From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, [email protected].


Funding/support: RB Salter Chair in Paediatric Surgical Research.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, [email protected].


Funding/support: RB Salter Chair in Paediatric Surgical Research.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, [email protected].


Funding/support: RB Salter Chair in Paediatric Surgical Research.

Study Overview

Objective. To assess the effectiveness of an intervention that focused on the home environment to reduce energy intake and increase physical activity among overweight and obese women.

Design. Randomized controlled trial.

Setting and participants. Study participants were overweight and obese females recruited via their providers from 3 community health centers (9 clinical sites) in southwest Georgia. Only women were recruited because of their potential role as gatekeepers of the home environment. Inclusion criteria included being aged 35 to 65 years at baseline, living with at least one other person, and living no further than 30 miles from the referring clinic. Exclusion criteria included patients with conditions that could impact their ability to be physically active and pregnant women.

Intervention. Participants in the intervention arm received 3 home visits and 4 coaching calls over 16 weeks. Core elements of the intervention were informed by social-cognitive theory and included a tailored home environment profile, goal setting, behavioral contracting for 6 healthy actions, and supportive materials delivered via mail. Home visits and coaching calls were completed by health coaches with at least high-school education and experience in social or customer service who had completed 2 days of formal training by university staff. Control condition patients received 3 mailings of educational booklets at 6-week intervals that included government documents encouraging adoption of US dietary and physical activity guidelines. All participants completed baseline, 6- and 12-month follow-up telephone interviews and wore an accelerometer at baseline and 6-month follow-up. Intervention patients also received follow-up surveys assessing satisfaction with the coach, home visits, telephone calls, and support materials.

Main outcome measures. The main outcomes were energy intake (average daily kilocalories from two 24-hour dietary recalls) and physical activity (hours per week spent in moderate or vigorous physical activity using the 7-day physical activity recall). Self-reported height and weight was used to calculate body mass index (BMI). Secondary outcome measures included self-reported weight loss and aspects of the home environment. Home food environment was assessed by asking participants about the presence of 3 unhealthy drinks and 8 unhealthy foods and snacks in the home in the past week, if fruits and vegetables and high-calorie snack foods were kept in easy to see and reach places in the home, how often the family ate meals and snacks in front of the TV, how often participants served healthier food or prepared foods using healthy cooking methods, and asking the number of days family meals were purchased from outside the home. Home activity environment was assessed by asking about rules regarding limits on time spent watching TV, using a computer, playing video games, and using other hand-held devices. The authors adapted a 14-item inventory to assess personal exercise equipment accessibility and availability in the home. Community facility use was assessed with 9 survey items that assessed frequency of use and spaces for exercise in the participants’ neighborhoods.

Main results. A total of 948 patients were referred, of which 751 were reached by phone and assessed for eligibility. 81 did not meet inclusion criteria, 203 declined to participate, and 118 did not complete baseline data collection, leaving 349 participants. Of these, 177 were randomized to the control group, 172 to the intervention, and 21 dropped out. The majority of participants were African-American women (84.8%) with an average age of 50.2 years (SD = 8.1) and average BMI of 38.3kg/m² (SD = 8.4). Most were low income, with 68.7% reporting an annual household income under $25,000, and nearly 50% reported fair or poor general health. Roughly 45% were employed and 49% lived in a rural area. At 6 months, 82.5% of participants completed data collection (n = 288); at 12 months, 76.8% completed data collection (n = 268). Participants who did not complete follow-up through 12 months were either non-responders (6 months: n = 36, 12 months: n = 44), refused (6 months: n = 3, 12 months: n = 7), or died (6 months: n = 0, 12 months: n = 1).

Daily energy consumption significantly decreased in the intervention group compared to the control group at 6 months (–274 vs. –69 kcal/day, P = 0.003), however there was no meaningful change in self-reported moderate to vigorous physical activity nor was there significant change in physical activity measured by accelerometers at 6 months compared to baseline. For secondary outcomes, self-reported weight loss at 6 months was significantly higher among intervention patients (mean, –9.1 lb) compared to control patients (mean, –5.0 pounds) (SD = 13.7 pounds; P = 0.03). In addition, at 12 months, 82.6% of intervention patients had not gained weight compared with 71.4% of control patients (P = 0.03). Intervention patients made several changes to their home food environments compared to control patients. Intervention patients had reduced the number of unhealthy drink and snacks, increased purchasing of fruits and vegetables, and reduced the frequency of watching TV while eating. In addition, they also improved meal preparation and service and reduced the number of non-home meals eaten. For home activity environment, having exercise equipment in a visible location changed significantly more in the intervention group compared to the control group. Intervention patients also incorporated more physical activity into their daily lives compared to control patients, and created more exercise space in their homes and yards. There were no significant differences in screen time rules, use of community facilities and spaces, and family social support for physical activity.

Conclusion. A moderate-intensity, coach-delivered weight gain prevention intervention targeting the home environment led to reduced energy intake and improved home environments to better facilitate healthy living and weight loss.

Commentary

More than half of all US adults are considered overweight or obese [1].Changing health behaviors has the best potential for decreasing morbidity and mortality and for improving quality of life and this has been supported by the literature in a wide variety of behaviors including smoking cessation and weight loss [2–4]. Currently, most overweight and obese patients are treated through primary care provider–based (PCP) counseling or referral to clinic-based weight management interventions. However, barriers to PCP weight management counseling include physicians’ negative attitudes towards the personal attributes of individuals with weight management issues, lack of time, and poor nutrition counseling competency [5–7]. In addition, there are notable differences between providers’ and patients’ beliefs about weight and weight loss; providers tend to believe patients lack self-control, while patients largely feel they should manage their weight problems on their own and that counseling from a provider is unhelpful [8]. Many patients report feeling judged by their doctor because of their weight, and very few of those who feel judged and discuss weight loss options actually lose a clinically significant amount of weight [9]. Considering the many barriers to providing/receiving weight management counseling in the clinic setting, weight management techniques provided outside the doctor’s office may be a more effective and feasible alternative.

The most common causes of death are related to lifestyle behaviors such as poor dietary habits and inactivity [10]. Since most calories are consumed within the home [11] and the average person spends the majority of their time in the home [12], interventions that target home-life behaviors are needed to combat weight gain. The Kegler et al study suggests that a moderate-intensity intervention targeted at changing home eating and exercise behaviors will be effective in changing home environments and reducing energy intake. While the authors had a fairly specific population, these findings suggest that interventions that specifically target health behaviors at home may have more potential for success than merely educating patients on the benefits of a healthy lifestyle.

This study has several strengths including the randomized controlled trial design, the intention-to-treat analysis, and low attrition rates. In addition, the intervention achieved reduced energy intake and improved health behaviors in the home, supporting significant weight loss among intervention participants, especially compared to control patients. Both of these suggest high adherence to the intervention, which is a complex but crucial component of successful weight loss and weight management [13]. Finally, the inclusion of a wide variety of secondary outcomes helped to distinguish between specific home environment changes to discern which aspects of the intervention were most successful. A limitation of the study was that the population was nearly entirely African American and from clinics in rural Georgia, which limits generalizability. However, the success of the intervention in this population is critical, as African American adults are nearly 1.5 times more likely to be obese compared to white adults, and greater than 75% of African Americans are overweight or obese [14]. Additionally, while the study did have significant success with energy intake and eating habits, the intervention was less successful with changing physical activity habits, and physical activity and exercise training can significantly impact weight loss and maintenance [15]. A final limitation is the use of self-reported weight and behaviors, which can reduce reliability of these results.

Applications for Clinical Practice

This study suggests that interventions that target health behaviors in the home may achieve better energy intake and physical activity outcomes and improve weight loss compared to traditional educational counseling. Providers may want to consider brief counseling around improving the home environment as opposed to or in addition to counseling around improving nutrition or physical activity. More research is necessary to understand whether this type of intervention is feasible and acceptable in other populations (eg, urban, other races). In addition, further research is necessary to improve the physical activity component of the intervention. The use of non-clinical providers has been shown to be effective in improving health outcomes [16] and this study provides further evidence on the impactful role that trained community residents can have on changing behaviors. These initiatives are vital to supplement weight loss and management efforts occurring in the clinical setting.

