Don't Screen Healthy Women for Ovarian Cancer

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Don't Screen Healthy Women for Ovarian Cancer

Clinicians need not screen women for ovarian cancer if they are otherwise healthy and have no known genetic mutations, such as BRCA1 or BRCA2 that could increase their ovarian cancer risk, according to a recommendation from the U.S. Preventive Services Task Force published online in the Annals of Internal Medicine and on the USPSTF website on Sept. 11.

After reviewing data from randomized, controlled trials between 2008 and 2011, a USPSTF Task Force determined that the number of deaths from ovarian cancer in U.S. women was not significantly reduced by annual screening with transvaginal ultrasound and serum CA-125 testing.

Monkey Business/Thinkstock.com
New data show that young women do not need to be screened for ovarian cancer, if they are otherwise healthy and have no known genetic mutations that could increase their risk for ovarian cancer.

In addition, the data revealed a high rate of false-positive results in asymptomatic women, who then may undergo unnecessary surgery and other harm, the USPSTF said in its statement.

In the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a randomized, controlled trial of 78,216 women in the United States, there was no significant difference in the number of ovarian cancer cases diagnosed in women randomized to annual screening vs. usual care (212 vs. 176) over 13 years. No significant differences were seen in the number of cancer deaths between the two groups. One-third of the women with false-positive results underwent oophorectomies, with nearly 21 major complications per 100 surgeries performed on the basis of false-positive results.

Data from another recent trial, the Shizuoka Cohort Study of Ovarian Cancer Screening, suggested that approximately 33 surgeries would be needed to diagnose 1 case of ovarian cancer detected by routine screening. More data are pending from an ongoing trial, the U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

Based on the available data, "There is adequate evidence that there is no mortality benefit to routine screening for ovarian cancer with transvaginal ultrasonography or single-threshold serum CA-125 testing, and that the harms of such screening are at least moderate," according to the USPSTF.

"Final results from UKCTOCS should provide more information about the relative benefits and harms of an algorithm-based approach to screening for ovarian cancer," the Task Force stated.

Neither the American Cancer Society nor the American College of Obstetricians and Gynecologists recommend screening asymptomatic, average-risk women for ovarian cancer, according to a USPSTF press release about the new recommendation.

The recommendation is a grade D, which the USPSTF defines as "moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," and providers therefore are discouraged from using the service.

This recommendation does not apply to women who are considered at high risk for ovarian cancer. Populations at increased risk of developing ovarian cancer include women with BRCA1 and BRCA2 genetic mutations, Lynch syndrome (hereditary nonpolyposis colon cancer), or a family history of ovarian cancer. A family history "generally means having two or more first- or second-degree relatives with a history of ovarian cancer or a combination of breast and ovarian cancer; for women of Ashkenazi Jewish heritage, it means having a first-degree relative (or two second-degree relatives on the same side of the family) with breast or ovarian cancer," according to the USPSTF statement.

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As one of the top five leading causes of cancer death among women, it is important that methods of screening and early detection of ovarian cancer be continually evaluated. Because of the lack of symptoms until metastatic disease is present, the majority of women are diagnosed with advanced-stage (stage IIIC) disease. For this reason, it is important that screening focus on asymptomatic women in an attempt to diagnose at an earlier stage and thus provide an opportunity for improved survival, according to Dr. Georgia A. McCann and Dr. Ritu Salani.

Based on the evidence reviewed, the USPSTF recommendation against screening asymptomatic women with CA-125 and pelvic ultrasound is valid and should be considered definitive. Furthermore, these recommendations reiterate the results of previous studies and, once again, report that screening does not provide an improvement in the detection of early-stage disease or translate to a survival advantage. Thus, screening asymptomatic women with current technologies does little more than provide false reassurance for women with normal findings and result in potentially unnecessary surgery (with a high complication rate) in women with abnormal findings.

However, the lack of screening tests amplifies the importance of asking patients about possible genetic predisposition by obtaining a thorough family history, as well as reviewing ovarian cancer symptoms such as abdominal bloating, abdominal/pelvic pain, early satiety, and changes in bowel/bladder function. If patients are found to be high risk or symptomatic, it is imperative that we, as health care providers, engage in the appropriate evaluation and management.

Given the morbidity and mortality of this disease, it is vital that research continues on the early detection of ovarian cancer. New biomarkers, improvements in imaging, and an enhanced understanding of genetics may allow for better screening methods to be evaluated soon. In the interim, providers should be aware of the pitfalls of ovarian cancer screening and continue to educate patients on the symptoms of ovarian cancer.

Dr McCann and Dr. Salani of the division of gynecologic oncology, department of obstetrics and gynecology at the Ohio State University, Columbus, commented on the USPSTF findings. They said they had no relevant financial disclosures.

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Body

As one of the top five leading causes of cancer death among women, it is important that methods of screening and early detection of ovarian cancer be continually evaluated. Because of the lack of symptoms until metastatic disease is present, the majority of women are diagnosed with advanced-stage (stage IIIC) disease. For this reason, it is important that screening focus on asymptomatic women in an attempt to diagnose at an earlier stage and thus provide an opportunity for improved survival, according to Dr. Georgia A. McCann and Dr. Ritu Salani.

Based on the evidence reviewed, the USPSTF recommendation against screening asymptomatic women with CA-125 and pelvic ultrasound is valid and should be considered definitive. Furthermore, these recommendations reiterate the results of previous studies and, once again, report that screening does not provide an improvement in the detection of early-stage disease or translate to a survival advantage. Thus, screening asymptomatic women with current technologies does little more than provide false reassurance for women with normal findings and result in potentially unnecessary surgery (with a high complication rate) in women with abnormal findings.

However, the lack of screening tests amplifies the importance of asking patients about possible genetic predisposition by obtaining a thorough family history, as well as reviewing ovarian cancer symptoms such as abdominal bloating, abdominal/pelvic pain, early satiety, and changes in bowel/bladder function. If patients are found to be high risk or symptomatic, it is imperative that we, as health care providers, engage in the appropriate evaluation and management.

Given the morbidity and mortality of this disease, it is vital that research continues on the early detection of ovarian cancer. New biomarkers, improvements in imaging, and an enhanced understanding of genetics may allow for better screening methods to be evaluated soon. In the interim, providers should be aware of the pitfalls of ovarian cancer screening and continue to educate patients on the symptoms of ovarian cancer.

Dr McCann and Dr. Salani of the division of gynecologic oncology, department of obstetrics and gynecology at the Ohio State University, Columbus, commented on the USPSTF findings. They said they had no relevant financial disclosures.

Body

As one of the top five leading causes of cancer death among women, it is important that methods of screening and early detection of ovarian cancer be continually evaluated. Because of the lack of symptoms until metastatic disease is present, the majority of women are diagnosed with advanced-stage (stage IIIC) disease. For this reason, it is important that screening focus on asymptomatic women in an attempt to diagnose at an earlier stage and thus provide an opportunity for improved survival, according to Dr. Georgia A. McCann and Dr. Ritu Salani.

Based on the evidence reviewed, the USPSTF recommendation against screening asymptomatic women with CA-125 and pelvic ultrasound is valid and should be considered definitive. Furthermore, these recommendations reiterate the results of previous studies and, once again, report that screening does not provide an improvement in the detection of early-stage disease or translate to a survival advantage. Thus, screening asymptomatic women with current technologies does little more than provide false reassurance for women with normal findings and result in potentially unnecessary surgery (with a high complication rate) in women with abnormal findings.

However, the lack of screening tests amplifies the importance of asking patients about possible genetic predisposition by obtaining a thorough family history, as well as reviewing ovarian cancer symptoms such as abdominal bloating, abdominal/pelvic pain, early satiety, and changes in bowel/bladder function. If patients are found to be high risk or symptomatic, it is imperative that we, as health care providers, engage in the appropriate evaluation and management.

Given the morbidity and mortality of this disease, it is vital that research continues on the early detection of ovarian cancer. New biomarkers, improvements in imaging, and an enhanced understanding of genetics may allow for better screening methods to be evaluated soon. In the interim, providers should be aware of the pitfalls of ovarian cancer screening and continue to educate patients on the symptoms of ovarian cancer.

Dr McCann and Dr. Salani of the division of gynecologic oncology, department of obstetrics and gynecology at the Ohio State University, Columbus, commented on the USPSTF findings. They said they had no relevant financial disclosures.

Title
Watch for Symptomatic Patients
Watch for Symptomatic Patients

Clinicians need not screen women for ovarian cancer if they are otherwise healthy and have no known genetic mutations, such as BRCA1 or BRCA2 that could increase their ovarian cancer risk, according to a recommendation from the U.S. Preventive Services Task Force published online in the Annals of Internal Medicine and on the USPSTF website on Sept. 11.

After reviewing data from randomized, controlled trials between 2008 and 2011, a USPSTF Task Force determined that the number of deaths from ovarian cancer in U.S. women was not significantly reduced by annual screening with transvaginal ultrasound and serum CA-125 testing.

Monkey Business/Thinkstock.com
New data show that young women do not need to be screened for ovarian cancer, if they are otherwise healthy and have no known genetic mutations that could increase their risk for ovarian cancer.

In addition, the data revealed a high rate of false-positive results in asymptomatic women, who then may undergo unnecessary surgery and other harm, the USPSTF said in its statement.

In the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a randomized, controlled trial of 78,216 women in the United States, there was no significant difference in the number of ovarian cancer cases diagnosed in women randomized to annual screening vs. usual care (212 vs. 176) over 13 years. No significant differences were seen in the number of cancer deaths between the two groups. One-third of the women with false-positive results underwent oophorectomies, with nearly 21 major complications per 100 surgeries performed on the basis of false-positive results.

Data from another recent trial, the Shizuoka Cohort Study of Ovarian Cancer Screening, suggested that approximately 33 surgeries would be needed to diagnose 1 case of ovarian cancer detected by routine screening. More data are pending from an ongoing trial, the U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

Based on the available data, "There is adequate evidence that there is no mortality benefit to routine screening for ovarian cancer with transvaginal ultrasonography or single-threshold serum CA-125 testing, and that the harms of such screening are at least moderate," according to the USPSTF.

"Final results from UKCTOCS should provide more information about the relative benefits and harms of an algorithm-based approach to screening for ovarian cancer," the Task Force stated.

Neither the American Cancer Society nor the American College of Obstetricians and Gynecologists recommend screening asymptomatic, average-risk women for ovarian cancer, according to a USPSTF press release about the new recommendation.

The recommendation is a grade D, which the USPSTF defines as "moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," and providers therefore are discouraged from using the service.

This recommendation does not apply to women who are considered at high risk for ovarian cancer. Populations at increased risk of developing ovarian cancer include women with BRCA1 and BRCA2 genetic mutations, Lynch syndrome (hereditary nonpolyposis colon cancer), or a family history of ovarian cancer. A family history "generally means having two or more first- or second-degree relatives with a history of ovarian cancer or a combination of breast and ovarian cancer; for women of Ashkenazi Jewish heritage, it means having a first-degree relative (or two second-degree relatives on the same side of the family) with breast or ovarian cancer," according to the USPSTF statement.

Clinicians need not screen women for ovarian cancer if they are otherwise healthy and have no known genetic mutations, such as BRCA1 or BRCA2 that could increase their ovarian cancer risk, according to a recommendation from the U.S. Preventive Services Task Force published online in the Annals of Internal Medicine and on the USPSTF website on Sept. 11.

