Primary Care Physicians Can Comprehensively Manage Patients with Sleep Apnea. A Noninferiority Randomized Controlled Trial

Abstract

Rationale: 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.Objectives: To determine differences in effectiveness between primary health care area (PHA) and in-laboratory specialized management protocols during 6 months of follow-up.Methods: 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.Measurements and Main Results: 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.Conclusions: 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).

Keywords: cost-effectiveness; portable monitor; primary care; sleep apnea.

Figure 1.

Flow chart of the study protocol. CPAP = continuous positive airway pressure; ITT = intention to treat; PHA = primary health care area.

Figure 2.

Differences between the arms in continuous positive airway pressure adherence at various periods of the study follow-up. The boxes represent tertiles, the transverse lines show medians, and central points show means. The lines outside the boxes indicate the maximum and minimum values. PHA = primary health care area.

Figure 3.

(A) Cost-effectiveness plane. The probabilistic Bayesian analysis indicated that primary health care area management was preferable. Although in-laboratory management is slightly more effective, this approach is much more expensive. (B) Cost-effectiveness plane according to the original mean values and incremental cost percentiles (P10 and P90) based on a sensitivity analysis using a probabilistic Bayesian approach. ESS = Epworth Sleepiness Scale; P10 and P90 = 10th and 90th cost percentiles, respectively.