3. Jansen 2004: 'Risk of bias' assessment for observational studies using the Newcastle‐Ottawa Scale (Wells 2013).
Risk of Bias | Assessment | Support for judgement |
Selection (one star each, maximum four stars) | 2 stars | |
Representativeness of the exposed cohort | 0 stars | This study only included participants with AML as opposed to all patients with haematological malignancies |
Selection of the non‐exposed cohort | 0 star | Participants in the control were from a second haematology centre, but there was no information to reassure that this cohort was drawn from the same community as exposed cohort |
Ascertainment of exposure | 1 star | Secondary analyses from HOVON 29, prospective randomised controlled trial |
Demonstration that outcome of interest was not present at start of study | 1 stars | The primary outcome and other outcomes were defined and were based on events that occurred after the study started |
Comparability of cohort on design and analyses (maximum of two stars) Recognition of at least 75% of the main potential confounding factors (2 stars) Recognition of 50% to 75% of the main potential confounding factors (1 star) | 0 stars | < 50% of potential cofounders considered and sex, age and AML type were adjusted for in the multiple regression model. There was no discussion on previous severe bleeding, use of anticoagulation, use of radiotherapy in addition to chemotherapy, previous cardiovascular disease, previous alloimmunisation or performance status |
Outcome (one star each, maximum of four stars) | 2 stars | |
Assessment of outcome | 0 stars | Not described |
Was follow‐up long enough for outcomes to occur? | 1 star | Yes, 31 days from chemotherapy |
Adequacy of follow‐up of cohorts | 0 star | Reported for all, except unclear for infection, mean Hb during follow‐up, total number of platelet/red blood cell units received |
Follow‐up equal between groups for primary and secondary outcomes? | 1 star | Follow‐up not significantly different |
Additional concerns | None | |
Overall assessment | 4 stars |
AML = acute myeloid leukaemia Hb = haemoglobin