Intervention vs control (placebo or sham) for Menière's disease or syndrome | ||||||
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Type of participants: Settings: Intervention: | ||||||
Illustrative comparative risks (95% CI)* | ||||||
Assumed risk | Corresponding risk | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Outcomes | Control | Intervention | ||||
Control of vertigo, follow-up: mean…months | ○○○○ |
We will use the GRADE approach to rate the overall quality of evidence. The quality of evidence reflects the extent to which we are confident that an estimate of effect is correct and we will apply this to the interpretation of results. There are four possible ratings: high, moderate, low and very low. A rating of high quality of evidence implies that we are confident in our estimate of effect and that further research is very unlikely to change our confidence in the estimate of effect. A rating of very low quality implies that any estimate of effect obtained is very uncertain. The GRADE approach rates evidence from RCTs that do not have serious limitations as high quality. However, several factors can lead to the downgrading of the evidence to moderate, low or very low. The degree of downgrading is determined by the seriousness of these factors: study limitations (risk of bias); inconsistency; indirectness of evidence; imprecision and publication bias.
This table will be constructed according to the recommendations described in Chapter 10 of the Cochrane Handbook for Systematic Reviews of Interventions (Handbook 2011). We will include the following outcomes in the ‘Summary of findings’ table: control of vertigo attacks, hearing, severity of vertigo attacks and tinnitus, perception of aural fullness, quality of life and adverse events.
*The basis for the assumed risk (eg, the median proportion of patients with control of vertigo related to the follow-up) will be provided in footnotes. The corresponding risk (and its 95% CI) will be based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
RCT, randomised controlled trial.