MEDICAL NEWS: Partial verification refers to the situation where a subset of patients is not verified by the reference (gold) standard and is excluded from the analysis. If partial verification is present, the observed (naive) measures of accuracy such as sensitivity and specificity are most likely to be biased. Recently, Harel and Zhou showed that partial verification can be considered as a missing data problem and that multiple imputation (MI) methods can be used to correct for this bias. They claim that even in simple situations where the verification is random within strata of the index test results, the so-called Begg and Greenes (B&G) correction method underestimates sensitivity and overestimates specificity as compared with the MI method. However, we were able to demonstrate that the B&G method produces similar results as MI, and that the claimed difference has been caused by a computational error. Additional research is needed to better understand which correction methods should be preferred in more complex scenarios of missing reference test outcome in diagnostic research. Copyright © 2008 John Wiley & Sons, Ltd.
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Aug
28
Multiple imputation to correct for partial verification bias revisited
≡ Category: Cancer, Cancer Lawsuits, Doctors, Drugs & RX, Hospitals, Medical News, Mesothelioma Info, Uncategorized, Vioxx Lawsuit | ≅ Leave a Comment
Aug
28
Bayesian adaptive model selection for optimizing group sequential clinical trials
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MEDICAL NEWS: This article presents a new approach to the problem of deriving an optimal design for a randomized group sequential clinical trial based on right-censored event times. We are motivated by the fact that, if the proportional hazards assumption is not met, then a conventional design’s actual power can differ substantially from its nominal value. We combine Bayesian decision theory, Bayesian model selection and forward simulation (FS) to obtain a group sequential procedure that maintains targeted false-positive rate and power, under a wide range of true event time distributions. At each interim analysis, the method adaptively chooses the most likely model and then applies the decision bounds that are optimal under the chosen model. A simulation study comparing this design with three conventional designs shows that, over a wide range of distributions, our proposed method performs at least as well as each conventional design, and in maNY (New York) cases it provides a much smaller trial. Copyright © 2008 John Wiley & Sons, Ltd.
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Aug
28
Association between umbilical cord glucocorticoids and blood pressure at age 3 years
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MEDICAL NEWS: Background:
Animal data show that decreased activity of placental 11-beta-hydroxysteroid dehydrogenase type 2 (11beta-HSD2), which potently inactivates glucocorticoids (e.g. cortisol) to inert forms (cortisone), allows increased access of maternal glucocorticoids to the fetus and ‘programs’ hypertension. Data in humans are limited. We examined in humans the association between venous umbilical cord blood glucocorticoids, a potential marker for placental 11beta-HSD2 enzyme activity, and blood pressure at age 3 years.
Methods:
Among 286 newborns in Project Viva, a prospective pre-birth cohort study based in eastern Massachusetts, we measured cortisol (F) and cortisone (E) in venous cord blood and used the ratio of F/E as a marker for placental 11beta-HSD2 activity. We measured blood pressure (BP) when the offspring reached age 3 years. Using mixed effects regression models to control for BP measurement conditions, maternal and child characteristics, we examined the association between the F/E ratio and child BP.
Results:
At age 3 years, each unit increase in the F/E ratio was associated with a 1.6 mm Hg increase in systolic BP (95% CI 0.0 to 3.1). The F/E ratio was not associated with diastolic blood pressure or birth weight for gestational age z-score.
Conclusions:
A higher F/E ratio in umbilical venous cord blood, likely reflecting reduced placental 11beta-HSD2 activity, was associated with higher systolic blood pressure at age 3 years. Our data suggest that increased fetal exposure to active maternal glucocorticoids may program later systolic blood pressure.
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Aug
28
Human Genome Sciences Completes Enrollment In Randomized Phase 2 Trial Of HGS-ETR1 In Non-small Cell Lung Cancer
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(Mesothelioma News) ROCKVILLE, Md. — Human Genome Sciences, Inc. today announced that it has completed the enrollment and initial dosing of patients in a randomized Phase 2 trial of HGS-ETR1 (mapatumumab) in combination with the chemotherapy (serious, serious drugs) agents paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC). “There is an urgent medical need for effective treatment options for non- small cell lung cancer because current treatment strategies have only a minimal impact on survival,” said Joachim von Pawel, M.D., a principal investigator in the study from the Asklepios Fachkliniken Munchen-Gauting, Germany. “The majority of patients who are newly diagnosed with non-small cell lung cancer have locally adv…
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Aug
28
FDA Grants Fast Track Designation For Oncogenex Pharmaceuticals’ Lead Product Candidate OGX-011
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(Mesothelioma News) BOTHELL, WA and VANCOUVER — OncoGenex Pharmaceuticals announced today that OGX-011, also known as custirsen sodium, received Fast Track designation from the U.S. Food & Drug Administration (FDA) in combination with docetaxel for progressive metastatic prostate cancer. OGX-011 is currently completing five Phase 2 clinical studies in prostate, lung and breast cancer, and is designed to inhibit the production of a specific protein, clusterin, associated with treatment resistance. Fast Track designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Based on this designation, the FDA will take actions as appropri…
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