Wang 2012.
| Methods | Randomised parallel‐group study. | |
| Participants |
N = 152 participants with a new OSA diagnosis. Incusion criteria: new OSA diagnosis, AHI ≥ 10, above elementary school education, 'conscious mind and able to communicate clearly' Exclusion criteria: personal or family history of mental illness, drug or alcohol abuse, severe cognitive impairment, 'concurrent oncologic or psychiatric diseases' Baseline characteristics: 6.8% female. Mean age NR. Mean AHI 43.1. Mean ESS=14.1. Mean BMI NR. Authors did not report mean age for full sample or by intervention arm (reported only distribution Ns per (4) age groups for each arm). Also did not report average BMI for full sample or by intervention arm (reported only distrubution Ns per (4) BMI groups for each arm). Country: China |
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| Interventions | Participants were randomised to one of four arms: PMR+EDU (n = 38), EDU (n = 38), PMR (n = 38), Control (n = 38). Education (EDU only): three nights of CPAP titration in the first week, 4‐hour group education session on OSA and CPAP in the first week, participants were given a brochure describing benefits of CPAP and CD containing a 20‐minute video demonstrating how to optimise CPAP treatment, 24‐hour consultation telephone line to the sleep nurses was available Progressive Muscle Relaxation Training (PMR only): one night of CPAP titration in the hospital, 12 × 40‐minute group Progressive Muscle Relaxation (PMR) practice sessions over 12 weeks, one per week. Self‐practice of PMR before each CPAP treatment. Brochure and CD with a guide for PMR practice at home. EDU + PMR: three nights of CPAP titration in the hospital. Combination of interventions as in Education and PMR group (see above) Control: one night of CPAP titration in the hospital in the first week Study duration: 12 weeks |
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| Outcomes |
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| Notes | Trialists included three intervention arms. One arm was Educational (EDU), one was Behavioral (PMR) and the third was Mixed (EDU+PRM). These were compared to control in respective meta‐analyses (i.e. Educational, Behavioral, Mixed). *Indicates primary outcome endpoint analysed in this review. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The patients were randomly assigned to a control group (C), an education group (E), a PMR group (P), and an education+PMR group (E+P) by block randomisation, resulting in 38 patients each group." 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 | High risk | 47.4% (Control) to 78.9% (E+P) of participants, corresponding to an overall availability of 63.8% across groups. |
| Selective reporting (reporting bias) | Unclear risk | No protocol, abstract, clinical trials entry available for comparison. |
| 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: "The patients were randomly assigned to a control group (C), an education group (E), a PMR group (P), and an education+PMR group (E+P) by block randomisation, resulting in 38 patients each group." No reference to random component or allocation concealment method. Key baseline characteristics (age, gender, AHI) were reported for all randomised participants and differences were insignificant (P values reported), consistent with chance. BMI was not presented and compared across intervention arms as a continuous variable; rather, distribution across derived BMI categories were compared across arms. In this comparison, there was no statistical difference in distribution. |
| Bias due to deviations from intended interventions (ROB2, primary outcome) | Low risk | No deviations documented; none suspected based upon review. Authors report, "The patients' CPAP adherence rates and dropout rates were analysed on an intention‐to‐treat basis. The nonadherent patients were those who either dropped out of the study or those who stayed in the study but only used CPAP for a fraction of the required time. All dropouts remained in the analysis." |
| Bias due to missing outcome data (ROB2, primary outcome) All outcomes | High risk | At 12 weeks (final endpoint assessed), outcome data were available for 47.4% (Control) to 78.9% (E+P) of participants, corresponding to an overall availability of 63.8% across groups. Neither analyses to correct for bias nor sensitivity analyses were conducted. Missing outcome data occurred due to study dropout, which could be related to the outcome. Therefore, it is possible that missingness in the outcome was influenced by its true value. Missing data (due to dropout) proportions differed by intervention arm at each endpoint. Though missing outcome data did not differ across groups, the only reason cited for missing outcome data was study dropout, which is likely to be related to the true value of the outcome. Thus, missingness in the outcome is likely dependent on its true value. |
| 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 reported. Through a threshold definition of "4 or more hours per night and at least 9 of each 14 nights of ventilator use" is uncommon relative to the more common definition (> 4 hours/night on at least 70% of nights), there is no evidence that multiple analyses (e.g. variable adherence 'thresholds') were conducted and only this one was reported. |
| Overall risk of bias (ROB2, primary outcome) Machine usage | High risk | ‐ |
AHI: Apnoea Hypopnoea Index; APAP: Automatic positive airway pressure; BAI: Beck Anxiety Inventory; BiPAP: Bi‐level positive airway pressure; BMI: Body Mass Index; BP: Blood pressure; CHF: Congestive Heart Failure; COPD: Chronic Obstructive Pulmonary Disease; CBI: cognitive behavioural therapy; CPAP: Continuous positive airway pressure; CSA: Central Sleep Apnoea; CVD: cardiovascular disease;DASS: Depression Anxiety Stress Scales; ESS: Epworth Sleepiness Scale; ESRD: End‐Stage Renal Disease; FOSQ: Functional Outcomes of Sleep Questionnaire; HADS: Hospital Anxiety and Depression Scale; HSAT: Home sleep Apnoea testing; ICSD: International Classification of Sleep Disorders; IQR: Interquartile range; LCOF: last observation carried forward; LTOT: long‐term oxygen therapy; mITT: Modified intention‐to‐treat; MSLT: Multiple sleep latency test; ODI: Oxygen saturation index; OSA: Obstructive sleep apnoea; OSAHS: Obstructive sleep apnoea‐hypopnoea syndrome; PAP: Positive airway pressure; PBS: Peer buddy system; PSG: Polysomnography; PSQI: Pittsburgh Sleep Quality Index; QoL: Quality of life; RCT: randomised controlled trial; RDI: Respiratory Disturbance Index; SAQLI: Sleep apnoea Quality of Life Index; SEMSA: Self‐efficacy in sleep apnoea; SF‐36: Short‐Form health survey, 36 items; SOC: Standard of care; TIA: Transient Ischaemic attack; TLC‐CPAP: Telephone‐linked communications‐continuous positive airway pressure; VA: Veterans Affairs.