The Trillium Health Centre, located in Mississauga, Ontario, serves more than 1 million residents in the Peel Region. At the time of the study reported here, this hospital had 794 acute, rehabilitation, and chronic care beds. An outbreak of CDAD was declared on February 28, 2007, after evidence of transmission among patients and an increase in the incidence of disease above the institution’s baseline rate. For this study, data were collected for patients with confirmed infection identified from February 28, 2007, until January 22, 2008, when the predefined number of case participants was reached. The outbreak continued beyond the date of study completion.
Case patients with hospital-acquired infection were identified from reports generated by the hospital’s Infection Prevention and Control department, which listed all positive results on assays for C. difficile toxin. The diagnosis of C. difficile infection in any patient was based on the occurrence of at least one positive result on the toxin assay during the outbreak period. Potential case patients were excluded if they had a negative result on the toxin assay despite colonoscopic evidence of pseudomembranous disease, if the C. difficile infection had been acquired in the community, if they had cancer or malignancy that had been treated with cancer chemotherapy in the preceding 8 weeks, or if the CDAD was a relapse of an earlier infection. A relapse was defined as an occurrence of the infection within 2 months of the initial infection. Therefore, for patients with a relapse within 2 months, data were recorded from only the initial infection, whereas for patients with a recurrent infection occurring more than 2 months after the initial infection, the initial infection and the recurrent infection were considered as 2 separate cases.
A total of 150 consecutive cases of C. difficile were included in the review of electronic medication administration records and charts. When further clarification was required, the original paper charts were retrieved and reviewed.
Case patients met the definition of the primary outcome if the electronic medication profile or medication administration record indicated that a PPI was being taken on the date of the CDAD diagnosis. This definition of “current use” was chosen to ensure accurate data collection from the electronic records. Past use of a PPI at any time before the date of the CDAD diagnosis was also recorded. A lenient definition of “past use” was used, as there is a lack of evidence to support a specific timeframe within which patients’ risk increases as a result of altered acid secretion. PPIs can substantially reduce stomach acidity after only a single dose. Past use was identified through the hospital’s electronic medication records or from the patient’s acknowledgement of use before admission to hospital, as noted in admission records.
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Potential controls were identified using a patient discharge report from the hospital’s medication information system (Meditech, version 5.62; Medical Information Technology, Inc, Westwood, Massachusetts). Controls were matched 1:1 to case patients for sex, age within 5 years, date of discharge within 1 month of the diagnosis of CDAD for the matched case, and hospital unit. Multiple potential controls were available for each case, and the matched control for any given case was selected at random from those available. Any control patient with microbiological evidence of a previous C. difficile infection or receipt of cancer chemotherapy within the preceding 8 weeks was excluded as a control. The electronic hospital records for all control patients were then reviewed. Paper charts were retrieved if required to clarify any information in the electronic file. The 1:1 ratio of cases to controls was chosen to ensure accuracy of data collection, appropriate matching of patients within the 2 groups, and feasibility of completing the study within the allotted time period.