2.7. Study outcomes:
The primary outcome was the pre- and post-intervention carbapenem
consumption as a direct measure of the ASP efficacy, while the secondary
outcomes was the pre- and post-intervention prevalence of theKlebsiella isolates and their resistance.
The study protocol was approved by the institutional review board of the
hospital. The requirements for informed consent were
waived for this retrospective
medical records review. Patient privacy and confidentiality of medical
records and data were maintained all through the study.
2.8. Statistical methods :
Data were collected and coded before analysis using the statistical
package of social science (SPSS version 25). Normal distribution of
different variables was tested using the z-value of skewness and
kurtosis between -1.96 and +1.96 (Doane & Seward, 2011) and the p-value
of Shapiro-Wilk’s test > 0.05 (Razali & Wah, 2011; Shapiro
& Wilk, 1965). The post-intervention was compared to pre-intervention
carbapenems consumption using the independent sample t-test. Chi-Square
test and odds ratio with 95% confidence interval (95% CI) were used
for comparison of qualitative data. One-way ANOVA (Analysis of Variance)
test was used to compare carbapenem consumption among the threeKlebsiella resistance grades. Two ordinal logistic regression
models were used to study the effect of each of carbapenem consumption
and the intervention program on Klebsiella resistance ordinal
grades. Statistical significance was considered at p-value ≤ 0.05.
RESULTS:
A total of 472 patients with positive culture results were initially
evaluated during the study period
of 22 months. After excluding 267 patients with culture results with
non-klebsiella organisms, the remaining 205 patients represented
our study sample. The initial 11 months from April 2017 till February
2018 represented the pre-intervention control period and included 61
patients (29.8 %), while the following 11 months from March 2018 till
January 2019 represented the post-intervention period and included 144
patients (70.2 %). Sputum samples were the most common representing 95
samples (46.3 %). Other samples included 38 for urine (18.5 %), 32 for
wound swabs (15.6 %), 23 for blood cultures (11.2 %), and 17 for other
samples (8 %).