Ward Kim L, McArdle Nigel, James Alan, Bremner Alexandra P, Simpson Laila, Cooper Matthew N, Palmer Lyle J, Fedson Annette C, Mukherjee Sutapa, Hillman David R
School of Population Health, The University of Western Australia, Perth, Australia.
Western Australian Sleep Disorders Research Institute, Queen Elizabeth Medical Centre, Perth, Australia.
J Clin Sleep Med. 2015 Apr 15;11(4):433-44. doi: 10.5664/jcsm.4600.
We hypothesized that a dual-channel portable monitor (PM) device could accurately identify patients who have a high pretest probability of obstructive sleep apnea (OSA), and we evaluated factors that may contribute to variability between PM and polysomnography (PSG) results.
Consecutive clinic patients (N = 104) with possible OSA completed a home PM study, a PM study simultaneous with laboratory PSG, and a second home PM study. Uniform data analysis methods were applied to both PM and PSG data. Primary outcomes of interest were the positive likelihood ratio (LR+) and sensitivity of the PM device to "rule-in" OSA, defined as an apnea-hypopnea index (AHI) ≥ 5 events/h on PSG. Effects of different test environment and study nights, and order of study and analysis methods (manual compared to automated) on PM diagnostic accuracy were assessed.
The PM has adequate LR+ (4.8), sensitivity (80%), and specificity (83%) for detecting OSA in the unattended home setting when benchmarked against laboratory PSG, with better LR+ (> 5) and specificity (100%) and unchanged sensitivity (80%) in the simultaneous laboratory comparison. There were no significant night-night (all p > 0.10) or study order effects (home or laboratory first, p = 0.08) on AHI measures. Manual PM data review improved case finding accuracy, although this was not statistically significant (all p > 0.07). Misclassification was more frequent where OSA was mild.
Overall performance of the PM device is consistent with current recommended criteria for an "acceptable" device to confidently "rule-in" OSA (AHI ≥ 5 events/h) in a high pretest probability clinic population. Our data support the utility of simple two-channel diagnostic devices to confirm the diagnosis of OSA in the home environment.
A commentary on this article appears in this issue on page 411.
我们假设双通道便携式监测仪（PM）设备能够准确识别阻塞性睡眠呼吸暂停（OSA）预测试概率较高的患者，并评估了可能导致PM与多导睡眠图（PSG）结果之间存在差异的因素。
连续的可能患有OSA的门诊患者（N = 104）完成了一项家庭PM研究、一项与实验室PSG同时进行的PM研究以及第二项家庭PM研究。对PM和PSG数据均采用统一的数据分析方法。感兴趣的主要结局是PM设备“确诊”OSA的阳性似然比（LR+）和敏感度，OSA定义为PSG上呼吸暂停低通气指数（AHI）≥5次/小时。评估了不同测试环境和研究夜晚以及研究顺序和分析方法（手动与自动相比）对PM诊断准确性的影响。
与实验室PSG相比，PM在无人值守的家庭环境中检测OSA具有足够的LR+（4.8）、敏感度（80%）和特异度（83%），在同时进行的实验室比较中具有更好的LR+（>5）和特异度（100%），而敏感度不变（80%）。在AHI测量方面，不存在显著的夜间差异（所有p>0.10）或研究顺序效应（先进行家庭或实验室研究，p = 0.08）。手动审查PM数据提高了病例发现的准确性，尽管这在统计学上不显著（所有p>0.07）。在OSA为轻度的情况下，错误分类更为频繁。
PM设备的总体性能与当前推荐的“可接受”设备标准一致，即在预测试概率较高的门诊人群中可靠地“确诊”OSA（AHI≥5次/小时）。我们的数据支持简单的双通道诊断设备在家庭环境中确认OSA诊断的实用性。
关于本文的一篇评论发表在本期第411页。
