ORIGINAL ARTICLE
Increasing Compliance With an Antibiotic Prophylaxis Guideline to Prevent Pediatric Surgical Site Infection Before and After Study Jeannette P. So, MSc,∗ Ilyas S. Aleem, MD,† Derek S. Tsang, MD,‡ Anne G. Matlow, MD, MSc, FRCPC,§ and James G. Wright, MD, MPH, FRCSC∗ ¶; for The SickKids Surgical Site Infection Task Force Objectives: To evaluate an intervention for improving antibiotic prophylaxis (AP) guideline compliance to prevent surgical site infections in children. Background: Although appropriate AP reduces surgical site infection, and guidelines improve quality of care, changing practice is difficult. To facilitate behavioral change, various barriers need to be addressed. Methods: A multidisciplinary task force at a pediatric hospital developed an evidence-based AP guideline. Subsequently, the guideline was posted in operating rooms and the online formulary, only recommended antibiotics were available in operating rooms, incoming trainees received orientation, antibiotic verification was included in time-out, computerized alerts were set for inappropriate postoperative prophylaxis, and surgeons received e-mails when guideline was not followed. AP indication and administration were documented for surgical procedures in July 2008 (preintervention), September 2011 (postintervention), and April–May 2013 (follow-up). Compliance was defined as complete—appropriate antibiotic, dose, timing, redosing, and duration when prophylaxis was indicated; partial—appropriate drug and timing when prophylaxis was indicated; and appropriate use—complete compliance when prophylaxis was indicated, no antibiotics when not indicated. Compliance at preintervention and follow-up was compared using χ 2 tests. Results: AP was indicated in 43.9% (187/426) and 62.0% (124/200) of surgical procedures at preintervention and follow-up, respectively. There were significant improvements in appropriate antibiotic use (51.6%–67.0%; P < 0.001), complete (26.2%–53.2%; P < 0.001) and partial compliance (73.3%– 88.7%, P = 0.001), correct dosage (77.5%–90.7%; P = 0.003), timing (83.3%–95.8%; P = 0.001), redosing (62.5%–95.8%, P = 0.003), and duration (47.1%–65.3%; P < 0.002).
From the ∗ Department of Surgery, The Hospital for Sick Children, Toronto, Ontario, Canada; †Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada; ‡Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; §Center for Patient Safety, University of Toronto, Toronto, Ontario, Canada; and ¶Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada. Members of The SickKids Surgical Site Infection Task Force include the following: Zoran Bojic, MHSc, PMP, CLA, ASQ-CMQOE; Rita Damignani, MSc BScPT; Annie Fecteau, MDCM, FRCP(C); Igor Luginbuehl, MD; Anne G. Matlow, MD, MSc, FRCPC; Jean Paul Paraiso, MSc; Lisa Pendergast, RN; Debi Senger, CHIM; Jeannette P. So, MSc; Laurie Streitenberger, BSc, RN, CIC; Kathryn Timberlake, PharmD; and James G. Wright, MD, MPH, FRCSC. Disclosure: Supported by funds from the Robert B. Salter Chair of Surgical Research held by Dr. Wright. Ms. Timberlake has received consulting fees from Pfizer for the antifungal voriconazole. For the remaining authors, no conflicts of interest were declared. Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.annalsofsurgery.com). Reprints: James G. Wright, MD, MPH, FRCSC, The Hospital for Sick Children, 555 University Ave, Black Wing, Room 1254, Toronto, Ontario, M5G 1X8, Canada. E-mail: [email protected]. C 2014 Wolters Kluwer Health, Inc. All rights reserved. Copyright ISSN: 0003-4932/14/26202-0403 DOI: 10.1097/SLA.0000000000000934
Annals of Surgery r Volume 262, Number 2, August 2015
Conclusions: A multifaceted intervention improved compliance with a pediatric AP guideline. Keywords: antibiotic prophylaxis, behavioral change, guideline compliance, intervention, pediatric surgery (Ann Surg 2015;262:403–408)
S
urgical site infection (SSI) is a serious adverse event leading to significant patient morbidity, mortality, and higher costs.1–3 Approximately 50% of SSIs are estimated to be preventable,3 and appropriate use of antibiotic prophylaxis (AP), including correct drug, dosage, timing, and redosing, is a key intervention to reduce the incidence of SSI.4–7 Practice guidelines that assist physicians in decision making are a potential strategy to facilitate appropriate use of prophylactic antibiotics.8,9 However, despite availability of various guidelines,4–5,10 prior reports suggest that clinician’s behavior has changed little and compliance remains suboptimal,11,12 particularly in pediatric surgery in which the benefits of antibiotics in children and adolescents are uncertain.13,14 In a 5-year retrospective study of general surgery and urology in 22 children’s hospitals, only 82% of patients received antibiotics when prophylaxis was indicated, and 40% of patients were given antibiotics without indication.13 A pediatric surgical study in Singapore reported that 57% of patients had appropriate antibiotics, 76% timely administration, and 41% appropriate duration, with 13% overall compliance.14 Although comparison among studies is difficult