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Introduction: Obeticholic acid (OCA) treatment for primary biliary cholangitis (PBC) was conditionally approved in the phase 3 POISE trial. The COBALT confirmatory trial assessed whether clinical outcomes in patients with PBC improve with OCA therapy., Methods: Patients randomized to OCA (5-10 mg) were compared with placebo (randomized controlled trial [RCT]) or external control (EC). The primary composite endpoint was time to death, liver transplant, model for end-stage liver disease score ≥15, uncontrolled ascites, or hospitalization for hepatic decompensation. A prespecified propensity score-weighted EC group was derived from a US healthcare claims database., Results: In the RCT, the primary endpoint occurred in 28.6% of OCA (n = 168) and 28.9% of placebo patients (n = 166; intent-to-treat analysis hazard ratio [HR] = 1.01, 95% confidence interval = 0.68-1.51), but functional unblinding and crossover to commercial therapy occurred, especially in the placebo arm. Correcting for these using inverse probability of censoring weighting and as-treated analyses shifted the HR to favor OCA. In the EC (n = 1,051), the weighted primary endpoint occurred in 10.1% of OCA and 21.5% of non-OCA patients (HR = 0.39; 95% confidence interval = 0.22-0.69; P = 0.001). No new safety signals were identified in the RCT., Discussion: Functional unblinding and treatment crossover, particularly in the placebo arm, confounded the intent-to-treat estimate of outcomes associated with OCA in the RCT. Comparison with the real-world EC showed that OCA treatment significantly reduced the risk of negative clinical outcomes. These analyses demonstrate the value of EC data in confirmatory trials and suggest that treatment with OCA improves clinical outcomes in patients with PBC., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Objectives: The objective of this study was to assess the factors affecting testing behaviours amongst the population in Ondo and Lagos States. Methods: A cross-sectional study involving 704 individuals who were considered eligible for COVID-19 testing in 4 local governments in Lagos (307) and Ondo (397) states in Nigeria, was conducted from April-June 2021. Respondents were selected using simple random sampling. A close-ended questionnaire was administered using a digital survey platform known as SurveyCTO. Data were analyzed using R 4.1.0. Results: In Lagos state, 52.4% were females, 47.2% were males while in Ondo, 55.2% were females, 44.6% were male. Chi-square tests of association revealed that socio demographic factors significantly associated with testing patterns was education level in Lagos, and none in Ondo. Testing behavior associated with testing patterns included awareness of nearby COVID-19 testing centers, internet access, knowledge of preexisting conditions and having another member of the family testing positive at 5% significance level. Conclusion: Knowledge of pre-existing conditions, knowledge of COVID-19 symptoms, and knowing where to go when having symptoms were significantly associated with testing and willingness to test., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Amoo, Tijani, Onuigbo, Oraegbu, Kareithi, Obi, Adeniji, Dosunmu, Karera, Filani, Akinreni, Ezike, Owoseni, Audu and Salako.)