—Natalie L. Ricci, Columbia University Mailman School of Public Health, and Katrina F. Mateo, MPH

Study Overview

Objective. To assess the effectiveness of an intervention that focused on the home environment to reduce energy intake and increase physical activity among overweight and obese women.

Design. Randomized controlled trial.

Setting and participants. Study participants were overweight and obese females recruited via their providers from 3 community health centers (9 clinical sites) in southwest Georgia. Only women were recruited because of their potential role as gatekeepers of the home environment. Inclusion criteria included being aged 35 to 65 years at baseline, living with at least one other person, and living no further than 30 miles from the referring clinic. Exclusion criteria included patients with conditions that could impact their ability to be physically active and pregnant women.

Intervention. Participants in the intervention arm received 3 home visits and 4 coaching calls over 16 weeks. Core elements of the intervention were informed by social-cognitive theory and included a tailored home environment profile, goal setting, behavioral contracting for 6 healthy actions, and supportive materials delivered via mail. Home visits and coaching calls were completed by health coaches with at least high-school education and experience in social or customer service who had completed 2 days of formal training by university staff. Control condition patients received 3 mailings of educational booklets at 6-week intervals that included government documents encouraging adoption of US dietary and physical activity guidelines. All participants completed baseline, 6- and 12-month follow-up telephone interviews and wore an accelerometer at baseline and 6-month follow-up. Intervention patients also received follow-up surveys assessing satisfaction with the coach, home visits, telephone calls, and support materials.

Main outcome measures. The main outcomes were energy intake (average daily kilocalories from two 24-hour dietary recalls) and physical activity (hours per week spent in moderate or vigorous physical activity using the 7-day physical activity recall). Self-reported height and weight was used to calculate body mass index (BMI). Secondary outcome measures included self-reported weight loss and aspects of the home environment. Home food environment was assessed by asking participants about the presence of 3 unhealthy drinks and 8 unhealthy foods and snacks in the home in the past week, if fruits and vegetables and high-calorie snack foods were kept in easy to see and reach places in the home, how often the family ate meals and snacks in front of the TV, how often participants served healthier food or prepared foods using healthy cooking methods, and asking the number of days family meals were purchased from outside the home. Home activity environment was assessed by asking about rules regarding limits on time spent watching TV, using a computer, playing video games, and using other hand-held devices. The authors adapted a 14-item inventory to assess personal exercise equipment accessibility and availability in the home. Community facility use was assessed with 9 survey items that assessed frequency of use and spaces for exercise in the participants’ neighborhoods.

Main results. A total of 948 patients were referred, of which 751 were reached by phone and assessed for eligibility. 81 did not meet inclusion criteria, 203 declined to participate, and 118 did not complete baseline data collection, leaving 349 participants. Of these, 177 were randomized to the control group, 172 to the intervention, and 21 dropped out. The majority of participants were African-American women (84.8%) with an average age of 50.2 years (SD = 8.1) and average BMI of 38.3kg/m² (SD = 8.4). Most were low income, with 68.7% reporting an annual household income under $25,000, and nearly 50% reported fair or poor general health. Roughly 45% were employed and 49% lived in a rural area. At 6 months, 82.5% of participants completed data collection (n = 288); at 12 months, 76.8% completed data collection (n = 268). Participants who did not complete follow-up through 12 months were either non-responders (6 months: n = 36, 12 months: n = 44), refused (6 months: n = 3, 12 months: n = 7), or died (6 months: n = 0, 12 months: n = 1).

Daily energy consumption significantly decreased in the intervention group compared to the control group at 6 months (–274 vs. –69 kcal/day, P = 0.003), however there was no meaningful change in self-reported moderate to vigorous physical activity nor was there significant change in physical activity measured by accelerometers at 6 months compared to baseline. For secondary outcomes, self-reported weight loss at 6 months was significantly higher among intervention patients (mean, –9.1 lb) compared to control patients (mean, –5.0 pounds) (SD = 13.7 pounds; P = 0.03). In addition, at 12 months, 82.6% of intervention patients had not gained weight compared with 71.4% of control patients (P = 0.03). Intervention patients made several changes to their home food environments compared to control patients. Intervention patients had reduced the number of unhealthy drink and snacks, increased purchasing of fruits and vegetables, and reduced the frequency of watching TV while eating. In addition, they also improved meal preparation and service and reduced the number of non-home meals eaten. For home activity environment, having exercise equipment in a visible location changed significantly more in the intervention group compared to the control group. Intervention patients also incorporated more physical activity into their daily lives compared to control patients, and created more exercise space in their homes and yards. There were no significant differences in screen time rules, use of community facilities and spaces, and family social support for physical activity.

Conclusion. A moderate-intensity, coach-delivered weight gain prevention intervention targeting the home environment led to reduced energy intake and improved home environments to better facilitate healthy living and weight loss.

Commentary

More than half of all US adults are considered overweight or obese [1].Changing health behaviors has the best potential for decreasing morbidity and mortality and for improving quality of life and this has been supported by the literature in a wide variety of behaviors including smoking cessation and weight loss [2–4]. Currently, most overweight and obese patients are treated through primary care provider–based (PCP) counseling or referral to clinic-based weight management interventions. However, barriers to PCP weight management counseling include physicians’ negative attitudes towards the personal attributes of individuals with weight management issues, lack of time, and poor nutrition counseling competency [5–7]. In addition, there are notable differences between providers’ and patients’ beliefs about weight and weight loss; providers tend to believe patients lack self-control, while patients largely feel they should manage their weight problems on their own and that counseling from a provider is unhelpful [8]. Many patients report feeling judged by their doctor because of their weight, and very few of those who feel judged and discuss weight loss options actually lose a clinically significant amount of weight [9]. Considering the many barriers to providing/receiving weight management counseling in the clinic setting, weight management techniques provided outside the doctor’s office may be a more effective and feasible alternative.

The most common causes of death are related to lifestyle behaviors such as poor dietary habits and inactivity [10]. Since most calories are consumed within the home [11] and the average person spends the majority of their time in the home [12], interventions that target home-life behaviors are needed to combat weight gain. The Kegler et al study suggests that a moderate-intensity intervention targeted at changing home eating and exercise behaviors will be effective in changing home environments and reducing energy intake. While the authors had a fairly specific population, these findings suggest that interventions that specifically target health behaviors at home may have more potential for success than merely educating patients on the benefits of a healthy lifestyle.

This study has several strengths including the randomized controlled trial design, the intention-to-treat analysis, and low attrition rates. In addition, the intervention achieved reduced energy intake and improved health behaviors in the home, supporting significant weight loss among intervention participants, especially compared to control patients. Both of these suggest high adherence to the intervention, which is a complex but crucial component of successful weight loss and weight management [13]. Finally, the inclusion of a wide variety of secondary outcomes helped to distinguish between specific home environment changes to discern which aspects of the intervention were most successful. A limitation of the study was that the population was nearly entirely African American and from clinics in rural Georgia, which limits generalizability. However, the success of the intervention in this population is critical, as African American adults are nearly 1.5 times more likely to be obese compared to white adults, and greater than 75% of African Americans are overweight or obese [14]. Additionally, while the study did have significant success with energy intake and eating habits, the intervention was less successful with changing physical activity habits, and physical activity and exercise training can significantly impact weight loss and maintenance [15]. A final limitation is the use of self-reported weight and behaviors, which can reduce reliability of these results.

