ASA Annual Meeting 2011

BOCA RATON, FLA.  – For patients with fulminant Clostridium difficile colitis, minimally invasive temporary loop ileostomy with colonic lavage may offer a novel life- and colon-saving alternative to colectomy.

In a series of 42 consecutive patients with severe complicated C. difficile colitis who underwent the surgery, 30-day mortality was only 19% and 39 patients (93%) preserved their colon, Dr. Brian Zuckerbraun reported at the annual meeting of the American Surgical Association.

This 19% mortality was impressively less than the 50% rate in 42 consecutive historical controls with similar Acute Physiology and Chronic Health Evaluation (APACHE) II scores who underwent subtotal colectomy at the same medical center just prior to introduction of the novel, less invasive operation. And the 50% mortality rate is on the low end of reported series, noted Dr. Zuckerbraun of the University of Pittsburgh.

"This approach may prove to be a better alternative to colectomy, because the colon is usually viable and can recover," he said. "Loop ileostomy and colonic lavage should be considered in all patients with severe complicated C. difficile colitis."

"Also, what we’re finding now because of our outcomes and the smaller insult of this therapy compared to colectomy is that our medical colleagues are willing to consult us earlier in the care of these patients. They’re not just thinking of surgery as a salvage operation when all else has failed," Dr. Zuckerbraun noted.

His presentation drew effusive audience praise.

"Two or three times a year I come across something that causes me to say, ‘I really wish I’d thought of that.’ This is one of those situations. I think this is a wonderful idea," said Dr. Robert G. Sawyer, a discussant.

Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville, was particularly impressed that the treatment enabled roughly 90% of patients to save their colon. "I believe this will become the standard technique in the treatment of severe C. difficile colitis in the future," he predicted.

Dr. Merril T. Dayton was equally impressed.

"We may be seeing a bit of history being made here: a new operation. If time bears out your study findings, this is a simpler and effective way to handle these complicated patients," observed Dr. Dayton, professor and chairman of the department of surgery at State University of New York, Buffalo.

Dr. Zuckerbraun explained the rationale for his novel treatment: fulminant C. difficile colitis is a disease of bacterial overgrowth and toxin production in which the colon is usually viable and without necrosis or perforation, meaning that it’s recoverable.

On this basis, he developed a procedure that begins with exploratory laparoscopy or laparotomy. This is followed by creation of a diverting loop ileostomy through which 8 L of propylene glycol electrolyte solution (GoLYTELY) is instilled intraoperatively. Antegrade colonic flushes with 500 mg of vancomycin in 500 mL of diluent are administered every 8 hours for 10 days.

The working hypothesis is that this combination of diversion, propylene glycol lavage, and vancomycin acts in cumulative fashion to reduce C. difficile counts, deprive the pathogen of nutrients, and alter the intraluminal milieu, perhaps changing colonic oxygen tension. Also, there is preliminary evidence to suggest propylene glycol may exert a pharmacologic effect involving protection of the colonic epithelium.

The 42 patients in his series were quite sick, with a mean APACHE II score of 29.7. Many were immunosuppressed. Preoperatively, 90% were in the intensive care unit, where most were intubated and/or on vasopressors.

Loop ileostomy and colonic lavage were accomplished laparoscopically in 35 of 42 patients. With increased experience, Dr. Zuckerbraun and his colleagues have decided that the only indication for open loop ileostomy via laparotomy is abdominal compartment syndrome.

One patient with abdominal compartment syndrome underwent colectomy immediately after loop ileostomy. Two more patients had colectomies during the postoperative period based upon clinical symptoms.

Eight patients died a mean of 13 days after surgery. Of the 34 who survived the 30-day postoperative period, 6 have subsequently died because of comorbid disease – none of these deaths was related to C. difficile.

Twenty-eight patients remain alive at a mean follow-up of 11.4 months. Of the 19 who have been followed for at least 6 months, 15 (79%) have had their ileostomies reversed. Surgeons initially considered performing the reversal during the same hospital stay, but they decided patients with fulminant C. difficile colitis have too many serious comorbidities to be able to handle a second operation early on.

