Selection bias decisions for trials reporting unadjusted analyses: comparison of results obtained using method details alone with results using method details and trial baseline informationa
|
Reported randomisation and allocation concealment methods |
'Risk of bias' judgementusing methods reporting
|
Information gained from study characteristics data |
Risk of bias using baseline information and methods reporting |
Unclear methods |
Unclear risk |
Baseline imbalances present for important prognostic variable(s) |
High risk |
Groups appear similar at baseline for all important prognostic variables |
Low risk |
Limited or no baseline details |
Unclear risk |
Would generate a truly random sample, with robust allocation concealment |
Low risk |
Baseline imbalances present for important prognostic variable(s) |
Unclear riskb
|
Groups appear similar at baseline for all important prognostic variables |
Low risk |
Limited baseline details, showing balance in some important prognostic variablesc
|
Low risk |
No baseline details |
Unclear risk |
Sequence is not truly randomised, or allocation concealment is inadequate |
High risk |
Baseline imbalances present for important prognostic variable(s) |
High risk |
Groups appear similar at baseline for all important prognostic variables |
Low risk |
Limited baseline details, showing balance in some important prognostic variablesc
|
Unclear risk |
No baseline details |
High risk |
aTaken from Corbett 2014; judgements highlighted in bold indicate situations in which the addition of baseline assessments would change the judgement about risk of selection bias, compared with using methods reporting alone.
bImbalance identified that appears likely to be due to chance.
cDetails for the remaining important prognostic variables are not reported. |