Penn State University College of Nursing, University Park, Pennsylvania.
University of Pennsylvania Perelman School of Medicine, Center for Sleep & Circadian Neurobiology, Philadelphia, Pennsylvania.
J Clin Sleep Med. 2018 Feb 15;14(2):173-181. doi: 10.5664/jcsm.6926.
Determine the Multivariable Apnea Prediction (MAP) index predictive utility for enrollment enrichment in a clinical trial wherein enrollment was prior to obstructive sleep apnea diagnosis.
Secondary analysis of screening data (n = 264) from randomized, double-blind, pilot trial. Clinical sleep center patients with complete screening and polysomnography data were included. To determine diagnostic test accuracy of the MAP index using apnea-hypopnea index criterion ≥ 10 events/h (primary) and ≥ 5, ≥ 15, and ≥ 30 events/h (secondary), sensitivity, specificity, negative and positive predictive values, likelihood positive and negative ratios, and receiver operating characteristic curves were calculated. Predictive utility was examined by characteristic variables.
Middle-aged, overweight or obese, men and women were included. Employing a MAP index threshold ≥ 0.5, sensitivity for obstructive sleep apnea (apnea-hypopnea index ≥ 10 events/h) was 83.6%; specificity was 46.4%; area under the curve = 0.74. Sensitivity was higher in males than females (95.3%, 68.7%, respectively); specificity was lower in males than females (30.4%, 57.6%, respectively) with similar area under the curve (0.74 versus 0.72, respectively). MAP accuracy was higher in younger versus older adults (younger than 50 years, or 50 years or older; area under the curve 0.82 versus 0.63, respectively). Varied apnea-hypopnea index criteria produced stable accuracy estimates.
Recruitment/enrollment is a high-cost endeavor. Screening procedures may confer resource savings but careful evaluation prior to study implementation assures effectiveness and efficiency.
The secondary analysis reports data from the SCIP-PA Trial (NCT 01454830); study information available at: https://clinicaltrials.gov.
确定多变量呼吸暂停预测（MAP）指数在临床试验中的预测效用，该试验的入组是在阻塞性睡眠呼吸暂停诊断之前进行的。
对随机、双盲、试验性试验的筛查数据（n=264）进行二次分析。纳入具有完整筛查和多导睡眠图数据的临床睡眠中心患者。为了确定 MAP 指数使用呼吸暂停-低通气指数标准（≥10 事件/小时[主要]和≥5、≥15 和≥30 事件/小时[次要]）的诊断测试准确性，计算了敏感性、特异性、阴性和阳性预测值、阳性和阴性似然比以及接收者操作特征曲线。通过特征变量检查预测效用。
纳入了中年、超重或肥胖的男性和女性。采用 MAP 指数阈值≥0.5，阻塞性睡眠呼吸暂停（呼吸暂停-低通气指数≥10 事件/小时）的敏感性为 83.6%；特异性为 46.4%；曲线下面积为 0.74。男性的敏感性高于女性（分别为 95.3%和 68.7%）；男性的特异性低于女性（分别为 30.4%和 57.6%），但曲线下面积相似（分别为 0.74 和 0.72）。年轻患者（年龄小于 50 岁或 50 岁或以上）的 MAP 准确性高于老年患者（年轻患者或老年患者；曲线下面积为 0.82 与 0.63）。不同的呼吸暂停-低通气指数标准产生了稳定的准确性估计值。
招募/入组是一项高成本的努力。筛选程序可能会节省资源，但在实施研究之前进行仔细评估可确保有效性和效率。
二次分析报告了 SCIP-PA 试验（NCT 01454830）的数据；研究信息可在以下网址获得：https://clinicaltrials.gov。