Applications for Clinical Practice

This study suggests that interventions that target health behaviors in the home may achieve better energy intake and physical activity outcomes and improve weight loss compared to traditional educational counseling. Providers may want to consider brief counseling around improving the home environment as opposed to or in addition to counseling around improving nutrition or physical activity. More research is necessary to understand whether this type of intervention is feasible and acceptable in other populations (eg, urban, other races). In addition, further research is necessary to improve the physical activity component of the intervention. The use of non-clinical providers has been shown to be effective in improving health outcomes [16] and this study provides further evidence on the impactful role that trained community residents can have on changing behaviors. These initiatives are vital to supplement weight loss and management efforts occurring in the clinical setting.

—Natalie L. Ricci, Columbia University Mailman School of Public Health, and Katrina F. Mateo, MPH

Study Overview

Objective. To assess the effectiveness of an intervention that focused on the home environment to reduce energy intake and increase physical activity among overweight and obese women.

Design. Randomized controlled trial.

Setting and participants. Study participants were overweight and obese females recruited via their providers from 3 community health centers (9 clinical sites) in southwest Georgia. Only women were recruited because of their potential role as gatekeepers of the home environment. Inclusion criteria included being aged 35 to 65 years at baseline, living with at least one other person, and living no further than 30 miles from the referring clinic. Exclusion criteria included patients with conditions that could impact their ability to be physically active and pregnant women.

Intervention. Participants in the intervention arm received 3 home visits and 4 coaching calls over 16 weeks. Core elements of the intervention were informed by social-cognitive theory and included a tailored home environment profile, goal setting, behavioral contracting for 6 healthy actions, and supportive materials delivered via mail. Home visits and coaching calls were completed by health coaches with at least high-school education and experience in social or customer service who had completed 2 days of formal training by university staff. Control condition patients received 3 mailings of educational booklets at 6-week intervals that included government documents encouraging adoption of US dietary and physical activity guidelines. All participants completed baseline, 6- and 12-month follow-up telephone interviews and wore an accelerometer at baseline and 6-month follow-up. Intervention patients also received follow-up surveys assessing satisfaction with the coach, home visits, telephone calls, and support materials.

Main outcome measures. The main outcomes were energy intake (average daily kilocalories from two 24-hour dietary recalls) and physical activity (hours per week spent in moderate or vigorous physical activity using the 7-day physical activity recall). Self-reported height and weight was used to calculate body mass index (BMI). Secondary outcome measures included self-reported weight loss and aspects of the home environment. Home food environment was assessed by asking participants about the presence of 3 unhealthy drinks and 8 unhealthy foods and snacks in the home in the past week, if fruits and vegetables and high-calorie snack foods were kept in easy to see and reach places in the home, how often the family ate meals and snacks in front of the TV, how often participants served healthier food or prepared foods using healthy cooking methods, and asking the number of days family meals were purchased from outside the home. Home activity environment was assessed by asking about rules regarding limits on time spent watching TV, using a computer, playing video games, and using other hand-held devices. The authors adapted a 14-item inventory to assess personal exercise equipment accessibility and availability in the home. Community facility use was assessed with 9 survey items that assessed frequency of use and spaces for exercise in the participants’ neighborhoods.

Main results. A total of 948 patients were referred, of which 751 were reached by phone and assessed for eligibility. 81 did not meet inclusion criteria, 203 declined to participate, and 118 did not complete baseline data collection, leaving 349 participants. Of these, 177 were randomized to the control group, 172 to the intervention, and 21 dropped out. The majority of participants were African-American women (84.8%) with an average age of 50.2 years (SD = 8.1) and average BMI of 38.3kg/m² (SD = 8.4). Most were low income, with 68.7% reporting an annual household income under $25,000, and nearly 50% reported fair or poor general health. Roughly 45% were employed and 49% lived in a rural area. At 6 months, 82.5% of participants completed data collection (n = 288); at 12 months, 76.8% completed data collection (n = 268). Participants who did not complete follow-up through 12 months were either non-responders (6 months: n = 36, 12 months: n = 44), refused (6 months: n = 3, 12 months: n = 7), or died (6 months: n = 0, 12 months: n = 1).

Daily energy consumption significantly decreased in the intervention group compared to the control group at 6 months (–274 vs. –69 kcal/day, P = 0.003), however there was no meaningful change in self-reported moderate to vigorous physical activity nor was there significant change in physical activity measured by accelerometers at 6 months compared to baseline. For secondary outcomes, self-reported weight loss at 6 months was significantly higher among intervention patients (mean, –9.1 lb) compared to control patients (mean, –5.0 pounds) (SD = 13.7 pounds; P = 0.03). In addition, at 12 months, 82.6% of intervention patients had not gained weight compared with 71.4% of control patients (P = 0.03). Intervention patients made several changes to their home food environments compared to control patients. Intervention patients had reduced the number of unhealthy drink and snacks, increased purchasing of fruits and vegetables, and reduced the frequency of watching TV while eating. In addition, they also improved meal preparation and service and reduced the number of non-home meals eaten. For home activity environment, having exercise equipment in a visible location changed significantly more in the intervention group compared to the control group. Intervention patients also incorporated more physical activity into their daily lives compared to control patients, and created more exercise space in their homes and yards. There were no significant differences in screen time rules, use of community facilities and spaces, and family social support for physical activity.

Conclusion. A moderate-intensity, coach-delivered weight gain prevention intervention targeting the home environment led to reduced energy intake and improved home environments to better facilitate healthy living and weight loss.

Commentary

More than half of all US adults are considered overweight or obese [1].Changing health behaviors has the best potential for decreasing morbidity and mortality and for improving quality of life and this has been supported by the literature in a wide variety of behaviors including smoking cessation and weight loss [2–4]. Currently, most overweight and obese patients are treated through primary care provider–based (PCP) counseling or referral to clinic-based weight management interventions. However, barriers to PCP weight management counseling include physicians’ negative attitudes towards the personal attributes of individuals with weight management issues, lack of time, and poor nutrition counseling competency [5–7]. In addition, there are notable differences between providers’ and patients’ beliefs about weight and weight loss; providers tend to believe patients lack self-control, while patients largely feel they should manage their weight problems on their own and that counseling from a provider is unhelpful [8]. Many patients report feeling judged by their doctor because of their weight, and very few of those who feel judged and discuss weight loss options actually lose a clinically significant amount of weight [9]. Considering the many barriers to providing/receiving weight management counseling in the clinic setting, weight management techniques provided outside the doctor’s office may be a more effective and feasible alternative.

The most common causes of death are related to lifestyle behaviors such as poor dietary habits and inactivity [10]. Since most calories are consumed within the home [11] and the average person spends the majority of their time in the home [12], interventions that target home-life behaviors are needed to combat weight gain. The Kegler et al study suggests that a moderate-intensity intervention targeted at changing home eating and exercise behaviors will be effective in changing home environments and reducing energy intake. While the authors had a fairly specific population, these findings suggest that interventions that specifically target health behaviors at home may have more potential for success than merely educating patients on the benefits of a healthy lifestyle.

This study has several strengths including the randomized controlled trial design, the intention-to-treat analysis, and low attrition rates. In addition, the intervention achieved reduced energy intake and improved health behaviors in the home, supporting significant weight loss among intervention participants, especially compared to control patients. Both of these suggest high adherence to the intervention, which is a complex but crucial component of successful weight loss and weight management [13]. Finally, the inclusion of a wide variety of secondary outcomes helped to distinguish between specific home environment changes to discern which aspects of the intervention were most successful. A limitation of the study was that the population was nearly entirely African American and from clinics in rural Georgia, which limits generalizability. However, the success of the intervention in this population is critical, as African American adults are nearly 1.5 times more likely to be obese compared to white adults, and greater than 75% of African Americans are overweight or obese [14]. Additionally, while the study did have significant success with energy intake and eating habits, the intervention was less successful with changing physical activity habits, and physical activity and exercise training can significantly impact weight loss and maintenance [15]. A final limitation is the use of self-reported weight and behaviors, which can reduce reliability of these results.

