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

Scala 2012.

Methods Randomised, parallel‐group study.
Participants N = 28 patients with newly‐diagnosed OSAS.
Inclusion criteria: newly‐diagnosed, OSAS.
Exclusion criteria: not reported.
Baseline characteristics: 75.3% female.Mean age 57 (±11.2). Mean AHI NR. Mean ESS 12.6. Mean BMI NR.
Country: Italy
Interventions Participants were randomised to standard care (SC, n = 15) or an educational intervention (EDU, n = 13).
EDU: 3 interactive sessions, video with discussion, focus group and role play, respectively 1, 2 and 3 months after receiving the CPAP device.
Study duration: 6 months
Outcomes
  • CPAP usage (hours/night) at 6 months (12 month results pending at time of report)

  • Sleepiness (ESS)

  • QoL (SF‐36)

  • Sleep quality (PSQI)


Outcomes measured at 6 months.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided regarding randomisation or how randomisation was achieved.
Allocation concealment (selection bias) Unclear risk No information related to allocation concealment method.
Blinding (performance bias and detection bias) 
 All outcomes High risk No evidence of blinding of participants, personnel or outcome assessors. Study had subjective outcomes, so knowing group assignment could influence these outcomes.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information available regarding missing outcome data.
Selective reporting (reporting bias) Unclear risk No protocol, abstract, clinical trials entry available for comparison. Results presented were in accordance with the plan specified in the Methods section of the publication.
Other bias Unclear risk No information present to determine baseline imbalances or deviations from intended interventions.
Bias arising from the randomisation process (ROB2, primary outcome) Unclear risk Based on information provided in translator form.
Bias due to deviations from intended interventions (ROB2, primary outcome) Low risk Authors report analyses were conducted by intention to treat.
Bias due to missing outcome data (ROB2, primary outcome) 
 All outcomes Unclear risk Based on information provided in translator form.
Bias in measurement of the outcome (ROB2, primary outcome) 
 All outcomes Low risk Outcome measured using objective CPAP usage data. Each intervention group outcome data ascertained via automated CPAP device monitoring. We confirmed by personal correspondence with author that all participants received the same CPAP device make and pressure delivery system. Outcome "assessor" is CPAP device: no knowledge of allocation possible.
Bias in selection of the reported result (ROB2, primary outcome) 
 All outcomes Unclear risk No protocol, abstract, clinical trials entry available for comparison. Results presented were in accordance with the plan specified in the Methods section of the publication. No information as to whether analysis plan was finalised before unblinded outcome data were available for analysis. Methods section indicates that multiple time points planned. One endpoint (6‐month) reported in the published study and one (12‐month) noted to be 'in progress.' No evidence that multiple analyses (e.g. variable adherence 'thresholds') were conducted. No threshold‐based adherence outcomes reported.
Overall risk of bias (ROB2, primary outcome) 
 Machine usage Unclear risk