because definitions of compliance differed, few of these studies provided explicit strategies for implementation, which is essential for effective uptake of guideline recommendations.15 Pathman et al16,17 proposed a 4-stage model to understanding utilization of clinical practice guidelines: awareness, agreement, adoption, and adherence. Various attitude-, knowledge-, and organizational-related factors facilitate or impede use of guidelines, including awareness, familiarity, agreement, outcome expectancy, self-efficacy, motivation or inertia of previous practice, and patient, guideline, and environmental elements.18 In general, behavioral change requires multiple different implementation and dissemination strategies to address the different factors. Therefore, in this study, we implemented and evaluated a multifaceted intervention for improving compliance with an AP practice guideline to prevent SSI in pediatric patients.
METHODS Setting The study was performed at The Hospital for Sick Children, a 278-bed academic pediatric hospital in Toronto, Canada, that performs approximately 12,000 surgical procedures per year. Before 2006, the only reference for AP use was the hospital formulary, which contained incomplete guidelines for all specialties and procedures. www.annalsofsurgery.com | 403
Copyright © 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 262, Number 2, August 2015
So et al
Multifaceted Intervention The first step was to develop comprehensive evidence-based guidelines. To raise awareness and secure input and support from all relevant stakeholders, we formed a multidisciplinary task force in May 2006 with representation from surgery, anesthesia, nursing, pharmacy, infection prevention and control, quality improvement and patient safety, information technology, and health records. The task force adapted existing evidence-based guidelines,19–21 including those from the American Academy of Pediatrics,22 Centers for Disease Control and Prevention,4 American Society of Health-System Pharmacists,23 Infectious Diseases Society of America,10 Surgical Infection Society,24 American Society for Gastrointestinal Endoscopy,25 and Surgical Infection Prevention Guideline Writers Workgroup,5 to create a pediatric surgical AP guideline (see Supplemental Digital Content 1 Appendix, available at http://links.lww.com/SLA/A639, which shows full guideline). The guideline encompassed all specialties, contained both child- and neonate-specific recommendations, listed alternative regimens for patients with allergies, and set intervals for dosing and discontinuation. The guideline was subsequently reviewed and revised by all surgical disciplines and by pharmacy for completeness and appropriateness. Once the guideline was approved by all disciplines, we initiated multiple implementation strategies. First, we collaborated with pharmacy to stock anesthesia carts with guideline-approved antibiotics and ensured that anesthesiologists were willing to administer antibiotics. Second, the guideline was posted on the online hospital formulary. Third, copies of specialty-specific guidelines were posted in the associated operating rooms (ORs). Fourth, AP verification was added to the surgical time-out checklist to be completed before surgery. Fifth, we developed an educational intervention for incoming residents and fellows. Beginning in July 2008, all new surgical and anesthesia residents and fellows received the AP guideline in their orientation packages and attended a mandatory educational session given by the surgeon-in-chief. The presentation provided information on guideline access, reviewed the criteria and evidence for appropriate AP use, and emphasized the importance of compliance for preventing SSI. Sixth, the final phase of the quality improvement initiative beginning May 2009 involved informatics. We programmed a reminder in the computerized patient order entry system that postoperative prophylaxis was not recommended for any but cardiac, transplant, and cochlear implant surgical procedures. The electronic alert provided a link to the online guideline and was triggered when clinicians attempted to prescribe postoperative prophylaxis for nonindicated patients. In addition, the task force mapped surgical prophylactic indications to every procedural code in the hospital’s Surgical Information Systems (SIS, Alpharetta, GA), with input from the surgeons. SIS is a software program for managing and interfacing perioperative information and workflow, including scheduling and intraoperative patient tracking. Details of surgical patients and procedures were all documented in SIS. OR nurses documented AP administration in the electronic OR log. Information technology programmed the SIS to automatically review all surgical procedures performed and sent e-mail notifications to surgeons the next day if a patient was given antibiotics without indication, not given antibiotic when indicated, or not given antibiotics within 60 minutes before skin incision when AP was indicated. Finally, aggregate data from the SIS was provided to all divisions and departments on a monthly basis.
