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Dr. Bowyer to Receive Robert Danis Prize from ISS/SIC
Mark W. Bowyer, MD, FACS, Chair of the American College of Surgeons Committee on Trauma’s Surgical Skills Committee, has been named the 2017 recipient of the Robert Danis Prize.
Mark W. Bowyer, MD, FACS, Chair of the American College of Surgeons Committee on Trauma’s Surgical Skills Committee, has been named the 2017 recipient of the Robert Danis Prize awarded by the International Society of Surgery/Société Internationale de Chirurgie (ISS/SIC). This award is presented to a surgeon who has made important contributions to the fields of trauma, burns, or critical care. Dr. Bowyer was selected for his lifelong commitment and broad contributions to the field of trauma and surgical simulation.
Dr. Bowyer, the Ben Eiseman Professor of Surgery and surgical director of simulation, division of trauma and combat surgery, department of surgery, Uniformed Services University of the Health Sciences (USUHS)–Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD, spent more than 22 years as an Air Force trauma and combat surgeon. He has taught trauma skills to thousands of medical students and physicians around the world in the last three decades and is one of the chief architects of the Advanced Surgical Skills for Exposures in Trauma course, which has been presented in more than 100 course sites in 11 countries in the last six years. Dr. Bowyer served as the Air Force’s “trauma czar” while serving Iraq, where he directed and coordinated all care provided to combat trauma patients.
In addition, he is the surgical director of the USUHS Val G. Hemming Simulation Center, where he has been on the forefront of using simulators to teach advanced trauma and acute care surgical skills and where he works to develop and validate augmented and virtual reality, as well as trauma, laparoscopic, acute care surgical, triage, and critical care-based simulators. At present, Dr. Bowyer is working on simulation projects to improve patient safety.
Dr. Bowyer will receive the Danis Prize during the ISS/SIC 2017 World Congress of Surgery, August 13−17 in Basel, Switzerland. (Read more about the World Congress of Surgery at www.wcs2017.org/.) Read more about Dr. Bowyer at bit.ly/2qcpETa.
Mark W. Bowyer, MD, FACS, Chair of the American College of Surgeons Committee on Trauma’s Surgical Skills Committee, has been named the 2017 recipient of the Robert Danis Prize.
Mark W. Bowyer, MD, FACS, Chair of the American College of Surgeons Committee on Trauma’s Surgical Skills Committee, has been named the 2017 recipient of the Robert Danis Prize awarded by the International Society of Surgery/Société Internationale de Chirurgie (ISS/SIC). This award is presented to a surgeon who has made important contributions to the fields of trauma, burns, or critical care. Dr. Bowyer was selected for his lifelong commitment and broad contributions to the field of trauma and surgical simulation.
Dr. Bowyer, the Ben Eiseman Professor of Surgery and surgical director of simulation, division of trauma and combat surgery, department of surgery, Uniformed Services University of the Health Sciences (USUHS)–Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD, spent more than 22 years as an Air Force trauma and combat surgeon. He has taught trauma skills to thousands of medical students and physicians around the world in the last three decades and is one of the chief architects of the Advanced Surgical Skills for Exposures in Trauma course, which has been presented in more than 100 course sites in 11 countries in the last six years. Dr. Bowyer served as the Air Force’s “trauma czar” while serving Iraq, where he directed and coordinated all care provided to combat trauma patients.
In addition, he is the surgical director of the USUHS Val G. Hemming Simulation Center, where he has been on the forefront of using simulators to teach advanced trauma and acute care surgical skills and where he works to develop and validate augmented and virtual reality, as well as trauma, laparoscopic, acute care surgical, triage, and critical care-based simulators. At present, Dr. Bowyer is working on simulation projects to improve patient safety.
Dr. Bowyer will receive the Danis Prize during the ISS/SIC 2017 World Congress of Surgery, August 13−17 in Basel, Switzerland. (Read more about the World Congress of Surgery at www.wcs2017.org/.) Read more about Dr. Bowyer at bit.ly/2qcpETa.
