Opinion
Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.
EDITORIAL
Bundled Approaches for Surgical Site Infection Prevention The Continuing Quest to Get to Zero Preeti N. Malani, MD, MSJ
Although a well-timed operation can enhance both duration and quality of life, postoperative complications, including surgical site infections (SSIs), can offset some of the benefits of the operation. In addition to functional loss and mortality, SSIs are associated with Related article page 2162 increased length of stay and higher health care costs.1,2 SSIs are the most common reason for readmission after surgery,3 accounting for nearly 20% of unplanned readmissions. Among infecting organisms, Staphylococcus aureus consistently ranks as the most prevalent pathogen associated with SSIs, particularly after cardiac and orthopedic procedures.4 S aureus SSIs can be devastating, especially when a prosthetic device is involved. Although the results vary, several prior investigations suggest that perioperative use of topical mupirocin along with chlorhexidine gluconate bathing among patients known to be colonized with methicillin-susceptible S aureus (MSSA) or methicillin-resistant S aureus (MRSA) may reduce the risk of SSIs.5,6 The evidence for benefit is most robust for cardiac and orthopedic procedures.7 Yet decolonization protocols are not consistently applied in US hospitals.8 In this issue of JAMA, Schweizer and colleagues9 report the results of the Study to Optimally Prevent SSIs in Select Cardiac and Orthopedic Procedures (STOP-SSI), a multicenter, pragmatic study that examined the implementation of a bundled intervention of screening, decolonization, and targeted antimicrobial prophylaxis to prevent complex S aureus SSIs (deep incisional or organ space infections) among patients undergoing cardiac surgery and hip or knee arthroplasties. The specific interventions were simple and included screening and then decolonizing individuals who were positive for either MSSA or MRSA using intranasal mupirocin and chlorhexidine bathing, both for 5 days. In addition, the standard surgical prophylaxis regimen was modified to include vancomycin (along with the usual first- or second-generation β-lactam) for individuals known to be colonized with MRSA. The study took place in 20 hospitals across the United States and included 42 534 unique operations, consisting of 10 833 cardiac procedures and 31 701 hip or knee arthroplasties. Use of the bundle was associated with a decrease in complex S aureus SSIs. Overall, 101 complex S aureus SSIs occurred after 28 218 operations during the preintervention period compared with 29 SSIs after 14 316 operations during the intervention; mean SSI rate per 10 000 operations decreased from 36 for the preintervention period to 21 for the intervention period; rate ratio (RR), 0.58 (95% CI, 0.37-0.92).
Although the absolute difference of 15 infections per 10 000 operations seems modest, each complex SSI prevented is clinically meaningful. For the individual patient, development of a serious SSI after cardiac or orthopedic surgery usually translates into months of parenteral antibiotics, additional surgical procedures, and extended inpatient and subacute care facility stays. The lengthy recovery can negate any benefit provided by the original operation. In a substantial portion, S aureus SSI will contribute to death.10,11 Given the considerable clinical and economic consequences of SSIs, some have suggested that the goal for the US health care system is zero tolerance of adverse events.12 The study by Schweizer et al has a number of notable strengths. For example, the inclusion of patients undergoing emergency or urgent operations, a population recognized as at high risk for SSI, improves the generalizability of the findings. In addition, the primary study outcome was limited to complex S aureus SSIs, eliminating much of the subjectivity of infection surveillance. Even though surveillance practices varied among participating hospitals, complicated S aureus SSIs are not clinically subtle and can be identified easily by any surveillance system. The pragmatic nature of this investigation is reflected in reported bundle compliance; even after a 3-month phase-in period, bundle adherence was 83%, with only 39% implementing all components of the bundled intervention (fully adherent). The authors observed a “dose-response” association for bundle adherence; rates of complex SSIs decreased significantly among patients in the fully adherent group (RR, 0.26 [95% CI, 0.10-0.69]) but not in the partially adherent or nonadherent groups. Although a matter of speculation, improved adherence to the bundle may produce better results in other settings, particularly if baseline infection rates are higher than those reported in this study. Moving forward, efforts to promote and maintain adherence to prevention protocols will remain important. Leveraging the potential of the electronic medical record through the use of automated reminders and checklists is one approach. Adherence rates were particularly low in urgent and emergency operations in which nearly half of surgeons and sites were not adherent. Given the experience reported by Schweizer et al, universal decolonization and routine use of vancomycin may be a suitable alternative for urgent operations. The authors tested 36 infecting isolates for evidence of high-level resistance to mupirocin or chlorhexidine gluconate; 1 isolate demonstrated high-level mupirocin resistance, and none carried qac genes. Although these results are
