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 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.

scholarly journals Management of Enzalutamide Related Adverse Events for Castration Resistant Prostate Cancer by Patient Reported Outcomes

2016 ◽  
Vol 27 ◽  
pp. vii78-vii79
Author(s):  
Taro Iguchi ◽  
Sayaka Yasuda ◽  
Minoru Kato ◽  
Takeshi Yamazaki ◽  
Satoshi Tamada ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Patient Reported

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.

Compliance of subjects using electronic patient-reported outcomes (ePRO) in multinational prostate trials.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 232-232
Author(s):  
Susan M. Dallabrida
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Quality Data ◽  
Data Set ◽  
Patient Reported ◽  
Clinic Visits

232 Background: Patient Reported Outcomes (PRO) and electronic PRO (ePRO) are increasingly becoming an important aspect of cancer clinical trials and patient care, especially with regard to measuring drug efficacy, patient quality of life and drug safety. Subject compliance with completion of PRO/ePRO assessments is an important component for obtaining accurate and high-quality data when conducting clinical trials. It has been hypothesized that patient health status, length of time in a trial and country of origin, may affect compliance. Methods: To address this hypothesis, an operational analysis was conducted to assess oncology subject completion compliance of PRO reports using an electronic tablet to determine its suitability and performance in use. Toward this objective, the compliance of prostate cancer patients in completing three electronic questionnaires that were administered at clinic visits was evaluated. Subjects were asked to complete the Brief Pain Inventory – Short Form (BPI-SF) at every clinic visit. At some clinic visits, subjects were asked to additionally complete the Functional Assessment of Cancer Therapy – Prostate (FACT-P) and the Euro Quality of Life 5 Dimensions (EQ-5D). Questionnaires were completed electronically on the tablet. Percent completion was calculated as the number of questionnaires completed divided by the number of questionnaires expected, based on attended clinic visits compiled for this review and the administration schedule for the questionnaires. Results: This review draws on the experience of over 1,000 subjects from 21 countries, and describes the individual and overall compliance with the expected questionnaire completion, the variance between subsequent visits, and compliance by country. Conclusions: The collection of ePRO using a clinic-based tablet yielded a highly complete data set in prostate cancer subjects demonstrating that this is an effective and feasible approach for recording symptoms and quality of life assessments.

scholarly journals Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry

2021 ◽  
pp. 495-505
Author(s):  
Rana R. McKay ◽  
Theresa Gold ◽  
Jelani C. Zarif ◽  
Ilkania M. Chowdhury-Paulino ◽  
Adam Friedant ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Race And Ethnicity ◽  
Working Group ◽  
Advanced Prostate Cancer ◽  
Unmet Need ◽  
Minority Populations ◽  
Eligibility Criteria ◽  
Patient Reported ◽  
The Impact

Prostate cancer disproportionately affects racial and ethnic minority populations. Reasons for disparate outcomes among minority patients are multifaceted and complex, involving factors at the patient, provider, and system levels. Although advancements in our understanding of disease biology have led to novel therapeutics for men with advanced prostate cancer, including the introduction of biomarker-driven therapeutics, pivotal translational studies and clinical trials are underrepresented by minority populations. Despite attempts to bridge the disparities gap, there remains an unmet need to expand minority engagement and participation in clinical trials to better define the impact of therapy on efficacy outcomes, quality of life, and role of biomarkers in diverse patient populations. The IRONMAN registry (ClinicalTrials.gov identifier: NCT03151629 ), a global, prospective, population-based study, was borne from this unmet medical need to address persistent gaps in our knowledge of advanced prostate cancer. Through integrated collection of clinical outcomes, patient-reported outcomes, epidemiologic data, and biospecimens, IRONMAN has the goal of expanding our understanding of how and why prostate cancer outcomes differ by race and ethnicity. To this end, the Diversity Working Group of the IRONMAN registry has developed informed strategies for site selection, recruitment, engagement and retention, and trial design and eligibility criteria to ensure broad inclusion and needs awareness of minority participants. In concert with systematic strategies to tackle the complex levels of disparate care, our ultimate goal is to expand minority engagement in clinical research and bridge the disparities gap in prostate cancer care.

A pilot study of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in a phase I clinical trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6587-6587 ◽  
Author(s):  
Rui Qin ◽  
Amylou C. Dueck ◽  
Daniel Satele ◽  
Julian R. Molina ◽  
Charles Erlichman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Adverse Events ◽  
Phase I ◽  
Patient Reported Outcomes ◽  
Point Of View ◽  
Phase I Clinical Trial ◽  
Phase I Clinical Trials ◽  
Patient Reported

6587 Background: Recently the Patient-Reported Outcomes version of the CTCAE was developed to augment clinically graded adverse events with information reported directly by patients on clinical trials (Basch, 2009). The validation and potential application of PRO-CTCAE in phase I clinical trials are of great interest as toxicity is the primary endpoint. Methods: Selected PRO-CTCAE items (21 items measuring 12 symptomatic adverse events) corresponding to the major adverse events required to be graded clinically were collected in an ongoing phase I clinical trial of weekly cilengitide and paclitaxel in patients with advanced solid malignancies (NCT01276496). PRO-CTCAE was administered in a paper booklet by a clinical research associate prior to treatment on days 1, 8 and 15 of their regular visits. These PRO-CTCAE items were summarized descriptively in comparison to clinician-assessed CTCAE ver 4.0 (NCI, 2009) during the first cycle. As a pilot study to assess feasibility of PRO-CTCAE in phase I trials, PRO-CTCAE was not intended for determination of dose-limiting toxicity. Results: Twelve patients were accrued to two separate doses of cilengitide and paclitaxel. The median age was 56 (range 36—67) and half of patients were female. All patients had an ECOG performance score <= 1. Over 90% of patients had received prior surgery and chemotherapy. All but one patient completed weekly PRO-CTCAE during the first cycle, the only patient refused to complete weeks 2 and 3 did not give a reason. PRO-CTCAE captured most of the symptomatic adverse events reflected in clinician-assessed CTCAE. Some symptomatic adverse events were not reported clinically by CTCAE but were reported by patients by PRO-CTCAE. Overall, PRO-CTCAE items indicated slightly more severe degree of symptoms experienced by patients than those reported in CTCAE. Conclusions: This is the first study that PRO-CTCAE items were integrated within regular study visits in a phase I trial. The administration of PRO-CTCAE has been proved feasible and fruitful, providing consistent and enhanced symptomatic toxicity from the patient point of view. The addition of PRO-CTCAE did not significantly increase patient burden. Clinical trial information: NCT01276496.

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