Article type
Year
Abstract
Introduction:
Objectives: To describe the quality of all 235 randomised clinical trials (RCTs) published in Hepatology from the first year of publication in 1981 through August 1998. Further, to examine the associations between quality and therapeutic area, number of centres, sponsorship, year of publication and country of origin (focusing on comparing U.S. versus non-U.S. RCTs).
Methods: The quality was assessed by means of a validated 5-point scale (Jadad et al. 1996 focusing on the adequacy of allocation sequence generation, double-blinding and description of follow-up) and by components (allocation concealment plus scale items).
Results: The median quality score was 3 points (range 1-5) with no significant changes during the study period. Fifty-two percent of the trials reported adequate generation of the allocation sequence, 34% adequate allocation concealment and 34% double-blinding. RCTs on portal hypertension were more likely to obtain high quality scores (>3 points) compared to other therapeutic areas (Odds Ratio (OR) 2.4, 95% Cl 1.1-5.5, p= .03). Multicentre RCTs obtained significantly higher quality scores compared to single centre RCTs (OR 3.4, 95% Cl 1.3-8.9, p= .01). RCTs sponsored by public organisations or by the drug and device industry obtained significantly higher quality scores compared to RCTs without external funding (OR 4.2, 95% Cl 2.1-8.6 and OR 4.7, 95% Cl 2.2-10.2, p= .0001). RCTs sponsored by public organisations compared to the drug and device industry did not differ significantly. The quality scores obtained by U.S and non-U.S. RCTs were not significantly different.
Discussion: The present study illustrates that the quality of randomised clinical trials needs improvement on fundamental aspects of trial design and report. Furthermore, therapeutic area, centre status, and sponsorship are identified as predictors of quality. Supported by The Danish Medical Research Council and The 1991 Pharmacy Foundation, Dk.
Objectives: To describe the quality of all 235 randomised clinical trials (RCTs) published in Hepatology from the first year of publication in 1981 through August 1998. Further, to examine the associations between quality and therapeutic area, number of centres, sponsorship, year of publication and country of origin (focusing on comparing U.S. versus non-U.S. RCTs).
Methods: The quality was assessed by means of a validated 5-point scale (Jadad et al. 1996 focusing on the adequacy of allocation sequence generation, double-blinding and description of follow-up) and by components (allocation concealment plus scale items).
Results: The median quality score was 3 points (range 1-5) with no significant changes during the study period. Fifty-two percent of the trials reported adequate generation of the allocation sequence, 34% adequate allocation concealment and 34% double-blinding. RCTs on portal hypertension were more likely to obtain high quality scores (>3 points) compared to other therapeutic areas (Odds Ratio (OR) 2.4, 95% Cl 1.1-5.5, p= .03). Multicentre RCTs obtained significantly higher quality scores compared to single centre RCTs (OR 3.4, 95% Cl 1.3-8.9, p= .01). RCTs sponsored by public organisations or by the drug and device industry obtained significantly higher quality scores compared to RCTs without external funding (OR 4.2, 95% Cl 2.1-8.6 and OR 4.7, 95% Cl 2.2-10.2, p= .0001). RCTs sponsored by public organisations compared to the drug and device industry did not differ significantly. The quality scores obtained by U.S and non-U.S. RCTs were not significantly different.
Discussion: The present study illustrates that the quality of randomised clinical trials needs improvement on fundamental aspects of trial design and report. Furthermore, therapeutic area, centre status, and sponsorship are identified as predictors of quality. Supported by The Danish Medical Research Council and The 1991 Pharmacy Foundation, Dk.