Connelly 2006.
Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 2 months, 3 months | |
Participants | End of treatment: N = 36
Start of treatment: N = 37
Sex: 18 F, 19 M
Mean age: 10.0 (range 7‐12) Source: clinic Diagnosis: headache Mean years of pain: not given |
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Interventions | "CD‐ROM behavioural” "Wait‐list neurology TAU" | |
Outcomes |
Primary pain outcome: clinical reduction in headache frequency
Primary disability outcome: Ped‐MIDAS Primary depression outcome: none Primary anxiety outcome: none Primary satisfaction outcome: none Measures reported: total pain (headache diary) Pediatric Migraine Disability Assessment (Ped‐MIDAS) |
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Notes |
Funding source: educational grant from AstraZeneca LP Declarations of interest: none stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly assigned to one of two groups by a research assistant using a uniform random numbers table." Comment: probably done |
Allocation concealment (selection bias) | Low risk | "Randomly assigned to one of two groups by a research assistant using a uniform random numbers table." Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Study neurologists remained blind to randomisation condition throughout the study. Chances of unbinding were limited because follow‐up appointments with the study neurologist were scheduled for 2 months following the initial assessment." Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Measures completed at home and mailed back |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition is described, however significant descriptions between completers and non‐completers were not reported |
Selective reporting (reporting bias) | Low risk | Data were fully reported |