Abstract
Abstract
Background
: Antibiotic resistance is a global problem that affects the surgical patient population. Guidelines for antibiotic use have been shown to be effective both in terms of protecting individuals undergoing surgery and ensuring appropriate prescribing. More than 5,000 cholecystectomies are performed each year in Norway. However, there are no national guidelines for prophylactic antibiotics. The aim of this study was to chart the existence of local guidelines and whether they were updated and used. This was in order to inform practice and contribute to a rational approach to antibiotic prophylaxis for cholecystectomies.
Methods
: An online questionnaire was sent to consultant surgeons from every hospital conducting cholecystectomies in Norway. Questions were related to the existence, content, and evaluation of any guidelines concerning prophylactic antibiotic treatment.
Results
: Thirty-seven of 47 hospitals responded. Overall, 17 of 37 had written guidelines, although this was higher in university hospitals (71%) than in local ones (39%). Not all hospitals with guidelines had them for both laparoscopic and open surgical methods. Most hospitals gave prophylaxis to patients undergoing open cholecystectomies. Guidelines for laparoscopic patients advised no prophylaxis in six institutions, four hospitals recommended prophylaxis of all their patients and others restricted their use to specific subpopulations. The majority with guidelines had revised their information within the last five years.
Conclusions
: The presence and contents of guidelines vary greatly among Norwegian hospitals. Although many used guidelines to highlight at-risk patients needing antibiotics, there were cases that advocated antibiotics to patients where the benefit is doubtful. We recommend the establishment of a national protocol to optimize antibiotic use, raise awareness of resistance, and promote the treatment of patients at high risk of developing a health care-associated infection.
Cholecystectomy is interesting with respect to both guidelines for the use of antibiotics and the actual use of these drugs. Although there is long-established evidence that prophylactic antibiotics improve patient outcomes in open cholecystectomies [10,11], this is not the case for laparoscopic cholecystectomies (LCs), which constitute more than 90% of all cholecystectomies. Recommendations for prophylaxis in LC have become more restricted as meta-analyses have revealed no difference in the outcomes of low-risk patients receiving prophylactic antibiotics and those not receiving them [12–14].
More than 5,000 cholecystectomies are performed each year in Norway. Given the evolving evidence for the lack of gain from the prophylactic use of antibiotics in low-risk groups, there appears to be great potential for intervention to reduce the prescribing of potentially non-beneficial antibiotics. For other types of surgery, such as cesarean section and colorectal surgery, Norway has national antibiotic guidelines. However, there are no established national guidelines or recommendations for prophylaxis, and no overview of common practice for cholecystectomies.
Norway established the Norwegian Surveillance System for Healthcare-Associated Infections (NOIS) in January 2005. It is mandatory for all Norwegian hospitals to participate in the register for a three-month period each year. The NOIS collects data about risk factors, antibiotic use, and outcomes of infection for all patients undergoing one of the selected operations. This provided us with the possibility of comparing our results with antibiotic prophylaxis in cholecystectomy with those reported in the NOIS. However, there is a choice of operations to report, and cholecystectomies are low in terms of priority.
The primary objective of the present study was to describe the current status of local guidelines with respect to antibiotic prophylaxis in cholecystectomy. We chose this objective to initiate debate and promote the use of guidelines both locally and nationally. Secondary objectives of the study were to describe the actual practice relating to the use of antibiotic prophylaxis in cholecystectomy, to assess compliance with existing guidelines for such prophylaxis, and to discover the prevalence of non-optimal prescribing and whether any form of risk stratification is used to determine the need for antibiotics.
Methods
The study was conducted through an Internet-based questionnaire designed with software developed by Questback (Oslo, Norway). After its assessment in a pilot survey, the questionnaire was sent to the head surgeons of all departments performing cholecystectomies. The survey was undertaken in the autumn of 2010. The questionnaires included general information about the hospital at which the head surgeon practiced, the existence of guidelines for the prophylactic use of antibiotics in cholecystectomy at the hospital, and questions about laparoscopic and open cholecystectomy and cholecystectomies in which there was laparoscopic-to-open conversion. We also asked about the existence of guidelines specific for the method of cholecystectomy to be used, common practice if there were no guidelines, whether antibiotics were recommended, the indications for prescribing them, which antibiotics were used, how often the guidelines were re-evaluated, and whether or not it was believed that the guidelines were followed. There were also sections for free-text commentary relating to all of the types of surgery done at each hospital to which the questionnaire was sent. Our goal was to achieve a response rate exceeding 75%, with a good representation of all the regions and all levels of care. Hospitals were classified as either local, central, or university hospitals. All non-respondents received a reminder and were followed up by telephone.
