Table 5
Participation of an epidemiologist/biostatistician and quality of multicentric studies
| Epidemiologist/biostatistician | ||||
|---|---|---|---|---|
| Yes % (n=112) | No % (n=117) | Crude OR (95% CI) | Adjusted OR5-150 (95% CI) | |
| Pre-study sample size estimation | ||||
| Yes | 55.6 | 42.9 | 1.7 (1.0, 2.8) | 1.6 (0.9, 2.7) |
| Inclusion/exclusion criteria | ||||
| Yes | 94.9 | 91.1 | 1.8 (0.7, 5.0) | 1.8 (0.6, 5.4) |
| Number of subjects asked for participation | ||||
| Yes | 34.2 | 36.6 | 0.9 (0.5, 1.5) | 0.9 (0.5, 1.5) |
| Number of subjects who agreed participation | ||||
| Yes | 23.1 | 30.4 | 0.7 (0.4, 1.2) | 0.7 (0.4, 1.2) |
| Blind randomisation | ||||
| Yes/not applicable | 40.3 | 31.3 | 1.5 (0.9, 2.5) | 1.5 (0.8, 2.6) |
| Assessment of baseline comparability of study groups | ||||
| Yes | 89.6 | 85.2 | 1.5 (0.7, 3.3) | 1.8 (0.8, 4.0) |
| Dates of starting/ending clinical trial | ||||
| Yes | 76.9 | 50.9 | 3.2 (1.8, 5.7) | 3.0 (1.7, 5.4) |
| Method to assess treatment compliance | ||||
| Yes | 53.0 | 41.1 | 1.6 (0.9, 2.7) | 1.4 (0.8, 2.5) |
| Masked assessment of outcome | ||||
| Yes | 56.4 | 51.8 | 1.2 (0.7, 2.0) | 1.1 (0.6, 1.9) |
| Outcome objectively assessed | ||||
| Yes | 91.5 | 84.8 | 1.9 (0.8, 4.3) | 1.9 (0.8, 4.5) |
| Existence of criteria to assess outcome | ||||
| Yes | 98.3 | 96.4 | 2.1 (0.3, 23.9) | 1.4 (0.2, 8.9) |
| Mentioning statistical procedures | ||||
| Yes | 99.2 | 97.3 | 3.2 (0.3, 169) | 2.0 (0.2, 22.6) |
| Analysis according to intention to treat | ||||
| Yes | 67.2 | 40.2 | 3.1 (1.8, 5.3) | 2.9 (1.6, 5.0) |
| Estimation of statistical power if results are non-significant | ||||
| Yes/not applicable | 89.7 | 88.4 | 1.1 (0.5, 2.6) | 1.2 (0.5, 2.8) |
-
↵5-150 Adjusted for funding and study sample size.
