Table.
GRADE Evaluation of interventions for Migraine headache in children.
| Important outcomes | Functional impairment, Migraine recurrence, Symptom relief | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of treatments for acute attacks of migraine headache in children? | |||||||||
| 5 (967) | Symptom relief | Sumatriptan versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for poor methodology in some RCTs (failure to report pre-crossover results; high withdrawal rates) |
| 2 (at least 1060) | Symptom relief | Rizatriptan versus placebo | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for pharmaceutical-sponsored study; consistency point deducted for inconsistent results; directness point deducted for generalisability (children received initial placebo treatment) |
| 2 (879) | Symptom relief | Zolmitriptan versus placebo | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results; consistency point deducted for conflicting results |
| 1 (274) | Symptom relief | Eletriptan versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (866) | Symptom relief | Almotriptan versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and no intention-to-treat analysis; directness point deducted for unclear generalisability as results are exploratory (reported although criteria for analysis not achieved) |
| 1 (866) | Migraine recurrence | Almotriptan versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and no intention-to-treat analysis; directness point deducted for unclear generalisability as results are exploratory (reported although criteria for analysis not achieved) |
| 3 (271) | Symptom relief | Ibuprofen versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and inclusion of flawed RCTs in meta-analysis |
| What are the effects of pharmacological prophylaxis for migraine headache in children? | |||||||||
| 3 (171) | Symptom relief | Propranolol versus placebo | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for sparse data and reporting of post-crossover results; consistency point deducted for heterogeneity among studies; directness point deducted for inclusion of co-intervention |
| 2 (178) | Symptom relief | Propranolol versus topiramate | 4 | –2 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data, and unclear allocation concealment and randomisation in one RCT; directness points deducted for single-site study (Iran), and use of additional interventions (painkillers) in one RCT |
| 1 (100) | Functional impairment | Propranolol versus topiramate | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data; directness points deducted for single-site study (Iran), and use of additional interventions (painkillers) in one RCT |
| 3 (at least 42) | Symptom relief | Flunarizine versus placebo | 4 | –3 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data, crossover design RCT, and unclear randomisation, blinding, and allocation concealment; directness points deducted for inclusion of population outside our group of interest, and use of additional interventions |
| 1 (32) | Symptom relief | Flunarizine versus propranolol | 4 | –2 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data, and unclear randomisation and blinding; directness points deducted for inclusion of population outside our group of interest, and use of additional interventions |
| 3 (at least 312) | Symptom relief | Topiramate versus placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, double reporting of placebo group in meta-analysis, and industry-sponsored studies |
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.