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FDA approves budesonide rectal foam for distal UC

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FDA approves budesonide rectal foam for distal UC

A rectal foam formulation of 2% budesonide has been approved by the Food and Drug Administration for treating distal ulcerative colitis, the manufacturer, Salix Pharmaceuticals, has announced.

The approved indication is for the induction of remission in patients with mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The foam is administered rectally and “overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon,” the company said in a statement announcing the final approval on Oct. 8.

The company will be marketing the product as Uceris.

The company also markets budesonide oral extended-release tablets under the same name.

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A rectal foam formulation of 2% budesonide has been approved by the Food and Drug Administration for treating distal ulcerative colitis, the manufacturer, Salix Pharmaceuticals, has announced.

The approved indication is for the induction of remission in patients with mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The foam is administered rectally and “overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon,” the company said in a statement announcing the final approval on Oct. 8.

The company will be marketing the product as Uceris.

The company also markets budesonide oral extended-release tablets under the same name.

[email protected]

A rectal foam formulation of 2% budesonide has been approved by the Food and Drug Administration for treating distal ulcerative colitis, the manufacturer, Salix Pharmaceuticals, has announced.

The approved indication is for the induction of remission in patients with mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The foam is administered rectally and “overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon,” the company said in a statement announcing the final approval on Oct. 8.

The company will be marketing the product as Uceris.

The company also markets budesonide oral extended-release tablets under the same name.

[email protected]

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Transanal extraction found effective in rectal cancer surgery

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Transanal extraction found effective in rectal cancer surgery

Patients who underwent laparoscopic total mesorectal excision with coloanal anastomosis for rectal cancer had similar rates of mortality and morbidity, regardless of whether the extraction was performed transanally or transabdominally, a long-term single-center study showed.

“There are few data of full laparoscopic coloanal anastomosis for rectal cancer, including small series and short follow-up,” authors led by Dr. Quentin Denost of the department of surgery at Saint-André Hospital, Bordeau, France, wrote. “Moreover, the risk of anastomotic or perineal recurrence induced by transanal extraction of the rectal specimen is not known.” In addition, they continued, functional outcomes of laparoscopic coloanal anastomosis “have never been reported, and therefore the potential risk of anal incontinence related to transanal specimen extraction has never been discussed.”

In an effort to investigate the long-term outcome of laparoscopic coloanal anastomosis for rectal cancer, the researchers evaluated records of 220 patients who underwent laparoscopic total mesorectal excision and coloanal anastomosis for rectal cancer at Saint-André Hospital between 2000 and 2010 (Ann. Surg. 2014 Sept. 1 [doi:10.1097/SLA.0000000000000855]). Study endpoints of interest were circumferential margin, mesorectal grade, local recurrence, survival, and functional outcome obtained by a questionnaire sent to patients free of disease with at least 1 year of follow-up after stoma closure.

More than half of the patients (63%) were male, their median age was 64, and their median body mass index was 25 kg/m2. The tumors were a median of 4 cm from the anal verge and 1 cm from the anal ring, and 82% of the patients had stage T3 or T4 disease.

The authors reported that the overall mortality and surgical morbidity rates were 0.5% and 17%, respectively, the rate of positive circumferential resection margin was 9%, and the median anal continence score was 6 (range, 0-20). After a median follow-up of 51 months, the local recurrence rate was 4%, while at 5 years, the overall survival and disease-free survival rates were 83% and 70%, respectively.

When the authors evaluated results by extraction site, no significant differences were observed between the transanal extraction and transabdomonal extraction groups in the rate of overall mortality (0.8% vs. 0%, respectively; P = 1.000), overall morbidity (34% vs. 43%), positive circumferential margin (7% vs. 11%; P = .324), mesorectal grade, local recurrence (4% vs. 5%; P = .98), and disease-free survival (72% vs. 68%; P = .63). The median continence score was 6 in both groups (P = .92).

The findings demonstrated that pelvic control and survival “were not compromised by the association between mini invasive surgery and ultralow sphincter preservation,” the authors concluded. “Moreover, we demonstrated the safety and efficacy of transanal extraction of the rectal specimen with similar oncologic and functional outcome than the conventional abdominal extraction. Because of the wound advantages of transanal extraction, in terms of abdominal wall preservation, transanal extraction can be recommended in laparoscopic surgical management of low rectal cancer.”

They acknowledged certain limitations of the study, including the fact that BMI was slightly lower in the transanal group, compared with the transabdomonal group (24.3 vs. 25.8 kg/m2, respectively; P = .01). This suggests “that some obese patients probably received transabdominal instead of transanal extraction,” Dr. Denost and associates wrote. “Therefore, as we recommend preventing excessive stretching of the anal sphincter during rectal extraction, we also recommend to be cautious when performing transanal extraction in obese patients with wide mesorectal specimen, especially to avoid mesorectal injury and tumor spillage.”

The authors reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

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Patients who underwent laparoscopic total mesorectal excision with coloanal anastomosis for rectal cancer had similar rates of mortality and morbidity, regardless of whether the extraction was performed transanally or transabdominally, a long-term single-center study showed.

“There are few data of full laparoscopic coloanal anastomosis for rectal cancer, including small series and short follow-up,” authors led by Dr. Quentin Denost of the department of surgery at Saint-André Hospital, Bordeau, France, wrote. “Moreover, the risk of anastomotic or perineal recurrence induced by transanal extraction of the rectal specimen is not known.” In addition, they continued, functional outcomes of laparoscopic coloanal anastomosis “have never been reported, and therefore the potential risk of anal incontinence related to transanal specimen extraction has never been discussed.”

In an effort to investigate the long-term outcome of laparoscopic coloanal anastomosis for rectal cancer, the researchers evaluated records of 220 patients who underwent laparoscopic total mesorectal excision and coloanal anastomosis for rectal cancer at Saint-André Hospital between 2000 and 2010 (Ann. Surg. 2014 Sept. 1 [doi:10.1097/SLA.0000000000000855]). Study endpoints of interest were circumferential margin, mesorectal grade, local recurrence, survival, and functional outcome obtained by a questionnaire sent to patients free of disease with at least 1 year of follow-up after stoma closure.

More than half of the patients (63%) were male, their median age was 64, and their median body mass index was 25 kg/m2. The tumors were a median of 4 cm from the anal verge and 1 cm from the anal ring, and 82% of the patients had stage T3 or T4 disease.

The authors reported that the overall mortality and surgical morbidity rates were 0.5% and 17%, respectively, the rate of positive circumferential resection margin was 9%, and the median anal continence score was 6 (range, 0-20). After a median follow-up of 51 months, the local recurrence rate was 4%, while at 5 years, the overall survival and disease-free survival rates were 83% and 70%, respectively.

When the authors evaluated results by extraction site, no significant differences were observed between the transanal extraction and transabdomonal extraction groups in the rate of overall mortality (0.8% vs. 0%, respectively; P = 1.000), overall morbidity (34% vs. 43%), positive circumferential margin (7% vs. 11%; P = .324), mesorectal grade, local recurrence (4% vs. 5%; P = .98), and disease-free survival (72% vs. 68%; P = .63). The median continence score was 6 in both groups (P = .92).

The findings demonstrated that pelvic control and survival “were not compromised by the association between mini invasive surgery and ultralow sphincter preservation,” the authors concluded. “Moreover, we demonstrated the safety and efficacy of transanal extraction of the rectal specimen with similar oncologic and functional outcome than the conventional abdominal extraction. Because of the wound advantages of transanal extraction, in terms of abdominal wall preservation, transanal extraction can be recommended in laparoscopic surgical management of low rectal cancer.”

They acknowledged certain limitations of the study, including the fact that BMI was slightly lower in the transanal group, compared with the transabdomonal group (24.3 vs. 25.8 kg/m2, respectively; P = .01). This suggests “that some obese patients probably received transabdominal instead of transanal extraction,” Dr. Denost and associates wrote. “Therefore, as we recommend preventing excessive stretching of the anal sphincter during rectal extraction, we also recommend to be cautious when performing transanal extraction in obese patients with wide mesorectal specimen, especially to avoid mesorectal injury and tumor spillage.”

The authors reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

Patients who underwent laparoscopic total mesorectal excision with coloanal anastomosis for rectal cancer had similar rates of mortality and morbidity, regardless of whether the extraction was performed transanally or transabdominally, a long-term single-center study showed.

“There are few data of full laparoscopic coloanal anastomosis for rectal cancer, including small series and short follow-up,” authors led by Dr. Quentin Denost of the department of surgery at Saint-André Hospital, Bordeau, France, wrote. “Moreover, the risk of anastomotic or perineal recurrence induced by transanal extraction of the rectal specimen is not known.” In addition, they continued, functional outcomes of laparoscopic coloanal anastomosis “have never been reported, and therefore the potential risk of anal incontinence related to transanal specimen extraction has never been discussed.”