in these 2 specialties were almost never indicated for prophylaxis. We collected data on eligible surgical procedures performed in July 2008 (preintervention), a random sample of procedures performed in the first 2 weeks of September 2011 (postintervention) and a stratified random sample of procedures performed in April and May 2013 (follow-up). For the postintervention and follow-up periods, cases were listed consecutively by date, and a random number generator was used to compile the samples. Cases with confirmed or suspected preoperative infection were excluded, including patients with otitis media, cholesteatoma, ingrown toenail, perforated appendix, abscess, sepsis, frank infection, and draining pus. We also excluded procedures that involved the oral cavity, isolated endoscopy (including foreign body removal), organ retrieval, and central venous line removal, which had no risk of postoperative infection. From OR logs, anesthesia records, and health records, we extracted patient and surgery characteristics and AP administration for each procedure. If antibiotics were given, the drug, timing, dosage, redosing, and duration were also collected. For procedures in which AP was not given in the OR, we manually conducted a chart review to determine whether patients received them before surgery, on the ward, or in the emergency department. Physicians were also consulted for clarification on any discrepancies between the OR log and the anesthesia record. Where differences could not be reconciled, we utilized the data from the anesthesia records. For each surgical procedure, we determined whether antibiotics were indicated. Moreover, for procedures with prophylaxis indicated and administered, we evaluated compliance with the 5 AP criteria (drug, timing, dosage, redosing, and duration) according to the guideline. The guideline contained a list of approved drugs for each type of procedure. Patients already on antibiotics for a preexisting condition before surgery did not require additional prophylaxis if the antibiotic spectrum covered the potential pathogens and they were not due for redosing. Recommended dosage was calculated on the basis of patients’ age and weight, and doses within 20% of the reference were considered appropriate. The guideline specified that antibiotics be given before applying the tourniquet, if one was required, and within 60 minutes before incision. Patients with β-lactam allergy or previous methicillin-resistant Staphylococcus aureus colonization or infection should have received vancomycin administered within 120 minutes before incision and infused over at least 60 minutes.5,22 According to the guideline, antibiotics were to be redosed every 2 half-lives during anesthesia (“top-up”) to ensure adequate tissue antimicrobial levels at wound closure.4 For surgical procedures involving excessive blood loss or extensive burns, intraoperative redosing to maintain antimicrobial levels was to be considered. Patients already on antibiotics before surgery were redosed if “top-up” was due during the procedure. Prophylaxis should be discontinued at the end of all procedures, including for patients with open wounds, indwelling catheters, or in situ drains or chest tubes. The exceptions for postoperative prophylaxis discontinuation were cardiac surgery, transplant, and cochlear implantation, which AP was extended for up to 48 hours postoperation.4–5,23 We defined complete compliance with the AP guideline as having correct antibiotic, dosage, timing, redosing, and duration when prophylaxis was indicated. Partial compliance was defined as correct drug and timing when prophylaxis was indicated. Appropriate use of AP was defined as complete compliance when prophylaxis was indicated, and antibiotics not given when not indicated.
