Falcone 2014.

Methods	Randomised, parallel‐group study.
Participants	N = 206 newly diagnosed patients with OSA Inclusion criteria: newly diagnosed OSA, AHI ≥15 events/hour, with or without daytime symptoms. Exclusion criteria: COPD, any global respiratory failure, central sleep apnoea syndrome, previous diagnosis of congestive heart failure or cardiomyopathy, any chronic neurological disorder, any severe mental or psychological impairment. Baseline characteristics: 25% female. Mean age 61.3. Mean AHI 54. Mean ESS 11.2. Mean BMI 32.1. Country: Italy
Interventions	Participants were randomised into educational support (ES, n = 103) or standard support group (SS, n = 103). SS: sleep medicine physician provided each participant with a full explanation (˜10 minutes) of the need for and benefits of CPAP. Prior to CPAP titration the participants received education regarding CPAP operation, mask placement, and a 20‐minute period of auto‐CPAP exposure. ES: in addition to standard support, each educational support group subject viewed 2 consecutive PSGs on the computer screen: the first recorded during a standard diagnostic overnight polysomnography, and the second during a full‐night polysomnography with nasal CPAP. The participant's attention was drawn only to the flow and oxyhaemoglobin saturation curves. Study duration: 12 months
Outcomes	CPAP usage (hours/night) at 1, 3*, 12 months. Sleepiness (ESS) Retention rate (number of participants returning for follow‐up divided by total N)
Notes	* Indicates primary outcome analysed in this review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was via predetermined balanced blocks, generated by tossing a coin.
Allocation concealment (selection bias)	Unclear risk	No reference to allocation concealment method and block size not reported.
Blinding (performance bias and detection bias) All outcomes	High risk	The participants were blinded to the group to which they were allocated, however no details provided as to means by which blinding was carried out/maintained. Moreover, subjective outcome assessors were likely aware of group assignment.
Incomplete outcome data (attrition bias) All outcomes	High risk	71 of 103 (69%) and 90 of 103 (87%) participants had outcome data at 3‐month endpoint.
Selective reporting (reporting bias)	Unclear risk	The study protocol is not available, but it is clear that the published reports include all expected outcomes.
Other bias	Low risk	No baseline imbalances or reported deviations from intended intervention.
Bias arising from the randomisation process (ROB2, primary outcome)	Unclear risk	Authors report: "Randomization was via predetermined balanced blocks, generated by tossing a coin." No reference to allocation concealment method and block size not reported. Key baseline characteristics (age, gender, BMI, AHI) were reported for all randomised participants and differences were insignificant (P values reported), consistent with chance.
Bias due to deviations from intended interventions (ROB2, primary outcome)	Low risk	Authors report: "The participants were blinded to the group to which they were allocated." No details provided as to means by which blinding was carried out/maintained. Authors report study is single‐blind. No deviations documented; none suspected based upon review. Authors report they performed ITT analysis. However, they also report, "participants who did not return for a follow‐up visit were considered nonadherent and dropped‐out the study, so the Epworth Sleepiness Scale scores and CPAP use data in the Results section are only for the adherent CPAP users." Thus, this appears to represent a mITT analysis.
Bias due to missing outcome data (ROB2, primary outcome) All outcomes	High risk	71 of 103 (69%) and 90 of 103 (87%) participants had outcome data at 3‐month endpoint. Neither analyses to correct for bias nor sensitivity analyses were conducted. Authors did not report reasons for missingness (dropouts), thus missingness could depend on true values. There are non‐significant differences in the proportion of missing outcome data between intervention groups. There are no reasons reported for missing outcome data other than "did not return for a follow‐up visit" so uncertain as to whether these reasons differ across groups. Per Cochrane Handbook, 8.13.2.2, "Even if incomplete outcome data are balanced in numbers across groups, bias can be introduced if the reasons for missing outcomes differ." Without specific reasons for missing data, the potential for bias cannot be adequately assessed.
Bias in measurement of the outcome (ROB2, primary outcome) All outcomes	Unclear risk	Outcome measured using objective CPAP usage data. Each intervention group outcome data ascertained via automated CPAP device monitoring. Unable to confirm with study author that distribution of CPAP device makes did not differ between intervention arms. 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; each planned outcome reported. Methods did not describe intention to assess threshold‐based adherence outcomes; these were reported for each primary endpoint.
Overall risk of bias (ROB2, primary outcome) Machine usage	High risk	‐