BACKGROUND: Variations in testing for Clostridium difficile infection can hinder patients' care, increase the risk of transmission, and skew epidemiological data. We aimed to measure the underdiagnosis of C difficile infection across Europe. METHODS: We did a questionnaire-based study at 482 participating hospitals across 20 European countries. Hospitals were questioned about their methods and testing policy for C difficile infection during the periods September, 2011, to August, 2012, and September, 2012, to August, 2013. On one day in winter, 2012-13 (December, 2012, or January, 2013), and summer, 2013 (July or August), every hospital sent all diarrhoeal samples submitted to their microbiology laboratory to a national coordinating laboratory for standardised testing of C difficile infection. Our primary outcome measures were the rates of testing for and cases of C difficile infection per 10 000 patient bed-days. Results of local and national C difficile infection testing were compared with each other. If the result was positive at the national laboratory but negative at the local hospital, the result was classified as undiagnosed C difficile infection. We compared differences in proportions with the Mann-Whitney test, or McNemar's test if data were matched. FINDINGS: During the study period, participating hospitals reported a mean of 65·8 tests (country range 4·6-223·3) for C difficile infection per 10 000 patient-bed days and a mean of 7·0 cases (country range 0·7-28·7) of C difficile infection per 10 000 patient-bed days. Only two-fifths of hospitals reported using optimum methods for testing of C difficile infection (defined by European guidelines), although the number of participating hospitals using optimum methods increased during the study period, from 152 (32%) of 468 in 2011-12 to 205 (48%) of 428 in 2012-13. Across all 482 European hospitals on the two sampling days, 148 (23%) of 641 samples positive for C difficile infection (as determined by the national laboratory) were not diagnosed by participating hospitals because of an absence of clinical suspicion, equating to about 74 missed diagnoses per day. INTERPRETATION: A wide variety of testing strategies for C difficile infection are used across Europe. Absence of clinical suspicion and suboptimum laboratory diagnostic methods mean that an estimated 40 000 inpatients with C difficile infection are potentially undiagnosed every year in 482 European hospitals. FUNDING: Astellas Pharmaceuticals Europe.

'Cantacuzino' National Institute of Research and Development for Microbiology and Immunology Bucharest Romania

Astellas Pharma Europe Chertsey UK

Austrian Agency for Health and Food Safety Institute for Medical Microbiology and Hygiene Vienna Austria

Bacteriology Unit National Institute for Health and Welfare Helsinki Finland

Catedrático Jefe de Servicio Microbiologica Clinica E Infecciosas Hospital General Universitario 'Gregorio Marañón' Madrid Spain

Department of Bacteriology National Centre for Epidemiology Budapest Hungary

Department of Infectious Diseases National Institute for Health 'Dr Ricardo Jorge' Lisbon Portugal

Department of Medical Microbiology Leiden University Medical Centre Leiden Netherlands

Department of Medical Microbiology Medical University of Warsaw Warsaw Poland

Department of Medical Microbiology University Hospital in Motol Prague Czech Republic

EUCLID European Coordinators University of Leeds Leeds UK

Health Protection Surveillance Centre and Beaumont Hospital Dublin Ireland

Institute of Medical Microbiology and Hygiene University of Saarland Medical Centre Homburg Saar Germany

Istituto Superiore di Sanità Department of Infectious Diseases Rome Italy

Jessenius Faculty of Medicine in Martin Comenius University Bratislava Martin Slovakia

National Centre of Infectious and Parasitic Diseases Sofia Bulgaria

National Laboratory for Health Environment and Food and University of Maribor Faculty of Medicine Maribor Slovenia

National Reference Laboratory for Clostridium difficile Université Pierre et Marie Curie Paris France

Örebro University Hospital Örebro Sweden

Univerisité Catholique de Louvain Institut de Recherché Expérimentale et Clinique Brussels Belgium

University Hospital Medical School University of Thessalia Larissa Greece

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Lancet Infect Dis. 2014 Dec;14(12):1167-8. doi: 10.1016/S1473-3099(14)71010-2. PubMed

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