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Table 9 Quality of reporting of the pivotal studies (n = 108)

From: Clinical evidence for orphan medicinal products-a cause for concern?

  Number of pivotal studies (%)
Reporting of an a priori stated research hypothesis
 Yes 71 (65.7%)
 No 12 (11.1%)
 Not reported 25 (23.1%)
Reporting of main endpoints
 Yes 101 (93.5%)
Reporting of sampling criteria
 Yes 100 (92.6%)
Description (i.e. age, gender) of patients included
 Yes 70 (64.8%)
Reported possible bias and/or confounding
 Yes 45 (41.7%)
Reporting of the intervention
 Yes 107 (99.1%)
Reporting of point estimates
 Yes, for all primary and secondary endpoints 39 (36.1%)
 Yes, but partially 67 (62.0%)
 No 2 (1.9%)
Reporting of measures of variability
 Yes, for all primary and secondary endpoints 15 (13.9%)
 Yes, but partially 59 (54.6%)
 No 34 (31.5%)
Reporting of actual probability values
 Yes 73 (67.6%)