Consensus position statement on advancing the standardised reporting of infection events in immunocompromised patients.

Patients can be immunocompromised from a diverse range of disease and treatment factors, including malignancies, autoimmune disorders and their treatments, and organ and stem-cell transplantation. Infections are a leading cause of morbidity and mortality in immunocompromised patients, and the disease treatment landscape is continually evolving. Despite being a critical but preventable and curable adverse event, the reporting of infection events in randomised trials lacks sufficient detail while inconsistency of categorisation and definition of infections in observational and registry studies limits comparability and future pooling of data. A core reporting dataset consisting of category, site, severity, organism, and endpoints was developed as a minimum standard for reporting of infection events in immunocompromised patients across study types. Further additional information is recommended depending on study type. The standardised reporting of infectious events and attributable complications in immunocompromised patients will improve diagnostic, treatment, and prevention approaches and facilitate future research in this patient group.

Informations de copyright

Copyright © 2023 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests BWT has received grants from Seqirus and MSD, and has been on the advisory board for Takeda, CSL-Behring, and Moderna. RdlC has consulted for Moderna and AstraZeneca, and received honoraria from MSD, Shionogi, Astellas, Moderna, Atara, Pfizer, and Gilead. HHH has consulted for Molecular Partners, Roche, and Vero Tx, and received honoraria from Gilead, MSD, and Vero Tx. LO-Z has received grants from Scynexis, Pulmocide, Gilead, Astellas, Pfizer, T2, and the National Institutes of Health, and has consulted for F2G, GSK, Melinta, Pfizer, Viracor, Cidara, and Gilead. BHT is on the advisory board for Pfizer and MSD. RMLH is on the advisory board for Takeda. PAG has consulted for MSD, Allovir, and Takeda; received honoraria from MSD, Atara, Takeda, and Gilead; and is on the data safety and monitoring and advisory boards for Reithera. NJM has received a grant from the Swiss National Science Foundation and meeting support from Bio Test and Pfizer. MAS has received grants from Gilead, MSD, and F2G. All other authors declare no competing interests.