After reviewing data from randomized, controlled trials between 2008 and 2011, a USPSTF Task Force determined that the number of deaths from ovarian cancer in U.S. women was not significantly reduced by annual screening with transvaginal ultrasound and serum CA-125 testing.

Monkey Business/Thinkstock.com
New data show that young women do not need to be screened for ovarian cancer, if they are otherwise healthy and have no known genetic mutations that could increase their risk for ovarian cancer.

In addition, the data revealed a high rate of false-positive results in asymptomatic women, who then may undergo unnecessary surgery and other harm, the USPSTF said in its statement.

In the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a randomized, controlled trial of 78,216 women in the United States, there was no significant difference in the number of ovarian cancer cases diagnosed in women randomized to annual screening vs. usual care (212 vs. 176) over 13 years. No significant differences were seen in the number of cancer deaths between the two groups. One-third of the women with false-positive results underwent oophorectomies, with nearly 21 major complications per 100 surgeries performed on the basis of false-positive results.

Data from another recent trial, the Shizuoka Cohort Study of Ovarian Cancer Screening, suggested that approximately 33 surgeries would be needed to diagnose 1 case of ovarian cancer detected by routine screening. More data are pending from an ongoing trial, the U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

Based on the available data, "There is adequate evidence that there is no mortality benefit to routine screening for ovarian cancer with transvaginal ultrasonography or single-threshold serum CA-125 testing, and that the harms of such screening are at least moderate," according to the USPSTF.

"Final results from UKCTOCS should provide more information about the relative benefits and harms of an algorithm-based approach to screening for ovarian cancer," the Task Force stated.

Neither the American Cancer Society nor the American College of Obstetricians and Gynecologists recommend screening asymptomatic, average-risk women for ovarian cancer, according to a USPSTF press release about the new recommendation.

The recommendation is a grade D, which the USPSTF defines as "moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," and providers therefore are discouraged from using the service.

This recommendation does not apply to women who are considered at high risk for ovarian cancer. Populations at increased risk of developing ovarian cancer include women with BRCA1 and BRCA2 genetic mutations, Lynch syndrome (hereditary nonpolyposis colon cancer), or a family history of ovarian cancer. A family history "generally means having two or more first- or second-degree relatives with a history of ovarian cancer or a combination of breast and ovarian cancer; for women of Ashkenazi Jewish heritage, it means having a first-degree relative (or two second-degree relatives on the same side of the family) with breast or ovarian cancer," according to the USPSTF statement.

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Don't Screen Healthy Women for Ovarian Cancer
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screen women for ovarian cancer, genetic mutations, BRCA1, BRCA2, ovarian cancer risk, U.S. Preventive Services Task Force, Annals of Internal Medicine, USPSTF, deaths from ovarian cancer, annual screening, transvaginal ultrasound, serum CA-125 testing, high rate of false-positive results, unnecessary surgery, Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, oophorectomies, Shizuoka Cohort Study of Ovarian Cancer Screening, U.K. Collaborative Trial of Ovarian Cancer Screening, (UKCTOCS),

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screen women for ovarian cancer, genetic mutations, BRCA1, BRCA2, ovarian cancer risk, U.S. Preventive Services Task Force, Annals of Internal Medicine, USPSTF, deaths from ovarian cancer, annual screening, transvaginal ultrasound, serum CA-125 testing, high rate of false-positive results, unnecessary surgery, Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, oophorectomies, Shizuoka Cohort Study of Ovarian Cancer Screening, U.K. Collaborative Trial of Ovarian Cancer Screening, (UKCTOCS),

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New Data Bolster Current Guidelines for Surveillance After Polypectomy (copy 1)

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New Data Bolster Current Guidelines for Surveillance After Polypectomy (copy 1)

Adults with no polyps at baseline colonoscopy and average risk for colorectal cancer can still wait 10 years until their next colonoscopy, according to updated surveillance guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer. The guidelines were published in the September issue of Gastroenterology.

New concerns, including the risk of interval colorectal cancer (CRC), the risk of proximal colorectal cancer, and the role of serrated polyps in carcinogenesis prompted an update to the guidelines, which were last revised in 2006, according to lead author Dr. David A. Lieberman of Oregon Health and Science University, Portland, and his colleagues.

Dr. David A. Lieberman

The task force is composed of GI specialists representing the three major GI professional organizations: American College of Gastroenterology (ACG), American Gastroenterological Association Institute (AGAI), and American Society for Gastrointestinal Endoscopy (ASGE).

Overall, the recommendations have not changed, but the task force reviewed the most recent literature and found additional evidence to support several categories of surveillance and screening intervals for adults with average risk of CRC at the time of a baseline screening.

Recommendations supported by new evidence include a 10-year interval for individuals with no polyps, and a 5- to 10-year interval for those with one or two tubular adenomas less than 10 mm in size. New evidence also supports a 3-year interval for patients with 3-10 tubular adenomas of any size, and also 3 years for patients with one or more tubular adenomas 10 mm or larger. In addition, data reported since 2006 support a 3-year surveillance interval for patients with one or more villous adenomas.

Recommendations that remain unchanged without additional evidence are a 10-year surveillance interval for individuals with hyperplastic polyps in the rectum or sigmoid, an interval of less than 3 years for those with more than 10 adenomas, and an interval of 3 years in cases of an adenoma with high-grade dysplasia.

In addition, serrated lesions are now included as part of the surveillance schedule after a baseline colonoscopy. Individuals with one or more sessile serrated polyps less than 10 mm in size and no dysplasia should be rescreened after 5 years. Those with one or more sessile serrated polyps 10 mm or larger, or any sessile serrated polyp with dysplasia, or a traditional serrated adenoma should be rescreened after 3 years.

Individuals with serrated polyposis syndrome (SPS) should be rescreened after 1 year. Serrated polyposis syndrome is defined as meeting one of three criteria (in agreement with the World Health Organization definition): at least five serrated polyps proximal to the sigmoid, with at least two measuring 10 mm or larger; any serrated polyps proximal to the sigmoid in patients with a family history of SPS; and more than 20 serrated polyps of any size throughout the colon.

The authors noted that the quality of the evidence supporting the current guidelines is low, and will require updates. "There are no longitudinal studies available on which to base surveillance intervals after resection," they said.

In addition, given new evidence about the increased risk of colonoscopy with advancing age, surveillance and screening should be discontinued when the risks outweigh the benefits, according to the guidelines. "The United States Preventive Services Task Forces determined that screening should not be continued after age 85 years because risk could exceed potential benefit," the task force noted. "It is the opinion of the MSTF that the decision to continue surveillance should be individualized, based on an assessment of benefit, risk, and co-morbidities."

However, "the guidelines are dynamic, and will be revised in the future, based on new evidence. This new evidence should include information about the quality of the baseline examinations," the authors said. "The task force recommends that all endoscopists monitor key quality indicators as part of a colonoscopy screening and surveillance program," they noted.

Lead author Dr. David Lieberman has served on the advisory boards of Given Imaging and Exact Sciences.

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Adults with no polyps at baseline colonoscopy and average risk for colorectal cancer can still wait 10 years until their next colonoscopy, according to updated surveillance guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer. The guidelines were published in the September issue of Gastroenterology.

New concerns, including the risk of interval colorectal cancer (CRC), the risk of proximal colorectal cancer, and the role of serrated polyps in carcinogenesis prompted an update to the guidelines, which were last revised in 2006, according to lead author Dr. David A. Lieberman of Oregon Health and Science University, Portland, and his colleagues.

Dr. David A. Lieberman

The task force is composed of GI specialists representing the three major GI professional organizations: American College of Gastroenterology (ACG), American Gastroenterological Association Institute (AGAI), and American Society for Gastrointestinal Endoscopy (ASGE).

Overall, the recommendations have not changed, but the task force reviewed the most recent literature and found additional evidence to support several categories of surveillance and screening intervals for adults with average risk of CRC at the time of a baseline screening.

Recommendations supported by new evidence include a 10-year interval for individuals with no polyps, and a 5- to 10-year interval for those with one or two tubular adenomas less than 10 mm in size. New evidence also supports a 3-year interval for patients with 3-10 tubular adenomas of any size, and also 3 years for patients with one or more tubular adenomas 10 mm or larger. In addition, data reported since 2006 support a 3-year surveillance interval for patients with one or more villous adenomas.

Recommendations that remain unchanged without additional evidence are a 10-year surveillance interval for individuals with hyperplastic polyps in the rectum or sigmoid, an interval of less than 3 years for those with more than 10 adenomas, and an interval of 3 years in cases of an adenoma with high-grade dysplasia.

In addition, serrated lesions are now included as part of the surveillance schedule after a baseline colonoscopy. Individuals with one or more sessile serrated polyps less than 10 mm in size and no dysplasia should be rescreened after 5 years. Those with one or more sessile serrated polyps 10 mm or larger, or any sessile serrated polyp with dysplasia, or a traditional serrated adenoma should be rescreened after 3 years.

Individuals with serrated polyposis syndrome (SPS) should be rescreened after 1 year. Serrated polyposis syndrome is defined as meeting one of three criteria (in agreement with the World Health Organization definition): at least five serrated polyps proximal to the sigmoid, with at least two measuring 10 mm or larger; any serrated polyps proximal to the sigmoid in patients with a family history of SPS; and more than 20 serrated polyps of any size throughout the colon.

The authors noted that the quality of the evidence supporting the current guidelines is low, and will require updates. "There are no longitudinal studies available on which to base surveillance intervals after resection," they said.

In addition, given new evidence about the increased risk of colonoscopy with advancing age, surveillance and screening should be discontinued when the risks outweigh the benefits, according to the guidelines. "The United States Preventive Services Task Forces determined that screening should not be continued after age 85 years because risk could exceed potential benefit," the task force noted. "It is the opinion of the MSTF that the decision to continue surveillance should be individualized, based on an assessment of benefit, risk, and co-morbidities."

However, "the guidelines are dynamic, and will be revised in the future, based on new evidence. This new evidence should include information about the quality of the baseline examinations," the authors said. "The task force recommends that all endoscopists monitor key quality indicators as part of a colonoscopy screening and surveillance program," they noted.

Lead author Dr. David Lieberman has served on the advisory boards of Given Imaging and Exact Sciences.

Adults with no polyps at baseline colonoscopy and average risk for colorectal cancer can still wait 10 years until their next colonoscopy, according to updated surveillance guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer. The guidelines were published in the September issue of Gastroenterology.

New concerns, including the risk of interval colorectal cancer (CRC), the risk of proximal colorectal cancer, and the role of serrated polyps in carcinogenesis prompted an update to the guidelines, which were last revised in 2006, according to lead author Dr. David A. Lieberman of Oregon Health and Science University, Portland, and his colleagues.

Dr. David A. Lieberman

The task force is composed of GI specialists representing the three major GI professional organizations: American College of Gastroenterology (ACG), American Gastroenterological Association Institute (AGAI), and American Society for Gastrointestinal Endoscopy (ASGE).

Overall, the recommendations have not changed, but the task force reviewed the most recent literature and found additional evidence to support several categories of surveillance and screening intervals for adults with average risk of CRC at the time of a baseline screening.

