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 |
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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 |
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Outcomes |
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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 |