Statistical Analysis Data Collection To examine the effects of the intervention on guideline compliance, we assessed AP use in cardiovascular, general surgery, neurosurgery, orthopedic, otolaryngology, plastics, and urology procedures. We excluded ophthalmology and dentistry because antibiotics 404 | www.annalsofsurgery.com
We assessed preintervention and follow-up compliance to evaluate practice changes. Postintervention compliance was reported to determine trends but was not included in the statistical analyses. Using an estimated baseline rate of 45% complete compliance, we required a sample size of 173 cases in each period to detect at least C 2014 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 262, Number 2, August 2015
Surgical Antibiotic Guideline Compliance
15% change at 80% power and 5% significance level. We used the χ 2 test with P < 0.05 (2-tailed) level of statistical significance to compare compliance rates and dichotomous variables and 1-way analysis of variance at P < 0.05 (2-tailed) significance to compare continuous variables. Missing values were not imputed. All analyses were conducted in SPSS 20 for Mac (IBM Corporation, Armonk, NY). Institutional ethics approval was obtained before study initiation.
RESULTS We reviewed 773 procedures preintervention, 192 procedures postintervention, and 220 procedures at follow-up. After excluding patients, 426, 157, and 200 cases that met the inclusion criteria were identified for each time period, respectively. As shown in Table 1, surgical procedures at follow-up had a greater proportion of inpatients (81% vs 67%), longer mean duration of surgery (115 min vs 97 min), and smaller proportion of patients with American Society of Anesthesiologists (ASA) physical status I or II (67% vs 78%). Administering antibiotics when indicated and not giving antibiotics when not indicated according to guideline improved from 81% (345/426) to 94% (188/200; P < 0.001). Reduction in administration of unnecessary antibiotics accounted for much of the increase (Table 2).
TABLE 2. Surgical Cases by Antibiotic Prophylaxis Indication and Administration Antibiotics Given Antibiotics Indicated Preintervention (%) Yes No Total Postintervention (%) Yes No Total Follow-up (%) Yes No Total
Complete and Partial Compliance For surgical procedures with prophylaxis indicated, complete compliance with the guideline improved from 26.2% (49/187) to 53.2% (66/200; P < 0.001). Cardiovascular and plastic surgery had the highest compliance. Complete compliance increased by a total of 50% in each of plastic surgery, orthopedic surgery, and otolaryngol-
TABLE 1. Characteristics of Surgical Cases
Age, mean, yr Weight, mean, kg Surgical duration, mean, min Sex (%) Male Female Admission type (%) Inpatient Outpatient ASA physical status (%)∗ I–II III–V Case type (%) Elective Emergency
Total
174 (93.0) 68 (28.5) 242
13 (7.0) 171 (71.5) 184
187 239 426
98 (94.2) 10 (18.9) 108
6 (5.8) 43 (81.1) 49
104 53 157
118 (95.2) 6 (7.9) 124
6 (4.8) 70 (92.1) 76
124 76 200
Appropriate Use of Antibiotic Prophylaxis
Appropriate use of AP increased from 52% to 67% (P < 0.001). The highest rate was in cardiovascular surgery, whereas improvements in orthopedic surgery were statistically significant. There were also trends of improvement in cardiovascular surgery, urology, and plastic surgery. Practice was relatively unchanged in otolaryngology and general surgery, and appropriate AP use declined in neurosurgery (Table 3).
