Sánchez-Quiroga M Ángeles, Corral Jaime, Gómez-de-Terreros Francisco J, Carmona-Bernal Carmen, Asensio-Cruz M Isabel, Cabello Marta, Martínez-Martínez M Ángeles, Egea Carlos J, Ordax Estrella, Barbe Ferran, Barca Javier, Masa Juan F
Virgen del Puerto Hospital, Plasencia, Spain.
Centro de Investigación en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.
Am J Respir Crit Care Med. 2018 Sep 1;198(5):648-656. doi: 10.1164/rccm.201710-2061OC.
General practitioners play a passive role in obstructive sleep apnea (OSA) management. Simplification of the diagnosis and use of a semiautomatic algorithm for treatment can facilitate the integration of general practitioners, which has cost advantages. To determine differences in effectiveness between primary health care area (PHA) and in-laboratory specialized management protocols during 6 months of follow-up. A multicenter, noninferiority, randomized, controlled trial with two open parallel arms and a cost-effectiveness analysis was performed in six tertiary hospitals in Spain. Sequentially screened patients with an intermediate to high OSA probability were randomized to PHA or in-laboratory management. The PHA arm involved a portable monitor with automatic scoring and semiautomatic therapeutic decision-making. The in-laboratory arm included polysomnography and specialized therapeutic decision-making. Patients in both arms received continuous positive airway pressure treatment or sleep hygiene and dietary treatment alone. The primary outcome measure was the Epworth Sleepiness Scale. Secondary outcomes were health-related quality of life, blood pressure, incidence of cardiovascular events, hospital resource utilization, continuous positive airway pressure adherence, and within-trial costs. In total, 307 patients were randomized and 303 were included in the intention-to-treat analysis. Based on the Epworth Sleepiness Scale, the PHA protocol was noninferior to the in-laboratory protocol. Secondary outcome variables were similar between the protocols. The cost-effectiveness relationship favored the PHA arm, with a cost difference of €537.8 per patient. PHA management may be an alternative to in-laboratory management for patients with an intermediate to high OSA probability. Given the clear economic advantage of outpatient management, this finding could change established clinical practice.Clinical trial registered with www.clinicaltrials.gov (NCT02141165).
全科医生在阻塞性睡眠呼吸暂停（OSA）管理中发挥着被动作用。简化诊断并使用半自动算法进行治疗有助于全科医生的参与，且具有成本优势。为确定初级卫生保健区域（PHA）管理方案与实验室专业管理方案在6个月随访期间的疗效差异。在西班牙的6家三级医院进行了一项多中心、非劣效性、随机对照试验，该试验有两个开放平行组，并进行了成本效益分析。对经序贯筛查、OSA概率为中到高的患者进行随机分组，分别接受PHA管理或实验室管理。PHA组采用便携式监测仪进行自动评分和半自动治疗决策。实验室组包括多导睡眠图检查和专业治疗决策。两组患者均接受持续气道正压通气治疗或单纯睡眠卫生及饮食治疗。主要结局指标为Epworth嗜睡量表。次要结局包括健康相关生活质量、血压、心血管事件发生率、医院资源利用情况、持续气道正压通气的依从性以及试验期间成本。共有307例患者被随机分组，303例纳入意向性分析。基于Epworth嗜睡量表，PHA管理方案不劣于实验室管理方案。各方案间次要结局变量相似。成本效益关系有利于PHA组，每位患者的成本差异为537.8欧元。对于OSA概率为中到高的患者，PHA管理可能是实验室管理的替代方案。鉴于门诊管理具有明显的经济优势，这一发现可能会改变既定的临床实践。临床试验已在www.clinicaltrials.gov注册（NCT02141165）。
