Damian McNamara

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.

ORLANDO – Neoadjuvant chemotherapy with interval debulking surgery yields similar overall and longer progression-free survival when compared with primary debulking surgery for women with stage IV epithelial ovarian cancer, according to a retrospective study.

"Our study suggests a potential wider role for neoadjuvant chemotherapy in management of stage IV ovarian cancer," Dr. Jose Alejandro Rauh-Hain said at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Rauh-Hain and his associates assessed 221 newly diagnosed women with stage IV ovarian cancer. Overall survival was not significantly different at a median of 33 months with neoadjuvant chemotherapy-interval debulking surgery group (NACT-IDS) and 29 months with primary debulking surgery, said Dr. Rauh-Hain, a clinical fellow in obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Median progression-free survival was 14 months for the 45 women in the NACT-IDS group, compared with 10 months among the 176 women treated with primary debulking only.

Patient records were evaluated to subclassify stage IV disease, site of tumor, and dissemination at time of initial diagnosis. All women received primary therapy from Jan. 1, 1995, to Dec. 31, 2007, at either of the two institutions.

The strengths of the study are a large number of patients, treatment based on physician discretion, and an optimal debulking surgery rate of 58%, which is similar to other studies, said invited discussant Dr. Peter Rose. A retrospective design; an unbalanced comparison (because the majority had primary debulking surgery); and a lack of uniform criteria to select neoadjuvant chemotherapy are limitations.

"It seems like we are mixing a lot of different tomatoes, big red ones and small green ones, and what we are getting is tomato sauce," said Dr. Rose, section head, department of obstetrics and gynecology at the Cleveland Clinic in Ohio.

Optimal cytoreduction, defined as residual disease smaller than 1 cm, was not significantly different between groups: 71% of the NACT-IDS and 58% of the primary debulking cohorts (P = .1).

The rate of complete resection to no residual disease was significantly higher among women who underwent NACT-IDS, 27%, vs. 7.5% of women treated with primary debulking (P less than .001).

Median follow-up was 28 months. The longest median overall survival was observed for women who had primary debulking surgery and no residual disease (72 months), but Dr. Rauh-Hain pointed out that "only 7.5% of these patients who underwent primary debulking had no residual disease." This success rate is similar to 8% of 360 women debulked to no residual disease in another report ( J. Clin. Oncol. 2008;26:83-9).

Median overall survival reached 32 months for the primary surgery group who had optimal cytoreduction and to 20 months if cytoreduction was suboptimal.

Dr. Rauh-Hain and his associates also evaluated median progression-free and overall survival rates by site of distant metastatic disease, including pleural effusion, liver, abdomen, distant lymph nodes, and spleen. The only significant difference was in median overall survival among women who had liver metastases and NACT-IDS, 43 months vs. 27 months with primary debulking. Median progression-free survival in this group was 15 months vs. 13 months.

The superior overall survival with NACT-IDS among women who presented with parenchymal liver metastases suggests this therapeutic strategy may be the preferred option for these patients, Dr. Rauh-Hain said.

The NACT-IDS group had a shorter mean length of hospital stay, 8 days vs. 12 days in the primary debulking surgery group. There also was a trend toward fewer postoperative complications in the NACT-IDS cohort, 15% vs. 27%. Also, no woman in the NACT-IDS group died within 30 days of their initial surgery, compared with eight women (5%) of the primary debulking surgery group.

Possible limitations were the retrospective design of the study; lack of information regarding previous or subsequent care at nonaffiliated institutions; and a lack of standardized treatment were possible limitations, Dr. Rauh-Hain said. A lower postoperative mortality rate in the NACT-IDS group suggests there could be selection bias in terms of treatment selection, he added.

Dr. Rauh-Hain said that he had no relevant disclosures. Dr. Rose said he is a member of the Lilly speakers bureau.

ORLANDO – Improper surgery, a lack of lymph node assessment, and improper or no chemotherapy top the list of reasons that women with ovarian cancer do not receive care consistent with National Comprehensive Cancer Network guidelines, according to a study of nearly 100,000 patients.

"Overall, we were quite sad to see that only 43% of patients appear to be receiving care adherent with the NCCN guidelines," Dr. Matthew A. Powell said at this year’s annual meeting of the Society of Gynecologic Oncologists (SGO). "The reasons for nonadherence were mostly surgical in nature."

Dr. Matthew A. Powell

Researchers assessed treatment of 96,802 women diagnosed with invasive epithelial ovarian cancer in the National Cancer Database from 1998 to 2007. They also evaluated mature 5-year survival data from 1998 to 2002.

To determine guideline adherence, Dr. Powell and his associates noted initial surgical procedure and initial front-line chemotherapy. They also assessed compliance by cancer stage, substage, and grade.

The primary reason for nonadherence was a lack of documented omentectomy (54,939 or 57% of the nonadherent cases). "In those patients who did have an omentectomy and stage I to IIIb cancer, we required them to have lymph node assessment," Dr. Powell said. "Unfortunately this also represented a large portion of the nonadherence."

Improper chemotherapy comprised the remainder of nonadherent cases, where patients received single-agent chemotherapy, no chemotherapy, or inappropriate chemotherapy based on cancer stage and grade.

Patients who underwent surgery only (with no evidence of chemotherapy in their records) included a large portion with stage IIIc and IV disease, Dr. Powell said. Only 8% of this cohort received care consistent with the National Comprehensive Cancer Network (NCCN) guidelines.

"One-third of patients had two or three reasons to be nonadherent to the guidelines," said Dr. Powell, who is on the obstetrics and gynecology faculty, Division of Gynecologic Oncology at the Washington University, St. Louis.

The NCCN established the ovarian cancer guidelines in 1997, and they underwent regular revisions, including major updates in 2000 and 2006, Dr. Powell said.

One aim of the study was to determine the validity of NCCN ovarian cancer clinical practice guidelines using a survival comparison. Adherence to the guidelines "does seem to correlate with improved survival and, perhaps, with better quality care. It translates to approximately a 13-month improved median survival for patients who were compliant," Dr. Powell said, adding this difference was "highly statistically significant" (hazard ratio, 1.44).

Adherence and survival correlated across each stage of cancer as well, Dr. Powell said.

During a Q & A session, Dr. Barbara Goff pointed out that some noncompliant care was delivered to patients at one of the 21 major institutions that form the NCCN. "I was surprised that only about 50%-55% of the time were patients at NCCN institutions receiving guideline-based therapy," said Dr. Goff, professor of gynecologic oncology at the University of Washington, Seattle.

