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Original article
Management of obstructive sleep apnoea in a primary care vs sleep unit setting: a randomised controlled trial
  1. Nuria Tarraubella1,
  2. Manuel Sánchez-de-la-Torre2,3,
  3. Nuria Nadal1,
  4. Jordi De Batlle2,
  5. Iván Benítez2,
  6. Anunciación Cortijo2,
  7. Maria Cruz Urgelés1,
  8. Virginia Sanchez1,
  9. Iñigo Lorente1,
  10. M Mercé Lavega1,
  11. Araceli Fuentes1,
  12. Joan Clotet1,
  13. Laia Llort1,
  14. Lidia Vilo1,
  15. M Carmen Juni1,
  16. Aurelia Juarez1,
  17. Maribel Gracia1,
  18. Anabel L Castro-Grattoni2,
  19. Lydia Pascual2,
  20. Olga Minguez2,
  21. Juan F Masa3,4,
  22. Ferran Barbé2,3
  1. 1 Atenció Primària Àmbit Lleida, Lleida, Spain
  2. 2 Translation Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova–Santa Maria, IRB Lleida, Lleida, Spain
  3. 3 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain
  4. 4 Respiratory Unit, Hospital San Pedro de Alcántara, Cáceres, Spain
  1. Correspondence to Dr Ferran Barbé, LleidaRespiratory Department, Hospital Universitari Arnau de Vilanova-Santa María, IRB Lleida, Lleida, 25198, Spain; febarbe.lleida.ics{at}gencat.cat

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–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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Footnotes

  • 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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