E. M. Basch
American Society of Clinical Oncology
CancerPhysical therapyCommon Terminology Criteria for Adverse EventsClinical trialMedicine
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Publications 15
#1Karim FizaziH-Index: 50
#2H. I. ScherH-Index: 15
Last. Johann S. de BonoH-Index: 97
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9 CitationsSource
#1Robert K. Nam (University of Texas Health Science Center at San Antonio)H-Index: 41
#2Thomas K. Oliver (University of Texas Health Science Center at San Antonio)H-Index: 22
Last. E. M. Basch (American Society of Clinical Oncology)H-Index: 7
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Prostate cancer is the second leading cause of cancer death among American men.1,2 Recent epidemiologic trends have shown a lower proportion of men diagnosed with advanced prostate cancer and a steady decrease in prostate cancer mortality rates, with an estimated number of deaths exceeding 30,000 deaths in 20113 and 28,000 in 2012.4 Whether prostate cancer screening with prostate-specific antigen (PSA) testing is a potential explanation for these trends is uncertain. What is known, on the basis ...
6 CitationsSource
4520 Background: Reduction in morbidity and clinical sequelae of bone metastases is a significant unmet medical need of mCRPC pts. AA, a potent androgen biosynthesis inhibitor, increases survival in mCRPC pts (HR = 0.646). Here we assess the effect of AA on pain control and SRE. Methods: COU-AA-301 is an international, randomized, double blind study of AA (1 g QD) + P (5 mg BID) vs placebo + P in mCRPC post D. Pain was assessed at baseline and each treatment cycle until discontinuation using the...
28 CitationsSource
e19605 Background: The standard lexicon for reporting adverse events in NCI-sponsored clinical trials is the Common Terminology Criteria for Adverse Events (CTCAE), which consists of over 800 indiv...
22 CitationsSource
#1Jennifer L. HayH-Index: 29
#2Thomas M. AtkinsonH-Index: 18
Last. E. M. BaschH-Index: 7
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9060 Background: A patient-reported outcomes (PRO) version of the NCI's Common Terminology Criteria for Adverse Events (CTCAE), is in development under a contract from the NCI (N02-PC-85002-29; PI: Basch). An essential step in refining these PRO items involves cognitive interviews to examine cancer patient comprehension and the extent to which items correspond to concepts of interest. Methods: Using prior research and investigator consensus, we developed item question verbiage, response options,...
3 CitationsSource
e19525 Background: More than 2.5 million individuals of child-bearing age are currently survivors of cancer. Many of these patients wish to become parents after treatment, and are concerned about p...
4 CitationsSource
#1Thomas M. AtkinsonH-Index: 18
#2Laura SitH-Index: 13
Last. E. M. BaschH-Index: 7
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e19505 Background: The Brief Pain Inventory (BPI) is a frequently used instrument designed to assess the patient-reported outcome of pain. Prior exploratory factor analysis study results have suggested a two-factor (i.e., pain intensity and pain interference) structure for this instrument; however, since the BPI was developed with an a priori hypothesis of the relationship amongst its items, it follows that investigations of construct validity should utilize confirmatory factor analysis (CFA). T...
1 CitationsSource
#1Amylou C. DueckH-Index: 4
#2Tito R. MendozaH-Index: 48
Last. E. M. BaschH-Index: 7
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TPS274 Background: Adverse symptoms in cancer clinical trials are reported by clinicians using the NCI's standard lexicon for adverse event reporting, the Common Terminology Criteria for Adverse Events (CTCAE). To directly include the patient perspective into this process, the NCI contracted to create patient-reported outcomes measures of CTCAE symptoms (N02-PC-85002-29; PI: Basch). Items representing 77 CTCAE symptoms were developed and refined via cognitive interviewing. In the current study, ...
5 CitationsSource
#1Thomas M. AtkinsonH-Index: 18
#2Tito R. MendozaH-Index: 48
Last. E. M. BaschH-Index: 7
view all 6 authors...
Context. In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance out- lines psychometric aspects that should be consid- ered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it m...
2 Citations