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. 2020 Apr 7;2020(4):CD007736. doi: 10.1002/14651858.CD007736.pub3

Hoet 2017.

Methods Randomised, parallel‐group study.
Participants N = 46 patients with a recent diagnosis of moderate to severe OSAS
Inclusion criteria: at least 18 years old, recently diagnosed with OSAS (AHI ≥20/hours).
Exclusion criteria: previous exposure to CPAP therapy, mixed/predominantly central sleep apnoea, language barriers, cognitive or psychiatric disorders making it difficult to comprehend information regarding CPAP therapy and provide informed consent, significant comorbidities such as severe COPD or hypoventilation syndromes.
Baseline characteristics: 63% female. Mean age 56.6 (±13.5). Mean AHI 49.5. Mean ESS 11. Mean BMI 31.5.
Country: Belgium
Interventions Participants were randomised to usual care (UC, n = 23) or telemonitoring (TM, n = 23) group.
TM: in addition to usual care, telemonitoring device was attached to CPAP machines. Via this device, sleep laboratory technical staff analysed participant data and contacted patients in the case of air leaks, residual AHI >10/hours, or CPAP use less than 3 hours in three consecutive days
UC: group educational session 1 month after CPAP initiation, and a visit to the pneumologist scheduled and 1.5 and 3 months after CPAP initiation.
Study duration: 3 months
Outcomes
  • CPAP usage (hours/night) at 3 months. [authors' secondary outcome]

  • Time of delay to the first technical intervention after CPAP initiation [authors primary outcome]

  • Types of interventions required

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Authors report: "..patients were randomised in permuted blocks between usual care or TM for CPAP follow‐up." Trialists provided no information regarding random component used in sequence generation or on how sequence concealment was achieved.
Allocation concealment (selection bias) Unclear risk Trialists provided no information regarding random component used in sequence generation or on how sequence concealment was achieved.
Blinding (performance bias and detection bias) 
 All outcomes Low risk No evidence of blinding of participants, personnel or outcome assessors. Study only had objective outcomes, so lack of blinding is not likely affect outcomes.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Outcome data available for 37 of 46 (80.4%).
Selective reporting (reporting bias) Low risk NCT02773953 entry: Secondary outcome measure, daily use of CPAP at 3 months, submitted to clinicaltrials.gov on 13 May 2016. Probably specified prior to unblinded outcome data available for analysis.
Other bias High risk Intervention group composition was 83% female while control group was 43% female, P = 0.0076. Gender is a potentially key prognostic factor in compliance and the between‐group difference is likely large enough to result in bias in the intervention effect estimate. No deviations from intended intervention reported or suspected.
Bias arising from the randomisation process (ROB2, primary outcome) High risk Authors report: "..patients were randomised in permuted blocks between usual care or TM for CPAP follow‐up." Trialists provided no information regarding random component used in sequence generation or on how sequence concealment was achieved. Intervention group composition was 83% female while control group was 43% female, P = 0.0076. Gender is a potentially key prognostic factor in compliance and the between‐group difference is likely large enough to result in bias in the intervention effect estimate.
Bias due to deviations from intended interventions (ROB2, primary outcome) Low risk No deviations documented; none suspected based upon review.
mITT used. Authors report, "During the 3‐month study period, four patients were lost to follow‐up in the TM group and three patients in the UC group. Two patients in the TM group had dysfunction of the TM system. Final analyses were performed on data for the remaining 37 patients (Fig. 1)."
Bias due to missing outcome data (ROB2, primary outcome) 
 All outcomes High risk Outcome data available for 37 of 46 (80.4%). Neither analyses to correct for bias nor sensitivity analyses were conducted. Loss to follow‐up could be related to participant health status. There are differences in proportion missing between outcome groups (intervention group > control group). There are no reasons provided for the loss‐to‐follow‐up in intervention (n = 3) or control (n = 4) groups. Equipment failure (n = 2) occurred only the intervention group.
Bias in measurement of the outcome (ROB2, primary outcome) 
 All outcomes Unclear risk No information
Bias in selection of the reported result (ROB2, primary outcome) 
 All outcomes Low risk NCT02773953 entry: Secondary outcome measure, daily use of CPAP at 3 months, submitted to clinicaltrials.gov on 13 May 2016. Probably specified prior to unblinded outcome data available for analysis. Per NCT entry, a single time point planned/analysed. Per NCT entry, multiple analyses (e.g. variable adherence 'thresholds') not conducted.
Overall risk of bias (ROB2, primary outcome) 
 Machine usage High risk