Turino 2017.

Methods	Prospective randomised controlled trial.
Participants	N = 100 newly diagnosed OSA patients Inclusion criteria: >18 years, newly diagnosed OSA requiring treatment with CPAP (AHI >15). Exclusion criteria: impaired lung function (overlap syndrome, obesity hypoventilation and restrictive disorders), severe heart failure, psychiatric disorders, periodic leg movements, pregnancy, other dyssomnias or parasomnias, history of previous CPAP treatment. Baseline characteristics: 23% female. Mean age 55 (NR). Mean AHI 52. Mean ESS NR. Mean BMI 35. Country: Spain
Interventions	Participants were randomised to standard management (SM, n = 48) or a telemonitoring programme (TM, n = 52) TM: each CPAP device equipped with mobile 2G technology capable of sending daily information on CPAP adherence, CPAP pressures, mask leak and residual respiratory events to the web database. Automatic alarms for the provider were generated in case of mask leak >30 L/minute for > 30% of the night or usage of < 4 hours/night on two consecutive nights. In case of alarm, the pulmonary specialist medical officer of the CPAP provider contacted the patient, providing case‐by‐case problem solving. SM: patients were fitted with a mask and given a CPAP device and a leaflet explaining how to use it. A short instruction session on CPAP device use was provided to patients and partners in the sleep unit by a trained nurse. This included a practical demonstration of how to put on the mask, and the correct management and cleaning of the tubes, masks and humidifier. Information on how to turn the CPAP device on and off was provided by the homecare provider at the time of machine delivery. All patients were visited after 1 month of treatment by the nurse at the sleep unit.
Outcomes	Machine usage (hours/night) at 1 month, 3* months QoL (EQ‐5D) Blood pressure BMI Symptoms Withdrawals Cost‐effectiveness
Notes	* Indicates primary outcome analysed in this Review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Patients were randomised to have CPAP therapy managed using standard care or a telemonitoring‐based strategy and followed up over 3 months." No reference to how randomisation 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	Unclear risk	Authors do not report any similar outcome (dropouts, withdrawals, missing) in the published report. Authors report that all analyses would be performed on intent‐to‐treat and per‐protocol basis. However, they do not report per‐protocol results. Additionally, all results tables Ns correspond to randomised Ns. Thus, it is unclear if there were any missing outcome data and, if so, how that was handled in the derivation of primary mean CPAP usage/adherence.
Selective reporting (reporting bias)	Unclear risk	Dates provided in trial's NCT entry do not allow us to determine if analysis plan was finalised before unblinded outcome data were available for analysis.
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: "Patients were randomised to have CPAP therapy managed using standard care or a telemonitoring‐based strategy and followed up over 3 months." No reference to random component or allocation concealment method. 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	Open‐label. No deviations documented; none suspected based upon review. ITT. Authors report, "All analyses were performed on both an intention‐to‐treat and a per‐protocol basis...," and "All results presented are for the intention‐to‐treat analysis...."
Bias due to missing outcome data (ROB2, primary outcome) All outcomes	Low risk	Protocol (NCT02517346) includes 'abandons at 3 months: Number of patients lost at follow up at 3 months of CPAP therapy' as a secondary outcome. Authors do not report this or any similar outcome (dropouts, withdrawals, missing) in the published report. Authors report that all analyses would be performed on intent‐to‐treat and per‐protocol basis. However, they do not report per‐protocol results. Additionally, all results tables Ns correspond to randomised Ns. Thus, it is unclear if there were any missing outcome data and, if so, how that was handled in the derivation of primary mean CPAP usage/adherence. In Methods, authors report, "Given the high motivation of both professionals and patients to be involved, no dropouts were anticipated and thus a total of 100 patients were planned to be recruited." Thus, it is possible that there were no dropouts.
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; devices identical or sufficiently similar (i.e. similar distributions of CPAP device make) across groups. Outcome "assessor" is CPAP device: no knowledge of allocation possible.
Bias in selection of the reported result (ROB2, primary outcome) All outcomes	Unclear risk	Publication (2017), abstract (2017) and ClinicalTrials.gov entry, NCT02517346 available and reviewed. NCT information first submitted 30 July 2015, last updated 15 Apr 2016. Study start date reported as January 2015. Primary outcome (CPAP adherence, hours/night, at 3 months) submitted 04 Aug2015 and is the same as current primary outcome (i.e. no updates/changes were submitted to ClinicalTrials.gov by authors). Published report includes primary outcome specified in NCT entry and also includes 1 month compliance. Actual primary completion date was listed in NCT entry as: 'Sep 2015 (final data collection for primary outcome measure)'. Dates of recruitment not specified in NCT entry. Journal submission received by journal 7 June 2016, accepted after revision 20 Nov 2016. Dates provided do not allow us to determine if analysis plan was finalized before unblinded outcome data were available for analysis. Protocol and Methods section of published report indicate one outcome time point (for primary adherence outcome) was planned. Results section reports two outcome time points, including planned primary. 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	‐