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Stem cell divisions help dictate cancer risk
The lifetime risk of many different types of cancer are correlated (0.81) with the total number of divisions of their tissue stem cells, a recent study round.
This can allow any of the most common cancer types to be differentiated into replicative (R) or deterministic (D) types, according to the results of a correlative literature review comparing cancer incidence in tissues to their known stem cell behavior. Whether a cancer is R or D has profound implications for prevention and detection, according to a report in Science (2015;347:78-81).
Extreme variation in the lifetime incidence of cancer across various tissues exist, ranging from levels such as 6.9% in the lung down to 0.00072% for laryngeal cartilage, according to Cristian Tomasetti, Ph.D., of the Johns Hopkins Bloomberg School of Public Heath and Dr. Bert Vogelstein of the Johns Hopkins Kimmel Cancer Center, both in Baltimore.
Environmental exposure to known carcinogens seems to be a factor in some, but this cannot explain why cancers of the small intestinal epithelium are three times less common than brain tumors, even though the intestinal cells are exposed to much higher levels of environmental mutagens than are the brain cells, which are protected by the blood-brain barrier. And heredity fails as a complete explanation, with only 5%-10% of cancers having a heritable component.
“If heredity and environment factors cannot fully explain the differences in organ-specific cancer risk, how else can these differences be explained?” the authors asked. They postulated that somatic cell mutation during DNA replication as the result of cell division may be a critical factor, implying that the greater level of cell division, the greater level of mutagenesis, and hence cancer. Stem cells, which both self-renew and are responsible for tissue maintenance were the obvious candidates for such mutations, and recently the technology has developed to detect and quantify them.
Via a literature search, the authors identified 31 tissue types in which stem cells had been quantitatively assessed, then plotted the total number of stem cell divisions during an average human lifetime for each of these tissues on the X axis, and the lifetime risk in the United States for the associated cancer types from sources such as the Surveillance, Epidemiology, and End Results (SEER) database. Not only was there a strikingly high positive correlation (0.81), which indicated that 65% of the differences of cancer risk among different tissues can be explained by the total number of stem cell divisions in these tissues, the correlation extended across five orders of magnitude, “thereby applying to cancers with enormous differences in incidence,” according to Dr. Tomasetti and Dr. Vogelstein.
They then proceeded to attempt to distinguish the effect of this cell-replicative component from environmental and hereditary factors that contribute to the incidence of cancer. They defined an extra risk score (ERS) as the log product of the lifetime risk of cancer and the total number of stem cell divisions. They then used unsupervised machine learning methods to classify tumors based only on this score into two groups. The result was 9 tumors with high scores and 22 tumors with low ERS scores. If the ERS was high, it meant that there were added factors, such as heredity and environment, contributing to increase the cancer incidence. These they referred to as D-tumors (deterministic). If the ERS was low, that meant that stochastic factors during cell division were the main contributors to incidence, which they called R-tumors (replicative). Upon inspection, the D-tumors were indeed those that had been previously found to have a high hereditary or environmental component. A notable D-tumor, for example, was lung cancer in smokers, while lung cancer in nonsmokers was designated an R-tumor.
“These results have could have important public health implications,” the researchers indicated.
“The maximum fraction of tumors that are preventable through primary prevention (such as vaccines against infectious agents or altered lifestyle) may be evaluated from their ERS. For nonhereditary D-tumors, this fraction is high and primary prevention may make a major impact. ... For R-tumors, primary prevention measures are not likely to be effective, and secondary prevention should be the major focus,” Dr. Tomasetti and Dr. Vogelstein concluded.
The authors reported no relevant disclosures.
This paper published in Science addresses the question of why different tissues in the body are more prone to carcinogenesis than others. The authors hypothesize that environmental factors or inherited predispositions do not explain these differences. An example given is melanocytes and basal epidermal cells in the skin. Each are exposed to the same carcinogen (UV light) at an identical dose, yet melanomas are much less common than are basal cell carcinomas. The explanation arrived at by the authors focuses on stem cells in each tissue.
Stem cells are the only cells that can self-renew and serve to maintain a tissue’s architecture and development. The authors performed a literature search and plotted the total number of stem cell divisions during the average lifetime of a human vs. the lifetime risk for cancer in that tissue type. A linear correlation was performed and found that 65% of the differences in cancer risk among different tissues were explained by total number of stem cell divisions in those tissues. In other words, the more stem cells divide in a tissue, the greater chance of mutations occurring leading to malignancy.
The simple yet elegant concept helps explain the melanoma and basal cell carcinoma differences as well as why those with familial adenomatous polyposis (APC) are 30 times more likely to develop colon carcinoma than duodenal cancer. Human colons have 150-fold more stem cell divisions than the small intestine. Amazingly, mice have more stem cell divisions in their small intestines and in the presence of APC mutation for adenomatous polyps, small intestine tumors are more common than ones in the colon. The authors’ findings suggest in cases where these tumors develop independent of environmental and hereditary factors, secondary prevention such as early detection need to be the driving focus to improve clinical outcomes.
Dr. Michael J. Liptay is the Mary and John Bent Professor and chairman of cardiovascular and thoracic surgery, director of cardiothoracic surgery, and chief of thoracic surgery at Rush University Medical Center, Chicago, and the medical editor of Thoracic Surgery News.
This paper published in Science addresses the question of why different tissues in the body are more prone to carcinogenesis than others. The authors hypothesize that environmental factors or inherited predispositions do not explain these differences. An example given is melanocytes and basal epidermal cells in the skin. Each are exposed to the same carcinogen (UV light) at an identical dose, yet melanomas are much less common than are basal cell carcinomas. The explanation arrived at by the authors focuses on stem cells in each tissue.
Stem cells are the only cells that can self-renew and serve to maintain a tissue’s architecture and development. The authors performed a literature search and plotted the total number of stem cell divisions during the average lifetime of a human vs. the lifetime risk for cancer in that tissue type. A linear correlation was performed and found that 65% of the differences in cancer risk among different tissues were explained by total number of stem cell divisions in those tissues. In other words, the more stem cells divide in a tissue, the greater chance of mutations occurring leading to malignancy.
The simple yet elegant concept helps explain the melanoma and basal cell carcinoma differences as well as why those with familial adenomatous polyposis (APC) are 30 times more likely to develop colon carcinoma than duodenal cancer. Human colons have 150-fold more stem cell divisions than the small intestine. Amazingly, mice have more stem cell divisions in their small intestines and in the presence of APC mutation for adenomatous polyps, small intestine tumors are more common than ones in the colon. The authors’ findings suggest in cases where these tumors develop independent of environmental and hereditary factors, secondary prevention such as early detection need to be the driving focus to improve clinical outcomes.
Dr. Michael J. Liptay is the Mary and John Bent Professor and chairman of cardiovascular and thoracic surgery, director of cardiothoracic surgery, and chief of thoracic surgery at Rush University Medical Center, Chicago, and the medical editor of Thoracic Surgery News.
This paper published in Science addresses the question of why different tissues in the body are more prone to carcinogenesis than others. The authors hypothesize that environmental factors or inherited predispositions do not explain these differences. An example given is melanocytes and basal epidermal cells in the skin. Each are exposed to the same carcinogen (UV light) at an identical dose, yet melanomas are much less common than are basal cell carcinomas. The explanation arrived at by the authors focuses on stem cells in each tissue.
Stem cells are the only cells that can self-renew and serve to maintain a tissue’s architecture and development. The authors performed a literature search and plotted the total number of stem cell divisions during the average lifetime of a human vs. the lifetime risk for cancer in that tissue type. A linear correlation was performed and found that 65% of the differences in cancer risk among different tissues were explained by total number of stem cell divisions in those tissues. In other words, the more stem cells divide in a tissue, the greater chance of mutations occurring leading to malignancy.
The simple yet elegant concept helps explain the melanoma and basal cell carcinoma differences as well as why those with familial adenomatous polyposis (APC) are 30 times more likely to develop colon carcinoma than duodenal cancer. Human colons have 150-fold more stem cell divisions than the small intestine. Amazingly, mice have more stem cell divisions in their small intestines and in the presence of APC mutation for adenomatous polyps, small intestine tumors are more common than ones in the colon. The authors’ findings suggest in cases where these tumors develop independent of environmental and hereditary factors, secondary prevention such as early detection need to be the driving focus to improve clinical outcomes.