Applications for Clinical Practice

This study suggests that interventions that target health behaviors in the home may achieve better energy intake and physical activity outcomes and improve weight loss compared to traditional educational counseling. Providers may want to consider brief counseling around improving the home environment as opposed to or in addition to counseling around improving nutrition or physical activity. More research is necessary to understand whether this type of intervention is feasible and acceptable in other populations (eg, urban, other races). In addition, further research is necessary to improve the physical activity component of the intervention. The use of non-clinical providers has been shown to be effective in improving health outcomes [16] and this study provides further evidence on the impactful role that trained community residents can have on changing behaviors. These initiatives are vital to supplement weight loss and management efforts occurring in the clinical setting.

—Natalie L. Ricci, Columbia University Mailman School of Public Health, and Katrina F. Mateo, MPH

MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

Twelve weeks of treatment with the anti-inflammatory drug losmapimod did not prevent cardiovascular death, myocardial infarction, or severe recurrent ischemia in patients hospitalized with acute MI, based on the results of LATITUDE-TIMI 60, a multicenter placebo-controlled phase 3 trial.

Losmapimod also did not significantly affect secondary outcomes such as all-cause mortality, said Dr. Michelle O’Donoghue at Brigham and Women’s Hospital in Boston and her associates.

“The results of this exploratory efficacy study did not justify proceeding to a larger efficacy trial in the existing patient population,” they concluded at the annual meeting of the American College of Cardiology and in a report published online April 4 in JAMA.

Losmapimod selectively inhibits pro-inflammatory p38 mitogen-activated protein kinase, which contributes to atherosclerosis and plaque destabilization and is activated by stressors such as oxidized low-density lipoprotein cholesterol, hypertension, ischemia, and volume overload. In a prior 12-week phase 2 study, losmapimod failed to reduce inflammatory biomarker levels or myonecrosis, but showed a trend toward lower rates of mortality, MI, recurrent ischemia, stroke, and heart failure, as well as improved left ventricular function.

Based on those observations, Dr. O’Donoghue and her associates randomly assigned 3,503 hospitalized patients with acute MI and at least one other cardiovascular risk factor to receive either losmapimod (7.5 mg twice daily) or placebo, along with guideline-recommended therapy for 12 weeks. Patients averaged 66 years old, about 90% were white, and about 30% were women. The primary endpoint was a composite of cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary revascularization (JAMA 2016 April 4 doi: 10.1001/jama.2016.3609).

The endpoint was met for 139 (8.1%) losmapimod patients and 123 (7%) placebo patients, for a non-significant hazard ratio of 1.16, said the researchers. Losmapimod was, however, associated with significant decreases in levels of high-sensitivity C-reactive protein and N-terminal pro-brain natriuretic peptide as compared with placebo, with durable effects at 12 weeks. Serious adverse events affected 16% of losmapimod patients and 14% of placebo patients, and rates of premature treatment discontinuation were 15.5% with losmapimod and nearly 14% with placebo. Losmapimod did not appear to increase the risk of infections compared with placebo at week 12, but did show a non-significant trend toward mildly increased hepatic transaminases.

“Because inflammation is believed to play a key role in atherogenesis, there remains intense interest to identify an anti-inflammatory therapeutic that will reduce the risk of cardiovascular events,” the researchers noted. “However, because inflammation acts along multiple redundant and interconnected pathways, the identification of an appropriate target may be difficult, and it is challenging to predict clinical efficacy prior to phase 3 testing. Ongoing clinical trials are currently evaluating additional anti-inflammatory therapeutics in patients with atherosclerosis, and will provide further insight into pathways that contribute to vascular disease.”

Pharmacodynamic data on losmapimod do not suggest that its anti-inflammatory effects increase at higher doses, the researchers also noted.

GlaxoSmithKline developed losmapimod and funded the study. Dr. O’Donoghue reported grant funding from Eisai, Merck, and AstraZeneca. The senior author and several coinvestigators disclosed relationships with numerous pharmaceutical companies.

Twelve weeks of treatment with the anti-inflammatory drug losmapimod did not prevent cardiovascular death, myocardial infarction, or severe recurrent ischemia in patients hospitalized with acute MI, based on the results of LATITUDE-TIMI 60, a multicenter placebo-controlled phase 3 trial.

Losmapimod also did not significantly affect secondary outcomes such as all-cause mortality, said Dr. Michelle O’Donoghue at Brigham and Women’s Hospital in Boston and her associates.

“The results of this exploratory efficacy study did not justify proceeding to a larger efficacy trial in the existing patient population,” they concluded at the annual meeting of the American College of Cardiology and in a report published online April 4 in JAMA.

Losmapimod selectively inhibits pro-inflammatory p38 mitogen-activated protein kinase, which contributes to atherosclerosis and plaque destabilization and is activated by stressors such as oxidized low-density lipoprotein cholesterol, hypertension, ischemia, and volume overload. In a prior 12-week phase 2 study, losmapimod failed to reduce inflammatory biomarker levels or myonecrosis, but showed a trend toward lower rates of mortality, MI, recurrent ischemia, stroke, and heart failure, as well as improved left ventricular function.

Based on those observations, Dr. O’Donoghue and her associates randomly assigned 3,503 hospitalized patients with acute MI and at least one other cardiovascular risk factor to receive either losmapimod (7.5 mg twice daily) or placebo, along with guideline-recommended therapy for 12 weeks. Patients averaged 66 years old, about 90% were white, and about 30% were women. The primary endpoint was a composite of cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary revascularization (JAMA 2016 April 4 doi: 10.1001/jama.2016.3609).

The endpoint was met for 139 (8.1%) losmapimod patients and 123 (7%) placebo patients, for a non-significant hazard ratio of 1.16, said the researchers. Losmapimod was, however, associated with significant decreases in levels of high-sensitivity C-reactive protein and N-terminal pro-brain natriuretic peptide as compared with placebo, with durable effects at 12 weeks. Serious adverse events affected 16% of losmapimod patients and 14% of placebo patients, and rates of premature treatment discontinuation were 15.5% with losmapimod and nearly 14% with placebo. Losmapimod did not appear to increase the risk of infections compared with placebo at week 12, but did show a non-significant trend toward mildly increased hepatic transaminases.

“Because inflammation is believed to play a key role in atherogenesis, there remains intense interest to identify an anti-inflammatory therapeutic that will reduce the risk of cardiovascular events,” the researchers noted. “However, because inflammation acts along multiple redundant and interconnected pathways, the identification of an appropriate target may be difficult, and it is challenging to predict clinical efficacy prior to phase 3 testing. Ongoing clinical trials are currently evaluating additional anti-inflammatory therapeutics in patients with atherosclerosis, and will provide further insight into pathways that contribute to vascular disease.”

Pharmacodynamic data on losmapimod do not suggest that its anti-inflammatory effects increase at higher doses, the researchers also noted.

GlaxoSmithKline developed losmapimod and funded the study. Dr. O’Donoghue reported grant funding from Eisai, Merck, and AstraZeneca. The senior author and several coinvestigators disclosed relationships with numerous pharmaceutical companies.

Twelve weeks of treatment with the anti-inflammatory drug losmapimod did not prevent cardiovascular death, myocardial infarction, or severe recurrent ischemia in patients hospitalized with acute MI, based on the results of LATITUDE-TIMI 60, a multicenter placebo-controlled phase 3 trial.

Losmapimod also did not significantly affect secondary outcomes such as all-cause mortality, said Dr. Michelle O’Donoghue at Brigham and Women’s Hospital in Boston and her associates.

“The results of this exploratory efficacy study did not justify proceeding to a larger efficacy trial in the existing patient population,” they concluded at the annual meeting of the American College of Cardiology and in a report published online April 4 in JAMA.

