Table 3

Quality aspects related to data collection during follow up

Epidemiologist/biostatistician
Yes % (n=178)No % (n=289)Crude OR (95% CI)Adjusted OR3-150 (95% CI)
Date of starting clinical trial
  Yes70.243.33.1 (2.1, 4.6)2.1 (1.4, 3.3)
Date of ending clinical trial
  Yes68.040.53.1 (2.1, 4.6)2.2 (1.4, 3.3)
Justification of no blindness
  Yes/not applicable64.664.71.0 (0.7, 1.5)1.0 (0.7, 1.5)
Method to assess treatment compliance
  Yes45.535.31.6 (1.1, 2.3)1.2 (0.8, 1.9)
Assessment of intervention compliance
  Yes90.586.91.4 (0.8, 2.6)1.4 (0.7, 2.6)
Collection of side effects
  Yes78.173.41.3 (0.8, 2.0)1.2 (0.8, 1.9)
Masked assessment of outcome
  Yes51.751.61.0 (0.7, 1.5)0.9 (0.6, 1.3)
Outcome objectively assessed
  Yes92.183.02.4 (1.3, 4.4)2.4 (1.2, 4.6)
Existence of criteria to assess outcome
  Yes97.295.51.6 (0.6, 4.5)1.3 (0.4, 3.9)
Number of subjects who abandoned the study
  Yes93.897.20.4 (0.2, 1.1)0.5 (0.2, 1.3)
  • 3-150 Adjusted for number of participating centres, funding, and study sample size.