Sanjeeva 2015.
Methods | Prospective randomised comparative study. | |
Participants | 41 participants were randomised 38 participants reached end of study Age (mean (SD)): DFX (n = 19): 5.23 (2.76) years; DFP (n = 19): 7.26 (2.42) years Gender (male/female): 22/16 Setting: Thalassemia day care centre of Indira Gandhi Institute of child health, Bengaluru Country: India Inclusion criteria
Exclusion criteria
Follow‐up: 12 months |
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Interventions | 2 groups:
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Outcomes |
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Notes | No funding or conflict of interest mentioned | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "These children were randomly divided into two groups as group 1 and group 2 by computer generated randomisation." |
Allocation concealment (selection bias) | Unclear risk | No details mentioned with regard to concealment of allocation. |
Blinding (performance bias and detection bias) All outcomes | High risk | No details given with regard to blinding. Due to different application frequencies, blinding is not likely, in particular regarding performance bias. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 3 dropouts due to AEs in deferiprone group, per protocol analysis. |
Selective reporting (reporting bias) | High risk | Measurements other than serum ferritin and AEs only given for 9 months (and only in the thesis document), but not for end of study (unsure whether not measured or not reported), although the author report measurements every 3 months. In the thesis document, fundoscopy, growth harm and hearing were part of the evaluation sheet at 12‐month follow‐up, but no results were reported. |
Other bias | Low risk | No other bias detected. |