Hoy 1999.
Methods | Randomised, parallel study. Method of randomisation not reported. ITT | |
Participants |
N = 80 patients with SAHS. Inclusion criteria: AHI ≥ 15, plus daytime sleepiness or two other major symptoms of the syndrome; resident within 50 miles of Edinburgh Exclusion criteria: prior use of CPAP; coexisting COPD, asthma or neurological problems Baseline characteristics: 2.5% female. Mean age 51 (±11). Mean AHI 58. Mean ESS 13. Mean BMI 33. Country: UK (Scotland) |
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Interventions | Participants were randomised into usual care (UC, n = 40) or Telemonitoring (TM, n = 40). TM: full explanation of need for and benefits of CPAP by sleep physician, 20‐minute video education programme, given mask to try for 20 minutes, titration of CPAP pressure overnight with following day discharge, nurses telephoned on days two and 21, reviewed in hospital at one, three and six months. Initial education at home with partner, two extra nights in hospital, sleep nurses' home visits to participant and partner at seven, 14 and 28 days and four months after starting CPAP UC: full explanation of need for and benefits of CPAP by sleep physician, 20‐minute video education programme, given mask to try for 20 minutes, titration of CPAP pressure overnight with following day discharge, nurses telephoned on days two and 21, reviewed in hospital at one, three and six months Study duration: 6 months |
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Outcomes |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Each participant was randomly assigned with predetermined balanced blocks generated by tossing a coin |
Allocation concealment (selection bias) | Unclear risk | Information not available |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Single‐blind: "Patients were blinded to the group to which they were allocated" Not enough information available to ascertain awareness of CPAP machine usage |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Data were analysed on an intention‐to‐treat basis" |
Selective reporting (reporting bias) | Unclear risk | Information not available |
Other bias | Unclear risk | Information not available |
Bias arising from the randomisation process (ROB2, primary outcome) | Unclear risk | Authors report, "Randomization of each patient was done with predetermined balanced blocks generated by tossing a coin. Patients were blinded to the group to which they were allocated." No reference to allocation concealment method. Key baseline characteristics (age, BMI, AHI) were reported for all randomised participants and differences were insignificant (P values reported), consistent with chance. Randomised participants included only 2 females (78 males); authors did not report treatment allocation by gender. |
Bias due to deviations from intended interventions (ROB2, primary outcome) | Low risk | No deviations documented; none suspected based upon review. ITT |
Bias due to missing outcome data (ROB2, primary outcome) All outcomes | Low risk | Authors report, "Seven of the 80 patients (four receiving standard and three intensive support) were unavailable for daytime function retesting at 6 mo; the four patients in the standard support group had stopped using CPAP, one patient in the intensive support group died of lung carcinoma diagnosed after randomisation, another stopped using CPAP, and one defaulted from daytime testing at 6 months. All 80 patients had their CPAP usage over the 6‐mo trial period recorded and analysed." |
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 | 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 displayed graphically but only final (6‐month) outcome reported in table. 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 | ‐ |