Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Neurology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
PLoS One. 2022 Jul 28;17(7):e0272303. doi: 10.1371/journal.pone.0272303. eCollection 2022.
Quantitative pupillometry is part of multimodal neuroprognostication of comatose patients after out-of-hospital cardiac arrest (OHCA). However, the reproducibility, repeatability, and reliability of quantitative pupillometry in this setting have not been investigated.
In a prospective blinded validation study, we compared manual and quantitative measurements of pupil size. Observer and device variability for all available parameters are expressed as mean difference (bias), limits of agreement (LoA), and reliability expressed as intraclass correlation coefficients (ICC) with a 95% confidence interval.
Fifty-six unique quadrupled sets of measurement derived from 14 sedated and comatose patients (mean age 70±12 years) were included. For manually measured pupil size, inter-observer bias was -0.14±0.44 mm, LoA of -1.00 to 0.71 mm, and ICC at 0.92 (0.86-0.95). For quantitative pupillometry, we found bias at 0.03±0.17 mm, LoA of -0.31 to 0.36 mm and ICCs at 0.99. Quantitative pupillometry also yielded lower bias and LoA and higher ICC for intra-observer and inter-device measurements. Correlation between manual and automated pupillometry was better in larger pupils, and quantitative pupillometry had less variability and higher ICC, when assessing small pupils. Further, observers failed to detect 26% of the quantitatively estimated abnormal reactivity with manual assessment. We found ICC >0.91 for all quantitative pupillary response parameters (except for latency with ICC 0.81-0.91).
Automated quantitative pupillometry has excellent reliability and twice the reproducibility and repeatability than manual pupillometry. This study further presents novel estimates of variability for all quantitative pupillary response parameters with excellent reliability.
定量瞳孔测量是对院外心脏骤停（OHCA）后昏迷患者进行多模态神经预后评估的一部分。然而，在这种情况下，定量瞳孔测量的可重复性、可重复性和可靠性尚未得到研究。
在一项前瞻性、盲法验证研究中，我们比较了手动和定量瞳孔大小测量。所有可用参数的观察者和设备变异性表示为平均差异（偏差）、协议界限（LoA）和可靠性表示为 95%置信区间内的组内相关系数（ICC）。
纳入了 14 名镇静和昏迷的患者（平均年龄 70±12 岁）的 56 个独特的四重测量集。对于手动测量的瞳孔大小，观察者之间的偏差为-0.14±0.44mm，LoA 为-1.00 至 0.71mm，ICC 为 0.92（0.86-0.95）。对于定量瞳孔测量，我们发现偏差为 0.03±0.17mm，LoA 为-0.31 至 0.36mm，ICC 为 0.99。定量瞳孔测量还产生了更小的偏差和 LoA，以及更高的 ICC，用于评估小瞳孔时的观察者内和设备间测量。手动和自动瞳孔测量之间的相关性在较大瞳孔中更好，而定量瞳孔测量的变异性更小，ICC 更高，在评估小瞳孔时也是如此。此外，观察者用手动评估未能检测到 26%的定量估计的异常反应。我们发现所有定量瞳孔反应参数的 ICC 均大于 0.91（除潜伏期 ICC 为 0.81-0.91 外）。
自动定量瞳孔测量具有出色的可靠性，并且重复性和可重复性是手动瞳孔测量的两倍。本研究进一步提出了所有定量瞳孔反应参数的变异性的新估计值，具有出色的可靠性。