"Most have required months to recover from the illness that brought them into the hospital in the first place, which often wasn’t C. difficile. We wait until they’re back on their feet again," Dr. Zuckerbraun explained.

The indications for temporary loop ileostomy and colonic lavage are, first, diagnosis of C. difficile colitis by toxin assay, a compatible CT scan, or endoscopic findings, along with any one of the following criteria: sepsis, peritonitis, change in mental status, ventilatory failure, vasopressor requirement, worsening abdominal pain or distention, or unexplained clinical deterioration, he said.

At the urging of medical intensivists and transplant physicians, the investigators have also performed this operation in two patients with multiple recurrent episodes of C. difficile colitis who were not critically ill. One patient had 19 prior episodes. The C. difficile was successfully eradicated in both cases. The new procedure, however, was undertaken only after the patients failed a trial of high-volume propylene glycol lavage by nasogastric tube, which the investigators have previously employed successfully to eradicate C. difficile infections in several other patients with multiply recurrent nonfulminant colitis.

Severe, complicated C. difficile colitis occurs in 4%-10% of C. difficile-associated disease, which is now the most common nosocomial infection.

Dr. Zuckerbraun reported no conflicts of interest.

BOCA RATON, FLA.  – For patients with fulminant Clostridium difficile colitis, minimally invasive temporary loop ileostomy with colonic lavage may offer a novel life- and colon-saving alternative to colectomy.

In a series of 42 consecutive patients with severe complicated C. difficile colitis who underwent the surgery, 30-day mortality was only 19% and 39 patients (93%) preserved their colon, Dr. Brian Zuckerbraun reported at the annual meeting of the American Surgical Association.

This 19% mortality was impressively less than the 50% rate in 42 consecutive historical controls with similar Acute Physiology and Chronic Health Evaluation (APACHE) II scores who underwent subtotal colectomy at the same medical center just prior to introduction of the novel, less invasive operation. And the 50% mortality rate is on the low end of reported series, noted Dr. Zuckerbraun of the University of Pittsburgh.

"This approach may prove to be a better alternative to colectomy, because the colon is usually viable and can recover," he said. "Loop ileostomy and colonic lavage should be considered in all patients with severe complicated C. difficile colitis."

"Also, what we’re finding now because of our outcomes and the smaller insult of this therapy compared to colectomy is that our medical colleagues are willing to consult us earlier in the care of these patients. They’re not just thinking of surgery as a salvage operation when all else has failed," Dr. Zuckerbraun noted.

His presentation drew effusive audience praise.

"Two or three times a year I come across something that causes me to say, ‘I really wish I’d thought of that.’ This is one of those situations. I think this is a wonderful idea," said Dr. Robert G. Sawyer, a discussant.

Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville, was particularly impressed that the treatment enabled roughly 90% of patients to save their colon. "I believe this will become the standard technique in the treatment of severe C. difficile colitis in the future," he predicted.

Dr. Merril T. Dayton was equally impressed.

"We may be seeing a bit of history being made here: a new operation. If time bears out your study findings, this is a simpler and effective way to handle these complicated patients," observed Dr. Dayton, professor and chairman of the department of surgery at State University of New York, Buffalo.

Dr. Zuckerbraun explained the rationale for his novel treatment: fulminant C. difficile colitis is a disease of bacterial overgrowth and toxin production in which the colon is usually viable and without necrosis or perforation, meaning that it’s recoverable.

On this basis, he developed a procedure that begins with exploratory laparoscopy or laparotomy. This is followed by creation of a diverting loop ileostomy through which 8 L of propylene glycol electrolyte solution (GoLYTELY) is instilled intraoperatively. Antegrade colonic flushes with 500 mg of vancomycin in 500 mL of diluent are administered every 8 hours for 10 days.

