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Pinyo Rattanaumpawan et al
Fig. 1. Study flow chart.
correlation of 0.0001. The mean DDD of targeted antibiotics per prescription was 7.0, with an intracluster correlation of 0.00001. We hypothesized that the pharmacist PPRA group would not be inferior to the fellow PPRA group in terms of the favorable clinical response (with a noninferiority margin of 10%) and mean DDD of targeted antibiotics per prescription (with a noninferiority margin of 1.5 DDD). After adjusting for the clustering effect (design effect), the total sample size for the favorable clinical response and DDD of targeted antibiotic was 600 prescriptions (100 per cluster) and 540 prescriptions (90 per cluster), respectively.
Statistical analysis
Categorical variables were reported as frequencies and percen- tages. According to the distribution of the data, continuous variables were reported as means±standard deviations, medians, and ranges. We used intention-to-treat analysis with clustering effect adjustment in assessing all treatment outcomes. We also calculated the percent agreement between the independent ID physician and the trained pharmacist or ID clinical fellow. We performed all analyses using Stata version 14.0 software (StataCorp, College Station, TX) with 2-sided analysis. We con- sidered a P value≤.05 to be statistically significant.
Results
During the 8-month study period (February to September 2013), there were 1,632 hospitalizations in the study medical wards: 799 hospitalizations in the pharmacist PPRA group and 833 in the fellow PPRA group. Of those 1,632 hospitalizations, there were 610 prescriptions with at least 1 dose of the targeted antibiotics: 303 prescriptions in the pharmacist PPRA group and 307 pre- scriptions in the fellow PPRA group). The study flow chart appears in Fig. 1.
Baseline and clinical characteristics
The baseline characteristics of the 2 groups are shown in Table 1. The mean ages of patients in the pharmacist PPRA and fellow PPRA groups were 60.06±19.22 and 60.48±19.03 years,
respectively. In both groups, ~60% of participants were female; almost all of them had at least 1 underlying disease. Most of the baseline characteristics were similar in the 2 groups. How- ever, patients in the pharmacist PPRA group had a higher proportion of neutropenia (6.3% vs 2.9%; P=.05), previous use of a urinary catheter (20.5% vs 13.4%; P=.02), and previous exposure to clindamycin during the previous 3 months (3.6% vs 1.0%; P=.03). Table 2 presents the clinical characteristics of the 2 groups (pharmacist PPRA versus fellow PPRA; P value). More than 90% of patients in both groups had clinically documented infections. Almost half of the infections were healthcare-associated infections (53.8% vs 55.7%; P=.41). The 3 leading types of infections in both groups were pneumonia (42.6% vs 44.6%; P=.61), urinary tract infections (21.1% vs 25.7%; P=.18), and bloodstream infections (25.7% vs 22.2%; P=.30).
Treatment outcomes
Table 3 displays the treatment outcomes between the 2 groups (pharmacist PPRA versus fellow PPRA; P value). All treatment outcomes were similar between the 2 groups (P > 0.05). Table 3 also shows the difference in outcomes of interest between the 2 groups. The lower bound of the 95% confidence interval (CI) of difference in all favorable treatment outcomes (favorable clinical response and favorable microbiological response) and the upper bound of the 95% CI of difference in all unfavorable treatment outcomes (ie, 28-day overall mortality, 28-day ID-related mor- tality, superimposed infection, clinically diagnosed antibiotic associated colitis, and antibiotic allergy) did not include the +10% noninferiority margin.
Antibiotic consumption and antibiotic expenditure
Data from the pharmacy database, including antibiotic con- sumption and expenditure from 610 hospitalizations, appear in Table 4. There were no significant differences in the DDD, cost of targeted antibiotics, cost of overall antibiotics per prescription, or length of hospital stay. The difference in the DDD of targeted antibiotic use (pharmacist PPRA minus fellow PPRA) was 0.62 (95% CI, –1.57 to 2.82).
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