Benefits and harms of hepatocellular carcinoma screening outreach in patients with cirrhosis: a multicenter randomized clinical trial
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Le résumé fourni par la source
BACKGROUND: The value of hepatocellular carcinoma screening is defined by the balance of benefits from early tumor detection vs harms because of false-positive results. We evaluated the value of a mailed outreach strategy for hepatocellular carcinoma screening in patients with cirrhosis. METHODS: We conducted a multicenter pragmatic randomized clinical trial comparing mailed outreach for hepatocellular carcinoma screening (n = 1436) and usual care with visit-based screening (n = 1436) among patients with cirrhosis at 3 health systems from March 2018 to September 2021. Outcomes of interest were early stage hepatocellular carcinoma detection (ie, screening benefit) and diagnostic evaluation for false-positive or indeterminate results (ie, screening harm). Screening harm was categorized as mild, moderate, and severe based on number and type of diagnostic exams. All patients were included in intention-to-screen analyses. RESULTS: Of 125 patients diagnosed with hepatocellular carcinoma (67 outreach and 58 usual care), 71.2% were found at an early stage per the Milan criteria. Early tumor detection did not statistically significantly differ between the outreach and usual care arms (64.2% vs 79.3%; P = .06). The proportion of patients with physical harms also did not differ between the outreach and usual care arms (10.8% vs 10.7%; P = .95) with 5.9% in both arms having mild harms; 4.0% and 3.8%, respectively, with moderate harms; and 0.9% and 1.0%, respectively, with severe harms. CONCLUSION: Most patients enrolled in hepatocellular carcinoma screening were detected at an early stage, and a minority experienced physical harms. A mailed outreach strategy did not increase early hepatocellular carcinoma detection or physical harms compared with usual care. CLINICAL TRIALS NUMBER: NCT02582918 and NCT03756051.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Benefits and harms of hepatocellular carcinoma screening outreach in patients with cirrhosis: a multicenter randomized clinical trial
- Date Crossref
- 17/09/2024
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Parkland Health & Hospital System pays non établi dans la noticeÉtablissement de santé
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The University of Texas Southwestern Medical Center pays non établi dans la noticeÉtablissement de santé
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Michael E. DeBakey VA Medical Center pays non établi dans la noticeÉtablissement de santé
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Center for Innovation pays non établi dans la noticeStructure de recherche
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Baylor College of Medicine Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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University of Texas Southwestern Medical Center and Parkland Health Hospital System Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
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Michael E. DeBakey Veterans Affairs Medical Center Effectiveness and Safety pays non établi dans la noticeÉtablissement de santé
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O’Donnell School of Public Health pays non établi dans la noticeUniversité ou école supérieure
Parkland Health & Hospital System, The University of Texas Southwestern Medical Center et Michael E. DeBakey VA Medical Center, avec 5 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.