@article {Tarraubellathoraxjnl-2017-211237, author = {Nuria Tarraubella and Manuel S{\'a}nchez-de-la-Torre and Nuria Nadal and Jordi De Batlle and Iv{\'a}n Ben{\'\i}tez and Anunciaci{\'o}n Cortijo and Maria Cruz Urgel{\'e}s and Virginia Sanchez and I{\~n}igo Lorente and M Merc{\'e} Lavega and Araceli Fuentes and Joan Clotet and Laia Llort and Lidia Vilo and M Carmen Juni and Aurelia Juarez and Maribel Gracia and Anabel L Castro-Grattoni and Lydia Pascual and Olga Minguez and Juan F Masa and Ferran Barb{\'e}}, title = {Management of obstructive sleep apnoea in a primary care vs sleep unit setting: a randomised controlled trial}, elocation-id = {thoraxjnl-2017-211237}, year = {2018}, doi = {10.1136/thoraxjnl-2017-211237}, publisher = {BMJ Publishing Group Ltd}, abstract = {Objective To assess the effectiveness and cost-effectiveness of primary care (PC) and sleep unit (SU) models for the management of subjects with suspected obstructive sleep apnoea (OSA).Methods Multicentre, open-label, two-arm, parallel-group, non-inferiority randomised controlled trial. A total of 302 subjects with suspected OSA and/or resistant hypertension were consecutively enrolled, 149 were treated at 11 PC units and 153 patients at a SU. The primary outcomes were a 6-month change in the Epworth Sleepiness Scale (ESS) score and Health Utilities Index (HUI). The non-inferiority margin for the ESS score was -2.0.Results A total of 80.2\% and 70.6\% of the PC and SU patients were diagnosed with OSA, respectively, and 59.3\% and 60.4\% of those were treated with CPAP in PC and SU units, respectively. The Apnoea{\textendash}Hypopnoea Index was similar between the groups (PC vs SU (median (IQR); 23.1 (26.8) events/h vs 21.8 (35.2) events/h), and the baseline ESS score was higher in the PC than in the SU group (10.3 (6.6) vs 9 (7.2)). After 6 months, the ESS score of the PC group decreased from a mean of 10.1 to 7.6 (-2.49; 95\% CI -3.3 to -1.69), and that of the SU group decreased from 8.85 to 5.73 (-3.11; 95\% CI -3.94 to 2.28). The adjusted difference between groups for the mean change in the ESS score was -1.25 (one-sided 95\% CI -1.88; p=0.025), supporting the non-inferiority of PC management. We did not observe differences in the HUI between groups. The cost analysis showed a median savings of {\texteuro}558.14/patient for the PC setting compared with the SU setting.Conclusions Among patients with suspected OSA, the PC model did not result in a worse ESS score or HUI than the specialist model and generated savings in terms of management cost. Therefore, the PC model was more cost-efficient than the SU model.Trial registration Results; \>\> NCT02234765, Clinical Trials.gov.}, issn = {0040-6376}, URL = {https://thorax.bmj.com/content/early/2018/07/30/thoraxjnl-2017-211237}, eprint = {https://thorax.bmj.com/content/early/2018/07/30/thoraxjnl-2017-211237.full.pdf}, journal = {Thorax} }