sponsored multicenter cancer clinical trials. CLINICALTRIAL ClinicalTrials.gov NCT01031641; https://clinicaltrials.gov/ct2/show/NCT01031641 (Archived by WebCite at http://www.webcitation.org/708hTjlTl)

scholarly journals ReCAP: Identifying Severe Adverse Event Clusters Using the National Cancer Institute’s Common Terminology Criteria for Adverse Events

2016 ◽  
Vol 12 (3) ◽  
pp. 245-246 ◽  
Author(s):  
Xiaobo Zhong ◽  
Emerson A. Lim ◽  
Dawn L. Hershman ◽  
Carol M. Moinpour ◽  
Joseph Unger ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Events ◽  
Advanced Prostate Cancer ◽  
Patient Reported Outcomes ◽  
Symptom Cluster ◽  
Standard Practice ◽  
Patient Reported ◽  
Grade 3

CONTEXT & QUESTION ASKED: Exploring the relationship among adverse events is important because those that arise from a common mechanism are amenable to a common intervention, which can improve symptom management, quality of life, and treatment adherence. To date, symptom cluster studies have used patient-reported data, which are not always available in clinical trials. In this study, we proposed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) to identify adverse event clusters because the CTCAE are collected as standard practice and can therefore be used when patient-reported outcomes are unavailable. Hence, is it feasible to identify severe adverse events clusters from data captured using the CTCAE in clinical trials? SUMMARY ANSWER: Six severe adverse events clusters were identified in patients with advanced prostate cancer. Identifying adverse events clusters using CTCAE data from clinical trials is feasible. METHODS: A variable-based hierarchical cluster analysis was conducted using the CTCAE data captured from 323 patients who experienced at least one grade 3 or higher adverse event in an advanced prostate cancer randomized clinical trial conducted by SWOG (S9916). BIAS, CONFOUNDING FACTOR(S), DRAWBACKS: The difficulty of using adverse event data from clinical trials is that often not all adverse events are recorded. In our study, only the highest severity grade for each adverse event type was recorded, and only grade 3 or higher adverse events were captured reliably. Moreover, in contrast to previous publications on symptom cluster that used patient-reported outcomes, the CTCAE is clinician reported and may not accurately reflect the presence of patient symptoms and the severity of these symptoms. REAL-LIFE IMPLICATIONS: Capturing adverse events using the CTCAE, which is standard practice in all clinical trials, can be used to understand the relationships among adverse events and to identify adverse events clusters when patient-reported outcomes are unavailable. [Figure: see text]

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.

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.

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