Dr. Michael J. Liptay is the Mary and John Bent Professor and chairman of cardiovascular and thoracic surgery, director of cardiothoracic surgery, and chief of thoracic surgery at Rush University Medical Center, Chicago, and the medical editor of Thoracic Surgery News.
The lifetime risk of many different types of cancer are correlated (0.81) with the total number of divisions of their tissue stem cells, a recent study round.
This can allow any of the most common cancer types to be differentiated into replicative (R) or deterministic (D) types, according to the results of a correlative literature review comparing cancer incidence in tissues to their known stem cell behavior. Whether a cancer is R or D has profound implications for prevention and detection, according to a report in Science (2015;347:78-81).
Extreme variation in the lifetime incidence of cancer across various tissues exist, ranging from levels such as 6.9% in the lung down to 0.00072% for laryngeal cartilage, according to Cristian Tomasetti, Ph.D., of the Johns Hopkins Bloomberg School of Public Heath and Dr. Bert Vogelstein of the Johns Hopkins Kimmel Cancer Center, both in Baltimore.
Environmental exposure to known carcinogens seems to be a factor in some, but this cannot explain why cancers of the small intestinal epithelium are three times less common than brain tumors, even though the intestinal cells are exposed to much higher levels of environmental mutagens than are the brain cells, which are protected by the blood-brain barrier. And heredity fails as a complete explanation, with only 5%-10% of cancers having a heritable component.
“If heredity and environment factors cannot fully explain the differences in organ-specific cancer risk, how else can these differences be explained?” the authors asked. They postulated that somatic cell mutation during DNA replication as the result of cell division may be a critical factor, implying that the greater level of cell division, the greater level of mutagenesis, and hence cancer. Stem cells, which both self-renew and are responsible for tissue maintenance were the obvious candidates for such mutations, and recently the technology has developed to detect and quantify them.
Via a literature search, the authors identified 31 tissue types in which stem cells had been quantitatively assessed, then plotted the total number of stem cell divisions during an average human lifetime for each of these tissues on the X axis, and the lifetime risk in the United States for the associated cancer types from sources such as the Surveillance, Epidemiology, and End Results (SEER) database. Not only was there a strikingly high positive correlation (0.81), which indicated that 65% of the differences of cancer risk among different tissues can be explained by the total number of stem cell divisions in these tissues, the correlation extended across five orders of magnitude, “thereby applying to cancers with enormous differences in incidence,” according to Dr. Tomasetti and Dr. Vogelstein.
They then proceeded to attempt to distinguish the effect of this cell-replicative component from environmental and hereditary factors that contribute to the incidence of cancer. They defined an extra risk score (ERS) as the log product of the lifetime risk of cancer and the total number of stem cell divisions. They then used unsupervised machine learning methods to classify tumors based only on this score into two groups. The result was 9 tumors with high scores and 22 tumors with low ERS scores. If the ERS was high, it meant that there were added factors, such as heredity and environment, contributing to increase the cancer incidence. These they referred to as D-tumors (deterministic). If the ERS was low, that meant that stochastic factors during cell division were the main contributors to incidence, which they called R-tumors (replicative). Upon inspection, the D-tumors were indeed those that had been previously found to have a high hereditary or environmental component. A notable D-tumor, for example, was lung cancer in smokers, while lung cancer in nonsmokers was designated an R-tumor.
“These results have could have important public health implications,” the researchers indicated.
“The maximum fraction of tumors that are preventable through primary prevention (such as vaccines against infectious agents or altered lifestyle) may be evaluated from their ERS. For nonhereditary D-tumors, this fraction is high and primary prevention may make a major impact. ... For R-tumors, primary prevention measures are not likely to be effective, and secondary prevention should be the major focus,” Dr. Tomasetti and Dr. Vogelstein concluded.
The authors reported no relevant disclosures.
The lifetime risk of many different types of cancer are correlated (0.81) with the total number of divisions of their tissue stem cells, a recent study round.
This can allow any of the most common cancer types to be differentiated into replicative (R) or deterministic (D) types, according to the results of a correlative literature review comparing cancer incidence in tissues to their known stem cell behavior. Whether a cancer is R or D has profound implications for prevention and detection, according to a report in Science (2015;347:78-81).
Extreme variation in the lifetime incidence of cancer across various tissues exist, ranging from levels such as 6.9% in the lung down to 0.00072% for laryngeal cartilage, according to Cristian Tomasetti, Ph.D., of the Johns Hopkins Bloomberg School of Public Heath and Dr. Bert Vogelstein of the Johns Hopkins Kimmel Cancer Center, both in Baltimore.
Environmental exposure to known carcinogens seems to be a factor in some, but this cannot explain why cancers of the small intestinal epithelium are three times less common than brain tumors, even though the intestinal cells are exposed to much higher levels of environmental mutagens than are the brain cells, which are protected by the blood-brain barrier. And heredity fails as a complete explanation, with only 5%-10% of cancers having a heritable component.
“If heredity and environment factors cannot fully explain the differences in organ-specific cancer risk, how else can these differences be explained?” the authors asked. They postulated that somatic cell mutation during DNA replication as the result of cell division may be a critical factor, implying that the greater level of cell division, the greater level of mutagenesis, and hence cancer. Stem cells, which both self-renew and are responsible for tissue maintenance were the obvious candidates for such mutations, and recently the technology has developed to detect and quantify them.
Via a literature search, the authors identified 31 tissue types in which stem cells had been quantitatively assessed, then plotted the total number of stem cell divisions during an average human lifetime for each of these tissues on the X axis, and the lifetime risk in the United States for the associated cancer types from sources such as the Surveillance, Epidemiology, and End Results (SEER) database. Not only was there a strikingly high positive correlation (0.81), which indicated that 65% of the differences of cancer risk among different tissues can be explained by the total number of stem cell divisions in these tissues, the correlation extended across five orders of magnitude, “thereby applying to cancers with enormous differences in incidence,” according to Dr. Tomasetti and Dr. Vogelstein.
They then proceeded to attempt to distinguish the effect of this cell-replicative component from environmental and hereditary factors that contribute to the incidence of cancer. They defined an extra risk score (ERS) as the log product of the lifetime risk of cancer and the total number of stem cell divisions. They then used unsupervised machine learning methods to classify tumors based only on this score into two groups. The result was 9 tumors with high scores and 22 tumors with low ERS scores. If the ERS was high, it meant that there were added factors, such as heredity and environment, contributing to increase the cancer incidence. These they referred to as D-tumors (deterministic). If the ERS was low, that meant that stochastic factors during cell division were the main contributors to incidence, which they called R-tumors (replicative). Upon inspection, the D-tumors were indeed those that had been previously found to have a high hereditary or environmental component. A notable D-tumor, for example, was lung cancer in smokers, while lung cancer in nonsmokers was designated an R-tumor.
“These results have could have important public health implications,” the researchers indicated.
“The maximum fraction of tumors that are preventable through primary prevention (such as vaccines against infectious agents or altered lifestyle) may be evaluated from their ERS. For nonhereditary D-tumors, this fraction is high and primary prevention may make a major impact. ... For R-tumors, primary prevention measures are not likely to be effective, and secondary prevention should be the major focus,” Dr. Tomasetti and Dr. Vogelstein concluded.
The authors reported no relevant disclosures.
FROM SCIENCE
Key clinical point: Only a third of the variation in cancer risk among tissues is because of the environment or inheritance, and this has implications with regard to prevention and detection.
Major finding: The lifetime risk of many different types of cancer are correlated (0.81) with the total number of divisions of their tissue stem cells.
Data source: Researchers performed a literature review to correlate cancer incidence in a variety of tissues with the nature, number, and hierarchical division patterns of the tissue’s stem cells.
Disclosures: The researchers reported no relevant disclosures.
Privacy issues transformed in the genomic era
Researchers are attempting to develop new models to deal with patient privacy issues, including profound levels of patient participation in the dissemination of personal data, in the new era of genomic medicine, according to an article in the January issue of Science written by Jennifer Couzin-Frankel, based on interviews with participants and investigators in the RUDY trial and other projects.
