User login
General surgeons have high confidence after training
SAN DIEGO – Graduates of U.S. surgical residency training are generally very satisfied with their postgraduate choices, whether they opt for fellowships or not.
However, the 20% who opt to practice as general surgeons rather than pursuing subspecialty and fellowship training are more confident of their skills as they emerge from residency. “Specialty training does not result in greater confidence,” said Dr. Mary Klingensmith, professor of surgery and vice chair for education at Washington University, St. Louis. She discussed these results and other insights drawn from a nationwide survey of surgical residency graduates at the annual meeting of the American Surgical Association.
Dr. Klingensmith noted that there is a growing deficit of general surgeons, with a 25% decline in practicing general surgeons over the last 2 decades and an additional 18% decline projected over the next 20 years. A need existed, she said, for a systematic survey of recent graduates to identify the factors that play into the decision to pursue postgraduate training rather than enter directly into practice as a general surgeon.
A survey developed by American Board of Surgery (ABS) directors and executive staff was sent to all allopathic general surgery (GS) graduates from 2009 to 2013. Of 5,512 graduates, 3,354 (61%) responded. About three-quarters of respondents were specialist surgeons (SS).
The analysis of survey results conducted by Dr. Klingensmith and her colleagues compared the general to the specialist surgeons’ responses, and linked the surveys to the ABS database, which provided demographic characteristics that included residency program type, performance on board exams, and the postgraduate fellowship pursued, if any.
Surgeons were surveyed about their level of confidence in the independent practice of 16 common general procedures, including such “bread and butter” procedures as laparoscopic appendectomy and cholecystectomy, herniorrhaphy, and screening colonoscopies. Respondents were also asked to indicate how confident they were performing less common procedures, including tracheostomies, arterioveneous (AV) fistulas for dialysis, laparoscopic Nissen fundoplications, thyroidectomies, and laparoscopic colon resections.
Responses on a five-point Likert scale were sorted by type of subspecialty training, if any. After the most confident group – pediatric surgeons – general surgeons were significantly more likely to feel confident in their surgical skills than were the other specialist surgeons (P < .0001). Essentially all general surgery respondents were “very” or “mostly” confident of their ability to perform such common procedures as laparoscopic appendectomies and cholecystectomies, as well as ventral herniorrhaphies. Confidence decreased for specialists and nonspecialists alike for the more complex and less common surgeries. Overall, 94% of general surgeons and 90% of specialist surgeons were very or mostly confident of their abilities.
For general surgeons, factors influencing their choices included the opportunity for a broad scope of practice (63%), the influence of a mentor (56%), readiness to be done with training (26%), and being confident with the amount of training received (26%). For the specialists, the most influential factors included high degree of interest in the chosen specialty (57%), interest in improving specific skills (35%), and the opportunity to increase confidence and experience (35%). Both groups felt they’d made the right decision overall: 94% of general surgery graduates and 90% of those pursuing fellowships were very or somewhat satisfied with their career choices.
Study limitations included the risk of nonresponder bias, and the fact that only the most common procedures were included in the survey. Also, no outcome data were available to validate self-perceptions of competence, said Dr. Klingensmith.
The survey and its analysis “have implications that are enormous for the workforce needs of the country, and it’s clear that lack of confidence is an issue for a small but likely significant number of trainees,” said discussant Dr. J. David Richardson of the University of Louisville (Ky.). Greater opportunities for general surgery rotations, as well as stronger general surgery mentorship during residency, may help increase the number of general surgeons entering practice in the future, said Dr. Klingensmith.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
SAN DIEGO – Graduates of U.S. surgical residency training are generally very satisfied with their postgraduate choices, whether they opt for fellowships or not.
However, the 20% who opt to practice as general surgeons rather than pursuing subspecialty and fellowship training are more confident of their skills as they emerge from residency. “Specialty training does not result in greater confidence,” said Dr. Mary Klingensmith, professor of surgery and vice chair for education at Washington University, St. Louis. She discussed these results and other insights drawn from a nationwide survey of surgical residency graduates at the annual meeting of the American Surgical Association.
Dr. Klingensmith noted that there is a growing deficit of general surgeons, with a 25% decline in practicing general surgeons over the last 2 decades and an additional 18% decline projected over the next 20 years. A need existed, she said, for a systematic survey of recent graduates to identify the factors that play into the decision to pursue postgraduate training rather than enter directly into practice as a general surgeon.
A survey developed by American Board of Surgery (ABS) directors and executive staff was sent to all allopathic general surgery (GS) graduates from 2009 to 2013. Of 5,512 graduates, 3,354 (61%) responded. About three-quarters of respondents were specialist surgeons (SS).
The analysis of survey results conducted by Dr. Klingensmith and her colleagues compared the general to the specialist surgeons’ responses, and linked the surveys to the ABS database, which provided demographic characteristics that included residency program type, performance on board exams, and the postgraduate fellowship pursued, if any.
Surgeons were surveyed about their level of confidence in the independent practice of 16 common general procedures, including such “bread and butter” procedures as laparoscopic appendectomy and cholecystectomy, herniorrhaphy, and screening colonoscopies. Respondents were also asked to indicate how confident they were performing less common procedures, including tracheostomies, arterioveneous (AV) fistulas for dialysis, laparoscopic Nissen fundoplications, thyroidectomies, and laparoscopic colon resections.
Responses on a five-point Likert scale were sorted by type of subspecialty training, if any. After the most confident group – pediatric surgeons – general surgeons were significantly more likely to feel confident in their surgical skills than were the other specialist surgeons (P < .0001). Essentially all general surgery respondents were “very” or “mostly” confident of their ability to perform such common procedures as laparoscopic appendectomies and cholecystectomies, as well as ventral herniorrhaphies. Confidence decreased for specialists and nonspecialists alike for the more complex and less common surgeries. Overall, 94% of general surgeons and 90% of specialist surgeons were very or mostly confident of their abilities.
For general surgeons, factors influencing their choices included the opportunity for a broad scope of practice (63%), the influence of a mentor (56%), readiness to be done with training (26%), and being confident with the amount of training received (26%). For the specialists, the most influential factors included high degree of interest in the chosen specialty (57%), interest in improving specific skills (35%), and the opportunity to increase confidence and experience (35%). Both groups felt they’d made the right decision overall: 94% of general surgery graduates and 90% of those pursuing fellowships were very or somewhat satisfied with their career choices.
Study limitations included the risk of nonresponder bias, and the fact that only the most common procedures were included in the survey. Also, no outcome data were available to validate self-perceptions of competence, said Dr. Klingensmith.
The survey and its analysis “have implications that are enormous for the workforce needs of the country, and it’s clear that lack of confidence is an issue for a small but likely significant number of trainees,” said discussant Dr. J. David Richardson of the University of Louisville (Ky.). Greater opportunities for general surgery rotations, as well as stronger general surgery mentorship during residency, may help increase the number of general surgeons entering practice in the future, said Dr. Klingensmith.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
SAN DIEGO – Graduates of U.S. surgical residency training are generally very satisfied with their postgraduate choices, whether they opt for fellowships or not.
However, the 20% who opt to practice as general surgeons rather than pursuing subspecialty and fellowship training are more confident of their skills as they emerge from residency. “Specialty training does not result in greater confidence,” said Dr. Mary Klingensmith, professor of surgery and vice chair for education at Washington University, St. Louis. She discussed these results and other insights drawn from a nationwide survey of surgical residency graduates at the annual meeting of the American Surgical Association.
Dr. Klingensmith noted that there is a growing deficit of general surgeons, with a 25% decline in practicing general surgeons over the last 2 decades and an additional 18% decline projected over the next 20 years. A need existed, she said, for a systematic survey of recent graduates to identify the factors that play into the decision to pursue postgraduate training rather than enter directly into practice as a general surgeon.
A survey developed by American Board of Surgery (ABS) directors and executive staff was sent to all allopathic general surgery (GS) graduates from 2009 to 2013. Of 5,512 graduates, 3,354 (61%) responded. About three-quarters of respondents were specialist surgeons (SS).
The analysis of survey results conducted by Dr. Klingensmith and her colleagues compared the general to the specialist surgeons’ responses, and linked the surveys to the ABS database, which provided demographic characteristics that included residency program type, performance on board exams, and the postgraduate fellowship pursued, if any.
Surgeons were surveyed about their level of confidence in the independent practice of 16 common general procedures, including such “bread and butter” procedures as laparoscopic appendectomy and cholecystectomy, herniorrhaphy, and screening colonoscopies. Respondents were also asked to indicate how confident they were performing less common procedures, including tracheostomies, arterioveneous (AV) fistulas for dialysis, laparoscopic Nissen fundoplications, thyroidectomies, and laparoscopic colon resections.
Responses on a five-point Likert scale were sorted by type of subspecialty training, if any. After the most confident group – pediatric surgeons – general surgeons were significantly more likely to feel confident in their surgical skills than were the other specialist surgeons (P < .0001). Essentially all general surgery respondents were “very” or “mostly” confident of their ability to perform such common procedures as laparoscopic appendectomies and cholecystectomies, as well as ventral herniorrhaphies. Confidence decreased for specialists and nonspecialists alike for the more complex and less common surgeries. Overall, 94% of general surgeons and 90% of specialist surgeons were very or mostly confident of their abilities.
For general surgeons, factors influencing their choices included the opportunity for a broad scope of practice (63%), the influence of a mentor (56%), readiness to be done with training (26%), and being confident with the amount of training received (26%). For the specialists, the most influential factors included high degree of interest in the chosen specialty (57%), interest in improving specific skills (35%), and the opportunity to increase confidence and experience (35%). Both groups felt they’d made the right decision overall: 94% of general surgery graduates and 90% of those pursuing fellowships were very or somewhat satisfied with their career choices.
Study limitations included the risk of nonresponder bias, and the fact that only the most common procedures were included in the survey. Also, no outcome data were available to validate self-perceptions of competence, said Dr. Klingensmith.
The survey and its analysis “have implications that are enormous for the workforce needs of the country, and it’s clear that lack of confidence is an issue for a small but likely significant number of trainees,” said discussant Dr. J. David Richardson of the University of Louisville (Ky.). Greater opportunities for general surgery rotations, as well as stronger general surgery mentorship during residency, may help increase the number of general surgeons entering practice in the future, said Dr. Klingensmith.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
AT THE ASA Annual Meeting
Key clinical point: U.S. surgical residency graduates who opt for general surgery are generally more confident than are those choosing fellowships; both groups are satisfied with their choices.
Major findings: General surgery graduates were more confident than were those who chose fellowships, but 94% of general surgery graduates and 90% of those pursuing fellowships were satisfied with their career choices.
Data source: American Board of Surgery survey of all U.S. allopathic surgery residency graduates from 2009 to 2013 to ascertain levels of confidence, perceptions of autonomy, and reasons for opting in or out of postgraduate fellowship training.
Disclosures: The authors reported no conflicts of interest. The ABS provided data to study authors, but the presentation does not necessarily reflect the opinions or policies of the ABS.
Staying fit through midlife may keep cholesterol down
Maintaining cardiorespiratory fitness through early adulthood and midlife delayed unfavorable elevations in blood cholesterol for a group of men whose fitness and overall health was studied over time.
“Strong evidence exists that physical activity is a major modifiable lifestyle factor for preventing dyslipidemia,” said study author Dr. Yong-Moon Mark Park of the University of South Carolina, Columbia and his associates. They used data from the large Aerobics Center Longitudinal Study (ACLS) to characterize age-related changes in the serum lipid profile and to determine whether cardiorespiratory fitness (CRF) might alter the trajectory of change through the lifespan (J. Am. Coll. Cardiol. 2015;65:2091-100 [doi:10.1016/j.jacc.2015.03.517]).
Assessing the relationship between CRF and blood lipid levels has potentially large clinical and public health significance, since “age-related changes in lipid and lipoprotein concentrations are overall unfavorable,” noted Dr. Park and his associates.
Ordinarily, levels of total cholesterol (TC), LDL cholesterol (LDL-C), and triglycerides (TG) tend to rise over time through middle age and then decrease. The overall pattern of change shows an inverted U shape, with the highest levels occurring at the end of midlife. HDL cholesterol (HDL-C) does not have a consistent pattern of change over time. Previous studies, including robust meta-analyses, have shown that aerobic activity reduces both LDL-C and non HDL-C, but the interplay between CRF and the normal age-related trajectory of blood lipids had not been well understood.
To characterize how CRF affects potentially harmful serum lipid and lipoprotein levels, investigators were able to draw on the ACLS data. This study has been accumulating demographic, lifestyle, medical, and fitness information for a large group of men since 1970.
The ACLS included a thorough assessment of clinical and lifestyle variables, including fasting lipid and glucose levels, blood pressure, body mass index and waist circumference calculation, and body fat calculation. Questionnaires tracked information about physical activity, smoking status, and alcohol use and included an extensive battery of medical history questions.
A modified peak exertion exercise treadmill test, with treadmill time expressed in metabolic equivalents, was used to assess CRF. The analysis standardized CRF for age strata and categorized subjects into low, middle, and high levels of fitness by tertile.
Final analysis included 11,418 men aged at least 20 years who completed at least two examinations and for whom complete study data were available.
Extensive and sophisticated statistical techniques accounted for the many covariates that varied over time, including blood pressure, body fat, waist circumference, and lifestyle factors. A sensitivity analysis was conducted to account for the effect of diabetes or widely varying dietary habits on blood lipid trajectories.
Men with the lowest levels of CRF tended to develop an abnormal lipid profile by as early as their mid-20s until their late 30s. This represented a shift of about 15 years from the age trends of those with the highest levels of CRF. Higher CRF was significantly associated with lower TC, LDL-C, TG, and non–HDL-C and with higher HDL-C, and lower CRF was associated with higher values of all serum lipid markers (all P < 0.0001).
Overall, Dr. Park and his associates said, CRF had a significant effect on the trajectory of change in blood lipid levels over time. “Specifically, CRF was consistently a protective factor for abnormal lipid and lipoprotein profiles, and this prominent effect most frequently appeared between the age of early 20s and early 60s for TC, LDL-C, and non–HDL-C, and between the age of early 20s and early 70s for TG and HDL-C.”
