Department of Medicine.
Department of Community Health Sciences.
Ann Am Thorac Soc. 2019 Dec;16(12):1558-1566. doi: 10.1513/AnnalsATS.201901-087OC.
Lack of timely access to diagnosis and treatment of sleep-disordered breathing (SDB) has sparked interest in using nonphysician providers. Previous studies of these alternative care providers (ACPs) excluded patients with more complicated forms of SDB and did not directly explore the impacts of a model incorporating ACPs on healthcare system performance, such as wait times. To evaluate the use of ACPs in the management of patients with severe SDB from a clinical and system perspective. In this noninferiority study, patients with severe SDB ( = 156) were enrolled from October 2014 to July 2016 and randomized to either sleep physician management or management by ACP with same-day sleep physician review. Severe SDB was defined as one of ) respiratory event index greater than 30/h, ) mean nocturnal oxygen saturation less than 85%, and ) arterial carbon dioxide greater than 45 mm Hg with respiratory event index greater than 15/h. The primary outcome was nightly positive airway pressure adherence at 3 months, using a noninferiority margin of 1 hour. Secondary outcomes included sleepiness, quality of life, patient satisfaction, wait times for diagnosis and treatment initiation, and demand for further testing and clinical assessment. Outcomes were evaluated using modified intention-to-treat and per-protocol analyses. Care delivery using ACPs was indeterminate compared with sleep physician care with respect to treatment adherence, because the 95% confidence interval included the noninferiority margin of 1 hour (mean difference, -0.5 [-1.49 to 0.49] h). Patients in the ACP arm reported greater improvements in sleepiness and quality of life; wait times were shorter for initial assessment (28%) and treatment initiation (18%). There was no difference in demand for sleep testing or clinical follow-up. Per-protocol analysis revealed similar results. Management of severe SDB using ACPs was indeterminate compared with sleep physician care. The small decrease in adherence in the ACP arm was balanced by benefits in patient-reported outcomes and reduction in wait times. In systems with unacceptably long wait times for SDB diagnosis and treatment, a small decrease in treatment adherence, as was observed in this study, may be an acceptable trade-off to improve access to care for patients with severe SDB.Clinical trial registered with www.clinicaltrials.gov (NCT02191085).
由于无法及时诊断和治疗睡眠呼吸障碍 (SDB)，人们对使用非医师提供者产生了兴趣。之前对这些替代护理提供者 (ACP) 的研究排除了病情更复杂的 SDB 患者，并且没有直接探讨在医疗保健系统绩效方面纳入 ACP 模型的影响，例如等待时间。从临床和系统角度评估 ACP 在严重 SDB 患者管理中的作用。在这项非劣效性研究中，2014 年 10 月至 2016 年 7 月，共招募了 156 名严重 SDB 患者，并将他们随机分配至睡眠医师管理组或 ACP 管理组（同日接受睡眠医师审查）。严重 SDB 的定义为以下三种情况之一：呼吸事件指数大于 30/h，夜间平均血氧饱和度小于 85%，且呼吸事件指数大于 15/h 时动脉二氧化碳分压大于 45mmHg。主要结局是 3 个月时每晚使用气道正压通气的依从性，使用非劣效性边界 1 小时。次要结局包括嗜睡、生活质量、患者满意度、诊断和治疗开始的等待时间以及对进一步检查和临床评估的需求。使用意向治疗和符合方案分析评估结局。与睡眠医师治疗相比，使用 ACP 提供治疗的结果不确定，因为 95%置信区间包括 1 小时的非劣效性边界（平均差异，-0.5 [1.49 至 0.49] h）。ACP 组患者的嗜睡和生活质量报告有更大的改善；初始评估（28%）和治疗开始（18%）的等待时间更短。对睡眠测试或临床随访的需求没有差异。符合方案分析显示了类似的结果。与睡眠医师治疗相比，使用 ACP 管理严重 SDB 的结果不确定。ACP 组依从性略有下降，但患者报告的结局得到改善，等待时间缩短，从而达到平衡。在 SDB 诊断和治疗的等待时间过长的系统中，正如本研究中观察到的那样，治疗依从性的小幅下降可能是改善严重 SDB 患者获得护理的可接受折衷方案。临床试验在 www.clinicaltrials.gov 注册（NCT02191085）。