Mark W. Bowyer, MD, FACS, Chair of the American College of Surgeons Committee on Trauma’s Surgical Skills Committee, has been named the 2017 recipient of the Robert Danis Prize.
Mark W. Bowyer, MD, FACS, Chair of the American College of Surgeons Committee on Trauma’s Surgical Skills Committee, has been named the 2017 recipient of the Robert Danis Prize awarded by the International Society of Surgery/Société Internationale de Chirurgie (ISS/SIC). This award is presented to a surgeon who has made important contributions to the fields of trauma, burns, or critical care. Dr. Bowyer was selected for his lifelong commitment and broad contributions to the field of trauma and surgical simulation.
Dr. Bowyer, the Ben Eiseman Professor of Surgery and surgical director of simulation, division of trauma and combat surgery, department of surgery, Uniformed Services University of the Health Sciences (USUHS)–Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD, spent more than 22 years as an Air Force trauma and combat surgeon. He has taught trauma skills to thousands of medical students and physicians around the world in the last three decades and is one of the chief architects of the Advanced Surgical Skills for Exposures in Trauma course, which has been presented in more than 100 course sites in 11 countries in the last six years. Dr. Bowyer served as the Air Force’s “trauma czar” while serving Iraq, where he directed and coordinated all care provided to combat trauma patients.
In addition, he is the surgical director of the USUHS Val G. Hemming Simulation Center, where he has been on the forefront of using simulators to teach advanced trauma and acute care surgical skills and where he works to develop and validate augmented and virtual reality, as well as trauma, laparoscopic, acute care surgical, triage, and critical care-based simulators. At present, Dr. Bowyer is working on simulation projects to improve patient safety.
Dr. Bowyer will receive the Danis Prize during the ISS/SIC 2017 World Congress of Surgery, August 13−17 in Basel, Switzerland. (Read more about the World Congress of Surgery at www.wcs2017.org/.) Read more about Dr. Bowyer at bit.ly/2qcpETa.
OSA in pregnancy linked to congenital anomalies
BOSTON – Newborns exposed to obstructive sleep apnea (OSA) in utero are at a higher risk of being diagnosed with congenital anomalies, according to a new study presented at the annual meeting of the Associated Professional Sleep Societies.
The researchers’ analysis covered data from more than 1.4 million births during 2010-2014. Circulatory, musculoskeletal, and central nervous systems were among the types of anomalies they saw in the 17.3% of babies born to mothers who had OSA during pregnancy. These babies were also more likely to require intensive care at birth, compared with those born to mothers who had not been diagnosed with OSA.
Additionally, the investigators found that the 0.1% of women who had a diagnosis of OSA were 2.76 times more likely to have babies that required some kind of resuscitative effort at birth. Specifically, 0.5% of the newborns of the mothers with OSA required resuscitation, compared with 0.1% of the other group’s babies. The newborns of women with OSA were also 2.25 times more likely to have a longer hospital stay.
Mothers with OSA were older and more likely to be non-Hispanic black and have a diagnosis of obesity, tobacco use, and drug use but not alcohol use.
“We can’t say for sure that sleep apnea is causing these outcomes,” said abstract presenter and principal investigator Ghada Bourjeily, MD, of Brown University and Miriam Hospital, both in Providence, R.I., in an interview.
“We know that women who have sleep apnea also often have other morbidities, so we don’t know what might have contributed to the congenital outcomes,” said Dr. Bourjeily. “We also don’t know if treating sleep apnea can reverse or prevent birth complications or even maternal complications, like preeclampsia or gestational diabetes.”
Ongoing studies are looking at maternal continuous positive airway pressure therapy use and neonatal outcomes, but “they are nothing to write home about yet,” she said.
“This is an underdiagnosed condition and it’s probably undercoded too, but we know from another study that the prevalence of OSA in the first trimester in an all-comers population that was screened for the condition is 4%,” said Dr. Bourjeily. “If another 3% of [the study participants] actually had OSA, then all of these findings are potentially underestimated.”