Recommendations supported by new evidence include a 10-year interval for individuals with no polyps, and a 5- to 10-year interval for those with one or two tubular adenomas less than 10 mm in size. New evidence also supports a 3-year interval for patients with 3-10 tubular adenomas of any size, and also 3 years for patients with one or more tubular adenomas 10 mm or larger. In addition, data reported since 2006 support a 3-year surveillance interval for patients with one or more villous adenomas.

Recommendations that remain unchanged without additional evidence are a 10-year surveillance interval for individuals with hyperplastic polyps in the rectum or sigmoid, an interval of less than 3 years for those with more than 10 adenomas, and an interval of 3 years in cases of an adenoma with high-grade dysplasia.

In addition, serrated lesions are now included as part of the surveillance schedule after a baseline colonoscopy. Individuals with one or more sessile serrated polyps less than 10 mm in size and no dysplasia should be rescreened after 5 years. Those with one or more sessile serrated polyps 10 mm or larger, or any sessile serrated polyp with dysplasia, or a traditional serrated adenoma should be rescreened after 3 years.

Individuals with serrated polyposis syndrome (SPS) should be rescreened after 1 year. Serrated polyposis syndrome is defined as meeting one of three criteria (in agreement with the World Health Organization definition): at least five serrated polyps proximal to the sigmoid, with at least two measuring 10 mm or larger; any serrated polyps proximal to the sigmoid in patients with a family history of SPS; and more than 20 serrated polyps of any size throughout the colon.

The authors noted that the quality of the evidence supporting the current guidelines is low, and will require updates. "There are no longitudinal studies available on which to base surveillance intervals after resection," they said.

In addition, given new evidence about the increased risk of colonoscopy with advancing age, surveillance and screening should be discontinued when the risks outweigh the benefits, according to the guidelines. "The United States Preventive Services Task Forces determined that screening should not be continued after age 85 years because risk could exceed potential benefit," the task force noted. "It is the opinion of the MSTF that the decision to continue surveillance should be individualized, based on an assessment of benefit, risk, and co-morbidities."

However, "the guidelines are dynamic, and will be revised in the future, based on new evidence. This new evidence should include information about the quality of the baseline examinations," the authors said. "The task force recommends that all endoscopists monitor key quality indicators as part of a colonoscopy screening and surveillance program," they noted.

Lead author Dr. David Lieberman has served on the advisory boards of Given Imaging and Exact Sciences.

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New Data Bolster Current Guidelines for Surveillance After Polypectomy (copy 1)
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Major Finding: Recommendations supported by new evidence include a 5- to 10-year interval for individuals with one or two tubular adenomas less than 10 mm in size.

Data Source: The data come from a review of English-language articles published between 2005 and 2011.

Disclosures: Lead author Dr. David Lieberman has served on the advisory boards of Given Imaging and Exact Sciences.

Post-Polypectomy Surveillance Guidelines Updated

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Post-Polypectomy Surveillance Guidelines Updated

Adults with no polyps at baseline colonoscopy and average risk for colorectal cancer can still wait 10 years until their next colonoscopy, according to updated surveillance guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer. The guidelines were published in the September issue of Gastroenterology.

New concerns, including the risk of interval colorectal cancer (CRC), the risk of proximal colorectal cancer, and the role of serrated polyps in carcinogenesis prompted an update to the guidelines, which were last revised in 2006, according to lead author Dr. David A. Lieberman of Oregon Health and Science University, Portland, and his colleagues.

Dr. David A. Lieberman

The task force is composed of GI specialists representing the three major GI professional organizations: the American Gastroenterological Association (AGA) Institute, American College of Gastroenterology (ACG), and American Society for Gastrointestinal Endoscopy (ASGE).

Overall, the recommendations have not changed, but the task force reviewed the most recent literature and found additional evidence to support several categories of surveillance and screening intervals for adults with average risk of CRC at the time of a baseline screening.

Recommendations supported by new evidence include a 10-year interval for individuals with no polyps, and a 5- to 10-year interval for those with one or two tubular adenomas less than 10 mm in size. New evidence also supports a 3-year interval for patients with 3-10 tubular adenomas of any size, and also 3 years for patients with one or more tubular adenomas 10 mm or larger. In addition, data reported since 2006 support a 3-year surveillance interval for patients with one or more villous adenomas.

Recommendations that remain unchanged without additional evidence are a 10-year surveillance interval for individuals with hyperplastic polyps in the rectum or sigmoid, an interval of less than 3 years for those with more than 10 adenomas, and an interval of 3 years in cases of an adenoma with high-grade dysplasia.

In addition, serrated lesions are now included as part of the surveillance schedule after a baseline colonoscopy. Individuals with one or more sessile serrated polyps less than 10 mm in size and no dysplasia should be rescreened after 5 years. Those with one or more sessile serrated polyps 10 mm or larger, or any sessile serrated polyp with dysplasia, or a traditional serrated adenoma should be rescreened after 3 years.

Individuals with serrated polyposis syndrome (SPS) should be rescreened after 1 year. Serrated polyposis syndrome is defined as meeting one of three criteria (in agreement with the World Health Organization definition): at least five serrated polyps proximal to the sigmoid, with at least two measuring 10 mm or larger; any serrated polyps proximal to the sigmoid in patients with a family history of SPS; and more than 20 serrated polyps of any size throughout the colon.

The authors noted that the quality of the evidence supporting the current guidelines is low, and will require updates. "There are no longitudinal studies available on which to base surveillance intervals after resection," they said.

In addition, given new evidence about the increased risk of colonoscopy with advancing age, surveillance and screening should be discontinued when the risks outweigh the benefits, according to the guidelines. "The United States Preventive Services Task Forces determined that screening should not be continued after age 85 years because risk could exceed potential benefit," the task force noted. "It is the opinion of the MSTF that the decision to continue surveillance should be individualized, based on an assessment of benefit, risk, and co-morbidities."

However, "the guidelines are dynamic, and will be revised in the future, based on new evidence. This new evidence should include information about the quality of the baseline examinations," the authors said. "The task force recommends that all endoscopists monitor key quality indicators as part of a colonoscopy screening and surveillance program," they noted.

Lead author Dr. David Lieberman has served on the advisory boards of Given Imaging and Exact Sciences.

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Adults with no polyps at baseline colonoscopy and average risk for colorectal cancer can still wait 10 years until their next colonoscopy, according to updated surveillance guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer. The guidelines were published in the September issue of Gastroenterology.

New concerns, including the risk of interval colorectal cancer (CRC), the risk of proximal colorectal cancer, and the role of serrated polyps in carcinogenesis prompted an update to the guidelines, which were last revised in 2006, according to lead author Dr. David A. Lieberman of Oregon Health and Science University, Portland, and his colleagues.

Dr. David A. Lieberman

The task force is composed of GI specialists representing the three major GI professional organizations: the American Gastroenterological Association (AGA) Institute, American College of Gastroenterology (ACG), and American Society for Gastrointestinal Endoscopy (ASGE).

Overall, the recommendations have not changed, but the task force reviewed the most recent literature and found additional evidence to support several categories of surveillance and screening intervals for adults with average risk of CRC at the time of a baseline screening.

Recommendations supported by new evidence include a 10-year interval for individuals with no polyps, and a 5- to 10-year interval for those with one or two tubular adenomas less than 10 mm in size. New evidence also supports a 3-year interval for patients with 3-10 tubular adenomas of any size, and also 3 years for patients with one or more tubular adenomas 10 mm or larger. In addition, data reported since 2006 support a 3-year surveillance interval for patients with one or more villous adenomas.

Recommendations that remain unchanged without additional evidence are a 10-year surveillance interval for individuals with hyperplastic polyps in the rectum or sigmoid, an interval of less than 3 years for those with more than 10 adenomas, and an interval of 3 years in cases of an adenoma with high-grade dysplasia.

In addition, serrated lesions are now included as part of the surveillance schedule after a baseline colonoscopy. Individuals with one or more sessile serrated polyps less than 10 mm in size and no dysplasia should be rescreened after 5 years. Those with one or more sessile serrated polyps 10 mm or larger, or any sessile serrated polyp with dysplasia, or a traditional serrated adenoma should be rescreened after 3 years.

Individuals with serrated polyposis syndrome (SPS) should be rescreened after 1 year. Serrated polyposis syndrome is defined as meeting one of three criteria (in agreement with the World Health Organization definition): at least five serrated polyps proximal to the sigmoid, with at least two measuring 10 mm or larger; any serrated polyps proximal to the sigmoid in patients with a family history of SPS; and more than 20 serrated polyps of any size throughout the colon.

The authors noted that the quality of the evidence supporting the current guidelines is low, and will require updates. "There are no longitudinal studies available on which to base surveillance intervals after resection," they said.

In addition, given new evidence about the increased risk of colonoscopy with advancing age, surveillance and screening should be discontinued when the risks outweigh the benefits, according to the guidelines. "The United States Preventive Services Task Forces determined that screening should not be continued after age 85 years because risk could exceed potential benefit," the task force noted. "It is the opinion of the MSTF that the decision to continue surveillance should be individualized, based on an assessment of benefit, risk, and co-morbidities."

However, "the guidelines are dynamic, and will be revised in the future, based on new evidence. This new evidence should include information about the quality of the baseline examinations," the authors said. "The task force recommends that all endoscopists monitor key quality indicators as part of a colonoscopy screening and surveillance program," they noted.

Lead author Dr. David Lieberman has served on the advisory boards of Given Imaging and Exact Sciences.

Adults with no polyps at baseline colonoscopy and average risk for colorectal cancer can still wait 10 years until their next colonoscopy, according to updated surveillance guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer. The guidelines were published in the September issue of Gastroenterology.

New concerns, including the risk of interval colorectal cancer (CRC), the risk of proximal colorectal cancer, and the role of serrated polyps in carcinogenesis prompted an update to the guidelines, which were last revised in 2006, according to lead author Dr. David A. Lieberman of Oregon Health and Science University, Portland, and his colleagues.

Dr. David A. Lieberman

The task force is composed of GI specialists representing the three major GI professional organizations: the American Gastroenterological Association (AGA) Institute, American College of Gastroenterology (ACG), and American Society for Gastrointestinal Endoscopy (ASGE).

Overall, the recommendations have not changed, but the task force reviewed the most recent literature and found additional evidence to support several categories of surveillance and screening intervals for adults with average risk of CRC at the time of a baseline screening.

Recommendations supported by new evidence include a 10-year interval for individuals with no polyps, and a 5- to 10-year interval for those with one or two tubular adenomas less than 10 mm in size. New evidence also supports a 3-year interval for patients with 3-10 tubular adenomas of any size, and also 3 years for patients with one or more tubular adenomas 10 mm or larger. In addition, data reported since 2006 support a 3-year surveillance interval for patients with one or more villous adenomas.

Recommendations that remain unchanged without additional evidence are a 10-year surveillance interval for individuals with hyperplastic polyps in the rectum or sigmoid, an interval of less than 3 years for those with more than 10 adenomas, and an interval of 3 years in cases of an adenoma with high-grade dysplasia.

In addition, serrated lesions are now included as part of the surveillance schedule after a baseline colonoscopy. Individuals with one or more sessile serrated polyps less than 10 mm in size and no dysplasia should be rescreened after 5 years. Those with one or more sessile serrated polyps 10 mm or larger, or any sessile serrated polyp with dysplasia, or a traditional serrated adenoma should be rescreened after 3 years.

