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. 2016 Jun 27;128(6):763–773. doi: 10.1182/blood-2016-03-674127

Table 3.

Quality assessment of randomized trials of maintenance treatment in AML

Reference No. of patients* Quality domains (risk of bias)
No. of postremission courses Sequence generation Allocation concealment Blinding Incomplete outcome data Selective outcome reporting Other sources of bias
1 22 41 1 Unclear Unclear High Unclear Unclear High
2 20 74 2-3 Unclear Unclear Unclear Unclear Unclear High
3 11 145 1 Unclear Unclear Unclear High High Unclear
4 13 32 1 Unclear Low Unclear High Unclear High
5 16 45 6 Unclear Unclear Unclear Low Low Low
6 15 76 1 Unclear Unclear Unclear Unclear Low Unclear
7 18 70 2 Unclear Low Unclear Unclear Unclear High
8 10 163 1 Unclear Unclear Unclear High Unclear High
9 14 102 1 Unclear Unclear Unclear Unclear Low Unclear
10 21 528 1 Unclear Low Unclear Unclear Low Unclear
11 17 161 2 Unclear Unclear Unclear Unclear Low Low
12 19 154 3 Unclear Unclear Unclear Unclear High Low
13 12 226 1 Unclear Unclear Unclear Unclear Low Unclear

Positive trials are shown in bold. Details of scoring are provided in Higgins et al.7 Low corresponds to low risk of bias; high corresponds to high risk of bias. The following score/domain correspondence was used: sequence generation (method to generate the allocation sequence [eg, random number table, computer random number generator, or minimization], allocation concealment (method used to conceal the allocation sequence [eg, central allocation, sequentially numbered drug containers of identical appearance]), binding (measures used to blind study participants and personnel from knowledge of which intervention a participant received [eg, no blinding, single blinded, or double blinded]), incomplete outcome data (completeness of outcome data for each main outcome, including attritions and exclusions and reasons for each [eg, no missing outcome data, imputation, reasons for missing outcome data unlikely to be related to true outcome, missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups]), selective outcome reporting (the possibility of selective outcome reporting [eg, all prespecified outcomes have been reported in the prespecified way]), other sources of bias (any concerns for bias from other sources [eg, early termination as a result of some data-dependent process]).

*

Randomly assigned between maintenance and observation arms.