Bakker 2010.
Methods | Randomised, double‐blind, parallel group study | |
Participants | N = 76 participants (53 M/23 F). Age not reported. BMI 35.6 kg/m2; AHI 60.2; ESS 13.6 Inclusion criteria: CPAP naive Exclusion criteria: significant cardiac, respiratory, psychiatric, or sleep comorbidities |
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Interventions | CPAP versus C‐Flex (identical devices) Study duration: 3 months |
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Outcomes |
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Funding & conflicts of interest statements | 'This study was funded by Philips‐Respironics. All authors received research support from Philips‐Respironics. Philips‐Respironics manufactures and markets CPAP and C‐Flex devices.' | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization to treatment was performed prior to manual titration using a (1, 2) urn randomization procedure" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization to treatment was performed prior to manual titration using a (1, 2) urn randomization procedure" |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "The study was a double‐blinded, parallel‐arm RCT of C‐Flex versus CPAP" Quote: "Patients were not able to access the C‐Flex menu option, and all references to "C‐Flex" on the device were covered" |
Blinding of participants and personnel (performance bias) AHI, blood pressure, treatment pressure | Low risk | Quote: "The study was a double‐blinded, parallel‐arm RCT of C‐Flex versus CPAP" Quote: "Patients were not able to access the C‐Flex menu option, and all references to "C‐Flex" on the device were covered" |
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 | Quote: "The data analyst remained blinded by random 3‐digit codes being assigned to all patients" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Two patients were withdrawn".........2 patients dropped out of the CPAP group............they were replaced with additional recruitment, and therefore analysis was conducted on a per‐protocol basis" |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No concerns identified |