In an effort to investigate the long-term outcome of laparoscopic coloanal anastomosis for rectal cancer, the researchers evaluated records of 220 patients who underwent laparoscopic total mesorectal excision and coloanal anastomosis for rectal cancer at Saint-André Hospital between 2000 and 2010 (Ann. Surg. 2014 Sept. 1 [doi:10.1097/SLA.0000000000000855]). Study endpoints of interest were circumferential margin, mesorectal grade, local recurrence, survival, and functional outcome obtained by a questionnaire sent to patients free of disease with at least 1 year of follow-up after stoma closure.

More than half of the patients (63%) were male, their median age was 64, and their median body mass index was 25 kg/m2. The tumors were a median of 4 cm from the anal verge and 1 cm from the anal ring, and 82% of the patients had stage T3 or T4 disease.

The authors reported that the overall mortality and surgical morbidity rates were 0.5% and 17%, respectively, the rate of positive circumferential resection margin was 9%, and the median anal continence score was 6 (range, 0-20). After a median follow-up of 51 months, the local recurrence rate was 4%, while at 5 years, the overall survival and disease-free survival rates were 83% and 70%, respectively.

When the authors evaluated results by extraction site, no significant differences were observed between the transanal extraction and transabdomonal extraction groups in the rate of overall mortality (0.8% vs. 0%, respectively; P = 1.000), overall morbidity (34% vs. 43%), positive circumferential margin (7% vs. 11%; P = .324), mesorectal grade, local recurrence (4% vs. 5%; P = .98), and disease-free survival (72% vs. 68%; P = .63). The median continence score was 6 in both groups (P = .92).

The findings demonstrated that pelvic control and survival “were not compromised by the association between mini invasive surgery and ultralow sphincter preservation,” the authors concluded. “Moreover, we demonstrated the safety and efficacy of transanal extraction of the rectal specimen with similar oncologic and functional outcome than the conventional abdominal extraction. Because of the wound advantages of transanal extraction, in terms of abdominal wall preservation, transanal extraction can be recommended in laparoscopic surgical management of low rectal cancer.”

They acknowledged certain limitations of the study, including the fact that BMI was slightly lower in the transanal group, compared with the transabdomonal group (24.3 vs. 25.8 kg/m2, respectively; P = .01). This suggests “that some obese patients probably received transabdominal instead of transanal extraction,” Dr. Denost and associates wrote. “Therefore, as we recommend preventing excessive stretching of the anal sphincter during rectal extraction, we also recommend to be cautious when performing transanal extraction in obese patients with wide mesorectal specimen, especially to avoid mesorectal injury and tumor spillage.”

The authors reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

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Transanal extraction found effective in rectal cancer surgery
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Transanal extraction found effective in rectal cancer surgery
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Key clinical point: Transanal extraction can be recommended in the laparoscopic surgical management of low rectal cancer.

Major finding: During laparoscopic total mesorectal excision, no significant differences were observed between patients who underwent transanal extraction or transabdomonal extraction in the rate of overall mortality (0.8% vs. 0%, respectively; P = 1.000), overall morbidity (34% vs. 43%), or local recurrence (4% vs. 5%; P = .98).

Data source: A single-center study of 220 patients who underwent laparoscopic total mesorectal excision and coloanal anastomosis for rectal cancer at Saint-André Hospital in Bordeaux, France, between 2000 and 2010.

Disclosures: The authors reported having no relevant financial disclosures.

Postoperative complications increase risk of death in CRC patients

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Postoperative complications increase risk of death in CRC patients

Patients who develop infectious complications after undergoing curative surgery for colorectal cancer face a significantly increased risk of death, results from a large retrospective study showed.

“The association of postoperative complications with long-term survival after major surgery has been suggested by several studies in mixed populations and is to some degree expected and intuitive,” authors led by Dr. Avo Artinyan, of the surgery department at Baylor College of Medicine, Houston, wrote online Sept. 1 in Annals of Surgery. “It has been difficult, however, to determine a specific cause-effect relationship, particularly because this association is noted even in patients who suffer late mortality, that is, those who presumably recover from postoperative complications.”

©sengulmurat/thinkstockphotos.com
Infectious complications resulting from colorectal cancer operations can lead to heightened risk of death.

In an effort to investigate the effect of postoperative complications on long-term survival after colorectal cancer resection, the researchers evaluated the records of 12,075 patients from the Veterans Affairs Surgical Quality Improvement Program and the Central Cancer Registry databases who underwent resection for nonmetastatic colorectal cancer from 1999 to 2009 (Ann. Surg. 2014 Sept. 1 [doi: 10.1097/SLA.0000000000000854]). They categorized patients by presence of any complication within 30 days and by type of complication (infectious vs. noninfectious); excluded patients who died within 90 days of the procedure; and performed univariate and multivariate analyses adjusted for patient, disease, and treatment factors.

The average age of the cohort was 69 years, 98% were men, more than two-thirds (69%) had an American Society of Anesthesiologists (ASA) classification score of 3, and 61% had stage 1 or 2 disease. Dr. Artinyan and his associates found that the overall morbidity and infectious complication rates were 27.8% and 22.5%, respectively.

Compared with patients who had no postoperative complications, those who did were older and had lower postoperative serum albumin, worse functional status, and higher ASA scores (P less than .001). Multivariate analysis revealed that the presence of any complication was associated with a 24% increased hazard of death (hazard ratio, 1.24; P less that .001). When the analysis was limited to the type of complication, patients with infectious complications (in particular, surgical site infections) had an increased hazard of death (HR, 1.31), predominately those with severe infections (HR, 1.41).

“To our knowledge, this is the largest single study to examine the association of postoperative complications with long-term survival for CRC,” the authors wrote. “Similar to other groups, we have demonstrated that postoperative complications occur in a significant proportion of patients after CRC resection and that most patients with postoperative morbidity have at least one infectious complication.”

They acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. “Additional limitations include the absence of margin data – which may have a considerable impact on both the risk of organ-space infections and disease recurrence – and the inability to calculate cancer-specific survival and other cancer-specific outcomes,” they wrote.

“Overall all-cause survival, however, is still a commonly used and useful outcome measure, and we have attempted to mitigate the effect of early non–cancer-related mortality with the exclusion of early deaths.”

The authors reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

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Patients who develop infectious complications after undergoing curative surgery for colorectal cancer face a significantly increased risk of death, results from a large retrospective study showed.

“The association of postoperative complications with long-term survival after major surgery has been suggested by several studies in mixed populations and is to some degree expected and intuitive,” authors led by Dr. Avo Artinyan, of the surgery department at Baylor College of Medicine, Houston, wrote online Sept. 1 in Annals of Surgery. “It has been difficult, however, to determine a specific cause-effect relationship, particularly because this association is noted even in patients who suffer late mortality, that is, those who presumably recover from postoperative complications.”

©sengulmurat/thinkstockphotos.com
Infectious complications resulting from colorectal cancer operations can lead to heightened risk of death.

In an effort to investigate the effect of postoperative complications on long-term survival after colorectal cancer resection, the researchers evaluated the records of 12,075 patients from the Veterans Affairs Surgical Quality Improvement Program and the Central Cancer Registry databases who underwent resection for nonmetastatic colorectal cancer from 1999 to 2009 (Ann. Surg. 2014 Sept. 1 [doi: 10.1097/SLA.0000000000000854]). They categorized patients by presence of any complication within 30 days and by type of complication (infectious vs. noninfectious); excluded patients who died within 90 days of the procedure; and performed univariate and multivariate analyses adjusted for patient, disease, and treatment factors.

The average age of the cohort was 69 years, 98% were men, more than two-thirds (69%) had an American Society of Anesthesiologists (ASA) classification score of 3, and 61% had stage 1 or 2 disease. Dr. Artinyan and his associates found that the overall morbidity and infectious complication rates were 27.8% and 22.5%, respectively.

Compared with patients who had no postoperative complications, those who did were older and had lower postoperative serum albumin, worse functional status, and higher ASA scores (P less than .001). Multivariate analysis revealed that the presence of any complication was associated with a 24% increased hazard of death (hazard ratio, 1.24; P less that .001). When the analysis was limited to the type of complication, patients with infectious complications (in particular, surgical site infections) had an increased hazard of death (HR, 1.31), predominately those with severe infections (HR, 1.41).

“To our knowledge, this is the largest single study to examine the association of postoperative complications with long-term survival for CRC,” the authors wrote. “Similar to other groups, we have demonstrated that postoperative complications occur in a significant proportion of patients after CRC resection and that most patients with postoperative morbidity have at least one infectious complication.”

They acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. “Additional limitations include the absence of margin data – which may have a considerable impact on both the risk of organ-space infections and disease recurrence – and the inability to calculate cancer-specific survival and other cancer-specific outcomes,” they wrote.

“Overall all-cause survival, however, is still a commonly used and useful outcome measure, and we have attempted to mitigate the effect of early non–cancer-related mortality with the exclusion of early deaths.”

The authors reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

Patients who develop infectious complications after undergoing curative surgery for colorectal cancer face a significantly increased risk of death, results from a large retrospective study showed.

“The association of postoperative complications with long-term survival after major surgery has been suggested by several studies in mixed populations and is to some degree expected and intuitive,” authors led by Dr. Avo Artinyan, of the surgery department at Baylor College of Medicine, Houston, wrote online Sept. 1 in Annals of Surgery. “It has been difficult, however, to determine a specific cause-effect relationship, particularly because this association is noted even in patients who suffer late mortality, that is, those who presumably recover from postoperative complications.”

©sengulmurat/thinkstockphotos.com
Infectious complications resulting from colorectal cancer operations can lead to heightened risk of death.

In an effort to investigate the effect of postoperative complications on long-term survival after colorectal cancer resection, the researchers evaluated the records of 12,075 patients from the Veterans Affairs Surgical Quality Improvement Program and the Central Cancer Registry databases who underwent resection for nonmetastatic colorectal cancer from 1999 to 2009 (Ann. Surg. 2014 Sept. 1 [doi: 10.1097/SLA.0000000000000854]). They categorized patients by presence of any complication within 30 days and by type of complication (infectious vs. noninfectious); excluded patients who died within 90 days of the procedure; and performed univariate and multivariate analyses adjusted for patient, disease, and treatment factors.

The average age of the cohort was 69 years, 98% were men, more than two-thirds (69%) had an American Society of Anesthesiologists (ASA) classification score of 3, and 61% had stage 1 or 2 disease. Dr. Artinyan and his associates found that the overall morbidity and infectious complication rates were 27.8% and 22.5%, respectively.

Compared with patients who had no postoperative complications, those who did were older and had lower postoperative serum albumin, worse functional status, and higher ASA scores (P less than .001). Multivariate analysis revealed that the presence of any complication was associated with a 24% increased hazard of death (hazard ratio, 1.24; P less that .001). When the analysis was limited to the type of complication, patients with infectious complications (in particular, surgical site infections) had an increased hazard of death (HR, 1.31), predominately those with severe infections (HR, 1.41).

“To our knowledge, this is the largest single study to examine the association of postoperative complications with long-term survival for CRC,” the authors wrote. “Similar to other groups, we have demonstrated that postoperative complications occur in a significant proportion of patients after CRC resection and that most patients with postoperative morbidity have at least one infectious complication.”

They acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. “Additional limitations include the absence of margin data – which may have a considerable impact on both the risk of organ-space infections and disease recurrence – and the inability to calculate cancer-specific survival and other cancer-specific outcomes,” they wrote.

“Overall all-cause survival, however, is still a commonly used and useful outcome measure, and we have attempted to mitigate the effect of early non–cancer-related mortality with the exclusion of early deaths.”

The authors reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

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Postoperative complications increase risk of death in CRC patients
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Key clinical point: Postoperative complications after colorectal cancer surgery are associated with decreased long-term survival.

Major finding: The presence of any complication after CRC surgery was associated with a 24% increased hazard of death (hazard ratio, 1.24; P less than .001).

Data source: A retrospective evaluation of 12,075 patients who underwent resection for nonmetastatic CRC from 1999-2009.

Disclosures: The authors reported having no financial disclosures.

Implementation of Universal Lynch Syndrome Screening in the VHA

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Implementation of Universal Lynch Syndrome Screening in the VHA
Hartzfeld DE.

Background: Colorectal cancer (CRC) is a common cancer and tumor analysis to screen for Lynch syndrome is recommended by several organizations. The Genomic Medicine Service (GMS) at the VHA has been charged with implementing a universal Lynch screening program within the VHA. Colorectal cancer is the third most common cancer and second most common cause of cancer death in the United States. Lynch syndrome, the most common inherited colon cancer predisposition syndrome, may be responsible for 3% of all CRCs, and increases an individual’s risks of colorectal, endometrial, ovarian, and stomach cancers. In 2009, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group found sufficient evidence to recommend using tumor analysis to screen for Lynch syndrome in all individuals newly diagnosed with CRC, regardless of age or family history, to reduce cancer morbidity and mortality. The NCCN guidelines now also recommend routine tumor testing for all patients diagnosed with CRC. Universal Lynch syndrome screening is also a goal of the CDC initiative, Healthy People 2020. As an integrated, nationwide health care system with over 7 million users and at least 4,000 CRC diagnoses a year, the VHA is in a unique position to identify an estimated 120 to 150 new cases of Lynch syndrome per year. Following these individuals with Lynch syndrome with appropriate screening will decrease the risk of subsequent cancers. In addition, education and cascade testing for relatives will increase the impact of a screening program. The GMS is a relatively new national service, which provides genetic counseling and diagnostic services to our nation’s veterans, using the VA’s telehealth infrastructure. In 2010, the Genomic Medicine Program Advisory Committee recommended that Lynch screening be implemented in the VHA. In 2011, the VHA and GMS began implementation with the following algorithm: MSI by PCR, with MSI-high tumors moving forward to IHC and BRAF if indicated and finally, germline testing after genetic counseling and informed consent.

Purpose: To evaluate the process of implementing universal Lynch screening in VAMCs with which GMS is aligned.

Methods: Empirical data collected during implementation in 8 sites. As many as 70 different VHA facilities perform colon resections; this translates to a significant coordination of effort to implement screening by 1 centralized program. The GMS is only aligned with about 60 sites nationally, and not all of them perform colon resections; 45 sites in which we are providing service perform colon resections. The GMS reached out to 13 of these sites.

Results: While there are national infrastructure tools, such as a single EHR, which improve care for veterans, the individual culture within each VAMC creates a myriad of challenges in defining one workable national protocol. Unique challenges have been identified in implementing a national program in numerous facilities. The greatest barriers to implementation include funding concerns, coordination of key players in multiple departments (GI, surgery, pathology, and hem/onc) and identification of a local clinical champion to manage the cases. Other barriers include coordination of follow-up after positive tumor screening results and program staff turnover.

Conclusions: Despite these barriers, genomic medicine has facilitated the establishment of universal Lynch screening in 8 VHA facilities. The GMS continues outreach to VAMCs that use our services to expand the Lynch screening program. Increased education regarding national guidelines as well as collaboration between multiple stakeholders will be necessary to accomplish VHA-wide implementation of universal Lynch syndrome screening.

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Hartzfeld DE.
Hartzfeld DE.

Background: Colorectal cancer (CRC) is a common cancer and tumor analysis to screen for Lynch syndrome is recommended by several organizations. The Genomic Medicine Service (GMS) at the VHA has been charged with implementing a universal Lynch screening program within the VHA. Colorectal cancer is the third most common cancer and second most common cause of cancer death in the United States. Lynch syndrome, the most common inherited colon cancer predisposition syndrome, may be responsible for 3% of all CRCs, and increases an individual’s risks of colorectal, endometrial, ovarian, and stomach cancers. In 2009, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group found sufficient evidence to recommend using tumor analysis to screen for Lynch syndrome in all individuals newly diagnosed with CRC, regardless of age or family history, to reduce cancer morbidity and mortality. The NCCN guidelines now also recommend routine tumor testing for all patients diagnosed with CRC. Universal Lynch syndrome screening is also a goal of the CDC initiative, Healthy People 2020. As an integrated, nationwide health care system with over 7 million users and at least 4,000 CRC diagnoses a year, the VHA is in a unique position to identify an estimated 120 to 150 new cases of Lynch syndrome per year. Following these individuals with Lynch syndrome with appropriate screening will decrease the risk of subsequent cancers. In addition, education and cascade testing for relatives will increase the impact of a screening program. The GMS is a relatively new national service, which provides genetic counseling and diagnostic services to our nation’s veterans, using the VA’s telehealth infrastructure. In 2010, the Genomic Medicine Program Advisory Committee recommended that Lynch screening be implemented in the VHA. In 2011, the VHA and GMS began implementation with the following algorithm: MSI by PCR, with MSI-high tumors moving forward to IHC and BRAF if indicated and finally, germline testing after genetic counseling and informed consent.

Purpose: To evaluate the process of implementing universal Lynch screening in VAMCs with which GMS is aligned.