The RUDY rheumatology registry in London is an example of such a new approach. RUDY, a registry used for research into rare bone diseases and vasculitis, has an emphasis on patients’ self-reported outcomes. In order to alleviate patients’ fears of loss of privacy because of data sharing, the study offers patients various controls over dissemination, according to one of the study’s principal investigators, Dr. Kassim Javaid, a University of Oxford (England) rheumatologist, wrote Ms. Couzin-Frankel (Science 2015;347:501-3).
Patients in the study can determine whether their blood, scans, and medical histories can be shared with other researchers. In addition, they will have access to a clinical trial Web page where they can find out whether their tissues samples are being used by other research groups.
This model is thought to not only increase the sense of patient participation and authority in the study, but also to provide transparency and accountability as to how their information is being used. Dr. Javaid refers to this strategy as “dynamic consent,” because patients can choose which portions of the study to participate in and whether to restrict their data and samples to RUDY investigators or to allow others to study them.
The problem of maintaining privacy is profound, because DNA sequencing provides such a potent means of individual identification. Ms. Couzin-Frankel cites in particular a case published in Science (2013;339:321-4), in which a group working with Dr. Yaniv Erlich showed that a man could be uniquely identified based on a partial DNA sequence of his Y chromosome, age, and U.S. state of residence, which is the type of information commonly posted in DNA databases widely accessible to the research community. By combining this information with data he found for others in the same family on popular genealogy databases, where more than 100,000 people already have posted DNA markers, Dr. Erlich could not only identify the donors of the DNA but also could identify their family members as far as second cousins once removed.
Although such data can be encrypted, reported Ms. Couzin-Frankel, Dr. Erlich pointed out that this can render the information largely useless for research and doesn’t even always protect the donor.
In contrast, however, many participants in trials and databases, such as the database/Web group PatientsLikeMe, see patient altruism as key. PatientsLikeMe has recruited more 300,000 people with more than 2,300 different diseases, who are sharing their health data, how they’re faring in clinical trials, and acting as a support group to one another in order to help medical scientists and drug companies further research their conditions. Patients voluntarily agree to this free flow of information, even though it decreases their privacy.
In another example in which patients cite altruistic reasons for giving up their privacy, the Personal Genome Project at Harvard Medical School in Boston, founded by geneticist George M. Church, Ph.D., has nearly 4,000 participants sharing their DNA sequences and health histories online for anyone to view. The Personal Genome Project even has a “real name” option, which allows participants to post their identity, Ms. Couzin-Frankel reports.
The Science article author, Ms. Couzin-Frankel, is a science journalist with no relevant financial conflicts. The RUDY study is funded by the University of Oxford and the U.K. National Institute for Health Research.
The article in Science raises important ethical questions, re: the deidentification of data and obtaining [of] informed consent when data or tissue or DNA alone can actually be used to identify the patient.
|
Dr. Jennifer S. Lawton |
When we obtain informed consent for participation in clinical trials, we ask our patients to take a “leap of faith” and trust us to maintain their privacy. Our patients personally gain little or nothing for participation, yet they altruistically allow their data or tissue to be used to improve the lives of others. Just as we do not want our Social Security number, bank account information, and credit card numbers to be public knowledge, we also do not want our genetic information – with potential risks of developing or predispositions for life-threatening diseases – public knowledge (or accessible to employers and insurance companies). These questions will be the topic of many ethical discussions in the future, and will provide an opportunity for innovative and advanced technology and methods to protect personal information.
Dr. Jennifer S. Lawton is the Acquired Cardiovascular Disease section editor for Thoracic Surgery News.
The article in Science raises important ethical questions, re: the deidentification of data and obtaining [of] informed consent when data or tissue or DNA alone can actually be used to identify the patient.
|
|
Dr. Jennifer S. Lawton |
When we obtain informed consent for participation in clinical trials, we ask our patients to take a “leap of faith” and trust us to maintain their privacy. Our patients personally gain little or nothing for participation, yet they altruistically allow their data or tissue to be used to improve the lives of others. Just as we do not want our Social Security number, bank account information, and credit card numbers to be public knowledge, we also do not want our genetic information – with potential risks of developing or predispositions for life-threatening diseases – public knowledge (or accessible to employers and insurance companies). These questions will be the topic of many ethical discussions in the future, and will provide an opportunity for innovative and advanced technology and methods to protect personal information.
Dr. Jennifer S. Lawton is the Acquired Cardiovascular Disease section editor for Thoracic Surgery News.
The article in Science raises important ethical questions, re: the deidentification of data and obtaining [of] informed consent when data or tissue or DNA alone can actually be used to identify the patient.
|
|
Dr. Jennifer S. Lawton |
When we obtain informed consent for participation in clinical trials, we ask our patients to take a “leap of faith” and trust us to maintain their privacy. Our patients personally gain little or nothing for participation, yet they altruistically allow their data or tissue to be used to improve the lives of others. Just as we do not want our Social Security number, bank account information, and credit card numbers to be public knowledge, we also do not want our genetic information – with potential risks of developing or predispositions for life-threatening diseases – public knowledge (or accessible to employers and insurance companies). These questions will be the topic of many ethical discussions in the future, and will provide an opportunity for innovative and advanced technology and methods to protect personal information.
Dr. Jennifer S. Lawton is the Acquired Cardiovascular Disease section editor for Thoracic Surgery News.
Researchers are attempting to develop new models to deal with patient privacy issues, including profound levels of patient participation in the dissemination of personal data, in the new era of genomic medicine, according to an article in the January issue of Science written by Jennifer Couzin-Frankel, based on interviews with participants and investigators in the RUDY trial and other projects.
The RUDY rheumatology registry in London is an example of such a new approach. RUDY, a registry used for research into rare bone diseases and vasculitis, has an emphasis on patients’ self-reported outcomes. In order to alleviate patients’ fears of loss of privacy because of data sharing, the study offers patients various controls over dissemination, according to one of the study’s principal investigators, Dr. Kassim Javaid, a University of Oxford (England) rheumatologist, wrote Ms. Couzin-Frankel (Science 2015;347:501-3).
Patients in the study can determine whether their blood, scans, and medical histories can be shared with other researchers. In addition, they will have access to a clinical trial Web page where they can find out whether their tissues samples are being used by other research groups.
This model is thought to not only increase the sense of patient participation and authority in the study, but also to provide transparency and accountability as to how their information is being used. Dr. Javaid refers to this strategy as “dynamic consent,” because patients can choose which portions of the study to participate in and whether to restrict their data and samples to RUDY investigators or to allow others to study them.
The problem of maintaining privacy is profound, because DNA sequencing provides such a potent means of individual identification. Ms. Couzin-Frankel cites in particular a case published in Science (2013;339:321-4), in which a group working with Dr. Yaniv Erlich showed that a man could be uniquely identified based on a partial DNA sequence of his Y chromosome, age, and U.S. state of residence, which is the type of information commonly posted in DNA databases widely accessible to the research community. By combining this information with data he found for others in the same family on popular genealogy databases, where more than 100,000 people already have posted DNA markers, Dr. Erlich could not only identify the donors of the DNA but also could identify their family members as far as second cousins once removed.
Although such data can be encrypted, reported Ms. Couzin-Frankel, Dr. Erlich pointed out that this can render the information largely useless for research and doesn’t even always protect the donor.
In contrast, however, many participants in trials and databases, such as the database/Web group PatientsLikeMe, see patient altruism as key. PatientsLikeMe has recruited more 300,000 people with more than 2,300 different diseases, who are sharing their health data, how they’re faring in clinical trials, and acting as a support group to one another in order to help medical scientists and drug companies further research their conditions. Patients voluntarily agree to this free flow of information, even though it decreases their privacy.
In another example in which patients cite altruistic reasons for giving up their privacy, the Personal Genome Project at Harvard Medical School in Boston, founded by geneticist George M. Church, Ph.D., has nearly 4,000 participants sharing their DNA sequences and health histories online for anyone to view. The Personal Genome Project even has a “real name” option, which allows participants to post their identity, Ms. Couzin-Frankel reports.
The Science article author, Ms. Couzin-Frankel, is a science journalist with no relevant financial conflicts. The RUDY study is funded by the University of Oxford and the U.K. National Institute for Health Research.
Researchers are attempting to develop new models to deal with patient privacy issues, including profound levels of patient participation in the dissemination of personal data, in the new era of genomic medicine, according to an article in the January issue of Science written by Jennifer Couzin-Frankel, based on interviews with participants and investigators in the RUDY trial and other projects.