Losmapimod selectively inhibits pro-inflammatory p38 mitogen-activated protein kinase, which contributes to atherosclerosis and plaque destabilization and is activated by stressors such as oxidized low-density lipoprotein cholesterol, hypertension, ischemia, and volume overload. In a prior 12-week phase 2 study, losmapimod failed to reduce inflammatory biomarker levels or myonecrosis, but showed a trend toward lower rates of mortality, MI, recurrent ischemia, stroke, and heart failure, as well as improved left ventricular function.

Based on those observations, Dr. O’Donoghue and her associates randomly assigned 3,503 hospitalized patients with acute MI and at least one other cardiovascular risk factor to receive either losmapimod (7.5 mg twice daily) or placebo, along with guideline-recommended therapy for 12 weeks. Patients averaged 66 years old, about 90% were white, and about 30% were women. The primary endpoint was a composite of cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary revascularization (JAMA 2016 April 4 doi: 10.1001/jama.2016.3609).

The endpoint was met for 139 (8.1%) losmapimod patients and 123 (7%) placebo patients, for a non-significant hazard ratio of 1.16, said the researchers. Losmapimod was, however, associated with significant decreases in levels of high-sensitivity C-reactive protein and N-terminal pro-brain natriuretic peptide as compared with placebo, with durable effects at 12 weeks. Serious adverse events affected 16% of losmapimod patients and 14% of placebo patients, and rates of premature treatment discontinuation were 15.5% with losmapimod and nearly 14% with placebo. Losmapimod did not appear to increase the risk of infections compared with placebo at week 12, but did show a non-significant trend toward mildly increased hepatic transaminases.

“Because inflammation is believed to play a key role in atherogenesis, there remains intense interest to identify an anti-inflammatory therapeutic that will reduce the risk of cardiovascular events,” the researchers noted. “However, because inflammation acts along multiple redundant and interconnected pathways, the identification of an appropriate target may be difficult, and it is challenging to predict clinical efficacy prior to phase 3 testing. Ongoing clinical trials are currently evaluating additional anti-inflammatory therapeutics in patients with atherosclerosis, and will provide further insight into pathways that contribute to vascular disease.”

Pharmacodynamic data on losmapimod do not suggest that its anti-inflammatory effects increase at higher doses, the researchers also noted.

GlaxoSmithKline developed losmapimod and funded the study. Dr. O’Donoghue reported grant funding from Eisai, Merck, and AstraZeneca. The senior author and several coinvestigators disclosed relationships with numerous pharmaceutical companies.

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

LOS ANGELES – Evidence is building for the hypothesis that impairments in the skin’s microbiome promote Staphylococcus aureus colonization and drive atopic dermatitis, Dr. Donald Y.M. Leung said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The link between the bacteria and atopic dermatitis has long been discussed, but its role in pathogenesis still needs definition, he said.

“We’ve never been able to look at the total bacterial composition of the skin, but now with next-generation sequencing it’s finally possible to look at all the phylla and species. Other investigators have shown that during flares of atopic dermatitis there’s a reduction in bacterial diversity and an increase in staph, with S. aureus being particularly abundant. Then, post-flare, you see see a drop in S. aureus; this clearly suggests (it’s) important,” according to Dr. Leung, head of the division of pediatric allergy and immunology at National Jewish Health in Denver and professor of pediatrics at the University of Colorado.

Staphylococcus aureus is known to secrete virulence factors including cytotoxins, superantigens, lipases, and proteases that activate inflammatory cells and can cause significant skin barrier dysfunction.

The discovery that filaggrin mutations result in structural abnormalities in the skin barrier and are associated with sharply increased rates of atopic dermatitis and peanut allergy have strengthened the association, but filaggrin can’t be the whole story. Mutations in filaggrin are largely confined to individuals of Northern European ancestry; African Americans don’t have filaggrin mutations.

Yet atopic dermatitis is a global phenomenon. Further, a skin barrier defect is not enough to cause atopic dermatitis, Dr. Leung said. But such a defect, whether caused by a filaggrin mutation or something else, allows S. aureus to attach to and colonize the skin. Staph overgrowth or infection then activates an inflammatory cell cascade involving natural killer T cells, mast cells, cytokines, and Langerhans cells. That’s why the most effective treatments for atopic dermatitis address both the need to rebuild the skin barrier as well as the counterproductive immune response, he added.

Elsewhere at the AAAAI meeting, Dr. Andrea L. Jones, of National Jewish Health, presented an analysis of 718 children and adolescents with atopic dermatitis, all of whom had been cultured for S. aureus, in that institution’s database. Methicillin-resistant S. aureus (MRSA) was found in 19%; 57% were positive for methicillin-sensitive S. aureus (MSSA) and 23% lacked S. aureus. Of note, the prevalence of peanut allergy was highest at 78% in the group with MRSA; the prevalence was 39% in those with MSSA and 4% in those without S. aureus.

The prevalence of allergies to wheat, egg, milk, or soybeans in the youths with atopic dermatitis was unrelated to MRSA colonization.

“Our hypothesis – although we need to do a prospective study – is that staph colonization may lead to barrier dysfunction and thus allow environmental allergens to invade through the skin. Interestingly enough, people who weren’t colonized by staph had a very low level of sensitization to peanut,” said Dr. Leung, who was the senior investigator in the study.

Dr. Leung was a coauthor on another study that points to a potential new avenue of treatment in atopic dermatitis. Presented by investigators at the University of California, San Diego, at a recent meeting of the Society for Investigative Dermatology, the study showed that atopic dermatitis is marked by a defect in the commensal skin bacteria which normally keep S. aureus in check.

In that study, the amount of S. aureus growing on a defined area of lesional skin of atopic dermatitis patients was nearly 10-fold greater than that on nonlesional skin and the skin of controls without atopic dermatitis.

Commensal bacteria on lesional skin may possess markedly reduced antimicrobial activity. The NIH-sponsored Atopic Dermatitis Research Network plans to conduct clinical trials to see if transplanting beneficial commensal bacteria will reduce staph colonization in atopic dermatitis patients and thereby result in therapeutic benefit, Dr. Leung noted.

He reported serving on scientific advisory boards for more than half a dozen pharmaceutical companies and receiving numerous research grants from the NIH.

[email protected]

LOS ANGELES – Evidence is building for the hypothesis that impairments in the skin’s microbiome promote Staphylococcus aureus colonization and drive atopic dermatitis, Dr. Donald Y.M. Leung said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The link between the bacteria and atopic dermatitis has long been discussed, but its role in pathogenesis still needs definition, he said.

“We’ve never been able to look at the total bacterial composition of the skin, but now with next-generation sequencing it’s finally possible to look at all the phylla and species. Other investigators have shown that during flares of atopic dermatitis there’s a reduction in bacterial diversity and an increase in staph, with S. aureus being particularly abundant. Then, post-flare, you see see a drop in S. aureus; this clearly suggests (it’s) important,” according to Dr. Leung, head of the division of pediatric allergy and immunology at National Jewish Health in Denver and professor of pediatrics at the University of Colorado.

Staphylococcus aureus is known to secrete virulence factors including cytotoxins, superantigens, lipases, and proteases that activate inflammatory cells and can cause significant skin barrier dysfunction.

The discovery that filaggrin mutations result in structural abnormalities in the skin barrier and are associated with sharply increased rates of atopic dermatitis and peanut allergy have strengthened the association, but filaggrin can’t be the whole story. Mutations in filaggrin are largely confined to individuals of Northern European ancestry; African Americans don’t have filaggrin mutations.

Yet atopic dermatitis is a global phenomenon. Further, a skin barrier defect is not enough to cause atopic dermatitis, Dr. Leung said. But such a defect, whether caused by a filaggrin mutation or something else, allows S. aureus to attach to and colonize the skin. Staph overgrowth or infection then activates an inflammatory cell cascade involving natural killer T cells, mast cells, cytokines, and Langerhans cells. That’s why the most effective treatments for atopic dermatitis address both the need to rebuild the skin barrier as well as the counterproductive immune response, he added.

