Tay 2020.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, multicentre, non‐inferiority trial Setting: 4 HCT centres, Canada Recruitment: March 2011 to February 2016 Maximum follow‐up: 100 days |
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Participants | 300 participants over 18 years of age undergoing autologous or allogeneic HCT for any haematological malignancy randomised There was one late exclusion
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Interventions |
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Outcomes | Primary outcome: health‐related quality of life (HRQOL) measured by FACT‐BMT score at day 100 | |
Notes |
Trial registration (prospective): NCT01237639 Trial funding: supported by grants from the Canadian Institute of Health Research and the Canadian Blood Services COI statement by investigators: "Jason Tay: Honoraria: Celgene, Takeda, Sanofi Canada, Amgen. David S. Allan: Other Relationship: Canadian Blood Services. Mohamed Elemary: Consulting or Advisory Role: Jazz Pharmaceuticals, Amgen, Roche Canada. Adrienne Fulford: Honoraria: Teva Pharmaceutical Industries; Consulting or Advisory Role: Amgen. Irwin Walker: Honoraria: Jazz Pharmaceuticals; Consulting or Advisory Role: Jazz Pharmaceuticals; Research Funding: Sanofi Canada;Travel, Accommodations, Expenses: Jazz Pharmaceuticals. Anargyros Xenocostas: Honoraria: Novartis (Inst), Amgen (Inst), Apobiologix (Inst), Pfizer (Inst); Research Funding: Novartis (Inst)" (Tay 2020 p 1474) No other potential conflicts of interest were reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence |
Allocation concealment (selection bias) | Low risk | Secure online electronic randomisation platform was used |
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' Not possible to blind patients or caregivers |
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' |
Blinding of outcome assessment (detection bias) Subjective measures | High risk | Health‐related outcomes were self‐reported and were trial primary outcomes. Patients were not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 300 participants were randomised. There was 1 late exclusion in the restrictive group and 2 in each group were lost to full follow‐up. 299 participants were included from ITT analysis |
Selective reporting (reporting bias) | Low risk | Trial was prospectively registered (NCT01237639). All outcomes appear to be reported |
Other bias | Low risk | None was evident. A small difference in storage age at transfusion between the 2 arms was noted. Overall transfusion adherence rate was 95% |