The RUDY rheumatology registry in London is an example of such a new approach. RUDY, a registry used for research into rare bone diseases and vasculitis, has an emphasis on patients’ self-reported outcomes. In order to alleviate patients’ fears of loss of privacy because of data sharing, the study offers patients various controls over dissemination, according to one of the study’s principal investigators, Dr. Kassim Javaid, a University of Oxford (England) rheumatologist, wrote Ms. Couzin-Frankel (Science 2015;347:501-3).
Patients in the study can determine whether their blood, scans, and medical histories can be shared with other researchers. In addition, they will have access to a clinical trial Web page where they can find out whether their tissues samples are being used by other research groups.
This model is thought to not only increase the sense of patient participation and authority in the study, but also to provide transparency and accountability as to how their information is being used. Dr. Javaid refers to this strategy as “dynamic consent,” because patients can choose which portions of the study to participate in and whether to restrict their data and samples to RUDY investigators or to allow others to study them.
The problem of maintaining privacy is profound, because DNA sequencing provides such a potent means of individual identification. Ms. Couzin-Frankel cites in particular a case published in Science (2013;339:321-4), in which a group working with Dr. Yaniv Erlich showed that a man could be uniquely identified based on a partial DNA sequence of his Y chromosome, age, and U.S. state of residence, which is the type of information commonly posted in DNA databases widely accessible to the research community. By combining this information with data he found for others in the same family on popular genealogy databases, where more than 100,000 people already have posted DNA markers, Dr. Erlich could not only identify the donors of the DNA but also could identify their family members as far as second cousins once removed.
Although such data can be encrypted, reported Ms. Couzin-Frankel, Dr. Erlich pointed out that this can render the information largely useless for research and doesn’t even always protect the donor.
In contrast, however, many participants in trials and databases, such as the database/Web group PatientsLikeMe, see patient altruism as key. PatientsLikeMe has recruited more 300,000 people with more than 2,300 different diseases, who are sharing their health data, how they’re faring in clinical trials, and acting as a support group to one another in order to help medical scientists and drug companies further research their conditions. Patients voluntarily agree to this free flow of information, even though it decreases their privacy.
In another example in which patients cite altruistic reasons for giving up their privacy, the Personal Genome Project at Harvard Medical School in Boston, founded by geneticist George M. Church, Ph.D., has nearly 4,000 participants sharing their DNA sequences and health histories online for anyone to view. The Personal Genome Project even has a “real name” option, which allows participants to post their identity, Ms. Couzin-Frankel reports.
The Science article author, Ms. Couzin-Frankel, is a science journalist with no relevant financial conflicts. The RUDY study is funded by the University of Oxford and the U.K. National Institute for Health Research.
FROM SCIENCE
Key clinical point: The RUDY rheumatology registry represents a new data-sharing model based on patient-researcher trust.
Major finding: Openness, full documentation, and reviews are the key to creating a community of trust that obviates the need for cryptographic protection of DNA sequences.
Data source: A review and interview-based summary of new modes of data-sharing in medical research, focusing on the RUDY trial.
Disclosures: Jennifer Couzin-Frankel, a science journalist, has no relevant financial conflicts. The RUDY study is funded by the University of Oxford (England) and the U.K. National Institute for Health Research.
Fast-track protocol cuts lung resection complications, LOS
CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.
“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).
Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.
Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.
To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.
Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.
It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.
After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).
The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.
Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.
In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).
Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.
Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.
The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.
An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.
“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”
CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.
“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”
The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.
“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).
Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.
Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.
To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.
Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.
It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.
After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).
The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.
Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.
In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).
Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.
Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.
The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.
An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.
“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”
CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.
“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”
The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.
“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).
Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.
Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.
To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.
Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.
It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.
After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).
The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.
Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.
In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).
Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.
Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.
The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.
An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.
“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”
CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.
“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”
The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: An enhanced recovery pathway reduces complications and hospital stay following lung cancer resection without raising readmissions or ED visits.
Major finding: Patients in the enhanced recovery pathway vs. traditional care had fewer overall complications (37% vs. 50%; P = .03) and threefold fewer UTIs (3% vs. 12%; P < .01).
Data source: Observational study of 234 patients undergoing lung resection.
Disclosures: The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
26% 1-year death, stroke rate after TAVR
One year after transcatheter aortic valve replacement in the United States, the overall mortality was 23.7%, the stroke rate was 4.1%, and the composite outcome of death and stroke was 26.0%, according to a report published online March 10 in JAMA.
Long-term outcomes for TAVR haven’t been well studied until now, yet the procedure is being performed with increasing frequency for aortic stenosis in patients who are too high risk to undergo conventional surgical aortic valve replacement, said Dr. David R. Holmes Jr. of the Mayo Clinic, Rochester, Minn., and his associates.
They assessed 1-year outcomes by analyzing administrative data from the Centers for Medicare & Medicaid Services and clinical data from the Transcatheter Valve Therapies Registry, an initiative of the Society of Thoracic Surgeons and the American College of Cardiology. The study involved 12,182 patients who underwent TAVR at 299 medical centers across the country during a 19-month period. The patients’ median age was 84 years; 95% were white and 52% were women. The transfemoral approach was used in most patients, but alternative approaches were used in roughly 44%. As expected for an elderly, high-risk study population, baseline functional status was poor and comorbidities were common. They included reduced left ventricular ejection fraction (26% of patients), prior stroke (12%), moderate or severe lung disease (28%), renal failure (16%), peripheral vascular disease (32%), and atrial fibrillation (42%), Dr. Holmes and his associates reported (JAMA 2015 March 10 [doi:10.1001/jama.2015.1474]).
In addition to the mortality and stroke rates listed above, the 1-year rate of one rehospitalization was 24.4%, that of two rehospitalizations was 12.5%, and that of three or more rehospitalizations was 11.6%. The 1-year readmission rate specifically for stroke, heart failure, or repeat aortic valve intervention was 18.6%. These are important considerations for elderly, fragile patients because rehospitalizations indicate “an unacceptable quality-of-life outcome” and are very costly, the investigators noted.
Several baseline characteristics, including male sex, severe chronic obstructive pulmonary disease, dialysis-dependent end-stage renal disease, older age, higher STS Predicted Risk of Operative Mortality (PROM) score, a history of atrial fibrillation/flutter, and use of an access route (other than transfemoral), were found to be independently associated with higher 1-year mortality. Thus, “It may be possible to identify patients who may not benefit from this procedure and who should be counseled accordingly.” For example, in this study there was a small (77 patients) very high-risk subset of patients – aged 85-94 years, dependent on dialysis, and having an STS PROM score greater than 15% – whose 1-year mortality was 53.5%.
The STS and the ACC supported this study, and support the Transcatheter Valve Therapies Registry. Dr. Holmes reported having no relevant financial disclosures; his associates reported ties to Boston Scientific, Edwards Lifesciences, Janssen, Eli Lilly, Boehringer Ingelheim, Bayer, and AstraZeneca.
One year after transcatheter aortic valve replacement in the United States, the overall mortality was 23.7%, the stroke rate was 4.1%, and the composite outcome of death and stroke was 26.0%, according to a report published online March 10 in JAMA.
Long-term outcomes for TAVR haven’t been well studied until now, yet the procedure is being performed with increasing frequency for aortic stenosis in patients who are too high risk to undergo conventional surgical aortic valve replacement, said Dr. David R. Holmes Jr. of the Mayo Clinic, Rochester, Minn., and his associates.
They assessed 1-year outcomes by analyzing administrative data from the Centers for Medicare & Medicaid Services and clinical data from the Transcatheter Valve Therapies Registry, an initiative of the Society of Thoracic Surgeons and the American College of Cardiology. The study involved 12,182 patients who underwent TAVR at 299 medical centers across the country during a 19-month period. The patients’ median age was 84 years; 95% were white and 52% were women. The transfemoral approach was used in most patients, but alternative approaches were used in roughly 44%. As expected for an elderly, high-risk study population, baseline functional status was poor and comorbidities were common. They included reduced left ventricular ejection fraction (26% of patients), prior stroke (12%), moderate or severe lung disease (28%), renal failure (16%), peripheral vascular disease (32%), and atrial fibrillation (42%), Dr. Holmes and his associates reported (JAMA 2015 March 10 [doi:10.1001/jama.2015.1474]).