Methods: Empirical data collected during implementation in 8 sites. As many as 70 different VHA facilities perform colon resections; this translates to a significant coordination of effort to implement screening by 1 centralized program. The GMS is only aligned with about 60 sites nationally, and not all of them perform colon resections; 45 sites in which we are providing service perform colon resections. The GMS reached out to 13 of these sites.

Results: While there are national infrastructure tools, such as a single EHR, which improve care for veterans, the individual culture within each VAMC creates a myriad of challenges in defining one workable national protocol. Unique challenges have been identified in implementing a national program in numerous facilities. The greatest barriers to implementation include funding concerns, coordination of key players in multiple departments (GI, surgery, pathology, and hem/onc) and identification of a local clinical champion to manage the cases. Other barriers include coordination of follow-up after positive tumor screening results and program staff turnover.

Conclusions: Despite these barriers, genomic medicine has facilitated the establishment of universal Lynch screening in 8 VHA facilities. The GMS continues outreach to VAMCs that use our services to expand the Lynch screening program. Increased education regarding national guidelines as well as collaboration between multiple stakeholders will be necessary to accomplish VHA-wide implementation of universal Lynch syndrome screening.

Background: Colorectal cancer (CRC) is a common cancer and tumor analysis to screen for Lynch syndrome is recommended by several organizations. The Genomic Medicine Service (GMS) at the VHA has been charged with implementing a universal Lynch screening program within the VHA. Colorectal cancer is the third most common cancer and second most common cause of cancer death in the United States. Lynch syndrome, the most common inherited colon cancer predisposition syndrome, may be responsible for 3% of all CRCs, and increases an individual’s risks of colorectal, endometrial, ovarian, and stomach cancers. In 2009, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group found sufficient evidence to recommend using tumor analysis to screen for Lynch syndrome in all individuals newly diagnosed with CRC, regardless of age or family history, to reduce cancer morbidity and mortality. The NCCN guidelines now also recommend routine tumor testing for all patients diagnosed with CRC. Universal Lynch syndrome screening is also a goal of the CDC initiative, Healthy People 2020. As an integrated, nationwide health care system with over 7 million users and at least 4,000 CRC diagnoses a year, the VHA is in a unique position to identify an estimated 120 to 150 new cases of Lynch syndrome per year. Following these individuals with Lynch syndrome with appropriate screening will decrease the risk of subsequent cancers. In addition, education and cascade testing for relatives will increase the impact of a screening program. The GMS is a relatively new national service, which provides genetic counseling and diagnostic services to our nation’s veterans, using the VA’s telehealth infrastructure. In 2010, the Genomic Medicine Program Advisory Committee recommended that Lynch screening be implemented in the VHA. In 2011, the VHA and GMS began implementation with the following algorithm: MSI by PCR, with MSI-high tumors moving forward to IHC and BRAF if indicated and finally, germline testing after genetic counseling and informed consent.

Purpose: To evaluate the process of implementing universal Lynch screening in VAMCs with which GMS is aligned.

Methods: Empirical data collected during implementation in 8 sites. As many as 70 different VHA facilities perform colon resections; this translates to a significant coordination of effort to implement screening by 1 centralized program. The GMS is only aligned with about 60 sites nationally, and not all of them perform colon resections; 45 sites in which we are providing service perform colon resections. The GMS reached out to 13 of these sites.

Results: While there are national infrastructure tools, such as a single EHR, which improve care for veterans, the individual culture within each VAMC creates a myriad of challenges in defining one workable national protocol. Unique challenges have been identified in implementing a national program in numerous facilities. The greatest barriers to implementation include funding concerns, coordination of key players in multiple departments (GI, surgery, pathology, and hem/onc) and identification of a local clinical champion to manage the cases. Other barriers include coordination of follow-up after positive tumor screening results and program staff turnover.

Conclusions: Despite these barriers, genomic medicine has facilitated the establishment of universal Lynch screening in 8 VHA facilities. The GMS continues outreach to VAMCs that use our services to expand the Lynch screening program. Increased education regarding national guidelines as well as collaboration between multiple stakeholders will be necessary to accomplish VHA-wide implementation of universal Lynch syndrome screening.

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Implementation of Universal Lynch Syndrome Screening in the VHA
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Implementation of Universal Lynch Syndrome Screening in the VHA
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2014 AVAHO meeting, cancer, Abstract 28, colorectal cancer, Lynch syndrome, universal Lynch syndrome screening, Genomic Medicine Service, GMS, Evaluation of Genomic Applications in Practice and Prevention working group, EGAPP working group
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2014 AVAHO meeting, cancer, Abstract 28, colorectal cancer, Lynch syndrome, universal Lynch syndrome screening, Genomic Medicine Service, GMS, Evaluation of Genomic Applications in Practice and Prevention working group, EGAPP working group
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Use of Adjuvant Chemotherapy In Stage III Colon Cancer: Analysis of National and VA Nebraska-Western Iowa Health Care System Data Using National Cancer Database

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Use of Adjuvant Chemotherapy In Stage III Colon Cancer: Analysis of National and VA Nebraska-Western Iowa Health Care System Data Using National Cancer Database
Upadhyay S, Dahal S, Silberstein PT.

Purpose: The National Comprehensive Cancer Network recommends chemotherapy for all stage III colon cancer patients. In fact, the American Society of Clinical Oncology quality program and the American College of Surgeons use administration of chemotherapy in stage III colon cancer as a quality measure. Though adjuvant chemotherapy improves overall survival in stage III colon cancer, prior studies have shown that it is underused. Its use was reported around 60%, with the use lower in females, the elderly, and African Americans. Our study uses a larger patient population from more recent years. We also analyzed different factors that may influence its use, including insurance type.

Methods: This is a retrospective study of stage 3 colon cancer patients diagnosed nationwide (n = 207,718) as well as at VA Nebraska-Western Iowa Health Care System (n = 10) in the National Cancer Data Base (NCDB). While the national data were available between 2000 and 2011, the data from the VAMC were available for 2010 and 2011. The NCDB contains about 70% of new cancer diagnosis in the U.S., deriving its data from > 1,500 American College of Surgeons-accredited cancer programs. Chi-square test was used to determine any difference in characteristics of patients who did or did not receive chemotherapy.

Results: One-fourth of all colon cancer patients at the VAMC were in stage III. Ninety percent of these patients received adjuvant chemotherapy. Nationwide, only 65% of such patients received adjuvant chemotherapy, with its use lower in elderly patients, whites, females, patients with one or more comorbidities, those with longer travel to treatment facility, and those with Medicare insurance, lower education, and lower income levels (all P < .05). Nonwhite and uninsured were more likely to be aged < 60 years.

Conclusions: This is the largest study to determine the use of chemotherapy in stage III colon cancer, both nationally and at local VAMC. Though its use nationwide has increased in recent years, the overall use is still low. Patient characteristics such as age, race, and gender, as well as socioeconomic factors influence its use. These findings have important implications for health care reform.

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2014 AVAHO meeting, cancer, Abstract 33, stage III colon cancer, adjuvant chemotherapy in stage III colon cancer, VA Nebraska-Western Iowa Health Care System, National Comprehensive Cancer Network
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Upadhyay S, Dahal S, Silberstein PT.
Upadhyay S, Dahal S, Silberstein PT.

Purpose: The National Comprehensive Cancer Network recommends chemotherapy for all stage III colon cancer patients. In fact, the American Society of Clinical Oncology quality program and the American College of Surgeons use administration of chemotherapy in stage III colon cancer as a quality measure. Though adjuvant chemotherapy improves overall survival in stage III colon cancer, prior studies have shown that it is underused. Its use was reported around 60%, with the use lower in females, the elderly, and African Americans. Our study uses a larger patient population from more recent years. We also analyzed different factors that may influence its use, including insurance type.

Methods: This is a retrospective study of stage 3 colon cancer patients diagnosed nationwide (n = 207,718) as well as at VA Nebraska-Western Iowa Health Care System (n = 10) in the National Cancer Data Base (NCDB). While the national data were available between 2000 and 2011, the data from the VAMC were available for 2010 and 2011. The NCDB contains about 70% of new cancer diagnosis in the U.S., deriving its data from > 1,500 American College of Surgeons-accredited cancer programs. Chi-square test was used to determine any difference in characteristics of patients who did or did not receive chemotherapy.

Results: One-fourth of all colon cancer patients at the VAMC were in stage III. Ninety percent of these patients received adjuvant chemotherapy. Nationwide, only 65% of such patients received adjuvant chemotherapy, with its use lower in elderly patients, whites, females, patients with one or more comorbidities, those with longer travel to treatment facility, and those with Medicare insurance, lower education, and lower income levels (all P < .05). Nonwhite and uninsured were more likely to be aged < 60 years.