The working hypothesis is that this combination of diversion, propylene glycol lavage, and vancomycin acts in cumulative fashion to reduce C. difficile counts, deprive the pathogen of nutrients, and alter the intraluminal milieu, perhaps changing colonic oxygen tension. Also, there is preliminary evidence to suggest propylene glycol may exert a pharmacologic effect involving protection of the colonic epithelium.

The 42 patients in his series were quite sick, with a mean APACHE II score of 29.7. Many were immunosuppressed. Preoperatively, 90% were in the intensive care unit, where most were intubated and/or on vasopressors.

Loop ileostomy and colonic lavage were accomplished laparoscopically in 35 of 42 patients. With increased experience, Dr. Zuckerbraun and his colleagues have decided that the only indication for open loop ileostomy via laparotomy is abdominal compartment syndrome.

One patient with abdominal compartment syndrome underwent colectomy immediately after loop ileostomy. Two more patients had colectomies during the postoperative period based upon clinical symptoms.

Eight patients died a mean of 13 days after surgery. Of the 34 who survived the 30-day postoperative period, 6 have subsequently died because of comorbid disease – none of these deaths was related to C. difficile.

Twenty-eight patients remain alive at a mean follow-up of 11.4 months. Of the 19 who have been followed for at least 6 months, 15 (79%) have had their ileostomies reversed. Surgeons initially considered performing the reversal during the same hospital stay, but they decided patients with fulminant C. difficile colitis have too many serious comorbidities to be able to handle a second operation early on.

"Most have required months to recover from the illness that brought them into the hospital in the first place, which often wasn’t C. difficile. We wait until they’re back on their feet again," Dr. Zuckerbraun explained.

The indications for temporary loop ileostomy and colonic lavage are, first, diagnosis of C. difficile colitis by toxin assay, a compatible CT scan, or endoscopic findings, along with any one of the following criteria: sepsis, peritonitis, change in mental status, ventilatory failure, vasopressor requirement, worsening abdominal pain or distention, or unexplained clinical deterioration, he said.

At the urging of medical intensivists and transplant physicians, the investigators have also performed this operation in two patients with multiple recurrent episodes of C. difficile colitis who were not critically ill. One patient had 19 prior episodes. The C. difficile was successfully eradicated in both cases. The new procedure, however, was undertaken only after the patients failed a trial of high-volume propylene glycol lavage by nasogastric tube, which the investigators have previously employed successfully to eradicate C. difficile infections in several other patients with multiply recurrent nonfulminant colitis.

Severe, complicated C. difficile colitis occurs in 4%-10% of C. difficile-associated disease, which is now the most common nosocomial infection.

Dr. Zuckerbraun reported no conflicts of interest.

BOCA RATON, FLA.  – For patients with fulminant Clostridium difficile colitis, minimally invasive temporary loop ileostomy with colonic lavage may offer a novel life- and colon-saving alternative to colectomy.

In a series of 42 consecutive patients with severe complicated C. difficile colitis who underwent the surgery, 30-day mortality was only 19% and 39 patients (93%) preserved their colon, Dr. Brian Zuckerbraun reported at the annual meeting of the American Surgical Association.

This 19% mortality was impressively less than the 50% rate in 42 consecutive historical controls with similar Acute Physiology and Chronic Health Evaluation (APACHE) II scores who underwent subtotal colectomy at the same medical center just prior to introduction of the novel, less invasive operation. And the 50% mortality rate is on the low end of reported series, noted Dr. Zuckerbraun of the University of Pittsburgh.

"This approach may prove to be a better alternative to colectomy, because the colon is usually viable and can recover," he said. "Loop ileostomy and colonic lavage should be considered in all patients with severe complicated C. difficile colitis."

"Also, what we’re finding now because of our outcomes and the smaller insult of this therapy compared to colectomy is that our medical colleagues are willing to consult us earlier in the care of these patients. They’re not just thinking of surgery as a salvage operation when all else has failed," Dr. Zuckerbraun noted.

His presentation drew effusive audience praise.

