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

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
Interventions CPAP versus C‐Flex (identical devices)
Study duration: 3 months
Outcomes
  1. Machine usage (average hours used and average days used)

  2. Quality of life (FOSQ and SF‐36)

  3. AHI

  4. Symptoms (ESS)

  5. Withdrawals

  6. Treatment pressure

  7. Tolerability (mask leak)

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 All outcomes Low risk Quote: "Two patients were withdrawn".........2 patients dropped out of the CPAP group............they were replaced with additional recruitment, and therefore analysis was conducted on a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