Conclusions: This is the largest study to determine the use of chemotherapy in stage III colon cancer, both nationally and at local VAMC. Though its use nationwide has increased in recent years, the overall use is still low. Patient characteristics such as age, race, and gender, as well as socioeconomic factors influence its use. These findings have important implications for health care reform.

Purpose: The National Comprehensive Cancer Network recommends chemotherapy for all stage III colon cancer patients. In fact, the American Society of Clinical Oncology quality program and the American College of Surgeons use administration of chemotherapy in stage III colon cancer as a quality measure. Though adjuvant chemotherapy improves overall survival in stage III colon cancer, prior studies have shown that it is underused. Its use was reported around 60%, with the use lower in females, the elderly, and African Americans. Our study uses a larger patient population from more recent years. We also analyzed different factors that may influence its use, including insurance type.

Methods: This is a retrospective study of stage 3 colon cancer patients diagnosed nationwide (n = 207,718) as well as at VA Nebraska-Western Iowa Health Care System (n = 10) in the National Cancer Data Base (NCDB). While the national data were available between 2000 and 2011, the data from the VAMC were available for 2010 and 2011. The NCDB contains about 70% of new cancer diagnosis in the U.S., deriving its data from > 1,500 American College of Surgeons-accredited cancer programs. Chi-square test was used to determine any difference in characteristics of patients who did or did not receive chemotherapy.

Results: One-fourth of all colon cancer patients at the VAMC were in stage III. Ninety percent of these patients received adjuvant chemotherapy. Nationwide, only 65% of such patients received adjuvant chemotherapy, with its use lower in elderly patients, whites, females, patients with one or more comorbidities, those with longer travel to treatment facility, and those with Medicare insurance, lower education, and lower income levels (all P < .05). Nonwhite and uninsured were more likely to be aged < 60 years.

Conclusions: This is the largest study to determine the use of chemotherapy in stage III colon cancer, both nationally and at local VAMC. Though its use nationwide has increased in recent years, the overall use is still low. Patient characteristics such as age, race, and gender, as well as socioeconomic factors influence its use. These findings have important implications for health care reform.

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Use of Adjuvant Chemotherapy In Stage III Colon Cancer: Analysis of National and VA Nebraska-Western Iowa Health Care System Data Using National Cancer Database
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Use of Adjuvant Chemotherapy In Stage III Colon Cancer: Analysis of National and VA Nebraska-Western Iowa Health Care System Data Using National Cancer Database
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2014 AVAHO meeting, cancer, Abstract 33, stage III colon cancer, adjuvant chemotherapy in stage III colon cancer, VA Nebraska-Western Iowa Health Care System, National Comprehensive Cancer Network
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2014 AVAHO meeting, cancer, Abstract 33, stage III colon cancer, adjuvant chemotherapy in stage III colon cancer, VA Nebraska-Western Iowa Health Care System, National Comprehensive Cancer Network
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Physician Nonadherence to Repeat Colonoscopy Guidelines for Screening and Polyp Surveillance in an Integrated Managed Care System

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Physician Nonadherence to Repeat Colonoscopy Guidelines for Screening and Polyp Surveillance in an Integrated Managed Care System
Grambow SC, Grubber J, Maciejewski ML.

Purpose: Colonoscopy can decrease colorectal cancer (CRC) mortality; however, performing colonoscopy more frequently than recommended may increase cost and risk. The primary aim of this study was to determine rates and correlates of physician nonadherence to guidelines for colonoscopy screening and polyp surveillance intervals. The effectiveness of cancer screening and prevention programs will be diminished if capacity is reduced by overutilization of colonoscopy due to physician nonadherence to published guidelines. Results from this study can inform efforts to improve these types of programs, enhance provider education, and better align use of colonoscopy for CRC screening and surveillance with clinical guidelines.

Methods: The VA electronic medical records of 2,443 patients aged 50 to 64 years, with a fiscal year 2008 VA facility-performed colonoscopy, and no colonoscopy in prior 10 years, were reviewed and data were abstracted. Additional physician data were merged from the American Medical Association master file. Patients with incomplete colonoscopies or inadequate bowel preparations were excluded from analysis (n = 988). Nonadherence was defined as any recommendation that did not match the guideline follow-up interval. Data were collected from 25 VA hospitals that were randomly selected from 85 qualifying facilities stratified by academic affiliation (academic/nonacademic), geographic region, resource level (complexity score = high vs medium/low), and subgroups that performed ≥ 500 colonoscopies in fiscal year 2008. Patients were grouped into clinical scenarios based on index colonoscopy results including no polyp/normal tissue (n = 893), hyperplastic polyp only (n = 203), low risk adenoma (1 to 2 adenomas < 1 cm; n = 231), and higher risk adenoma (3-10 adenomas or any adenoma ≥ 1 cm or high grade dysplasia; n=128). The proportion of nonadherent recommendations was calculated for each of these 4 groups. We calculated adjusted odds ratios (OR) and 95% confidence intervals (CI) for the association between nonadherence, risk group, and physician characteristics, using SUDAAN software (v11.0.0) to account for our complex sample design.

Results: The overall nonadherence rate was 36% and ranged from 3% to 80% across medical facilities. Nonadherence varied by colonoscopy results: 28% among normal colonoscopies, 52% for hyperplastic polyps, 45% for low risk adenomas, and 49% for higher risk adenomas. All nonadherent recommendations dictated a shorter interval. In adjusted analyses, nonadherence was significantly higher for colonoscopies with hyperplastic (OR = 3.1, 95% CI [1.7, 5.6], or adenomatous polyps [low risk adenoma OR = 2.1], 95% CI [1.1, 4.2]; high risk adenoma OR = 2.8, 95% CI [1.2, 6.7]) compared with normal colonoscopies. Nonadherence was also significantly associated with geographic region, Charlson comorbidity score, and colonoscopy type. There were higher adjusted odds of nonadherence for colonoscopies performed in the Northeast than those of the Midwest (OR = 4.6, 95% CI [1.8, 11.8]); for increasing comorbidity (OR = 1.2 for a 1-unit Charlson score increase, 95% CI [1.1, 1.]), and for colonoscopies in which the indication was surveillance rather than screening (OR = 2.5, 95% CI [1.1, 5.6]). No other statistically significant associations were noted.

Conclusions: In a managed care setting with salaried physicians, more than one-third of recommendations suggested a need for repeat colonoscopy sooner than guidelines. The strongest predictors of nonadherence were colonoscopy findings and geographic region. Further research should investigate if targeting nonadherence to colonoscopy guidelines can reduce colonoscopy overuse and associated health care costs.

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2014 AVAHO meeting, cancer, Abstract 37, polyp surveillance, physician nonadherence, repeat colonoscopy guidelines, colorectal cancer mortality
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Grambow SC, Grubber J, Maciejewski ML.
Grambow SC, Grubber J, Maciejewski ML.

Purpose: Colonoscopy can decrease colorectal cancer (CRC) mortality; however, performing colonoscopy more frequently than recommended may increase cost and risk. The primary aim of this study was to determine rates and correlates of physician nonadherence to guidelines for colonoscopy screening and polyp surveillance intervals. The effectiveness of cancer screening and prevention programs will be diminished if capacity is reduced by overutilization of colonoscopy due to physician nonadherence to published guidelines. Results from this study can inform efforts to improve these types of programs, enhance provider education, and better align use of colonoscopy for CRC screening and surveillance with clinical guidelines.

Methods: The VA electronic medical records of 2,443 patients aged 50 to 64 years, with a fiscal year 2008 VA facility-performed colonoscopy, and no colonoscopy in prior 10 years, were reviewed and data were abstracted. Additional physician data were merged from the American Medical Association master file. Patients with incomplete colonoscopies or inadequate bowel preparations were excluded from analysis (n = 988). Nonadherence was defined as any recommendation that did not match the guideline follow-up interval. Data were collected from 25 VA hospitals that were randomly selected from 85 qualifying facilities stratified by academic affiliation (academic/nonacademic), geographic region, resource level (complexity score = high vs medium/low), and subgroups that performed ≥ 500 colonoscopies in fiscal year 2008. Patients were grouped into clinical scenarios based on index colonoscopy results including no polyp/normal tissue (n = 893), hyperplastic polyp only (n = 203), low risk adenoma (1 to 2 adenomas < 1 cm; n = 231), and higher risk adenoma (3-10 adenomas or any adenoma ≥ 1 cm or high grade dysplasia; n=128). The proportion of nonadherent recommendations was calculated for each of these 4 groups. We calculated adjusted odds ratios (OR) and 95% confidence intervals (CI) for the association between nonadherence, risk group, and physician characteristics, using SUDAAN software (v11.0.0) to account for our complex sample design.

