Prospective derivation and validation of a clinical prediction rule for recurrent Clostridium difficile infection

Gastroenterology. 2009 Apr;136(4):1206-14. doi: 10.1053/j.gastro.2008.12.038. Epub 2008 Dec 13.

Abstract

Background & aims: Prevention of recurrent Clostridium difficile infection (CDI) is a substantial therapeutic challenge. A previous prospective study of 63 patients with CDI identified risk factors associated with recurrence. This study aimed to develop a prediction rule for recurrent CDI using the above derivation cohort and prospectively evaluate the performance of this rule in an independent validation cohort.

Methods: The clinical prediction rule was developed by multivariate logistic regression analysis and included the following variables: age>65 years, severe or fulminant illness (by the Horn index), and additional antibiotic use after CDI therapy. A second rule combined data on serum concentrations of immunoglobulin G (IgG) against toxin A with the clinical predictors. Both rules were then evaluated prospectively in an independent cohort of 89 patients with CDI.

Results: The clinical prediction rule discriminated between patients with and without recurrent CDI, with an area under the curve of the receiver-operating-characteristic curve of 0.83 (95% confidence interval [CI]: 0.70-0.95) in the derivation cohort and 0.80 (95% CI: 0.67-0.92) in the validation cohort. The rule correctly classified 77.3% (95% CI: 62.2%-88.5%) and 71.9% (95% CI: 59.2%-82.4%) of patients in the derivation and validation cohorts, respectively. The combined rule performed well in the derivation cohort but not in the validation cohort (area under the curve of the receiver-operating-characteristic curve, 0.89 vs 0.62; diagnostic accuracy, 93.8% vs 69.2%, respectively).

Conclusions: We prospectively derived and validated a clinical prediction rule for recurrent CDI that is simple, reliable, and accurate and can be used to identify high-risk patients most likely to benefit from measures to prevent recurrence.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / therapeutic use
  • Bacterial Toxins / immunology
  • Clostridioides difficile / pathogenicity*
  • Enterocolitis, Pseudomembranous / blood
  • Enterocolitis, Pseudomembranous / epidemiology*
  • Enterocolitis, Pseudomembranous / prevention & control*
  • Enterotoxins / immunology
  • Female
  • Humans
  • Immunoglobulin G / blood
  • Logistic Models
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • ROC Curve
  • Risk Factors
  • Secondary Prevention
  • Sensitivity and Specificity

Substances

  • Anti-Bacterial Agents
  • Bacterial Toxins
  • Enterotoxins
  • Immunoglobulin G
  • tcdA protein, Clostridium difficile