Methods |
|
Participants |
Country: Italy
Setting: single centre
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HD patients aged 18 to 75 years; routine use of EPO with no change in the 3 months preceding enrolment; rHuEPO dosage: < 120 IU/Kg/wk and EPO resistance index, 10 IU/kg/wk of Hb in the 3 months preceding enrolment; assurance from patients not to use EPO during the study; maintenance bicarbonate dialysis thrice‐weekly for at least 6 months previously with a cellulose dialyser; dialysis dosage > 1.2 of equilibrated single‐pool Kt/V; negligible residual renal function; no change in iron, folic acid, vitamin B12 or ACEi in the 3 months preceding the study
Number (eligible/randomised/analysed): 23/15/10
Mean age: 59.9 ± 7.2 years
Gender (M/F): 6/4
Exclusion criteria: unstable conditions in the 3 months prior to the study; treatment with drugs affecting erythropoiesis; blood transfusion in the 3 months preceding enrolment
|
Interventions |
Treatment group
Control group
Co‐interventions: NS |
Outcomes |
|
Notes |
Exclusions post randomisation but pre‐intervention: not stated
Stop or end point/s: not stated
Additional data requested from authors: method of randomisation; details regarding blinding
Funding: not stated
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not stated |
Allocation concealment (selection bias) |
Unclear risk |
Not stated |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not stated; probably not done |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not stated; probably not done |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
33% loss to follow‐up (5/15 patients whose Hb dropped at monthly checks were withdrawn from the study) |
Selective reporting (reporting bias) |
High risk |
Data at the end of first phase of treatment not available |
Other bias |
High risk |
Carry over effect present because of the cross‐over design; data not available for meta‐analysis |