Table A5:
GRADE Evidence Profile for the Comparison of nVNS and Control, Acute Treatment, Migraine
| Number of studies (design) | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Upgrade considerations | Quality |
|---|---|---|---|---|---|---|---|
| Pain relief: response | |||||||
| 1 (RCT) | No serious limitationsa | No serious limitationsb | No serious limitations | Serious limitations (-1)c | Undetected | None | ⊕⊕⊕ Moderate |
| Pain relief: response in 50% or more of attacks | |||||||
| 1 (RCT) | Serious limitations (-1)a | No serious limitationsb | No serious limitations | Serious limitations (-1)d | Undetected | None | ⊕⊕ Low |
| Pain relief: sustained treatment response | |||||||
| 1 (RCT) | Serious limitations (-1)a | No serious limitationsb | No serious limitations | Serious limitations (-1)e | Undetected | None | ⊕⊕ Low |
| Pain freedom | |||||||
| 1 (RCT) | No serious limitationsa | No serious limitationsb | No serious limitations | Serious limitations (-1)f | Undetected | None | ⊕⊕⊕ Moderate |
| Pain freedom in 50% or more of attacks | |||||||
| 1 (RCT) | Very serious limitations (-2)a | No serious limitationsb | No serious limitations | Serious limitations (-1)g | Undetected | None | ⊕ Very low |
| Sustained pain freedom | |||||||
| 1 (RCT) | Very serious limitations (-2)a | No serious limitationsb | No serious limitations | Serious limitations (-1)h | Undetected | None | ⊕ Very low |
| Headache intensity | |||||||
| 1 (RCT) | Very serious limitations (-2)a | No serious limitationsa | No serious limitations | Serious limitations (-1)i | Undetected | None | ⊕ Very low |
| Acute medication use | |||||||
| 1 (RCT) | No serious limitationsa | No serious limitationsb | Serious limitations (-1)j | Serious limitations (-1)k | Undetection | None | ⊕⊕ Low |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; nVNS, noninvasive vagus nerve stimulation; RCT, randomized controlled trial.
See Table A1.
Only 1 RCT contributed to the assessment.
Small sample size, with a very wide confidence interval ranging from a very small and not clinically meaningful increase (1% absolute risk increase, 3% relative increase) to a very large benefit.
Small sample size, with a very wide confidence interval ranging from a very small and not clinically meaningful increase (2% absolute risk increase, 4% relative increase) to a very large benefit.
Small sample size with a confidence interval that included a meaningful decrease and an increase in response.
Small sample size with a wide confidence interval that crossed no effect in treatment.
Small sample size with a very wide confidence interval.
Small sample size that crossed no effect in treatment.
Small sample size; no variance was provided to appropriately assess imprecision.
It was unclear how this was defined, or the measures. Patients were instructed not to take medication for 120 minutes after treatment, and this was unlikely to represent true practice.
Small sample size with a confidence interval that crossed no effect (P > .05); insufficient data to assess the degree of variance around the effect estimate.