The majority of OSA in pregnant women that has been identified in prospective studies is mild and not necessarily something that most physicians would treat, she noted. “In our study, the ones who were diagnosed were those who probably went to their doctors and complained of sleepiness or loud snoring.”
The researchers also determined that the newborns of mothers with sleep apnea were more likely to be admitted to an intensive care unit (25.3% vs. 8.1%) or a special care nursery (34.9% vs. 13.6%).
A diagnosis of OSA was established when a diagnosis code for OSA was present on the delivery discharge record. Maternal and infant outcomes were collected for ICD-9 and procedural codes.
Dr. Bourjeily received research equipment support from Respironics.
BOSTON – Newborns exposed to obstructive sleep apnea (OSA) in utero are at a higher risk of being diagnosed with congenital anomalies, according to a new study presented at the annual meeting of the Associated Professional Sleep Societies.
The researchers’ analysis covered data from more than 1.4 million births during 2010-2014. Circulatory, musculoskeletal, and central nervous systems were among the types of anomalies they saw in the 17.3% of babies born to mothers who had OSA during pregnancy. These babies were also more likely to require intensive care at birth, compared with those born to mothers who had not been diagnosed with OSA.
Additionally, the investigators found that the 0.1% of women who had a diagnosis of OSA were 2.76 times more likely to have babies that required some kind of resuscitative effort at birth. Specifically, 0.5% of the newborns of the mothers with OSA required resuscitation, compared with 0.1% of the other group’s babies. The newborns of women with OSA were also 2.25 times more likely to have a longer hospital stay.
Mothers with OSA were older and more likely to be non-Hispanic black and have a diagnosis of obesity, tobacco use, and drug use but not alcohol use.
“We can’t say for sure that sleep apnea is causing these outcomes,” said abstract presenter and principal investigator Ghada Bourjeily, MD, of Brown University and Miriam Hospital, both in Providence, R.I., in an interview.
“We know that women who have sleep apnea also often have other morbidities, so we don’t know what might have contributed to the congenital outcomes,” said Dr. Bourjeily. “We also don’t know if treating sleep apnea can reverse or prevent birth complications or even maternal complications, like preeclampsia or gestational diabetes.”
Ongoing studies are looking at maternal continuous positive airway pressure therapy use and neonatal outcomes, but “they are nothing to write home about yet,” she said.
“This is an underdiagnosed condition and it’s probably undercoded too, but we know from another study that the prevalence of OSA in the first trimester in an all-comers population that was screened for the condition is 4%,” said Dr. Bourjeily. “If another 3% of [the study participants] actually had OSA, then all of these findings are potentially underestimated.”
The majority of OSA in pregnant women that has been identified in prospective studies is mild and not necessarily something that most physicians would treat, she noted. “In our study, the ones who were diagnosed were those who probably went to their doctors and complained of sleepiness or loud snoring.”
The researchers also determined that the newborns of mothers with sleep apnea were more likely to be admitted to an intensive care unit (25.3% vs. 8.1%) or a special care nursery (34.9% vs. 13.6%).
A diagnosis of OSA was established when a diagnosis code for OSA was present on the delivery discharge record. Maternal and infant outcomes were collected for ICD-9 and procedural codes.
Dr. Bourjeily received research equipment support from Respironics.
BOSTON – Newborns exposed to obstructive sleep apnea (OSA) in utero are at a higher risk of being diagnosed with congenital anomalies, according to a new study presented at the annual meeting of the Associated Professional Sleep Societies.
The researchers’ analysis covered data from more than 1.4 million births during 2010-2014. Circulatory, musculoskeletal, and central nervous systems were among the types of anomalies they saw in the 17.3% of babies born to mothers who had OSA during pregnancy. These babies were also more likely to require intensive care at birth, compared with those born to mothers who had not been diagnosed with OSA.
