Table 2. Frequency of description of design elements and design element options in the two preclinical datasets evaluated (CAMARADES (brain trauma/stroke) and toxicology).
Design element | Element options | CAMARADES N = 100 |
Toxicology N = 100 |
---|---|---|---|
Control group | None | 0 | 0 |
Concurrent | 98 | 92 | |
Historic | 0 | 0 | |
Unclear | 2 | 8 | |
Unit of concern | Group | 0 | 12 |
Individual | 92 | 37 | |
Nested | 0 | 17 | |
Unclear | 8 | 34 | |
Arrangement of the factors | Complete factorial | 27 | 42 |
Cross-over | 0 | 0 | |
Incomplete factorial | 12 | 11 | |
Parallel | 58 | 24 | |
Split-Plot | 0 | 20 | |
Unclear | 3 | 3 | |
Allocation | Haphazard | 0 | 0 |
Minimization | 0 | 0 | |
Random | 79 | 62 | |
Systematic | 0 | 0 | |
Unclear | 21 | 38 | |
Concealment (a) | Intervention allocation | 12 | 0 |
NDD* | 88 | 100 | |
Concealment (b) | Outcome assessment | 60 | 12 |
NDD* | 40 | 88 | |
Independence (a) | Pseudo-replication | 44 | 50 |
NDD* | 56 | 50 | |
Independence (b) | Repeated measures | 40 | 59 |
NDD* | 60 | 41 | |
Investigator-identified study design | Provided | 0 | 7 |
NDD* | 100 | 93 | |
Nature of the factors | All could be randomized | 94 | 69 |
Some could be randomized | 5 | 30 | |
None could be randomized | 0 | 0 | |
Unclear | 1 | 1 |
* NDD = no discernable description: neither reviewer/reader was able to find text that described this element.