"We were quite surprised adherence was that low at centers that write the guidelines," Dr. Powell responded. A higher percentage of referred patients, a lack of information on patients who intentionally decline treatment, and/or less-than-ideal documentation in the database could be contributing factors, he said. "This is obviously a focus for future research."

Patient, tumor, and treatment characteristics were considered in the 5-year survival analysis. "As we all would guess, stage was predictive, with advancing stage [associated] with worse survival," Dr. Powell said. Patients with higher grade cancers also fared worse.

Dr. Powell and his associates also assessed their data according to center volume. For example, in the lowest volume centers (with one to six cases per year), adherence was 40% and median survival was 31 months. At the highest volume centers (with 26 or more cases per year), adherence was 55% and median survival increased to 46 months.

Asked if factors such as increasing age and comorbidity could result in nonadherent, yet appropriate care, Dr. Powell responded. "It’s clear patients with more comorbidities tend to not have NCCN-compliant care." He added, "We want to set a bar and evaluate based on that bar, but it doesn’t mean there cannot be exceptions, patient factors and others.

"We need to measure what we are doing before we can improve," Dr. Powell said. The Society of Gynecologic Oncologists just created a Quality and Data Outcomes Committee designed to assess and measure quality of care as physician performance comes under increased reimbursement pressure in the next few years.

Dr. Powell said he had no relevant disclosures.

ORLANDO – Improper surgery, a lack of lymph node assessment, and improper or no chemotherapy top the list of reasons that women with ovarian cancer do not receive care consistent with National Comprehensive Cancer Network guidelines, according to a study of nearly 100,000 patients.

"Overall, we were quite sad to see that only 43% of patients appear to be receiving care adherent with the NCCN guidelines," Dr. Matthew A. Powell said at this year’s annual meeting of the Society of Gynecologic Oncologists (SGO). "The reasons for nonadherence were mostly surgical in nature."

Dr. Matthew A. Powell

Researchers assessed treatment of 96,802 women diagnosed with invasive epithelial ovarian cancer in the National Cancer Database from 1998 to 2007. They also evaluated mature 5-year survival data from 1998 to 2002.

To determine guideline adherence, Dr. Powell and his associates noted initial surgical procedure and initial front-line chemotherapy. They also assessed compliance by cancer stage, substage, and grade.

The primary reason for nonadherence was a lack of documented omentectomy (54,939 or 57% of the nonadherent cases). "In those patients who did have an omentectomy and stage I to IIIb cancer, we required them to have lymph node assessment," Dr. Powell said. "Unfortunately this also represented a large portion of the nonadherence."

Improper chemotherapy comprised the remainder of nonadherent cases, where patients received single-agent chemotherapy, no chemotherapy, or inappropriate chemotherapy based on cancer stage and grade.

Patients who underwent surgery only (with no evidence of chemotherapy in their records) included a large portion with stage IIIc and IV disease, Dr. Powell said. Only 8% of this cohort received care consistent with the National Comprehensive Cancer Network (NCCN) guidelines.

"One-third of patients had two or three reasons to be nonadherent to the guidelines," said Dr. Powell, who is on the obstetrics and gynecology faculty, Division of Gynecologic Oncology at the Washington University, St. Louis.

The NCCN established the ovarian cancer guidelines in 1997, and they underwent regular revisions, including major updates in 2000 and 2006, Dr. Powell said.

One aim of the study was to determine the validity of NCCN ovarian cancer clinical practice guidelines using a survival comparison. Adherence to the guidelines "does seem to correlate with improved survival and, perhaps, with better quality care. It translates to approximately a 13-month improved median survival for patients who were compliant," Dr. Powell said, adding this difference was "highly statistically significant" (hazard ratio, 1.44).

Adherence and survival correlated across each stage of cancer as well, Dr. Powell said.

During a Q & A session, Dr. Barbara Goff pointed out that some noncompliant care was delivered to patients at one of the 21 major institutions that form the NCCN. "I was surprised that only about 50%-55% of the time were patients at NCCN institutions receiving guideline-based therapy," said Dr. Goff, professor of gynecologic oncology at the University of Washington, Seattle.

"We were quite surprised adherence was that low at centers that write the guidelines," Dr. Powell responded. A higher percentage of referred patients, a lack of information on patients who intentionally decline treatment, and/or less-than-ideal documentation in the database could be contributing factors, he said. "This is obviously a focus for future research."

Patient, tumor, and treatment characteristics were considered in the 5-year survival analysis. "As we all would guess, stage was predictive, with advancing stage [associated] with worse survival," Dr. Powell said. Patients with higher grade cancers also fared worse.

Dr. Powell and his associates also assessed their data according to center volume. For example, in the lowest volume centers (with one to six cases per year), adherence was 40% and median survival was 31 months. At the highest volume centers (with 26 or more cases per year), adherence was 55% and median survival increased to 46 months.

Asked if factors such as increasing age and comorbidity could result in nonadherent, yet appropriate care, Dr. Powell responded. "It’s clear patients with more comorbidities tend to not have NCCN-compliant care." He added, "We want to set a bar and evaluate based on that bar, but it doesn’t mean there cannot be exceptions, patient factors and others.

"We need to measure what we are doing before we can improve," Dr. Powell said. The Society of Gynecologic Oncologists just created a Quality and Data Outcomes Committee designed to assess and measure quality of care as physician performance comes under increased reimbursement pressure in the next few years.

Dr. Powell said he had no relevant disclosures.

ORLANDO – Improper surgery, a lack of lymph node assessment, and improper or no chemotherapy top the list of reasons that women with ovarian cancer do not receive care consistent with National Comprehensive Cancer Network guidelines, according to a study of nearly 100,000 patients.

"Overall, we were quite sad to see that only 43% of patients appear to be receiving care adherent with the NCCN guidelines," Dr. Matthew A. Powell said at this year’s annual meeting of the Society of Gynecologic Oncologists (SGO). "The reasons for nonadherence were mostly surgical in nature."

Dr. Matthew A. Powell

Researchers assessed treatment of 96,802 women diagnosed with invasive epithelial ovarian cancer in the National Cancer Database from 1998 to 2007. They also evaluated mature 5-year survival data from 1998 to 2002.

To determine guideline adherence, Dr. Powell and his associates noted initial surgical procedure and initial front-line chemotherapy. They also assessed compliance by cancer stage, substage, and grade.