Individuals with serrated polyposis syndrome (SPS) should be rescreened after 1 year. Serrated polyposis syndrome is defined as meeting one of three criteria (in agreement with the World Health Organization definition): at least five serrated polyps proximal to the sigmoid, with at least two measuring 10 mm or larger; any serrated polyps proximal to the sigmoid in patients with a family history of SPS; and more than 20 serrated polyps of any size throughout the colon.

The authors noted that the quality of the evidence supporting the current guidelines is low, and will require updates. "There are no longitudinal studies available on which to base surveillance intervals after resection," they said.

In addition, given new evidence about the increased risk of colonoscopy with advancing age, surveillance and screening should be discontinued when the risks outweigh the benefits, according to the guidelines. "The United States Preventive Services Task Forces determined that screening should not be continued after age 85 years because risk could exceed potential benefit," the task force noted. "It is the opinion of the MSTF that the decision to continue surveillance should be individualized, based on an assessment of benefit, risk, and co-morbidities."

However, "the guidelines are dynamic, and will be revised in the future, based on new evidence. This new evidence should include information about the quality of the baseline examinations," the authors said. "The task force recommends that all endoscopists monitor key quality indicators as part of a colonoscopy screening and surveillance program," they noted.

Lead author Dr. David Lieberman has served on the advisory boards of Given Imaging and Exact Sciences.

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Major Finding: Recommendations supported by new evidence include a 5- to 10-year interval for individuals with one or two tubular adenomas less than 10 mm in size.

Data Source: The data come from a review of English-language articles published between 2005 and 2011.

Disclosures: Lead author Dr. David Lieberman has served on the advisory boards of Given Imaging and Exact Sciences.

Stopping the Flu Starts With You

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Immunization. It's not just for patients anymore. But was it ever?

"It is extremely important for health care workers to get vaccinated every year," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn. Health care workers are diligent by nature, and they often come to work when they are sick, he said. Also, healthy adults often shed the flu virus before they are infected, and they might attribute a runny nose or early flu symptoms to a cold, he added.

Safety issues aside, some hospitals and organizations have made immunization a condition of employment, Dr. Talbot said. "It is now being seen as a professional responsibility," he said.

©Leah-Anne Thompson/iStockphoto.com

Dr. Talbot served on the review panel for "Strategies for Implementing Successful Influenza Immunization Programs for Health Care Personnel Project." A 10-month effort completed in 2009, the Joint Commission project sought to provide information about barriers to successful flu vaccine programs along with strategies for overcoming them.

The Centers for Disease Control and Prevention has also weighed in, recommending flu vaccination for all health care personnel, based on the advice of the Advisory Committee on Immunization Practices and the Hospital Infection Control Practices Advisory Committee.

According to the CDC, health care facilities should offer easy-access vaccination sites and "targeted education about the disease, including disease risk among HCP and patients, and about the vaccine."

"You have to really try to address the misconceptions of the vaccine and there are things that are not proven by science," Dr. Talbot said.

The right attitude can go a long way, he added, pointing out that flu immunization programs for healthcare workers are more likely to succeed if they are presented in a nonadversarial way, with an emphasis on improving safety for patients.

For the latest information on this season’s flu vaccine and vaccine safety, check out the Centers for Disease Control and Prevention’s Seasonal Flu section.

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Immunization. It's not just for patients anymore. But was it ever?

"It is extremely important for health care workers to get vaccinated every year," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn. Health care workers are diligent by nature, and they often come to work when they are sick, he said. Also, healthy adults often shed the flu virus before they are infected, and they might attribute a runny nose or early flu symptoms to a cold, he added.

Safety issues aside, some hospitals and organizations have made immunization a condition of employment, Dr. Talbot said. "It is now being seen as a professional responsibility," he said.

©Leah-Anne Thompson/iStockphoto.com

Dr. Talbot served on the review panel for "Strategies for Implementing Successful Influenza Immunization Programs for Health Care Personnel Project." A 10-month effort completed in 2009, the Joint Commission project sought to provide information about barriers to successful flu vaccine programs along with strategies for overcoming them.

The Centers for Disease Control and Prevention has also weighed in, recommending flu vaccination for all health care personnel, based on the advice of the Advisory Committee on Immunization Practices and the Hospital Infection Control Practices Advisory Committee.

According to the CDC, health care facilities should offer easy-access vaccination sites and "targeted education about the disease, including disease risk among HCP and patients, and about the vaccine."

"You have to really try to address the misconceptions of the vaccine and there are things that are not proven by science," Dr. Talbot said.

The right attitude can go a long way, he added, pointing out that flu immunization programs for healthcare workers are more likely to succeed if they are presented in a nonadversarial way, with an emphasis on improving safety for patients.

For the latest information on this season’s flu vaccine and vaccine safety, check out the Centers for Disease Control and Prevention’s Seasonal Flu section.

Immunization. It's not just for patients anymore. But was it ever?

"It is extremely important for health care workers to get vaccinated every year," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn. Health care workers are diligent by nature, and they often come to work when they are sick, he said. Also, healthy adults often shed the flu virus before they are infected, and they might attribute a runny nose or early flu symptoms to a cold, he added.

Safety issues aside, some hospitals and organizations have made immunization a condition of employment, Dr. Talbot said. "It is now being seen as a professional responsibility," he said.

©Leah-Anne Thompson/iStockphoto.com

Dr. Talbot served on the review panel for "Strategies for Implementing Successful Influenza Immunization Programs for Health Care Personnel Project." A 10-month effort completed in 2009, the Joint Commission project sought to provide information about barriers to successful flu vaccine programs along with strategies for overcoming them.

The Centers for Disease Control and Prevention has also weighed in, recommending flu vaccination for all health care personnel, based on the advice of the Advisory Committee on Immunization Practices and the Hospital Infection Control Practices Advisory Committee.

According to the CDC, health care facilities should offer easy-access vaccination sites and "targeted education about the disease, including disease risk among HCP and patients, and about the vaccine."

"You have to really try to address the misconceptions of the vaccine and there are things that are not proven by science," Dr. Talbot said.

The right attitude can go a long way, he added, pointing out that flu immunization programs for healthcare workers are more likely to succeed if they are presented in a nonadversarial way, with an emphasis on improving safety for patients.

For the latest information on this season’s flu vaccine and vaccine safety, check out the Centers for Disease Control and Prevention’s Seasonal Flu section.

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Inpatient Flu Vaccine Protocols Leave Nothing to Chance

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It’s late October, and a 70-year-old woman with a past medical history of type 2 diabetes and hypothyroidism, as well as a remote history of laryngeal cancer, presents with a COPD exacerbation. The records say she hasn’t had a flu shot. Would she get one at your center?

Experience says if there’s protocol in place designed for people like her, she’s in luck. But if there’s not ... her case points to room for quality improvement.

PODCAST: Dr. Thomas Talbot speaks more about where the flu vaccine fits into the world of hospitalist medicine.

"The reason vaccinating patients has become a safety measure is that we have found that many patients will encounter health care by being seen in an emergency department, being admitted to a hospital, or being seen by their physician, and not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn.

"These are missed opportunities when we have had patients in our health care system and haven’t taken advantage of the opportunity to vaccinate them," Dr. Talbot said.

"That has been the impetus for a lot of new quality measures for those patients who are admitted to the hospital. Once their acute issue has been cared for and they are getting ready to go home, get them their vaccines while you have them there," to protect them against influenza, and also pneumococcal disease, he said.

But it’s not always an easy thing to do, Dr. Talbot said.

"It is challenging to implement an inpatient vaccination program," he said. "During a hospitalization, you are trying to get the patient supported for the illness that brought them into the hospital. You don’t want to do anything that may interrupt that care plan," he said.

"I think the places that have seemed to hard-wire [a vaccination program] have locked it into a nurse-directed order set that may be implemented upon discharge, along with education. Or, [it] may be implemented a few days into the hospitalization so as to avoid that first 48 hours when a lot of activity is happening around the acute illness," Dr. Talbot said. This approach helps ensure that vaccination doesn’t fall off the radar, and allows time to get the vaccine as well as educate patients, he said.

"One of the challenges with this type of program is making sure that the patient’s outpatient provider is aware that they have received immunizations," Dr. Talbot added. "We don’t want individuals to get an unnecessary additional flu shot or pneumococcal vaccination," he said. Documentation and communication are key factors, as is having a mechanism in the hospital to track vaccinations so a returning patient does not receive a second vaccine unnecessarily, he said.

Another challenge to implementing inpatient immunization is the concern that some sick patients who receive a flu vaccine won’t mount the same immune response as they would while healthy, Dr. Talbot said.

"In particular populations, such as those immediately post transplant, where we know that the immune response would not be robust, immunization should be deferred," he emphasized.

©Micah Young/istockphoto.com
"Many patients will encounter health care ... not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious."

"However, there is no evidence to suggest that giving a vaccine during a hospitalization will adversely impact the course of most illnesses for which people are admitted," he said.

Dr. Talbot also emphasized the importance of vaccination for health care workers.

In developing its Hospital Inpatient Quality measures, the Joint Commission looked to a 2006 National Quality Forum work group recommendation that "influenza and pneumococcal vaccination measures should apply to all patients regardless of diagnosis."

As of August 2012, a proposal from the Centers for Medicare and Medicaid Services requiring certain Medicare providers and suppliers to offer all eligible and consenting patients flu vaccination during flu season had not been approved, and flu vaccination policies and practices vary among hospitals.

But last January 1, inpatient immunization for pneu­monia and influenza officially  became a new Joint Commission core measure set for hospital accreditation programs.  Because it is a such a new program, quar­terly data have only recently begun to be categorized in this way, the commission said.

Polishing a Protocol

Dr. Alexander Carbo

An inpatient immunization program is working in Boston at Beth Israel Deaconess Medical Center. BIDMC first initiated an inpatient flu immunization protocol in 2006, and it has been refined over time, said Dr. Alexander Carbo, a hospitalist in the division of general medicine and primary care at BIDMC, Jaime Levash, project administrator for QI and professional development, and Margie Serrano, RN, who work together as part of the medical center’s Influenza Inpatient Immunization Initiative. They described the BIDMC protocol as follows:

 

 

– When adult patients (aged 18 years and older) are admitted to BIDMC, the online medical record automatically checks to see when patients have been immunized (or have contraindications such as an allergy).

– If the patient’s vaccine status is unknown in our system, or if the patient previously refused vaccine, upon admission, the ordering providers are prompted to write for the influenza vaccine protocol, or to provide a reason for not initiating the protocol (such as a prior immunization, or allergy).

– If the protocol is initiated, the nursing staff screens the patient for appropriateness for vaccine and then either provides vaccine (with documentation) or documents the contraindication in the online medical record.

– During subsequent admissions, providers will be re-prompted to write for the vaccine protocol if the patient previously refused vaccine or if vaccine was not given (for a reason other than listed contraindications); otherwise, the prompt will not appear (the computer system tracks prior immunizations and contraindications, so as not to revaccinate patients or reprompt for patients with contraindications during the same influenza season).

The BIDMC team has tweaked the protocol over time to make it more effective at the 650-bed center, Dr. Carbo said. "We have added a hard stop at discharge to ensure that each patient’s immunization status is accounted for during their admission," he said.

