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. 2017 Jan 10;2017(1):CD010971. doi: 10.1002/14651858.CD010971.pub2

Robins 2005.

Methods RCT with usual care control
Follow‐up: postintervention (3 months), 6 months' and 12 months' follow‐up
Participants Location: USA
Setting: recruited from paediatric gastroenterology clinics
Sample size: 86 children (46 intervention, 40 control)
Sex: 30 boys, 39 girls (data reported for completers only)
Dropouts/withdrawals: 11 control
Diagnosis: RAP diagnosed using Apley criteria (Apley 1958)
Mean age: intervention: 10.8 (SD 2.5; range not reported) years; control: 11.9 (SD 2.3; range not reported) years. Overall range for both groups: 6 to 16 years
Interventions Intervention: cognitive behavioural therapy, for child and parent (non‐group format), 40 minutes x 5, every 2 weeks, as well as usual medical care
Control: usual medical care (usual individualised care including visits with physicians and advice on diet)
Outcomes
  1. Pain (Abdominal Pain Index; Walker 1997): child and parent

  2. Functional disability due to pain (Functional Disability Inventory; Walker 1991): child

Notes Study dates: August 1998 to April 2000
Funding: grant from the Nemours Research Programs
Declarations of Interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: coin flip status, with a witness, but procedure unclear
Allocation concealment (selection bias) Unclear risk Comment: no details provided of how coin flip was managed, or whether done in advance
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: only clinicians delivering usual medical care were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: self report outcomes and participants aware of intervention
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: clear numbers at follow‐up not reported
Selective reporting (reporting bias) Low risk Comment: all outcomes reported
Other bias Unclear risk Comment: issues relate to differences at baseline, sufficient numbers not recruited, larger loss to follow‐up than expected, and merged results