Consensus position statement on advancing the standardised reporting of infection events in immunocompromised patients - 21/12/23

Doi : 10.1016/S1473-3099(23)00377-8

Benjamin W Teh, PhD ^a,^b,^{*
Co-first authors}⁎ , Malgorzata Mikulska, PhD ^c,^d,^{*
Co-first authors}, Dina Averbuch, MD ^e,^f, Rafael de la Camara, ProfMD ^g, Hans H Hirsch, ProfMD ^h,ⁱ, Murat Akova, ProfMD ^j, Luis Ostrosky-Zeichner, ProfMD ^k, John W Baddley, ProfMD ^l, Ban Hock Tan, ProfMBBS ^m, Alessandra Mularoni, MD ⁿ, Aruna K Subramanian, ProfMD ^o, Ricardo M La Hoz, MD ^p, Tina Marinelli, MBBS ^q, Peter Boan, MBBS ^r,^s, Jose Maria Aguado, ProfPhD ^t, Paolo A Grossi, ProfMD ^u, Johan Maertens, ProfPhD ^v, Nicolas J Mueller, ProfMD ^w,^{^{†
Co-senior authors}}, Monica A Slavin, ProfMD ^a,^b,^x,^{^{†
Co-senior authors}}
^a Department of Infectious Diseases, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
^b Sir Peter MacCallum Department of Oncology, University of Melbourne, VIC, Australia
^c Division of Infectious Diseases, Department of Health Sciences, University of Genoa, Genoa, Italy
^d IRCCS Ospedale Policlinico San Martino, Genoa, Italy
^e Pediatric Infectious Diseases, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel
^f Hadassah Medical Center, Jerusalem, Israel
^g Department of Haematology, Hospital de la Princesa, Madrid, Spain
^h Transplantation & Clinical Virology, Department of Biomedicine, University of Basel, Basel, Switzerland
ⁱ Infectious Diseases & Hospital Epidemiology, University Hospital Basel, Basel, Switzerland
^j Department of Infectious Diseases, Hacettepe University School of Medicine, Ankara, Turkey
^k Division of Infectious Diseases, McGovern Medical School, University of Texas, Houston, TX, USA
^l Department of Medicine, Division of Infectious Diseases, University of Maryland School of Medicine, Baltimore, MD, USA
^m Department of Infectious Diseases, Singapore General Hospital, Singapore
ⁿ Department of Infectious Diseases, Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (IRCCS), Palermo, Italy
^o Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA, USA
^p Division of Infectious Diseases and Geographic Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA
^q Department of Infectious Diseases, Royal Prince Alfred Hospital, Sydney, NSW, Australia
^r Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, WA, Australia
^s Department of Microbiology, PathWest Laboratory Medicine WA, Fiona Stanley Hospital, Murdoch, WA, Australia
^t Unit of Infectious Diseases, Hospital Universitario “12 de Octubre”, Instituto de Investigación Sanitaria Hospital “12 de Octubre” (imas12), CIBERINFEC, Universidad Complutense, Madrid, Spain
^u Infectious and Tropical Diseases Unit, Department of Medicine and Surgery, University of Insubria-ASST-Sette Laghi, Varese, Italy
^v Department of Haematology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium
^w Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zürich, Switzerland
^x Victorian Infectious Diseases Service, Royal Melbourne Hospital, Parkville, VIC, Australia

^*Correspondence to: Assoc Prof Benjamin W Teh, Department of Infectious Diseases, Peter MacCallum Cancer Centre, Melbourne 3000, VIC, AustraliaDepartment of Infectious DiseasesPeter MacCallum Cancer CentreMelbourneVIC3000Australia

Summary

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.

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Plan

Introduction

Development process

Core minimum reporting dataset

Additional context required for studies evaluating new therapies and pathogen-based studies

Additional data for randomised controlled trials

Additional data for observational studies

Additional data for pathogen-based studies

Special considerations for assessing infection events in immunocompromised patients

Future directions

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Vol 24 - N° 1

P. e59-e68 - janvier 2024 Retour au numéro

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Consensus position statement on advancing the standardised reporting of infection events in immunocompromised patients - 21/12/23

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