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Review
. 2024 Aug;24(8):e513-e521.
doi: 10.1016/S1473-3099(23)00778-8. Epub 2024 Mar 5.

A reference standard for urinary tract infection research: a multidisciplinary Delphi consensus study

Manu P Bilsen  1 , Simon P Conroy  2 , Caroline Schneeberger  3 , Tamara N Platteel  4 , Cees van Nieuwkoop  5 , Lona Mody  6 , Jeffrey M Caterino  7 , Suzanne E Geerlings  8 , Bela Köves  9 , Florian Wagenlehner  10 , Marleen Kunneman  11 , Leo G Visser  12 , Merel M C Lambregts  12 ; UTI Reference Standard Consensus Group
Collaborators, Affiliations
Review

A reference standard for urinary tract infection research: a multidisciplinary Delphi consensus study

Manu P Bilsen et al. Lancet Infect Dis. 2024 Aug.

Abstract

The absence of a consensus-based reference standard for urinary tract infection (UTI) research adversely affects the internal and external validity of diagnostic and therapeutic studies. This omission hinders the accumulation of evidence for a disease that imposes a substantial burden on patients and society, particularly in an era of increasing antimicrobial resistance. We did a three-round Delphi study involving an international, multidisciplinary panel of UTI experts (n=46) and achieved a high degree of consensus (94%) on the final reference standard. New-onset dysuria, urinary frequency, and urinary urgency were considered major symptoms, and non-specific symptoms in older patients were not deemed indicative of UTI. The reference standard distinguishes between UTI with and without systemic involvement, abandoning the term complicated UTI. Moreover, different levels of pyuria were incorporated in the reference standard, encouraging quantification of pyuria in studies done in all health-care settings. The traditional bacteriuria threshold (105 colony-forming units per mL) was lowered to 104 colony-forming units per mL. This new reference standard can be used for UTI research across many patient populations and has the potential to increase homogeneity between studies.

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Conflict of interest statement

Declaration of interests SPC reports modest royalties for book editing roles for Oxford University Press and Springer. LM reports a grant from the National Institutes of Health (NIH)—National Institute on Aging (Principle Investigator on National Institute on Aging funded T32 program, Principle Investigator of a K24 mentorship award, Pepper Center Core Director for a National Institute on Aging funded P30), a grant from Veterans Affairs (Clinical Science Research and Development Merit Review Grant Award to conduct research in the veteran population), a grant from the Centers for Disease Control and Prevention via Abt Associates (Centers for Disease Control and Prevention has given a contract to Abt Associates to study viral transmission dynamics in nursing homes; University of Michigan has received a subcontract from Abt associates to study viral shedding among nursing home residents and staff affected by COVID-19), a grant from D Dan and Betty Kahn Foundation (to study nasal microbiome in older nursing home patients), personal fees from the NIH (to serve on study sections), personal fees from Up-to-date (to serve as an author and editor for its Infection and Aging section), personal fees from University of Connecticut OAIC Pepper Center External Advisory Board (to serve on the external advisory board of a National Institute on Aging funded P30), and personal fees from Northwestern University OAIC Pepper Center (to serve on the external advisory board of a National Institute on Aging funded P30). JMC was supported by a grant from the NIH–National Institute on Aging (R01 AG050801). SEG reports receiving consulting fees for being on the international advisory board of Immunotek regarding the MV140 vaccine, and being a consultant for Biomerieux regarding the development of diagnostics tests (fees paid to institution). FW reports receiving consulting fees for being an advisor–consultant for Venatorx Pharmaceuticals, GlaxoSmithKline, Spero Pharmaceuticals, and Bionorica; was supported by Bionorica and GlaxoSmithKline for attending meetings, travel, or both; has received honoraria for speaking at events for Astellas, AstraZeneca, Bionorica, GlaxoSmith line, Janssen, Klosterfrau, MIP Pharma, OM Pharma, and Pfizer; has been part of an advisory board of Achaogen, AstraZeneca, Bionorica, Janssen, LeoPharma, MerLion, Merck Sharp & Dohme, OM Pharma–Vifor Pharma, Pfizer, RosenPharma, Shionogi, Venatorx Pharmaceuticals, and GlaxoSmithKline; has contributed to the development of the German S3 guideline for urinary tract infections, and the Infections in Urology guideline of the European Association of Urology; reports previous study participation for Achaogen, Bionorica, Enteris BioPharma, Helperby Therapeutics, OM Pharma–Vifor Pharma, Shionogi, Deutsches Zentrum für Infektionsforschung; and has been a speaker for the German Research Foundation (Bacterial Renal Infections and Defense). MMCL reports having received a grant for being a Principal Investigator of the E.mbrace study. LGV reports being a co-investigator in a stage III pharmacy-driven vaccine trial to prevent septicemia for UTI by Janssen. All other authors declare no competing interests. None of the funding agencies mentioned above had any role in the conduct of the work or writing of the manuscript.

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