Flett 1999.
Methods |
Method of randomisation: sequence generation not clearly described. Allocation carried out by the hospital pharmacy. Blinding: participants and person administering treatment were aware of treatment allocation. Research clinicians were blinded to the intervention arms. Intention‐to‐treat analysis: no Loss of follow‐up: 2 dropouts from the BoNT‐A group ("one for social reasons, and the other at parental request because of the perceived need to treat differently by a combination of botulinum toxin A and fixed plaster treatment") Unit of analysis: lower limb for local measures and likely child for global measures |
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Participants |
Place: 1 centre in Australia Period of study: not described Number assigned: 20 Number assessed: 18
Inclusion criteria:
Exclusion criteria:
Age:
Gender:
Motor distribution:
GMFCS:
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Interventions |
BoNT‐A group:
Casts group:
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Outcomes |
Length of follow‐up:
Primary outcomes:
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Notes |
Comments: none Source of funding: Crippled Children’s Association Research and Development Fund Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: not clearly described |
Allocation concealment (selection bias) | Low risk | Comment: central allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Comment: study protocol not available. It appears that the relevant outcomes were addressed. |
Other bias | Low risk | Comment: no other sources of bias identified |