Plans for the 2012-2013 flu season are similar to last year’s protocols, but will incorporate some of the newer CDC guidelines for immunizing patients with egg allergies, Dr. Carbo said.

©Catherine Lane/iStockphoto.com
Implementing an inpatient vaccination program is challenging but important for future care.

In addition, "BIDMC mandates immunization for all employees in patient care areas (allowing exceptions for previously noted contraindications) and strongly encourages vaccination for all other staff," he noted.

Dr. Carbo’s advice to hospitalists about how to succeed in inpatient immunizations: "Work with a multidisciplinary team," he said. "When we started in 2006, I did this in collaboration with one of the nursing leaders. Now we have a multidisciplinary team that includes representatives from the nursing staff, the pharmacy staff, information systems, and communications," he said.

Read the Sign

The 566-bed University of Wisconsin Hospital Center (UWHC) in Madison is also harnessing the power of protocol.

"We realized that, as one of our quality control measures, we were monitoring what proportion of our patient population was being vaccinated against pneumonia and influenza and we weren’t doing as well as we would have liked," said Dr. Nasia Safdar, hospital epidemiologist for the UWHC.

Immunizing inpatients was a top choice among UWHC’s efforts to optimize vaccination, but, said Dr. Safdar: "It turned out quickly that it was easier said than done." But the Wisconsin hospital faced the challenge with a protocol similar to the one used at BIDMC. "It took a lot of the repeated questioning and thinking out of the equation because everyone is familiar with the protocol," Dr. Safdar said. "If a patient meets the criteria, they will be vaccinated."

Status is checked upon admission, and barring any specific objection or event, eligible patients get the vaccine at some point during their relationship with the Wisconsin hospital. For example, a transplant patient would not receive a vaccine at the time of the hospital stay for the transplant, but could be vaccinated at a follow-up visit 6 months later, she explained.

"Another thing we have done is to put notices on patients’ doors that say, ‘Eligible for Vaccination Before Discharge,’ and the pharmacist, who is typically involved in the discharge medication process, knows right away that this is a patient who needs to be vaccinated," she said. "It is a visible marker of something that needs to be done," Dr. Safdar said.

Dr. Talbot, Dr. Carbo, and Dr. Safdar reported having no financial conflicts to disclose.

**This story was updated Sept. 6, 2012.

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It’s late October, and a 70-year-old woman with a past medical history of type 2 diabetes and hypothyroidism, as well as a remote history of laryngeal cancer, presents with a COPD exacerbation. The records say she hasn’t had a flu shot. Would she get one at your center?

Experience says if there’s protocol in place designed for people like her, she’s in luck. But if there’s not ... her case points to room for quality improvement.

PODCAST: Dr. Thomas Talbot speaks more about where the flu vaccine fits into the world of hospitalist medicine.

"The reason vaccinating patients has become a safety measure is that we have found that many patients will encounter health care by being seen in an emergency department, being admitted to a hospital, or being seen by their physician, and not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn.

"These are missed opportunities when we have had patients in our health care system and haven’t taken advantage of the opportunity to vaccinate them," Dr. Talbot said.

"That has been the impetus for a lot of new quality measures for those patients who are admitted to the hospital. Once their acute issue has been cared for and they are getting ready to go home, get them their vaccines while you have them there," to protect them against influenza, and also pneumococcal disease, he said.

But it’s not always an easy thing to do, Dr. Talbot said.

"It is challenging to implement an inpatient vaccination program," he said. "During a hospitalization, you are trying to get the patient supported for the illness that brought them into the hospital. You don’t want to do anything that may interrupt that care plan," he said.

"I think the places that have seemed to hard-wire [a vaccination program] have locked it into a nurse-directed order set that may be implemented upon discharge, along with education. Or, [it] may be implemented a few days into the hospitalization so as to avoid that first 48 hours when a lot of activity is happening around the acute illness," Dr. Talbot said. This approach helps ensure that vaccination doesn’t fall off the radar, and allows time to get the vaccine as well as educate patients, he said.

"One of the challenges with this type of program is making sure that the patient’s outpatient provider is aware that they have received immunizations," Dr. Talbot added. "We don’t want individuals to get an unnecessary additional flu shot or pneumococcal vaccination," he said. Documentation and communication are key factors, as is having a mechanism in the hospital to track vaccinations so a returning patient does not receive a second vaccine unnecessarily, he said.

Another challenge to implementing inpatient immunization is the concern that some sick patients who receive a flu vaccine won’t mount the same immune response as they would while healthy, Dr. Talbot said.

"In particular populations, such as those immediately post transplant, where we know that the immune response would not be robust, immunization should be deferred," he emphasized.

©Micah Young/istockphoto.com
"Many patients will encounter health care ... not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious."

"However, there is no evidence to suggest that giving a vaccine during a hospitalization will adversely impact the course of most illnesses for which people are admitted," he said.

Dr. Talbot also emphasized the importance of vaccination for health care workers.

In developing its Hospital Inpatient Quality measures, the Joint Commission looked to a 2006 National Quality Forum work group recommendation that "influenza and pneumococcal vaccination measures should apply to all patients regardless of diagnosis."

As of August 2012, a proposal from the Centers for Medicare and Medicaid Services requiring certain Medicare providers and suppliers to offer all eligible and consenting patients flu vaccination during flu season had not been approved, and flu vaccination policies and practices vary among hospitals.

But last January 1, inpatient immunization for pneu­monia and influenza officially  became a new Joint Commission core measure set for hospital accreditation programs.  Because it is a such a new program, quar­terly data have only recently begun to be categorized in this way, the commission said.

Polishing a Protocol

Dr. Alexander Carbo

An inpatient immunization program is working in Boston at Beth Israel Deaconess Medical Center. BIDMC first initiated an inpatient flu immunization protocol in 2006, and it has been refined over time, said Dr. Alexander Carbo, a hospitalist in the division of general medicine and primary care at BIDMC, Jaime Levash, project administrator for QI and professional development, and Margie Serrano, RN, who work together as part of the medical center’s Influenza Inpatient Immunization Initiative. They described the BIDMC protocol as follows:

 

 

– When adult patients (aged 18 years and older) are admitted to BIDMC, the online medical record automatically checks to see when patients have been immunized (or have contraindications such as an allergy).

– If the patient’s vaccine status is unknown in our system, or if the patient previously refused vaccine, upon admission, the ordering providers are prompted to write for the influenza vaccine protocol, or to provide a reason for not initiating the protocol (such as a prior immunization, or allergy).

– If the protocol is initiated, the nursing staff screens the patient for appropriateness for vaccine and then either provides vaccine (with documentation) or documents the contraindication in the online medical record.

– During subsequent admissions, providers will be re-prompted to write for the vaccine protocol if the patient previously refused vaccine or if vaccine was not given (for a reason other than listed contraindications); otherwise, the prompt will not appear (the computer system tracks prior immunizations and contraindications, so as not to revaccinate patients or reprompt for patients with contraindications during the same influenza season).

The BIDMC team has tweaked the protocol over time to make it more effective at the 650-bed center, Dr. Carbo said. "We have added a hard stop at discharge to ensure that each patient’s immunization status is accounted for during their admission," he said.

Plans for the 2012-2013 flu season are similar to last year’s protocols, but will incorporate some of the newer CDC guidelines for immunizing patients with egg allergies, Dr. Carbo said.

©Catherine Lane/iStockphoto.com
Implementing an inpatient vaccination program is challenging but important for future care.

In addition, "BIDMC mandates immunization for all employees in patient care areas (allowing exceptions for previously noted contraindications) and strongly encourages vaccination for all other staff," he noted.

Dr. Carbo’s advice to hospitalists about how to succeed in inpatient immunizations: "Work with a multidisciplinary team," he said. "When we started in 2006, I did this in collaboration with one of the nursing leaders. Now we have a multidisciplinary team that includes representatives from the nursing staff, the pharmacy staff, information systems, and communications," he said.

Read the Sign

The 566-bed University of Wisconsin Hospital Center (UWHC) in Madison is also harnessing the power of protocol.

"We realized that, as one of our quality control measures, we were monitoring what proportion of our patient population was being vaccinated against pneumonia and influenza and we weren’t doing as well as we would have liked," said Dr. Nasia Safdar, hospital epidemiologist for the UWHC.

Immunizing inpatients was a top choice among UWHC’s efforts to optimize vaccination, but, said Dr. Safdar: "It turned out quickly that it was easier said than done." But the Wisconsin hospital faced the challenge with a protocol similar to the one used at BIDMC. "It took a lot of the repeated questioning and thinking out of the equation because everyone is familiar with the protocol," Dr. Safdar said. "If a patient meets the criteria, they will be vaccinated."

Status is checked upon admission, and barring any specific objection or event, eligible patients get the vaccine at some point during their relationship with the Wisconsin hospital. For example, a transplant patient would not receive a vaccine at the time of the hospital stay for the transplant, but could be vaccinated at a follow-up visit 6 months later, she explained.

"Another thing we have done is to put notices on patients’ doors that say, ‘Eligible for Vaccination Before Discharge,’ and the pharmacist, who is typically involved in the discharge medication process, knows right away that this is a patient who needs to be vaccinated," she said. "It is a visible marker of something that needs to be done," Dr. Safdar said.

Dr. Talbot, Dr. Carbo, and Dr. Safdar reported having no financial conflicts to disclose.

**This story was updated Sept. 6, 2012.

It’s late October, and a 70-year-old woman with a past medical history of type 2 diabetes and hypothyroidism, as well as a remote history of laryngeal cancer, presents with a COPD exacerbation. The records say she hasn’t had a flu shot. Would she get one at your center?

Experience says if there’s protocol in place designed for people like her, she’s in luck. But if there’s not ... her case points to room for quality improvement.

PODCAST: Dr. Thomas Talbot speaks more about where the flu vaccine fits into the world of hospitalist medicine.

"The reason vaccinating patients has become a safety measure is that we have found that many patients will encounter health care by being seen in an emergency department, being admitted to a hospital, or being seen by their physician, and not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn.

"These are missed opportunities when we have had patients in our health care system and haven’t taken advantage of the opportunity to vaccinate them," Dr. Talbot said.

"That has been the impetus for a lot of new quality measures for those patients who are admitted to the hospital. Once their acute issue has been cared for and they are getting ready to go home, get them their vaccines while you have them there," to protect them against influenza, and also pneumococcal disease, he said.

But it’s not always an easy thing to do, Dr. Talbot said.

"It is challenging to implement an inpatient vaccination program," he said. "During a hospitalization, you are trying to get the patient supported for the illness that brought them into the hospital. You don’t want to do anything that may interrupt that care plan," he said.

"I think the places that have seemed to hard-wire [a vaccination program] have locked it into a nurse-directed order set that may be implemented upon discharge, along with education. Or, [it] may be implemented a few days into the hospitalization so as to avoid that first 48 hours when a lot of activity is happening around the acute illness," Dr. Talbot said. This approach helps ensure that vaccination doesn’t fall off the radar, and allows time to get the vaccine as well as educate patients, he said.

"One of the challenges with this type of program is making sure that the patient’s outpatient provider is aware that they have received immunizations," Dr. Talbot added. "We don’t want individuals to get an unnecessary additional flu shot or pneumococcal vaccination," he said. Documentation and communication are key factors, as is having a mechanism in the hospital to track vaccinations so a returning patient does not receive a second vaccine unnecessarily, he said.