The primary reason for nonadherence was a lack of documented omentectomy (54,939 or 57% of the nonadherent cases). "In those patients who did have an omentectomy and stage I to IIIb cancer, we required them to have lymph node assessment," Dr. Powell said. "Unfortunately this also represented a large portion of the nonadherence."

Improper chemotherapy comprised the remainder of nonadherent cases, where patients received single-agent chemotherapy, no chemotherapy, or inappropriate chemotherapy based on cancer stage and grade.

Patients who underwent surgery only (with no evidence of chemotherapy in their records) included a large portion with stage IIIc and IV disease, Dr. Powell said. Only 8% of this cohort received care consistent with the National Comprehensive Cancer Network (NCCN) guidelines.

"One-third of patients had two or three reasons to be nonadherent to the guidelines," said Dr. Powell, who is on the obstetrics and gynecology faculty, Division of Gynecologic Oncology at the Washington University, St. Louis.

The NCCN established the ovarian cancer guidelines in 1997, and they underwent regular revisions, including major updates in 2000 and 2006, Dr. Powell said.

One aim of the study was to determine the validity of NCCN ovarian cancer clinical practice guidelines using a survival comparison. Adherence to the guidelines "does seem to correlate with improved survival and, perhaps, with better quality care. It translates to approximately a 13-month improved median survival for patients who were compliant," Dr. Powell said, adding this difference was "highly statistically significant" (hazard ratio, 1.44).

Adherence and survival correlated across each stage of cancer as well, Dr. Powell said.

During a Q & A session, Dr. Barbara Goff pointed out that some noncompliant care was delivered to patients at one of the 21 major institutions that form the NCCN. "I was surprised that only about 50%-55% of the time were patients at NCCN institutions receiving guideline-based therapy," said Dr. Goff, professor of gynecologic oncology at the University of Washington, Seattle.

"We were quite surprised adherence was that low at centers that write the guidelines," Dr. Powell responded. A higher percentage of referred patients, a lack of information on patients who intentionally decline treatment, and/or less-than-ideal documentation in the database could be contributing factors, he said. "This is obviously a focus for future research."

Patient, tumor, and treatment characteristics were considered in the 5-year survival analysis. "As we all would guess, stage was predictive, with advancing stage [associated] with worse survival," Dr. Powell said. Patients with higher grade cancers also fared worse.

Dr. Powell and his associates also assessed their data according to center volume. For example, in the lowest volume centers (with one to six cases per year), adherence was 40% and median survival was 31 months. At the highest volume centers (with 26 or more cases per year), adherence was 55% and median survival increased to 46 months.

Asked if factors such as increasing age and comorbidity could result in nonadherent, yet appropriate care, Dr. Powell responded. "It’s clear patients with more comorbidities tend to not have NCCN-compliant care." He added, "We want to set a bar and evaluate based on that bar, but it doesn’t mean there cannot be exceptions, patient factors and others.

"We need to measure what we are doing before we can improve," Dr. Powell said. The Society of Gynecologic Oncologists just created a Quality and Data Outcomes Committee designed to assess and measure quality of care as physician performance comes under increased reimbursement pressure in the next few years.

Dr. Powell said he had no relevant disclosures.

ORLANDO – Improper surgery, a lack of lymph node assessment, and improper or no chemotherapy top the list of reasons that women with ovarian cancer do not receive care consistent with National Comprehensive Cancer Network guidelines, according to a study of nearly 100,000 patients.

"Overall, we were quite sad to see that only 43% of patients appear to be receiving care adherent with the NCCN guidelines," Dr. Matthew A. Powell said at this year’s annual meeting of the Society of Gynecologic Oncologists (SGO). "The reasons for nonadherence were mostly surgical in nature."

Dr. Matthew A. Powell

Researchers assessed treatment of 96,802 women diagnosed with invasive epithelial ovarian cancer in the National Cancer Database from 1998 to 2007. They also evaluated mature 5-year survival data from 1998 to 2002.

To determine guideline adherence, Dr. Powell and his associates noted initial surgical procedure and initial front-line chemotherapy. They also assessed compliance by cancer stage, substage, and grade.

The primary reason for nonadherence was a lack of documented omentectomy (54,939 or 57% of the nonadherent cases). "In those patients who did have an omentectomy and stage I to IIIb cancer, we required them to have lymph node assessment," Dr. Powell said. "Unfortunately this also represented a large portion of the nonadherence."

Improper chemotherapy comprised the remainder of nonadherent cases, where patients received single-agent chemotherapy, no chemotherapy, or inappropriate chemotherapy based on cancer stage and grade.

Patients who underwent surgery only (with no evidence of chemotherapy in their records) included a large portion with stage IIIc and IV disease, Dr. Powell said. Only 8% of this cohort received care consistent with the National Comprehensive Cancer Network (NCCN) guidelines.

"One-third of patients had two or three reasons to be nonadherent to the guidelines," said Dr. Powell, who is on the obstetrics and gynecology faculty, Division of Gynecologic Oncology at the Washington University, St. Louis.

The NCCN established the ovarian cancer guidelines in 1997, and they underwent regular revisions, including major updates in 2000 and 2006, Dr. Powell said.

One aim of the study was to determine the validity of NCCN ovarian cancer clinical practice guidelines using a survival comparison. Adherence to the guidelines "does seem to correlate with improved survival and, perhaps, with better quality care. It translates to approximately a 13-month improved median survival for patients who were compliant," Dr. Powell said, adding this difference was "highly statistically significant" (hazard ratio, 1.44).

Adherence and survival correlated across each stage of cancer as well, Dr. Powell said.

During a Q & A session, Dr. Barbara Goff pointed out that some noncompliant care was delivered to patients at one of the 21 major institutions that form the NCCN. "I was surprised that only about 50%-55% of the time were patients at NCCN institutions receiving guideline-based therapy," said Dr. Goff, professor of gynecologic oncology at the University of Washington, Seattle.

"We were quite surprised adherence was that low at centers that write the guidelines," Dr. Powell responded. A higher percentage of referred patients, a lack of information on patients who intentionally decline treatment, and/or less-than-ideal documentation in the database could be contributing factors, he said. "This is obviously a focus for future research."

Patient, tumor, and treatment characteristics were considered in the 5-year survival analysis. "As we all would guess, stage was predictive, with advancing stage [associated] with worse survival," Dr. Powell said. Patients with higher grade cancers also fared worse.