In addition to the mortality and stroke rates listed above, the 1-year rate of one rehospitalization was 24.4%, that of two rehospitalizations was 12.5%, and that of three or more rehospitalizations was 11.6%. The 1-year readmission rate specifically for stroke, heart failure, or repeat aortic valve intervention was 18.6%. These are important considerations for elderly, fragile patients because rehospitalizations indicate “an unacceptable quality-of-life outcome” and are very costly, the investigators noted.
Several baseline characteristics, including male sex, severe chronic obstructive pulmonary disease, dialysis-dependent end-stage renal disease, older age, higher STS Predicted Risk of Operative Mortality (PROM) score, a history of atrial fibrillation/flutter, and use of an access route (other than transfemoral), were found to be independently associated with higher 1-year mortality. Thus, “It may be possible to identify patients who may not benefit from this procedure and who should be counseled accordingly.” For example, in this study there was a small (77 patients) very high-risk subset of patients – aged 85-94 years, dependent on dialysis, and having an STS PROM score greater than 15% – whose 1-year mortality was 53.5%.
The STS and the ACC supported this study, and support the Transcatheter Valve Therapies Registry. Dr. Holmes reported having no relevant financial disclosures; his associates reported ties to Boston Scientific, Edwards Lifesciences, Janssen, Eli Lilly, Boehringer Ingelheim, Bayer, and AstraZeneca.
One year after transcatheter aortic valve replacement in the United States, the overall mortality was 23.7%, the stroke rate was 4.1%, and the composite outcome of death and stroke was 26.0%, according to a report published online March 10 in JAMA.
Long-term outcomes for TAVR haven’t been well studied until now, yet the procedure is being performed with increasing frequency for aortic stenosis in patients who are too high risk to undergo conventional surgical aortic valve replacement, said Dr. David R. Holmes Jr. of the Mayo Clinic, Rochester, Minn., and his associates.
They assessed 1-year outcomes by analyzing administrative data from the Centers for Medicare & Medicaid Services and clinical data from the Transcatheter Valve Therapies Registry, an initiative of the Society of Thoracic Surgeons and the American College of Cardiology. The study involved 12,182 patients who underwent TAVR at 299 medical centers across the country during a 19-month period. The patients’ median age was 84 years; 95% were white and 52% were women. The transfemoral approach was used in most patients, but alternative approaches were used in roughly 44%. As expected for an elderly, high-risk study population, baseline functional status was poor and comorbidities were common. They included reduced left ventricular ejection fraction (26% of patients), prior stroke (12%), moderate or severe lung disease (28%), renal failure (16%), peripheral vascular disease (32%), and atrial fibrillation (42%), Dr. Holmes and his associates reported (JAMA 2015 March 10 [doi:10.1001/jama.2015.1474]).
In addition to the mortality and stroke rates listed above, the 1-year rate of one rehospitalization was 24.4%, that of two rehospitalizations was 12.5%, and that of three or more rehospitalizations was 11.6%. The 1-year readmission rate specifically for stroke, heart failure, or repeat aortic valve intervention was 18.6%. These are important considerations for elderly, fragile patients because rehospitalizations indicate “an unacceptable quality-of-life outcome” and are very costly, the investigators noted.
Several baseline characteristics, including male sex, severe chronic obstructive pulmonary disease, dialysis-dependent end-stage renal disease, older age, higher STS Predicted Risk of Operative Mortality (PROM) score, a history of atrial fibrillation/flutter, and use of an access route (other than transfemoral), were found to be independently associated with higher 1-year mortality. Thus, “It may be possible to identify patients who may not benefit from this procedure and who should be counseled accordingly.” For example, in this study there was a small (77 patients) very high-risk subset of patients – aged 85-94 years, dependent on dialysis, and having an STS PROM score greater than 15% – whose 1-year mortality was 53.5%.
The STS and the ACC supported this study, and support the Transcatheter Valve Therapies Registry. Dr. Holmes reported having no relevant financial disclosures; his associates reported ties to Boston Scientific, Edwards Lifesciences, Janssen, Eli Lilly, Boehringer Ingelheim, Bayer, and AstraZeneca.
FROM JAMA
Key clinical point: Severe chronic obstructive pulmonary disease, end-stage renal disease, older age, higher STS PROM score, and use of an access route (other than transfemoral) are among the baseline characteristics linked with higher 1-year mortality after TAVR.
Major finding: The overall mortality was 23.7%, the stroke rate was 4.1%, and the composite rate of death and stroke was 26% 1 year after TAVR.
Data source: An analysis of data from the Transcatheter Valve Therapies Registry for 12,182 patients who underwent TAVR procedures at 299 U.S. hospitals during a 19-month period.
Disclosures: The Society of Thoracic Surgeons and the American College of Cardiology supported this study, and support the Transcatheter Valve Therapies Registry. Dr. Holmes reported having no relevant financial disclosures; his associates reported ties to Boston Scientific, Edwards Lifesciences, Janssen, Eli Lilly, Boehringer Ingelheim, Bayer, and AstraZeneca.
Genetic blood profiles can estimate risk levels of VTE patients
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).
Esophagogastric cancer patients on chemotherapy more likely to develop VTE
Incidence rates for developing venous thromboembolism (VTE) among esophagogastric cancer patients undergoing neoadjuvant chemotherapy in combination with curative intended surgery were significantly higher among patients with initial stage III and IV cancers and gastric cancer, according to a new study published in Thrombosis Research.
In the clinical prospective study, 129 patients with lower esophageal, gastroesophageal, and gastric cancer were examined between 2008 and 2011. Baseline assessments were recorded via bilateral compression ultrasound (biCUS) for deep vein thrombosis and computer tomography pulmonary angiography for pulmonary embolism. The patients received a chemotherapy regimen of oxaliplatin, capecitabine, and epirubicin, with curative intended surgery, and were examined before undergoing preoperative chemotherapy, surgery, and postoperative chemotherapy. The researchers encountered 21 VTE cases, or 16% of the total number of patients examined, with VTE incidences twice as likely to be asymptomatic than symptomatic.
The authors noted that state-of-the-art technology helped boost VTE detection rates among asymptomatic patients, and older studies may have underreported incidences of the disease.
“Although our study only included 129 patients, the systematic use of biCUS strongly suggests that the frequency of VTE is much greater than that previously reported for these types of cancer,” wrote Dr. Anders Christian Larsen and his associates at Aalborg University Hospital, Denmark.
Read more here (Thrombosis Research 2015 [doi:10.1016/j.thromres.2015.01.021]).
Incidence rates for developing venous thromboembolism (VTE) among esophagogastric cancer patients undergoing neoadjuvant chemotherapy in combination with curative intended surgery were significantly higher among patients with initial stage III and IV cancers and gastric cancer, according to a new study published in Thrombosis Research.
In the clinical prospective study, 129 patients with lower esophageal, gastroesophageal, and gastric cancer were examined between 2008 and 2011. Baseline assessments were recorded via bilateral compression ultrasound (biCUS) for deep vein thrombosis and computer tomography pulmonary angiography for pulmonary embolism. The patients received a chemotherapy regimen of oxaliplatin, capecitabine, and epirubicin, with curative intended surgery, and were examined before undergoing preoperative chemotherapy, surgery, and postoperative chemotherapy. The researchers encountered 21 VTE cases, or 16% of the total number of patients examined, with VTE incidences twice as likely to be asymptomatic than symptomatic.
The authors noted that state-of-the-art technology helped boost VTE detection rates among asymptomatic patients, and older studies may have underreported incidences of the disease.
“Although our study only included 129 patients, the systematic use of biCUS strongly suggests that the frequency of VTE is much greater than that previously reported for these types of cancer,” wrote Dr. Anders Christian Larsen and his associates at Aalborg University Hospital, Denmark.
Read more here (Thrombosis Research 2015 [doi:10.1016/j.thromres.2015.01.021]).
Incidence rates for developing venous thromboembolism (VTE) among esophagogastric cancer patients undergoing neoadjuvant chemotherapy in combination with curative intended surgery were significantly higher among patients with initial stage III and IV cancers and gastric cancer, according to a new study published in Thrombosis Research.