Results: The overall nonadherence rate was 36% and ranged from 3% to 80% across medical facilities. Nonadherence varied by colonoscopy results: 28% among normal colonoscopies, 52% for hyperplastic polyps, 45% for low risk adenomas, and 49% for higher risk adenomas. All nonadherent recommendations dictated a shorter interval. In adjusted analyses, nonadherence was significantly higher for colonoscopies with hyperplastic (OR = 3.1, 95% CI [1.7, 5.6], or adenomatous polyps [low risk adenoma OR = 2.1], 95% CI [1.1, 4.2]; high risk adenoma OR = 2.8, 95% CI [1.2, 6.7]) compared with normal colonoscopies. Nonadherence was also significantly associated with geographic region, Charlson comorbidity score, and colonoscopy type. There were higher adjusted odds of nonadherence for colonoscopies performed in the Northeast than those of the Midwest (OR = 4.6, 95% CI [1.8, 11.8]); for increasing comorbidity (OR = 1.2 for a 1-unit Charlson score increase, 95% CI [1.1, 1.]), and for colonoscopies in which the indication was surveillance rather than screening (OR = 2.5, 95% CI [1.1, 5.6]). No other statistically significant associations were noted.

Conclusions: In a managed care setting with salaried physicians, more than one-third of recommendations suggested a need for repeat colonoscopy sooner than guidelines. The strongest predictors of nonadherence were colonoscopy findings and geographic region. Further research should investigate if targeting nonadherence to colonoscopy guidelines can reduce colonoscopy overuse and associated health care costs.

Purpose: Colonoscopy can decrease colorectal cancer (CRC) mortality; however, performing colonoscopy more frequently than recommended may increase cost and risk. The primary aim of this study was to determine rates and correlates of physician nonadherence to guidelines for colonoscopy screening and polyp surveillance intervals. The effectiveness of cancer screening and prevention programs will be diminished if capacity is reduced by overutilization of colonoscopy due to physician nonadherence to published guidelines. Results from this study can inform efforts to improve these types of programs, enhance provider education, and better align use of colonoscopy for CRC screening and surveillance with clinical guidelines.

Methods: The VA electronic medical records of 2,443 patients aged 50 to 64 years, with a fiscal year 2008 VA facility-performed colonoscopy, and no colonoscopy in prior 10 years, were reviewed and data were abstracted. Additional physician data were merged from the American Medical Association master file. Patients with incomplete colonoscopies or inadequate bowel preparations were excluded from analysis (n = 988). Nonadherence was defined as any recommendation that did not match the guideline follow-up interval. Data were collected from 25 VA hospitals that were randomly selected from 85 qualifying facilities stratified by academic affiliation (academic/nonacademic), geographic region, resource level (complexity score = high vs medium/low), and subgroups that performed ≥ 500 colonoscopies in fiscal year 2008. Patients were grouped into clinical scenarios based on index colonoscopy results including no polyp/normal tissue (n = 893), hyperplastic polyp only (n = 203), low risk adenoma (1 to 2 adenomas < 1 cm; n = 231), and higher risk adenoma (3-10 adenomas or any adenoma ≥ 1 cm or high grade dysplasia; n=128). The proportion of nonadherent recommendations was calculated for each of these 4 groups. We calculated adjusted odds ratios (OR) and 95% confidence intervals (CI) for the association between nonadherence, risk group, and physician characteristics, using SUDAAN software (v11.0.0) to account for our complex sample design.

Results: The overall nonadherence rate was 36% and ranged from 3% to 80% across medical facilities. Nonadherence varied by colonoscopy results: 28% among normal colonoscopies, 52% for hyperplastic polyps, 45% for low risk adenomas, and 49% for higher risk adenomas. All nonadherent recommendations dictated a shorter interval. In adjusted analyses, nonadherence was significantly higher for colonoscopies with hyperplastic (OR = 3.1, 95% CI [1.7, 5.6], or adenomatous polyps [low risk adenoma OR = 2.1], 95% CI [1.1, 4.2]; high risk adenoma OR = 2.8, 95% CI [1.2, 6.7]) compared with normal colonoscopies. Nonadherence was also significantly associated with geographic region, Charlson comorbidity score, and colonoscopy type. There were higher adjusted odds of nonadherence for colonoscopies performed in the Northeast than those of the Midwest (OR = 4.6, 95% CI [1.8, 11.8]); for increasing comorbidity (OR = 1.2 for a 1-unit Charlson score increase, 95% CI [1.1, 1.]), and for colonoscopies in which the indication was surveillance rather than screening (OR = 2.5, 95% CI [1.1, 5.6]). No other statistically significant associations were noted.

Conclusions: In a managed care setting with salaried physicians, more than one-third of recommendations suggested a need for repeat colonoscopy sooner than guidelines. The strongest predictors of nonadherence were colonoscopy findings and geographic region. Further research should investigate if targeting nonadherence to colonoscopy guidelines can reduce colonoscopy overuse and associated health care costs.

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Physician Nonadherence to Repeat Colonoscopy Guidelines for Screening and Polyp Surveillance in an Integrated Managed Care System
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Physician Nonadherence to Repeat Colonoscopy Guidelines for Screening and Polyp Surveillance in an Integrated Managed Care System
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2014 AVAHO meeting, cancer, Abstract 37, polyp surveillance, physician nonadherence, repeat colonoscopy guidelines, colorectal cancer mortality
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2014 AVAHO meeting, cancer, Abstract 37, polyp surveillance, physician nonadherence, repeat colonoscopy guidelines, colorectal cancer mortality
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Endorectal Ultrasound (ERUS): Improving Veteran Patient Care and Outcomes While Streamlining Preoperative Evaluation in Rectal Cancer

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Endorectal Ultrasound (ERUS): Improving Veteran Patient Care and Outcomes While Streamlining Preoperative Evaluation in Rectal Cancer
Valdez-Boyle L, Schneider SL.

Purpose: ERUS is the gold standard imaging for staging of rectal neoplasms. It determines location, distance, penetration depth, regional lymph node status, and is critical to guiding treatment of rectal cancer. ERUS allows the evaluation of the tumor postoperatively as a means of minimally invasive and cost-effective local surveillance for local recurrence. ERUS was not available at the Raymond G. Murphy VAMC in Albuquerque, New Mexico before 2010 so veterans were outsourced to other facilities for screening. This resulted in delaying treatment up to 12 weeks. Thirty-nine percent (7/18) of patients were delayed over 30 days to the start of treatment. Cost to the institution was fee for service $2,500 and loss of revenue-specialist consultation/procedure.

Methods: In 2010, the NMVAHCS purchased a BK medical ultrasound with a rigid rectal probe. A standard operating procedure was established as well as training for staff on the actual procedure as well as the cleaning and disinfection of the equipment. The physician, a fellowship trained colorectal surgeon, took a refresher course on ERUS as well.

Results: The first ERUS procedure was done on June 15, 2010. Since that time the outsourcing of rectal ultrasounds has ceased. A total of 78 patients have been referred to colorectal surgery for ERUS staging and surveillance. We have calculated a cost savings to the institution of $195,000 for fee basis of the procedure. In addition the Raymond G. Murphy VAMC has benefited in revenue earned for the specialty consultation and cost of the procedure. Most important, we have decreased the time from the initial consult to ERUS completion to 7-10 days. This gets our veterans to their definitive cancer treatment faster. Additionally, it provides continuity of care by keeping everything in the VA system and making it easier for ongoing surveillance.

Conclusions: ERUS is the imaging modality of choice. It is user dependent. However, it remains the most economical when compared to MRI. It is a relatively simple and inexpensive tool that can be utilized in the clinic setting. The patients benefit from expedited staging and quicker onset of treatment for rectal cancer.

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2014 AVAHO meeting, cancer, Abstract 54, endorectal ultrasound ERUS, preoperative evaluation in rectal cancer, rectal neoplasms, Raymond G Murphy VAMC in Albuquerque New Mexico
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Valdez-Boyle L, Schneider SL.
Valdez-Boyle L, Schneider SL.

Purpose: ERUS is the gold standard imaging for staging of rectal neoplasms. It determines location, distance, penetration depth, regional lymph node status, and is critical to guiding treatment of rectal cancer. ERUS allows the evaluation of the tumor postoperatively as a means of minimally invasive and cost-effective local surveillance for local recurrence. ERUS was not available at the Raymond G. Murphy VAMC in Albuquerque, New Mexico before 2010 so veterans were outsourced to other facilities for screening. This resulted in delaying treatment up to 12 weeks. Thirty-nine percent (7/18) of patients were delayed over 30 days to the start of treatment. Cost to the institution was fee for service $2,500 and loss of revenue-specialist consultation/procedure.