Dr. Powell and his associates also assessed their data according to center volume. For example, in the lowest volume centers (with one to six cases per year), adherence was 40% and median survival was 31 months. At the highest volume centers (with 26 or more cases per year), adherence was 55% and median survival increased to 46 months.

Asked if factors such as increasing age and comorbidity could result in nonadherent, yet appropriate care, Dr. Powell responded. "It’s clear patients with more comorbidities tend to not have NCCN-compliant care." He added, "We want to set a bar and evaluate based on that bar, but it doesn’t mean there cannot be exceptions, patient factors and others.

"We need to measure what we are doing before we can improve," Dr. Powell said. The Society of Gynecologic Oncologists just created a Quality and Data Outcomes Committee designed to assess and measure quality of care as physician performance comes under increased reimbursement pressure in the next few years.

Dr. Powell said he had no relevant disclosures.

ORLANDO – Improper surgery, a lack of lymph node assessment, and improper or no chemotherapy top the list of reasons that women with ovarian cancer do not receive care consistent with National Comprehensive Cancer Network guidelines, according to a study of nearly 100,000 patients.

"Overall, we were quite sad to see that only 43% of patients appear to be receiving care adherent with the NCCN guidelines," Dr. Matthew A. Powell said at this year’s annual meeting of the Society of Gynecologic Oncologists (SGO). "The reasons for nonadherence were mostly surgical in nature."

Dr. Matthew A. Powell

Researchers assessed treatment of 96,802 women diagnosed with invasive epithelial ovarian cancer in the National Cancer Database from 1998 to 2007. They also evaluated mature 5-year survival data from 1998 to 2002.

To determine guideline adherence, Dr. Powell and his associates noted initial surgical procedure and initial front-line chemotherapy. They also assessed compliance by cancer stage, substage, and grade.

The primary reason for nonadherence was a lack of documented omentectomy (54,939 or 57% of the nonadherent cases). "In those patients who did have an omentectomy and stage I to IIIb cancer, we required them to have lymph node assessment," Dr. Powell said. "Unfortunately this also represented a large portion of the nonadherence."

Improper chemotherapy comprised the remainder of nonadherent cases, where patients received single-agent chemotherapy, no chemotherapy, or inappropriate chemotherapy based on cancer stage and grade.

Patients who underwent surgery only (with no evidence of chemotherapy in their records) included a large portion with stage IIIc and IV disease, Dr. Powell said. Only 8% of this cohort received care consistent with the National Comprehensive Cancer Network (NCCN) guidelines.

"One-third of patients had two or three reasons to be nonadherent to the guidelines," said Dr. Powell, who is on the obstetrics and gynecology faculty, Division of Gynecologic Oncology at the Washington University, St. Louis.

The NCCN established the ovarian cancer guidelines in 1997, and they underwent regular revisions, including major updates in 2000 and 2006, Dr. Powell said.

One aim of the study was to determine the validity of NCCN ovarian cancer clinical practice guidelines using a survival comparison. Adherence to the guidelines "does seem to correlate with improved survival and, perhaps, with better quality care. It translates to approximately a 13-month improved median survival for patients who were compliant," Dr. Powell said, adding this difference was "highly statistically significant" (hazard ratio, 1.44).

Adherence and survival correlated across each stage of cancer as well, Dr. Powell said.

During a Q & A session, Dr. Barbara Goff pointed out that some noncompliant care was delivered to patients at one of the 21 major institutions that form the NCCN. "I was surprised that only about 50%-55% of the time were patients at NCCN institutions receiving guideline-based therapy," said Dr. Goff, professor of gynecologic oncology at the University of Washington, Seattle.

"We were quite surprised adherence was that low at centers that write the guidelines," Dr. Powell responded. A higher percentage of referred patients, a lack of information on patients who intentionally decline treatment, and/or less-than-ideal documentation in the database could be contributing factors, he said. "This is obviously a focus for future research."

Patient, tumor, and treatment characteristics were considered in the 5-year survival analysis. "As we all would guess, stage was predictive, with advancing stage [associated] with worse survival," Dr. Powell said. Patients with higher grade cancers also fared worse.

Dr. Powell and his associates also assessed their data according to center volume. For example, in the lowest volume centers (with one to six cases per year), adherence was 40% and median survival was 31 months. At the highest volume centers (with 26 or more cases per year), adherence was 55% and median survival increased to 46 months.

Asked if factors such as increasing age and comorbidity could result in nonadherent, yet appropriate care, Dr. Powell responded. "It’s clear patients with more comorbidities tend to not have NCCN-compliant care." He added, "We want to set a bar and evaluate based on that bar, but it doesn’t mean there cannot be exceptions, patient factors and others.

"We need to measure what we are doing before we can improve," Dr. Powell said. The Society of Gynecologic Oncologists just created a Quality and Data Outcomes Committee designed to assess and measure quality of care as physician performance comes under increased reimbursement pressure in the next few years.

Dr. Powell said he had no relevant disclosures.

ORLANDO – Improper surgery, a lack of lymph node assessment, and improper or no chemotherapy top the list of reasons that women with ovarian cancer do not receive care consistent with National Comprehensive Cancer Network guidelines, according to a study of nearly 100,000 patients.

"Overall, we were quite sad to see that only 43% of patients appear to be receiving care adherent with the NCCN guidelines," Dr. Matthew A. Powell said at this year’s annual meeting of the Society of Gynecologic Oncologists (SGO). "The reasons for nonadherence were mostly surgical in nature."

Dr. Matthew A. Powell

Researchers assessed treatment of 96,802 women diagnosed with invasive epithelial ovarian cancer in the National Cancer Database from 1998 to 2007. They also evaluated mature 5-year survival data from 1998 to 2002.

To determine guideline adherence, Dr. Powell and his associates noted initial surgical procedure and initial front-line chemotherapy. They also assessed compliance by cancer stage, substage, and grade.

The primary reason for nonadherence was a lack of documented omentectomy (54,939 or 57% of the nonadherent cases). "In those patients who did have an omentectomy and stage I to IIIb cancer, we required them to have lymph node assessment," Dr. Powell said. "Unfortunately this also represented a large portion of the nonadherence."

Improper chemotherapy comprised the remainder of nonadherent cases, where patients received single-agent chemotherapy, no chemotherapy, or inappropriate chemotherapy based on cancer stage and grade.

Patients who underwent surgery only (with no evidence of chemotherapy in their records) included a large portion with stage IIIc and IV disease, Dr. Powell said. Only 8% of this cohort received care consistent with the National Comprehensive Cancer Network (NCCN) guidelines.

