Practice variation in perioperative antibiotic use in Japan
Department of Healthcare Economics and Quality Management and 1 Department of General Medicine and Clinical Epidemiology, Kyoto University Graduate School of Medicine, Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Objectives. Under the fee-for-service system, the overuse and misuse of perioperative antibiotics have become serious concerns in Japan. The objective of the present study is to investigate practice variations of perioperative antimicrobial prophylaxis between and within hospitals, and to identify any opportunities for improvement.
Methods. We polled 319 surgeons in six specialties employed by 11 teaching hospitals in Japan. We developed questionnaires with vignettes, asking physicians about their practice of antimicrobial prophylaxis in six surgical procedures (gastrectomy, hysterectomy, cataract surgery, clipping of cerebral aneurysm, hip fracture surgery, and coronary artery bypass graft) and utilization of institutional clinical pathways.
Results. Average durations of prophylaxis varied by procedure, from 1.6 days for cataract surgery to 5.8 days for clipping surgery. Variation was also observed between institutions for the same procedure, e.g. institutional averages for the duration of prophylaxis for gastrectomy ranged from 2.3 to 7 days. Large intra-institutional variation in prophylaxis duration and inconsistent use of clinical pathways were observed in the cases of gastrectomy, hip fracture surgery, and clipping surgery. At one hospital, 20% of physicians performing gastrectomy indicated the use of an institutional clinical pathway, and prophylaxis duration ranged from 3 to 6 days. For cataract surgery and hysterectomy, clinical pathways were universally applied and intra-institutional practice variation was small, yet prophylaxis duration varied widely between hospitals and third-generation cephalosporins were used extensively. Average length of prophylaxis for hysterectomy ranged from 1.8 to 6 days and 43% of respondents prescribed third-generation cephalosporins.
Conclusions. In Japan, perioperative antimicrobial prophylaxis lacks standardization. Efforts to strengthen an evidence-based approach to antimicrobial prophylaxis need to be made a priority at both the national and institutional levels.
Keywords: antibiotic prophylaxis, critical pathways, guideline adherence, perioperative care, physician practice patterns
Address reprint requests to Yuichi Imanaka, Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, Konoe-cho, Yoshida, Sakyo-ku, Kyoto 606-8501, Japan. E-mail: imanaka{at}pbh.med.kyoto-u.ac.jp
Accepted for publication June 4, 2004.
Although antimicrobial prophylaxis is effective in reducing the incidence of postoperative wound infections for a number of different operative procedures [1,2], inappropriate and indiscriminate use of antibacterial agents can potentially lead to a number of problems. These problems include the emergence of antimicrobial-resistant bacteria, an increased number of patients experiencing adverse drug events, and increased drug-related costs. More importantly, methicillin-resistant Staphylococcus aureus (MRSA) has been reported with increasing frequency worldwide [37], and already accounts for substantial hospital morbidity and mortality, as well as expense [4,8].
Japanese physicians are alleged to use more antibiotics than physicians in the United States and European countries. In 1979, Fujii reported that the per capita consumption of antibiotics in Japan was three times that of the United States and eight times that of the United Kingdom [9]. Currently, the epidemic proportion of MRSA in Japan is the highest in the world [10]. Several studies have shown the overuse and/or misuse of perioperative antibiotics in Japan. In 1989, Ishibiki reported that third-generation cephalosporins were used in 30% of gastrectomy and cholecystectomy cases, and in 65% of colorectal surgery cases [11]. A 1994 survey conducted by the Japanese Society of Gastroenterological Surgery of its member hospitals showed a prolonged duration of prophylaxis, although preincisional antibiotic administration was performed by only one-third of the hospitals surveyed [12]. In 2002, Hayashi surveyed academically affiliated hospitals throughout Japan, and found that >5 days of prophylaxis is common in cases of radical hysterectomy [13].