Additionally, the investigators found that the 0.1% of women who had a diagnosis of OSA were 2.76 times more likely to have babies that required some kind of resuscitative effort at birth. Specifically, 0.5% of the newborns of the mothers with OSA required resuscitation, compared with 0.1% of the other group’s babies. The newborns of women with OSA were also 2.25 times more likely to have a longer hospital stay.
Mothers with OSA were older and more likely to be non-Hispanic black and have a diagnosis of obesity, tobacco use, and drug use but not alcohol use.
“We can’t say for sure that sleep apnea is causing these outcomes,” said abstract presenter and principal investigator Ghada Bourjeily, MD, of Brown University and Miriam Hospital, both in Providence, R.I., in an interview.
“We know that women who have sleep apnea also often have other morbidities, so we don’t know what might have contributed to the congenital outcomes,” said Dr. Bourjeily. “We also don’t know if treating sleep apnea can reverse or prevent birth complications or even maternal complications, like preeclampsia or gestational diabetes.”
Ongoing studies are looking at maternal continuous positive airway pressure therapy use and neonatal outcomes, but “they are nothing to write home about yet,” she said.
“This is an underdiagnosed condition and it’s probably undercoded too, but we know from another study that the prevalence of OSA in the first trimester in an all-comers population that was screened for the condition is 4%,” said Dr. Bourjeily. “If another 3% of [the study participants] actually had OSA, then all of these findings are potentially underestimated.”
The majority of OSA in pregnant women that has been identified in prospective studies is mild and not necessarily something that most physicians would treat, she noted. “In our study, the ones who were diagnosed were those who probably went to their doctors and complained of sleepiness or loud snoring.”
The researchers also determined that the newborns of mothers with sleep apnea were more likely to be admitted to an intensive care unit (25.3% vs. 8.1%) or a special care nursery (34.9% vs. 13.6%).
A diagnosis of OSA was established when a diagnosis code for OSA was present on the delivery discharge record. Maternal and infant outcomes were collected for ICD-9 and procedural codes.
Dr. Bourjeily received research equipment support from Respironics.
AT SLEEP 2017
Key clinical point: This large cohort study is the first study to show an increased risk of congenital anomalies and resuscitation at birth in newborns born to mothers with diagnosed obstructive sleep apnea (OSA).
Major finding: Of babies born to a mother with OSA, 17.3% had a congenital anomaly, compared with 10.6% of those born to mothers without OSA (P less than .001). This difference remained significant after adjusting for potential confounders.
Data source: A national cohort study including more than 1.4 million linked maternal and newborn records with a delivery hospitalization during 2010-2014.
Disclosures: Dr. Bourjeily received research equipment support from Respironics.
Laparoscopic colectomy cost savings linked to surgeon experience
Laparoscopic colectomy is less expensive than open colectomy only when it is performed by surgeons experienced with the laparoscopic approach, according to a study published in the Annals of Surgery.
Many studies have demonstrated that compared with the open surgery, the laparoscopic approach reduces the cost of major abdominal operations including colectomy by as much as 50%. These savings are attributed to the shorter length of stay and lower complication rate associated with laparoscopic surgery.
“The present study underscores and clarifies the complex relationship between surgeon experience, postoperative complications, and healthcare payments. It builds on prior analyses of surgical cohorts that demonstrate an association of higher complication rates with significantly increased total episode payments,” the investigators wrote.
To assess payments for laparoscopic vs. open colectomy, they performed a population-based analysis of information in a national Medicare database regarding 182,852 procedures done in 2010-2012. They included payments for complications, readmissions, and postacute care as well as for the surgery and hospital stay.
To examine any possible effects of the surgeons’ experience on the resulting costs, the data were divided into quartiles of experience with laparoscopy. The investigators then compared surgeons with the least experience (the lowest quartile), the most experience (the highest quartile), and intermediate experience (the two middle quartiles).
Among the surgeons with the least experience in laparoscopy, Medicare payments were actually higher for laparoscopic ($26,915) than for open colectomy ($23,312). In contrast, among surgeons with the most experience, payments were substantially lower for laparoscopic ($20,476) than for open colectomy ($23,793).
