Pépin 2016.
Methods | Single‐centre, randomised controlled, double‐blind, parallel group trial | |
Participants | N = 322 participants (225 M/97 F). Age: 58; BMI: 30 kg/m2 AHI: 38.8 Inclusion criteria: age: 18 to 80 years, capable of providing written informed consent, patients claiming social insurance and patients with OSA needing CPAP treatment Exclusion criteria: cardiac failure known and treated, central apnoea syndrome, patients who stopped CPAP treatment in the previous year, pregnancy, patients under guardianship, imprisoned patients, patients in hospital, patients included in another clinical study |
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Interventions | Fixed versus auto‐CPAP Study duration: 4 months |
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Outcomes |
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Funding & conflicts of interest statements | Quote: "The study was funded by the Fondation Agir pour les maladies chroniques. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication." Author conflicts of interest: none declared |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was conducted by...a computer‐generated random numbers list (six patients per block)." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was conducted by telephone call to a clinical trials statistician, independent of the study..." |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "All patients, investigators and outcome assessment technicians were blinded to the arms to which the patients were allocated." |
Blinding of participants and personnel (performance bias) AHI, blood pressure, treatment pressure | Low risk | These outcomes unlikely to be affected by awareness of treatment group. |
Blinding of outcome assessment (detection bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "All patients, investigators and outcome assessment technicians were blinded to the arms to which the patients were allocated." |
Blinding of outcome assessment (detection bias) AHI, blood pressure, treatment pressure | Low risk | These outcomes unlikely to be affected by awareness of treatment group. |
Incomplete outcome data (attrition bias) All outcomes | High risk | High and imbalanced rate of withdrawal between intervention groups. Multiplie imputation method used to replace missing values from ITT analysis. |
Selective reporting (reporting bias) | High risk | Quality of life, as measured by SF‐36 was described as not different between the two arms. The trial registry record indicated that symptoms was also measured but this was not reported in the trial publication. |
Other bias | Low risk | No concerns identified |