Rationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review
Table 3
Change in trial quality over time and odds of a positive trial relative to trial quality.
Quality item
Quality item reported in trial N (%)
Association between reporting of quality item and publication year OR per year post 1979 (95% CI), p
Association between reporting of quality item and likelihood of a positive trial OR (95% CI), p
Risk of bias
Allocation concealment
68 (35.1)
1.06 (1.00, 1.14), 0.09
2.04 (0.67, 6.16), 0.21
Sequence generation
58 (29.9) †
1.0 (0.85, 1.17), 0.99
3.27 (0.27, 40.2), 0.35
Detection bias addressed
90 (46.4) ‡
1.02 (0.96, 1.08), 0.55
0.83 (0.36, 1.91), 0.67
Intervention dose
Dose schedule report
148 (76.3)
1.06 (1.01, 1.10), 0.01
1.52 (0.76, 3.09), 0.24
Dose intensity report
69 (35.6)
1.06 (1.01, 1.12), 0.02
0.49 (0.26, 0.92), 0.03
Dose justified
36 (18.6)
1.01 (0.95, 1.06), 0.89
0.59 (0.28, 1.26), 0.17
Trial design
Hypothesis stated
71 (36.6)
1.09 (1.03, 1.15), 0.002
1.33 (0.73, 2.46), 0.36
Primary outcome stated
49 (25.3)
1.16 (1.08, 1.26), <0.001
1.22 (0.61, 2.45), 0.56
Trial phase stated
15 (7.7)
1.09 (0.98, 1.20), 0.12
0.70 (0.40, 1.24), 0.22
Registration of trial
10 (5.2)
3.32 (1.58, 6.95), 0.001
0.61 (0.37, 5.49), 0.61
Use of committees
1 (0.5)
1.33 (0.68, 2.63), 0.41
N/A §
Study sites specified
124 (63.9)
1.01 (0.96, 1.05), 0.87
0.99 (0.53, 1.84), 0.97
Biological rationale of intervention stated
60 (30.9)
1.11 (1.04, 1.17), 0.001
2.18 (1.14, 4.19), 0.02
Compliance with intervention reported
69 (35.6)
1.05 (1.01 1.10), 0.048
1.33 (0.71, 2.49), 0.37
Actual intervention received reported
22 (11.3)
1.14 (1.03, 1.27), 0.02
1.48 (0.57, 3.84), 0.42
Adverse events reported
22 (11.3)
1.09 (1.01, 1.19), 0.07
1.42 (0.56, 3.62), 0.46
OR= odds ratio. Logistic regression adjusted for number of outcomes and sample size. †Out of 113 trials that were scored in the corresponding Cochrane review. ‡Out of 179 trials that were scored in the corresponding Cochrane review. §As "design committee= 1" predicted positive trial perfectly, odds ratio cannot be calculated.