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reassuring, continued monitoring is prudent because the emergence of resistance is well described, most notably with prolonged use of mupirocin. In addition, it is very difficult to assess the relationship between implementation of the bundle used in this study and the overall ecology of antimicrobial resistance in a particular hospital (with the possibility of increased perioperative vancomycin use), an issue of major national and international concern. The study’s setting is among its limitations. All 20 study sites were from a single health care system with a wellestablished quality improvement infrastructure. Although the study is presented as pragmatic, certain factors in this health care system may differ from other clinical settings, including a below-average baseline infection rate. It remains unclear what challenges and barriers may present as this bundle is implemented at other institutions. Further studies in different settings will offer additional guidance. Although this study is a noteworthy addition to a growing body of high-quality infection prevention trials, many ARTICLE INFORMATION Author Affiliations: Division of Infectious Diseases, Department of Internal Medicine, University of Michigan Health System, Ann Arbor; Associate Editor, JAMA. Corresponding Author: Preeti N. Malani, MD, MSJ, 3119 Taubman Center, Ann Arbor, MI 48109-5378 ([email protected]). Conflict of Interest Disclosures: Dr Malani has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. REFERENCES 1. Schweizer ML, Cullen JJ, Perencevich EN, Vaughan Sarrazin MS. Costs associated with surgical site infections in Veterans Affairs hospitals. JAMA Surg. 2014;149(6):575-581. 2. Young MH, Washer L, Malani PN. Surgical site infections in older adults: epidemiology and management strategies. Drugs Aging. 2008;25(5): 399-414. 3. Merkow RP, Ju MH, Chung JW, et al. Underlying reasons associated with hospital readmission
2132
questions remain. Although S aureus remains the principal pathogen in terms of prevalence and associated morbidity, many other organisms also cause SSIs. As such, decolonization of MSSA and MRSA can be only one aspect of SSI prevention. Although the current findings demonstrate a decrease in S aureus SSIs, the authors did not find a decrease in gram-negative SSIs or complex SSIs caused by any pathogen. This finding might reflect the overall low rate of infection, but also is a poignant reminder that additional strategies are still needed. Public reporting and nonpayment for preventable complications (including some SSIs) have intensified efforts to eliminate infections—“to get to zero.” The low-hanging fruit for SSI prevention has been picked and incremental decreases are unlikely to come from simple interventions. Although getting to zero is unlikely to be achievable, efforts that move closer to this elusive goal hold tremendous value for clinicians, hospitals, payers, and, most importantly, patients.
following surgery in the United States. JAMA. 2015; 313(5):483-495. 4. Sievert DM, Ricks P, Edwards JR, et al; National Healthcare Safety Network (NHSN) Team and Participating NHSN Facilities. Antimicrobialresistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2009-2010. Infect Control Hosp Epidemiol. 2013;34 (1):1-14. 5. Bode LG, Kluytmans JA, Wertheim HF, et al. Preventing surgical-site infections in nasal carriers of Staphylococcus aureus. N Engl J Med. 2010; 362(1):9-17. 6. Schweizer M, Perencevich E, McDanel J, et al. Effectiveness of a bundled intervention of decolonization and prophylaxis to decrease gram-positive surgical site infections after cardiac or orthopedic surgery: systematic review and meta-analysis. BMJ. 2013;346:f2743.
8. Kline S, Highness M, Herwaldt LA, Perl TM. Variable screening and decolonization protocols for Staphylococcus aureus carriage prior to surgical procedures. Infect Control Hosp Epidemiol. 2014;35 (7):880-882. 9. Schweizer ML, Chiang H-Y, Septimus E, et al. Association of a bundled intervention with surgical site infections among patients undergoing cardiac, hip, or knee surgery. JAMA. doi:10.1001/jama.2015 .5387. 10. Big C, Malani PN. Staphylococcus aureus bloodstream infections in older adults: clinical outcomes and risk factors for in-hospital mortality. J Am Geriatr Soc. 2010;58(2):300-305. 11. Malani PN. Preventing postoperative Staphylococcus aureus infections: the search continues. JAMA. 2013;309(13):1408-1409. 12. Chassin MR, Baker DW. Aiming higher to enhance professionalism: beyond accreditation and certification. JAMA. 2015;313(18):1795-1796.
7. Anderson DJ, Podgorny K, Berríos-Torres SI, et al. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35(6):605-627.
JAMA June 2, 2015 Volume 313, Number 21 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
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Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.