Preintervention Postintervention (N = 426) (N = 157)
No
TABLE 3. Appropriate Use of Surgical Antibiotic Prophylaxis by Service
Appropriate Use of Antibiotic Prophylaxis
Variable
Yes
Follow-up (N = 200)
P 0.428 0.451 0.041
6.7 28.0 97.2
7.2 29.3 126.0
7.1 29.5 115.2
64.3 35.7
61.8 38.2
57.5 42.5
66.9 33.1
89.6 10.4
80.5 19.5
0.101
Increasing Compliance With an Antibiotic Prophylaxis Guideline to Prevent Pediatric Surgical Site Infection Before and After Study Jeannette P. So, MSc,∗ Ilyas S. Aleem, MD,† Derek S. Tsang, MD,‡ Anne G. Matlow, MD, MSc, FRCPC,§ and James G. Wright, MD, MPH, FRCSC∗ ¶; for The SickKids Surgical Site Infection Task Force Objectives: To evaluate an intervention for improving antibiotic prophylaxis (AP) guideline compliance to prevent surgical site infections in children. Background: Although appropriate AP reduces surgical site infection, and guidelines improve quality of care, changing practice is difficult. To facilitate behavioral change, various barriers need to be addressed. Methods: A multidisciplinary task force at a pediatric hospital developed an evidence-based AP guideline. Subsequently, the guideline was posted in operating rooms and the online formulary, only recommended antibiotics were available in operating rooms, incoming trainees received orientation, antibiotic verification was included in time-out, computerized alerts were set for inappropriate postoperative prophylaxis, and surgeons received e-mails when guideline was not followed. AP indication and administration were documented for surgical procedures in July 2008 (preintervention), September 2011 (postintervention), and April–May 2013 (follow-up). Compliance was defined as complete—appropriate antibiotic, dose, timing, redosing, and duration when prophylaxis was indicated; partial—appropriate drug and timing when prophylaxis was indicated; and appropriate use—complete compliance when prophylaxis was indicated, no antibiotics when not indicated. Compliance at preintervention and follow-up was compared using χ 2 tests. Results: AP was indicated in 43.9% (187/426) and 62.0% (124/200) of surgical procedures at preintervention and follow-up, respectively. There were significant improvements in appropriate antibiotic use (51.6%–67.0%; P < 0.001), complete (26.2%–53.2%; P < 0.001) and partial compliance (73.3%– 88.7%, P = 0.001), correct dosage (77.5%–90.7%; P = 0.003), timing (83.3%–95.8%; P = 0.001), redosing (62.5%–95.8%, P = 0.003), and duration (47.1%–65.3%; P < 0.002).
From the ∗ Department of Surgery, The Hospital for Sick Children, Toronto, Ontario, Canada; †Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada; ‡Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; §Center for Patient Safety, University of Toronto, Toronto, Ontario, Canada; and ¶Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada. Members of The SickKids Surgical Site Infection Task Force include the following: Zoran Bojic, MHSc, PMP, CLA, ASQ-CMQOE; Rita Damignani, MSc BScPT; Annie Fecteau, MDCM, FRCP(C); Igor Luginbuehl, MD; Anne G. Matlow, MD, MSc, FRCPC; Jean Paul Paraiso, MSc; Lisa Pendergast, RN; Debi Senger, CHIM; Jeannette P. So, MSc; Laurie Streitenberger, BSc, RN, CIC; Kathryn Timberlake, PharmD; and James G. Wright, MD, MPH, FRCSC. Disclosure: Supported by funds from the Robert B. Salter Chair of Surgical Research held by Dr. Wright. Ms. Timberlake has received consulting fees from Pfizer for the antifungal voriconazole. For the remaining authors, no conflicts of interest were declared. Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.annalsofsurgery.com). Reprints: James G. Wright, MD, MPH, FRCSC, The Hospital for Sick Children, 555 University Ave, Black Wing, Room 1254, Toronto, Ontario, M5G 1X8, Canada. E-mail: [email protected]. C 2014 Wolters Kluwer Health, Inc. All rights reserved. Copyright ISSN: 0003-4932/14/26202-0403 DOI: 10.1097/SLA.0000000000000934
Annals of Surgery r Volume 262, Number 2, August 2015
Conclusions: A multifaceted intervention improved compliance with a pediatric AP guideline. Keywords: antibiotic prophylaxis, behavioral change, guideline compliance, intervention, pediatric surgery (Ann Surg 2015;262:403–408)
S
urgical site infection (SSI) is a serious adverse event leading to significant patient morbidity, mortality, and higher costs.1–3 Approximately 50% of SSIs are estimated to be preventable,3 and appropriate use of antibiotic prophylaxis (AP), including correct drug, dosage, timing, and redosing, is a key intervention to reduce the incidence of SSI.4–7 Practice guidelines that assist physicians in decision making are a potential strategy to facilitate appropriate use of prophylactic antibiotics.8,9 However, despite availability of various guidelines,4–5,10 prior reports suggest that clinician’s behavior has changed little and compliance remains suboptimal,11,12 particularly in pediatric surgery in which the benefits of antibiotics in children and adolescents are uncertain.13,14 In a 5-year retrospective study of general surgery and urology in 22 children’s hospitals, only 82% of patients received antibiotics when prophylaxis was indicated, and 40% of patients were given antibiotics without indication.13 A pediatric surgical study in Singapore reported that 57% of patients had