Antic Nick A, Buchan Catherine, Esterman Adrian, Hensley Michael, Naughton Matthew T, Rowland Sharn, Williamson Bernadette, Windler Samantha, Eckermann Simon, McEvoy R Doug
Adelaide Institute for Sleep Health, RGH, 202-16 Daws Road, Daw Park, SA 5041, Australia.
Am J Respir Crit Care Med. 2009 Mar 15;179(6):501-8. doi: 10.1164/rccm.200810-1558OC. Epub 2009 Jan 8.
Obstructive sleep apnea (OSA) is a prevalent disease. Often limited clinical resources result in long patient waiting lists. Simpler validated methods of care are needed.
To demonstrate that a nurse-led model of care can produce health outcomes in symptomatic moderate-severe OSA not inferior to physician-led care.
A randomized controlled multicenter noninferiority clinical trial was performed. Of 1,427 potentially eligible patients at 3 centers, 882 consented to the trial. Of these, 263 were excluded on the basis of clinical criteria. Of the remaining 619, 195 met home oximetry criteria for high-probability moderate-severe OSA and were randomized to 2 models of care: model A, the simplified model, using home autoadjusting positive airway pressure to set therapeutic continuous positive airway pressure (CPAP), with all care supervised by an experienced nurse; and model B, involving two laboratory polysomnograms to diagnose and treat OSA, with clinical care supervised by a sleep physician. The primary end point was change in Epworth Sleepiness Scale (ESS) score after 3 months of CPAP. Other outcome measures were collected.
For the primary outcome change in ESS score, nurse-led management was no worse than physician-led management (4.02 vs. 4.15; difference, -0.13; 95% confidence interval: -1.52, 1.25) given a prespecified noninferiority margin of -2 for the lower 95% confidence interval. There were also no differences between both groups in CPAP adherence at 3 months or other outcome measures. Within-trial costs were significantly less in model A.
A simplified nurse-led model of care has demonstrated noninferior results to physician-directed care in the management of symptomatic moderate-severe OSA, while being less costly. Clinical trial registered with http://www.anzctr.org.au (ACTRN012605000064606).
阻塞性睡眠呼吸暂停（OSA）是一种常见疾病。临床资源往往有限，导致患者等待名单过长。因此需要更简单且经过验证的护理方法。
证明由护士主导的护理模式在有症状的中重度OSA患者中产生的健康结果不劣于医生主导的护理。
进行了一项随机对照多中心非劣效性临床试验。在3个中心的1427名潜在合格患者中，882名同意参加试验。其中，263名因临床标准被排除。在其余的619名患者中，195名符合家庭血氧测定法中高概率中重度OSA的标准，并被随机分配到两种护理模式：模式A，简化模式，使用家庭自动调压正压通气来设置治疗性持续气道正压通气（CPAP），所有护理由一名经验丰富的护士监督；模式B，涉及两次实验室多导睡眠图来诊断和治疗OSA，临床护理由一名睡眠医生监督。主要终点是CPAP治疗3个月后爱泼华嗜睡量表（ESS）评分的变化。还收集了其他结局指标。
对于ESS评分的主要结局变化，在预先设定的95%置信区间下限非劣效界值为-2的情况下，护士主导的管理并不比医生主导的管理差（4.02对4.15；差值为-0.13；95%置信区间：-1.52，1.25）。两组在3个月时的CPAP依从性或其他结局指标方面也没有差异。模式A的试验内成本显著更低。
在有症状的中重度OSA管理中，简化的护士主导护理模式已证明其结果不劣于医生主导的护理，同时成本更低。临床试验已在http://www.anzctr.org.au注册（ACTRN012605000064606）。