Another challenge to implementing inpatient immunization is the concern that some sick patients who receive a flu vaccine won’t mount the same immune response as they would while healthy, Dr. Talbot said.

"In particular populations, such as those immediately post transplant, where we know that the immune response would not be robust, immunization should be deferred," he emphasized.

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"Many patients will encounter health care ... not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious."

"However, there is no evidence to suggest that giving a vaccine during a hospitalization will adversely impact the course of most illnesses for which people are admitted," he said.

Dr. Talbot also emphasized the importance of vaccination for health care workers.

In developing its Hospital Inpatient Quality measures, the Joint Commission looked to a 2006 National Quality Forum work group recommendation that "influenza and pneumococcal vaccination measures should apply to all patients regardless of diagnosis."

As of August 2012, a proposal from the Centers for Medicare and Medicaid Services requiring certain Medicare providers and suppliers to offer all eligible and consenting patients flu vaccination during flu season had not been approved, and flu vaccination policies and practices vary among hospitals.

But last January 1, inpatient immunization for pneu­monia and influenza officially  became a new Joint Commission core measure set for hospital accreditation programs.  Because it is a such a new program, quar­terly data have only recently begun to be categorized in this way, the commission said.

Polishing a Protocol

Dr. Alexander Carbo

An inpatient immunization program is working in Boston at Beth Israel Deaconess Medical Center. BIDMC first initiated an inpatient flu immunization protocol in 2006, and it has been refined over time, said Dr. Alexander Carbo, a hospitalist in the division of general medicine and primary care at BIDMC, Jaime Levash, project administrator for QI and professional development, and Margie Serrano, RN, who work together as part of the medical center’s Influenza Inpatient Immunization Initiative. They described the BIDMC protocol as follows:

 

 

– When adult patients (aged 18 years and older) are admitted to BIDMC, the online medical record automatically checks to see when patients have been immunized (or have contraindications such as an allergy).

– If the patient’s vaccine status is unknown in our system, or if the patient previously refused vaccine, upon admission, the ordering providers are prompted to write for the influenza vaccine protocol, or to provide a reason for not initiating the protocol (such as a prior immunization, or allergy).

– If the protocol is initiated, the nursing staff screens the patient for appropriateness for vaccine and then either provides vaccine (with documentation) or documents the contraindication in the online medical record.

– During subsequent admissions, providers will be re-prompted to write for the vaccine protocol if the patient previously refused vaccine or if vaccine was not given (for a reason other than listed contraindications); otherwise, the prompt will not appear (the computer system tracks prior immunizations and contraindications, so as not to revaccinate patients or reprompt for patients with contraindications during the same influenza season).

The BIDMC team has tweaked the protocol over time to make it more effective at the 650-bed center, Dr. Carbo said. "We have added a hard stop at discharge to ensure that each patient’s immunization status is accounted for during their admission," he said.

Plans for the 2012-2013 flu season are similar to last year’s protocols, but will incorporate some of the newer CDC guidelines for immunizing patients with egg allergies, Dr. Carbo said.

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Implementing an inpatient vaccination program is challenging but important for future care.

In addition, "BIDMC mandates immunization for all employees in patient care areas (allowing exceptions for previously noted contraindications) and strongly encourages vaccination for all other staff," he noted.

Dr. Carbo’s advice to hospitalists about how to succeed in inpatient immunizations: "Work with a multidisciplinary team," he said. "When we started in 2006, I did this in collaboration with one of the nursing leaders. Now we have a multidisciplinary team that includes representatives from the nursing staff, the pharmacy staff, information systems, and communications," he said.

Read the Sign

The 566-bed University of Wisconsin Hospital Center (UWHC) in Madison is also harnessing the power of protocol.

"We realized that, as one of our quality control measures, we were monitoring what proportion of our patient population was being vaccinated against pneumonia and influenza and we weren’t doing as well as we would have liked," said Dr. Nasia Safdar, hospital epidemiologist for the UWHC.

Immunizing inpatients was a top choice among UWHC’s efforts to optimize vaccination, but, said Dr. Safdar: "It turned out quickly that it was easier said than done." But the Wisconsin hospital faced the challenge with a protocol similar to the one used at BIDMC. "It took a lot of the repeated questioning and thinking out of the equation because everyone is familiar with the protocol," Dr. Safdar said. "If a patient meets the criteria, they will be vaccinated."

Status is checked upon admission, and barring any specific objection or event, eligible patients get the vaccine at some point during their relationship with the Wisconsin hospital. For example, a transplant patient would not receive a vaccine at the time of the hospital stay for the transplant, but could be vaccinated at a follow-up visit 6 months later, she explained.

"Another thing we have done is to put notices on patients’ doors that say, ‘Eligible for Vaccination Before Discharge,’ and the pharmacist, who is typically involved in the discharge medication process, knows right away that this is a patient who needs to be vaccinated," she said. "It is a visible marker of something that needs to be done," Dr. Safdar said.

Dr. Talbot, Dr. Carbo, and Dr. Safdar reported having no financial conflicts to disclose.

**This story was updated Sept. 6, 2012.

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CDC Urges Hep C Test for Baby Boomers

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The Centers for Disease Control and Prevention recommends that all Americans aged 47-67 years should be tested once for hepatitis C infection, according to a CDC statement published Aug. 16 online. The CDC proposed the recommendation in May 2012.

Data from previous studies suggest that the baby boomers, defined by the CDC as individuals born between 1945 and 1965, are at increased risk for hepatitis C for many reasons, including blood transfusions, hospital exposures, and a possible history of risky behaviors in their younger years. However, many people in this age group are amenable to hepatitis C testing if it is available to them.

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    A one-time hepatitis C test for all baby boomers could potentially identify more than 800,000 new cases.

According to the CDC statement, "1 in 30 baby boomers has been infected with hepatitis C, and most don’t know it." This life-threatening infection has few symptoms and affects approximately 3.2 million U.S. adults, most of whom are baby boomers, according to the CDC. Hepatitis C is the leading cause of liver transplantation in the United States, and the virus causes serious liver diseases including cirrhosis and liver cancer.

The CDC said in the statement that a one-time hepatitis C test for all baby boomers could potentially identify more than 800,000 additional cases. If treated early, up to 75% of these individuals could be cured, avoiding the costs and serious complications associated with untreated hepatitis C infections. New therapies have recently improved the cure rate significantly.

The CDC encourages clinicians to promote hepatitis C testing to their baby boomer patients.

"Identifying these hidden infections early will allow more baby boomers to receive care and treatment, before they develop life-threatening liver disease," Dr. Kevin Fenton, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, said in the CDC statement. One-time hepatitis C testing for baby boomers "could potentially save tens of thousands of lives," he said.

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The Centers for Disease Control and Prevention recommends that all Americans aged 47-67 years should be tested once for hepatitis C infection, according to a CDC statement published Aug. 16 online. The CDC proposed the recommendation in May 2012.

Data from previous studies suggest that the baby boomers, defined by the CDC as individuals born between 1945 and 1965, are at increased risk for hepatitis C for many reasons, including blood transfusions, hospital exposures, and a possible history of risky behaviors in their younger years. However, many people in this age group are amenable to hepatitis C testing if it is available to them.

Photo courtesy US Veterans Admin.
    A one-time hepatitis C test for all baby boomers could potentially identify more than 800,000 new cases.

According to the CDC statement, "1 in 30 baby boomers has been infected with hepatitis C, and most don’t know it." This life-threatening infection has few symptoms and affects approximately 3.2 million U.S. adults, most of whom are baby boomers, according to the CDC. Hepatitis C is the leading cause of liver transplantation in the United States, and the virus causes serious liver diseases including cirrhosis and liver cancer.

The CDC said in the statement that a one-time hepatitis C test for all baby boomers could potentially identify more than 800,000 additional cases. If treated early, up to 75% of these individuals could be cured, avoiding the costs and serious complications associated with untreated hepatitis C infections. New therapies have recently improved the cure rate significantly.

The CDC encourages clinicians to promote hepatitis C testing to their baby boomer patients.

"Identifying these hidden infections early will allow more baby boomers to receive care and treatment, before they develop life-threatening liver disease," Dr. Kevin Fenton, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, said in the CDC statement. One-time hepatitis C testing for baby boomers "could potentially save tens of thousands of lives," he said.

The Centers for Disease Control and Prevention recommends that all Americans aged 47-67 years should be tested once for hepatitis C infection, according to a CDC statement published Aug. 16 online. The CDC proposed the recommendation in May 2012.

Data from previous studies suggest that the baby boomers, defined by the CDC as individuals born between 1945 and 1965, are at increased risk for hepatitis C for many reasons, including blood transfusions, hospital exposures, and a possible history of risky behaviors in their younger years. However, many people in this age group are amenable to hepatitis C testing if it is available to them.

Photo courtesy US Veterans Admin.
    A one-time hepatitis C test for all baby boomers could potentially identify more than 800,000 new cases.

According to the CDC statement, "1 in 30 baby boomers has been infected with hepatitis C, and most don’t know it." This life-threatening infection has few symptoms and affects approximately 3.2 million U.S. adults, most of whom are baby boomers, according to the CDC. Hepatitis C is the leading cause of liver transplantation in the United States, and the virus causes serious liver diseases including cirrhosis and liver cancer.

The CDC said in the statement that a one-time hepatitis C test for all baby boomers could potentially identify more than 800,000 additional cases. If treated early, up to 75% of these individuals could be cured, avoiding the costs and serious complications associated with untreated hepatitis C infections. New therapies have recently improved the cure rate significantly.

The CDC encourages clinicians to promote hepatitis C testing to their baby boomer patients.

"Identifying these hidden infections early will allow more baby boomers to receive care and treatment, before they develop life-threatening liver disease," Dr. Kevin Fenton, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, said in the CDC statement. One-time hepatitis C testing for baby boomers "could potentially save tens of thousands of lives," he said.

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Romidepsin-Decitabine Duo Battles Breast and Kidney Cancers

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Two blood cancer drugs, romidepsin and decitabine, may form a partnership that can treat specific types of breast and kidney cancers, based on data from a stem cell study published online in Molecular Cancer Therapeutics.

Each drug is approved by the Food and Drug Administration to treat hematologic cancer, but this study uniquely combined romidepsin (Istodax) and decitabine (Dacogen) to activate a tumor suppressor gene that is inactive in triple-negative breast cancer and clear cell renal cell carcinoma.

Activating the gene known as secreted frizzled-related protein 1 (sFRP1) killed kidney and breast cancer cells in multiple cell lines tested, but only when the drugs were used in tandem (Mol. Cancer Ther. July 23, 2012 [doi:10.1158/1535-7163.MCT-11-0873]).

Ultimately, clinicians may be able to target treatment of triple-negative breast cancer and clear cell renal cell carcinoma by identifying which patients have tumors in which sFRP1 is inactivated, the researchers noted. "We predict that there are a number of drug targetable genes that are re-expressed after combinatorial treatment that possess antitumor activity," they said.

"We now have the basis for a clinical trial aimed at providing effective therapy for two drug-resistant cancers and perhaps many more tumor types in the future," senior author John A. Copland, Ph.D., of the Mayo Clinic in Jacksonville, Florida, added in a statement issued July 31 by the Mayo Clinic.

