All difficulties (15 items) | Scientifica difficulties (7 items) | Logisticalb difficulties (7 items) | ||||
---|---|---|---|---|---|---|
Mean | p-value | Mean | p-value | Mean | p-value | |
Study design | .45 | .002 | .047 | |||
Interventional | 2.7 | 0.9 | 1.8 | |||
Observational | 2.9 | 1.4 | 1.4 | |||
First decision of the REC | .25 | .89 | .022 | |||
Positive, positive with recommendations, positive with written modifications required | 2.7 | 1.1 | 1.5 | |||
Positive with conditions and reassessment, negative/non-consideration | 3.1 | 1.1 | 2.0 | |||
Origin of the study protocol | <.001 | <.001 | .12 | |||
Public (hospital, University, etc.) | 3.1 | 1.4 | 1.6 | |||
Private (industry, foundation) | 1.6 | 0.2 | 1.3 | |||
Sample size | .33 | .092 | .96 | |||
≤ median (100) | 2.9 | 1.3 | 1.6 | |||
> median | 2.6 | 1.0 | 1.6 | |||
Number of centers | <.001 | <.001 | .21 | |||
Single | 3.2 | 1.5 | 1.7 | |||
Multicenter | 2.1 | 0.6 | 1.5 | |||
Type of research | .79 | .084 | .006 | |||
Clinical (intervention, diagnosis, prognosis) | 2.8 | 1.0 | 1.8 | |||
Others (health/illness, public health/health economics, methods, other) | 2.7 | 1.3 | 1.3 | |||
Self-reported trainings in quantitative methods | .37 | .16 | .80 | |||
None | 2.9 | 1.3 | 1.6 | |||
Any | 2.7 | 1.0 | 1.6 | |||
Presence of a statistician on study team (N = 384) | .086 | <.001 | .54 | |||
No | 2.9 | 1.3 | 1.6 | |||
Yes | 2.4 | 0.6 | 1.7 | |||
Study published | .71 | .90 | .34 | |||
No | 2.7 | 1.1 | 1.5 | |||
Yes | 2.8 | 1.1 | 1.6 |