title: Recommendations for authors of manuscripts reporting inhibitor cases developed in previously treated patients with hemophilia: communication from the SSC of the ISTH.
abstract: Aim The scope of this recommendation is to provide guidance for reporting of inhibitor cases in previously treated patients (PTPs) with hemophilia A. This guidance is intended to improve transparency and completeness of reporting of observed events; it does not cover planning, executing or analyzing original studies aimed at the assessment of inhibitor rates. Recommendation We recommend that for each case of inhibitor development reported in a published paper, a paragraph or a table is included in the main publication reporting as a minimum the underlined data fields in Table . We recommend transparent reporting when any of the suggested information is not available. We recommend that particular care is used in reporting the timeline of events by clearly identifying a reference time-point. We suggest that journals in the field adopt this guidance as instructions for the authors and as a guide for reviewers. Conclusion Development of inhibitors in PTPs is a very rare event. Standardized reporting of inhibitor characteristics will contribute to generating a body of evidence otherwise not available. Case by case reporting of the recommended data elements may shed light on the natural history and risk factors of inhibitor development in PTPs and be useful for tailoring care in similar future cases.
authors: Department of Medicine, McMaster University, Hamilton, ON, Canada.|Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
authors: A
authors: 0000-0002-3331-8766
authors: A
authors: Iorio
authors: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
authors: A M
authors: 0000-0003-0449-0572
authors: AM
authors: Barbara
authors: Department of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.
authors: F
authors: F
authors: Bernardi
authors: Pathology, Queens University, Kingston, ON, Canada.
authors: D
authors: D
authors: Lillicrap
authors: Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital, Sheffield, UK.
authors: M
authors: M
authors: Makris
authors: A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.|Department of Pathophysiology and Transplantation Università degli Studi di Milano, Milan, Italy.
authors: F
authors: F
authors: Peyvandi
authors: Einthoven Laboratory for Experimental Vascular Medicine, Leiden University Medical Center, Leiden, the Netherlands.
authors: F
authors: F
authors: Rosendaal
mesh_terms: D003029:Coagulants; D003625:Data Collection; D005164:Factor IX / Q000037:antagonists & inhibitors / Q000276:immunology; D005169:Factor VIII / Q000037:antagonists & inhibitors / Q000276:immunology; D006405:Hematology / Q000379:methods / Q000592:standards*; D006467:Hemophilia A / Q000628:therapy*; D006801:Humans; D015994:Incidence; D033181:Information Dissemination / Q000379:methods*; D007518:Isoantibodies / Q000276:immunology*; D011642:Publications; D012307:Risk Factors; D013997:Time Factors
chemical_list: D003029:Coagulants; D007518:Isoantibodies; D005169:Factor VIII; D005164:Factor IX