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. 2017 Nov 6;2017(11):CD008727. doi: 10.1002/14651858.CD008727.pub4

1. 'Risk of bias' assessment criteria for observational studies.

  Internal validity External validity
Study group Selection bias (representative: yes/no):
  • if it consisted of more than 90% of the original cohort of children with ALL treated with glucocorticoids; or

  • if it was a random sample with respect to treatment.

Reporting bias (well defined: yes/no):
  • if treatment protocol was mentioned; and

  • if (cumulative) dose of glucocorticoid treatment was mentioned; and

  • if type of glucocorticoid treatment was mentioned; and

  • if duration of glucocorticoid treatment was mentioned; and

  • if method of cessation of glucocorticoid treatment was mentioned.

Follow‐up Attrition bias (adequate: yes/no):
  • if outcome was assessed at end date of the study for 60% to 90% of study group; or

  • if outcome was assessed for more than 90% of the study group but with an unknown end date.

Reporting bias (well defined: yes/no):
  • if length of follow‐up was mentioned; and

  • if frequency of measuring outcomes was mentioned.

Outcome Detection bias (blinding: yes/no):
  • if outcome assessor was blinded to glucocorticoid treatment.

Reporting bias (well defined: yes/no):
  • if methods of detection were described; and

  • if outcome definition was objective and precise.

Risk estimation Confounding (adjustment for other factors: yes/no):
  • if important prognostic factors (i.e. age, sex, cotreatment) or follow‐up was taken adequately into account.

Analysis (well defined: yes/no):
  • if risk ratio, odds ratio, attributable risk, linear or logistic regression model, mean difference, or Chi2 statistic was calculated.

ALL: acute lymphoblastic leukaemia.