A major limitation of this study was that it included only men. Additionally, participants were over 95% non-Hispanic white, were mostly college graduates, and were of relatively high socioeconomic status. No information about lipid-lowering medication was available, though the authors attempted to control for this lack of data by excluding those with dyslipidemia or known cardiovascular disease at enrollment and follow-up.
The clear association of higher levels of CRF with a delayed elevation of the blood lipid profile shows that “promoting CRF may contribute to a possible delay of dyslipidemia and its related atherosclerosis and CVD,” said Dr. Park and his coworkers.
The study was supported by the National Institutes of Health. One of the investigators is a member of the advisory boards of Technogym, Santech, and Clarity; has received unrestricted research grants from the Coca-Cola Company, Technogym, and BodyMedia; and has received book royalties from Human Kinetics. The other investigators reported having no conflicts of interest.
The clinically relevant insights in this study should be used as a springboard to bring a greater attention to fitness in everyday clinical practice.
Achieving greater levels of fitness at a younger age may provide an opportunity to significantly delay the rise of unfavorable serum lipids and lipoproteins, potentially delaying the onset of atherosclerosis by many years. Among younger patients in the ACLS cohort, the inverse relationship between CRF and fitness was particularly strong, and higher levels of CRF were associated with higher levels of HDL-C through the lifespan.
Enrollees in the ACLS study were, overall, healthier, leaner, and fitter than the general population, so results drawn from ACLS data may have even greater implications for higher-risk populations with more typical fitness and body mass profiles. Caution should be used, though, when generalizing results to women or a more racially diverse population.
However, clinicians should be wary of using patient self-reports of physical activity as an accurate marker for CRF. Subjective assessment of physical activity may significantly underreport activity and fitness as defined by objective criteria, and should not be used as a surrogate for objective measures of fitness.
Physical activity prescriptions by physicians represent an opportunity to encourage physical activity during youth through to midlife and are underused, especially among younger patients. Additionally, closer self-monitoring of activity, as well as the use of pedometers and smart fitness devices, may help individuals assess fitness and activity more realistically.
Dr. Usman Baber and Dr. Paolo Boffetta are from the Mount Sinai School of Medicine, New York. The authors reported no conflicts of interest (J. Am. Coll. Cardiol. 2015;65:2101-3).
The clinically relevant insights in this study should be used as a springboard to bring a greater attention to fitness in everyday clinical practice.
Achieving greater levels of fitness at a younger age may provide an opportunity to significantly delay the rise of unfavorable serum lipids and lipoproteins, potentially delaying the onset of atherosclerosis by many years. Among younger patients in the ACLS cohort, the inverse relationship between CRF and fitness was particularly strong, and higher levels of CRF were associated with higher levels of HDL-C through the lifespan.
Enrollees in the ACLS study were, overall, healthier, leaner, and fitter than the general population, so results drawn from ACLS data may have even greater implications for higher-risk populations with more typical fitness and body mass profiles. Caution should be used, though, when generalizing results to women or a more racially diverse population.
However, clinicians should be wary of using patient self-reports of physical activity as an accurate marker for CRF. Subjective assessment of physical activity may significantly underreport activity and fitness as defined by objective criteria, and should not be used as a surrogate for objective measures of fitness.
Physical activity prescriptions by physicians represent an opportunity to encourage physical activity during youth through to midlife and are underused, especially among younger patients. Additionally, closer self-monitoring of activity, as well as the use of pedometers and smart fitness devices, may help individuals assess fitness and activity more realistically.
Dr. Usman Baber and Dr. Paolo Boffetta are from the Mount Sinai School of Medicine, New York. The authors reported no conflicts of interest (J. Am. Coll. Cardiol. 2015;65:2101-3).
The clinically relevant insights in this study should be used as a springboard to bring a greater attention to fitness in everyday clinical practice.
Achieving greater levels of fitness at a younger age may provide an opportunity to significantly delay the rise of unfavorable serum lipids and lipoproteins, potentially delaying the onset of atherosclerosis by many years. Among younger patients in the ACLS cohort, the inverse relationship between CRF and fitness was particularly strong, and higher levels of CRF were associated with higher levels of HDL-C through the lifespan.
Enrollees in the ACLS study were, overall, healthier, leaner, and fitter than the general population, so results drawn from ACLS data may have even greater implications for higher-risk populations with more typical fitness and body mass profiles. Caution should be used, though, when generalizing results to women or a more racially diverse population.
However, clinicians should be wary of using patient self-reports of physical activity as an accurate marker for CRF. Subjective assessment of physical activity may significantly underreport activity and fitness as defined by objective criteria, and should not be used as a surrogate for objective measures of fitness.
Physical activity prescriptions by physicians represent an opportunity to encourage physical activity during youth through to midlife and are underused, especially among younger patients. Additionally, closer self-monitoring of activity, as well as the use of pedometers and smart fitness devices, may help individuals assess fitness and activity more realistically.
Dr. Usman Baber and Dr. Paolo Boffetta are from the Mount Sinai School of Medicine, New York. The authors reported no conflicts of interest (J. Am. Coll. Cardiol. 2015;65:2101-3).
Maintaining cardiorespiratory fitness through early adulthood and midlife delayed unfavorable elevations in blood cholesterol for a group of men whose fitness and overall health was studied over time.
“Strong evidence exists that physical activity is a major modifiable lifestyle factor for preventing dyslipidemia,” said study author Dr. Yong-Moon Mark Park of the University of South Carolina, Columbia and his associates. They used data from the large Aerobics Center Longitudinal Study (ACLS) to characterize age-related changes in the serum lipid profile and to determine whether cardiorespiratory fitness (CRF) might alter the trajectory of change through the lifespan (J. Am. Coll. Cardiol. 2015;65:2091-100 [doi:10.1016/j.jacc.2015.03.517]).
Assessing the relationship between CRF and blood lipid levels has potentially large clinical and public health significance, since “age-related changes in lipid and lipoprotein concentrations are overall unfavorable,” noted Dr. Park and his associates.
Ordinarily, levels of total cholesterol (TC), LDL cholesterol (LDL-C), and triglycerides (TG) tend to rise over time through middle age and then decrease. The overall pattern of change shows an inverted U shape, with the highest levels occurring at the end of midlife. HDL cholesterol (HDL-C) does not have a consistent pattern of change over time. Previous studies, including robust meta-analyses, have shown that aerobic activity reduces both LDL-C and non HDL-C, but the interplay between CRF and the normal age-related trajectory of blood lipids had not been well understood.
To characterize how CRF affects potentially harmful serum lipid and lipoprotein levels, investigators were able to draw on the ACLS data. This study has been accumulating demographic, lifestyle, medical, and fitness information for a large group of men since 1970.
The ACLS included a thorough assessment of clinical and lifestyle variables, including fasting lipid and glucose levels, blood pressure, body mass index and waist circumference calculation, and body fat calculation. Questionnaires tracked information about physical activity, smoking status, and alcohol use and included an extensive battery of medical history questions.
A modified peak exertion exercise treadmill test, with treadmill time expressed in metabolic equivalents, was used to assess CRF. The analysis standardized CRF for age strata and categorized subjects into low, middle, and high levels of fitness by tertile.
Final analysis included 11,418 men aged at least 20 years who completed at least two examinations and for whom complete study data were available.
Extensive and sophisticated statistical techniques accounted for the many covariates that varied over time, including blood pressure, body fat, waist circumference, and lifestyle factors. A sensitivity analysis was conducted to account for the effect of diabetes or widely varying dietary habits on blood lipid trajectories.
Men with the lowest levels of CRF tended to develop an abnormal lipid profile by as early as their mid-20s until their late 30s. This represented a shift of about 15 years from the age trends of those with the highest levels of CRF. Higher CRF was significantly associated with lower TC, LDL-C, TG, and non–HDL-C and with higher HDL-C, and lower CRF was associated with higher values of all serum lipid markers (all P < 0.0001).
Overall, Dr. Park and his associates said, CRF had a significant effect on the trajectory of change in blood lipid levels over time. “Specifically, CRF was consistently a protective factor for abnormal lipid and lipoprotein profiles, and this prominent effect most frequently appeared between the age of early 20s and early 60s for TC, LDL-C, and non–HDL-C, and between the age of early 20s and early 70s for TG and HDL-C.”
A major limitation of this study was that it included only men. Additionally, participants were over 95% non-Hispanic white, were mostly college graduates, and were of relatively high socioeconomic status. No information about lipid-lowering medication was available, though the authors attempted to control for this lack of data by excluding those with dyslipidemia or known cardiovascular disease at enrollment and follow-up.
The clear association of higher levels of CRF with a delayed elevation of the blood lipid profile shows that “promoting CRF may contribute to a possible delay of dyslipidemia and its related atherosclerosis and CVD,” said Dr. Park and his coworkers.
The study was supported by the National Institutes of Health. One of the investigators is a member of the advisory boards of Technogym, Santech, and Clarity; has received unrestricted research grants from the Coca-Cola Company, Technogym, and BodyMedia; and has received book royalties from Human Kinetics. The other investigators reported having no conflicts of interest.
Maintaining cardiorespiratory fitness through early adulthood and midlife delayed unfavorable elevations in blood cholesterol for a group of men whose fitness and overall health was studied over time.
“Strong evidence exists that physical activity is a major modifiable lifestyle factor for preventing dyslipidemia,” said study author Dr. Yong-Moon Mark Park of the University of South Carolina, Columbia and his associates. They used data from the large Aerobics Center Longitudinal Study (ACLS) to characterize age-related changes in the serum lipid profile and to determine whether cardiorespiratory fitness (CRF) might alter the trajectory of change through the lifespan (J. Am. Coll. Cardiol. 2015;65:2091-100 [doi:10.1016/j.jacc.2015.03.517]).
Assessing the relationship between CRF and blood lipid levels has potentially large clinical and public health significance, since “age-related changes in lipid and lipoprotein concentrations are overall unfavorable,” noted Dr. Park and his associates.
Ordinarily, levels of total cholesterol (TC), LDL cholesterol (LDL-C), and triglycerides (TG) tend to rise over time through middle age and then decrease. The overall pattern of change shows an inverted U shape, with the highest levels occurring at the end of midlife. HDL cholesterol (HDL-C) does not have a consistent pattern of change over time. Previous studies, including robust meta-analyses, have shown that aerobic activity reduces both LDL-C and non HDL-C, but the interplay between CRF and the normal age-related trajectory of blood lipids had not been well understood.
To characterize how CRF affects potentially harmful serum lipid and lipoprotein levels, investigators were able to draw on the ACLS data. This study has been accumulating demographic, lifestyle, medical, and fitness information for a large group of men since 1970.
The ACLS included a thorough assessment of clinical and lifestyle variables, including fasting lipid and glucose levels, blood pressure, body mass index and waist circumference calculation, and body fat calculation. Questionnaires tracked information about physical activity, smoking status, and alcohol use and included an extensive battery of medical history questions.
A modified peak exertion exercise treadmill test, with treadmill time expressed in metabolic equivalents, was used to assess CRF. The analysis standardized CRF for age strata and categorized subjects into low, middle, and high levels of fitness by tertile.
Final analysis included 11,418 men aged at least 20 years who completed at least two examinations and for whom complete study data were available.
Extensive and sophisticated statistical techniques accounted for the many covariates that varied over time, including blood pressure, body fat, waist circumference, and lifestyle factors. A sensitivity analysis was conducted to account for the effect of diabetes or widely varying dietary habits on blood lipid trajectories.
Men with the lowest levels of CRF tended to develop an abnormal lipid profile by as early as their mid-20s until their late 30s. This represented a shift of about 15 years from the age trends of those with the highest levels of CRF. Higher CRF was significantly associated with lower TC, LDL-C, TG, and non–HDL-C and with higher HDL-C, and lower CRF was associated with higher values of all serum lipid markers (all P < 0.0001).
Overall, Dr. Park and his associates said, CRF had a significant effect on the trajectory of change in blood lipid levels over time. “Specifically, CRF was consistently a protective factor for abnormal lipid and lipoprotein profiles, and this prominent effect most frequently appeared between the age of early 20s and early 60s for TC, LDL-C, and non–HDL-C, and between the age of early 20s and early 70s for TG and HDL-C.”
A major limitation of this study was that it included only men. Additionally, participants were over 95% non-Hispanic white, were mostly college graduates, and were of relatively high socioeconomic status. No information about lipid-lowering medication was available, though the authors attempted to control for this lack of data by excluding those with dyslipidemia or known cardiovascular disease at enrollment and follow-up.
The clear association of higher levels of CRF with a delayed elevation of the blood lipid profile shows that “promoting CRF may contribute to a possible delay of dyslipidemia and its related atherosclerosis and CVD,” said Dr. Park and his coworkers.
The study was supported by the National Institutes of Health. One of the investigators is a member of the advisory boards of Technogym, Santech, and Clarity; has received unrestricted research grants from the Coca-Cola Company, Technogym, and BodyMedia; and has received book royalties from Human Kinetics. The other investigators reported having no conflicts of interest.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Higher levels of cardiorespiratory fitness delayed age-related adverse changes in serum lipids.
Major findings: For healthy men with no history of dyslipidemia, maintaining cardiorespiratory fitness was associated with a delay of about 15 years in the rise of unfavorable blood lipid levels.
Data source: Prospective study of 11,418 men enrolled in the Aerobic Center Longitudinal Study between 1970 and 2006.
Disclosures: The study was supported by the National Institutes of Health. One of the investigators is a member of the advisory boards of Technogym, Santech, and Clarity; has received unrestricted research grants from the Coca-Cola Company, Technogym, and BodyMedia; and has received book royalties from Human Kinetics. The other investigators reported having no conflicts of interest.
Celiac disease more than doubles neuropathy risk
Individuals with biopsy-confirmed celiac disease have more than double the risk of receiving a diagnosis of neuropathy when compared with the general population, and the risk persists even when other potentially contributing conditions and lifestyle factors are considered.
The use of Swedish population registries enabled first author Dr. Sujata P. Thawani of Columbia University, New York, and her colleagues to find that the risk of neuropathy was increased both before and after a diagnosis of celiac disease (CD).
