Binomial Confidence Interval

2005 ◽  
Author(s):  
Clifford E. Lunneborg
Keyword(s):  
Confidence Interval ◽  
Binomial Confidence Interval

Breast cancer overdiagnosis in stop-screen trials: More uncertainty than previously reported

2020 ◽  
pp. 096914132095078
Author(s):  
Stuart G Baker ◽  
Philip C Prorok
Keyword(s):  
Breast Cancer ◽  
Cancer Screening ◽  
Confidence Interval ◽  
Breast Cancer Screening ◽  
Confidence Intervals ◽  
Latent Class ◽  
Screening Program ◽  
Screen Interval ◽  
Binomial Confidence Interval

Objective According to the Independent UK Panel on Breast Cancer Screening, the most reliable estimates of overdiagnosis for breast cancer screening come from stop-screen trials Canada 1, Canada 2, and Malmo. The screen-interval overdiagnosis fraction is the fraction of cancers in a screening program that are overdiagnosed. We used the cumulative incidence method to estimate screen-interval overdiagnosis fraction. Our goal was to derive confidence intervals for estimated screen-interval overdiagnosis fraction and adjust for refusers in these trials. Methods We first show that the UK Panel’s use of a 95% binomial confidence interval for estimated screen-interval overdiagnosis fraction was incorrect. We then derive a correct 95% binomial-Poisson confidence interval. We also use the method of latent-class instrumental variables to adjust for refusers. Results For the Canada 1 trial, the estimated screen-interval overdiagnosis fraction was 0.23 with a 95% binomial confidence interval of (0.18, 0.27) and a 95% binomial-Poisson confidence interval of (0.04, 0.41). For the Canada 2 trial, the estimated screen-interval overdiagnosis fraction was 0.16 with a 95% binomial confidence interval of (0.12, 0.19) and a 95% binomial-Poisson confidence interval of (−0.01, 0.32). For the Malmo trial, the estimated screen-interval overdiagnosis fraction was 0.19 with a 95% binomial confidence interval of (0.15, 0.22). Adjusting for refusers, the estimated screen-interval overdiagnosis fraction was 0.26 with a 95% binomial-Poisson confidence interval of (0.03, 0.50). Conclusion The correct 95% binomial-Poisson confidence interval s for the estimated screen-interval overdiagnosis fraction based on the Canada 1, Canada 2, and Malmo stop-screen trials are much wider than the previously reported incorrect 95% binomial confidence intervals. The 95% binomial-Poisson confidence intervals widen as follow-up time increases, an unappreciated downside of longer follow-up in stop-screen trials.

scholarly journals On the binomial confidence interval and probabilistic robust control

Automatica ◽  
2004 ◽  
Vol 40 (10) ◽  
pp. 1787-1789 ◽  
Author(s):  
Xinjia Chen ◽  
Kemin Zhou ◽  
Jorge L Aravena
Keyword(s):  
Robust Control ◽  
Confidence Interval ◽  
Binomial Confidence Interval

NEXT: A phase II, open-label study of nivolumab adjuvant to chemoradiation in patients (pts) with localized muscle invasive bladder cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. TPS605-TPS605
Author(s):  
Sumati Gupta ◽  
Benjamin Louis Maughan ◽  
Christopher B. Dechet ◽  
William Thomas Lowrance ◽  
Brock O Neil ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Confidence Interval ◽  
Sample Size ◽  
Local Control ◽  
Tumor Tissue ◽  
Invasive Bladder Cancer ◽  
Open Label ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive ◽  
Binomial Confidence Interval

TPS605 Background: In pts with localized muscle invasive bladder cancer (MIBC), trimodality bladder preserving therapy (TMT), with transurethral resection of bladder tumor, radio-sensitizing chemotherapy and definitive radiation, has up to a 50% risk of local and systemic relapse during the 2-year post treatment phase. We hypothesize that by inhibiting immune checkpoints, chemo-radiation induced tumor specific immune response will be enhanced both locally and abscopally, resulting in better failure-free survival (FFS). In the NEXT trial, we evaluate the efficacy of nivolumab after completion of the TMT in this setting. Methods: Pts with localized MIBC who have completed standard TMT are eligible. Pts receive nivolumab 480 mg intravenously every 4 weeks for up to 12 doses. Treatment with nivolumab begins within 90 days of completion of TMT. Subjects undergo surveillance cystoscopic and scan based assessments on study. Archived tumor tissue at baseline and at relapse is obtained for correlative studies. The primary endpoint is 2-year FFS. Secondary endpoints include FFS at 2 years in patients with intact bladder, rate of radical cystectomy (RC), cystoscopic local control, distant FFS in patients with intact bladder and those that undergo RC, overall survival, toxicity and quality of life. Exploratory endpoints include to characterize changes in immune cell subsets that can be correlated with clinical outcome and to assess the correlation of response to PD-L1 expression in pretreatment tumor tissue in the study subjects. The planned sample size for this single arm, open label trial is 28 pts. Kaplan-Meier methods will be used to plot survival endpoints and cystoscopic local control rates. Exact binomial methods will be used to provide 6 months, 1-year and 2-year estimates for these endpoints. The sample size justification is based on the maximum width of a two-sided 95% binomial confidence interval for 2 year FFS. With 28 evaluable subjects, a 95% exact binomial confidence interval, estimated using the method of Clopper-Pearson, will extend no more than 20% from the observed FFS. Clinical trial information: NCT03171025.

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