Yakymenko 2018.
| Study characteristics | ||
| Methods |
Design: RCT, parallel 2‐arm, open‐label, single‐site, phase 2 (feasibility) trial Setting: oncology department, university teaching hospital, Copenhagen, Denmark Recruitment: March 2010 to March 2013 Maximum follow‐up: follow‐up during chemotherapy cycles |
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| Participants | 133 participants undergoing chemotherapy at the Department of Oncology
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| Interventions |
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| Outcomes |
Primary objective (authors stated): to establish correlation between quality of life and Hb
Secondary objectives: to compare relief of symptoms and improvement in quality of life between randomisation arms, to provide data to plan a larger randomised trial (e.g. safety, completion rate, clinician compliance with protocol) Outcome data were not presented by transfusion group |
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| Notes |
Trial registration: NCT 01116479 (submitted in April 2010; trial had already begun in March 2010, but registration was deemed prospective) Trial funding: not reported COI statement by investigators: "the authors have no competing interests" (Yakymenko 2018 p 214) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "When included, patients were randomly assigned to one of two transfusion trigger levels through a computer programme" (Yakymenko 2018 p 209) |
| Allocation concealment (selection bias) | Unclear risk | As above ‐ no information other than ‐ "When included, patients were randomly assigned to one of two transfusion trigger levels through a computer programme" (Yakymenko 2018 p 209) |
| 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' Unblinded |
| 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 | Self‐reported questionnaires were applied in an unblinded trial |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Of 65 participants in the restrictive arm, 28 received RBC transfusion. Reasons for 37 who did not included termination of chemotherapy (20); patient request (1); death (1); unknown (2); 'end of study period' (13). 5 questionnaires from the remaining 28 were missing, so 23/28 questionnaires were analysed Of 68 participants in the liberal arm, 58 received RBC transfusion. 10 did not, because of termination of chemotherapy (3); patient request (4); death (2); 'end of study period' (1). 12 questionnaires of the remaining 28 were missing, so 46/58 questionnaires were analysed |
| Selective reporting (reporting bias) | Low risk | Paper does not appear to be explicit about timing of deaths (3); however, the questionnaires appear to have been administered within 7 days of any transfusions delivered, so in our view (since deaths are reported as reasons for not getting questionnaires filled in), these deaths must have occurred within a 7‐day period Trial registration close to prospective; investigators submitted registration on 28 April for a trial that began in March |
| Other bias | Low risk | Trial was stopped early due to 'low accrual'. Investigators aimed to recruit 180 participants |
Abbreviations
ACS: acute coronary syndrome ARDS: acute respiratory distress syndrome ASA: American Society of Anaestheologists BMT: bone marrow transplant CABG: coronary artery bypass grafting CARE: Cardiac Anesthesia Risk Evaluation CMML: chronic myelomonocytic leukaemia COPD: chronic obstructive pulmonary disease CPB: cardiopulmonary bypass DSMB: Data Safety Monitoring Board ECG: electrocardiogram GI: gastrointestinal Hb: haemoglobin concentration Hct: haematocrit HCT: hematopoietic cell transplantation HE: health economics ICU: intensive care unit IHD: ischaemic heart disease IQR: interquartile range ITT: intention‐to‐treat MACE: major adverse cardiac events MDS: myelodysplastic syndrome M/F: male/female MODS: multiple organ dysfunction syndrome MPN: myeloproliferative neoplasm PAB: preoperatively donated autologous blood PCI: percutaneous coronary intervention PI: principal investigator PLTs: platelets QOL: quality of life RBCs: red blood cells RCT: randomised controlled trial RMI: Rivermead Mobility Index ROTEM: rotational thromboelastometry SB: Sengstaken‐Blakemore SD: standard deviation SF‐12: Short Form Health Survey TKA: total knee arthroplasty VA: US Department of Veterans Affairs WHO: World Health Organization