In the clinical prospective study, 129 patients with lower esophageal, gastroesophageal, and gastric cancer were examined between 2008 and 2011. Baseline assessments were recorded via bilateral compression ultrasound (biCUS) for deep vein thrombosis and computer tomography pulmonary angiography for pulmonary embolism. The patients received a chemotherapy regimen of oxaliplatin, capecitabine, and epirubicin, with curative intended surgery, and were examined before undergoing preoperative chemotherapy, surgery, and postoperative chemotherapy. The researchers encountered 21 VTE cases, or 16% of the total number of patients examined, with VTE incidences twice as likely to be asymptomatic than symptomatic.
The authors noted that state-of-the-art technology helped boost VTE detection rates among asymptomatic patients, and older studies may have underreported incidences of the disease.
“Although our study only included 129 patients, the systematic use of biCUS strongly suggests that the frequency of VTE is much greater than that previously reported for these types of cancer,” wrote Dr. Anders Christian Larsen and his associates at Aalborg University Hospital, Denmark.
Read more here (Thrombosis Research 2015 [doi:10.1016/j.thromres.2015.01.021]).
New: Applications Open for 'Every Heartbeat Matters' Valve Disease Fellowship; Deadline March 31st
The AATS Graham Foundation is pleased to announce a new partnership with the Edwards Lifesciences Foundation — the Every Heartbeat Matters Valve Fellowship. The mission of Every Heartbeat Matters is to impact the global burden of heart valve disease by serving one million people by 2020.
The fellowship’s goal is to enhance the knowledge and skills of practicing cardiothoracic surgeons who are already treating or committed to treating underserved patients worldwide. It provides up to three months of advanced heart valve disease training and education at a host institution.
Curriculum
The Fellowship curriculum will cover non-thrombogenic valve surgery, focusing on advanced training in valve reconstruction and use of biological valve replacements (surgical and transcatheter) for:
** Degenerative mitral valve disease
** Rheumatic mitral valve disease
** Aortic stenosis/regurgitation
** Functional tricuspid regurgitation
** Endocarditis
Training Center
The applicant is responsible for identifying a training center whose curriculum includes a sufficient amount of mitral, aortic and tricuspid valve surgery to fulfill his/her fellowship goals. S/he must include a letter of support from the institution chosen.
Benefits
The Fellowship will provide annual awards to defray travel and living expenses. There will be two funding levels:
** Level One — Up to $7,500 (up to one month)
** Level Two — Up to $15,000 (between one and three months)
Eligibility Criteria
To apply for the fellowship, an applicant must:
** Have completed his/her cardiac and/or cardiothoracic surgery training.
** Meet all necessary prerequisites for travel to and from the training center such as a visa and license requirements.
** Provide information on the number of underserved patients s/he cares for annually.
Application Process
Each surgeon must fill out the formal application and include the following in his/her submission:
** Curriculum vitae
** If serving in a hospital/medical school — a letter from his/her chief/chair.
** A letter of support from the proposed training center.
** A detailed plan outline for the proposed training, including with a timeline.
** A one-page narrative describing: (1) Learning goals while at the proposed training center. (2) The relationship of the planned course of study to his/her prior work and professional goals.
** A detailed outline of his/her current practice with an estimate of the number of underserved patients s/he treats annually, including: (1) Types of diseases currently treated. (2) An estimate of the number of VHD patients s/he may serve after training is completed.
Post-Fellowship Reporting
Fellows will be required to provide two reports detailing benefits of their training.
Deadline: March 31, 2015
For more information: http://aatsgrahamfoundation.org/awards_valveFellowship.cgi
AATS Graham Foundation: www.AATSGrahamFoundation.org
The AATS Graham Foundation is pleased to announce a new partnership with the Edwards Lifesciences Foundation — the Every Heartbeat Matters Valve Fellowship. The mission of Every Heartbeat Matters is to impact the global burden of heart valve disease by serving one million people by 2020.
The fellowship’s goal is to enhance the knowledge and skills of practicing cardiothoracic surgeons who are already treating or committed to treating underserved patients worldwide. It provides up to three months of advanced heart valve disease training and education at a host institution.
Curriculum
The Fellowship curriculum will cover non-thrombogenic valve surgery, focusing on advanced training in valve reconstruction and use of biological valve replacements (surgical and transcatheter) for:
** Degenerative mitral valve disease
** Rheumatic mitral valve disease
** Aortic stenosis/regurgitation
** Functional tricuspid regurgitation
** Endocarditis
Training Center
The applicant is responsible for identifying a training center whose curriculum includes a sufficient amount of mitral, aortic and tricuspid valve surgery to fulfill his/her fellowship goals. S/he must include a letter of support from the institution chosen.
Benefits
The Fellowship will provide annual awards to defray travel and living expenses. There will be two funding levels:
** Level One — Up to $7,500 (up to one month)
** Level Two — Up to $15,000 (between one and three months)
Eligibility Criteria
To apply for the fellowship, an applicant must:
** Have completed his/her cardiac and/or cardiothoracic surgery training.
** Meet all necessary prerequisites for travel to and from the training center such as a visa and license requirements.
** Provide information on the number of underserved patients s/he cares for annually.
Application Process
Each surgeon must fill out the formal application and include the following in his/her submission:
** Curriculum vitae
** If serving in a hospital/medical school — a letter from his/her chief/chair.
** A letter of support from the proposed training center.
** A detailed plan outline for the proposed training, including with a timeline.
** A one-page narrative describing: (1) Learning goals while at the proposed training center. (2) The relationship of the planned course of study to his/her prior work and professional goals.
** A detailed outline of his/her current practice with an estimate of the number of underserved patients s/he treats annually, including: (1) Types of diseases currently treated. (2) An estimate of the number of VHD patients s/he may serve after training is completed.
Post-Fellowship Reporting
Fellows will be required to provide two reports detailing benefits of their training.
Deadline: March 31, 2015
For more information: http://aatsgrahamfoundation.org/awards_valveFellowship.cgi
AATS Graham Foundation: www.AATSGrahamFoundation.org
The AATS Graham Foundation is pleased to announce a new partnership with the Edwards Lifesciences Foundation — the Every Heartbeat Matters Valve Fellowship. The mission of Every Heartbeat Matters is to impact the global burden of heart valve disease by serving one million people by 2020.
The fellowship’s goal is to enhance the knowledge and skills of practicing cardiothoracic surgeons who are already treating or committed to treating underserved patients worldwide. It provides up to three months of advanced heart valve disease training and education at a host institution.
Curriculum
The Fellowship curriculum will cover non-thrombogenic valve surgery, focusing on advanced training in valve reconstruction and use of biological valve replacements (surgical and transcatheter) for:
** Degenerative mitral valve disease
** Rheumatic mitral valve disease
** Aortic stenosis/regurgitation
** Functional tricuspid regurgitation
** Endocarditis
Training Center
The applicant is responsible for identifying a training center whose curriculum includes a sufficient amount of mitral, aortic and tricuspid valve surgery to fulfill his/her fellowship goals. S/he must include a letter of support from the institution chosen.
Benefits
The Fellowship will provide annual awards to defray travel and living expenses. There will be two funding levels:
** Level One — Up to $7,500 (up to one month)
** Level Two — Up to $15,000 (between one and three months)
Eligibility Criteria
To apply for the fellowship, an applicant must:
** Have completed his/her cardiac and/or cardiothoracic surgery training.
** Meet all necessary prerequisites for travel to and from the training center such as a visa and license requirements.
** Provide information on the number of underserved patients s/he cares for annually.
Application Process
Each surgeon must fill out the formal application and include the following in his/her submission:
** Curriculum vitae
** If serving in a hospital/medical school — a letter from his/her chief/chair.
** A letter of support from the proposed training center.
** A detailed plan outline for the proposed training, including with a timeline.
** A one-page narrative describing: (1) Learning goals while at the proposed training center. (2) The relationship of the planned course of study to his/her prior work and professional goals.
** A detailed outline of his/her current practice with an estimate of the number of underserved patients s/he treats annually, including: (1) Types of diseases currently treated. (2) An estimate of the number of VHD patients s/he may serve after training is completed.
Post-Fellowship Reporting
Fellows will be required to provide two reports detailing benefits of their training.
