Kosan 2004.
Methods | RCT. Parallel design. Location: Turkey. Single centre. |
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Participants | 39 pediatric outpatients with the diagnosis of FMF, diagnosed based on Tel Hashomer criteria. 20 participants randomised to colchicine 2 or 3 times per day (divided‐dose group) and 19 to colchicine once daily (single‐dose group). Age, mean (SD): single‐dose group 9.8 (4.3) years; divided‐dose group 10.2 (4.0) years. Gender: 21 females, 18 males. | |
Interventions | Single‐dose group: colchicine 0.97 ± 0.35 mg/day once daily. Divided‐dose group: colchicine 0.95 ± 0.30 mg/day, dose divided into 2 or 3 times daily. NB not stated if mean and SD or mean and SE reported. |
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Outcomes |
Outcomes measured at 8 months. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly divided in two groups", however, the exactly randomization method was unclear. |
Allocation concealment (selection bias) | Unclear risk | The exact method of allocation concealment was unclear. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding, however, the review's secondary outcome of acute phase response was not influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding, however, the review's secondary outcome of acute phase response was not influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data reported. |
Selective reporting (reporting bias) | Unclear risk | Protocol could not be reviewed; moreover, the methods section did not predefine outcome measurements. |
Other bias | High risk | Differences of FMF severity between groups were not described. |