QUALITY ASSESSMENT OF REPORTS ON CLINICAL-TRIALS IN THE JOURNAL-OF-HEPATOLOGY

Background/Aims: Electronic searches on databases for randomised clini cal trials and controlled clinical trials do not identify as many tria ls as handsearches, and trial reporting may be flawed. The aims were t o identify all fully reported randomised clinical trials in the Journa l of Hepatology and to make a qualitative assessment of the reporting. Methods: The publications were identified by systematically handsearc hing the full text of the journal and searching MEDLINE. Central dimen sions of trial quality were used to assess the reporting quality of th e trials. Results: Randomised clinical trials represented 8.4% of the original articles (171/2028). Ten original articles (0.5%) could not b e classified. A search on MEDLINE identified 81.3% of the randomised c linical trials, i,e., 139 out of the 171 identified by the handsearch. A total of 166 randomised clinical trials could be quality assessed. Forty-seven (28.3%) of them reported adequate generation of allocation sequence; 22 (13.3%) adequate allocation concealment; 95 (57.2%) allo wed intention-to-treat analysis with only a few losses to follow-up; 5 0 (30.1%) were double-blind; 33 (19.9%) reported sample-size calculati ons; 13 trials (7.8%) employed the crossover design; and the median nu mber of subjects per intervention arm in parallel group trials was 19 subjects (interquartile range: 11-31; range: 5-519). The quality of re porting was significantly better in regular issue articles than in sup plement articles. Conclusions: Many important randomised clinical tria ls are published in the Journal of Hepatology, but there seems to be a mple room for improvement of quality of reporting.