Sundic 2014.
Methods | Randomised clinical trial. | |
Participants | Country: Norway. Number randomised: 62. Post‐randomisation dropouts: 0 (0%). Revised sample size: 62. Mean age: 42 years. Number of women: 6 (9.7%). Symptomatic: not stated. Asymptomatic: not stated. Mean follow‐up period (for all groups): 3 months. Target used for iron reduction: serum ferritin ≤ 50 μg/L. Inclusion criteria:
Exclusion criteria:
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Interventions | Participants were randomly assigned to 2 groups. Group 1: therapeutic erythrocytapheresis (n = 30). Further details: 400 mL per single treatment bi‐weekly*. Group 2: phlebotomy (n = 32). Further details: 450 mL per single treatment weekly. Treatment duration: 12 weeks. |
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Outcomes | Adverse events. | |
Notes | We attempted to contact the corresponding author in June 2015 to obtain additional information on risk of bias and outcomes. We did not receive any reply. * It was unclear whether the authors meant 'bi‐weekly' to be once every two weeks or twice weekly. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomisation procedure was centralised to one of the participating centres, using a randomly generated sequence". |
Allocation concealment (selection bias) | Unclear risk | Comment: this information was not available. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "different treatment". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was not available. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were 6 dropouts/withdrawal but data regarding tolerance reported. |
Selective reporting (reporting bias) | High risk | Comment: no data about mortality but just tolerability. |
For‐profit bias | Low risk | Quote: "Grants from Helse Vest RHF and Helse Fonna HF (public hospital trusts)". |
Other bias | Low risk | Comment: no other risk of bias. |