EDITORIAL
Bundled Approaches for Surgical Site Infection Prevention The Continuing Quest to Get to Zero Preeti N. Malani, MD, MSJ
Although a well-timed operation can enhance both duration and quality of life, postoperative complications, including surgical site infections (SSIs), can offset some of the benefits of the operation. In addition to functional loss and mortality, SSIs are associated with Related article page 2162 increased length of stay and higher health care costs.1,2 SSIs are the most common reason for readmission after surgery,3 accounting for nearly 20% of unplanned readmissions. Among infecting organisms, Staphylococcus aureus consistently ranks as the most prevalent pathogen associated with SSIs, particularly after cardiac and orthopedic procedures.4 S aureus SSIs can be devastating, especially when a prosthetic device is involved. Although the results vary, several prior investigations suggest that perioperative use of topical mupirocin along with chlorhexidine gluconate bathing among patients known to be colonized with methicillin-susceptible S aureus (MSSA) or methicillin-resistant S aureus (MRSA) may reduce the risk of SSIs.5,6 The evidence for benefit is most robust for cardiac and orthopedic procedures.7 Yet decolonization protocols are not consistently applied in US hospitals.8 In this issue of JAMA, Schweizer and colleagues9 report the results of the Study to Optimally Prevent SSIs in Select Cardiac and Orthopedic Procedures (STOP-SSI), a multicenter, pragmatic study that examined the implementation of a bundled intervention of screening, decolonization, and targeted antimicrobial prophylaxis to prevent complex S aureus SSIs (deep incisional or organ space infections) among patients undergoing cardiac surgery and hip or knee arthroplasties. The specific interventions were simple and included screening and then decolonizing individuals who were positive for either MSSA or MRSA using intranasal mupirocin and chlorhexidine bathing, both for 5 days. In addition, the standard surgical prophylaxis regimen was modified to include vancomycin (along with the usual first- or second-generation β-lactam) for individuals known to be colonized with MRSA. The study took place in 20 hospitals across the United States and included 42 534 unique operations, consisting of 10 833 cardiac procedures and 31 701 hip or knee arthroplasties. Use of the bundle was associated with a decrease in complex S aureus SSIs. Overall, 101 complex S aureus SSIs occurred after 28 218 operations during the preintervention period compared with 29 SSIs after 14 316 operations during the intervention; mean SSI rate per 10 000 operations decreased from 36 for the preintervention period to 21 for the intervention period; rate ratio (RR), 0.58 (95% CI, 0.37-0.92).
Although the absolute difference of 15 infections per 10 000 operations seems modest, each complex SSI prevented is clinically meaningful. For the individual patient, development of a serious SSI after cardiac or orthopedic surgery usually translates into months of parenteral antibiotics, additional surgical procedures, and extended inpatient and subacute care facility stays. The lengthy recovery can negate any benefit provided by the original operation. In a substantial portion, S aureus SSI will contribute to death.10,11 Given the considerable clinical and economic consequences of SSIs, some have suggested that the goal for the US health care system is zero tolerance of adverse events.12 The study by Schweizer et al has a number of notable strengths. For example, the inclusion of patients undergoing emergency or urgent operations, a population recognized as at high risk for SSI, improves the generalizability of the findings. In addition, the primary study outcome was limited to complex S aureus SSIs, eliminating much of the subjectivity of infection surveillance. Even though surveillance practices varied among participating hospitals, complicated S aureus SSIs are not clinically subtle and can be identified easily by any surveillance system. The pragmatic nature of this investigation is reflected in reported bundle compliance; even after a 3-month phase-in period, bundle adherence was 83%, with only 39% implementing all components of the bundled intervention (fully adherent). The authors observed a “dose-response” association for bundle adherence; rates of complex SSIs decreased significantly among patients in the fully adherent group (RR, 0.26 [95% CI, 0.10-0.69]) but not in the partially adherent or nonadherent groups. Although a matter of speculation, improved adherence to the bundle may produce better results in other settings, particularly if baseline infection rates are higher than those reported in this study. Moving forward, efforts to promote and maintain adherence to prevention protocols will remain important. Leveraging the potential of the electronic medical record through the use of automated reminders and checklists is one approach. Adherence rates were particularly low in urgent and emergency operations in which nearly half of surgeons and sites were not adherent. Given the experience reported by Schweizer et al, universal decolonization and routine use of vancomycin may be a suitable alternative for urgent operations. The authors tested 36 infecting isolates for evidence of high-level resistance to mupirocin or chlorhexidine gluconate; 1 isolate demonstrated high-level mupirocin resistance, and none carried qac genes. Although these results are