appropriate antibiotics, 76% timely administration, and 41% appropriate duration, with 13% overall compliance.14 Although comparison among studies is difficult because definitions of compliance differed, few of these studies provided explicit strategies for implementation, which is essential for effective uptake of guideline recommendations.15 Pathman et al16,17 proposed a 4-stage model to understanding utilization of clinical practice guidelines: awareness, agreement, adoption, and adherence. Various attitude-, knowledge-, and organizational-related factors facilitate or impede use of guidelines, including awareness, familiarity, agreement, outcome expectancy, self-efficacy, motivation or inertia of previous practice, and patient, guideline, and environmental elements.18 In general, behavioral change requires multiple different implementation and dissemination strategies to address the different factors. Therefore, in this study, we implemented and evaluated a multifaceted intervention for improving compliance with an AP practice guideline to prevent SSI in pediatric patients.
METHODS Setting The study was performed at The Hospital for Sick Children, a 278-bed academic pediatric hospital in Toronto, Canada, that performs approximately 12,000 surgical procedures per year. Before 2006, the only reference for AP use was the hospital formulary, which contained incomplete guidelines for all specialties and procedures. www.annalsofsurgery.com | 403
Copyright © 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 262, Number 2, August 2015
So et al
Multifaceted Intervention The first step was to develop comprehensive evidence-based guidelines. To raise awareness and secure input and support from all relevant stakeholders, we formed a multidisciplinary task force in May 2006 with representation from surgery, anesthesia, nursing, pharmacy, infection prevention and control, quality improvement and patient safety, information technology, and health records. The task force adapted existing evidence-based guidelines,19–21 including those from the American Academy of Pediatrics,22 Centers for Disease Control and Prevention,4 American Society of Health-System Pharmacists,23 Infectious Diseases Society of America,10 Surgical Infection Society,24 American Society for Gastrointestinal Endoscopy,25 and Surgical Infection Prevention Guideline Writers Workgroup,5 to create a pediatric surgical AP guideline (see Supplemental Digital Content 1 Appendix, available at http://links.lww.com/SLA/A639, which shows full guideline). The guideline encompassed all specialties, contained both child- and neonate-specific recommendations, listed alternative regimens for patients with allergies, and set intervals for dosing and discontinuation. The guideline was subsequently reviewed and revised by all surgical disciplines and by pharmacy for completeness and appropriateness. Once the guideline was approved by all disciplines, we initiated multiple implementation strategies. First, we collaborated with pharmacy to stock anesthesia carts with guideline-approved antibiotics and ensured that anesthesiologists were willing to administer antibiotics. Second, the guideline was posted on the online hospital formulary. Third, copies of specialty-specific guidelines were posted in the associated operating rooms (ORs). Fourth, AP verification was added to the surgical time-out checklist to be completed before surgery. Fifth, we developed an educational intervention for incoming residents and fellows. Beginning in July 2008, all new surgical and anesthesia residents and fellows received the AP guideline in their orientation packages and attended a mandatory educational session given by the surgeon-in-chief. The presentation provided information on guideline access, reviewed the criteria and evidence for appropriate AP use, and emphasized the importance of compliance for preventing SSI. Sixth, the final phase of the quality improvement initiative beginning May 2009 involved informatics. We programmed a reminder in the computerized patient order entry system that postoperative prophylaxis was not recommended for any but cardiac, transplant, and cochlear implant surgical procedures. The electronic alert provided a link to the online guideline and was triggered when clinicians attempted to prescribe postoperative prophylaxis for nonindicated patients. In addition, the task force mapped surgical prophylactic indications to every procedural code in the hospital’s Surgical Information Systems (SIS, Alpharetta, GA), with input from the surgeons. SIS is a software program for managing and interfacing perioperative information and workflow, including scheduling and intraoperative patient tracking. Details of surgical patients and procedures were all documented in SIS. OR nurses documented AP administration in the electronic OR log. Information technology programmed the SIS to automatically review all surgical procedures performed and sent e-mail notifications to surgeons the next day if a patient was given antibiotics without indication, not given antibiotic when indicated, or not given antibiotics within 60 minutes before skin incision when AP was indicated. Finally, aggregate data from the SIS was provided to all divisions and departments on a monthly basis.