The researchers had no financial conflicts to disclose. The study was funded in part by grants from several organizations, including the National Cancer Institute; Kidney Cancer Research at Mayo Clinic, Florida; and the Breast Cancer Research Foundation.

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Two blood cancer drugs, romidepsin and decitabine, may form a partnership that can treat specific types of breast and kidney cancers, based on data from a stem cell study published online in Molecular Cancer Therapeutics.

Each drug is approved by the Food and Drug Administration to treat hematologic cancer, but this study uniquely combined romidepsin (Istodax) and decitabine (Dacogen) to activate a tumor suppressor gene that is inactive in triple-negative breast cancer and clear cell renal cell carcinoma.

Activating the gene known as secreted frizzled-related protein 1 (sFRP1) killed kidney and breast cancer cells in multiple cell lines tested, but only when the drugs were used in tandem (Mol. Cancer Ther. July 23, 2012 [doi:10.1158/1535-7163.MCT-11-0873]).

Ultimately, clinicians may be able to target treatment of triple-negative breast cancer and clear cell renal cell carcinoma by identifying which patients have tumors in which sFRP1 is inactivated, the researchers noted. "We predict that there are a number of drug targetable genes that are re-expressed after combinatorial treatment that possess antitumor activity," they said.

"We now have the basis for a clinical trial aimed at providing effective therapy for two drug-resistant cancers and perhaps many more tumor types in the future," senior author John A. Copland, Ph.D., of the Mayo Clinic in Jacksonville, Florida, added in a statement issued July 31 by the Mayo Clinic.

The researchers had no financial conflicts to disclose. The study was funded in part by grants from several organizations, including the National Cancer Institute; Kidney Cancer Research at Mayo Clinic, Florida; and the Breast Cancer Research Foundation.

Two blood cancer drugs, romidepsin and decitabine, may form a partnership that can treat specific types of breast and kidney cancers, based on data from a stem cell study published online in Molecular Cancer Therapeutics.

Each drug is approved by the Food and Drug Administration to treat hematologic cancer, but this study uniquely combined romidepsin (Istodax) and decitabine (Dacogen) to activate a tumor suppressor gene that is inactive in triple-negative breast cancer and clear cell renal cell carcinoma.

Activating the gene known as secreted frizzled-related protein 1 (sFRP1) killed kidney and breast cancer cells in multiple cell lines tested, but only when the drugs were used in tandem (Mol. Cancer Ther. July 23, 2012 [doi:10.1158/1535-7163.MCT-11-0873]).

Ultimately, clinicians may be able to target treatment of triple-negative breast cancer and clear cell renal cell carcinoma by identifying which patients have tumors in which sFRP1 is inactivated, the researchers noted. "We predict that there are a number of drug targetable genes that are re-expressed after combinatorial treatment that possess antitumor activity," they said.

"We now have the basis for a clinical trial aimed at providing effective therapy for two drug-resistant cancers and perhaps many more tumor types in the future," senior author John A. Copland, Ph.D., of the Mayo Clinic in Jacksonville, Florida, added in a statement issued July 31 by the Mayo Clinic.

The researchers had no financial conflicts to disclose. The study was funded in part by grants from several organizations, including the National Cancer Institute; Kidney Cancer Research at Mayo Clinic, Florida; and the Breast Cancer Research Foundation.

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FROM MOLECULAR CANCER THERAPEUTICS

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FDA Restricts Use of Wingspan Stent

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New labeling changes approved by the Food and Drug Administration limit the patients eligible for treatment with the Stryker Wingspan Stent System, according to a statement and safety communication issued by the agency on Aug. 8.

The changes specify the patients most likely to benefit from treatment with the stent system. Data from studies conducted since the system’s approval in 2005 suggest that the risks, including stroke and death, may outweigh the benefits for some patients, according to the press release.

"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Under the new label, the Wingspan system is approved only for patients aged 22-80 years who meet four specific criteria: two or more strokes despite aggressive medical management; a most recent stroke more than 7 days prior to planned treatment with the Wingspan system; 70%-99% stenosis (due to atherosclerosis of the intracranial artery related to the recurrent strokes); and good recovery from previous strokes, defined in part by a modified Rankin score of 3 or less before treatment with the Wingspan system.

According to the safety communication, the Wingspan system should not be used for "the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)."

The FDA approved the changes after reviewing data from the original clinical study, postapproval studies, and the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study.

The safety communication states that "a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB)," and that the physician is responsible for obtaining IRB approval before treating a patient with the Wingspan system.

Clinicians can report adverse events associated with the Wingspan system to the FDA via the MedWatch program. The safety communication can be viewed here.

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New labeling changes approved by the Food and Drug Administration limit the patients eligible for treatment with the Stryker Wingspan Stent System, according to a statement and safety communication issued by the agency on Aug. 8.

The changes specify the patients most likely to benefit from treatment with the stent system. Data from studies conducted since the system’s approval in 2005 suggest that the risks, including stroke and death, may outweigh the benefits for some patients, according to the press release.

"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Under the new label, the Wingspan system is approved only for patients aged 22-80 years who meet four specific criteria: two or more strokes despite aggressive medical management; a most recent stroke more than 7 days prior to planned treatment with the Wingspan system; 70%-99% stenosis (due to atherosclerosis of the intracranial artery related to the recurrent strokes); and good recovery from previous strokes, defined in part by a modified Rankin score of 3 or less before treatment with the Wingspan system.

According to the safety communication, the Wingspan system should not be used for "the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)."

The FDA approved the changes after reviewing data from the original clinical study, postapproval studies, and the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study.

The safety communication states that "a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB)," and that the physician is responsible for obtaining IRB approval before treating a patient with the Wingspan system.

Clinicians can report adverse events associated with the Wingspan system to the FDA via the MedWatch program. The safety communication can be viewed here.

New labeling changes approved by the Food and Drug Administration limit the patients eligible for treatment with the Stryker Wingspan Stent System, according to a statement and safety communication issued by the agency on Aug. 8.

The changes specify the patients most likely to benefit from treatment with the stent system. Data from studies conducted since the system’s approval in 2005 suggest that the risks, including stroke and death, may outweigh the benefits for some patients, according to the press release.

"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Under the new label, the Wingspan system is approved only for patients aged 22-80 years who meet four specific criteria: two or more strokes despite aggressive medical management; a most recent stroke more than 7 days prior to planned treatment with the Wingspan system; 70%-99% stenosis (due to atherosclerosis of the intracranial artery related to the recurrent strokes); and good recovery from previous strokes, defined in part by a modified Rankin score of 3 or less before treatment with the Wingspan system.

According to the safety communication, the Wingspan system should not be used for "the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)."

The FDA approved the changes after reviewing data from the original clinical study, postapproval studies, and the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study.

The safety communication states that "a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB)," and that the physician is responsible for obtaining IRB approval before treating a patient with the Wingspan system.

Clinicians can report adverse events associated with the Wingspan system to the FDA via the MedWatch program. The safety communication can be viewed here.

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Childhood Violence Exposure Predicts Sexual Risk

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WASHINGTON – Exposure to violence in childhood significantly increased the odds of early dating and sexual behavior in adolescents, based on data from 177 high-risk black girls in a low-income urban setting. The findings were presented at the annual meeting of the Society for Prevention Research.

"Currently, young African American adolescent girls are at disproportionate risk for poor sexual health outcomes," said Helen Wilson, Ph.D., of the college of health professions at the Rosalind Franklin University of Medicine and Science, Chicago.

Data from the Centers for Disease Control and Prevention indicate that black women aged 15-24 years have the highest rates of gonorrhea and chlamydia in the United States, she added.

However, there is not consistent evidence that black girls are more likely to take sexual risks, she said.

"There is growing recognition that violence exposure is associated with sexual risk," she said. Violence exposure also disproportionately affects youths who grow up in low-income, urban communities, she noted.

In this study, Dr. Wilson and her colleagues reviewed data from 177 girls who were participating in a longitudinal study on mother-daughter relationships and HIV risk behavior. Data were initially collected at baseline (when the girls were aged 12-16 years) and at 6, 12, 18, and 24 months.

"There is growing recognition that violence exposure is associated with sexual risk."

In a recent follow-up, the same participants responded to questions using the Lifetime Trauma and Victimization History. Sexual behavior was assessed via the AIDS Risk Behavior Assessment at all time points during the study.

Overall, 44% of the girls reported some type of violence during childhood (defined as having experienced physical or sexual victimization and/or having witnessed violence before 12 years of age).

The girls who reported exposure to childhood violence were significantly more likely than those who reported no childhood violence exposure to report sexual experience, inconsistent condom use, and a higher number of sexual partners. This trend persisted across all six time points. In addition, more extensive involvement in dating relationships in early adolescence helped to explain this relationship, said Dr. Wilson.

The results were limited by the retrospective nature of the self-reports and a lack of data about sexual partners, Dr. Wilson said, as well as a lack of generalizability of the findings to other adolescent girls. But these findings suggest that early interventions in this population might help to delay sexual activity and reduce sexual risk in low-income girls with histories of exposure to violence.

"Addressing general dating behavior should be part of such interventions," Dr. Wilson said. "Girls who are already involved in dating relationships may benefit most from early interventions to promote healthy romantic relationships and reduce sexual risk," she noted.

More research is needed about the role of partner relationships in linking violence exposure to sexual risk in high-risk adolescent girls, said Dr. Wilson. Prospective studies beginning with clear evidence of violence exposure in childhood would support stronger conclusions about this relationship, she added.

Dr. Wilson had no financial conflicts to disclose. The research was supported by a grant from the National Institute of Mental Health.

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WASHINGTON – Exposure to violence in childhood significantly increased the odds of early dating and sexual behavior in adolescents, based on data from 177 high-risk black girls in a low-income urban setting. The findings were presented at the annual meeting of the Society for Prevention Research.

"Currently, young African American adolescent girls are at disproportionate risk for poor sexual health outcomes," said Helen Wilson, Ph.D., of the college of health professions at the Rosalind Franklin University of Medicine and Science, Chicago.

Data from the Centers for Disease Control and Prevention indicate that black women aged 15-24 years have the highest rates of gonorrhea and chlamydia in the United States, she added.

However, there is not consistent evidence that black girls are more likely to take sexual risks, she said.

"There is growing recognition that violence exposure is associated with sexual risk," she said. Violence exposure also disproportionately affects youths who grow up in low-income, urban communities, she noted.

In this study, Dr. Wilson and her colleagues reviewed data from 177 girls who were participating in a longitudinal study on mother-daughter relationships and HIV risk behavior. Data were initially collected at baseline (when the girls were aged 12-16 years) and at 6, 12, 18, and 24 months.

"There is growing recognition that violence exposure is associated with sexual risk."

In a recent follow-up, the same participants responded to questions using the Lifetime Trauma and Victimization History. Sexual behavior was assessed via the AIDS Risk Behavior Assessment at all time points during the study.

Overall, 44% of the girls reported some type of violence during childhood (defined as having experienced physical or sexual victimization and/or having witnessed violence before 12 years of age).

The girls who reported exposure to childhood violence were significantly more likely than those who reported no childhood violence exposure to report sexual experience, inconsistent condom use, and a higher number of sexual partners. This trend persisted across all six time points. In addition, more extensive involvement in dating relationships in early adolescence helped to explain this relationship, said Dr. Wilson.