Elsewhere at the AAAAI meeting, Dr. Andrea L. Jones, of National Jewish Health, presented an analysis of 718 children and adolescents with atopic dermatitis, all of whom had been cultured for S. aureus, in that institution’s database. Methicillin-resistant S. aureus (MRSA) was found in 19%; 57% were positive for methicillin-sensitive S. aureus (MSSA) and 23% lacked S. aureus. Of note, the prevalence of peanut allergy was highest at 78% in the group with MRSA; the prevalence was 39% in those with MSSA and 4% in those without S. aureus.

The prevalence of allergies to wheat, egg, milk, or soybeans in the youths with atopic dermatitis was unrelated to MRSA colonization.

“Our hypothesis – although we need to do a prospective study – is that staph colonization may lead to barrier dysfunction and thus allow environmental allergens to invade through the skin. Interestingly enough, people who weren’t colonized by staph had a very low level of sensitization to peanut,” said Dr. Leung, who was the senior investigator in the study.

Dr. Leung was a coauthor on another study that points to a potential new avenue of treatment in atopic dermatitis. Presented by investigators at the University of California, San Diego, at a recent meeting of the Society for Investigative Dermatology, the study showed that atopic dermatitis is marked by a defect in the commensal skin bacteria which normally keep S. aureus in check.

In that study, the amount of S. aureus growing on a defined area of lesional skin of atopic dermatitis patients was nearly 10-fold greater than that on nonlesional skin and the skin of controls without atopic dermatitis.

Commensal bacteria on lesional skin may possess markedly reduced antimicrobial activity. The NIH-sponsored Atopic Dermatitis Research Network plans to conduct clinical trials to see if transplanting beneficial commensal bacteria will reduce staph colonization in atopic dermatitis patients and thereby result in therapeutic benefit, Dr. Leung noted.

He reported serving on scientific advisory boards for more than half a dozen pharmaceutical companies and receiving numerous research grants from the NIH.

[email protected]

LOS ANGELES – Evidence is building for the hypothesis that impairments in the skin’s microbiome promote Staphylococcus aureus colonization and drive atopic dermatitis, Dr. Donald Y.M. Leung said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The link between the bacteria and atopic dermatitis has long been discussed, but its role in pathogenesis still needs definition, he said.

“We’ve never been able to look at the total bacterial composition of the skin, but now with next-generation sequencing it’s finally possible to look at all the phylla and species. Other investigators have shown that during flares of atopic dermatitis there’s a reduction in bacterial diversity and an increase in staph, with S. aureus being particularly abundant. Then, post-flare, you see see a drop in S. aureus; this clearly suggests (it’s) important,” according to Dr. Leung, head of the division of pediatric allergy and immunology at National Jewish Health in Denver and professor of pediatrics at the University of Colorado.

Staphylococcus aureus is known to secrete virulence factors including cytotoxins, superantigens, lipases, and proteases that activate inflammatory cells and can cause significant skin barrier dysfunction.

The discovery that filaggrin mutations result in structural abnormalities in the skin barrier and are associated with sharply increased rates of atopic dermatitis and peanut allergy have strengthened the association, but filaggrin can’t be the whole story. Mutations in filaggrin are largely confined to individuals of Northern European ancestry; African Americans don’t have filaggrin mutations.

Yet atopic dermatitis is a global phenomenon. Further, a skin barrier defect is not enough to cause atopic dermatitis, Dr. Leung said. But such a defect, whether caused by a filaggrin mutation or something else, allows S. aureus to attach to and colonize the skin. Staph overgrowth or infection then activates an inflammatory cell cascade involving natural killer T cells, mast cells, cytokines, and Langerhans cells. That’s why the most effective treatments for atopic dermatitis address both the need to rebuild the skin barrier as well as the counterproductive immune response, he added.

Elsewhere at the AAAAI meeting, Dr. Andrea L. Jones, of National Jewish Health, presented an analysis of 718 children and adolescents with atopic dermatitis, all of whom had been cultured for S. aureus, in that institution’s database. Methicillin-resistant S. aureus (MRSA) was found in 19%; 57% were positive for methicillin-sensitive S. aureus (MSSA) and 23% lacked S. aureus. Of note, the prevalence of peanut allergy was highest at 78% in the group with MRSA; the prevalence was 39% in those with MSSA and 4% in those without S. aureus.

The prevalence of allergies to wheat, egg, milk, or soybeans in the youths with atopic dermatitis was unrelated to MRSA colonization.

“Our hypothesis – although we need to do a prospective study – is that staph colonization may lead to barrier dysfunction and thus allow environmental allergens to invade through the skin. Interestingly enough, people who weren’t colonized by staph had a very low level of sensitization to peanut,” said Dr. Leung, who was the senior investigator in the study.

Dr. Leung was a coauthor on another study that points to a potential new avenue of treatment in atopic dermatitis. Presented by investigators at the University of California, San Diego, at a recent meeting of the Society for Investigative Dermatology, the study showed that atopic dermatitis is marked by a defect in the commensal skin bacteria which normally keep S. aureus in check.

In that study, the amount of S. aureus growing on a defined area of lesional skin of atopic dermatitis patients was nearly 10-fold greater than that on nonlesional skin and the skin of controls without atopic dermatitis.

Commensal bacteria on lesional skin may possess markedly reduced antimicrobial activity. The NIH-sponsored Atopic Dermatitis Research Network plans to conduct clinical trials to see if transplanting beneficial commensal bacteria will reduce staph colonization in atopic dermatitis patients and thereby result in therapeutic benefit, Dr. Leung noted.

He reported serving on scientific advisory boards for more than half a dozen pharmaceutical companies and receiving numerous research grants from the NIH.

[email protected]

Clinical question: What is the incidence and outcome of patients with ischemic hepatitis?

Background: Ischemic hepatitis, or shock liver, is often diagnosed in patients with massive increase in aminotransferase levels most often exceeding 1000 IU/L in the setting of hepatic hypoperfusion. The data on overall incidence and mortality of these patients are limited.

Study Design: Systematic review and meta-analysis.

Setting: Variable.

Synopsis: Using a combination of PubMed, Embase, and Web of Science, the study included 24 papers on incidence and outcomes of ischemic hepatitis published between 1965 and 2015 with a combined total of 1,782 cases. The incidence of ischemic hepatitis varied based on patient location with incidence of 2/1000 in all inpatient admissions and 2.5/100 in ICU admissions. The majority of patients suffered from cardiac comorbidities and decompensation during their admission. Inpatient mortality with ischemic hepatitis was 49%.

Interestingly, only 52.9% of patients had an episode of documented hypotension.

Hospitalists taking care of patients with massive rise in aminotransferases should consider ischemic hepatitis higher in their differential, even in the absence of documented hypotension.

There was significant variability in study design, sample size, and inclusion criteria among the studies, which reduces generalizability of this systematic review.

Bottom line: Ischemic hepatitis is associated with very high mortality and should be suspected in patients with high levels of alanine aminotransferase/aspartate aminotransferase even in the absence of documented hypotension.

Citation: Tapper EB, Sengupta N, Bonder A. The incidence and outcomes of ischemic hepatitis: a systematic review with meta-analysis. Am J Med. 2015;128(12):1314-1321.

Short Take

Music Can Help Ease Pain and Anxiety after Surgery

A systematic review and meta-analysis showed that music reduces pain and anxiety and decreases the need for pain medication in postoperative patients regardless of type of music or at what interval of the operative period the music was initiated.

Citation: Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015;386(10004):1659-1671

Clinical question: What is the incidence and outcome of patients with ischemic hepatitis?

Background: Ischemic hepatitis, or shock liver, is often diagnosed in patients with massive increase in aminotransferase levels most often exceeding 1000 IU/L in the setting of hepatic hypoperfusion. The data on overall incidence and mortality of these patients are limited.

Study Design: Systematic review and meta-analysis.

Setting: Variable.