in these 2 specialties were almost never indicated for prophylaxis. We collected data on eligible surgical procedures performed in July 2008 (preintervention), a random sample of procedures performed in the first 2 weeks of September 2011 (postintervention) and a stratified random sample of procedures performed in April and May 2013 (follow-up). For the postintervention and follow-up periods, cases were listed consecutively by date, and a random number generator was used to compile the samples. Cases with confirmed or suspected preoperative infection were excluded, including patients with otitis media, cholesteatoma, ingrown toenail, perforated appendix, abscess, sepsis, frank infection, and draining pus. We also excluded procedures that involved the oral cavity, isolated endoscopy (including foreign body removal), organ retrieval, and central venous line removal, which had no risk of postoperative infection. From OR logs, anesthesia records, and health records, we extracted patient and surgery characteristics and AP administration for each procedure. If antibiotics were given, the drug, timing, dosage, redosing, and duration were also collected. For procedures in which AP was not given in the OR, we manually conducted a chart review to determine whether patients received them before surgery, on the ward, or in the emergency department. Physicians were also consulted for clarification on any discrepancies between the OR log and the anesthesia record. Where differences could not be reconciled, we utilized the data from the anesthesia records. For each surgical procedure, we determined whether antibiotics were indicated. Moreover, for procedures with prophylaxis indicated and administered, we evaluated compliance with the 5 AP criteria (drug, timing, dosage, redosing, and duration) according to the guideline. The guideline contained a list of approved drugs for each type of procedure. Patients already on antibiotics for a preexisting condition before surgery did not require additional prophylaxis if the antibiotic spectrum covered the potential pathogens and they were not due for redosing. Recommended dosage was calculated on the basis of patients’ age and weight, and doses within 20% of the reference were considered appropriate. The guideline specified that antibiotics be given before applying the tourniquet, if one was required, and within 60 minutes before incision. Patients with β-lactam allergy or previous methicillin-resistant Staphylococcus aureus colonization or infection should have received vancomycin administered within 120 minutes before incision and infused over at least 60 minutes.5,22 According to the guideline, antibiotics were to be redosed every 2 half-lives during anesthesia (“top-up”) to ensure adequate tissue antimicrobial levels at wound closure.4 For surgical procedures involving excessive blood loss or extensive burns, intraoperative redosing to maintain antimicrobial levels was to be considered. Patients already on antibiotics before surgery were redosed if “top-up” was due during the procedure. Prophylaxis should be discontinued at the end of all procedures, including for patients with open wounds, indwelling catheters, or in situ drains or chest tubes. The exceptions for postoperative prophylaxis discontinuation were cardiac surgery, transplant, and cochlear implantation, which AP was extended for up to 48 hours postoperation.4–5,23 We defined complete compliance with the AP guideline as having correct antibiotic, dosage, timing, redosing, and duration when prophylaxis was indicated. Partial compliance was defined as correct drug and timing when prophylaxis was indicated. Appropriate use of AP was defined as complete compliance when prophylaxis was indicated, and antibiotics not given when not indicated.