"One-third of patients had two or three reasons to be nonadherent to the guidelines," said Dr. Powell, who is on the obstetrics and gynecology faculty, Division of Gynecologic Oncology at the Washington University, St. Louis.

The NCCN established the ovarian cancer guidelines in 1997, and they underwent regular revisions, including major updates in 2000 and 2006, Dr. Powell said.

One aim of the study was to determine the validity of NCCN ovarian cancer clinical practice guidelines using a survival comparison. Adherence to the guidelines "does seem to correlate with improved survival and, perhaps, with better quality care. It translates to approximately a 13-month improved median survival for patients who were compliant," Dr. Powell said, adding this difference was "highly statistically significant" (hazard ratio, 1.44).

Adherence and survival correlated across each stage of cancer as well, Dr. Powell said.

During a Q & A session, Dr. Barbara Goff pointed out that some noncompliant care was delivered to patients at one of the 21 major institutions that form the NCCN. "I was surprised that only about 50%-55% of the time were patients at NCCN institutions receiving guideline-based therapy," said Dr. Goff, professor of gynecologic oncology at the University of Washington, Seattle.

"We were quite surprised adherence was that low at centers that write the guidelines," Dr. Powell responded. A higher percentage of referred patients, a lack of information on patients who intentionally decline treatment, and/or less-than-ideal documentation in the database could be contributing factors, he said. "This is obviously a focus for future research."

Patient, tumor, and treatment characteristics were considered in the 5-year survival analysis. "As we all would guess, stage was predictive, with advancing stage [associated] with worse survival," Dr. Powell said. Patients with higher grade cancers also fared worse.

Dr. Powell and his associates also assessed their data according to center volume. For example, in the lowest volume centers (with one to six cases per year), adherence was 40% and median survival was 31 months. At the highest volume centers (with 26 or more cases per year), adherence was 55% and median survival increased to 46 months.

Asked if factors such as increasing age and comorbidity could result in nonadherent, yet appropriate care, Dr. Powell responded. "It’s clear patients with more comorbidities tend to not have NCCN-compliant care." He added, "We want to set a bar and evaluate based on that bar, but it doesn’t mean there cannot be exceptions, patient factors and others.

"We need to measure what we are doing before we can improve," Dr. Powell said. The Society of Gynecologic Oncologists just created a Quality and Data Outcomes Committee designed to assess and measure quality of care as physician performance comes under increased reimbursement pressure in the next few years.

Dr. Powell said he had no relevant disclosures.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

BOCA RATON, FLA. – Researchers at the National Institute on Drug Abuse are conferring on concise, standard screening questions that psychiatrists, primary care physicians, and other clinicians can use to identify patients with substance use disorders.

As part of the Affordable Care Act, the agency is devising a standard core set of screening questions to identify patients with drug, alcohol, and/or tobacco use disorders.

The screen will be incorporated into a national electronic health record system, Dr. Robert W. Lindblad said at the meeting.

The aim is to develop a concise set of questions for quick identification in primary care settings, as well as a larger number of more comprehensive questions for screening and treatment in substance disorder treatment settings. "Our efforts here go beyond identification but also to characterize, treat, and/or refer," he said.

"Some of your early feedback is: You cannot look at drugs if you are not looking at alcohol also. Then you have to ask about tobacco also. Being able to ask about all three areas is important," said Dr. Lindblad, a contractor for the National Institute on Drug Abuse (NIDA) and chief medical officer of Emmes Corp. in Rockville, Md.

Researchers began this initiative by looking at existing systems. "There wasn’t really anything out there for us," Dr. Lindblad said. "The VA has a great system, Kaiser has a great system, but the VA and Kaiser systems don’t talk to each other." So researchers started development of "common data elements" that any electronic health record system could incorporate, he said.

"Regarding common data elements ... we are probably creating a lot of these," said Robert Gore-Langton, Ph.D., an Emmes employee who manages the NIDA Clinical Trials Network Data and Statistics Center 2.

Screening questions are likely to address mental health, addiction history and status, addiction treatment history and status, family and social support, and legal and criminal status.

A person attending the meeting asked whether patients will complete questionnaires online before an appointment or in a physician’s office. "That is still unclear," Dr. Gore-Langton replied. "It will probably be filled out before patients see the doctor, maybe on a tablet. It will be the same as information on forms patients fill out in an office [historically], but done electronically."

If patients answer no to all core screening questions, they will be finished. If they respond yes to one or more questions, it will prompt the system to ask subsequent queries.

Emmes Corp. is a NIDA Clinical Trial Network Clinical Coordinating Center.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

NAPLES, FLA. – Presence of metabolic syndrome is a risk factor for poor outcomes during superficial femoral artery interventions, according to a retrospective database study.

Although approximately half of patients with peripheral artery disease also have metabolic syndrome, its impact on peripheral interventions is not unknown, Dr. Christopher J. Smolock said at the annual meeting of the Southern Association for Vascular Surgery.

To find out more, Dr. Smolock and his associates reviewed a database of 870 patients who underwent endovascular treatment for symptomatic superficial femoral artery (SFA) disease. In this study, 46% of patients met criteria for metabolic syndrome, the average age was 67 years, and 64% were men.

A total 1,006 limbs of these patients were treated between 1999 and 2009 at the DeBakey Heart and Vascular Center at the Methodist Hospital in Houston. The researchers compared patient factors at presentation and outcomes between patients without metabolic syndrome (542 treated limbs) and patients with the syndrome (464 treated limbs).

Limbs in the metabolic syndrome group were significantly more likely to come from women (44% vs. 31%), to come from patients with critical ischemia symptoms of pain at rest and tissue loss (54% vs. 38%), and to feature more advanced SFA lesions (51% vs. 31%), compared with limbs in the group without metabolic syndrome.

Claudication was a presentation for 46% of the limbs in the group with metabolic syndrome versus 62% of limbs in the non–metabolic syndrome group.

The investigators compared 30-day mortality and morbidity between these groups. In addition, they assessed the 5-year rates for primary and secondary patency; freedom from recurrent symptoms; and limb salvage. “We wanted to look at metabolic syndrome’s effect on these outcomes,” said Dr. Smolock of the DeBakey Heart and Vascular Center.

“This addresses the important topic of outcomes with SFA interventions in those with metabolic syndrome,” said study discussant Dr. Scott L. Stevens. “Of note, mortality was not increased among those with metabolic syndrome.” Dr. Stevens is a vascular surgeon at the University of Tennessee Medical Center in Knoxville.