Deadline: March 31, 2015
For more information: http://aatsgrahamfoundation.org/awards_valveFellowship.cgi
AATS Graham Foundation: www.AATSGrahamFoundation.org
ACS NSQIP hospitals steadily improve surgical outcomes
Surgical performance data gathered within the American College of Surgeons, National Surgical Quality Improvement Program (ACS NSQIP) from the period of 2006-2013 indicate improved performance by most participating hospitals over time. In the categories of mortality, morbidity, and surgical site infections (SSI), the ratio of observed to expected surgery-related adverse events declined over time, showing that with increasing years of participation in ACS NSQIP, hospitals saw cumulative reductions in observed/expected ratios.
Dr. Clifford Y. Ko, coauthor of the report, an ACS Fellow and professor of surgery at David Geffen School of Medicine, University of California Los Angeles, spoke in an interview about the results, which were published in Annals of Surgery.
“An important finding from our study is that hospitals get better when they participate in ACS NSQIP, and the longer they are in the program, the better they get. It means that if hospitals commit to going on the journey of quality improvement, the longer they are on that journey, the better they get, the more experience they get in quality improvement, and the more their outcomes improve.
“Another important point that became evident from the analysis was that the biggest area for improvement is in the rate of complications, more so than mortality. The mortality rate is already low, and the number of preventable deaths is low. There are many more preventable complications than preventable deaths. The data show that risk-adjusted complications decrease over time because many opportunities lie in decreasing rates of infection, blood clot, pneumonia, urinary tract infection, and others. Whatever rate the hospital starts in ACS NSQIP, there is more opportunity to realize improvements in the number of complications than in mortality.”
The researchers used clinical data collected from 2006 to 2013 from 515 hospitals participating in ACS NSQIP.
Hospitals participating in the program receive semiannual reports that benchmark performance compared to other similar institutions. But the performance benchmarks are continuously updated to reflect current practices across groups of similar institutions, so individual hospitals cannot gauge whether their performance improves over time relative to fixed standard.
“The aim of the study was to determine if over several years hospitals who participated in ACS NSQIP got better. Benchmarking data provides feedback, but does not indicate whether over time hospitals improve. Our analysis looked at hospital performance longitudinally to evaluate if they got better from year to year,” said Dr. Ko.
To make meaningful comparisons of surgical outcomes, expected outcomes were calculated based on risk adjustments to compensate for differences in patient characteristics and the risk profile of procedures performed. Dr. Ko explained, “Large, tertiary institutions that care for very sick patients, or very complex cases, are expected to have worse outcomes than hospitals that perform more common procedures with lower expected event rates. In this analysis, the results of interest are the trends in observed/expected (O/E) event rates, which adjust for these risks.”
For all hospitals, 62%, 70%, and 65% had negative slopes for mortality, morbidity, and any SSI, respectively. The O/E ratios for mortality, morbidity, and SSI declined with each year of participation in the program, and the slope of the decline was steepest for morbidity and SSI. SSI is the most common complication and largely mirrors morbidity. For hospitals in the program at least 3 years, annual reductions in mortality, morbidity, and SSI were estimated to be 0.8%, 3.1%, and 2.6%, respectively.
One of the hallmarks of ACS NSQIP is the accuracy of the data, which come directly from medical records. In a large study comparing clinical with billing (or administrative) data, Dr. Ko and colleagues found the accuracy of billing data to be low.
“In a 2-year study we merged clinical and administrative data from over 100,000 patients and found the agreement to be poor. Billing data had a detection rate for SSI of 25% and a false-positive rate of 70%,” he said.
“In developing programs to improve patient care, we want to base our work on the most accurate data possible. Our analysis shows that hospitals committed to using ACS NSQIP improve over time.”
The authors reported having no financial disclosures.
Surgical performance data gathered within the American College of Surgeons, National Surgical Quality Improvement Program (ACS NSQIP) from the period of 2006-2013 indicate improved performance by most participating hospitals over time. In the categories of mortality, morbidity, and surgical site infections (SSI), the ratio of observed to expected surgery-related adverse events declined over time, showing that with increasing years of participation in ACS NSQIP, hospitals saw cumulative reductions in observed/expected ratios.
Dr. Clifford Y. Ko, coauthor of the report, an ACS Fellow and professor of surgery at David Geffen School of Medicine, University of California Los Angeles, spoke in an interview about the results, which were published in Annals of Surgery.
“An important finding from our study is that hospitals get better when they participate in ACS NSQIP, and the longer they are in the program, the better they get. It means that if hospitals commit to going on the journey of quality improvement, the longer they are on that journey, the better they get, the more experience they get in quality improvement, and the more their outcomes improve.
“Another important point that became evident from the analysis was that the biggest area for improvement is in the rate of complications, more so than mortality. The mortality rate is already low, and the number of preventable deaths is low. There are many more preventable complications than preventable deaths. The data show that risk-adjusted complications decrease over time because many opportunities lie in decreasing rates of infection, blood clot, pneumonia, urinary tract infection, and others. Whatever rate the hospital starts in ACS NSQIP, there is more opportunity to realize improvements in the number of complications than in mortality.”
The researchers used clinical data collected from 2006 to 2013 from 515 hospitals participating in ACS NSQIP.
Hospitals participating in the program receive semiannual reports that benchmark performance compared to other similar institutions. But the performance benchmarks are continuously updated to reflect current practices across groups of similar institutions, so individual hospitals cannot gauge whether their performance improves over time relative to fixed standard.
“The aim of the study was to determine if over several years hospitals who participated in ACS NSQIP got better. Benchmarking data provides feedback, but does not indicate whether over time hospitals improve. Our analysis looked at hospital performance longitudinally to evaluate if they got better from year to year,” said Dr. Ko.
To make meaningful comparisons of surgical outcomes, expected outcomes were calculated based on risk adjustments to compensate for differences in patient characteristics and the risk profile of procedures performed. Dr. Ko explained, “Large, tertiary institutions that care for very sick patients, or very complex cases, are expected to have worse outcomes than hospitals that perform more common procedures with lower expected event rates. In this analysis, the results of interest are the trends in observed/expected (O/E) event rates, which adjust for these risks.”
For all hospitals, 62%, 70%, and 65% had negative slopes for mortality, morbidity, and any SSI, respectively. The O/E ratios for mortality, morbidity, and SSI declined with each year of participation in the program, and the slope of the decline was steepest for morbidity and SSI. SSI is the most common complication and largely mirrors morbidity. For hospitals in the program at least 3 years, annual reductions in mortality, morbidity, and SSI were estimated to be 0.8%, 3.1%, and 2.6%, respectively.
One of the hallmarks of ACS NSQIP is the accuracy of the data, which come directly from medical records. In a large study comparing clinical with billing (or administrative) data, Dr. Ko and colleagues found the accuracy of billing data to be low.
“In a 2-year study we merged clinical and administrative data from over 100,000 patients and found the agreement to be poor. Billing data had a detection rate for SSI of 25% and a false-positive rate of 70%,” he said.
“In developing programs to improve patient care, we want to base our work on the most accurate data possible. Our analysis shows that hospitals committed to using ACS NSQIP improve over time.”
The authors reported having no financial disclosures.
Surgical performance data gathered within the American College of Surgeons, National Surgical Quality Improvement Program (ACS NSQIP) from the period of 2006-2013 indicate improved performance by most participating hospitals over time. In the categories of mortality, morbidity, and surgical site infections (SSI), the ratio of observed to expected surgery-related adverse events declined over time, showing that with increasing years of participation in ACS NSQIP, hospitals saw cumulative reductions in observed/expected ratios.
Dr. Clifford Y. Ko, coauthor of the report, an ACS Fellow and professor of surgery at David Geffen School of Medicine, University of California Los Angeles, spoke in an interview about the results, which were published in Annals of Surgery.
“An important finding from our study is that hospitals get better when they participate in ACS NSQIP, and the longer they are in the program, the better they get. It means that if hospitals commit to going on the journey of quality improvement, the longer they are on that journey, the better they get, the more experience they get in quality improvement, and the more their outcomes improve.
“Another important point that became evident from the analysis was that the biggest area for improvement is in the rate of complications, more so than mortality. The mortality rate is already low, and the number of preventable deaths is low. There are many more preventable complications than preventable deaths. The data show that risk-adjusted complications decrease over time because many opportunities lie in decreasing rates of infection, blood clot, pneumonia, urinary tract infection, and others. Whatever rate the hospital starts in ACS NSQIP, there is more opportunity to realize improvements in the number of complications than in mortality.”