“We found an increased risk of neuropathy in patients with CD that persists after CD diagnosis. Although absolute risks for neuropathy are low, CD is a potentially treatable condition with a young age of onset. Our findings suggest that screening could be beneficial in patients with neuropathy,” they wrote (JAMA Neurol. 2015 May 11 [doi:10.1001/jamaneurol.2015.0475]).Neuropathy has a known association with CD, an immune-mediated disorder characterized by sensitivity to gluten with an incidence of about 1% in Western Europe. Previous studies had reported that up to one-third of celiac disease patients also experienced neuropathy, but the literature had not completely characterized the prevalence of neuropathy in the CD population.
Dr. Thawani and her associates used Swedish pathology registers to identify individuals whose small intestine biopsies showed villous atrophy between 1969 and 2008 (Marsh stage 3, n = 28,232). These individuals were categorized as having CD. Neuropathy diagnoses were drawn from national patient and pharmacy registers. Each CD patient was matched with up to five age- and sex-matched controls (n = 139,473) from the Swedish Total Population Registry, all of whom were diagnosed in the same year and were from the same county as the matched CD patient.
Although 41.7% of CD patients were diagnosed in childhood, the median age at diagnosis was 29 years. About 62% of patients in both groups were female. For CD patients, the absolute risk of neuropathy was 64 per 100,000 patient-years, compared with 15 per 100,000 patients-years in the control group (hazard ratio, 2.5; 95% confidence interval, 2.0-2.9; P < .001).
The risk of neuropathy for patients with CD was not affected by gender, absolute age, or age at diagnosis. The risk of neuropathy for those with CD remained about 2.5 times higher than the matched controls, even after accounting for diabetes status, the presence of other autoimmune disorders, vitamin deficiencies, and alcohol use. Although vitamin B12 deficiency has been associated with CD and may contribute to neuropathy, the investigators noted that, “in our analysis, the influence of vitamin deficiencies did not significantly affect our risk estimate.”
Nonspecified neuropathy was the most commonly reported type of neuropathy. Other subtypes of neuropathy were tracked, but limitations of coding and reporting prevented tracking sensory ganglionopathy, the second most commonly reported neuropathy in CD.
The strengths of the study included the large sample size and the study’s statistical strengths. The retrospective nature of the study was an overall limitation, and the homogeneous study population (over 90% of patients in both arms were of Nordic heritage) limited the study’s generalizability.
Surveillance bias may account for some of the increased risk for neuropathy, noted Dr. Thawani and her colleagues. This was hinted at by the fact that a diagnosis of neuropathy tended to follow closely on the CD diagnosis; physicians may have been more attuned to detecting potential sequelae of the CD diagnosis during this time period. Notably, though, patients with a prior neuropathy diagnosis also were more likely to be diagnosed with CD, showing a bidirectional relationship.
“These data may also suggest that the two diseases may share risk factors or a common underlying etiology for the development of neuropathy, such as a potential role of immunologic mechanisms,” they wrote.
The authors reported no conflicts of interest. The investigators received support from the Swedish Society of Medicine, the Swedish Research Council, and the National Center for Advancing Translational Sciences.
Individuals with biopsy-confirmed celiac disease have more than double the risk of receiving a diagnosis of neuropathy when compared with the general population, and the risk persists even when other potentially contributing conditions and lifestyle factors are considered.
The use of Swedish population registries enabled first author Dr. Sujata P. Thawani of Columbia University, New York, and her colleagues to find that the risk of neuropathy was increased both before and after a diagnosis of celiac disease (CD).
“We found an increased risk of neuropathy in patients with CD that persists after CD diagnosis. Although absolute risks for neuropathy are low, CD is a potentially treatable condition with a young age of onset. Our findings suggest that screening could be beneficial in patients with neuropathy,” they wrote (JAMA Neurol. 2015 May 11 [doi:10.1001/jamaneurol.2015.0475]).Neuropathy has a known association with CD, an immune-mediated disorder characterized by sensitivity to gluten with an incidence of about 1% in Western Europe. Previous studies had reported that up to one-third of celiac disease patients also experienced neuropathy, but the literature had not completely characterized the prevalence of neuropathy in the CD population.
Dr. Thawani and her associates used Swedish pathology registers to identify individuals whose small intestine biopsies showed villous atrophy between 1969 and 2008 (Marsh stage 3, n = 28,232). These individuals were categorized as having CD. Neuropathy diagnoses were drawn from national patient and pharmacy registers. Each CD patient was matched with up to five age- and sex-matched controls (n = 139,473) from the Swedish Total Population Registry, all of whom were diagnosed in the same year and were from the same county as the matched CD patient.
Although 41.7% of CD patients were diagnosed in childhood, the median age at diagnosis was 29 years. About 62% of patients in both groups were female. For CD patients, the absolute risk of neuropathy was 64 per 100,000 patient-years, compared with 15 per 100,000 patients-years in the control group (hazard ratio, 2.5; 95% confidence interval, 2.0-2.9; P < .001).
The risk of neuropathy for patients with CD was not affected by gender, absolute age, or age at diagnosis. The risk of neuropathy for those with CD remained about 2.5 times higher than the matched controls, even after accounting for diabetes status, the presence of other autoimmune disorders, vitamin deficiencies, and alcohol use. Although vitamin B12 deficiency has been associated with CD and may contribute to neuropathy, the investigators noted that, “in our analysis, the influence of vitamin deficiencies did not significantly affect our risk estimate.”
Nonspecified neuropathy was the most commonly reported type of neuropathy. Other subtypes of neuropathy were tracked, but limitations of coding and reporting prevented tracking sensory ganglionopathy, the second most commonly reported neuropathy in CD.
The strengths of the study included the large sample size and the study’s statistical strengths. The retrospective nature of the study was an overall limitation, and the homogeneous study population (over 90% of patients in both arms were of Nordic heritage) limited the study’s generalizability.
Surveillance bias may account for some of the increased risk for neuropathy, noted Dr. Thawani and her colleagues. This was hinted at by the fact that a diagnosis of neuropathy tended to follow closely on the CD diagnosis; physicians may have been more attuned to detecting potential sequelae of the CD diagnosis during this time period. Notably, though, patients with a prior neuropathy diagnosis also were more likely to be diagnosed with CD, showing a bidirectional relationship.
“These data may also suggest that the two diseases may share risk factors or a common underlying etiology for the development of neuropathy, such as a potential role of immunologic mechanisms,” they wrote.
The authors reported no conflicts of interest. The investigators received support from the Swedish Society of Medicine, the Swedish Research Council, and the National Center for Advancing Translational Sciences.
Individuals with biopsy-confirmed celiac disease have more than double the risk of receiving a diagnosis of neuropathy when compared with the general population, and the risk persists even when other potentially contributing conditions and lifestyle factors are considered.
The use of Swedish population registries enabled first author Dr. Sujata P. Thawani of Columbia University, New York, and her colleagues to find that the risk of neuropathy was increased both before and after a diagnosis of celiac disease (CD).
“We found an increased risk of neuropathy in patients with CD that persists after CD diagnosis. Although absolute risks for neuropathy are low, CD is a potentially treatable condition with a young age of onset. Our findings suggest that screening could be beneficial in patients with neuropathy,” they wrote (JAMA Neurol. 2015 May 11 [doi:10.1001/jamaneurol.2015.0475]).Neuropathy has a known association with CD, an immune-mediated disorder characterized by sensitivity to gluten with an incidence of about 1% in Western Europe. Previous studies had reported that up to one-third of celiac disease patients also experienced neuropathy, but the literature had not completely characterized the prevalence of neuropathy in the CD population.
Dr. Thawani and her associates used Swedish pathology registers to identify individuals whose small intestine biopsies showed villous atrophy between 1969 and 2008 (Marsh stage 3, n = 28,232). These individuals were categorized as having CD. Neuropathy diagnoses were drawn from national patient and pharmacy registers. Each CD patient was matched with up to five age- and sex-matched controls (n = 139,473) from the Swedish Total Population Registry, all of whom were diagnosed in the same year and were from the same county as the matched CD patient.
Although 41.7% of CD patients were diagnosed in childhood, the median age at diagnosis was 29 years. About 62% of patients in both groups were female. For CD patients, the absolute risk of neuropathy was 64 per 100,000 patient-years, compared with 15 per 100,000 patients-years in the control group (hazard ratio, 2.5; 95% confidence interval, 2.0-2.9; P < .001).
The risk of neuropathy for patients with CD was not affected by gender, absolute age, or age at diagnosis. The risk of neuropathy for those with CD remained about 2.5 times higher than the matched controls, even after accounting for diabetes status, the presence of other autoimmune disorders, vitamin deficiencies, and alcohol use. Although vitamin B12 deficiency has been associated with CD and may contribute to neuropathy, the investigators noted that, “in our analysis, the influence of vitamin deficiencies did not significantly affect our risk estimate.”
Nonspecified neuropathy was the most commonly reported type of neuropathy. Other subtypes of neuropathy were tracked, but limitations of coding and reporting prevented tracking sensory ganglionopathy, the second most commonly reported neuropathy in CD.
The strengths of the study included the large sample size and the study’s statistical strengths. The retrospective nature of the study was an overall limitation, and the homogeneous study population (over 90% of patients in both arms were of Nordic heritage) limited the study’s generalizability.
Surveillance bias may account for some of the increased risk for neuropathy, noted Dr. Thawani and her colleagues. This was hinted at by the fact that a diagnosis of neuropathy tended to follow closely on the CD diagnosis; physicians may have been more attuned to detecting potential sequelae of the CD diagnosis during this time period. Notably, though, patients with a prior neuropathy diagnosis also were more likely to be diagnosed with CD, showing a bidirectional relationship.
“These data may also suggest that the two diseases may share risk factors or a common underlying etiology for the development of neuropathy, such as a potential role of immunologic mechanisms,” they wrote.
The authors reported no conflicts of interest. The investigators received support from the Swedish Society of Medicine, the Swedish Research Council, and the National Center for Advancing Translational Sciences.
FROM JAMA NEUROLOGY
Key clinical point: Screening for celiac disease could be beneficial in patients with neuropathy.
Major findings: The risk of neuropathy for individuals with celiac disease was 2.5 times that of controls, even after adjusting for comorbidities and patient characteristics.
Data source: Review of 28,232 patients with biopsy-confirmed celiac disease and 139,473 matched controls from 1969 to 2008, drawn from Swedish patient registries.
Disclosures: The authors reported no conflicts of interest. The investigators received support from the Swedish Society of Medicine, the Swedish Research Council, and the National Center for Advancing Translational Sciences.
ASA: Radiation lowers local recurrence risk for DCIS patients with close or positive margins
SAN DIEGO – Radiation may benefit women with ductal carcinoma in situ (DCIS) who have breast-conserving surgery if their tumor margins are close or positive; however, wide tumor margins alone also may convey the same protection from local recurrence, Dr. Kimberly Van Zee reported at the annual meeting of the American Surgical Association.
Dr. Van Zee and her colleagues on the breast surgery service at New York’s Sloan Kettering Cancer Center examined the data from a large institutional database of DCIS patients to assess the relative benefit of radiation for various margin widths. They discovered that after adjusting for the other variables, patients with the widest tumor margins saw very little reduction in risk of 10-year recurrence when radiation was added – only 6%. However, this was still a significant difference and represented a hazard ratio of 0.54. Radiation gave patients with positive margins an absolute 18% risk reduction, for a hazard ratio of 0.10.
“We know that radiation reduces risk in all subsets of women with DCIS undergoing breast-conserving surgery,” she said. “But we really wanted to evaluate the relationship between margin width and recurrence and find the best margin width for DCIS with breast-conserving surgery.”
Over 20% of breast cancers are DCIS, and though overall mortality is low, as many as one in three patients will have local recurrence of their cancer. Radiation reduces the risk of local recurrence by about 50%, but it does not reduce the already low mortality associated with DCIS, she said.
Since radiation for DCIS may be associated with an increased risk for cardiovascular disease and certain rare malignancies, Dr. Van Zee said she and her colleagues were interested in identifying those women who were already at low risk for recurrence and would see little increased benefit from radiation.
Dr. Van Zee and her associates conducted a retrospective review of a prospectively collected database of women with DCIS who received treatment at Sloan Kettering Cancer Center between 1978 and 2010. The database contained multiple patient- and procedure-specific variables that were also factored into multivariable analysis in order to evaluate the relationships between margin width and recurrence, and to account for the contribution of radiation to reducing the risk of recurrence in women who received breast-conserving surgery for DCIS.
Overall, the database contained data for nearly 3,000 patients. Of the 2,996 studied, 72% were over the age of 50 and about 67% were postmenopausal. In 87% of cases, the diagnosis was made radiologically rather than clinically, and 60% of the patients had low or intermediate nuclear grade disease.
Dr. Van Zee and her colleagues assessed the 10-year recurrence rate for the 2,788 women whose excision margin width was known. Only 3% of these women had positive margins, and 75% had margin widths greater than 2 mm.
On multivariable analysis, wider margin width was associated with a significantly decreased 10-year risk of recurrence, but only for individuals who had not received radiation (P less than .0001). The hazard ratios for recurrence became progressively lower as margins widened, dropping to 0.31 for a margin of 10 mm or more.
Dr. Van Zee noted that the study was limited by its retrospective nature and the relatively small number of cases with positive margins. Also, cases with positive or close margins usually had more limited or focal disease at the margins, so recurrence rate estimates for this group may have underestimated risk of recurrence for those who had more significant disease.
During the discussion following her presentation, Dr. Van Zee noted that multiple factors are related to the risk of local recurrence, and that nomograms exist to help calculate risk and guide the decision to recommend radiation in women with close margins.
Dr. Patrick Borgen, chairman of the department of surgery at Maimonides Medical Center, New York, remarked that “biology beats technique. A growing wealth of information exists that there is a reservoir of DCIS that will progress so slowly as not to be significant. Is the next step in refining our approach better class prediction using genomic profiling?”