Statistical Analysis Data Collection To examine the effects of the intervention on guideline compliance, we assessed AP use in cardiovascular, general surgery, neurosurgery, orthopedic, otolaryngology, plastics, and urology procedures. We excluded ophthalmology and dentistry because antibiotics 404 | www.annalsofsurgery.com
We assessed preintervention and follow-up compliance to evaluate practice changes. Postintervention compliance was reported to determine trends but was not included in the statistical analyses. Using an estimated baseline rate of 45% complete compliance, we required a sample size of 173 cases in each period to detect at least C 2014 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 262, Number 2, August 2015
Surgical Antibiotic Guideline Compliance
15% change at 80% power and 5% significance level. We used the χ 2 test with P < 0.05 (2-tailed) level of statistical significance to compare compliance rates and dichotomous variables and 1-way analysis of variance at P < 0.05 (2-tailed) significance to compare continuous variables. Missing values were not imputed. All analyses were conducted in SPSS 20 for Mac (IBM Corporation, Armonk, NY). Institutional ethics approval was obtained before study initiation.
RESULTS We reviewed 773 procedures preintervention, 192 procedures postintervention, and 220 procedures at follow-up. After excluding patients, 426, 157, and 200 cases that met the inclusion criteria were identified for each time period, respectively. As shown in Table 1, surgical procedures at follow-up had a greater proportion of inpatients (81% vs 67%), longer mean duration of surgery (115 min vs 97 min), and smaller proportion of patients with American Society of Anesthesiologists (ASA) physical status I or II (67% vs 78%). Administering antibiotics when indicated and not giving antibiotics when not indicated according to guideline improved from 81% (345/426) to 94% (188/200; P < 0.001). Reduction in administration of unnecessary antibiotics accounted for much of the increase (Table 2).
TABLE 2. Surgical Cases by Antibiotic Prophylaxis Indication and Administration Antibiotics Given Antibiotics Indicated Preintervention (%) Yes No Total Postintervention (%) Yes No Total Follow-up (%) Yes No Total
Complete and Partial Compliance For surgical procedures with prophylaxis indicated, complete compliance with the guideline improved from 26.2% (49/187) to 53.2% (66/200; P < 0.001). Cardiovascular and plastic surgery had the highest compliance. Complete compliance increased by a total of 50% in each of plastic surgery, orthopedic surgery, and otolaryngol-
TABLE 1. Characteristics of Surgical Cases
Age, mean, yr Weight, mean, kg Surgical duration, mean, min Sex (%) Male Female Admission type (%) Inpatient Outpatient ASA physical status (%)∗ I–II III–V Case type (%) Elective Emergency
Total
174 (93.0) 68 (28.5) 242
13 (7.0) 171 (71.5) 184
187 239 426
98 (94.2) 10 (18.9) 108
6 (5.8) 43 (81.1) 49
104 53 157
118 (95.2) 6 (7.9) 124
6 (4.8) 70 (92.1) 76
124 76 200
Appropriate Use of Antibiotic Prophylaxis
Appropriate use of AP increased from 52% to 67% (P < 0.001). The highest rate was in cardiovascular surgery, whereas improvements in orthopedic surgery were statistically significant. There were also trends of improvement in cardiovascular surgery, urology, and plastic surgery. Practice was relatively unchanged in otolaryngology and general surgery, and appropriate AP use declined in neurosurgery (Table 3).
Preintervention Postintervention (N = 426) (N = 157)
No
TABLE 3. Appropriate Use of Surgical Antibiotic Prophylaxis by Service
Appropriate Use of Antibiotic Prophylaxis
Variable
Yes
Follow-up (N = 200)
P 0.428 0.451 0.041
6.7 28.0 97.2
7.2 29.3 126.0
7.1 29.5 115.2
64.3 35.7
61.8 38.2
57.5 42.5
66.9 33.1
89.6 10.4
80.5 19.5
0.101