This difference was attributed to the less experienced surgeons’ higher complication rates; higher readmission rates; and greater need for postacute care services, such as discharging the patient to a skilled nursing facility rather than home, the investigators said (Ann Surg. 2017 May 25. doi: 10.1097/SLA.0000000000002312).
These findings demonstrate that “the financial benefits of laparoscopy are only realized when the surgeon has appropriate experience or proficiency.” They have important implications, highlighting the need for more rigorous credentialing standards for individual surgeons and for improving continuing medical education through more extensive proctoring or coaching to enhance surgical skills, Dr. Sheetz and his associates said.
The study results also “make a business case for investing in the training and retraining of surgeons in practice,” they added
“New procedures are continually introduced into practice, and surgeons need to take the time to learn them safely. Taking time to learn new procedures is expensive. Increasing the number of surgeons at a given hospital who are, however, proficient with complex laparoscopy has an important beneficial impact on the financial bottom line for hospitals and health care payers,” the investigators noted.
This study was supported by The National Institutes of Health. Dr. Sheetz and his associates reported having no relevant financial disclosures.
Laparoscopic colectomy is less expensive than open colectomy only when it is performed by surgeons experienced with the laparoscopic approach, according to a study published in the Annals of Surgery.
Many studies have demonstrated that compared with the open surgery, the laparoscopic approach reduces the cost of major abdominal operations including colectomy by as much as 50%. These savings are attributed to the shorter length of stay and lower complication rate associated with laparoscopic surgery.
“The present study underscores and clarifies the complex relationship between surgeon experience, postoperative complications, and healthcare payments. It builds on prior analyses of surgical cohorts that demonstrate an association of higher complication rates with significantly increased total episode payments,” the investigators wrote.
To assess payments for laparoscopic vs. open colectomy, they performed a population-based analysis of information in a national Medicare database regarding 182,852 procedures done in 2010-2012. They included payments for complications, readmissions, and postacute care as well as for the surgery and hospital stay.
To examine any possible effects of the surgeons’ experience on the resulting costs, the data were divided into quartiles of experience with laparoscopy. The investigators then compared surgeons with the least experience (the lowest quartile), the most experience (the highest quartile), and intermediate experience (the two middle quartiles).
Among the surgeons with the least experience in laparoscopy, Medicare payments were actually higher for laparoscopic ($26,915) than for open colectomy ($23,312). In contrast, among surgeons with the most experience, payments were substantially lower for laparoscopic ($20,476) than for open colectomy ($23,793).
This difference was attributed to the less experienced surgeons’ higher complication rates; higher readmission rates; and greater need for postacute care services, such as discharging the patient to a skilled nursing facility rather than home, the investigators said (Ann Surg. 2017 May 25. doi: 10.1097/SLA.0000000000002312).
These findings demonstrate that “the financial benefits of laparoscopy are only realized when the surgeon has appropriate experience or proficiency.” They have important implications, highlighting the need for more rigorous credentialing standards for individual surgeons and for improving continuing medical education through more extensive proctoring or coaching to enhance surgical skills, Dr. Sheetz and his associates said.
The study results also “make a business case for investing in the training and retraining of surgeons in practice,” they added
“New procedures are continually introduced into practice, and surgeons need to take the time to learn them safely. Taking time to learn new procedures is expensive. Increasing the number of surgeons at a given hospital who are, however, proficient with complex laparoscopy has an important beneficial impact on the financial bottom line for hospitals and health care payers,” the investigators noted.
This study was supported by The National Institutes of Health. Dr. Sheetz and his associates reported having no relevant financial disclosures.
Laparoscopic colectomy is less expensive than open colectomy only when it is performed by surgeons experienced with the laparoscopic approach, according to a study published in the Annals of Surgery.
Many studies have demonstrated that compared with the open surgery, the laparoscopic approach reduces the cost of major abdominal operations including colectomy by as much as 50%. These savings are attributed to the shorter length of stay and lower complication rate associated with laparoscopic surgery.
