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–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 €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.
- sleep apnoea
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NT and MST contributed equally.
Contributors Study design: MSdlT, FB. Data acquisition: NT, NN, AC, MCU, VS, IL, MML, AF, JC, LL, LV, MCJ, AJ, MG, LP, OM. Data analysis and interpretation: NT, MSdlT, NN, JDB, IDB, FB. Manuscript draft and revision for intellectual content and approval of the final version: NT, MSdlT, NN, JDB, IDB, AC, MCU, VS, IL, MML, AF, JC, LL, LV, MCJ, AJ, MG, AC, LP, OM, FB. Guarantor of the study: FB.
Funding Fondo de Investigación Sanitaria (PI13/02004) (Fondo Europeo de Desarrollo Regional (FEDER), Una manera de hacer Europa), the Spanish Respiratory Society (SEPAR) and ALLER.
Competing interests None declared.
Patient consent Not required.
Ethics approval The study protocol and consent documents were approved by the Ethical Committee for Clinical Research of the Hospital Arnau de Vilanova–Santa Maria (Lleida, Spain; registration no. CEIC1221).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The authors commit to making the relevant anonymised patient level data available on reasonable request.
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