To resolve the overuse and misuse of antibiotics in Japan, we must address how each medical institution can standardize medical practices among its physicians on an evidence-based model. The objective of the present study is to survey the current methods of antibiotic prophylaxis, as well as practice variation between and within hospitals, to identify opportunities for improvement.
| Methods |
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We conducted a cross-sectional survey between January and February 2003 using a self-administrated questionnaire. Our study settings were 11 general hospitals, each of which has >500 beds, provides tertiary care, and is certified for residency training. These hospitals are members of the Voluntary Hospitals of Japan Quality Indicator Project, an initiative to collect data for performance measures and apply the results to quality improvement activities. We asked each hospitals director to deliver the questionnaire to physicians practicing in each of six specialties: abdominal surgery, cardiovascular surgery, neurosurgery, orthopedics, gynecology, and ophthalmology. Questionnaires with vignettes were developed to ask these physicians about their perioperative use of prophylactic antibiotics in six common surgical procedures: subtotal gastrectomy, abdominal hysterectomy, cataract surgery, clipping of cerebral aneurysm, hip fracture surgery, and coronary artery bypass graft (CABG). The gastrectomy vignette presented to abdominal surgeons reads: The patient is a 50-year-old woman with early-stage gastric cancer. You are planning to perform a subtotal gastrectomy. She does not have any other medical problems or infections. Suppose there are no difficulties or complications during the surgery, and that the postoperative course is fair. Questions referring to the antibiotic agent used, the timing of its administration, its dosage, administration route, homogeneity, and the duration of antibiotics prophylaxis were as follows:
- How many times do you perform this surgical procedure per year, either as a primary surgeon or as an assistant?
- Which antibiotic agent is used?
- Which route is used to administer antibiotics?
- How long and how many times is the drug administered?
- Does your hospital have a clinical pathway or a clinical guideline of antimicrobial prophylaxis for this type of surgical patient? (Recognition of an institutional clinical pathway.)
- What is the expected postoperative infection rate (including surgical site infection, pneumonia, urinary tract infection and catheter-related infection) in this typical case?
The timing of antibiotics administration on the date of operation was classified into three time frames: preincisional, intra-operative, and postoperative. Recognition of an institutional clinical pathway was classified into two categories: recognize if the answer to Does your hospital have a clinical pathway of antimicrobial prophylaxis for this type of surgical patient? was yes; and do not recognize if the answer was no, regardless of the answers of other physicians in the same hospital. We used analysis of variance (ANOVA) to test whether durations of intravenous antimicrobial prophylaxis were different between the hospitals. We also conducted ANOVA to test the association between physicians recognition of an institutional clinical pathway and the duration of prophylaxis or the use of third-generation cephalosporins.
| Results |
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Of the 319 physicians surveyed, 225 (71%) responded. We did not send reminders because the response rate of the first collection was relatively high. The numbers of physicians and the response rates by specialty and by hospital are shown in Table 1. The annual surgical volumes were generally small for all surgical procedures, except cataract surgery (Table 2). Eight respondents answered that they did not perform the surgical procedure in question, and thus were excluded from the subsequent analyses.
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Most respondents to the cataract surgery vignette (97%) and the hysterectomy vignette (95%) answered that their hospitals implement clinical pathways or guidelines for antibiotic prophylaxis, while only 41% of the neurosurgeons and 57% of the cardiac surgeons recognized institutional clinical pathways or guidelines for these types of patients (Table 3). Ironically, physicians working in the same division of the same hospital sometimes gave different answers regarding the implementation of the institutional clinical pathway. The numbers of hospitals in which the physicians disagreed on the institutional clinical pathway were six in abdominal surgery, four in neurosurgery, three in orthopedics, and one each in cardiac surgery and gynecology.
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Antimicrobial agents used
First- or second-generation cephalosporins were most frequently used in all types of surgery (Table 2). Third-generation cephalosporins were extensively used in cataract surgery (50%) and hysterectomy (43%). Forty-three percent of respondents used more than one intravenous antimicrobial agent in CABG, while most respondents (9598%) used single agents in other types of surgery. Of the 34 ophthalmologists, 22 (65%) used antibiotic eye drops (new quinolone-type), and eight (24%) used subconjunctival antibiotics (aminoglycosides). The administration of a third-generation cephalosporin was not associated with the physicinans recognition of the institutional clinical pathway in any type of surgery.