The researchers used clinical data collected from 2006 to 2013 from 515 hospitals participating in ACS NSQIP.
Hospitals participating in the program receive semiannual reports that benchmark performance compared to other similar institutions. But the performance benchmarks are continuously updated to reflect current practices across groups of similar institutions, so individual hospitals cannot gauge whether their performance improves over time relative to fixed standard.
“The aim of the study was to determine if over several years hospitals who participated in ACS NSQIP got better. Benchmarking data provides feedback, but does not indicate whether over time hospitals improve. Our analysis looked at hospital performance longitudinally to evaluate if they got better from year to year,” said Dr. Ko.
To make meaningful comparisons of surgical outcomes, expected outcomes were calculated based on risk adjustments to compensate for differences in patient characteristics and the risk profile of procedures performed. Dr. Ko explained, “Large, tertiary institutions that care for very sick patients, or very complex cases, are expected to have worse outcomes than hospitals that perform more common procedures with lower expected event rates. In this analysis, the results of interest are the trends in observed/expected (O/E) event rates, which adjust for these risks.”
For all hospitals, 62%, 70%, and 65% had negative slopes for mortality, morbidity, and any SSI, respectively. The O/E ratios for mortality, morbidity, and SSI declined with each year of participation in the program, and the slope of the decline was steepest for morbidity and SSI. SSI is the most common complication and largely mirrors morbidity. For hospitals in the program at least 3 years, annual reductions in mortality, morbidity, and SSI were estimated to be 0.8%, 3.1%, and 2.6%, respectively.
One of the hallmarks of ACS NSQIP is the accuracy of the data, which come directly from medical records. In a large study comparing clinical with billing (or administrative) data, Dr. Ko and colleagues found the accuracy of billing data to be low.
“In a 2-year study we merged clinical and administrative data from over 100,000 patients and found the agreement to be poor. Billing data had a detection rate for SSI of 25% and a false-positive rate of 70%,” he said.
“In developing programs to improve patient care, we want to base our work on the most accurate data possible. Our analysis shows that hospitals committed to using ACS NSQIP improve over time.”
The authors reported having no financial disclosures.
FROM ANNALS OF SURGERY
Key clinical point: As length of hospital participation in ACS NSQIP increased, the ratio of observed/expected surgery-related adverse events declined.
Major finding: Improvements in morbidity were observed in 70% of participating hospitals; for surgical site infections, in 65% of hospitals; for mortality, in 62% of hospitals.
Data source: Clinical data from 2006 to 2013 from 515 hospitals participating in ACS NSQIP.
Disclosures: The authors reported having no financial disclosures.
FDA: Limit testosterone use to men with specific medical conditions
Testosterone therapy is not appropriate for men with age-related low testosterone because it may be associated with an increased risk of cardiovascular events, the Food and Drug Administration has determined.
The agency will now require labeling changes to all prescription testosterone products, clarifying their appropriate use, and warning about a possible increased risk of heart attack and stroke in any patient taking the hormone. Testosterone is approved only for men with specific medical conditions, but is widely used off label for men with age-related low testosterone.
“Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy,” an FDA statement said. “We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.”
The statement arose from a September 2014 recommendation by the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. The groups reviewed studies of aging men using testosterone – some of which reported an increased risk of heart attack, stroke, or death associated with testosterone treatment – and voted 20-1 that the current indication, as worded in the labeling for all testosterone products, should be tightened to make it clear that testosterone therapy is not indicated for men with age-related reductions in testosterone.
Any clinician who prescribes testosterone to a patient who later experiences a cardiovascular event should report that toFDA’s MedWatch Safety Information and Adverse Event Reporting Program.
On Twitter @alz_gal
Testosterone therapy is not appropriate for men with age-related low testosterone because it may be associated with an increased risk of cardiovascular events, the Food and Drug Administration has determined.
The agency will now require labeling changes to all prescription testosterone products, clarifying their appropriate use, and warning about a possible increased risk of heart attack and stroke in any patient taking the hormone. Testosterone is approved only for men with specific medical conditions, but is widely used off label for men with age-related low testosterone.
“Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy,” an FDA statement said. “We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.”
The statement arose from a September 2014 recommendation by the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. The groups reviewed studies of aging men using testosterone – some of which reported an increased risk of heart attack, stroke, or death associated with testosterone treatment – and voted 20-1 that the current indication, as worded in the labeling for all testosterone products, should be tightened to make it clear that testosterone therapy is not indicated for men with age-related reductions in testosterone.
Any clinician who prescribes testosterone to a patient who later experiences a cardiovascular event should report that toFDA’s MedWatch Safety Information and Adverse Event Reporting Program.
On Twitter @alz_gal
Testosterone therapy is not appropriate for men with age-related low testosterone because it may be associated with an increased risk of cardiovascular events, the Food and Drug Administration has determined.
The agency will now require labeling changes to all prescription testosterone products, clarifying their appropriate use, and warning about a possible increased risk of heart attack and stroke in any patient taking the hormone. Testosterone is approved only for men with specific medical conditions, but is widely used off label for men with age-related low testosterone.
“Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy,” an FDA statement said. “We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.”
The statement arose from a September 2014 recommendation by the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. The groups reviewed studies of aging men using testosterone – some of which reported an increased risk of heart attack, stroke, or death associated with testosterone treatment – and voted 20-1 that the current indication, as worded in the labeling for all testosterone products, should be tightened to make it clear that testosterone therapy is not indicated for men with age-related reductions in testosterone.
Any clinician who prescribes testosterone to a patient who later experiences a cardiovascular event should report that toFDA’s MedWatch Safety Information and Adverse Event Reporting Program.
On Twitter @alz_gal
STS releases public surgical outcomes report
The Society of Thoracic Surgeons has released a public online report of national surgical outcomes from its Congenital Heart Surgery Database, the association has announced.
The STS report focuses on pediatric and congenital cardiac malformations, and includes 4-year observed, expected, and risk-adjusted mortality rates, the society said in a statement.
Twenty-five sites participated in the first round of STS public online reporting, similar to the observed participation in the first round of public reporting in the STS Adult Cardiac Surgery Database, which started in 2010.
“Reporting hospital surgical outcomes using risk-adjusted analysis is extremely important because it allows for a fair assessment, on a level playing field, of outcomes across hospitals that treat different populations of patients,” Dr. Marshall L. Jacobs, STS CHSD Task Force chair, said in the statement.
For more information, visit http://www.sts.org/quality-research-patient-safety/sts-public-reporting-online.
The Society of Thoracic Surgeons has released a public online report of national surgical outcomes from its Congenital Heart Surgery Database, the association has announced.
The STS report focuses on pediatric and congenital cardiac malformations, and includes 4-year observed, expected, and risk-adjusted mortality rates, the society said in a statement.
Twenty-five sites participated in the first round of STS public online reporting, similar to the observed participation in the first round of public reporting in the STS Adult Cardiac Surgery Database, which started in 2010.
“Reporting hospital surgical outcomes using risk-adjusted analysis is extremely important because it allows for a fair assessment, on a level playing field, of outcomes across hospitals that treat different populations of patients,” Dr. Marshall L. Jacobs, STS CHSD Task Force chair, said in the statement.
For more information, visit http://www.sts.org/quality-research-patient-safety/sts-public-reporting-online.
The Society of Thoracic Surgeons has released a public online report of national surgical outcomes from its Congenital Heart Surgery Database, the association has announced.
The STS report focuses on pediatric and congenital cardiac malformations, and includes 4-year observed, expected, and risk-adjusted mortality rates, the society said in a statement.
Twenty-five sites participated in the first round of STS public online reporting, similar to the observed participation in the first round of public reporting in the STS Adult Cardiac Surgery Database, which started in 2010.
“Reporting hospital surgical outcomes using risk-adjusted analysis is extremely important because it allows for a fair assessment, on a level playing field, of outcomes across hospitals that treat different populations of patients,” Dr. Marshall L. Jacobs, STS CHSD Task Force chair, said in the statement.
For more information, visit http://www.sts.org/quality-research-patient-safety/sts-public-reporting-online.