An extension of STARD statements for reporting diagnostic accuracy studies on liver fibrosis tests: the Liver-FibroSTARD standards

Jérôme Boursier; Victor de Ledinghen; Thierry Poynard; Jérôme Guéchot; Fabrice Carrat; Vincent Leroy; Grace Lai-Hung Wong; Mireen Friedrich-Rust; Mirella Fraquelli; Mario Plebani; Giada Sebastiani; Robert Myers; Paul Angulo; Sandrine Bertrais; Dominique Wendum; Ivan Bricault; Paul Calès; ARDENT group; AFEF

doi:10.1016/j.jhep.2014.10.042

An extension of STARD statements for reporting diagnostic accuracy studies on liver fibrosis tests: the Liver-FibroSTARD standards

J Hepatol. 2015 Apr;62(4):807-15. doi: 10.1016/j.jhep.2014.10.042. Epub 2014 Nov 5.

Authors

Jérôme Boursier¹, Victor de Ledinghen², Thierry Poynard³, Jérôme Guéchot⁴, Fabrice Carrat⁵, Vincent Leroy⁶, Grace Lai-Hung Wong⁷, Mireen Friedrich-Rust⁸, Mirella Fraquelli⁹, Mario Plebani¹⁰, Giada Sebastiani¹¹, Robert Myers¹², Paul Angulo¹³, Sandrine Bertrais¹, Dominique Wendum¹⁴, Ivan Bricault¹⁵, Paul Calès¹⁶; ARDENT group; AFEF

Affiliations

¹ Hepatology Department, University Hospital & LUNAM University, Angers, France.
² Centre d'investigation de la fibrose hépatique, Hôpital Haut-Lévêque, Pessac, France; INSERM U1053, Université de Bordeaux, Bordeaux, France.
³ Assistance Publique Hôpitaux de Paris, La Pitiè Salpêtrière & University Pierre et Marie Curie, Paris, France.
⁴ Department of Laboratory Medicine, Saint-Antoine Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
⁵ 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.
⁶ Hepato-Gastroenterology Clinic, University Hospital, INSERM U823, Grenoble Alpes University, Grenoble, France.
⁷ Institute of Digestive Disease, Department of Medicine & Therapeutics, and State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.
⁸ Department of Internal Medicine 1, J.W. Goethe-University Hospital, Frankfurt am Main, Germany.
⁹ Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milano, Italy.
¹⁰ Department of Laboratory Medicine, University-Hospital, Padova, Italy.
¹¹ Division of Gastroenterology, Royal Victoria Hospital, McGill University Health Centre, Montreal, QC, Canada.
¹² Liver Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.
¹³ Division of Digestive Diseases and Nutrition, University of Kentucky, Medical Center, Lexington, USA.
¹⁴ Department of Pathology, Saint Antoine Hospital, Assistance Publique Hôpitaux de Paris, Sorbonne Universités, University Pierre et Marie Curie, Paris, France.
¹⁵ Department of Radiology, University Hospital Michallon, Grenoble Alpes University, Grenoble, France.
¹⁶ Hepatology Department, University Hospital & LUNAM University, Angers, France. Electronic address: paul.cales@univ-angers.fr.

PMID: 25450206
DOI: 10.1016/j.jhep.2014.10.042

Abstract

Background & aims: 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.

Keywords: Chronic liver diseases; Cirrhosis; Diagnostic tests; Liver fibrosis; STARD.

MeSH terms

Clinical Protocols
Data Accuracy*
Dimensional Measurement Accuracy*
Disease Management
France
Humans
Liver Cirrhosis / diagnosis*
Liver Function Tests / standards*
Quality Improvement
Reference Standards
Reproducibility of Results
Research Report / standards*