The results were limited by the retrospective nature of the self-reports and a lack of data about sexual partners, Dr. Wilson said, as well as a lack of generalizability of the findings to other adolescent girls. But these findings suggest that early interventions in this population might help to delay sexual activity and reduce sexual risk in low-income girls with histories of exposure to violence.

"Addressing general dating behavior should be part of such interventions," Dr. Wilson said. "Girls who are already involved in dating relationships may benefit most from early interventions to promote healthy romantic relationships and reduce sexual risk," she noted.

More research is needed about the role of partner relationships in linking violence exposure to sexual risk in high-risk adolescent girls, said Dr. Wilson. Prospective studies beginning with clear evidence of violence exposure in childhood would support stronger conclusions about this relationship, she added.

Dr. Wilson had no financial conflicts to disclose. The research was supported by a grant from the National Institute of Mental Health.

WASHINGTON – Exposure to violence in childhood significantly increased the odds of early dating and sexual behavior in adolescents, based on data from 177 high-risk black girls in a low-income urban setting. The findings were presented at the annual meeting of the Society for Prevention Research.

"Currently, young African American adolescent girls are at disproportionate risk for poor sexual health outcomes," said Helen Wilson, Ph.D., of the college of health professions at the Rosalind Franklin University of Medicine and Science, Chicago.

Data from the Centers for Disease Control and Prevention indicate that black women aged 15-24 years have the highest rates of gonorrhea and chlamydia in the United States, she added.

However, there is not consistent evidence that black girls are more likely to take sexual risks, she said.

"There is growing recognition that violence exposure is associated with sexual risk," she said. Violence exposure also disproportionately affects youths who grow up in low-income, urban communities, she noted.

In this study, Dr. Wilson and her colleagues reviewed data from 177 girls who were participating in a longitudinal study on mother-daughter relationships and HIV risk behavior. Data were initially collected at baseline (when the girls were aged 12-16 years) and at 6, 12, 18, and 24 months.

"There is growing recognition that violence exposure is associated with sexual risk."

In a recent follow-up, the same participants responded to questions using the Lifetime Trauma and Victimization History. Sexual behavior was assessed via the AIDS Risk Behavior Assessment at all time points during the study.

Overall, 44% of the girls reported some type of violence during childhood (defined as having experienced physical or sexual victimization and/or having witnessed violence before 12 years of age).

The girls who reported exposure to childhood violence were significantly more likely than those who reported no childhood violence exposure to report sexual experience, inconsistent condom use, and a higher number of sexual partners. This trend persisted across all six time points. In addition, more extensive involvement in dating relationships in early adolescence helped to explain this relationship, said Dr. Wilson.

The results were limited by the retrospective nature of the self-reports and a lack of data about sexual partners, Dr. Wilson said, as well as a lack of generalizability of the findings to other adolescent girls. But these findings suggest that early interventions in this population might help to delay sexual activity and reduce sexual risk in low-income girls with histories of exposure to violence.

"Addressing general dating behavior should be part of such interventions," Dr. Wilson said. "Girls who are already involved in dating relationships may benefit most from early interventions to promote healthy romantic relationships and reduce sexual risk," she noted.

More research is needed about the role of partner relationships in linking violence exposure to sexual risk in high-risk adolescent girls, said Dr. Wilson. Prospective studies beginning with clear evidence of violence exposure in childhood would support stronger conclusions about this relationship, she added.

Dr. Wilson had no financial conflicts to disclose. The research was supported by a grant from the National Institute of Mental Health.

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AT THE ANNUAL MEETING OF THE SOCIETY FOR PREVENTION RESEARCH

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Vitals

Major Finding: A significantly higher probability of sexual experience and inconsistent condom use were reported by the 44% girls who said they had experienced physical or sexual victimization or witnessed violence before age 12 years.

Data Source: Data were reviewed for 177 high-risk black girls participating in a longitudinal study on mother-daughter relationships and HIV risk behavior.

Disclosures: Dr. Wilson had no financial conflicts to disclose. The research was supported by a grant from the National Institute of Mental Health.

Support for Parents Curbs Drug Use in Kids

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WASHINGTON  – A culturally tailored family intervention program significantly reduced current drug use and risky sexual behaviors in high-risk Hispanic youth, in a randomized trial of more than 200 teens.

Data from the Monitoring the Future survey showed high rates of problem behavior in Hispanic youth, said Guillermo Prado, Ph.D., of the division of epidemiology and population health sciences at the University of Miami. He and his colleagues hypothesized that a family-centered intervention (called Familias Unidas) could reduce these behaviors.

The multiparent group intervention focused on positive parenting, communication with teens about sex, and family support. "Part of the group session is dedicated to helping the parents create social support networks," similar to what they might have had in their countries of origin, he said. "We hypothesized that our family intervention would have an impact and that the results would be mediated by improvements in family function."

The researchers recruited 242 Hispanic delinquent youth and their families from the juvenile justice system or the Miami–Dade County Public Schools system. The youth were randomized to either Familias Unidas (120) or a community practice program that served as a control (122). The average age of the participants was 15 years, and 35% were foreign born. The average household income ranged from $15,000 to $19,000 annually.

Overall, teens in the intervention group showed a significant drop in reported illicit drug use, compared with the controls, Dr. Prado reported at the annual meeting of the Society for Prevention Research.

Approximately 30% of teens in the intervention group were using drugs at baseline, but this number dropped to 20% at 6 months, followed by a leveling off of drug use, compared with steady increases in the control group over time.

Alcohol dependence was not a formal diagnosis, Dr. Prado noted. However, the trajectory for alcohol dependence among controls was very flat; while the intervention group showed a decrease from 15% at baseline to 5% by 12 months’ follow-up. The lack of impact of the intervention on current alcohol use (as opposed to dependence) was an interesting finding, he said.

"In Hispanic culture, alcohol use is considered more normative," and parents are less likely to notice teens’ alcohol consumption until there are signs of alcohol dependence, which might explain this finding, he said.

With respect to the percentage of youth who have sex while under the influence of alcohol or drugs, there was a significant increase in the control group over time, compared with a steady level in the intervention group.

On further analysis, "our family-based intervention is most efficacious for families who report high family risk (such as poor communication and low parental involvement)," Dr. Prado noted.

Data from a post hoc analysis suggests that the effectiveness of Familias Unidas varies by parental environmental exposure, including levels of immigration stress and levels of social support, which could be areas for future research, he noted.

Dr. Prado said he had no relevant financial conflicts.

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WASHINGTON  – A culturally tailored family intervention program significantly reduced current drug use and risky sexual behaviors in high-risk Hispanic youth, in a randomized trial of more than 200 teens.

Data from the Monitoring the Future survey showed high rates of problem behavior in Hispanic youth, said Guillermo Prado, Ph.D., of the division of epidemiology and population health sciences at the University of Miami. He and his colleagues hypothesized that a family-centered intervention (called Familias Unidas) could reduce these behaviors.

The multiparent group intervention focused on positive parenting, communication with teens about sex, and family support. "Part of the group session is dedicated to helping the parents create social support networks," similar to what they might have had in their countries of origin, he said. "We hypothesized that our family intervention would have an impact and that the results would be mediated by improvements in family function."

The researchers recruited 242 Hispanic delinquent youth and their families from the juvenile justice system or the Miami–Dade County Public Schools system. The youth were randomized to either Familias Unidas (120) or a community practice program that served as a control (122). The average age of the participants was 15 years, and 35% were foreign born. The average household income ranged from $15,000 to $19,000 annually.

Overall, teens in the intervention group showed a significant drop in reported illicit drug use, compared with the controls, Dr. Prado reported at the annual meeting of the Society for Prevention Research.

Approximately 30% of teens in the intervention group were using drugs at baseline, but this number dropped to 20% at 6 months, followed by a leveling off of drug use, compared with steady increases in the control group over time.

Alcohol dependence was not a formal diagnosis, Dr. Prado noted. However, the trajectory for alcohol dependence among controls was very flat; while the intervention group showed a decrease from 15% at baseline to 5% by 12 months’ follow-up. The lack of impact of the intervention on current alcohol use (as opposed to dependence) was an interesting finding, he said.

"In Hispanic culture, alcohol use is considered more normative," and parents are less likely to notice teens’ alcohol consumption until there are signs of alcohol dependence, which might explain this finding, he said.

With respect to the percentage of youth who have sex while under the influence of alcohol or drugs, there was a significant increase in the control group over time, compared with a steady level in the intervention group.

On further analysis, "our family-based intervention is most efficacious for families who report high family risk (such as poor communication and low parental involvement)," Dr. Prado noted.

Data from a post hoc analysis suggests that the effectiveness of Familias Unidas varies by parental environmental exposure, including levels of immigration stress and levels of social support, which could be areas for future research, he noted.

Dr. Prado said he had no relevant financial conflicts.

WASHINGTON  – A culturally tailored family intervention program significantly reduced current drug use and risky sexual behaviors in high-risk Hispanic youth, in a randomized trial of more than 200 teens.

Data from the Monitoring the Future survey showed high rates of problem behavior in Hispanic youth, said Guillermo Prado, Ph.D., of the division of epidemiology and population health sciences at the University of Miami. He and his colleagues hypothesized that a family-centered intervention (called Familias Unidas) could reduce these behaviors.

The multiparent group intervention focused on positive parenting, communication with teens about sex, and family support. "Part of the group session is dedicated to helping the parents create social support networks," similar to what they might have had in their countries of origin, he said. "We hypothesized that our family intervention would have an impact and that the results would be mediated by improvements in family function."

The researchers recruited 242 Hispanic delinquent youth and their families from the juvenile justice system or the Miami–Dade County Public Schools system. The youth were randomized to either Familias Unidas (120) or a community practice program that served as a control (122). The average age of the participants was 15 years, and 35% were foreign born. The average household income ranged from $15,000 to $19,000 annually.

Overall, teens in the intervention group showed a significant drop in reported illicit drug use, compared with the controls, Dr. Prado reported at the annual meeting of the Society for Prevention Research.

Approximately 30% of teens in the intervention group were using drugs at baseline, but this number dropped to 20% at 6 months, followed by a leveling off of drug use, compared with steady increases in the control group over time.

Alcohol dependence was not a formal diagnosis, Dr. Prado noted. However, the trajectory for alcohol dependence among controls was very flat; while the intervention group showed a decrease from 15% at baseline to 5% by 12 months’ follow-up. The lack of impact of the intervention on current alcohol use (as opposed to dependence) was an interesting finding, he said.

"In Hispanic culture, alcohol use is considered more normative," and parents are less likely to notice teens’ alcohol consumption until there are signs of alcohol dependence, which might explain this finding, he said.

With respect to the percentage of youth who have sex while under the influence of alcohol or drugs, there was a significant increase in the control group over time, compared with a steady level in the intervention group.

On further analysis, "our family-based intervention is most efficacious for families who report high family risk (such as poor communication and low parental involvement)," Dr. Prado noted.

Data from a post hoc analysis suggests that the effectiveness of Familias Unidas varies by parental environmental exposure, including levels of immigration stress and levels of social support, which could be areas for future research, he noted.

Dr. Prado said he had no relevant financial conflicts.

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Major Finding: After a family-based intervention, illicit drug use in Hispanic teens dropped from 30% to 20% 6 months later.

Data Source: The data were taken from a randomized trial of 242 high-risk Hispanic teens and their families.

Disclosures: Dr. Prado said he had no relevant financial conflicts.