Dr. Van Zee agreed that genomic profiling will play a role, but noted that a study comparing DCIS score and multiple clinical variables would be expensive and archival pathology specimens would be difficult to obtain. Studies will mostly have to be prospective, she said.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
This article was updated May 11, 2015.
SAN DIEGO – Radiation may benefit women with ductal carcinoma in situ (DCIS) who have breast-conserving surgery if their tumor margins are close or positive; however, wide tumor margins alone also may convey the same protection from local recurrence, Dr. Kimberly Van Zee reported at the annual meeting of the American Surgical Association.
Dr. Van Zee and her colleagues on the breast surgery service at New York’s Sloan Kettering Cancer Center examined the data from a large institutional database of DCIS patients to assess the relative benefit of radiation for various margin widths. They discovered that after adjusting for the other variables, patients with the widest tumor margins saw very little reduction in risk of 10-year recurrence when radiation was added – only 6%. However, this was still a significant difference and represented a hazard ratio of 0.54. Radiation gave patients with positive margins an absolute 18% risk reduction, for a hazard ratio of 0.10.
“We know that radiation reduces risk in all subsets of women with DCIS undergoing breast-conserving surgery,” she said. “But we really wanted to evaluate the relationship between margin width and recurrence and find the best margin width for DCIS with breast-conserving surgery.”
Over 20% of breast cancers are DCIS, and though overall mortality is low, as many as one in three patients will have local recurrence of their cancer. Radiation reduces the risk of local recurrence by about 50%, but it does not reduce the already low mortality associated with DCIS, she said.
Since radiation for DCIS may be associated with an increased risk for cardiovascular disease and certain rare malignancies, Dr. Van Zee said she and her colleagues were interested in identifying those women who were already at low risk for recurrence and would see little increased benefit from radiation.
Dr. Van Zee and her associates conducted a retrospective review of a prospectively collected database of women with DCIS who received treatment at Sloan Kettering Cancer Center between 1978 and 2010. The database contained multiple patient- and procedure-specific variables that were also factored into multivariable analysis in order to evaluate the relationships between margin width and recurrence, and to account for the contribution of radiation to reducing the risk of recurrence in women who received breast-conserving surgery for DCIS.
Overall, the database contained data for nearly 3,000 patients. Of the 2,996 studied, 72% were over the age of 50 and about 67% were postmenopausal. In 87% of cases, the diagnosis was made radiologically rather than clinically, and 60% of the patients had low or intermediate nuclear grade disease.
Dr. Van Zee and her colleagues assessed the 10-year recurrence rate for the 2,788 women whose excision margin width was known. Only 3% of these women had positive margins, and 75% had margin widths greater than 2 mm.
On multivariable analysis, wider margin width was associated with a significantly decreased 10-year risk of recurrence, but only for individuals who had not received radiation (P less than .0001). The hazard ratios for recurrence became progressively lower as margins widened, dropping to 0.31 for a margin of 10 mm or more.
Dr. Van Zee noted that the study was limited by its retrospective nature and the relatively small number of cases with positive margins. Also, cases with positive or close margins usually had more limited or focal disease at the margins, so recurrence rate estimates for this group may have underestimated risk of recurrence for those who had more significant disease.
During the discussion following her presentation, Dr. Van Zee noted that multiple factors are related to the risk of local recurrence, and that nomograms exist to help calculate risk and guide the decision to recommend radiation in women with close margins.
Dr. Patrick Borgen, chairman of the department of surgery at Maimonides Medical Center, New York, remarked that “biology beats technique. A growing wealth of information exists that there is a reservoir of DCIS that will progress so slowly as not to be significant. Is the next step in refining our approach better class prediction using genomic profiling?”
Dr. Van Zee agreed that genomic profiling will play a role, but noted that a study comparing DCIS score and multiple clinical variables would be expensive and archival pathology specimens would be difficult to obtain. Studies will mostly have to be prospective, she said.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
This article was updated May 11, 2015.
SAN DIEGO – Radiation may benefit women with ductal carcinoma in situ (DCIS) who have breast-conserving surgery if their tumor margins are close or positive; however, wide tumor margins alone also may convey the same protection from local recurrence, Dr. Kimberly Van Zee reported at the annual meeting of the American Surgical Association.
Dr. Van Zee and her colleagues on the breast surgery service at New York’s Sloan Kettering Cancer Center examined the data from a large institutional database of DCIS patients to assess the relative benefit of radiation for various margin widths. They discovered that after adjusting for the other variables, patients with the widest tumor margins saw very little reduction in risk of 10-year recurrence when radiation was added – only 6%. However, this was still a significant difference and represented a hazard ratio of 0.54. Radiation gave patients with positive margins an absolute 18% risk reduction, for a hazard ratio of 0.10.
“We know that radiation reduces risk in all subsets of women with DCIS undergoing breast-conserving surgery,” she said. “But we really wanted to evaluate the relationship between margin width and recurrence and find the best margin width for DCIS with breast-conserving surgery.”
Over 20% of breast cancers are DCIS, and though overall mortality is low, as many as one in three patients will have local recurrence of their cancer. Radiation reduces the risk of local recurrence by about 50%, but it does not reduce the already low mortality associated with DCIS, she said.
Since radiation for DCIS may be associated with an increased risk for cardiovascular disease and certain rare malignancies, Dr. Van Zee said she and her colleagues were interested in identifying those women who were already at low risk for recurrence and would see little increased benefit from radiation.
Dr. Van Zee and her associates conducted a retrospective review of a prospectively collected database of women with DCIS who received treatment at Sloan Kettering Cancer Center between 1978 and 2010. The database contained multiple patient- and procedure-specific variables that were also factored into multivariable analysis in order to evaluate the relationships between margin width and recurrence, and to account for the contribution of radiation to reducing the risk of recurrence in women who received breast-conserving surgery for DCIS.
Overall, the database contained data for nearly 3,000 patients. Of the 2,996 studied, 72% were over the age of 50 and about 67% were postmenopausal. In 87% of cases, the diagnosis was made radiologically rather than clinically, and 60% of the patients had low or intermediate nuclear grade disease.
Dr. Van Zee and her colleagues assessed the 10-year recurrence rate for the 2,788 women whose excision margin width was known. Only 3% of these women had positive margins, and 75% had margin widths greater than 2 mm.
On multivariable analysis, wider margin width was associated with a significantly decreased 10-year risk of recurrence, but only for individuals who had not received radiation (P less than .0001). The hazard ratios for recurrence became progressively lower as margins widened, dropping to 0.31 for a margin of 10 mm or more.
Dr. Van Zee noted that the study was limited by its retrospective nature and the relatively small number of cases with positive margins. Also, cases with positive or close margins usually had more limited or focal disease at the margins, so recurrence rate estimates for this group may have underestimated risk of recurrence for those who had more significant disease.
During the discussion following her presentation, Dr. Van Zee noted that multiple factors are related to the risk of local recurrence, and that nomograms exist to help calculate risk and guide the decision to recommend radiation in women with close margins.
Dr. Patrick Borgen, chairman of the department of surgery at Maimonides Medical Center, New York, remarked that “biology beats technique. A growing wealth of information exists that there is a reservoir of DCIS that will progress so slowly as not to be significant. Is the next step in refining our approach better class prediction using genomic profiling?”
Dr. Van Zee agreed that genomic profiling will play a role, but noted that a study comparing DCIS score and multiple clinical variables would be expensive and archival pathology specimens would be difficult to obtain. Studies will mostly have to be prospective, she said.
The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.
This article was updated May 11, 2015.
AT THE ASA ANNUAL MEETING
Key clinical point: Ductal carcinoma in situ patients with close or positive tumor margins may benefit more from radiation.
Major finding: Radiation gave patients with positive margins an absolute 18% risk reduction, for a hazard ratio of 0.10.
Data source: Retrospective review of a prospective database of DCIS patients undergoing breast-conserving surgery from 1978 to 2010.
Disclosures: The authors reported no disclosures.
ASA: Tumors glow green in new ‘optical biopsy’ technique
SAN DIEGO – A technique that causes tumors to glow allowed surgeons to identify pulmonary adenocarcinomas accurately and quickly in the operating room, according to findings presented at the annual meeting of the American Surgical Association.
The molecular imaging technique, dubbed an “optical biopsy,” was 100% accurate in identifying pulmonary adenocarcinomas in wedge resection of lung nodules. Using an agent derived from fireflies, Dr. Sunil Singhal and his associates at the University of Pennsylvania, Philadelphia, tagged a ligand specific to lung adenocarcinoma and infused patients with the preparation before surgery so that cancerous nodules would light up in the operating room.
About 800,000 surgeries for cancer are performed in the United States annually, and surgery remains the most effective overall treatment since it affords the opportunity for complete resection and accurate staging, but technical challenges presist in many cancer surgeries, including the difficulty of ensuring negative margins, identifying in situ disease, and ascertaining which lymph nodes are malignant, Dr. Singhal noted.
“We depend on our hands, eyes and intuition,” he said. “This is fallible.”
The molecular imaging technique developed by Dr. Singhal and his colleagues has the potential to improve surgical precision by giving surgeons a clear visual indication of which tissue is malignant and needs to be excised. The technique identifies a receptor specific to a particular type of cancer cell and tags an appropriate ligand with a molecule that glows – a fluorophore – before surgery. With uptake of the tagged ligand, the tumor cells glow visibly and are clearly identified during surgery.
The small proof-of-principle study used fluorescein bound to a folate ligand for folate receptor alpha (FRalpha). This receptor is specific to pulmonary adenocarcinoma, the most commonly diagnosed cancer among the approximately 250,000 solitary pulmonary nodules detected as incidental findings on CT scans.
The 30 solitary pulmonary nodules in the study underwent a wedge resection and an optical biopsy, since patients had all received the fluorescein-tagged ligand infusion before surgery. Nineteen of the tumors fluoresced and were provisionally identified as pulmonary adenocarcinoma. Of the 11 that did not fluoresce, five were later identified as benign, three were other types of lung cancer, and three represented metastatic disease.
All nodules also were subject to frozen section, with provisional identification of 13 as lung adenocarcinoma, 8 as cancer of unknown origin, 6 as benign, 2 as metastatic renal adenocarcinoma, and 1 as a nonadenocarcinoma lung cancer.
One of the nodules read as benign on frozen section had been correctly identified as pulmonary adenocarcinoma by optical biopsy, which had 100% positive predictive value for pulmonary adenocarcinoma in this series, according to Dr. Singhal.
He stressed, however, that this technique should not be viewed as a replacement for pathology, but rather as an adjunct.
“If the tumor glows, we predict lung adenocarcinoma. If the tumor does not glow, we have no information and we follow the standard of care,” he said.
Going forward, Dr. Singhal and his colleagues plan to identify other candidate ligands for tagging, as well as developing fluorophores in a variety of colors. These could be infused simultaneously and allow differentiation between various tumor types. They also are developing materials that glow in the near-infrared spectrum and are detectable by specialized cameras.
Discussant Dr. Fabrizio Michelassi, chairman of the department of surgery at Weill Cornell Medical College and surgeon-in-chief at New York-Presbyterian/Weill Cornell Medical Center, asked whether the technique would be useful in identifying malignant sites in a diffusely inflamed field. Addressing the examples of Barrett’s esophagus and Crohn’s disease, Dr. Singhal affirmed the utility of optical biopsy in these conditions.
“As long as you have blood supply to that location, you can use whatever molecular contrast agent you want,” he said.
Dr. David Harpole, vice chief of the division of surgical services at Duke University Medical Center, applauded Dr. Singhal and his colleagues for taking a pertinent clinical problem to the laboratory. “Rapid intraoperative assessment of suspicious nodules is important,” he said, calling for a multi-institutional prospective cohort analysis to move the work forward.
The investigators reported no relevant financial disclosures. The study was supported by the National Institutes of Health, the Department of Defense, and the Veterans Health Administration.
SAN DIEGO – A technique that causes tumors to glow allowed surgeons to identify pulmonary adenocarcinomas accurately and quickly in the operating room, according to findings presented at the annual meeting of the American Surgical Association.
The molecular imaging technique, dubbed an “optical biopsy,” was 100% accurate in identifying pulmonary adenocarcinomas in wedge resection of lung nodules. Using an agent derived from fireflies, Dr. Sunil Singhal and his associates at the University of Pennsylvania, Philadelphia, tagged a ligand specific to lung adenocarcinoma and infused patients with the preparation before surgery so that cancerous nodules would light up in the operating room.
About 800,000 surgeries for cancer are performed in the United States annually, and surgery remains the most effective overall treatment since it affords the opportunity for complete resection and accurate staging, but technical challenges presist in many cancer surgeries, including the difficulty of ensuring negative margins, identifying in situ disease, and ascertaining which lymph nodes are malignant, Dr. Singhal noted.
“We depend on our hands, eyes and intuition,” he said. “This is fallible.”
The molecular imaging technique developed by Dr. Singhal and his colleagues has the potential to improve surgical precision by giving surgeons a clear visual indication of which tissue is malignant and needs to be excised. The technique identifies a receptor specific to a particular type of cancer cell and tags an appropriate ligand with a molecule that glows – a fluorophore – before surgery. With uptake of the tagged ligand, the tumor cells glow visibly and are clearly identified during surgery.
The small proof-of-principle study used fluorescein bound to a folate ligand for folate receptor alpha (FRalpha). This receptor is specific to pulmonary adenocarcinoma, the most commonly diagnosed cancer among the approximately 250,000 solitary pulmonary nodules detected as incidental findings on CT scans.
The 30 solitary pulmonary nodules in the study underwent a wedge resection and an optical biopsy, since patients had all received the fluorescein-tagged ligand infusion before surgery. Nineteen of the tumors fluoresced and were provisionally identified as pulmonary adenocarcinoma. Of the 11 that did not fluoresce, five were later identified as benign, three were other types of lung cancer, and three represented metastatic disease.
All nodules also were subject to frozen section, with provisional identification of 13 as lung adenocarcinoma, 8 as cancer of unknown origin, 6 as benign, 2 as metastatic renal adenocarcinoma, and 1 as a nonadenocarcinoma lung cancer.
