RATIONALE: 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. OBJECTIVES: To demonstrate that a nurse-led model of care can produce health outcomes in symptomatic moderate-severe OSA not inferior to physician-led care. METHODS: 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. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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).
RCT Entities:
RATIONALE: 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. OBJECTIVES: To demonstrate that a nurse-led model of care can produce health outcomes in symptomatic moderate-severe OSA not inferior to physician-led care. METHODS: 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. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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).
Authors: A Roebuck; V Monasterio; E Gederi; M Osipov; J Behar; A Malhotra; T Penzel; G D Clifford Journal: Physiol Meas Date: 2013-12-17 Impact factor: 2.833
Authors: Lien Desteghe; Jeroen M L Hendriks; R Doug McEvoy; Ching Li Chai-Coetzer; Paul Dendale; Prashanthan Sanders; Hein Heidbuchel; Dominik Linz Journal: Clin Res Cardiol Date: 2018-04-12 Impact factor: 5.460
Authors: Adam V Benjafield; Najib T Ayas; Peter R Eastwood; Raphael Heinzer; Mary S M Ip; Mary J Morrell; Carlos M Nunez; Sanjay R Patel; Thomas Penzel; Jean-Louis Pépin; Paul E Peppard; Sanjeev Sinha; Sergio Tufik; Kate Valentine; Atul Malhotra Journal: Lancet Respir Med Date: 2019-07-09 Impact factor: 30.700
Authors: Susheel P Patil; Indu A Ayappa; Sean M Caples; R Joh Kimoff; Sanjay R Patel; Christopher G Harrod Journal: J Clin Sleep Med Date: 2019-02-15 Impact factor: 4.062