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Modified exact sample size for a binomial proportion with special emphasis on diagnostic test parameter estimation.

机译:修改后的二项式比例的精确样本量,尤其着重于诊断测试参数估计。

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The design of epidemiologic studies for the validation of diagnostic tests necessitates accurate sample size calculations to allow for the estimation of diagnostic sensitivity and specificity within a specified level of precision and with the desired level of confidence. Confidence intervals based on the normal approximation to the binomial do not achieve the specified coverage when the proportion is close to 1. A sample size algorithm based on the exact mid-P method of confidence interval estimation was developed to address the limitations of normal approximation methods. This algorithm resulted in sample sizes that achieved the appropriate confidence interval width even in situations when normal approximation methods performed poorly.
机译:为了验证诊断测试的流行病学研究的设计,必须进行准确的样本量计算,以允许在指定的精确度水平和期望的置信度内估计诊断的敏感性和特异性。当比例接近1时,基于二项式正态近似的置信区间不会达到指定的覆盖率。开发了一种基于精确中间P方法的置信区间估计的样本量算法,以解决正态近似法的局限性。即使在常规逼近方法效果不佳的情况下,该算法也能获得合适的置信区间宽度。

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