Synopsis: Using a combination of PubMed, Embase, and Web of Science, the study included 24 papers on incidence and outcomes of ischemic hepatitis published between 1965 and 2015 with a combined total of 1,782 cases. The incidence of ischemic hepatitis varied based on patient location with incidence of 2/1000 in all inpatient admissions and 2.5/100 in ICU admissions. The majority of patients suffered from cardiac comorbidities and decompensation during their admission. Inpatient mortality with ischemic hepatitis was 49%.

Interestingly, only 52.9% of patients had an episode of documented hypotension.

Hospitalists taking care of patients with massive rise in aminotransferases should consider ischemic hepatitis higher in their differential, even in the absence of documented hypotension.

There was significant variability in study design, sample size, and inclusion criteria among the studies, which reduces generalizability of this systematic review.

Bottom line: Ischemic hepatitis is associated with very high mortality and should be suspected in patients with high levels of alanine aminotransferase/aspartate aminotransferase even in the absence of documented hypotension.

Citation: Tapper EB, Sengupta N, Bonder A. The incidence and outcomes of ischemic hepatitis: a systematic review with meta-analysis. Am J Med. 2015;128(12):1314-1321.

Short Take

Music Can Help Ease Pain and Anxiety after Surgery

A systematic review and meta-analysis showed that music reduces pain and anxiety and decreases the need for pain medication in postoperative patients regardless of type of music or at what interval of the operative period the music was initiated.

Citation: Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015;386(10004):1659-1671

Clinical question: What is the incidence and outcome of patients with ischemic hepatitis?

Background: Ischemic hepatitis, or shock liver, is often diagnosed in patients with massive increase in aminotransferase levels most often exceeding 1000 IU/L in the setting of hepatic hypoperfusion. The data on overall incidence and mortality of these patients are limited.

Study Design: Systematic review and meta-analysis.

Setting: Variable.

Synopsis: Using a combination of PubMed, Embase, and Web of Science, the study included 24 papers on incidence and outcomes of ischemic hepatitis published between 1965 and 2015 with a combined total of 1,782 cases. The incidence of ischemic hepatitis varied based on patient location with incidence of 2/1000 in all inpatient admissions and 2.5/100 in ICU admissions. The majority of patients suffered from cardiac comorbidities and decompensation during their admission. Inpatient mortality with ischemic hepatitis was 49%.

Interestingly, only 52.9% of patients had an episode of documented hypotension.

Hospitalists taking care of patients with massive rise in aminotransferases should consider ischemic hepatitis higher in their differential, even in the absence of documented hypotension.

There was significant variability in study design, sample size, and inclusion criteria among the studies, which reduces generalizability of this systematic review.

Bottom line: Ischemic hepatitis is associated with very high mortality and should be suspected in patients with high levels of alanine aminotransferase/aspartate aminotransferase even in the absence of documented hypotension.

Citation: Tapper EB, Sengupta N, Bonder A. The incidence and outcomes of ischemic hepatitis: a systematic review with meta-analysis. Am J Med. 2015;128(12):1314-1321.

Short Take

Music Can Help Ease Pain and Anxiety after Surgery

A systematic review and meta-analysis showed that music reduces pain and anxiety and decreases the need for pain medication in postoperative patients regardless of type of music or at what interval of the operative period the music was initiated.

Citation: Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015;386(10004):1659-1671

Micrograph showing DLBCL

A microRNA known as miR-181a dampens signals from the NF-κB pathway and affects the pathogenesis of diffuse large B-cell lymphoma (DLBCL), according to research published in Blood.

The study showed that, by reducing NF-κB signaling, miR-181a hinders tumor cell proliferation and survival.

And the effect is more pronounced in activated B-cell-like (ABC) DLBCL than in germinal center B-cell-like (GCB) DLBCL.

The researchers therefore believe miR-181a could be used to treat ABC DLBCL.

“The miR-181a microRNA is one of the first examples of a pathway that deactivates NF-κB at multiple levels, functioning as a master regulator,” said study author Izidore S. Lossos, MD, of the University of Miami Miller School of Medicine in Florida.

“In certain tumors, there is no expression of this microRNA, which allows cells to propagate. We believe miR-181a could eventually be used

therapeutically.”

To understand the role of miR-181a in the different types of DLBCL, Dr Lossos and his colleaguese studied both cell lines and mouse models.

The team found that miR-181a levels were significantly lower in ABC DLBCL than in GCB DLBCL.

When they increased miR-181a expression in DLBCL cell lines, the researchers observed a reduction in NF-κB activity and a decrease in cell proliferation and survival. These effects were more potent in ABC DLBCL than in GCB DLBCL.

When the researchers increased miR-181a expression in the mouse models, they observed a significant  reduction in tumor growth and a significant increase in animal survival, but only in ABC DLBCL. In GCB DLBCL, there were no significant changes compared to controls.

The researchers said the ability of miR-181a to reduce NF-κB levels may be why the presence of miR-181a has been linked to better outcomes for certain DLBCL patients. Previous studies by Dr Lossos’s group have shown that DLBCL patients whose tumors contain more miR-181a have better prognoses.

With the current study, the team found that miR-181a is a master regulator, turning off a number of genes in the NF-κB pathway, including CARD11, a known DLBCL oncogene, and a number of transcription factors that drive NF-κB signaling.

“We knew that miR181a was biomarker for survival,” Dr Lossos said. “This explains the mechanisms behind it.”

In addition to providing a better understanding of the NF-κB pathway, these results provide hope that miR-181a could be used to improve treatment for patients with ABC DLBCL.

“We are trying to develop miR-181a as a potential therapy,” Dr Lossos said. “But we are only at the beginning. Much more work needs to be done. It will not be a simple journey, but we are sure it can be done and tested in humans eventually to see that it indeed will improve patients’ outcomes.”

Micrograph showing DLBCL

A microRNA known as miR-181a dampens signals from the NF-κB pathway and affects the pathogenesis of diffuse large B-cell lymphoma (DLBCL), according to research published in Blood.

The study showed that, by reducing NF-κB signaling, miR-181a hinders tumor cell proliferation and survival.

And the effect is more pronounced in activated B-cell-like (ABC) DLBCL than in germinal center B-cell-like (GCB) DLBCL.

The researchers therefore believe miR-181a could be used to treat ABC DLBCL.

“The miR-181a microRNA is one of the first examples of a pathway that deactivates NF-κB at multiple levels, functioning as a master regulator,” said study author Izidore S. Lossos, MD, of the University of Miami Miller School of Medicine in Florida.

“In certain tumors, there is no expression of this microRNA, which allows cells to propagate. We believe miR-181a could eventually be used

therapeutically.”

To understand the role of miR-181a in the different types of DLBCL, Dr Lossos and his colleaguese studied both cell lines and mouse models.

The team found that miR-181a levels were significantly lower in ABC DLBCL than in GCB DLBCL.

When they increased miR-181a expression in DLBCL cell lines, the researchers observed a reduction in NF-κB activity and a decrease in cell proliferation and survival. These effects were more potent in ABC DLBCL than in GCB DLBCL.

When the researchers increased miR-181a expression in the mouse models, they observed a significant  reduction in tumor growth and a significant increase in animal survival, but only in ABC DLBCL. In GCB DLBCL, there were no significant changes compared to controls.

The researchers said the ability of miR-181a to reduce NF-κB levels may be why the presence of miR-181a has been linked to better outcomes for certain DLBCL patients. Previous studies by Dr Lossos’s group have shown that DLBCL patients whose tumors contain more miR-181a have better prognoses.

With the current study, the team found that miR-181a is a master regulator, turning off a number of genes in the NF-κB pathway, including CARD11, a known DLBCL oncogene, and a number of transcription factors that drive NF-κB signaling.

“We knew that miR181a was biomarker for survival,” Dr Lossos said. “This explains the mechanisms behind it.”

In addition to providing a better understanding of the NF-κB pathway, these results provide hope that miR-181a could be used to improve treatment for patients with ABC DLBCL.