One of the nodules read as benign on frozen section had been correctly identified as pulmonary adenocarcinoma by optical biopsy, which had 100% positive predictive value for pulmonary adenocarcinoma in this series, according to Dr. Singhal.
He stressed, however, that this technique should not be viewed as a replacement for pathology, but rather as an adjunct.
“If the tumor glows, we predict lung adenocarcinoma. If the tumor does not glow, we have no information and we follow the standard of care,” he said.
Going forward, Dr. Singhal and his colleagues plan to identify other candidate ligands for tagging, as well as developing fluorophores in a variety of colors. These could be infused simultaneously and allow differentiation between various tumor types. They also are developing materials that glow in the near-infrared spectrum and are detectable by specialized cameras.
Discussant Dr. Fabrizio Michelassi, chairman of the department of surgery at Weill Cornell Medical College and surgeon-in-chief at New York-Presbyterian/Weill Cornell Medical Center, asked whether the technique would be useful in identifying malignant sites in a diffusely inflamed field. Addressing the examples of Barrett’s esophagus and Crohn’s disease, Dr. Singhal affirmed the utility of optical biopsy in these conditions.
“As long as you have blood supply to that location, you can use whatever molecular contrast agent you want,” he said.
Dr. David Harpole, vice chief of the division of surgical services at Duke University Medical Center, applauded Dr. Singhal and his colleagues for taking a pertinent clinical problem to the laboratory. “Rapid intraoperative assessment of suspicious nodules is important,” he said, calling for a multi-institutional prospective cohort analysis to move the work forward.
The investigators reported no relevant financial disclosures. The study was supported by the National Institutes of Health, the Department of Defense, and the Veterans Health Administration.
SAN DIEGO – A technique that causes tumors to glow allowed surgeons to identify pulmonary adenocarcinomas accurately and quickly in the operating room, according to findings presented at the annual meeting of the American Surgical Association.
The molecular imaging technique, dubbed an “optical biopsy,” was 100% accurate in identifying pulmonary adenocarcinomas in wedge resection of lung nodules. Using an agent derived from fireflies, Dr. Sunil Singhal and his associates at the University of Pennsylvania, Philadelphia, tagged a ligand specific to lung adenocarcinoma and infused patients with the preparation before surgery so that cancerous nodules would light up in the operating room.
About 800,000 surgeries for cancer are performed in the United States annually, and surgery remains the most effective overall treatment since it affords the opportunity for complete resection and accurate staging, but technical challenges presist in many cancer surgeries, including the difficulty of ensuring negative margins, identifying in situ disease, and ascertaining which lymph nodes are malignant, Dr. Singhal noted.
“We depend on our hands, eyes and intuition,” he said. “This is fallible.”
The molecular imaging technique developed by Dr. Singhal and his colleagues has the potential to improve surgical precision by giving surgeons a clear visual indication of which tissue is malignant and needs to be excised. The technique identifies a receptor specific to a particular type of cancer cell and tags an appropriate ligand with a molecule that glows – a fluorophore – before surgery. With uptake of the tagged ligand, the tumor cells glow visibly and are clearly identified during surgery.
The small proof-of-principle study used fluorescein bound to a folate ligand for folate receptor alpha (FRalpha). This receptor is specific to pulmonary adenocarcinoma, the most commonly diagnosed cancer among the approximately 250,000 solitary pulmonary nodules detected as incidental findings on CT scans.
The 30 solitary pulmonary nodules in the study underwent a wedge resection and an optical biopsy, since patients had all received the fluorescein-tagged ligand infusion before surgery. Nineteen of the tumors fluoresced and were provisionally identified as pulmonary adenocarcinoma. Of the 11 that did not fluoresce, five were later identified as benign, three were other types of lung cancer, and three represented metastatic disease.
All nodules also were subject to frozen section, with provisional identification of 13 as lung adenocarcinoma, 8 as cancer of unknown origin, 6 as benign, 2 as metastatic renal adenocarcinoma, and 1 as a nonadenocarcinoma lung cancer.
One of the nodules read as benign on frozen section had been correctly identified as pulmonary adenocarcinoma by optical biopsy, which had 100% positive predictive value for pulmonary adenocarcinoma in this series, according to Dr. Singhal.
He stressed, however, that this technique should not be viewed as a replacement for pathology, but rather as an adjunct.
“If the tumor glows, we predict lung adenocarcinoma. If the tumor does not glow, we have no information and we follow the standard of care,” he said.
Going forward, Dr. Singhal and his colleagues plan to identify other candidate ligands for tagging, as well as developing fluorophores in a variety of colors. These could be infused simultaneously and allow differentiation between various tumor types. They also are developing materials that glow in the near-infrared spectrum and are detectable by specialized cameras.
Discussant Dr. Fabrizio Michelassi, chairman of the department of surgery at Weill Cornell Medical College and surgeon-in-chief at New York-Presbyterian/Weill Cornell Medical Center, asked whether the technique would be useful in identifying malignant sites in a diffusely inflamed field. Addressing the examples of Barrett’s esophagus and Crohn’s disease, Dr. Singhal affirmed the utility of optical biopsy in these conditions.
“As long as you have blood supply to that location, you can use whatever molecular contrast agent you want,” he said.
Dr. David Harpole, vice chief of the division of surgical services at Duke University Medical Center, applauded Dr. Singhal and his colleagues for taking a pertinent clinical problem to the laboratory. “Rapid intraoperative assessment of suspicious nodules is important,” he said, calling for a multi-institutional prospective cohort analysis to move the work forward.
The investigators reported no relevant financial disclosures. The study was supported by the National Institutes of Health, the Department of Defense, and the Veterans Health Administration.
AT THE ASA ANNUAL MEETING
Key clinical point: Fluorescein-tagged tumors glowed visibly and allowed accurate detection of pulmonary adenocarcinomas.
Major finding: A novel molecular imaging technique correctly identified 19 of 19 pulmonary adenocarcinomas with no false positives in a small proof-of-principle study.
Data source: Case series of 30 consecutive patients with a solitary pulmonary nodule and no diagnosis who were candidates for wedge resection, conducted at an academic medical center.
Disclosures: The authors reported no relevant financial disclosures. The study was supported by the National Institutes of Health, the Department of Defense, and the Veterans Health Administration.
Prehospital Mechanical CPR Doesn’t Improve Survival
In a pragmatically designed real-world trial, patients who sustained out-of-hospital cardiac arrest received no survival advantage when rescuers used a mechanical chest compression device rather than conventional CPR.
The Pre-Hospital Randomised Assessment of a Mechanical Compression Device in Cardiac Arrest (PARAMEDIC) study assessed how patients in cardiac arrest fared when given chest compressions by the LUCAS-2 device, compared with manual compressions. Dr. Gavin Perkins, clinical professor at the University of Warwick in Coventry, England, and his coinvestigators reported survival rates and neurologic outcomes for the two resuscitation methods in a 3-year study designed to assess real-life use of mechanical CPR (Lancet 2015;385:947-55).
Adult patients who sustained nontraumatic cardiac arrest within the service area of four large ambulance districts in the United Kingdom were randomized 1:2 to receive either mechanical or manual compressions – trial arm was decided by whether the ambulance arriving on scene carried the trial device, the LUCAS-2 mechanical chest compression system. Rescuers employed standard European Resuscitation Council guidelines and had advanced airway management, defibrillation, and drug administration capabilities.
PARAMEDIC’s primary outcome measure was 30-day survival, assessed by an intention-to-treat analysis. For the LUCAS-2 group, 104 of 1,652 patients (6%) achieved 30-day survival, compared with 193 of 2,819 (7%) in the manual compression group, a nonsignificant difference. Baseline characteristics and intensity of intervention were similar between the two groups. Further per-protocol statistical analyses confirmed nonsuperiority of LUCAS-2 for 30-day survival.
Overall, patients who received mechanical compressions had slightly worse neurologic outcomes, and a subgroup analysis found that survival rates were slightly lower for patients with an initially shockable rhythm – ventricular fibrillation or ventricular tachycardia – with use of the LUCAS-2.
The study’s robust real-world design aspects included the assignment method, which eliminated selection bias. Also, first responders received only the usual amount of training for new resuscitation technologies and were exposed to the typical one or two cardiac arrests per year. No CPR feedback technology was used for either the LUCAS-2 or for manual CPR. Because of the nature of the intervention, ambulance staff gathering initial data were not blinded; however, reported Dr. Perkins, dispatchers and those who assessed the primary outcome measure did not know which form of resuscitation had been delivered.
Noting that PARAMEDIC provides realistic information about outcomes using mechanical CPR, the authors said that “health-care systems will need to consider carefully the findings from this and previous studies when considering the role of mechanical CPR during out-of-hospital cardiac arrest.”
The study was funded by the U.K.’s National Institute for Health Research health technology assessment program; several authors also reported funding from this program during the study period. Dr. Perkins receives support as the director of research for the Intensive Care Foundation. No other conflicts of interest were reported.
In a pragmatically designed real-world trial, patients who sustained out-of-hospital cardiac arrest received no survival advantage when rescuers used a mechanical chest compression device rather than conventional CPR.
The Pre-Hospital Randomised Assessment of a Mechanical Compression Device in Cardiac Arrest (PARAMEDIC) study assessed how patients in cardiac arrest fared when given chest compressions by the LUCAS-2 device, compared with manual compressions. Dr. Gavin Perkins, clinical professor at the University of Warwick in Coventry, England, and his coinvestigators reported survival rates and neurologic outcomes for the two resuscitation methods in a 3-year study designed to assess real-life use of mechanical CPR (Lancet 2015;385:947-55).
Adult patients who sustained nontraumatic cardiac arrest within the service area of four large ambulance districts in the United Kingdom were randomized 1:2 to receive either mechanical or manual compressions – trial arm was decided by whether the ambulance arriving on scene carried the trial device, the LUCAS-2 mechanical chest compression system. Rescuers employed standard European Resuscitation Council guidelines and had advanced airway management, defibrillation, and drug administration capabilities.
PARAMEDIC’s primary outcome measure was 30-day survival, assessed by an intention-to-treat analysis. For the LUCAS-2 group, 104 of 1,652 patients (6%) achieved 30-day survival, compared with 193 of 2,819 (7%) in the manual compression group, a nonsignificant difference. Baseline characteristics and intensity of intervention were similar between the two groups. Further per-protocol statistical analyses confirmed nonsuperiority of LUCAS-2 for 30-day survival.
Overall, patients who received mechanical compressions had slightly worse neurologic outcomes, and a subgroup analysis found that survival rates were slightly lower for patients with an initially shockable rhythm – ventricular fibrillation or ventricular tachycardia – with use of the LUCAS-2.
The study’s robust real-world design aspects included the assignment method, which eliminated selection bias. Also, first responders received only the usual amount of training for new resuscitation technologies and were exposed to the typical one or two cardiac arrests per year. No CPR feedback technology was used for either the LUCAS-2 or for manual CPR. Because of the nature of the intervention, ambulance staff gathering initial data were not blinded; however, reported Dr. Perkins, dispatchers and those who assessed the primary outcome measure did not know which form of resuscitation had been delivered.
Noting that PARAMEDIC provides realistic information about outcomes using mechanical CPR, the authors said that “health-care systems will need to consider carefully the findings from this and previous studies when considering the role of mechanical CPR during out-of-hospital cardiac arrest.”
The study was funded by the U.K.’s National Institute for Health Research health technology assessment program; several authors also reported funding from this program during the study period. Dr. Perkins receives support as the director of research for the Intensive Care Foundation. No other conflicts of interest were reported.
In a pragmatically designed real-world trial, patients who sustained out-of-hospital cardiac arrest received no survival advantage when rescuers used a mechanical chest compression device rather than conventional CPR.
The Pre-Hospital Randomised Assessment of a Mechanical Compression Device in Cardiac Arrest (PARAMEDIC) study assessed how patients in cardiac arrest fared when given chest compressions by the LUCAS-2 device, compared with manual compressions. Dr. Gavin Perkins, clinical professor at the University of Warwick in Coventry, England, and his coinvestigators reported survival rates and neurologic outcomes for the two resuscitation methods in a 3-year study designed to assess real-life use of mechanical CPR (Lancet 2015;385:947-55).
Adult patients who sustained nontraumatic cardiac arrest within the service area of four large ambulance districts in the United Kingdom were randomized 1:2 to receive either mechanical or manual compressions – trial arm was decided by whether the ambulance arriving on scene carried the trial device, the LUCAS-2 mechanical chest compression system. Rescuers employed standard European Resuscitation Council guidelines and had advanced airway management, defibrillation, and drug administration capabilities.
PARAMEDIC’s primary outcome measure was 30-day survival, assessed by an intention-to-treat analysis. For the LUCAS-2 group, 104 of 1,652 patients (6%) achieved 30-day survival, compared with 193 of 2,819 (7%) in the manual compression group, a nonsignificant difference. Baseline characteristics and intensity of intervention were similar between the two groups. Further per-protocol statistical analyses confirmed nonsuperiority of LUCAS-2 for 30-day survival.
Overall, patients who received mechanical compressions had slightly worse neurologic outcomes, and a subgroup analysis found that survival rates were slightly lower for patients with an initially shockable rhythm – ventricular fibrillation or ventricular tachycardia – with use of the LUCAS-2.
The study’s robust real-world design aspects included the assignment method, which eliminated selection bias. Also, first responders received only the usual amount of training for new resuscitation technologies and were exposed to the typical one or two cardiac arrests per year. No CPR feedback technology was used for either the LUCAS-2 or for manual CPR. Because of the nature of the intervention, ambulance staff gathering initial data were not blinded; however, reported Dr. Perkins, dispatchers and those who assessed the primary outcome measure did not know which form of resuscitation had been delivered.
Noting that PARAMEDIC provides realistic information about outcomes using mechanical CPR, the authors said that “health-care systems will need to consider carefully the findings from this and previous studies when considering the role of mechanical CPR during out-of-hospital cardiac arrest.”
The study was funded by the U.K.’s National Institute for Health Research health technology assessment program; several authors also reported funding from this program during the study period. Dr. Perkins receives support as the director of research for the Intensive Care Foundation. No other conflicts of interest were reported.
