ArticleHepatology (Baltimore, Md.)2020
Ordinal Outcomes Are Superior to Binary Outcomes for Designing and Evaluating Clinical Trials in Compensated Cirrhosis.
Article in Hepatology (Baltimore, Md.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed.
- Statistical Practice of Ordinal Outcome Analysis in Neurologic Trials: A Literature Review.Neurology · 2025Review
- A roadmap for clinical trials in MASH-related compensated cirrhosis.Nature reviews. Gastroenterology & hepatology · 2024Review
- A Bayesian quasi-likelihood design for identifying the minimum effective dose and maximum utility dose in dose-ranging studies.Statistical methods in medical research · 2024Article
- Distinct on-treatment HCC risks associated with different decompensation events in HBV patients with cirrhosis.Hepatology international · 2023Article
- Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure.Contemporary clinical trials communications · 2023Article
- Statistical analyses of ordinal outcomes in randomised controlled trials: protocol for a scoping review.Trials · 2023Article
- Combined analysis of gut microbiota, diet and PNPLA3 polymorphism in biopsy-proven non-alcoholic fatty liver disease.Liver international : official journal of the International Association for the Study of the Liver · 2021Article
- Methodological approaches for analysing data from therapeutic efficacy studies.Malaria journal · 2021Article
- [Methodological considerations in the design of clinical trial for innovative hepatitis B drugs].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2020Article
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
BACKGROUND AND
aimsPrevention of decompensation is a primary therapeutic target in patients with compensated cirrhosis (CC). However, a major problem is the large sample size and long follow-up required to demonstrate a significant treatment effect because of the relatively low baseline risk. For this reason, it has been recently suggested that ordinal outcomes may be used in this area to gain power and reduce sample size. The aim of this study was to assess the applicability of ordinal outcomes in cirrhosis. APPROACH AND
resultsAn inception cohort of 202 patients with CC (no ascites, gastrointestinal bleeding, encephalopathy, or jaundice) without esophageal varices was included, and 5-year outcome is reported. Etiology was mostly viral and alcoholic, and there were no dropouts. Ordinal outcome was set according to six grades with a previously established prognostic ordinality: grade 1 = no disease progression; grade 2 = development of varices; grade 3 = bleeding alone; grade 4 = nonbleeding single decompensation; grade 5 = more than one decompensating event; and grade 6 = death. At the 60-month time point, patients were distributed in grades 1 through 6 as follows: 129, 43, 2, 7, 5, and 16, respectively. Emulation of a clinical trial performed by dividing patients based on baseline platelet count into two groups (cutoff, 150 × 10
conclusionsCompared to traditional binary outcomes, the use of ordinal outcomes in trials of cirrhosis decompensation may provide more power and thus may require a smaller sample size.
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