There was no significant difference in 30-day mortality: 0.2% in the metabolic syndrome group and the 1.3% in the nonsyndrome group.

A lower percentage of the metabolic syndrome group, 67% vs. 73%, experienced freedom from recurrent symptoms over 5 years.

“Primary patency decreased as well significantly over 5 years in those with metabolic syndrome,” Dr. Smolock said. The study revealed 56% of the metabolic syndrome group had 5-year primary patency, compared with 66% in unaffected group; 71% vs. 78% had assisted primary patency; and 71% vs. 78% had secondary patency. Secondary patency decreased also, but there was no significant difference between groups, he added.

Because critical ischemia more often affected the group with metabolic syndrome, the rate of limb amputation was higher in this group (22% versus 13% of the unaffected group at 5 years).

Dr. Stevens asked why the metabolic group experienced significantly higher morbidity but not mortality, compared with the unaffected group. This might be because the mortality figures were calculated for only the first 30 days and not over the 5 years, Dr. Smolock said. In addition, the low 30-day mortality “could speak to this being a local procedure, not [one] done under general anesthesia.” He added, “I hope some of that has to do with our risk-reduction strategies preoperatively.”

“What changes have you made in your practice to reduce risk factors in those patients with metabolic syndrome?” Dr. Stevens asked.

“Our beta blocker, statin, and aspirin use were not at levels we wanted,” Dr. Smolock replied. So use of these agents is now prescribed for all patients without a contraindication, he said.

Dr. Stevens also asked if metabolic syndrome might just be a surrogate for patients with smaller arteries and/or more plaque. “I don’t think this is because of small or poor targets,” Dr. Smolock said. “The SVS [Society for Vascular Surgery] runoff score was equal between the groups. Diabetes is a risk in and of itself for small or poor targets, but it’s not something we could see anatomically.”

Metabolic syndrome was defined in this study using the National Heart, Lung and Blood Institute/American Heart Association criteria. Therefore, patients had to have three or more of the following: systolic blood pressure of 130 mm Hg or greater/diastolic blood pressure of 85 mm Hg or greater; triglycerides of 150 mg/dL or greater; HDL cholesterol of 50 mg/dL or lower for women or 40 mg/dL or lower for men; fasting blood glucose of 110 mg/dL or greater; or body mass index of 30 kg/m2 or greater.

Dr. Smolock said that he had no relevant disclosures.

NAPLES, FLA. – Presence of metabolic syndrome is a risk factor for poor outcomes during superficial femoral artery interventions, according to a retrospective database study.

Although approximately half of patients with peripheral artery disease also have metabolic syndrome, its impact on peripheral interventions is not unknown, Dr. Christopher J. Smolock said at the annual meeting of the Southern Association for Vascular Surgery.

To find out more, Dr. Smolock and his associates reviewed a database of 870 patients who underwent endovascular treatment for symptomatic superficial femoral artery (SFA) disease. In this study, 46% of patients met criteria for metabolic syndrome, the average age was 67 years, and 64% were men.

A total 1,006 limbs of these patients were treated between 1999 and 2009 at the DeBakey Heart and Vascular Center at the Methodist Hospital in Houston. The researchers compared patient factors at presentation and outcomes between patients without metabolic syndrome (542 treated limbs) and patients with the syndrome (464 treated limbs).

Limbs in the metabolic syndrome group were significantly more likely to come from women (44% vs. 31%), to come from patients with critical ischemia symptoms of pain at rest and tissue loss (54% vs. 38%), and to feature more advanced SFA lesions (51% vs. 31%), compared with limbs in the group without metabolic syndrome.

Claudication was a presentation for 46% of the limbs in the group with metabolic syndrome versus 62% of limbs in the non–metabolic syndrome group.

The investigators compared 30-day mortality and morbidity between these groups. In addition, they assessed the 5-year rates for primary and secondary patency; freedom from recurrent symptoms; and limb salvage. “We wanted to look at metabolic syndrome’s effect on these outcomes,” said Dr. Smolock of the DeBakey Heart and Vascular Center.

“This addresses the important topic of outcomes with SFA interventions in those with metabolic syndrome,” said study discussant Dr. Scott L. Stevens. “Of note, mortality was not increased among those with metabolic syndrome.” Dr. Stevens is a vascular surgeon at the University of Tennessee Medical Center in Knoxville.

There was no significant difference in 30-day mortality: 0.2% in the metabolic syndrome group and the 1.3% in the nonsyndrome group.

A lower percentage of the metabolic syndrome group, 67% vs. 73%, experienced freedom from recurrent symptoms over 5 years.

“Primary patency decreased as well significantly over 5 years in those with metabolic syndrome,” Dr. Smolock said. The study revealed 56% of the metabolic syndrome group had 5-year primary patency, compared with 66% in unaffected group; 71% vs. 78% had assisted primary patency; and 71% vs. 78% had secondary patency. Secondary patency decreased also, but there was no significant difference between groups, he added.

Because critical ischemia more often affected the group with metabolic syndrome, the rate of limb amputation was higher in this group (22% versus 13% of the unaffected group at 5 years).

Dr. Stevens asked why the metabolic group experienced significantly higher morbidity but not mortality, compared with the unaffected group. This might be because the mortality figures were calculated for only the first 30 days and not over the 5 years, Dr. Smolock said. In addition, the low 30-day mortality “could speak to this being a local procedure, not [one] done under general anesthesia.” He added, “I hope some of that has to do with our risk-reduction strategies preoperatively.”

“What changes have you made in your practice to reduce risk factors in those patients with metabolic syndrome?” Dr. Stevens asked.

“Our beta blocker, statin, and aspirin use were not at levels we wanted,” Dr. Smolock replied. So use of these agents is now prescribed for all patients without a contraindication, he said.

Dr. Stevens also asked if metabolic syndrome might just be a surrogate for patients with smaller arteries and/or more plaque. “I don’t think this is because of small or poor targets,” Dr. Smolock said. “The SVS [Society for Vascular Surgery] runoff score was equal between the groups. Diabetes is a risk in and of itself for small or poor targets, but it’s not something we could see anatomically.”

Metabolic syndrome was defined in this study using the National Heart, Lung and Blood Institute/American Heart Association criteria. Therefore, patients had to have three or more of the following: systolic blood pressure of 130 mm Hg or greater/diastolic blood pressure of 85 mm Hg or greater; triglycerides of 150 mg/dL or greater; HDL cholesterol of 50 mg/dL or lower for women or 40 mg/dL or lower for men; fasting blood glucose of 110 mg/dL or greater; or body mass index of 30 kg/m2 or greater.