FROM THE LANCET
Prehospital mechanical CPR doesn’t improve survival
In a pragmatically designed real-world trial, patients who sustained out-of-hospital cardiac arrest received no survival advantage when rescuers used a mechanical chest compression device rather than conventional CPR.
The Pre-Hospital Randomised Assessment of a Mechanical Compression Device in Cardiac Arrest (PARAMEDIC) study assessed how patients in cardiac arrest fared when given chest compressions by the LUCAS-2 device, compared with manual compressions. Dr. Gavin Perkins, clinical professor at the University of Warwick in Coventry, England, and his coinvestigators reported survival rates and neurologic outcomes for the two resuscitation methods in a 3-year study designed to assess real-life use of mechanical CPR (Lancet 2015;385:947-55).
Adult patients who sustained nontraumatic cardiac arrest within the service area of four large ambulance districts in the United Kingdom were randomized 1:2 to receive either mechanical or manual compressions – trial arm was decided by whether the ambulance arriving on scene carried the trial device, the LUCAS-2 mechanical chest compression system. Rescuers employed standard European Resuscitation Council guidelines and had advanced airway management, defibrillation, and drug administration capabilities.
PARAMEDIC’s primary outcome measure was 30-day survival, assessed by an intention-to-treat analysis. For the LUCAS-2 group, 104 of 1,652 patients (6%) achieved 30-day survival, compared with 193 of 2,819 (7%) in the manual compression group, a nonsignificant difference. Baseline characteristics and intensity of intervention were similar between the two groups. Further per-protocol statistical analyses confirmed nonsuperiority of LUCAS-2 for 30-day survival.
Overall, patients who received mechanical compressions had slightly worse neurologic outcomes, and a subgroup analysis found that survival rates were slightly lower for patients with an initially shockable rhythm – ventricular fibrillation or ventricular tachycardia – with use of the LUCAS-2.
The study’s robust real-world design aspects included the assignment method, which eliminated selection bias. Also, first responders received only the usual amount of training for new resuscitation technologies and were exposed to the typical one or two cardiac arrests per year. No CPR feedback technology was used for either the LUCAS-2 or for manual CPR. Because of the nature of the intervention, ambulance staff gathering initial data were not blinded; however, reported Dr. Perkins, dispatchers and those who assessed the primary outcome measure did not know which form of resuscitation had been delivered.
Noting that PARAMEDIC provides realistic information about outcomes using mechanical CPR, the authors said that “health-care systems will need to consider carefully the findings from this and previous studies when considering the role of mechanical CPR during out-of-hospital cardiac arrest.”
The study was funded by the U.K.’s National Institute for Health Research health technology assessment program; several authors also reported funding from this program during the study period. Dr. Perkins receives support as the director of research for the Intensive Care Foundation. No other conflicts of interest were reported.
In a pragmatically designed real-world trial, patients who sustained out-of-hospital cardiac arrest received no survival advantage when rescuers used a mechanical chest compression device rather than conventional CPR.
The Pre-Hospital Randomised Assessment of a Mechanical Compression Device in Cardiac Arrest (PARAMEDIC) study assessed how patients in cardiac arrest fared when given chest compressions by the LUCAS-2 device, compared with manual compressions. Dr. Gavin Perkins, clinical professor at the University of Warwick in Coventry, England, and his coinvestigators reported survival rates and neurologic outcomes for the two resuscitation methods in a 3-year study designed to assess real-life use of mechanical CPR (Lancet 2015;385:947-55).
Adult patients who sustained nontraumatic cardiac arrest within the service area of four large ambulance districts in the United Kingdom were randomized 1:2 to receive either mechanical or manual compressions – trial arm was decided by whether the ambulance arriving on scene carried the trial device, the LUCAS-2 mechanical chest compression system. Rescuers employed standard European Resuscitation Council guidelines and had advanced airway management, defibrillation, and drug administration capabilities.
PARAMEDIC’s primary outcome measure was 30-day survival, assessed by an intention-to-treat analysis. For the LUCAS-2 group, 104 of 1,652 patients (6%) achieved 30-day survival, compared with 193 of 2,819 (7%) in the manual compression group, a nonsignificant difference. Baseline characteristics and intensity of intervention were similar between the two groups. Further per-protocol statistical analyses confirmed nonsuperiority of LUCAS-2 for 30-day survival.
Overall, patients who received mechanical compressions had slightly worse neurologic outcomes, and a subgroup analysis found that survival rates were slightly lower for patients with an initially shockable rhythm – ventricular fibrillation or ventricular tachycardia – with use of the LUCAS-2.
The study’s robust real-world design aspects included the assignment method, which eliminated selection bias. Also, first responders received only the usual amount of training for new resuscitation technologies and were exposed to the typical one or two cardiac arrests per year. No CPR feedback technology was used for either the LUCAS-2 or for manual CPR. Because of the nature of the intervention, ambulance staff gathering initial data were not blinded; however, reported Dr. Perkins, dispatchers and those who assessed the primary outcome measure did not know which form of resuscitation had been delivered.
Noting that PARAMEDIC provides realistic information about outcomes using mechanical CPR, the authors said that “health-care systems will need to consider carefully the findings from this and previous studies when considering the role of mechanical CPR during out-of-hospital cardiac arrest.”
The study was funded by the U.K.’s National Institute for Health Research health technology assessment program; several authors also reported funding from this program during the study period. Dr. Perkins receives support as the director of research for the Intensive Care Foundation. No other conflicts of interest were reported.
In a pragmatically designed real-world trial, patients who sustained out-of-hospital cardiac arrest received no survival advantage when rescuers used a mechanical chest compression device rather than conventional CPR.
The Pre-Hospital Randomised Assessment of a Mechanical Compression Device in Cardiac Arrest (PARAMEDIC) study assessed how patients in cardiac arrest fared when given chest compressions by the LUCAS-2 device, compared with manual compressions. Dr. Gavin Perkins, clinical professor at the University of Warwick in Coventry, England, and his coinvestigators reported survival rates and neurologic outcomes for the two resuscitation methods in a 3-year study designed to assess real-life use of mechanical CPR (Lancet 2015;385:947-55).
Adult patients who sustained nontraumatic cardiac arrest within the service area of four large ambulance districts in the United Kingdom were randomized 1:2 to receive either mechanical or manual compressions – trial arm was decided by whether the ambulance arriving on scene carried the trial device, the LUCAS-2 mechanical chest compression system. Rescuers employed standard European Resuscitation Council guidelines and had advanced airway management, defibrillation, and drug administration capabilities.
PARAMEDIC’s primary outcome measure was 30-day survival, assessed by an intention-to-treat analysis. For the LUCAS-2 group, 104 of 1,652 patients (6%) achieved 30-day survival, compared with 193 of 2,819 (7%) in the manual compression group, a nonsignificant difference. Baseline characteristics and intensity of intervention were similar between the two groups. Further per-protocol statistical analyses confirmed nonsuperiority of LUCAS-2 for 30-day survival.
Overall, patients who received mechanical compressions had slightly worse neurologic outcomes, and a subgroup analysis found that survival rates were slightly lower for patients with an initially shockable rhythm – ventricular fibrillation or ventricular tachycardia – with use of the LUCAS-2.
The study’s robust real-world design aspects included the assignment method, which eliminated selection bias. Also, first responders received only the usual amount of training for new resuscitation technologies and were exposed to the typical one or two cardiac arrests per year. No CPR feedback technology was used for either the LUCAS-2 or for manual CPR. Because of the nature of the intervention, ambulance staff gathering initial data were not blinded; however, reported Dr. Perkins, dispatchers and those who assessed the primary outcome measure did not know which form of resuscitation had been delivered.
Noting that PARAMEDIC provides realistic information about outcomes using mechanical CPR, the authors said that “health-care systems will need to consider carefully the findings from this and previous studies when considering the role of mechanical CPR during out-of-hospital cardiac arrest.”
The study was funded by the U.K.’s National Institute for Health Research health technology assessment program; several authors also reported funding from this program during the study period. Dr. Perkins receives support as the director of research for the Intensive Care Foundation. No other conflicts of interest were reported.
FROM THE LANCET
Key clinical point: Chest compressions via mechanical CPR did not confer greater 30-day survival than manual compressions.
Major finding: 30-day survival was similar for 1,653 patients assigned to mechanical ventilation (6%) and 2,819 assigned to manual compressions (7%).
Data source: The PARAMEDIC trial, a cluster-randomized open-label trial with four large ambulance services in the United Kingdom delivering conventional or mechanical resuscitation to 4,471 adults with nontraumatic prehospital cardiac arrest.
Disclosures: The study was funded by the U.K.’s National Institute for Health Research health technology assessment program; several authors also reported funding from this program during the study period. Dr. Perkins receives support as the director of research for the Intensive Care Foundation. No other conflicts of interest were reported.
RA patients face significant out-of-pocket costs under Medicare
Medicare Part D recipients with rheumatoid arthritis face an average of over $2,700 per year in out-of-pocket expenses for biologic disease-modifying antirheumatic drugs, a figure that constitutes a “substantial disincentive” to adherence, according to Dr. Jinoos Yazdany of the division of rheumatology at the University of California, San Francisco, and her colleagues.
For patients with rheumatoid arthritis (RA) who do not respond to less costly nonbiologic disease-modifying antirheumatic drugs (DMARDs), early and aggressive treatment with biologic agents is key to slowing disease progression. However, biologic DMARDs can cost $20,000 or more per year, and may need to be taken over the course of a lifetime.
Dr. Yazdany and her colleagues’ current study examined 2013 data for all 2,737 Medicare Part D formularies, drawn from the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary and Pharmacy Network Files. Outpatient formularies from all 50 states and the District of Columbia were included. Although all plans covered at least one biologic DMARD, 95% required prior authorization and patients’ coinsurance averaged nearly 30% (Arthritis Rheumatol. 2015 April 21 [doi:10.1002/art.39079]).
A study from 2006 previously showed that estimated out-of-pocket costs for biological DMARDs would exceed $4,000 annually for low-income Medicare beneficiaries in the first year of Part D (Arthritis Rheum. 2009;61:745-54). The current study indicates that even 8 years after Part D plans were implemented, they continued “to use high cost sharing as a primary cost-control mechanism for biologic DMARDs, placing a substantial financial burden on patients who require such drugs for adequate control of their RA symptoms,” the investigators wrote.
Dr. Yazdany and her associates reported that during the period before spending limits were reached and catastrophic coverage was triggered, mean patient cost-sharing for biologic DMARDs was $835 per month. Infliximab was the least expensive option at $269 per month, while anakinra cost patients a mean $2,993 per month. Medicare Advantage plans were more likely to cover biologic agents, but at a higher average patient cost of $862 per month.
Of the nine nonbiologic DMARDs, six were covered by almost all plans with copayments of $5-$10 per month; the least expensive option in each plan averaged $48 per year in out-of-pocket costs. Prior authorizations were not needed for nonbiologic agents.
Dr. Yazdany and colleagues raised the question of whether the policies of prior authorizations, tiered coverage, and high levels of patient cost-sharing contribute to achieving high value care for those with RA who fail first-line therapy. Evidence-based guidelines would move these patients to biologic therapy, but the high level of patient cost-sharing in the current Medicare payment structure has previously been shown to reduce adherence, potentially speeding disease progression and worsening outcomes.
“We have avoided the issue of cost-effectiveness analysis,” Dr. Yazdany said, noting that to date, Medicare has not used reference pricing or negotiated drug costs, in contrast to government payers in many other countries. “We should all work to decrease out-of-pocket costs for people grappling with this serious disease,” she said. “The current situation is really unacceptable. That’s why we need to talk about it.”
Policies for better patient stratification are needed to reduce overall out-of-pocket expenses for those with RA using biologic DMARDs. This study is a very important step, and should help to generate more – and much-needed – conversation around this issue.
Dr. Michael Ward |
Adding more information about younger RA patients will help refine knowledge of who should be using these agents and when they are most effective. There is a growing effort to establish a multilayer research database that would cover a younger population to augment the large and publicly available Medicare database of those 65 and older. CMS data are widely used and publicly available, and effectively track a national population, but are limited by capturing only information about older adults who are further along in their disease course.
An important part of the cost-effectiveness conversation going forward will revolve around understanding whether there is utility in using biologic DMARDs very early in the disease process of RA to gain control of the disease. This early intervention may allow patients to taper off medication at a later point. However, clinicians currently don’t have clear indications for when to taper a patient off a biologic DMARD. Better delineation of answers to these clinical questions will help to clarify the cost-effectiveness analysis.
Dr. Michael M. Ward is a senior investigator at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md. These remarks were drawn from a telephone interview. He reported no disclosures.
Policies for better patient stratification are needed to reduce overall out-of-pocket expenses for those with RA using biologic DMARDs. This study is a very important step, and should help to generate more – and much-needed – conversation around this issue.
Dr. Michael Ward |
Adding more information about younger RA patients will help refine knowledge of who should be using these agents and when they are most effective. There is a growing effort to establish a multilayer research database that would cover a younger population to augment the large and publicly available Medicare database of those 65 and older. CMS data are widely used and publicly available, and effectively track a national population, but are limited by capturing only information about older adults who are further along in their disease course.
An important part of the cost-effectiveness conversation going forward will revolve around understanding whether there is utility in using biologic DMARDs very early in the disease process of RA to gain control of the disease. This early intervention may allow patients to taper off medication at a later point. However, clinicians currently don’t have clear indications for when to taper a patient off a biologic DMARD. Better delineation of answers to these clinical questions will help to clarify the cost-effectiveness analysis.
Dr. Michael M. Ward is a senior investigator at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md. These remarks were drawn from a telephone interview. He reported no disclosures.
Policies for better patient stratification are needed to reduce overall out-of-pocket expenses for those with RA using biologic DMARDs. This study is a very important step, and should help to generate more – and much-needed – conversation around this issue.
Dr. Michael Ward |
Adding more information about younger RA patients will help refine knowledge of who should be using these agents and when they are most effective. There is a growing effort to establish a multilayer research database that would cover a younger population to augment the large and publicly available Medicare database of those 65 and older. CMS data are widely used and publicly available, and effectively track a national population, but are limited by capturing only information about older adults who are further along in their disease course.