Methods: In 2010, the NMVAHCS purchased a BK medical ultrasound with a rigid rectal probe. A standard operating procedure was established as well as training for staff on the actual procedure as well as the cleaning and disinfection of the equipment. The physician, a fellowship trained colorectal surgeon, took a refresher course on ERUS as well.

Results: The first ERUS procedure was done on June 15, 2010. Since that time the outsourcing of rectal ultrasounds has ceased. A total of 78 patients have been referred to colorectal surgery for ERUS staging and surveillance. We have calculated a cost savings to the institution of $195,000 for fee basis of the procedure. In addition the Raymond G. Murphy VAMC has benefited in revenue earned for the specialty consultation and cost of the procedure. Most important, we have decreased the time from the initial consult to ERUS completion to 7-10 days. This gets our veterans to their definitive cancer treatment faster. Additionally, it provides continuity of care by keeping everything in the VA system and making it easier for ongoing surveillance.

Conclusions: ERUS is the imaging modality of choice. It is user dependent. However, it remains the most economical when compared to MRI. It is a relatively simple and inexpensive tool that can be utilized in the clinic setting. The patients benefit from expedited staging and quicker onset of treatment for rectal cancer.

Purpose: ERUS is the gold standard imaging for staging of rectal neoplasms. It determines location, distance, penetration depth, regional lymph node status, and is critical to guiding treatment of rectal cancer. ERUS allows the evaluation of the tumor postoperatively as a means of minimally invasive and cost-effective local surveillance for local recurrence. ERUS was not available at the Raymond G. Murphy VAMC in Albuquerque, New Mexico before 2010 so veterans were outsourced to other facilities for screening. This resulted in delaying treatment up to 12 weeks. Thirty-nine percent (7/18) of patients were delayed over 30 days to the start of treatment. Cost to the institution was fee for service $2,500 and loss of revenue-specialist consultation/procedure.

Methods: In 2010, the NMVAHCS purchased a BK medical ultrasound with a rigid rectal probe. A standard operating procedure was established as well as training for staff on the actual procedure as well as the cleaning and disinfection of the equipment. The physician, a fellowship trained colorectal surgeon, took a refresher course on ERUS as well.

Results: The first ERUS procedure was done on June 15, 2010. Since that time the outsourcing of rectal ultrasounds has ceased. A total of 78 patients have been referred to colorectal surgery for ERUS staging and surveillance. We have calculated a cost savings to the institution of $195,000 for fee basis of the procedure. In addition the Raymond G. Murphy VAMC has benefited in revenue earned for the specialty consultation and cost of the procedure. Most important, we have decreased the time from the initial consult to ERUS completion to 7-10 days. This gets our veterans to their definitive cancer treatment faster. Additionally, it provides continuity of care by keeping everything in the VA system and making it easier for ongoing surveillance.

Conclusions: ERUS is the imaging modality of choice. It is user dependent. However, it remains the most economical when compared to MRI. It is a relatively simple and inexpensive tool that can be utilized in the clinic setting. The patients benefit from expedited staging and quicker onset of treatment for rectal cancer.

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Endorectal Ultrasound (ERUS): Improving Veteran Patient Care and Outcomes While Streamlining Preoperative Evaluation in Rectal Cancer
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Endorectal Ultrasound (ERUS): Improving Veteran Patient Care and Outcomes While Streamlining Preoperative Evaluation in Rectal Cancer
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2014 AVAHO meeting, cancer, Abstract 54, endorectal ultrasound ERUS, preoperative evaluation in rectal cancer, rectal neoplasms, Raymond G Murphy VAMC in Albuquerque New Mexico
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2014 AVAHO meeting, cancer, Abstract 54, endorectal ultrasound ERUS, preoperative evaluation in rectal cancer, rectal neoplasms, Raymond G Murphy VAMC in Albuquerque New Mexico
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One Veterans Affairs Medical Center’s Experience with Colorectal Carcinoma

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One Veterans Affairs Medical Center’s Experience with Colorectal Carcinoma
Gavrancic T, Liu Q, Jain V, Park Y-HA.

Purpose: This study was performed in order to evaluate if patients were offered or received appropriate workup and treatment according to colon cancer stage. Rectal cancer was diagnosed in 3 and colon cancer in 81 patients over 5 years.  Patients were diagnosed with stage I in 26 cases (30%), stage II in 21 cases (25%), stage III in 15 cases (17.9 %), stage IV in 21 cases (25%), and 1 patient TIS (0.1%).

Methods: The study was designed as a retrospective single institution (JJP VAMC ) chart review of all patients who were diagnosed with colorectal cancer from 1/1/2008-12/31/2012 which included a total of 86 patients. NCCN guidelines 2014 were used as reference for workup, treatment and surveillance according to TNM classification. Data elements included the following: pre-operative CEA/ CT chest, abdomen, pelvis, colonoscopy; surgical resection and chemotherapy; follow up CEA, CT, colonoscopy. Excluded patients included those who eloped or were permanently lost follow up.

Results: Complete workup was done in 64% cases, incomplete in 36% cases without significant difference from 2008-2012. Incomplete workup defined as: missing CT chest (in 100% of those cases CXR was done and without mass suggestive for metastasis) 11 cases, CEA 3 cases, CT abdomen, pelvis and chest in 1 case, and both CT and CEA in 7 cases.  Stage IV colorectal carcinoma patients were tested for KRAS/BRAF in 10 cases  (47.6%; 3 KRAS positive, 7 negative) and not tested in 11 cases (52.4%). However, there has been progressive improvement in following guidelines for testing of KRAS from 2008-2012 from 45% (2008), 50% (2009), 75% (2010), 75% (2011) to 100% in 2012. 

Treatment was found to have 100% compliance with NCCN guidelines according to TNM classification.  Surveillance according to NCCN guidelines was in full compliance in 59 cases (77.7%), incomplete follow up in 17 cases (22.3%) with missing CT chest or CEA, and from which only 1 patient was missing follow up colonoscopy (1.3%).

 Conclusions: Complete compliance with 100% appropriate therapy was offered to veterans at one VA according to NCCN guidelines from 2008-2012. Aside from omitting CT chest when replaced by normal CXR, workup was complete in 90% of cases. Improvement in testing for KRAS/BRAF in stage IV colorectal carcinoma was done over the years with achievement of 100% in 2012. Surveillance was satisfactory as incomplete follow up was found in only 20%.  Given the future emphasis on cancer survivorship, a focus on adherence to surveillance should be a strong part of the VA’s future goals.

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2014 AVAHO meeting, cancer, Abstract 58, colorectal carcinoma, testing for KRAS/BRAF in stage IV colorectal carcinoma, adherence to surveillance
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Gavrancic T, Liu Q, Jain V, Park Y-HA.
Gavrancic T, Liu Q, Jain V, Park Y-HA.

Purpose: This study was performed in order to evaluate if patients were offered or received appropriate workup and treatment according to colon cancer stage. Rectal cancer was diagnosed in 3 and colon cancer in 81 patients over 5 years.  Patients were diagnosed with stage I in 26 cases (30%), stage II in 21 cases (25%), stage III in 15 cases (17.9 %), stage IV in 21 cases (25%), and 1 patient TIS (0.1%).

Methods: The study was designed as a retrospective single institution (JJP VAMC ) chart review of all patients who were diagnosed with colorectal cancer from 1/1/2008-12/31/2012 which included a total of 86 patients. NCCN guidelines 2014 were used as reference for workup, treatment and surveillance according to TNM classification. Data elements included the following: pre-operative CEA/ CT chest, abdomen, pelvis, colonoscopy; surgical resection and chemotherapy; follow up CEA, CT, colonoscopy. Excluded patients included those who eloped or were permanently lost follow up.

Results: Complete workup was done in 64% cases, incomplete in 36% cases without significant difference from 2008-2012. Incomplete workup defined as: missing CT chest (in 100% of those cases CXR was done and without mass suggestive for metastasis) 11 cases, CEA 3 cases, CT abdomen, pelvis and chest in 1 case, and both CT and CEA in 7 cases.  Stage IV colorectal carcinoma patients were tested for KRAS/BRAF in 10 cases  (47.6%; 3 KRAS positive, 7 negative) and not tested in 11 cases (52.4%). However, there has been progressive improvement in following guidelines for testing of KRAS from 2008-2012 from 45% (2008), 50% (2009), 75% (2010), 75% (2011) to 100% in 2012. 