Timing and duration of antibiotic prophylaxis
All orthopedists, 93% of cardiac surgeons, 87% of abdominal surgeons, 79% of neurosurgeons, 79% of gynecologists, and 73% of ophthalmologists performed preincisional antibiotic prophylaxis. Durations of prophylaxis varied widely between and within the hospitals (Table 3). Difference in prophylaxis duration among the hospitals was observed in all surgical procedure except clipping surgery. Ninety-four percent of ophthalmologists, 25% of gynecologists, and 13% of orthopedists administered antibiotics orally after a few days of intravenous administration. The average duration of additional oral dose of antibiotics was 3.3 days in cases of cataract surgery and 1.0 day in cases of hysterectomy.
Duration of intravenous prophylaxis was generally not associated with the physicians recognition of an institutional clinical pathway, except in cases of CABG where recognition of a clinical pathway was significantly associated with a shorter duration of prophylaxis (3.6 versus 6.0 days, P = 0.03). However, the recognition of an institutional clinical pathway seemed to effectively standardize physician care within the same hospital. For example, intra-institutional variation in duration of antimicrobial prophylaxis was small in cases of cataract surgery and hysterectomy, procedures for which clinical pathways are highly utilized. Physicians expectation of infection rate was not associated with duration of prophylaxis in any type of surgery.
| Discussion |
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Concern about the overuse of antibiotics in Japan has lead to the development of numerous practice guidelines [1417] and an increasing emphasis on evidence-based medicine. Yet while Japanese guidelines advise against the prolonged use of antibiotics, they do not set a definite standard for the duration of prophylaxis.
Our study revealed that the common practice of antimicrobial prophylaxis in Japan was remarkably different from the practices recommended by various guidelines in North America [1821] (Table 4) and from those practices reported by other developed countries [22,23]. The major differences were found in the duration of prophylaxis and the antimicrobial agent used. The non-Japanese guidelines recommend a single preincisional dose of antimicrobial agents for most clean and clean-contaminated surgeries such as gastrectomy, hysterectomy, hip fracture, and clipping surgeries, while most of the surgeons surveyed in our study administered multiple doses. Third-generation cephalosporins were commonly used in cases of hysterectomy and cataract surgery, while the foreign guidelines do not recommend use of these agents, not only because they are expensive and less effective against staphylococci, but also because their widespread use promotes the emergence of resistance [18].
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Our study also revealed a great variation in antimicrobial prophylaxis among the physicians. Although many physicians routinely prescribed a long course of prophylaxis, some specified a single dose, in accordance with evidence-based guidelines. Variations were even found among physicians in the same hospital. These variations were related to whether the hospital had a clinical pathway and whether the physicians adhered to it. We also observed diverse practice patterns among the hospitals. Even when practice is standardized within individual institutions, inter-hospital variation in the duration of prophylaxis and agents used suggests that clinical pathways are not always developed to the same standards.
It has been argued that the inappropriate prophylactic administration of antibiotics has arisen primarily from physicians great fear of postoperative infection [24]. Mashita and Shinagawa conducted surveys of surgeons in several specialties and found that about half of them thought that antimicrobial prophylaxis should be performed to prevent possible postoperative infections, including pneumonia, urinary tract infection, and catheter-related infections [25,26]. In addition to beliefs about clinical appropriateness, physicians are motivated by the concern that their patients may accuse them of negligence if short-course prophylaxis were to result in postoperative infection.
Clinical pathways can standardize physicians practice patterns and improve health outcomes [27]. Clinical pathways were introduced into Japan in the late 1990s and rapidly came into wide use in large hospitals. However, our study showed a mixed impact of clinical pathways on physicians practices or behaviors. Firstly, physicians may not always adhere to a clinical pathway even though others in the same hospital do. In the case of gastrectomy, clipping surgery, and hip fracture surgery, recognition of an institutional clinical pathway was not consistent among physicians in the same hospital, and wide variations in antimicrobial prophylaxis were reported. On the other hand, clinical pathways, once implemented effectively, can standardize physicians practices. In the case of cataract surgery and hysterectomy, for which almost all physicians acknowledged their institutional clinical paths, variations in prophylaxis were seldom observed within a hospital. Our study also suggested that clinical pathways in Japan are not necessarily developed on the basis of scientific evidence. Ironically, the utilization of a third-generation antibiotic was most common in cases of hysterectomy and cataract surgery, in which clinical pathways were most widely used.