An important part of the cost-effectiveness conversation going forward will revolve around understanding whether there is utility in using biologic DMARDs very early in the disease process of RA to gain control of the disease. This early intervention may allow patients to taper off medication at a later point. However, clinicians currently don’t have clear indications for when to taper a patient off a biologic DMARD. Better delineation of answers to these clinical questions will help to clarify the cost-effectiveness analysis.
Dr. Michael M. Ward is a senior investigator at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md. These remarks were drawn from a telephone interview. He reported no disclosures.
Medicare Part D recipients with rheumatoid arthritis face an average of over $2,700 per year in out-of-pocket expenses for biologic disease-modifying antirheumatic drugs, a figure that constitutes a “substantial disincentive” to adherence, according to Dr. Jinoos Yazdany of the division of rheumatology at the University of California, San Francisco, and her colleagues.
For patients with rheumatoid arthritis (RA) who do not respond to less costly nonbiologic disease-modifying antirheumatic drugs (DMARDs), early and aggressive treatment with biologic agents is key to slowing disease progression. However, biologic DMARDs can cost $20,000 or more per year, and may need to be taken over the course of a lifetime.
Dr. Yazdany and her colleagues’ current study examined 2013 data for all 2,737 Medicare Part D formularies, drawn from the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary and Pharmacy Network Files. Outpatient formularies from all 50 states and the District of Columbia were included. Although all plans covered at least one biologic DMARD, 95% required prior authorization and patients’ coinsurance averaged nearly 30% (Arthritis Rheumatol. 2015 April 21 [doi:10.1002/art.39079]).
A study from 2006 previously showed that estimated out-of-pocket costs for biological DMARDs would exceed $4,000 annually for low-income Medicare beneficiaries in the first year of Part D (Arthritis Rheum. 2009;61:745-54). The current study indicates that even 8 years after Part D plans were implemented, they continued “to use high cost sharing as a primary cost-control mechanism for biologic DMARDs, placing a substantial financial burden on patients who require such drugs for adequate control of their RA symptoms,” the investigators wrote.
Dr. Yazdany and her associates reported that during the period before spending limits were reached and catastrophic coverage was triggered, mean patient cost-sharing for biologic DMARDs was $835 per month. Infliximab was the least expensive option at $269 per month, while anakinra cost patients a mean $2,993 per month. Medicare Advantage plans were more likely to cover biologic agents, but at a higher average patient cost of $862 per month.
Of the nine nonbiologic DMARDs, six were covered by almost all plans with copayments of $5-$10 per month; the least expensive option in each plan averaged $48 per year in out-of-pocket costs. Prior authorizations were not needed for nonbiologic agents.
Dr. Yazdany and colleagues raised the question of whether the policies of prior authorizations, tiered coverage, and high levels of patient cost-sharing contribute to achieving high value care for those with RA who fail first-line therapy. Evidence-based guidelines would move these patients to biologic therapy, but the high level of patient cost-sharing in the current Medicare payment structure has previously been shown to reduce adherence, potentially speeding disease progression and worsening outcomes.
“We have avoided the issue of cost-effectiveness analysis,” Dr. Yazdany said, noting that to date, Medicare has not used reference pricing or negotiated drug costs, in contrast to government payers in many other countries. “We should all work to decrease out-of-pocket costs for people grappling with this serious disease,” she said. “The current situation is really unacceptable. That’s why we need to talk about it.”
Medicare Part D recipients with rheumatoid arthritis face an average of over $2,700 per year in out-of-pocket expenses for biologic disease-modifying antirheumatic drugs, a figure that constitutes a “substantial disincentive” to adherence, according to Dr. Jinoos Yazdany of the division of rheumatology at the University of California, San Francisco, and her colleagues.
For patients with rheumatoid arthritis (RA) who do not respond to less costly nonbiologic disease-modifying antirheumatic drugs (DMARDs), early and aggressive treatment with biologic agents is key to slowing disease progression. However, biologic DMARDs can cost $20,000 or more per year, and may need to be taken over the course of a lifetime.
Dr. Yazdany and her colleagues’ current study examined 2013 data for all 2,737 Medicare Part D formularies, drawn from the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary and Pharmacy Network Files. Outpatient formularies from all 50 states and the District of Columbia were included. Although all plans covered at least one biologic DMARD, 95% required prior authorization and patients’ coinsurance averaged nearly 30% (Arthritis Rheumatol. 2015 April 21 [doi:10.1002/art.39079]).
A study from 2006 previously showed that estimated out-of-pocket costs for biological DMARDs would exceed $4,000 annually for low-income Medicare beneficiaries in the first year of Part D (Arthritis Rheum. 2009;61:745-54). The current study indicates that even 8 years after Part D plans were implemented, they continued “to use high cost sharing as a primary cost-control mechanism for biologic DMARDs, placing a substantial financial burden on patients who require such drugs for adequate control of their RA symptoms,” the investigators wrote.
Dr. Yazdany and her associates reported that during the period before spending limits were reached and catastrophic coverage was triggered, mean patient cost-sharing for biologic DMARDs was $835 per month. Infliximab was the least expensive option at $269 per month, while anakinra cost patients a mean $2,993 per month. Medicare Advantage plans were more likely to cover biologic agents, but at a higher average patient cost of $862 per month.
Of the nine nonbiologic DMARDs, six were covered by almost all plans with copayments of $5-$10 per month; the least expensive option in each plan averaged $48 per year in out-of-pocket costs. Prior authorizations were not needed for nonbiologic agents.
Dr. Yazdany and colleagues raised the question of whether the policies of prior authorizations, tiered coverage, and high levels of patient cost-sharing contribute to achieving high value care for those with RA who fail first-line therapy. Evidence-based guidelines would move these patients to biologic therapy, but the high level of patient cost-sharing in the current Medicare payment structure has previously been shown to reduce adherence, potentially speeding disease progression and worsening outcomes.
“We have avoided the issue of cost-effectiveness analysis,” Dr. Yazdany said, noting that to date, Medicare has not used reference pricing or negotiated drug costs, in contrast to government payers in many other countries. “We should all work to decrease out-of-pocket costs for people grappling with this serious disease,” she said. “The current situation is really unacceptable. That’s why we need to talk about it.”
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point: Patients with rheumatoid arthritis face significant cost sharing for biologic disease modifying agents under Medicare Part D.
Major findings: Mean out-of-pocket costs for Medicare Part D recipients receiving these treatments were over $2,700 per year before catastrophic coverage began paying 95% of charges.
Data source: Cross-sectional analysis of 2,737 Medicare Part D formularies drawn from the Centers for Medicare & Medicaid Services’ database, including a comparison of Medicare Advantage to stand-alone Medicare Part D plans and a comparison of biologic and nonbiologic disease modifying drugs.
Disclosures: The Agency for Healthcare Research and Quality and the Hawaii Medical Service Association Endowed Chair in Health Services and Quality Research funded the study. The authors reported no conflicts of interest.
Depression combined with diabetes more than doubles dementia risk
Depression and type 2 diabetes mellitus can separately increase the risk for dementia, but that risk is even greater when both conditions are present. Further, the increased risk was greatest in younger patients, increasing almost fivefold among those under 65 years, compared with those with neither depression nor diabetes, researchers said in a study published April 15.
In the largest study to date that examined dementia risk in those with comorbid depression and diabetes, Dr. Wayne Katon of the University of Washington, Seattle, and his colleagues found an enhancement of risk for dementia in those with both conditions. The finding is worrisome, because diabetes is occurring at ever-younger ages, and people are living longer than ever.
Knowing from previous studies that depression increases the risk of all-cause dementia and taking into account that depression is associated with increased risk for diabetes, Dr. Katon and his colleagues examined both separate and summed all-cause dementia risks for depression and diabetes They said their study was the first to assess the excess risk of these two diagnoses over that of the general population (JAMA Psychiatry 2015 April 15 [doi:10.1001/jamapsychiatry.2015.0082]).
Drawing on large and comprehensive Danish national health registries, the population-based cohort study included a total of 2,454,532 adults who were at least 50 years old and without dementia at enrollment. Of these, 477,133 (19.4%) had depression; 223,174 (9.1%) had diabetes; 95,691 (3.9%) had both. Patient group allocations, as well as incident dementia diagnoses, were determined by tracking physician-assigned diagnosis codes and by interrogating a prescription registry. Statistical analysis adjusted for the effect of other comorbidities, as well as for potentially confounding demographic variations.
During the 7 years of the follow-up period, the hazard ratio for developing dementia among those with comorbid depression and diabetes was 2.17 (95% confidence interval, 2.10-2.24); for those with depression alone, 1.20 (95% CI, 1.17-1.23), and for those with diabetes alone, 1.83 (95% CI, 1.80-1.87). For those younger than age 65 years, the hazard ratio for dementia with both DM and depression was 4.84 (95% CI, 4.21-5.55).
The study’s strengths included the large sample size and the very small attrition rate inherent in the robust Danish database. However, the population’s homogeneity limits generalizability. Additionally, only those who sought treatment for depression or diabetes were included, creating a selection bias toward more severe disease.
Though the study’s overall findings are clear, the causality is not. However, Dr. Katon and his coauthors observed, “Although underlying causal mechanisms are unclear, one explanation could be that depression and [diabetes] have many shared risk factors for dementia,” including obesity, inflammation, and vascular disease.
A globally aging population coupled with increased prevalence of chronic disease earlier in life in the developed world presents a demographic and health challenge: How do we help people live well, longer into old age?
The burgeoning field of geroscience seeks to unlock biological and environmental clues that will help us live well as we continue to live longer. With a goal of pushing back the onset of age-related morbidities, especially dementia, cross-disciplinary geroscience research seeks to pinpoint biomarkers of aging. These may include inflammatory markers, direct examination of telomere length, and other measures of oxidative stress.
![]() |
Dr. Charles F. Reynolds III |
Mediators of age-related morbidity include genetic, dietary, and pharmacologic manipulation, as well as exercise, with its powerful pleiotropic effects. All are important and must be coupled with minimizing such behavioral health risks as smoking, insufficient sleep, inactivity, and social isolation if quality of life is to be maintained into old age. Cross-disciplinary research funded by the MacArthur Foundation Research Network on an Aging Society shows the powerful impact of a healthy lifestyle.
Some health interventions are critical: More aggressive depression treatment, for example, may help delay dementia. Treatment of depression helps both by improving cognition and by facilitating better overall health; for example, patients with diabetes have improved glycemic control when depression is treated. Targeted and evidence-based interventions for depression can preserve cognitive function, reduce disability, and improve adherence to other medical and lifestyle interventions for chronic disease.
Dr. Charles F. Reynolds III is the University of Pittsburgh Medical Center Endowed Professor in Geriatric Psychiatry, and director of the Aging Institute at the university and of the John A. Hartford Center of Excellence in Geriatric Psychiatry. These points are summarized from his editorial accompanying Dr. Katon’s article, published online in JAMA Psychiatry on April 15. (JAMA Psychiatry 2015 April 15 [doi:10.1001/jamapsychiatry.2015.0174]). His disclosures include pharmaceutical support from Bristol-Myers Squibb, Forest, Pfizer, and Eli Lilly.
A globally aging population coupled with increased prevalence of chronic disease earlier in life in the developed world presents a demographic and health challenge: How do we help people live well, longer into old age?
The burgeoning field of geroscience seeks to unlock biological and environmental clues that will help us live well as we continue to live longer. With a goal of pushing back the onset of age-related morbidities, especially dementia, cross-disciplinary geroscience research seeks to pinpoint biomarkers of aging. These may include inflammatory markers, direct examination of telomere length, and other measures of oxidative stress.
![]() |
Dr. Charles F. Reynolds III |
Mediators of age-related morbidity include genetic, dietary, and pharmacologic manipulation, as well as exercise, with its powerful pleiotropic effects. All are important and must be coupled with minimizing such behavioral health risks as smoking, insufficient sleep, inactivity, and social isolation if quality of life is to be maintained into old age. Cross-disciplinary research funded by the MacArthur Foundation Research Network on an Aging Society shows the powerful impact of a healthy lifestyle.
Some health interventions are critical: More aggressive depression treatment, for example, may help delay dementia. Treatment of depression helps both by improving cognition and by facilitating better overall health; for example, patients with diabetes have improved glycemic control when depression is treated. Targeted and evidence-based interventions for depression can preserve cognitive function, reduce disability, and improve adherence to other medical and lifestyle interventions for chronic disease.
Dr. Charles F. Reynolds III is the University of Pittsburgh Medical Center Endowed Professor in Geriatric Psychiatry, and director of the Aging Institute at the university and of the John A. Hartford Center of Excellence in Geriatric Psychiatry. These points are summarized from his editorial accompanying Dr. Katon’s article, published online in JAMA Psychiatry on April 15. (JAMA Psychiatry 2015 April 15 [doi:10.1001/jamapsychiatry.2015.0174]). His disclosures include pharmaceutical support from Bristol-Myers Squibb, Forest, Pfizer, and Eli Lilly.
A globally aging population coupled with increased prevalence of chronic disease earlier in life in the developed world presents a demographic and health challenge: How do we help people live well, longer into old age?
The burgeoning field of geroscience seeks to unlock biological and environmental clues that will help us live well as we continue to live longer. With a goal of pushing back the onset of age-related morbidities, especially dementia, cross-disciplinary geroscience research seeks to pinpoint biomarkers of aging. These may include inflammatory markers, direct examination of telomere length, and other measures of oxidative stress.
![]() |
Dr. Charles F. Reynolds III |
Mediators of age-related morbidity include genetic, dietary, and pharmacologic manipulation, as well as exercise, with its powerful pleiotropic effects. All are important and must be coupled with minimizing such behavioral health risks as smoking, insufficient sleep, inactivity, and social isolation if quality of life is to be maintained into old age. Cross-disciplinary research funded by the MacArthur Foundation Research Network on an Aging Society shows the powerful impact of a healthy lifestyle.