“We are trying to develop miR-181a as a potential therapy,” Dr Lossos said. “But we are only at the beginning. Much more work needs to be done. It will not be a simple journey, but we are sure it can be done and tested in humans eventually to see that it indeed will improve patients’ outcomes.”

Micrograph showing DLBCL

A microRNA known as miR-181a dampens signals from the NF-κB pathway and affects the pathogenesis of diffuse large B-cell lymphoma (DLBCL), according to research published in Blood.

The study showed that, by reducing NF-κB signaling, miR-181a hinders tumor cell proliferation and survival.

And the effect is more pronounced in activated B-cell-like (ABC) DLBCL than in germinal center B-cell-like (GCB) DLBCL.

The researchers therefore believe miR-181a could be used to treat ABC DLBCL.

“The miR-181a microRNA is one of the first examples of a pathway that deactivates NF-κB at multiple levels, functioning as a master regulator,” said study author Izidore S. Lossos, MD, of the University of Miami Miller School of Medicine in Florida.

“In certain tumors, there is no expression of this microRNA, which allows cells to propagate. We believe miR-181a could eventually be used

therapeutically.”

To understand the role of miR-181a in the different types of DLBCL, Dr Lossos and his colleaguese studied both cell lines and mouse models.

The team found that miR-181a levels were significantly lower in ABC DLBCL than in GCB DLBCL.

When they increased miR-181a expression in DLBCL cell lines, the researchers observed a reduction in NF-κB activity and a decrease in cell proliferation and survival. These effects were more potent in ABC DLBCL than in GCB DLBCL.

When the researchers increased miR-181a expression in the mouse models, they observed a significant  reduction in tumor growth and a significant increase in animal survival, but only in ABC DLBCL. In GCB DLBCL, there were no significant changes compared to controls.

The researchers said the ability of miR-181a to reduce NF-κB levels may be why the presence of miR-181a has been linked to better outcomes for certain DLBCL patients. Previous studies by Dr Lossos’s group have shown that DLBCL patients whose tumors contain more miR-181a have better prognoses.

With the current study, the team found that miR-181a is a master regulator, turning off a number of genes in the NF-κB pathway, including CARD11, a known DLBCL oncogene, and a number of transcription factors that drive NF-κB signaling.

“We knew that miR181a was biomarker for survival,” Dr Lossos said. “This explains the mechanisms behind it.”

In addition to providing a better understanding of the NF-κB pathway, these results provide hope that miR-181a could be used to improve treatment for patients with ABC DLBCL.

“We are trying to develop miR-181a as a potential therapy,” Dr Lossos said. “But we are only at the beginning. Much more work needs to be done. It will not be a simple journey, but we are sure it can be done and tested in humans eventually to see that it indeed will improve patients’ outcomes.”

Blood vessels

A study published in Nature Cell Biology helps explain how hemodynamic forces contribute to the formation of new vascular lumens during blood vessel morphogenesis.

Investigators found that blood flow drives lumen expansion during sprouting angiogenesis in vivo by inducing spherical deformations of the apical

membrane of endothelial cells, in a process dubbed “inverse blebbing.”

“This work, combined with previous studies, highlights the importance of balanced endothelial cell contractility in allowing the expansion and maintenance of endothelial lumens during blood vessel development,” said study author Holger Gerhardt, PhD, of the Max Delbrück Center for Molecular Medicine in Berlin, Germany.

These results challenge the previous idea that sprouting cells expand lumens independently of blood flow during angiogenesis through the generation and fusion of intracellular vacuoles.

The investigators showed that hemodynamic forces dynamically shape the apical membrane of single or groups of endothelial cells during angiogenesis to form and expand new lumenized vascular tubes.

“We find that this process relies on a tight balance between the forces applied on the membrane and the local contractile responses from the endothelial cells, as impairing this balance either way leads to lumen defects,” Dr Gerhardt said.

These findings suggest the process of blebbing does not require a specific polarity but is likely to be generally applicable to situations in which external versus internal pressure differences challenge the stability and elasticity of the actin cortex.

It more generally raises the question of the role of apical membrane contractility in the adaptation to varying hemodynamic environments, both during blood vessel morphogenesis, as connections form or remodel, and in pathological settings.

“Understanding whether and how this plasticity of the apical membrane and its underlying cortex is challenged in pathological conditions, where vessels exhibit altered perfusion and lack organized structure, has the potential to provide deeper insight into mechanisms of vascular adaptation and maladaptation,” Dr Gerhardt said. “We will definitely further investigate this.”

Blood vessels

A study published in Nature Cell Biology helps explain how hemodynamic forces contribute to the formation of new vascular lumens during blood vessel morphogenesis.

Investigators found that blood flow drives lumen expansion during sprouting angiogenesis in vivo by inducing spherical deformations of the apical

membrane of endothelial cells, in a process dubbed “inverse blebbing.”

“This work, combined with previous studies, highlights the importance of balanced endothelial cell contractility in allowing the expansion and maintenance of endothelial lumens during blood vessel development,” said study author Holger Gerhardt, PhD, of the Max Delbrück Center for Molecular Medicine in Berlin, Germany.

These results challenge the previous idea that sprouting cells expand lumens independently of blood flow during angiogenesis through the generation and fusion of intracellular vacuoles.

The investigators showed that hemodynamic forces dynamically shape the apical membrane of single or groups of endothelial cells during angiogenesis to form and expand new lumenized vascular tubes.

“We find that this process relies on a tight balance between the forces applied on the membrane and the local contractile responses from the endothelial cells, as impairing this balance either way leads to lumen defects,” Dr Gerhardt said.

These findings suggest the process of blebbing does not require a specific polarity but is likely to be generally applicable to situations in which external versus internal pressure differences challenge the stability and elasticity of the actin cortex.

It more generally raises the question of the role of apical membrane contractility in the adaptation to varying hemodynamic environments, both during blood vessel morphogenesis, as connections form or remodel, and in pathological settings.

“Understanding whether and how this plasticity of the apical membrane and its underlying cortex is challenged in pathological conditions, where vessels exhibit altered perfusion and lack organized structure, has the potential to provide deeper insight into mechanisms of vascular adaptation and maladaptation,” Dr Gerhardt said. “We will definitely further investigate this.”

Blood vessels

A study published in Nature Cell Biology helps explain how hemodynamic forces contribute to the formation of new vascular lumens during blood vessel morphogenesis.

Investigators found that blood flow drives lumen expansion during sprouting angiogenesis in vivo by inducing spherical deformations of the apical

membrane of endothelial cells, in a process dubbed “inverse blebbing.”

“This work, combined with previous studies, highlights the importance of balanced endothelial cell contractility in allowing the expansion and maintenance of endothelial lumens during blood vessel development,” said study author Holger Gerhardt, PhD, of the Max Delbrück Center for Molecular Medicine in Berlin, Germany.

These results challenge the previous idea that sprouting cells expand lumens independently of blood flow during angiogenesis through the generation and fusion of intracellular vacuoles.

The investigators showed that hemodynamic forces dynamically shape the apical membrane of single or groups of endothelial cells during angiogenesis to form and expand new lumenized vascular tubes.

“We find that this process relies on a tight balance between the forces applied on the membrane and the local contractile responses from the endothelial cells, as impairing this balance either way leads to lumen defects,” Dr Gerhardt said.

These findings suggest the process of blebbing does not require a specific polarity but is likely to be generally applicable to situations in which external versus internal pressure differences challenge the stability and elasticity of the actin cortex.

It more generally raises the question of the role of apical membrane contractility in the adaptation to varying hemodynamic environments, both during blood vessel morphogenesis, as connections form or remodel, and in pathological settings.

“Understanding whether and how this plasticity of the apical membrane and its underlying cortex is challenged in pathological conditions, where vessels exhibit altered perfusion and lack organized structure, has the potential to provide deeper insight into mechanisms of vascular adaptation and maladaptation,” Dr Gerhardt said. “We will definitely further investigate this.”