title: An extension of STARD statements for reporting diagnostic accuracy studies on liver fibrosis tests: the Liver-FibroSTARD standards.
abstract: OBJECTIVE
  Chronic liver diseases are highly prevalent and require an accurate evaluation of liver fibrosis to determine patient management. Over the last decade, great effort has been made to develop non-invasive liver fibrosis tests. The ensuing increase of literature is, however, impaired by extensive heterogeneity in the quality of published reports. The Standards for Reporting of Diagnostic Accuracy Studies (STARD), first published in 2003, were developed to improve the quality of research reports on diagnostic studies. We aimed to evaluate STARD statements in the setting of diagnostic studies on non-invasive liver fibrosis tests, and to propose an extended version developed specifically for those studies.
  
  
  METHODS
  Eight French experts evaluated STARD statement adequacy in 10 studies on non-invasive liver fibrosis tests and then developed an extended version with a glossary. The new checklist and glossary were independently evaluated by seven international experts.
  
  
  RESULTS
  Fourteen of the 25 STARD items were considered only partially adequate for the evaluation of diagnostic studies on non-invasive liver fibrosis tests. Inter-expert agreement was at least very good for 8 STARD items (32%), moderate for 9 (36%), and poor or very poor for 8 (32%). The experts' proposals were developed into the new Liver-FibroSTARD standards including a checklist with 62 items/sub-items and a corresponding comprehensive glossary. New proposals were inserted in the 25 STARD items as a complementary module. Independent evaluation of the Liver-FibroSTARD checklist showed at least very good inter-expert agreement for 39 items/sub-items (63%), moderate agreement for 11 (18%), and poor or very poor agreement for only 12 (19%).
  
  
  CONCLUSIONS
  As a supplement of the STARD statements, the Liver-FibroSTARD checklist and its glossary are new tools specifically designed for the evaluation of diagnostic studies about non-invasive liver fibrosis tests.
authors.affiliation: Hepatology Department, University Hospital & LUNAM University, Angers, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Boursier
authors.affiliation: Centre d'investigation de la fibrose hépatique, Hôpital Haut-Lévêque, Pessac, France; INSERM U1053, Université de Bordeaux, Bordeaux, France.
authors.forename: Victor
authors.initials: V
authors.lastname: de Ledinghen
authors.affiliation: Assistance Publique Hôpitaux de Paris, La Pitiè Salpêtrière & University Pierre et Marie Curie, Paris, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
authors.affiliation: Department of Laboratory Medicine, Saint-Antoine Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Guéchot
authors.affiliation: Sorbonne Universités, University Pierre et Marie Curie, UMR S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France; Public Health Unit, Saint-Antoine Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Carrat
authors.affiliation: Hepato-Gastroenterology Clinic, University Hospital, INSERM U823, Grenoble Alpes University, Grenoble, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Leroy
authors.affiliation: Institute of Digestive Disease, Department of Medicine & Therapeutics, and State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.
authors.forename: Grace Lai-Hung
authors.initials: GL
authors.lastname: Wong
authors.affiliation: Department of Internal Medicine 1, J.W. Goethe-University Hospital, Frankfurt am Main, Germany.
authors.forename: Mireen
authors.initials: M
authors.lastname: Friedrich-Rust
authors.affiliation: Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milano, Italy.
authors.forename: Mirella
authors.initials: M
authors.lastname: Fraquelli
authors.affiliation: Department of Laboratory Medicine, University-Hospital, Padova, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Plebani
authors.affiliation: Division of Gastroenterology, Royal Victoria Hospital, McGill University Health Centre, Montreal, QC, Canada.
authors.forename: Giada
authors.initials: G
authors.lastname: Sebastiani
authors.affiliation: Liver Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Myers
authors.affiliation: Division of Digestive Diseases and Nutrition, University of Kentucky, Medical Center, Lexington, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Angulo
authors.affiliation: Hepatology Department, University Hospital & LUNAM University, Angers, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Bertrais
authors.affiliation: Department of Pathology, Saint Antoine Hospital, Assistance Publique Hôpitaux de Paris, Sorbonne Universités, University Pierre et Marie Curie, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Wendum
authors.affiliation: Department of Radiology, University Hospital Michallon, Grenoble Alpes University, Grenoble, France.
authors.forename: Ivan
authors.initials: I
authors.lastname: Bricault
authors.affiliation: Hepatology Department, University Hospital & LUNAM University, Angers, France. Electronic address: paul.cales@univ-angers.fr.
authors.forename: Paul
authors.initials: P
authors.lastname: Calès
mesh_terms: D002985:Clinical Protocols; D000068598:Data Accuracy; D061827:Dimensional Measurement Accuracy; D019468:Disease Management; D005602:France; D006801:Humans; D008103:Liver Cirrhosis / Q000175:diagnosis*; D008111:Liver Function Tests / Q000592:standards*; D058996:Quality Improvement; D012015:Reference Standards; D015203:Reproducibility of Results; D058028:Research Report / Q000592:standards*
keywords: Chronic liver diseases; Cirrhosis; Diagnostic tests; Liver fibrosis; STARD