Munafo 2016.

Methods	Randomised, parallel‐group study.
Participants	N = 122 newly diagnosed patients with OSA. Inclusion criteria: age 18–80 years, CPAP‐naïve, confirmed OSA (AHI 5–70) diagnosis based on polysomnography (PSG) or home sleep test, access to and be able to utilise communication technology (text messaging, e‐mail). Exclusion criteria: prominent central apnoea (>20 %), claustrophobia, current use of mandibular repositioning device, other OSA therapy. Baseline characteristics: 31% female. Mean age 51.2 (±11.2). Mean AHI=30.4. Mean ESS=10.5. Mean BMI=33.2. Country: USA
Interventions	Participants were randomised to standard of care (SOC, n = 64) alone, or SOC + web‐based automated telehealth messaging program (TH, n = 58). SOC: patients were dispensed a CPAP device on Day 0, then contacted via phone on Days 1, 7, 14, 30, and 90. CPAP usage and efficacy data were tracked via the wireless modem attached to CPAP machine. Modem data were accessed via online platform. Frequent phone calls and return clinic visits were provided, as necessary. TH: CPAP device dispensed on Day 0, along with a pamphlet about U‐Sleep, a web‐based application to monitor adherence and message patients and providers via automated series of text messages/emails were triggered by pre‐set conditions. Study duration: 3 months
Outcomes	CPAP usage (hours/night) at 90 days N of adherent participants (Medicare: use for ≥ 4 hours/night on 70 % of nights during a 30 consecutive‐day period anytime during first 90 days of initial usage) Sleepiness (ESS) Residual AHI Withdrawals Resource use All outcomes measured at 90 days.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only information provided as to the randomisation procedures used was within Methods: participants subsection, where authors report: "A simple randomisation scheme was used to allocate patients to CPAP treatment plus SOC or TH." Trialists provided no information regarding random component used in sequence generation or on how sequence concealment was achieved.
Allocation concealment (selection bias)	Unclear risk	No reference 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	High risk	There are differences in the proportion of missing outcome data between intervention groups. There are no reasons for missing outcome data other than 'loss‐to‐follow‐up,' so uncertain as to whether these reasons differ by group.
Selective reporting (reporting bias)	Low risk	No protocol available. Published abstract (2014) listed the same primary outcomes, time points.
Other bias	Low risk	No baseline imbalances or reported/suspected deviations from intended intervention.
Bias arising from the randomisation process (ROB2, primary outcome)	Unclear risk	Only information provided as to the randomisation procedures used was within Methods: participants subsection, where authors report: "A simple randomisation scheme was used to allocate patients to CPAP treatment plus SOC or TH." Trialists provided no information regarding random component used in sequence generation or on how sequence concealment was achieved. Key baseline characteristics (age, gender, BMI, AHI) were reported and differences were insignificant (P values reported), consistent with chance.
Bias due to deviations from intended interventions (ROB2, primary outcome)	Low risk	No deviations documented; none suspected based upon review. Only observed deviations from planned intervention is non‐compliance with behavioural intervention which is typical of routine care, so unrelated to the experimental context. ITT conducted only for 'Medicare Adherence' definition ‐ "...use for ≥4 hours/night on 70 % of nights during a 30 consecutive‐day period anytime during the first 90 days of initial usage." (p. 779) Authors report, "Primary endpoint analyses were generated for the intention‐to‐treat (ITT) and completed cases (CC) populations. The ITT population included all randomised patients except two who withdrew consent. Patients with no compliance data, and one patient who never enrolled in the U‐Sleep program, were considered non‐adherent to CPAP; for those lost‐to‐follow‐up, adherence results for the last available assessment were used. The CC population included patients who completed the study according to the protocol. Additional analyses were conducted in the CC population without imputation for missing values."
Bias due to missing outcome data (ROB2, primary outcome) All outcomes	High risk	Authors report: "Primary endpoint analyses were generated for the intention‐to‐treat (ITT) and completed cases (CC) populations. The ITT population included all randomised patients except two who withdrew consent. Patients with no compliance data, and one patient who never enrolled in the U‐Sleep program, were considered non‐adherent to CPAP; for those lost‐to‐follow‐up, adherence results for the last available assessment were used. The CC population included patients who completed the study according to the protocol. Additional analyses were conducted in the CC population without imputation for missing values." (p. 779) Reviewer note: Neither analyses to correct for bias nor sensitivity analyses were conducted. Authors note: "There are some limitations to this study. Firstly, the ability of the study to detect a significant difference in adherence and daily usage between the TH and SOC groups was reduced by the exclusion of 18 patients from the final analysis and the high adherence rate in the SOC group. Of the 18 patients with insufficient data, 12 were from the TH group and 6 were from the SOC group. Examination of the characteristics of these patients did not provide any explanation for the difference in dropout rates between the two groups, and there is no evidence that treatment allocation played any role." (p.783) Reviewer note: There is insufficient information regarding reasons for missing outcome data and, therefore, to conclude that the reasons are unrelated to outcome. There are differences in the proportion of missing outcome data between intervention groups. There are no reasons for missing outcome data other than 'loss‐to‐follow‐up,' so uncertain as to whether these reasons differ by group.
Bias in measurement of the outcome (ROB2, primary outcome) All outcomes	Low risk	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 available. Published abstract (2014) listed the same primary outcomes, time points. Methods section indicates that one, commonly‐employed threshold adherence definition was planned; this outcome was reported in Results. No evidence that multiple analyses (e.g. variable adherence 'thresholds') were conducted.
Overall risk of bias (ROB2, primary outcome) Machine usage	High risk	‐