Robitaille 2013.
Study characteristics | ||
Methods |
Design: RCT, intended to be multicentre trial Setting: 1 institution (not identified), Canada Recruitment: June 2009 Maximum follow‐up: intended to be 5 years (overall survival) |
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Participants | Children aged 1 to 18 years who were undergoing an allogeneic BMT for malignant or benign disease (except sickle cell disease) were eligible Recruitment target was 62; enrolment was 6 3 ‐ liberal threshold trigger transfusion strategy 3 ‐ restrictive threshold trigger transfusion strategy |
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Interventions |
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Outcomes | Time to neutrophil engraftment, time to platelet engraftment, transfusions given, length of stay, immune reconstitution, mortality/overall survival (2 to 5 years), graft vs host disease, relapse, chimerism | |
Notes | Trial closed early due to an excess of cases of veno‐occlusive disease in 3 out of 6 cases, all in the intervention (liberal) arm Trial registration: NCT00937053 Trial funding: Fonds de laRecherche en Santé du Québec (grants 9967 and 24460) COI statement by investigators: "the authors declare no conflict of interest to report" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization of patients was done on the first day of their conditioning regimen using a web‐based randomization system" (Robitaille 2013 p 469) |
Allocation concealment (selection bias) | Low risk | As above ‐ no further information supplied |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Blinding of personnel for this intervention is not feasible, but in our view, for objective outcomes such as mortality (the primary outcome used within this review), we graded risk of bias as 'low' |
Blinding of outcome assessment (detection bias) Objective measures | Low risk | Blinding of mortality (the primary outcome used within this review) is not relevant, and we graded risk of bias as 'low' Primary outcome of veno‐occlusive diease is also a hard outcome |
Blinding of outcome assessment (detection bias) Subjective measures | Low risk | No data from subjective outcomes (e.g. function) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented for small cohort |
Selective reporting (reporting bias) | Low risk | All data presented for small cohort; 1 death at 6 months in experimental arm. Small sample size rendered many predefined outcomes inappropriate |
Other bias | Low risk | Trial closed early due to an excess of cases of veno‐occlusive disease in 3 out of 6 cases, all in the intervention (liberal) arm Overall considered at low risk of bias based on limited data available for analysis within this review |