Soares‐Pires 2013.

Methods	Randomised, parallel‐group study.
Participants	N = 202 patients with OSAHS. Inclusion criteria: AHI ≥15 or ≥5 events per hour plus symptoms that included unintentional sleep episodes while awake, daytime sleepiness, unrefreshing sleep, fatigue, insomnia, gasping or choking, or loud snoring and/or apnoea described by the patient's bed partner. Exclusion criteria: lung disease, obesity hypoventilation syndrome, restrictive ventilatory syndromes, long‐term oxygen therapy, Cheyne–Stokes breathing pattern, central apnoea, cognitive disability. Baseline characteristics: 29.5% female. Median age 58.5. Median AHI 38. Median ESS 12. Median BMI 32. Country: Portugal
Interventions	Education group: participants were assigned to a single group education session one month after beginning APAP therapy. Sessions were conducted by a pulmonologist, a psychologist, and a respiratory physiotherapist. Sessions included information regarding OSAHS, its symptoms and risks, APAP treatment, the importance of good adherence, and different machine interfaces. Patients were invited to share their experience on the use of APAP, and each patient's adherence reports were analysed and discussed. Patients' concerns, fears, and beliefs were also addressed. Standard Care: the sleep physician provided a brief explanation of the disease to patients of both groups, as well as informed patients of the need for APAP treatment, its benefits and function mode. None of the patients had previously received any form of PAP therapy. Approximately 3–5 days after the prescription, technicians from the PAP systems delivery companies performed a home visit to drop the APAP device. In this visit, an explanation on how to turn on and off the machine and on the placement of the interface was provided to all patients. Study duration: 6 months
Outcomes	CPAP usage (hours/night) at 6 months. N of adherent participants (usage > 4 hours/night for ≥ 70% days withdrawals
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No reference to random component or allocation concealment method.
Allocation concealment (selection bias)	Unclear risk	No reference to random component or allocation concealment method.
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	Data were available/analysed for 146 of 202 (72.3%) randomised participants.
Selective reporting (reporting bias)	High risk	No protocol, abstract, clinical trials entry available for comparison. However likely that definition was chosen for its result.
Other bias	Unclear risk	Incomplete information available regarding baseline differences for variables of interest. No deviations from intended interventions reported or suspected.
Bias arising from the randomisation process (ROB2, primary outcome)	Unclear risk	Only information provided as to the randomisation procedures used was within METHODS: "Patients were randomised into a study group and a control group. All patients in the study group were assigned to a single group education session, approximately 1 month after beginning APAP therapy (Fig. 1). Patients in the control group did not participate in the education session." No reference to random component or allocation concealment method. In the Methods (Study Design) section, and in the study design flow diagram (Figure 1), authors report that 202 participants were randomised to study arm, GI (n = 100) and control arm, G2 (n = 102). In the results section, authors report, "We evaluated 146 patients, 103 (70.5 %) males and 43 (29.5 %) females, with a median age of 58.5 years. Most patients were obese, hypertensive, and had severe OSAHS (Table 5). Baseline demographic and clinical characteristics did not differ in the study and control groups (Table 5)." This implies that Table 5 provides baseline characteristics and comparisons for only those who were analysed (n = 146) rather than for all randomised participants (n = 202). Therefore, cannot determine if baseline differences between intervention groups suggests a problem with randomisation.
Bias due to deviations from intended interventions (ROB2, primary outcome)	Low risk	No deviations documented; none suspected based upon review. Probably mITT.
Bias due to missing outcome data (ROB2, primary outcome) All outcomes	High risk	Data were available/analysed for 146 of 202 (72.3%) randomised participants. Neither analyses to correct for bias nor sensitivity analyses were conducted. Missing outcome data occurred for undocumented reasons and, therefore, missingness could be related to the outcome. There are no significant differences between intervention arms in the proportions of missing outcome data. However, there are no reasons for missing outcome data other than 'dropped out,' so review authors cannot evaluate whether specific reasons provide evidence that missingness depends on true value or whether these reasons differ across intervention arms. Without this information, it is likely that those who are non‐adherent would be more likely to drop out and that, therefore, missingness depends on the true value of the outcome (adherence). 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." Since authors provide no information as to the reasons for dropouts, 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. Authors reported using one of two device makes in the study (ResMed, Breas), but did not provide information as to the distributions of device make in each intervention arm. Outcome "assessor" is CPAP device: no knowledge of allocation possible. Unable to confirm with study author that distribution of CPAP device makes did not differ between intervention arms.
Bias in selection of the reported result (ROB2, primary outcome) All outcomes	High 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 one outcome time point (for primary adherence outcome) was planned. Results section reports one outcome time point. Authors report, "After 6 months of APAP therapy, usage data were downloaded by sleep technicians during a home visit. Adherence data, air leakage, air pressure delivered, and residual AHI were recorded. Adherence was analysed as a continuous and as a dichotomous variable. When analysed as a continuous variable, we recorded the percentage of days the APAP was used and the mean effective use per [*]effective day, defined as the cumulative time of effective use divided by the number of days APAP was actually used. When analysed as a dichotomous variable, we compared adherent versus non‐adherent. Patients were defined as being adherent if they used APAP at least 4 hours per night for at least 70 % of days." These outcomes were reported in results section. However, standard reporting for daily use is mean use per day over *all days in the study period. Mean use per effective day will result in upward bias in usage estimates. Since mean use per day was likely also calculated, the decision to report mean use per effective day suggests that the numerical result being assessed was selected on the basis of the results from multiple outcome measurements. Methods section indicates that one, commonly‐employed threshold adherence definition was planned; this outcome was reported in Results.
Overall risk of bias (ROB2, primary outcome) Machine usage	High risk	‐