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. 2019 Dec 2;2019(12):CD003531. doi: 10.1002/14651858.CD003531.pub4

Ballard 2007.

Methods Randomised, double‐blind, parallel group trial
Participants N = 104 participants (67 M/37 F); Age 52 years; BMI 33 kg/m2; AHI 42; ESS not reported
Inclusion criteria: non‐adherent with CPAP based on 14‐day run‐in (< 4 hours/day); previous diagnosis of OSA
Exclusion criteria: compliant with CPAP during run‐in
Interventions Bi‐PAP with flexible pressure setting versus fixed CPAP setting (identical machine)
Run‐in: phase 1 of study identified non‐adherent CPAP users (those using CPAP < 4 hours/day)
Study duration: 12 weeks
Outcomes
  1. Machine usage (average hours used and using therapy > 4 hrs)

  2. Quality of life (FOSQ)

Funding & conflicts of interest statements Quote: "This study was supported by a grant from Respironics, Inc. Respironics reimbursed National Jewish Medical and Research Center for part of Dr. Ballard’s time. Dr. Gay has received research support from ResMed. Dr. Strollo has indicated no financial conflicts of interest."
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were then provided a modified positive airway pressure device (BiPAP Pro, Respironics Inc.) randomly set to either CPAP or BiFlex mode at appropriate pressure(s)"
Allocation concealment (selection bias) Unclear risk Quote: "Patients were then provided a modified positive airway pressure device (BiPAP Pro, Respironics Inc.) randomly set to either CPAP or BiFlex mode at appropriate pressure(s)"
Blinding of participants and personnel (performance bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects Low risk Quote: "Both patients and the investigators were blinded as to the specific mode assigned to each patient."
Blinding of participants and personnel (performance bias) 
 AHI, blood pressure, treatment pressure Low risk Quote: "Both patients and the investigators were blinded as to the specific mode assigned to each patient."
Blinding of outcome assessment (detection bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects Low risk Identical machine appearance unlikely to affect measurement of these outcomes.
Blinding of outcome assessment (detection bias) 
 AHI, blood pressure, treatment pressure Low risk Identical machine appearance unlikely to affect measurement of these outcomes.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Study reported to have been analysed on ITT principles. Unlikley to bias machine usage data but quality of life collected from completers. There was differential dropout and this may have influenced the results.
Selective reporting (reporting bias) Unclear risk Insufficient information available
Other bias Low risk No concerns identified