Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Randomized clinical trials in HEPATOLOGY: predictors of quality

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Preemptive-TIPS improves outcome in high-risk variceal bleeding: An observational study

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Response to AASLD editorial/message from the president

    Research output: Contribution to journalComment/debateResearchpeer-review

  3. Novel Biomarker Discovery in Non-Alcoholic Steatohepatitis (NASH): Translation of Complex Data into Clear Results

    Research output: Contribution to journalConference abstract in journalResearchpeer-review

  4. Viral persistence, liver disease and host response in Hepatitis C-like virus rat model

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Exercise-Based Rehabilitation for Heart Failure: Cochrane Systematic Review, Meta-Analysis, and Trial Sequential Analysis

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Plasma expanders for people with cirrhosis and large ascites treated with abdominal paracentesis

    Research output: Contribution to journalReviewResearchpeer-review

  3. Radix Sophorae flavescentis versus other drugs or herbs for chronic hepatitis B

    Research output: Contribution to journalReviewResearchpeer-review

  4. Social skills training for attention deficit hyperactivity disorder (ADHD) in children aged 5 to 18 years

    Research output: Contribution to journalReviewResearchpeer-review

  5. Power estimations for non-primary outcomes in randomised clinical trials

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations
Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998. Quality was assessed by means of a validated 5-point scale and separate quality components associated with empirical evidence of bias. Only 26% of all RCTs reported sample size calculations, 52% adequate generation of the allocation sequence, 34% adequate allocation concealment and 34% double-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate portal hypertension (odds ratio [OR]: 2.4; 95% CI: 1.1-5.5; P =.03), be multicentered (OR: 3.4; 95% CI: 1.3-8.9; P =.01), sponsored by public organizations (OR: 4.2; 95% CI: 2.1-8.6; P =.0001), or the drug and device industry (OR: 4.7; 95% CI: 2.2-10.2; P =.0001) compared with other therapeutic areas, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers involved and external funding.
Original languageEnglish
JournalHepatology
Volume30
Issue number5
Pages (from-to)1134-8
Number of pages5
ISSN0270-9139
DOIs
Publication statusPublished - Nov 1999

    Research areas

  • Bias (Epidemiology), Clinical Trials as Topic, Ethics, Medical, Gastroenterology, Humans, Liver Diseases, MEDLINE, Periodicals as Topic, Randomized Controlled Trials as Topic, Reproducibility of Results, Research Design, United States

ID: 38925806