jama.com
(Reprinted) JAMA June 2, 2015 Volume 313, Number 21
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a New York University User on 06/06/2015
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Opinion Editorial
reassuring, continued monitoring is prudent because the emergence of resistance is well described, most notably with prolonged use of mupirocin. In addition, it is very difficult to assess the relationship between implementation of the bundle used in this study and the overall ecology of antimicrobial resistance in a particular hospital (with the possibility of increased perioperative vancomycin use), an issue of major national and international concern. The study’s setting is among its limitations. All 20 study sites were from a single health care system with a wellestablished quality improvement infrastructure. Although the study is presented as pragmatic, certain factors in this health care system may differ from other clinical settings, including a below-average baseline infection rate. It remains unclear what challenges and barriers may present as this bundle is implemented at other institutions. Further studies in different settings will offer additional guidance. Although this study is a noteworthy addition to a growing body of high-quality infection prevention trials, many ARTICLE INFORMATION Author Affiliations: Division of Infectious Diseases, Department of Internal Medicine, University of Michigan Health System, Ann Arbor; Associate Editor, JAMA. Corresponding Author: Preeti N. Malani, MD, MSJ, 3119 Taubman Center, Ann Arbor, MI 48109-5378 ([email protected]). Conflict of Interest Disclosures: Dr Malani has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. REFERENCES 1. Schweizer ML, Cullen JJ, Perencevich EN, Vaughan Sarrazin MS. Costs associated with surgical site infections in Veterans Affairs hospitals. JAMA Surg. 2014;149(6):575-581. 2. Young MH, Washer L, Malani PN. Surgical site infections in older adults: epidemiology and management strategies. Drugs Aging. 2008;25(5): 399-414. 3. Merkow RP, Ju MH, Chung JW, et al. Underlying reasons associated with hospital readmission
2132
questions remain. Although S aureus remains the principal pathogen in terms of prevalence and associated morbidity, many other organisms also cause SSIs. As such, decolonization of MSSA and MRSA can be only one aspect of SSI prevention. Although the current findings demonstrate a decrease in S aureus SSIs, the authors did not find a decrease in gram-negative SSIs or complex SSIs caused by any pathogen. This finding might reflect the overall low rate of infection, but also is a poignant reminder that additional strategies are still needed. Public reporting and nonpayment for preventable complications (including some SSIs) have intensified efforts to eliminate infections—“to get to zero.” The low-hanging fruit for SSI prevention has been picked and incremental decreases are unlikely to come from simple interventions. Although getting to zero is unlikely to be achievable, efforts that move closer to this elusive goal hold tremendous value for clinicians, hospitals, payers, and, most importantly, patients.
following surgery in the United States. JAMA. 2015; 313(5):483-495. 4. Sievert DM, Ricks P, Edwards JR, et al; National Healthcare Safety Network (NHSN) Team and Participating NHSN Facilities. Antimicrobialresistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2009-2010. Infect Control Hosp Epidemiol. 2013;34 (1):1-14. 5. Bode LG, Kluytmans JA, Wertheim HF, et al. Preventing surgical-site infections in nasal carriers of Staphylococcus aureus. N Engl J Med. 2010; 362(1):9-17. 6. Schweizer M, Perencevich E, McDanel J, et al. Effectiveness of a bundled intervention of decolonization and prophylaxis to decrease gram-positive surgical site infections after cardiac or orthopedic surgery: systematic review and meta-analysis. BMJ. 2013;346:f2743.
8. Kline S, Highness M, Herwaldt LA, Perl TM. Variable screening and decolonization protocols for Staphylococcus aureus carriage prior to surgical procedures. Infect Control Hosp Epidemiol. 2014;35 (7):880-882. 9. Schweizer ML, Chiang H-Y, Septimus E, et al. Association of a bundled intervention with surgical site infections among patients undergoing cardiac, hip, or knee surgery. JAMA. doi:10.1001/jama.2015 .5387. 10. Big C, Malani PN. Staphylococcus aureus bloodstream infections in older adults: clinical outcomes and risk factors for in-hospital mortality. J Am Geriatr Soc. 2010;58(2):300-305. 11. Malani PN. Preventing postoperative Staphylococcus aureus infections: the search continues. JAMA. 2013;309(13):1408-1409. 12. Chassin MR, Baker DW. Aiming higher to enhance professionalism: beyond accreditation and certification. JAMA. 2015;313(18):1795-1796.
7. Anderson DJ, Podgorny K, Berríos-Torres SI, et al. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35(6):605-627.
JAMA June 2, 2015 Volume 313, Number 21 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
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