“The present study underscores and clarifies the complex relationship between surgeon experience, postoperative complications, and healthcare payments. It builds on prior analyses of surgical cohorts that demonstrate an association of higher complication rates with significantly increased total episode payments,” the investigators wrote.
To assess payments for laparoscopic vs. open colectomy, they performed a population-based analysis of information in a national Medicare database regarding 182,852 procedures done in 2010-2012. They included payments for complications, readmissions, and postacute care as well as for the surgery and hospital stay.
To examine any possible effects of the surgeons’ experience on the resulting costs, the data were divided into quartiles of experience with laparoscopy. The investigators then compared surgeons with the least experience (the lowest quartile), the most experience (the highest quartile), and intermediate experience (the two middle quartiles).
Among the surgeons with the least experience in laparoscopy, Medicare payments were actually higher for laparoscopic ($26,915) than for open colectomy ($23,312). In contrast, among surgeons with the most experience, payments were substantially lower for laparoscopic ($20,476) than for open colectomy ($23,793).
This difference was attributed to the less experienced surgeons’ higher complication rates; higher readmission rates; and greater need for postacute care services, such as discharging the patient to a skilled nursing facility rather than home, the investigators said (Ann Surg. 2017 May 25. doi: 10.1097/SLA.0000000000002312).
These findings demonstrate that “the financial benefits of laparoscopy are only realized when the surgeon has appropriate experience or proficiency.” They have important implications, highlighting the need for more rigorous credentialing standards for individual surgeons and for improving continuing medical education through more extensive proctoring or coaching to enhance surgical skills, Dr. Sheetz and his associates said.
The study results also “make a business case for investing in the training and retraining of surgeons in practice,” they added
“New procedures are continually introduced into practice, and surgeons need to take the time to learn them safely. Taking time to learn new procedures is expensive. Increasing the number of surgeons at a given hospital who are, however, proficient with complex laparoscopy has an important beneficial impact on the financial bottom line for hospitals and health care payers,” the investigators noted.
This study was supported by The National Institutes of Health. Dr. Sheetz and his associates reported having no relevant financial disclosures.
FROM THE ANNALS OF SURGERY
Key clinical point: Laparoscopic colectomy is less expensive than open colectomy only when it is performed by surgeons experienced with the laparoscopic approach.
Major finding: Among the surgeons with the least experience in laparoscopy, Medicare payments were actually higher for laparoscopic ($26,915) than for open colectomy ($23,312).
Data source: An analysis of Medicare payment data for 182,852 patients who had laparoscopic or open colectomy in 2010-2012.
Disclosures: This study was supported by The National Institutes of Health. Dr. Sheetz and his associates reported having no relevant financial disclosures.
Commentary—Promising Results Should Prompt Further Study
During the past 20 years, mindfulness-based training has become an increasingly popular treatment for many conditions, including migraine. In the February online issue of the Journal of Headache and Pain, Dr. Grazzi addresses medication overuse chronic migraine (CM-MO) and provides initial evidence for the consideration of mindfulness training to help reduce headache symptoms.
However, the reader should take seriously the authors’ caution that “although our findings are encouraging and suggestive of the independent value of mindfulness for headache care, certain design limitations preclude us [from] making unequivocal claims.”
Since the goal of a noninferiority trial is to assess whether a new therapy is at least as beneficial as standard treatment, extra caution is necessary when interpreting findings from an underpowered feasibility study. In general, a useful approach to noninferiority is to determine whether the confidence intervals include effect sizes that one might consider clinically meaningful. Instead of focusing on whether the mindfulness-based training group performed the same as the comparison group, we should accept the valuable information that is presented. The take away message from this pilot study is threefold. Mindfulness-based training is potentially acceptable to patients with CM-MO. Patients with CM-MO might be amenable to participating in a fully powered randomized controlled trial of mindfulness-based training. Finally, it is possible that mindfulness-based training may show improvement similar in magnitude to pharmaceuticals. Overall, Grazzi et al have laid the groundwork for a fully powered, randomized version of their study.