Dr. Smolock said that he had no relevant disclosures.

NAPLES, FLA. – Presence of metabolic syndrome is a risk factor for poor outcomes during superficial femoral artery interventions, according to a retrospective database study.

Although approximately half of patients with peripheral artery disease also have metabolic syndrome, its impact on peripheral interventions is not unknown, Dr. Christopher J. Smolock said at the annual meeting of the Southern Association for Vascular Surgery.

To find out more, Dr. Smolock and his associates reviewed a database of 870 patients who underwent endovascular treatment for symptomatic superficial femoral artery (SFA) disease. In this study, 46% of patients met criteria for metabolic syndrome, the average age was 67 years, and 64% were men.

A total 1,006 limbs of these patients were treated between 1999 and 2009 at the DeBakey Heart and Vascular Center at the Methodist Hospital in Houston. The researchers compared patient factors at presentation and outcomes between patients without metabolic syndrome (542 treated limbs) and patients with the syndrome (464 treated limbs).

Limbs in the metabolic syndrome group were significantly more likely to come from women (44% vs. 31%), to come from patients with critical ischemia symptoms of pain at rest and tissue loss (54% vs. 38%), and to feature more advanced SFA lesions (51% vs. 31%), compared with limbs in the group without metabolic syndrome.

Claudication was a presentation for 46% of the limbs in the group with metabolic syndrome versus 62% of limbs in the non–metabolic syndrome group.

The investigators compared 30-day mortality and morbidity between these groups. In addition, they assessed the 5-year rates for primary and secondary patency; freedom from recurrent symptoms; and limb salvage. “We wanted to look at metabolic syndrome’s effect on these outcomes,” said Dr. Smolock of the DeBakey Heart and Vascular Center.

“This addresses the important topic of outcomes with SFA interventions in those with metabolic syndrome,” said study discussant Dr. Scott L. Stevens. “Of note, mortality was not increased among those with metabolic syndrome.” Dr. Stevens is a vascular surgeon at the University of Tennessee Medical Center in Knoxville.

There was no significant difference in 30-day mortality: 0.2% in the metabolic syndrome group and the 1.3% in the nonsyndrome group.

A lower percentage of the metabolic syndrome group, 67% vs. 73%, experienced freedom from recurrent symptoms over 5 years.

“Primary patency decreased as well significantly over 5 years in those with metabolic syndrome,” Dr. Smolock said. The study revealed 56% of the metabolic syndrome group had 5-year primary patency, compared with 66% in unaffected group; 71% vs. 78% had assisted primary patency; and 71% vs. 78% had secondary patency. Secondary patency decreased also, but there was no significant difference between groups, he added.

Because critical ischemia more often affected the group with metabolic syndrome, the rate of limb amputation was higher in this group (22% versus 13% of the unaffected group at 5 years).

Dr. Stevens asked why the metabolic group experienced significantly higher morbidity but not mortality, compared with the unaffected group. This might be because the mortality figures were calculated for only the first 30 days and not over the 5 years, Dr. Smolock said. In addition, the low 30-day mortality “could speak to this being a local procedure, not [one] done under general anesthesia.” He added, “I hope some of that has to do with our risk-reduction strategies preoperatively.”

“What changes have you made in your practice to reduce risk factors in those patients with metabolic syndrome?” Dr. Stevens asked.

“Our beta blocker, statin, and aspirin use were not at levels we wanted,” Dr. Smolock replied. So use of these agents is now prescribed for all patients without a contraindication, he said.

Dr. Stevens also asked if metabolic syndrome might just be a surrogate for patients with smaller arteries and/or more plaque. “I don’t think this is because of small or poor targets,” Dr. Smolock said. “The SVS [Society for Vascular Surgery] runoff score was equal between the groups. Diabetes is a risk in and of itself for small or poor targets, but it’s not something we could see anatomically.”

Metabolic syndrome was defined in this study using the National Heart, Lung and Blood Institute/American Heart Association criteria. Therefore, patients had to have three or more of the following: systolic blood pressure of 130 mm Hg or greater/diastolic blood pressure of 85 mm Hg or greater; triglycerides of 150 mg/dL or greater; HDL cholesterol of 50 mg/dL or lower for women or 40 mg/dL or lower for men; fasting blood glucose of 110 mg/dL or greater; or body mass index of 30 kg/m2 or greater.

Dr. Smolock said that he had no relevant disclosures.

MIAMI BEACH – Sublative skin rejuvenation is a resurfacing technology that seeks to provide the best of both worlds – efficacy closer to more intensive ablative procedures and an adverse event profile more akin to gentler, nonablative techniques.

Sublative rejuvenation can be performed on the full face, with good results around the eyes and the neck, Dr. Robert A. Weiss said at the symposium.

"We've gotten some very nice skin contraction and smoothing in the periorbital area," he said.

The fractional radiofrequency eMatrix system (Syneron) offers deep volumetric heating into the dermis with minimal epidermal disruption, said Dr. Weiss, director of the Maryland Laser, Skin, and Vein Institute in Hunt Valley. Subsequent dermal remodeling with minimal downtime are other advantages of this treatment.

The Food and Drug Administration cleared marketing of the applicator for use in dermatologic procedures requiring ablation of soft tissue and skin resurfacing.

The device tip is a grid of negatively- and positively-charged electrodes between which bipolar radiofrequency energy flows. The current can be controlled and varied depending on individual patient factors. Because this is a fractional technology, intact tissue is left between the electrode pins to speed healing and recovery.

The standard protocol is three to four treatment sessions spaced 4-6 weeks apart. Touch-up sessions, as indicated, are generally every 6 months or so.

The full face can be treated in 20 minutes, said Dr. Weiss, also of the department of dermatology at Johns Hopkins University, Baltimore. Improvements in acne scarring and wrinkles can be observed as well.

Ask patients to return 2-3 days after treatment to check for any adverse events, he said. Postoperative discomfort, significant pain, erythema, edema, and pigmentary changes can arise in the short or long term. Patient discomfort is usually tolerable and can be managed with topical anesthetics.

Postprocedure redness with nonablative techniques typically lasts a few hours to 1-2 days; with ablative procedures, 5-7 days (and sometimes up to 10 days); and with sublative treatment, a patient will have red dots on their skin and redness that lasts for a day or 2, Dr. Weiss said. "So it's really somewhere in the middle between ablative and nonablative."

