title: A Multi-Center Prospective Derivation and Validation of a Clinical Prediction Tool for Severe Clostridium difficile Infection.
abstract: OBJECTIVE
  Prediction of severe clinical outcomes in Clostridium difficile infection (CDI) is important to inform management decisions for optimum patient care. Currently, treatment recommendations for CDI vary based on disease severity but validated methods to predict severe disease are lacking. The aim of the study was to derive and validate a clinical prediction tool for severe outcomes in CDI.
  
  
  METHODS
  A cohort totaling 638 patients with CDI was prospectively studied at three tertiary care clinical sites (Boston, Dublin and Houston). The clinical prediction rule (CPR) was developed by multivariate logistic regression analysis using the Boston cohort and the performance of this model was then evaluated in the combined Houston and Dublin cohorts.
  
  
  RESULTS
  The CPR included the following three binary variables: age ≥ 65 years, peak serum creatinine ≥ 2 mg/dL and peak peripheral blood leukocyte count of ≥ 20,000 cells/μL. The Clostridium difficile severity score (CDSS) correctly classified 76.5% (95% CI: 70.87-81.31) and 72.5% (95% CI: 67.52-76.91) of patients in the derivation and validation cohorts, respectively. In the validation cohort, CDSS scores of 0, 1, 2 or 3 were associated with severe clinical outcomes of CDI in 4.7%, 13.8%, 33.3% and 40.0% of cases respectively.
  
  
  CONCLUSIONS
  We prospectively derived and validated a clinical prediction rule for severe CDI that is simple, reliable and accurate and can be used to identify high-risk patients most likely to benefit from measures to prevent complications of CDI.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Xi
authors.initials: X
authors.lastname: Na
authors.affiliation: Department of Medicine for the Older Person, Mater Misericordiae University Hospital and University College Dublin, Dublin, Ireland.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Martin
authors.affiliation: Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Saurabh
authors.initials: S
authors.lastname: Sethi
authors.affiliation: Department of Medicine for the Older Person, Mater Misericordiae University Hospital and University College Dublin, Dublin, Ireland.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Kyne
authors.affiliation: University of Houston College of Pharmacy, Houston, Texas, United States of America.
authors.forename: Kevin W
authors.initials: KW
authors.lastname: Garey
authors.affiliation: Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Sarah W
authors.initials: SW
authors.lastname: Flores
authors.affiliation: Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Mary
authors.initials: M
authors.lastname: Hu
authors.affiliation: University of Houston College of Pharmacy, Houston, Texas, United States of America.
authors.forename: Dhara N
authors.initials: DN
authors.lastname: Shah
authors.affiliation: Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Kelsey
authors.initials: K
authors.lastname: Shields
authors.affiliation: Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Leffler
authors.affiliation: Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Ciarán P
authors.initials: CP
authors.lastname: Kelly
mesh_terms: D000368:Aged; D016360:Clostridioides difficile / Q000302:isolation & purification* / Q000472:pathogenicity; D003015:Clostridium Infections / Q000175:diagnosis* / Q000382:microbiology / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index