A descriptive analysis was performed to evaluate the existence and use of guidelines for antibiotic prophylaxis in cholecystectomy. The results were compared with answers registered in the NOIS for 2010.
Results
The 47 hospitals that perform cholecystectomies in Norway are located in all parts of the country and at all levels of the health care system. We received completed questionnaires from 37 of these 47 hospitals, for a response rate of 79% (Fig. 1). We received answers from all four health regions of Norway and from 22 of 30 local, seven of nine central, and all 8 university hospitals. All of the results described in the following sections are based on the responses from these 37 hospitals.
Geographic distribution of hospitals participating in the study.
Overall, 17 of the 37 (46%) hospitals from which we received completed questionnaires had formal guidelines for the use of prophylactic antibiotics for at least one type of cholecystectomy procedure. Table 1 shows the extent of guidelines for both laparoscopic and open cholecystectomies. Fourteen of the 17 hospitals that had guidelines for cholecystectomy had guidelines for LC, and 12 hospitals had guidelines for open procedures. It is important to note that although there was overlap, several hospitals had guidelines exclusively for one type of surgery and not the other.
The existence of written guidelines for both laparoscopic and open cholecystectomies by hospital type. The table shows that some hospitals had guidelines for only one type of surgery, and that a higher proportion of university hospitals had written guidelines for both laparoscopic and open surgeries.
The results for guidelines for antibiotic prophylaxis among the 17 hospitals that provided completed questionnaires in our surgey are summarized in Table 2. Of the hospitals with guidelines for open cholecystectomy (n=12), all gave antibiotics to at least one defined group of patients, five gave prophylaxis to all of their cholecystectomy patients, and other hospitals had specific indications for prophylaxis, such as age >70 years, or highlighted the need for prophylaxis in patients with prosthetic heart valves. In terms of laparoscopic procedures, six hospitals gave no prophylaxis, four gave prophylaxis to all of their cholecystectomy patients, and the others restricted prophylaxis to subsets of patients such as those with engrafted heart valves. Additionally, we asked those hospitals without written guidelines to describe their practice regarding the use of prophylactic antibiotics. In this group of hospitals the majority gave no prophylactic antibiotics to either patients undergoing either laparoscopic or open cholecystectomy.
Table 2 identifies which groups of patients recieved prophylactic antibiotics prior to cholecystectomy. This is stratified into both type of surgery and whether or not the hospital had written guidelines.
Five of the 17 hospitals that submitted completed questionnaires had evaluated their guidelines within the year preceding our study, seven had done so within the preceding five years, and two had done so more than five years previously. In those hospitals with guidelines for laparoscopic cholecystectomy we found no correlation between recent review and antibiotic practice. In 13 of the 14 hospitals with guidelines for LC the lead consultant felt that staff members were either good or very good at following departmental policy. For both laparoscopic and open surgery, doxycycline and cefuroxime were the two most popular antibiotics of first choice. There was no difference in terms of the existence of guidelines for cholecystectomy in the hospitals participating in the NOIS and those not participating.
For those hospitals that also participated in the NOIS, we were able to compare the reported intention to treat versus that recorded in the patient records. Eleven hospitals fulfilled the criteria of having no written guidelines for intention to treat, reported not giving antibiotics to laparoscopy patients, and participated in the NOIS register. An analysis of the NOIS database found that 18% of patients in this group were registered as having received prophylactic antibiotics. Only seven hospitals had written guidelines pertaining to laparoscopic surgery and participated in NOIS, of which only two reported not giving antibiotics to laparoscopy patients. The low numbers involved made further analysis into whether hospitals complied with their own guidelines very difficult.