Contraindications include any facelift or eyelid surgery 1 year prior to sublative resurfacing; injections of botulinum toxin, collagen, or fat (or any biomaterial augmentation) within the last 6 months; and any facial dermabrasion, resurfacing, or deep chemical peeling within the last 3 months.

Treat a hidden test spot to gauge individual response prior to full treatment, Dr. Weiss recommended. Gauge response after 24-48 hours for skin types I-III and 5-7 days for skin types IV-VI to ensure safety.

Cold packs or Synercool (Syneron) can be used immediately after treatment to cool the area if patients are uncomfortable. Advise patients to apply emollient cream and to use at least 30 SPF or greater sunscreen for at least a month.

"It's a promising technology, and I think we will know more a year from now," Dr. Weiss said.

He is a researcher for Syneron and received some initial free use of equipment.

MIAMI BEACH – Sublative skin rejuvenation is a resurfacing technology that seeks to provide the best of both worlds – efficacy closer to more intensive ablative procedures and an adverse event profile more akin to gentler, nonablative techniques.

Sublative rejuvenation can be performed on the full face, with good results around the eyes and the neck, Dr. Robert A. Weiss said at the symposium.

"We've gotten some very nice skin contraction and smoothing in the periorbital area," he said.

The fractional radiofrequency eMatrix system (Syneron) offers deep volumetric heating into the dermis with minimal epidermal disruption, said Dr. Weiss, director of the Maryland Laser, Skin, and Vein Institute in Hunt Valley. Subsequent dermal remodeling with minimal downtime are other advantages of this treatment.

The Food and Drug Administration cleared marketing of the applicator for use in dermatologic procedures requiring ablation of soft tissue and skin resurfacing.

The device tip is a grid of negatively- and positively-charged electrodes between which bipolar radiofrequency energy flows. The current can be controlled and varied depending on individual patient factors. Because this is a fractional technology, intact tissue is left between the electrode pins to speed healing and recovery.

The standard protocol is three to four treatment sessions spaced 4-6 weeks apart. Touch-up sessions, as indicated, are generally every 6 months or so.

The full face can be treated in 20 minutes, said Dr. Weiss, also of the department of dermatology at Johns Hopkins University, Baltimore. Improvements in acne scarring and wrinkles can be observed as well.

Ask patients to return 2-3 days after treatment to check for any adverse events, he said. Postoperative discomfort, significant pain, erythema, edema, and pigmentary changes can arise in the short or long term. Patient discomfort is usually tolerable and can be managed with topical anesthetics.

Postprocedure redness with nonablative techniques typically lasts a few hours to 1-2 days; with ablative procedures, 5-7 days (and sometimes up to 10 days); and with sublative treatment, a patient will have red dots on their skin and redness that lasts for a day or 2, Dr. Weiss said. "So it's really somewhere in the middle between ablative and nonablative."

Contraindications include any facelift or eyelid surgery 1 year prior to sublative resurfacing; injections of botulinum toxin, collagen, or fat (or any biomaterial augmentation) within the last 6 months; and any facial dermabrasion, resurfacing, or deep chemical peeling within the last 3 months.

Treat a hidden test spot to gauge individual response prior to full treatment, Dr. Weiss recommended. Gauge response after 24-48 hours for skin types I-III and 5-7 days for skin types IV-VI to ensure safety.

Cold packs or Synercool (Syneron) can be used immediately after treatment to cool the area if patients are uncomfortable. Advise patients to apply emollient cream and to use at least 30 SPF or greater sunscreen for at least a month.

"It's a promising technology, and I think we will know more a year from now," Dr. Weiss said.

He is a researcher for Syneron and received some initial free use of equipment.

MIAMI BEACH – Sublative skin rejuvenation is a resurfacing technology that seeks to provide the best of both worlds – efficacy closer to more intensive ablative procedures and an adverse event profile more akin to gentler, nonablative techniques.

Sublative rejuvenation can be performed on the full face, with good results around the eyes and the neck, Dr. Robert A. Weiss said at the symposium.

"We've gotten some very nice skin contraction and smoothing in the periorbital area," he said.

The fractional radiofrequency eMatrix system (Syneron) offers deep volumetric heating into the dermis with minimal epidermal disruption, said Dr. Weiss, director of the Maryland Laser, Skin, and Vein Institute in Hunt Valley. Subsequent dermal remodeling with minimal downtime are other advantages of this treatment.

The Food and Drug Administration cleared marketing of the applicator for use in dermatologic procedures requiring ablation of soft tissue and skin resurfacing.

The device tip is a grid of negatively- and positively-charged electrodes between which bipolar radiofrequency energy flows. The current can be controlled and varied depending on individual patient factors. Because this is a fractional technology, intact tissue is left between the electrode pins to speed healing and recovery.

The standard protocol is three to four treatment sessions spaced 4-6 weeks apart. Touch-up sessions, as indicated, are generally every 6 months or so.

The full face can be treated in 20 minutes, said Dr. Weiss, also of the department of dermatology at Johns Hopkins University, Baltimore. Improvements in acne scarring and wrinkles can be observed as well.

Ask patients to return 2-3 days after treatment to check for any adverse events, he said. Postoperative discomfort, significant pain, erythema, edema, and pigmentary changes can arise in the short or long term. Patient discomfort is usually tolerable and can be managed with topical anesthetics.

Postprocedure redness with nonablative techniques typically lasts a few hours to 1-2 days; with ablative procedures, 5-7 days (and sometimes up to 10 days); and with sublative treatment, a patient will have red dots on their skin and redness that lasts for a day or 2, Dr. Weiss said. "So it's really somewhere in the middle between ablative and nonablative."

Contraindications include any facelift or eyelid surgery 1 year prior to sublative resurfacing; injections of botulinum toxin, collagen, or fat (or any biomaterial augmentation) within the last 6 months; and any facial dermabrasion, resurfacing, or deep chemical peeling within the last 3 months.

Treat a hidden test spot to gauge individual response prior to full treatment, Dr. Weiss recommended. Gauge response after 24-48 hours for skin types I-III and 5-7 days for skin types IV-VI to ensure safety.

Cold packs or Synercool (Syneron) can be used immediately after treatment to cool the area if patients are uncomfortable. Advise patients to apply emollient cream and to use at least 30 SPF or greater sunscreen for at least a month.

"It's a promising technology, and I think we will know more a year from now," Dr. Weiss said.

He is a researcher for Syneron and received some initial free use of equipment.