—Alice R. Pressman, PhD
Director of Analytics and Evaluation
Sutter Health
Walnut Creek, California
During the past 20 years, mindfulness-based training has become an increasingly popular treatment for many conditions, including migraine. In the February online issue of the Journal of Headache and Pain, Dr. Grazzi addresses medication overuse chronic migraine (CM-MO) and provides initial evidence for the consideration of mindfulness training to help reduce headache symptoms.
However, the reader should take seriously the authors’ caution that “although our findings are encouraging and suggestive of the independent value of mindfulness for headache care, certain design limitations preclude us [from] making unequivocal claims.”
Since the goal of a noninferiority trial is to assess whether a new therapy is at least as beneficial as standard treatment, extra caution is necessary when interpreting findings from an underpowered feasibility study. In general, a useful approach to noninferiority is to determine whether the confidence intervals include effect sizes that one might consider clinically meaningful. Instead of focusing on whether the mindfulness-based training group performed the same as the comparison group, we should accept the valuable information that is presented. The take away message from this pilot study is threefold. Mindfulness-based training is potentially acceptable to patients with CM-MO. Patients with CM-MO might be amenable to participating in a fully powered randomized controlled trial of mindfulness-based training. Finally, it is possible that mindfulness-based training may show improvement similar in magnitude to pharmaceuticals. Overall, Grazzi et al have laid the groundwork for a fully powered, randomized version of their study.
—Alice R. Pressman, PhD
Director of Analytics and Evaluation
Sutter Health
Walnut Creek, California
During the past 20 years, mindfulness-based training has become an increasingly popular treatment for many conditions, including migraine. In the February online issue of the Journal of Headache and Pain, Dr. Grazzi addresses medication overuse chronic migraine (CM-MO) and provides initial evidence for the consideration of mindfulness training to help reduce headache symptoms.
However, the reader should take seriously the authors’ caution that “although our findings are encouraging and suggestive of the independent value of mindfulness for headache care, certain design limitations preclude us [from] making unequivocal claims.”
Since the goal of a noninferiority trial is to assess whether a new therapy is at least as beneficial as standard treatment, extra caution is necessary when interpreting findings from an underpowered feasibility study. In general, a useful approach to noninferiority is to determine whether the confidence intervals include effect sizes that one might consider clinically meaningful. Instead of focusing on whether the mindfulness-based training group performed the same as the comparison group, we should accept the valuable information that is presented. The take away message from this pilot study is threefold. Mindfulness-based training is potentially acceptable to patients with CM-MO. Patients with CM-MO might be amenable to participating in a fully powered randomized controlled trial of mindfulness-based training. Finally, it is possible that mindfulness-based training may show improvement similar in magnitude to pharmaceuticals. Overall, Grazzi et al have laid the groundwork for a fully powered, randomized version of their study.
—Alice R. Pressman, PhD
Director of Analytics and Evaluation
Sutter Health
Walnut Creek, California
Hypogonadism after testicular cancer treatment can have lifelong impact
CHICAGO – Hypogonadism may compromise the long-term health outlook for many younger men who have been successfully treated for testicular cancer, according to an analysis conducted by the Platinum Study Group.
“Today, 95% of all testicular cancer patients are cured of their disease thanks to cisplatin-based chemotherapy. Nowadays, testicular cancer survivors can expect to live for over 40 years from the time of their diagnosis,” lead investigator Mohammad Issam Abu Zaid, MBBS, said in a press briefing at the annual meeting of the American Society of Clinical Oncology. “However, they are at risk of other health problems that may be related to their cancer treatment, including late complications from chemotherapy.”
“Testicular cancer survivors, especially those treated with chemotherapy, are at increased risk for hypogonadism, a problem that can be associated with predisposing factors for heart disease,” summarized Dr. Abu Zaid, of Indiana University in Indianapolis. “Mitigating approaches are the usual weight control, exercise, and monitoring of blood pressure and cholesterol levels.”
