M Sánchez-de-la-Torre1, N Nadal2, A Cortijo3, J F Masa4, J Duran-Cantolla5, J Valls6, S Serra3, A Sánchez-de-la-Torre1, M Gracia7, F Ferrer7, I Lorente7, M C Urgeles7, T Alonso7, A Fuentes7, F Armengol7, M Lumbierres3, F J Vázquez-Polo8, F Barbé1. 1. Respiratory Department, Arnau de Vilanova-Santa María University Hospital, IRB Lleida, Lleida, Catalonia, Spain Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain. 2. Respiratory Department, Arnau de Vilanova-Santa María University Hospital, IRB Lleida, Lleida, Catalonia, Spain Primary Care Unit of Lleida, Catalonia, Spain. 3. Respiratory Department, Arnau de Vilanova-Santa María University Hospital, IRB Lleida, Lleida, Catalonia, Spain. 4. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Respiratory Department, San Pedro de Alcantara Hospital, Cáceres, Spain. 5. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Araba University Hospital, UPV, BioAraba Institute, Vitoria, Spain. 6. Department of Statistics, IRB Lleida, Catalonia, Spain. 7. Primary Care Unit of Lleida, Catalonia, Spain. 8. Las Palmas de Gran Canaria University, Las Palmas de Gran Canaria, Spain.
Abstract
OBJECTIVE: To evaluate whether follow-up of patients with obstructive sleep apnoea (OSA) undergoing CPAP treatment could be performed in primary care (PC) settings. DESIGN: Non-inferiority, randomised, prospective controlled study. SETTINGS: Sleep unit (SU) at the University Hospital and in 8 PC units in Lleida, Spain. PARTICIPANTS: Patients with OSA were randomised to be followed up at the SU or PC units over a 6-month period. MAIN OUTCOMES MEASURED: The primary outcome was CPAP compliance at 6 months. The secondary outcomes were Epworth Sleep Scale (ESS) score, EuroQoL, patient satisfaction, body mass index (BMI), blood pressure and cost-effectiveness. RESULTS: We included 101 patients in PC ((mean±SD) apnoea-hypopnoea index (AHI) 50.8±22.9/h, age 56.2±11 years, 74% male) and 109 in the SU (AHI 51.4±24.4/h, age 55.8±11 years, 77% male)). The CPAP compliance was (mean (95% CI) 4.94 (4.47 to 5.5) vs 5.23 (4.79 to 5.66) h, p=0.18) in PC and SU groups, respectively. In the SU group, there were greater improvements in ESS scores (mean change 1.79, 95% CI +0.05 to +3.53, p=0.04) and patient satisfaction (-1.49, 95% CI -2.22 to -0.76); there was a significant mean difference in BMI between the groups (0.57, 95% CI +0.01 to +1.13, p=0.04). In the PC setting, there was a cost saving of 60%, with similar effectiveness, as well as a decrease in systolic blood pressure (-5.32; 95% CI -10.91 to +0.28, p=0.06). CONCLUSIONS: For patients with OSA, treatment provided in a PC setting did not result in worse CPAP compliance compared with a specialist model and was shown to be a cost-effective alternative. TRIAL REGISTRATION NUMBER: Clinical Trials NCT01918449. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVE: To evaluate whether follow-up of patients with obstructive sleep apnoea (OSA) undergoing CPAP treatment could be performed in primary care (PC) settings. DESIGN: Non-inferiority, randomised, prospective controlled study. SETTINGS: Sleep unit (SU) at the University Hospital and in 8 PC units in Lleida, Spain. PARTICIPANTS: Patients with OSA were randomised to be followed up at the SU or PC units over a 6-month period. MAIN OUTCOMES MEASURED: The primary outcome was CPAP compliance at 6 months. The secondary outcomes were Epworth Sleep Scale (ESS) score, EuroQoL, patient satisfaction, body mass index (BMI), blood pressure and cost-effectiveness. RESULTS: We included 101 patients in PC ((mean±SD) apnoea-hypopnoea index (AHI) 50.8±22.9/h, age 56.2±11 years, 74% male) and 109 in the SU (AHI 51.4±24.4/h, age 55.8±11 years, 77% male)). The CPAP compliance was (mean (95% CI) 4.94 (4.47 to 5.5) vs 5.23 (4.79 to 5.66) h, p=0.18) in PC and SU groups, respectively. In the SU group, there were greater improvements in ESS scores (mean change 1.79, 95% CI +0.05 to +3.53, p=0.04) and patient satisfaction (-1.49, 95% CI -2.22 to -0.76); there was a significant mean difference in BMI between the groups (0.57, 95% CI +0.01 to +1.13, p=0.04). In the PC setting, there was a cost saving of 60%, with similar effectiveness, as well as a decrease in systolic blood pressure (-5.32; 95% CI -10.91 to +0.28, p=0.06). CONCLUSIONS: For patients with OSA, treatment provided in a PC setting did not result in worse CPAP compliance compared with a specialist model and was shown to be a cost-effective alternative. TRIAL REGISTRATION NUMBER: Clinical Trials NCT01918449. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Patricia Peñacoba; M Antònia Llauger; Ana M Fortuna; Xavier Flor; Gabriel Sampol; Anna Maria Pedro Pijoan; Núria Grau; Carme Santiveri; Joan Juvanteny; José Ignacio Aoiz; Joan Bayó; Patricia Lloberes; Mercè Mayos Journal: J Clin Sleep Med Date: 2020-09-15 Impact factor: 4.062
Authors: Sachin R Pendharkar; Marcus Povitz; Nick Bansback; Charles F P George; Debra Morrison; Najib T Ayas Journal: CMAJ Date: 2017-12-11 Impact factor: 8.262
Authors: Lucas M Donovan; Aditi Shah; Ching Li Chai-Coetzer; Ferran Barbé; Najib T Ayas; Vishesh K Kapur Journal: Chest Date: 2019-10-19 Impact factor: 9.410
Authors: M Ángeles Sánchez-Quiroga; Jaime Corral; Francisco J Gómez-de-Terreros; Carmen Carmona-Bernal; M Isabel Asensio-Cruz; Marta Cabello; M Ángeles Martínez-Martínez; Carlos J Egea; Estrella Ordax; Ferran Barbe; Javier Barca; Juan F Masa Journal: Am J Respir Crit Care Med Date: 2018-09-01 Impact factor: 21.405
Authors: Daniela V Pachito; Ângela M Bagattini; Luciano F Drager; Alan L Eckeli; Aline Rocha Journal: Sleep Breath Date: 2021-03-31 Impact factor: 2.816
Authors: Jennifer Corrigan; Willis H Tsai; Ada Ip-Buting; Christopher Ng; Imhokhai Ogah; Peter Peller; Heather Sharpe; Cheryl Laratta; Sachin R Pendharkar Journal: J Clin Sleep Med Date: 2022-04-01 Impact factor: 4.062