title: Role of primary care in the follow-up of patients with obstructive sleep apnoea undergoing CPAP treatment: a randomised controlled trial.
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.
  
  
  METHODS
  Non-inferiority, randomised, prospective controlled study.
  
  
  METHODS
  Sleep unit (SU) at the University Hospital and in 8 PC units in Lleida, Spain.
  
  
  METHODS
  Patients with OSA were randomised to be followed up at the SU or PC units over a 6-month period.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  Clinical Trials NCT01918449.
authors.affiliation: 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.
authors.forename: M
authors.initials: M
authors.lastname: Sánchez-de-la-Torre
authors.affiliation: Respiratory Department, Arnau de Vilanova-Santa María University Hospital, IRB Lleida, Lleida, Catalonia, Spain Primary Care Unit of Lleida, Catalonia, Spain.
authors.forename: N
authors.initials: N
authors.lastname: Nadal
authors.affiliation: Respiratory Department, Arnau de Vilanova-Santa María University Hospital, IRB Lleida, Lleida, Catalonia, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Cortijo
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Respiratory Department, San Pedro de Alcantara Hospital, Cáceres, Spain.
authors.forename: J F
authors.initials: JF
authors.lastname: Masa
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Araba University Hospital, UPV, BioAraba Institute, Vitoria, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Duran-Cantolla
authors.affiliation: Department of Statistics, IRB Lleida, Catalonia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Valls
authors.affiliation: Respiratory Department, Arnau de Vilanova-Santa María University Hospital, IRB Lleida, Lleida, Catalonia, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Serra
authors.affiliation: 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.
authors.forename: A
authors.initials: A
authors.lastname: Sánchez-de-la-Torre
authors.affiliation: Primary Care Unit of Lleida, Catalonia, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Gracia
authors.affiliation: Primary Care Unit of Lleida, Catalonia, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Ferrer
authors.affiliation: Primary Care Unit of Lleida, Catalonia, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Lorente
authors.affiliation: Primary Care Unit of Lleida, Catalonia, Spain.
authors.forename: M C
authors.initials: MC
authors.lastname: Urgeles
authors.affiliation: Primary Care Unit of Lleida, Catalonia, Spain.
authors.forename: T
authors.initials: T
authors.lastname: Alonso
authors.affiliation: Primary Care Unit of Lleida, Catalonia, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Fuentes
authors.affiliation: Primary Care Unit of Lleida, Catalonia, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Armengol
authors.affiliation: Respiratory Department, Arnau de Vilanova-Santa María University Hospital, IRB Lleida, Lleida, Catalonia, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Lumbierres
authors.affiliation: Las Palmas de Gran Canaria University, Las Palmas de Gran Canaria, Spain.
authors.forename: F J
authors.initials: FJ
authors.lastname: Vázquez-Polo
authors.affiliation: 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.
authors.forename: F
authors.initials: F
authors.lastname: Barbé
mesh_terms: D000328:Adult; D000368:Aged; D045422:Continuous Positive Airway Pressure / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care / Q000191:economics / Q000458:organization & administration; D005260:Female; D005500:Follow-Up Studies; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008134:Long-Term Care / Q000191:economics / Q000458:organization & administration; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000706:statistics & numerical data; D011320:Primary Health Care / Q000191:economics / Q000458:organization & administration*; D020181:Sleep Apnea, Obstructive / Q000191:economics / Q000628:therapy*; D013030:Spain
keywords: Sleep apnoea