Department of Medicine, The Gregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham, Birmingham, AL, USA.
Department of Medicine, The Gregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham, Birmingham, AL, USA.
J Cyst Fibros. 2017 Sep;16(5):573-578. doi: 10.1016/j.jcf.2017.04.011. Epub 2017 Apr 29.
Nasal Potential Difference (NPD) is a biomarker of CFTR activity used to diagnose CF and monitor experimental therapies. Limited studies have been performed to assess agreement between expert readers of NPD interpretation using a scoring algorithm.
We developed a standardized scoring algorithm for "interpretability" and "confidence" for PD (potential difference) measures, and sought to determine the degree of agreement on NPD parameters between trained readers.
There was excellent agreement for interpretability between NPD readers for CF and fair agreement for normal tracings but slight agreement of interpretability in indeterminate tracings. Amongst interpretable tracings, excellent correlation of mean scores for Ringer's Baseline PD, Δ, and Δ was observed. There was slight agreement regarding confidence of the interpretable PD tracings, resulting in divergence of the Ringers and Δ, and ΔCl PDs between "high" and "low" confidence CF tracings.
A multi-reader process with adjudication is important for scoring NPDs for diagnosis and in monitoring of CF clinical trials.
鼻内压差（NPD）是一种 CFTR 活性的生物标志物，用于诊断 CF 并监测实验性治疗。目前已经进行了一些有限的研究，以评估使用评分算法的 NPD 解读专家读者之间的一致性。
我们开发了一种用于 PD（潜在差异）测量的“可解释性”和“置信度”的标准化评分算法，并试图确定训练有素的读者在 NPD 参数上的一致性程度。
CF 患者的 NPD 读者在可解释性方面具有极好的一致性，而在正常描记方面具有良好的一致性，但在不确定描记方面具有轻微的一致性。在可解释的描记中，观察到 Ringer's Baseline PD、Δ 和 Δ 的平均评分具有极好的相关性。可解释 PD 描记的置信度有轻微的一致性，导致“高”和“低”置信 CF 描记之间的 Ringers 和 Δ 以及 ΔCl PD 之间存在分歧。
对于 CF 的诊断和 CF 临床试验的监测，使用评分算法进行 NPD 的多读者处理和裁决非常重要。