Discussion
The existence and content of guidelines for antibiotic prophylaxis for cholecystectomies varies widely throughout Norway. Interestingly, most hospitals do not have formal guidelines for this. We achieved a good response rate to the questionnaire (∼80%) and importantly, all of the major university hospitals in Norway took part in our study, as also did many of the country's central and local hospitals.
There are some limitations to our study. First, there may be a problem concerning response bias, in that those hospitals that participated may have been more motivated to review their antibiotic policies than those that did not participate. Furthermore, because the reporting of cholecystectomies to the NOIS is not at present obligatory, we did not have enough data to permit a meaningful evaluation of antibiotic use as compared with the guidelines for such use at all levels for all types of hospitals and both types of surgery.
The patient group that undergoes open cholecystectomy has gradually decreased to less than 10% of all patients undergoing lapasroscopy as experience with laparoscopy has increased. The open procedures done on these patients are often acute and complicated operations and are at high risk for becoming infected postoperatively. There is substantial literature supporting the use of prophylactic antibiotics in open cholecystectomy, and our results suggest that in Norway most hospitals continue to prescribe antibiotic drugs in an effort to avoid postoperative infections in patients undergoing this procedure.
In terms of laparoscopic operations, recent studies suggest that for low-risk patients the prophylactic use of antibiotics does not improve individual patient outcomes [12–14]. Although six of the hospitals in our study that had written guidelines did not give any antibiotic prophylaxis to patients undergoing LC, it was interesting that four of the hospitals in the same bracket gave prophylactic antibiotics to every patient. This appears to be in conflict with the evidence from the studies cited above, and shows the inadequacy of support for rational prescribing if the content of these rules is not correct or up-to-date or both, even though the restrictive nature of the guidelines can itself be important. It is perhaps worrisome that the recent review of their own guidelines for antibiotic prophylaxis by individual hospitals does not correlate with uniform practice, in that these guidelines should be based on the same data. This finding argues further for a national standard for antibiotic prophylaxis that can be regularly assessed and updated. None of the university hospitals in our study gave prophylactic antibiotics to all of their patients, and two of them used their written guidelines to designate high-risk groups that would benefit from antibiotic prophylaxis, such as patients with diabetes mellitus or those older than 70 years of age [6,15]. The prescription of antibiotics by specific indication highlights the role that guidelines can play in directing the use of these drugs to those patients who need them most and in reducing the overall use of antibiotics, thereby aiding the battle against resistant microorganisms.
It could have been expected that surgery departments that participate in the NOIS may be more motivated to have developed their own guidelines for antibiotic prophylaxis. However, our results indicate that this does not appear to be the case. This may suggest that even departments that are actively involved in the surveillance of surgical-site infections may not value guidelines very highly. Although it is difficult on the basis of our results to know what actually happens in hospitals without guidelines for antibiotic prophylaxis, most appear to either restrict or not give antibiotics in the same way as do hospitals that have guidelines.
In conclusion, there is wide variation in the existence in Norwegian hospitals of guidelines for antibiotic prophylaxis in cholecystectomy. Furthermore, both the content and currency of the existing guidelines are far from uniform. Given the relatively uniform nature of the Norwegian health care system and the population at risk for infection (with a lack of known regional differences in antibiotic susceptibility), national guidelines for antibiotic prophylaxis in cholecystectomy that are relevant for all hospitals should be an attainable goal. Many hospitals have already established guidelines for LC, and some are beginning to use them to target patients with the most to gain from the prophylactic use of antibiotics in this procedure.
National guidelines for antibiotic prophylaxis in cholecystectomy, even those that advise restriction of the prophylactic use of antibiotics, can help to ensure more uniform practice and better individual outcomes for high-risk patients and better national outcomes in terms of microbial resistance to antibiotic drugs. We recommend that surgeons performing cholecystectomies in Norway draw up a standardized national recommendation for prophylaxis in cholecystectomy to ensure high-quality prescribing and uniform care throughout the country.
Footnotes
Acknowledgments and Author Disclosure Statement
We acknowledge gratefully the time and effort spent by all the surgeons who participated in our survey. We also thank Alicia Barrasa, scientific coordinator of the European Program for Interventional Epidemiology, for her useful insights. The authors have no conflicts of interest in the work described here.