Hoving 2009a.

Methods	Randomised controlled trial. Randomisation by random sequence generation, investigator blinded to next assignment in sequence. After randomisation, treatment was open‐label and non‐blinded
Participants	17 patients with spastic cerebral palsy, 7 to 16 years
Interventions	Intrathecal baclofen via implanted pump
Outcomes	Evaluated after 6 months of treatment. Primary outcome measures: PEDI (Pediatric Evaluation of Disability Inventory) ‐ caregiver assistance scale of the self‐care domain and visual analogue scale for individually formulated problems. Other outcome measures Ashworth score, PEDI ‐ functional skills scale and caregiver assistance scale within self‐care domain, GMFM (Gross Motor Function Measure), CHQ‐PF50 (Child Health Questionnaire ‐Parent Form 50)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	p241 "An independent statistician generated the allocation schedule with an unpredictable sequence of assignments."
Allocation concealment (selection bias)	Low risk	p241 "The investigator who enrolled the children has no entry to this list and was, at the time of each enrolment, not aware of the next assignment in the sequence."
Incomplete outcome data (attrition bias) All outcomes	Low risk	p242 Figure 1 documents no attrition.
Selective reporting (reporting bias)	Low risk	p243 Table 3 records all results
Blinding (performance bias and detection bias)	High risk	p241 "After randomisation, the treatment was open‐label and non‐blinded."
Potential for carry‐over effect in cross‐over study design	Low risk	Not relevant to this study as not cross‐over design

H/M ratio: ratio of the maximal H amplitude to maximal M amplitude (an index of spasticity)