A controlled Intervention Study: Comparison of Intervention on the Antibiotic Prophylaxis of Three Clean Surgeries in Chinese Tertiary Hospitals ()
1. Introduction
The use of antibiotic prophylaxis is an accepted and widely practiced feature in modern surgeries. The prevention and control of infection is a priority in healthcare, and the emergence of antibiotic resistance is a worldwide phenomenon. Though a lowered incidence of SSI with the use of prophylactic antibiotics is well documented, the inappropriateness of antibiotic prophylaxis has also been extensively demonstrated in many situations. Antibiotics are often used in wrong doses, for too long, or with too broad a spectrum of antimicrobial activity [1-4]. Antimicrobial resistance, superinfection and unnecessary costs are common consequences of inappropriate surgical antibiotic prophylaxis [2,5]. Hence, rational use of antibiotics is essential.
World Health Assembly (WHA) resolutions in 1998, 2005 and 2007 urged WHO Member States to formulate measures to encourage appropriate and cost-effective use of medicines [6]. Countries were also encouraged to develop sustainable systems to monitor the volumes and patterns of medicine use and the impact of control measures, and to develop and implement effective interventions to improve the use of medicines. The Chinese Ministry of Health committed to work with WHO on this aspect of medicines use. A series of regulations and rules, working mechanisms and approaches have been developed and implemented in health facilities to improve the use of medicines, especially antibiotics. To monitor the volume and patterns of antibiotic use and the impact of control measures, a National Monitoring Network on Clinical Antibiotics Use (Network) was established in China in 2005, and has been regularly collecting antibiotic use data from 120 tertiary general hospitals around the country. The monitoring report from 2006 to 2007 showed that the proportion of irrational antibiotic use in surgical practice was widespread and serious [7].
With the support of WHO, the Ministry of Health initiated an intervention project to promote rational antibiotic prophylaxis in clean surgeries from 2008 to 2009.
2. Patients and Methods
2.1. Hospital Sampling
The study was conducted in 176 tertiary hospitals in China totally. The sampling frame is within the Network which consists of 164 tertiary hospitals distributed in 31 provinces as control group (CG). All provinces were divided into three groups based on its annual Gross Domestic Product per capita in 2007, three hospitals were randomly selected from each group, and nine hospitals were selected as intervention group (IG). Three hospitals volunteered to join IG, a total of twelve tertiary general hospitals were included in IG.
2.2. Target Surgeries
Three common clean surgeries (thyroidectomy, mastectomy and hernia) were targeted for the intervention.
2.3. Baseline Survey and Evaluation of Rationality
Hospitals in IG were required to collect all the medical records of patients who underwent one of the three targeted surgeries, and discharged in the month of March 2008. Two trained clinical pharmacists were responsible for evaluating the rationality of antibiotic prophylaxis of these cases based on the National Guideline [8]. If no antibiotic was used in a case, it was judged as rational. Non-indicated cases treated with antibiotics were judged as irrational. For those indicated cases using antibiotics, a rational use measurement system (Table 1) was formulated by a group of senior clinical specialists. Ten indicators were identified for evaluating the rationality.
Table 1. Indicators and weights of the rationality evaluation system for antibiotic prophylaxis in clean surgeries.
Each indicator was given a weight, important factors received higher scores. The value range of the rationality score ranged 1 - 100, the larger the score, the more rational the antibiotic use was.
2.4. Interventions
A set of intervention strategies was implemented in the twelve hospitals in IG in three waves between May 2008 and May 2009 (May. to Sep. 2008, Jan. to Feb. 2009, and Apr. to May 2009 respectively), which covered administrative and technical interventions implemented by both the central authority and the local hospitals. Central authority administrative interventions consisted of circulation and implementation of the regulation of Enhance management of rational application of antimicrobials in clinic, issued by the Ministry of Health [9], and also the Ministry of Health’s views about management of application of antimicrobials in clinics [10]. Central authority technical interventions comprised launching the Drug and Therapeutics Committee (DTC) training course in the respective provinces, and circulating to physicians with materials and literatures on rational antibiotic prophylaxis in clean surgery. Hospital administrative interventions included formulating the rules of Antimicrobials’ application in hospital, and compiling the Management catalogue of antimicrobials in hospitals. Hospital technical interventions involved establishing focused groups and using the Monitoring/Training/Planning (MTP) method [11] to assist the compliance of relevant rules and regulations, identifying and setting targets and strategies for those outliers of antibiotic prophylaxis in the three targeted clean surgeries.
2.5. Post intervention Data Collection and Analysis
Post intervention data collection and evaluation of rationality were conducted after each intervention in the month of Sep. 2008, Mar. and Jun. 2009 in IG. The scope and objective of the data collection were the same as that of the baseline survey. Rationality scores were calculated statistically based on the weight of each of the ten indicators, in order to evaluate the effect of the intervention. The general linear model (GLM) statistical tool was applied for multiple factor analysis on numerical data. GLM of Repeated Measure was used to trend test rationality scores preand post-intervention.
2.6. External Control
To avoid the time selection confounding factor due to the self-controlled design, this study took the Network as the external control group (CG), and conducted multi-factor analysis using the GLM. According to the routine data reporting procedures of the Network, each hospital was required to randomly select fifteen surgery cases from all the discharged cases in the 2nd week of the 1st month of each quarter (Jan. Mar., June and Sept.), and reported to the Network every half year in June and Dec. There were 164 hospitals providing data to the Network in Mar.2008, and 171 hospitals in Mar. and June 2009 (additional hospitals joint the Network). All targeted clean surgery cases were identified from the Network as control sample. The database was built with Epidata® 3.1 and all data analysis was done by SPSS® 11.0.
The Ministry of Health approved and supported this study, and allowed use of data collected from IG and the Network. All hospitals were informed of the study.
3. Results
3.1. Number of Cases
There were a total of 3,961 cases enrolled in the IG in the whole course of all interventions, and 657 cases analyzed in the CG. Considering the workload of extracting CG data from the Network half year reporting system, only cases in Mar. 2008 were separated from the reporting system as baseline sample (212), while the cases reported in the first half year of 2009 were not separated, which included the cases collected in Mar. and Jun. (445). Table 2 shows the number and percentage of cases specified by both time and type of surgeries.
3.2. Duration of Medication and Combination
The average duration of antibiotic medication declined from 4.9 to 4.1 days after three waves of interventions (P < 0.05, Kruskal-Wallis, H. test), the incidence of pre0 scribing a combination of antibiotics also declined slightly (Table 3).
Table 2. Number and percentage of cases enrolled in the project during four study periods.
IG, intervention group. CG, control group. *Percentage of the number of deferent clean surgeries in the number of IG.
3.3. Rationality Evaluation on Antibiotic Use
Table 4 shows the composition of three categories of cases (Pearson χ2 test, P < 0.01). The percentage of cases not using antibiotics (rational) after the first intervention increased significantly from 3.5% to 11.5%, and remained at that level following the second (12.3%) and third interventions (11.9%). As these were elective clean cases, these were very low figures. The percentage of non-indicated cases treated with antibiotics (irrational) was reduced from 61.9% to 53.1% after two waves of interventions, but rebounded to 60.9% in June 2009 following the 3rd wave of intervention.