"Two or three times a year I come across something that causes me to say, ‘I really wish I’d thought of that.’ This is one of those situations. I think this is a wonderful idea," said Dr. Robert G. Sawyer, a discussant.

Dr. Sawyer, professor of surgery and public health sciences and chief of acute care surgery at the University of Virginia, Charlottesville, was particularly impressed that the treatment enabled roughly 90% of patients to save their colon. "I believe this will become the standard technique in the treatment of severe C. difficile colitis in the future," he predicted.

Dr. Merril T. Dayton was equally impressed.

"We may be seeing a bit of history being made here: a new operation. If time bears out your study findings, this is a simpler and effective way to handle these complicated patients," observed Dr. Dayton, professor and chairman of the department of surgery at State University of New York, Buffalo.

Dr. Zuckerbraun explained the rationale for his novel treatment: fulminant C. difficile colitis is a disease of bacterial overgrowth and toxin production in which the colon is usually viable and without necrosis or perforation, meaning that it’s recoverable.

On this basis, he developed a procedure that begins with exploratory laparoscopy or laparotomy. This is followed by creation of a diverting loop ileostomy through which 8 L of propylene glycol electrolyte solution (GoLYTELY) is instilled intraoperatively. Antegrade colonic flushes with 500 mg of vancomycin in 500 mL of diluent are administered every 8 hours for 10 days.

The working hypothesis is that this combination of diversion, propylene glycol lavage, and vancomycin acts in cumulative fashion to reduce C. difficile counts, deprive the pathogen of nutrients, and alter the intraluminal milieu, perhaps changing colonic oxygen tension. Also, there is preliminary evidence to suggest propylene glycol may exert a pharmacologic effect involving protection of the colonic epithelium.

The 42 patients in his series were quite sick, with a mean APACHE II score of 29.7. Many were immunosuppressed. Preoperatively, 90% were in the intensive care unit, where most were intubated and/or on vasopressors.

Loop ileostomy and colonic lavage were accomplished laparoscopically in 35 of 42 patients. With increased experience, Dr. Zuckerbraun and his colleagues have decided that the only indication for open loop ileostomy via laparotomy is abdominal compartment syndrome.

One patient with abdominal compartment syndrome underwent colectomy immediately after loop ileostomy. Two more patients had colectomies during the postoperative period based upon clinical symptoms.

Eight patients died a mean of 13 days after surgery. Of the 34 who survived the 30-day postoperative period, 6 have subsequently died because of comorbid disease – none of these deaths was related to C. difficile.

Twenty-eight patients remain alive at a mean follow-up of 11.4 months. Of the 19 who have been followed for at least 6 months, 15 (79%) have had their ileostomies reversed. Surgeons initially considered performing the reversal during the same hospital stay, but they decided patients with fulminant C. difficile colitis have too many serious comorbidities to be able to handle a second operation early on.

"Most have required months to recover from the illness that brought them into the hospital in the first place, which often wasn’t C. difficile. We wait until they’re back on their feet again," Dr. Zuckerbraun explained.

The indications for temporary loop ileostomy and colonic lavage are, first, diagnosis of C. difficile colitis by toxin assay, a compatible CT scan, or endoscopic findings, along with any one of the following criteria: sepsis, peritonitis, change in mental status, ventilatory failure, vasopressor requirement, worsening abdominal pain or distention, or unexplained clinical deterioration, he said.

At the urging of medical intensivists and transplant physicians, the investigators have also performed this operation in two patients with multiple recurrent episodes of C. difficile colitis who were not critically ill. One patient had 19 prior episodes. The C. difficile was successfully eradicated in both cases. The new procedure, however, was undertaken only after the patients failed a trial of high-volume propylene glycol lavage by nasogastric tube, which the investigators have previously employed successfully to eradicate C. difficile infections in several other patients with multiply recurrent nonfulminant colitis.

Severe, complicated C. difficile colitis occurs in 4%-10% of C. difficile-associated disease, which is now the most common nosocomial infection.

Dr. Zuckerbraun reported no conflicts of interest.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge. But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures. In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests.