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with reduced need for OPAT staff intervention compared to vancomycin.12 Given the well-established concerns regarding antimicrobial
toxicity and the challenges of balancing convenience and comfort with safety and effectiveness, we sought to compare the rates and timing of ADEs and healthcare utilization between patients receiving OPAT antibiotic treatment with vancomycin and dap- tomycin to inform clinical decision making.
Methods Setting
We performed a single-center, retrospective observational cohort study of patients receiving treatment with either daptomycin or vancomycin in the OPAT program of a large tertiary-care aca- demic medical center. Patients enrolled in the OPAT program require consultation with an infectious disease physician, including the determination of the need for >14 days of par- enteral antibiotics following hospital discharge. All enrolled patients have documentation in an integrated inpatient/outpatient electronic health record (EHR) outlining diagnosis, antimicrobial type, dose, anticipated treatment duration, and recommendations for weekly laboratory safety monitoring, based on Infectious Diseases Society of America (IDSA) OPAT Guidelines.16 Laboratory data, clinic visit notes, and telephone notes are entered into the EHR by OPAT staff. Notes from home visits by external infusion companies and visiting nurse agencies were not available.
Cohort identification
Adult patients receiving their initial OPAT treatment course for management of skin and soft-tissue infections, bone and joint infections (including hardware-associated infections and diabetic ulcer infections), bacterial endocarditis, and bacteremia or endovascular infections who were treated with a regimen con- taining vancomycin or daptomycin were eligible for inclusion. The study period was July 1, 2013, through September 30, 2016. Patients were excluded for the following reasons: the initial hos- pital discharge was to hospice care, OPAT enrollment occurred as an outpatient, post-discharge management and follow-up were with a provider outside of the study site’s Infectious Disease OPAT clinic, the patient was receiving chronic renal replacement therapy, or if death occurred prior to completion of OPAT treatment (Fig. 1).
Data collection and definitions
Dates of enrollment, hospital discharge, and infection diagnosis were extracted from the OPAT database. The cohort entry date was defined as the date of discharge from the initial hospitaliza- tion. Data abstracted from the EHR included demographics, insurance status, baseline clinical and laboratory characteristics (Table 1), microbiology results (site of culture and bacterial organism), other antimicrobials administered during OPAT treatment, location of disposition and receipt of OPAT treatment (home, long-term acute care, or skilled nursing facility), type of vascular access used for infusion, recommended and actual duration of OPAT, frequency of clinic visits and telephone calls with OPAT clinic staff, availability of safety lab testing results, and the occurrence and type of ADEs related to antibiotic therapy.
Fig. 1. Patient selection. aSkin and soft-tissue infections, bone and joint infections, endocarditis, and bacteremia/endovascular infections. Abbreviations: OPAT, out- patient parenteral antibiotic therapy; VAN, vancomycin; DAP, daptomycin.
Laboratory testing was considered discordant with IDSA OPAT guidelines if recommended labs were unavailable for review by the treating OPAT physician in the EHR for >1 week of the patient’s treatment course.16 Charlson comorbidity index (CCI) was cal- culated using the International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) or International Classification of Disease, Tenth Revision (ICD-10) codes obtained from hospital fiscal databases.26,27
Outcomes
The primary outcome was defined as a change or early dis- continuation of the antibiotic of interest due to an ADE occurring >7 days prior to the anticipated end date of treatment. An ADE was defined as harm or injury to the individual attributed to the antimicrobial agent according to the treating OPAT physician, as documented in clinic or telephone notes. Secondary outcomes were time from OPAT enrollment to occurrence of ADE, unplanned hospital readmissions and emergency room visits during the 30-day window after completion of OPAT, and change or early discontinuation of the antibiotic of interest due to reason other than ADE occurring >7 days prior to the anticipated end date of treatment. Hospital readmissions and emergency room visits were not independently counted as ADEs, though they may have been related to an ADE.
Gregory M. Schrank et al
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