Treatment was found to have 100% compliance with NCCN guidelines according to TNM classification.  Surveillance according to NCCN guidelines was in full compliance in 59 cases (77.7%), incomplete follow up in 17 cases (22.3%) with missing CT chest or CEA, and from which only 1 patient was missing follow up colonoscopy (1.3%).

 Conclusions: Complete compliance with 100% appropriate therapy was offered to veterans at one VA according to NCCN guidelines from 2008-2012. Aside from omitting CT chest when replaced by normal CXR, workup was complete in 90% of cases. Improvement in testing for KRAS/BRAF in stage IV colorectal carcinoma was done over the years with achievement of 100% in 2012. Surveillance was satisfactory as incomplete follow up was found in only 20%.  Given the future emphasis on cancer survivorship, a focus on adherence to surveillance should be a strong part of the VA’s future goals.

Purpose: This study was performed in order to evaluate if patients were offered or received appropriate workup and treatment according to colon cancer stage. Rectal cancer was diagnosed in 3 and colon cancer in 81 patients over 5 years.  Patients were diagnosed with stage I in 26 cases (30%), stage II in 21 cases (25%), stage III in 15 cases (17.9 %), stage IV in 21 cases (25%), and 1 patient TIS (0.1%).

Methods: The study was designed as a retrospective single institution (JJP VAMC ) chart review of all patients who were diagnosed with colorectal cancer from 1/1/2008-12/31/2012 which included a total of 86 patients. NCCN guidelines 2014 were used as reference for workup, treatment and surveillance according to TNM classification. Data elements included the following: pre-operative CEA/ CT chest, abdomen, pelvis, colonoscopy; surgical resection and chemotherapy; follow up CEA, CT, colonoscopy. Excluded patients included those who eloped or were permanently lost follow up.

Results: Complete workup was done in 64% cases, incomplete in 36% cases without significant difference from 2008-2012. Incomplete workup defined as: missing CT chest (in 100% of those cases CXR was done and without mass suggestive for metastasis) 11 cases, CEA 3 cases, CT abdomen, pelvis and chest in 1 case, and both CT and CEA in 7 cases.  Stage IV colorectal carcinoma patients were tested for KRAS/BRAF in 10 cases  (47.6%; 3 KRAS positive, 7 negative) and not tested in 11 cases (52.4%). However, there has been progressive improvement in following guidelines for testing of KRAS from 2008-2012 from 45% (2008), 50% (2009), 75% (2010), 75% (2011) to 100% in 2012. 

Treatment was found to have 100% compliance with NCCN guidelines according to TNM classification.  Surveillance according to NCCN guidelines was in full compliance in 59 cases (77.7%), incomplete follow up in 17 cases (22.3%) with missing CT chest or CEA, and from which only 1 patient was missing follow up colonoscopy (1.3%).

 Conclusions: Complete compliance with 100% appropriate therapy was offered to veterans at one VA according to NCCN guidelines from 2008-2012. Aside from omitting CT chest when replaced by normal CXR, workup was complete in 90% of cases. Improvement in testing for KRAS/BRAF in stage IV colorectal carcinoma was done over the years with achievement of 100% in 2012. Surveillance was satisfactory as incomplete follow up was found in only 20%.  Given the future emphasis on cancer survivorship, a focus on adherence to surveillance should be a strong part of the VA’s future goals.

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One Veterans Affairs Medical Center’s Experience with Colorectal Carcinoma
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Bundled preventive care reduced surgical site infections

A bottom-up fix for infections
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Bundled preventive care reduced surgical site infections

Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.

The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.

©XiXinXing/Thinkstock.com
Using prevention strategies can help mitigate the number of surgical site infections after colorectal surgery by as much as 14%.

To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.

The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).

Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).

The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.

Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.

Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.

A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.

It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.

Dr. Keenan reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

References

Body

The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.

This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).

The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.

Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.

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Body

The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.

This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).

The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.

Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.

Body

The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.

This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).

The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.

Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.

Title
A bottom-up fix for infections
A bottom-up fix for infections

Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.

The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.

©XiXinXing/Thinkstock.com
Using prevention strategies can help mitigate the number of surgical site infections after colorectal surgery by as much as 14%.

To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.

The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).

Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).

The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.

Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.

Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.

A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.

It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.

Dr. Keenan reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.

The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.

©XiXinXing/Thinkstock.com
Using prevention strategies can help mitigate the number of surgical site infections after colorectal surgery by as much as 14%.

To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.

The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).

Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).

The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.

Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.

Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.

A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.

It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.

Dr. Keenan reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

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FROM JAMA SURGERY

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Key clinical point: Bundled preventive care significantly reduced surgical site infection after colorectal surgery.

Major finding: Superficial surgical site infection occurred in about 19% before and about 6% after implementing bundled care.

Data source: A retrospective study of 559 patients undergoing colorectal surgery, 62% before bundled-care implementation.

Disclosures: Dr. Keenan reported having no relevant financial disclosures.

Fast Facts: Metastatic Colorectal Cancer

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Fast Facts: Metastatic Colorectal Cancer

To read more about this topic, read "Metastatic Colorectal Cancer."

▶Patients with limited metastatic disease to the liver or lungs may be eligible for complete resection upfront or after neoadjuvant therapy, and many will have long PFS or even cure

▶Metastatic colon cancer can affect up to 50% of patients diagnosed with the disease

▶Appropriate evaluation of the extent of the disease and patients' general health by a multidisciplinary team will determine goals of treatment

▶Patients with widely metastatic disease will benefit from different systemic chemotherapy regimens given sequentially and punctuated by "chemo holidays." With this strategy, survival can be doubled or tripled

▶Managing toxicity from systemic chemotherapy is paramount to maintain QOL. Myelosuppression, mucositis, cold-induced neuropathy, fatigue, and rash are the most common AEs and can be managed to maintain QOL

▶Hypertensive crisis, bleeding or thrombosis, GI perforation, and RPLS should prompt the discontinuation of bevacizumab and similar drugs

▶Biologic agents, such as antiangiogenic and anti-EGFR agents, when used with chemotherapy, added some benefit but their effect was not equal across treatment regimens

▶5-FU is considered the staple for all chemotherapy regimens used in this disease. The addition of irinotecan or oxaliplatin to 5-FU improved RRs and PFS but did not always result in improvement of OS.

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To read more about this topic, read "Metastatic Colorectal Cancer."

▶Patients with limited metastatic disease to the liver or lungs may be eligible for complete resection upfront or after neoadjuvant therapy, and many will have long PFS or even cure

▶Metastatic colon cancer can affect up to 50% of patients diagnosed with the disease

▶Appropriate evaluation of the extent of the disease and patients' general health by a multidisciplinary team will determine goals of treatment

▶Patients with widely metastatic disease will benefit from different systemic chemotherapy regimens given sequentially and punctuated by "chemo holidays." With this strategy, survival can be doubled or tripled

▶Managing toxicity from systemic chemotherapy is paramount to maintain QOL. Myelosuppression, mucositis, cold-induced neuropathy, fatigue, and rash are the most common AEs and can be managed to maintain QOL

▶Hypertensive crisis, bleeding or thrombosis, GI perforation, and RPLS should prompt the discontinuation of bevacizumab and similar drugs

▶Biologic agents, such as antiangiogenic and anti-EGFR agents, when used with chemotherapy, added some benefit but their effect was not equal across treatment regimens

▶5-FU is considered the staple for all chemotherapy regimens used in this disease. The addition of irinotecan or oxaliplatin to 5-FU improved RRs and PFS but did not always result in improvement of OS.

To read more about this topic, read "Metastatic Colorectal Cancer."

▶Patients with limited metastatic disease to the liver or lungs may be eligible for complete resection upfront or after neoadjuvant therapy, and many will have long PFS or even cure

▶Metastatic colon cancer can affect up to 50% of patients diagnosed with the disease

▶Appropriate evaluation of the extent of the disease and patients' general health by a multidisciplinary team will determine goals of treatment

▶Patients with widely metastatic disease will benefit from different systemic chemotherapy regimens given sequentially and punctuated by "chemo holidays." With this strategy, survival can be doubled or tripled

▶Managing toxicity from systemic chemotherapy is paramount to maintain QOL. Myelosuppression, mucositis, cold-induced neuropathy, fatigue, and rash are the most common AEs and can be managed to maintain QOL

▶Hypertensive crisis, bleeding or thrombosis, GI perforation, and RPLS should prompt the discontinuation of bevacizumab and similar drugs

▶Biologic agents, such as antiangiogenic and anti-EGFR agents, when used with chemotherapy, added some benefit but their effect was not equal across treatment regimens

▶5-FU is considered the staple for all chemotherapy regimens used in this disease. The addition of irinotecan or oxaliplatin to 5-FU improved RRs and PFS but did not always result in improvement of OS.

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