Table.
Important outcomes | Frequency and severity of acute attacks of vertigo, Functional impairment, Hearing acuity, Quality of life, Sensation of aural fullness, Severity of tinnitus | ||||||||
Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
What are the effects of intratympanic interventions to prevent attacks and delay disease progression of Menière’s disease? | |||||||||
2 (50) | Frequency and severity of acute attacks of vertigo | Intratympanic gentamicin versus placebo/sham treatment/no treatment/usual care | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for weak methods, incomplete reporting of results, and sparse data; directness point deducted for clinical heterogeneity between RCTs |
2 (50) | Hearing acuity | Intratympanic gentamicin versus placebo/sham treatment/no treatment/usual care | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for weak methods, incomplete reporting of results, and sparse data; directness point deducted for clinical heterogeneity between RCTs |
1 (28) | Severity of tinnitus | Intratympanic gentamicin versus placebo/sham treatment/no treatment/usual care | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for weak methods and sparse data; directness point deducted for unclear statistical analysis between groups |
1 (28) | Sensation of aural fullness | Intratympanic gentamicin versus placebo/sham treatment/no treatment/usual care | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for weak methods, incomplete reporting of results, and sparse data |
1 (18) | Frequency and severity of acute attacks of vertigo | Intratympanic corticosteroids versus placebo/sham treatment/no treatment/usual care | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for weak methods, incomplete reporting of results, and sparse data |
2 (38) | Hearing acuity | Intratympanic corticosteroids versus placebo/sham treatment/no treatment/usual care | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for weak methods, incomplete reporting of results, and sparse data |
2 (38) | Severity of tinnitus | Intratympanic corticosteroids versus placebo/sham treatment/no treatment/usual care | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for weak methods, incomplete reporting of results, and sparse data |
1 (18) | Functional impairment | Intratympanic corticosteroids versus placebo/sham treatment/no treatment/usual care | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for weak methods and sparse data |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.