Several options exist that might change physicians practices of antimicrobial prophylaxis. Firstly, practice guidelines developed at a national level, by professional societies or the government, may carry enough weight to begin to standardize practice patterns. If the longer duration of prophylaxis in Japan has resulted from physicians resistance to changing from an overly cautious strategy, physicians are more likely to alter their practice when the change is supported by a formal guideline. Secondly, guideline implementation as part of an organizational strategy can effectively promote positive change among physicians [28]. Thirdly, effective surgical site infection surveillance programs in combination with antibiotics utilization reviews could be established in each institution to help physicians understand better the consequences of their practices. Traditionally, professional self-regulation and hospital quality control have not worked well in Japan [29], and neither professional societies nor hospital administrators have intervened sufficiently in physicians practices. This non-interference policy has undoubtedly led to the current epidemic of overuse and misuse of antibiotics. Initiatives by each institution to set and promote quality standards, as well as those to modernize and strengthen professional self-regulation on the principles of performance review, such as the clinical governance concept of the National Health Service, would be necessary to deliver standardized quality of care. Each health care organization must demonstrate strong leadership to gain a consensus regarding the best practice and standardization of care among physicians. And finally, economic incentives could be introduced to balance unintended incentives created by the fee-for-service system. It is not likely that any single strategy in isolation can provide an effective solution. A credible response, therefore, will necessarily involve a combination of these and other approaches.
Our study has several limitations that must be acknowledged. Firstly, our study measured physicians attitudes toward antimicrobial prophylaxis rather than their behaviors. A social desirability bias may have induced the physicians to report the practices they think they should perform rather than those they actually do. However, even if such a bias existed, our study still showed a great variation in practices. Moreover, we presumed that the cases in the vignettes had no problematic co-morbidities or complications during their clinical courses. Therefore, it is unlikely that our study underestimated the overuse of antibiotics. A second general limitation of this study is that our subjects were surgeons working in only 11 participating hospitals. Thus, the findings presented here do not necessarily represent the actual state of perioperative antimicrobial prophylaxis throughout Japan. However, we do not think our subjects use more antibiotics than other physicians, because all of the participating physicians were working at teaching hospitals with a relatively high morale for improvement quality through performance measurement. Our study implies that even more variation may be found throughout Japan. Thirdly, we did not analyze physician and hospital factors, other than physician awareness of clinical pathways, which may explain the existing pattern of practice. Another study is necessary to address how factors such as physicians age, position within the hospital, type of training, years in practice, and infection control units within the hospital affect practice patterns.
In conclusion, our study revealed a great variation in perioperative antimicrobial prophylaxis among hospitals and physicians. Practices in Japan were much different from those recommended by evidence-based guidelines from other countries. It was also suggested that clinical pathways could effectively standardize physicians practice, although at this stage, they are often not developed based on robust scientific evidence. In order to promote the appropriate use of antibiotics in Japan, future studies should focus more clearly on identifying reasons for non-compliance with evidence-based guidelines and institutional clinical pathways, and identifying effective interventions for standardizing practice at both national and institutional levels.
The authors are extremely grateful to the participant hospitals of the Voluntary Hospitals of Japan Quality Indicator Project for their cooperation with the study: Teine Keijinkai Hospital (Sapporo), Nikko Memorial Hospital (Muroran), Takeda General Hospital (Aizu Wakamatsu), Kameda Medical Center (Kamogawa), Kawakita General Hospital (Tokyo), Seirei Hamamatsu General Hospital (Hamamatsu), Keiju Medical Center (Nanao), Toyota Memorial Hospital (Toyota), Rakuwa-kai Otowa Hospital (Kyoto), Kurashiki Central Hospital (Kurashiki), and Asou Iizuka Hospital (Iizuka). This research was funded in part by Health and Labor Science Research Grants for Research on Policy Planning and Evaluation from the Ministry of Health Labor and Welfare (H13-Seisaku-030).
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