Some health interventions are critical: More aggressive depression treatment, for example, may help delay dementia. Treatment of depression helps both by improving cognition and by facilitating better overall health; for example, patients with diabetes have improved glycemic control when depression is treated. Targeted and evidence-based interventions for depression can preserve cognitive function, reduce disability, and improve adherence to other medical and lifestyle interventions for chronic disease.
Dr. Charles F. Reynolds III is the University of Pittsburgh Medical Center Endowed Professor in Geriatric Psychiatry, and director of the Aging Institute at the university and of the John A. Hartford Center of Excellence in Geriatric Psychiatry. These points are summarized from his editorial accompanying Dr. Katon’s article, published online in JAMA Psychiatry on April 15. (JAMA Psychiatry 2015 April 15 [doi:10.1001/jamapsychiatry.2015.0174]). His disclosures include pharmaceutical support from Bristol-Myers Squibb, Forest, Pfizer, and Eli Lilly.
Depression and type 2 diabetes mellitus can separately increase the risk for dementia, but that risk is even greater when both conditions are present. Further, the increased risk was greatest in younger patients, increasing almost fivefold among those under 65 years, compared with those with neither depression nor diabetes, researchers said in a study published April 15.
In the largest study to date that examined dementia risk in those with comorbid depression and diabetes, Dr. Wayne Katon of the University of Washington, Seattle, and his colleagues found an enhancement of risk for dementia in those with both conditions. The finding is worrisome, because diabetes is occurring at ever-younger ages, and people are living longer than ever.
Knowing from previous studies that depression increases the risk of all-cause dementia and taking into account that depression is associated with increased risk for diabetes, Dr. Katon and his colleagues examined both separate and summed all-cause dementia risks for depression and diabetes They said their study was the first to assess the excess risk of these two diagnoses over that of the general population (JAMA Psychiatry 2015 April 15 [doi:10.1001/jamapsychiatry.2015.0082]).
Drawing on large and comprehensive Danish national health registries, the population-based cohort study included a total of 2,454,532 adults who were at least 50 years old and without dementia at enrollment. Of these, 477,133 (19.4%) had depression; 223,174 (9.1%) had diabetes; 95,691 (3.9%) had both. Patient group allocations, as well as incident dementia diagnoses, were determined by tracking physician-assigned diagnosis codes and by interrogating a prescription registry. Statistical analysis adjusted for the effect of other comorbidities, as well as for potentially confounding demographic variations.
During the 7 years of the follow-up period, the hazard ratio for developing dementia among those with comorbid depression and diabetes was 2.17 (95% confidence interval, 2.10-2.24); for those with depression alone, 1.20 (95% CI, 1.17-1.23), and for those with diabetes alone, 1.83 (95% CI, 1.80-1.87). For those younger than age 65 years, the hazard ratio for dementia with both DM and depression was 4.84 (95% CI, 4.21-5.55).
The study’s strengths included the large sample size and the very small attrition rate inherent in the robust Danish database. However, the population’s homogeneity limits generalizability. Additionally, only those who sought treatment for depression or diabetes were included, creating a selection bias toward more severe disease.
Though the study’s overall findings are clear, the causality is not. However, Dr. Katon and his coauthors observed, “Although underlying causal mechanisms are unclear, one explanation could be that depression and [diabetes] have many shared risk factors for dementia,” including obesity, inflammation, and vascular disease.
Depression and type 2 diabetes mellitus can separately increase the risk for dementia, but that risk is even greater when both conditions are present. Further, the increased risk was greatest in younger patients, increasing almost fivefold among those under 65 years, compared with those with neither depression nor diabetes, researchers said in a study published April 15.
In the largest study to date that examined dementia risk in those with comorbid depression and diabetes, Dr. Wayne Katon of the University of Washington, Seattle, and his colleagues found an enhancement of risk for dementia in those with both conditions. The finding is worrisome, because diabetes is occurring at ever-younger ages, and people are living longer than ever.
Knowing from previous studies that depression increases the risk of all-cause dementia and taking into account that depression is associated with increased risk for diabetes, Dr. Katon and his colleagues examined both separate and summed all-cause dementia risks for depression and diabetes They said their study was the first to assess the excess risk of these two diagnoses over that of the general population (JAMA Psychiatry 2015 April 15 [doi:10.1001/jamapsychiatry.2015.0082]).
Drawing on large and comprehensive Danish national health registries, the population-based cohort study included a total of 2,454,532 adults who were at least 50 years old and without dementia at enrollment. Of these, 477,133 (19.4%) had depression; 223,174 (9.1%) had diabetes; 95,691 (3.9%) had both. Patient group allocations, as well as incident dementia diagnoses, were determined by tracking physician-assigned diagnosis codes and by interrogating a prescription registry. Statistical analysis adjusted for the effect of other comorbidities, as well as for potentially confounding demographic variations.
During the 7 years of the follow-up period, the hazard ratio for developing dementia among those with comorbid depression and diabetes was 2.17 (95% confidence interval, 2.10-2.24); for those with depression alone, 1.20 (95% CI, 1.17-1.23), and for those with diabetes alone, 1.83 (95% CI, 1.80-1.87). For those younger than age 65 years, the hazard ratio for dementia with both DM and depression was 4.84 (95% CI, 4.21-5.55).
The study’s strengths included the large sample size and the very small attrition rate inherent in the robust Danish database. However, the population’s homogeneity limits generalizability. Additionally, only those who sought treatment for depression or diabetes were included, creating a selection bias toward more severe disease.
Though the study’s overall findings are clear, the causality is not. However, Dr. Katon and his coauthors observed, “Although underlying causal mechanisms are unclear, one explanation could be that depression and [diabetes] have many shared risk factors for dementia,” including obesity, inflammation, and vascular disease.
FROM JAMA PSYCHIATRY
Key clinical point: Comorbid depression and type 2 diabetes mellitus increased dementia risk by more than the summed separate risks.
Major finding: The excess risk for dementia in comorbid depression and diabetes was more than twice that for those with neither diagnosis and greater than the individual summed risks; the effect was greatest for those under age 65 years, with a hazard ratio of 4.84.
Data source: Population-based cohort study of approximately 2.5 million Danish adults, with data drawn from centralized Danish national patient registers between 2007 and 2013.
Disclosures: The study was funded by the National Institutes of Health and by an unrestricted grant from the Lundbeck Foundation. The authors reported no conflicts of interest.
Melanoma Incidence Drops for US Children and Teens
The incidence of melanoma among American children and teens decreased by approximately 12% from 2004 to 2010, with the decline most notable for adolescents. The findings were published online in the Journal of Pediatrics.
In a review of data from the period of 2000-2010, Dr. Laura Campbell of Stanford (Calif.) University and her colleagues at Case Western Reserve University in Cleveland found an overall reduction in melanoma diagnoses of 11.58% per year for the period of 2004-2010 (J. Pediatr. 2015 [doi: 10.1016/j.jpeds. 2015.02.050]).
The study was conducted at Case Western Reserve University, and the researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER-18) registry to examine trends in the incidence of pediatric melanoma.
Of note, the number of new melanoma cases decreased significantly (approximately 11%) among 15- to19-year-olds between 2003 and 2010. In addition, the overall incidence of melanoma decreased significantly (7%) among boys between 2000 and 2010.
The data revealed significant decreases for the number of new cases of melanoma on the trunk (15% per year from 2004 to 2010) and upper extremities (5% from 2000 to 2010).
Dr. Campbell and her colleagues determined that a melanoma diagnosis was equally likely for male and female patients, and was more common in older than in younger patients. White patients had by far the greatest incidence of melanoma, with 97% of the overall diagnoses; 90% of the cases were in non-Hispanic whites. Superficial spreading melanoma was the most common type of melanoma, at 31%, though nodular histology was seen almost as frequently in the 0- to 9-year-olds. This younger group was more likely to have thicker tumors, ulceration, lymph node involvement, and distant metastases.
Drawing on this large registry allowed researchers more confidence that they were identifying true trends in melanoma incidence, Dr. Campbell noted.
The reasons for this decrease, which stands in contrast to earlier data showing increased incidence rates of pediatric melanoma, were not examined in this study. However, Dr. Campbell drew on these earlier studies, as well as some international studies, to identify the potential contribution of public health campaigns advocating sun protection. These campaigns began in the 1990s in the United States, and would have benefited the 15- to 19-year olds in the SEER-18 data, in whom melanoma incidence decreased beginning in 2003. Some Swedish and Australian studies showing decreased melanoma cases were confounded by an immigration-driven decrease in the highest risk light-skinned population, noted Dr. Campbell; however, the quality of the SEER-18 data allowed researchers to account for this variable, she said.
Although the widespread adoption of sun-protective behaviors (wearing hats and protective clothing, using sunscreen appropriately, and avoiding midday sun exposure) may have accounted for some of the reduction in pediatric melanomas, other societal changes may have been at play.
“We hypothesize that there has been a shift in youth participating increasingly in indoor activities, such as television/electronic devices, which may be decreasing their UVR exposure,” Dr. Campbell said.
The incidence of melanoma among American children and teens decreased by approximately 12% from 2004 to 2010, with the decline most notable for adolescents. The findings were published online in the Journal of Pediatrics.
In a review of data from the period of 2000-2010, Dr. Laura Campbell of Stanford (Calif.) University and her colleagues at Case Western Reserve University in Cleveland found an overall reduction in melanoma diagnoses of 11.58% per year for the period of 2004-2010 (J. Pediatr. 2015 [doi: 10.1016/j.jpeds. 2015.02.050]).
The study was conducted at Case Western Reserve University, and the researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER-18) registry to examine trends in the incidence of pediatric melanoma.
Of note, the number of new melanoma cases decreased significantly (approximately 11%) among 15- to19-year-olds between 2003 and 2010. In addition, the overall incidence of melanoma decreased significantly (7%) among boys between 2000 and 2010.
The data revealed significant decreases for the number of new cases of melanoma on the trunk (15% per year from 2004 to 2010) and upper extremities (5% from 2000 to 2010).
Dr. Campbell and her colleagues determined that a melanoma diagnosis was equally likely for male and female patients, and was more common in older than in younger patients. White patients had by far the greatest incidence of melanoma, with 97% of the overall diagnoses; 90% of the cases were in non-Hispanic whites. Superficial spreading melanoma was the most common type of melanoma, at 31%, though nodular histology was seen almost as frequently in the 0- to 9-year-olds. This younger group was more likely to have thicker tumors, ulceration, lymph node involvement, and distant metastases.
Drawing on this large registry allowed researchers more confidence that they were identifying true trends in melanoma incidence, Dr. Campbell noted.
The reasons for this decrease, which stands in contrast to earlier data showing increased incidence rates of pediatric melanoma, were not examined in this study. However, Dr. Campbell drew on these earlier studies, as well as some international studies, to identify the potential contribution of public health campaigns advocating sun protection. These campaigns began in the 1990s in the United States, and would have benefited the 15- to 19-year olds in the SEER-18 data, in whom melanoma incidence decreased beginning in 2003. Some Swedish and Australian studies showing decreased melanoma cases were confounded by an immigration-driven decrease in the highest risk light-skinned population, noted Dr. Campbell; however, the quality of the SEER-18 data allowed researchers to account for this variable, she said.
Although the widespread adoption of sun-protective behaviors (wearing hats and protective clothing, using sunscreen appropriately, and avoiding midday sun exposure) may have accounted for some of the reduction in pediatric melanomas, other societal changes may have been at play.
“We hypothesize that there has been a shift in youth participating increasingly in indoor activities, such as television/electronic devices, which may be decreasing their UVR exposure,” Dr. Campbell said.
The incidence of melanoma among American children and teens decreased by approximately 12% from 2004 to 2010, with the decline most notable for adolescents. The findings were published online in the Journal of Pediatrics.
In a review of data from the period of 2000-2010, Dr. Laura Campbell of Stanford (Calif.) University and her colleagues at Case Western Reserve University in Cleveland found an overall reduction in melanoma diagnoses of 11.58% per year for the period of 2004-2010 (J. Pediatr. 2015 [doi: 10.1016/j.jpeds. 2015.02.050]).
The study was conducted at Case Western Reserve University, and the researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER-18) registry to examine trends in the incidence of pediatric melanoma.
Of note, the number of new melanoma cases decreased significantly (approximately 11%) among 15- to19-year-olds between 2003 and 2010. In addition, the overall incidence of melanoma decreased significantly (7%) among boys between 2000 and 2010.
The data revealed significant decreases for the number of new cases of melanoma on the trunk (15% per year from 2004 to 2010) and upper extremities (5% from 2000 to 2010).
Dr. Campbell and her colleagues determined that a melanoma diagnosis was equally likely for male and female patients, and was more common in older than in younger patients. White patients had by far the greatest incidence of melanoma, with 97% of the overall diagnoses; 90% of the cases were in non-Hispanic whites. Superficial spreading melanoma was the most common type of melanoma, at 31%, though nodular histology was seen almost as frequently in the 0- to 9-year-olds. This younger group was more likely to have thicker tumors, ulceration, lymph node involvement, and distant metastases.
Drawing on this large registry allowed researchers more confidence that they were identifying true trends in melanoma incidence, Dr. Campbell noted.
The reasons for this decrease, which stands in contrast to earlier data showing increased incidence rates of pediatric melanoma, were not examined in this study. However, Dr. Campbell drew on these earlier studies, as well as some international studies, to identify the potential contribution of public health campaigns advocating sun protection. These campaigns began in the 1990s in the United States, and would have benefited the 15- to 19-year olds in the SEER-18 data, in whom melanoma incidence decreased beginning in 2003. Some Swedish and Australian studies showing decreased melanoma cases were confounded by an immigration-driven decrease in the highest risk light-skinned population, noted Dr. Campbell; however, the quality of the SEER-18 data allowed researchers to account for this variable, she said.
Although the widespread adoption of sun-protective behaviors (wearing hats and protective clothing, using sunscreen appropriately, and avoiding midday sun exposure) may have accounted for some of the reduction in pediatric melanomas, other societal changes may have been at play.
“We hypothesize that there has been a shift in youth participating increasingly in indoor activities, such as television/electronic devices, which may be decreasing their UVR exposure,” Dr. Campbell said.
FROM THE JOURNAL OF PEDIATRICS