Jansen 2020.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, multicentre, non‐inferiority trial Setting: 3 sites (1 university and 2 general hospitals) in the Netherlands Recruitment: July 2002 to August 2004 Maximum follow‐up: 12 months |
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Participants | 19 adult participants (≥ 18 years of age) with diagnosed myelodysplasia according to the French‐American‐British classification and dependent on RBC transfusion (e.g. who had ≥ 1 RBC transfusion recently)
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Interventions |
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Outcomes | Primary endpoint: physical fatigue, measured with the Multidimensional Fatigue Inventory | |
Notes |
Trial registration (post hoc, 2005): ISRCTN43616311 Trial funding: no information COI statement by investigators: "the authors have no conflict of interest to declare" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
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' Participants were blinded but physicians and nurses were not |
Blinding of outcome assessment (detection bias) Subjective measures | High risk | Participants were reported to be blinded, but this was not tested. Physicians and nurses were not blinded. Quality of life outcomes including fatigue were reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Insufficient data. 1 death in restrictive arm, 2 in liberal arm, but timing not provided. Follow‐up was incomplete "After randomization 6 out of 10 patients (60%) from the restrictive and 5 out of 9 patients (55.5%) from the liberal arm completed or still participated when the study terminated. Reasons of study withdrawal were withdrawal of informed consent (two in the restrictive and one in the liberal arm), death (one in the restrictive and two in the liberal arm) and usage of growth factors (one patient in each arm)" Thus, the trial's primary outcome data were available for 11/19 participants |
Selective reporting (reporting bias) | Unclear risk | Insufficient data; trial registration was done post hoc, and trial report was provided only in the form of a letter |
Other bias | Unclear risk | Terminated prematurely "The Temple study was terminated prematurely due to the slow recruitment rate with only 21 patients in three hospitals in 2 years. Patients who were still participating when the study ended, received transfusion therapy according to the guidelines of the local hospital" (Jansen 2020 p 879) |