Yardley 2006.
Methods | Design: randomised controlled trial | |
Participants |
Number: 360 Age: mean age 59.2 (SD 12.3) Gender: 113 males, 31.4% Setting: participants received the intervention in the community after being recruited from a Ménière's society Eligibility criteria: participants with Ménière's disease (non‐acute phase) who had experienced dizziness of imbalance in the last 12 months, had consulted their GP regarding involvement in the study Exclusion criteria: other vestibular disorder Baseline characteristics: no differences between groups on any of the participant characteristics |
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Interventions |
Intervention group: VR (booklet of exercises) (n = 120) Comparator group 1: SC (booklet for self management) (n = 120) Comparator group 2: waiting list control (n = 120) VR versus other VR versus control |
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Outcomes | Primary outcomes: questionnaire (better versus same/worse), VSS, PEI Secondary outcomes: DHI, HADS, DBS, adherence | |
Notes | Only 17 participants of the sample of 360 failed to complete the final follow‐up | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "An independent research administrator allocated participants to the intervention arms using a computer randomisation program" |
Allocation concealment (selection bias) | Low risk | Participants were sent a letter directly by the independent research administrator informing them of group allocation |
Blinding (performance bias and detection bias) All outcomes | High risk | Neither participants nor assessors were blinded to group allocation. Outcomes were assessed by the use of questionnaires |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The drop‐out rate was reported to be 5% |
Selective reporting (reporting bias) | Low risk | Study protocol not available but all data appear to be reported |
Other bias | Low risk | The study appears to be free of other sources of bias |