Levy 2010.
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 3‐month follow‐up, 6‐month follow‐up | |
| Participants | End of treatment: n = 168; follow‐up 3 months: n = 143; follow‐up 6 months: n = 154 Start of treatment: n = 200 Sex: 145 F, 55 M Mean (SD) age = 11.21 years (2.55) Source = paediatric gastroenterology clinics at Seattle Children's Hospital and the Atlantic Health System in Morristown, New Jersey. Seattle participants were also recruited through local area clinics and community‐posted flyers Diagnosis = functional abdominal pain Mean years of pain = 3+ episodes of abdominal pain during a 3‐month period |
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| Interventions | "Cognitive‐behavioural treatment" "Educational intervention" | |
| Outcomes | Primary pain outcome: Faces Pain Scale‐Revised Primary disability outcome: Functional Disability Inventory Primary depression outcome: Children's Depression Inventory Primary anxiety outcome: Multidimensional Anxiety Scale for Children
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| Notes | COI: "William E. Whitehead is a member of the Board of Directors of the Rome Foundation. Nader Youssef is currently the Director of Clinical Research at AstraZeneca LP. At the time the study was conducted, however, he was not affiliated with this company and contributed to the project by his appointment at Goryeb Children’s Hospital." Funding: "This study was supported by grant number 5R01HD036069 from the National Institutes of Health — National Institute of Child Health and Human Development." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomisation was then performed by a different researcher using a computerised random‐number generator, stratifying by age." Comment: probably done |
| Allocation concealment (selection bias) | Low risk | "Randomisation was then performed by a different researcher using a computerised random‐number generator, stratifying by age." Comment: probably done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Nurse assessors were blind to the treatment assignment of the children." Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition was described; significant differences between completers and non‐completers are not reported |
| Selective reporting (reporting bias) | Unclear risk | Data were fully reported when requested |