Expert perspective
“This is an important study, and it sends a loud message to those of us who take care of testis cancer patients, my area of expertise. ... We need to watch for hypogonadism, and we need to ask survivors about it. We need to examine them thinking about it, and, in patients who we are worried [they] might have hypogonadism, we need to do blood tests for testosterone and other hormone levels,” commented ASCO Expert Timothy D. Gilligan, MD, MSc, of the Cleveland Clinic in Ohio. “These are young patients, they have many years of life, so it’s many decades of suffering from consequences of this if it’s undetected.”
The findings were not surprising based on his personal experience and on evidence from the prostate cancer field showing the adverse metabolic effects of withdrawing testosterone, he said. Although the prevalence of hypogonadism found in the study was higher than that found in other studies, given the large size of the cohort, it should be taken seriously. Additionally, even if the true prevalence is somewhat lower, the absolute number of survivors affected would be substantial.
“We need to be cautious though and make sure people don’t misunderstand and think that this means we should test testosterone levels in all patients, which is a risky thing to do because the definition of normal testosterone is very fuzzy,” Dr. Gilligan stressed. “There is a wide range of normal, and what’s normal for me may not be the same as what’s normal for another man. So, looking for symptoms is really what guides this work, and, when there are symptoms, then testing is important.”
Study details
The Platinum Study is a large, ongoing, multicenter North American–based cohort study of testicular cancer survivors who received cisplatin as part of their chemotherapy.
Dr. Abu Zaid and his colleagues analyzed data from 491 participants who were aged 50 years or younger at diagnosis. All completed questionnaires addressing comorbidities, medications, and health behaviors; underwent physical examination; had measurement of testosterone levels; and had a genetic analysis.
The men were by and large young at the time of evaluation, with a mean age of just 38 years, he reported in the press briefing and a poster session at the meeting.
Overall, 38.5% had hypogonadism, defined in the study as a serum testosterone level of 3 ng/mL or lower or as use of testosterone replacement therapy.
In a multivariate analysis, survivors’ odds of hypogonadism increased with age (odds ratio, 1.41 per 10-year increment; P = .007) and were higher for those having a body mass index of 25 kg/m2 or greater, vs. lower (OR, 2.22; P = .003). On the other hand, there was a trend whereby survivors who engaged in any vigorous-intensity physical activity, vs. none, were less likely to have hypogonadism (OR, 0.64; P = .06).
The odds rose with number of risk alleles in the sex hormone–binding globulin gene, but findings were not significant, Dr. Abu Zaid said. They were also statistically indistinguishable across groups differing with respect to the chemotherapy regimen received and socioeconomic factors.
Compared with counterparts having normal testosterone levels, survivors having hypogonadism were up to four times more likely to be taking medication to treat dyslipidemia (20.1% vs. 6.0%; P less than .001), hypertension (18.5% vs. 10.6%; P = .013), erectile dysfunction (19.6% vs. 11.9%; P = .018), diabetes (5.8% vs. 2.6%; P = .067), and anxiety or depression (14.8% vs. 9.3%; P = .060).
Testicular cancer survivors should not universally have testosterone testing, agreed Dr. Abu Zaid. Such a practice might lead to overtreatment, and, in older men at least, use of testosterone itself has been linked to elevated cardiovascular risk.
“You really want to treat somebody who has symptoms related to hypogonadism: constant fatigue, night sweats, and depressed mood and some other symptoms that are well known to the clinician,” he maintained. “At the moment, we have no studies done looking at testosterone replacement in young men. I would hypothesize that we actually help them by giving them testosterone, and that’s what I tell my patients.”
CHICAGO – Hypogonadism may compromise the long-term health outlook for many younger men who have been successfully treated for testicular cancer, according to an analysis conducted by the Platinum Study Group.
“Today, 95% of all testicular cancer patients are cured of their disease thanks to cisplatin-based chemotherapy. Nowadays, testicular cancer survivors can expect to live for over 40 years from the time of their diagnosis,” lead investigator Mohammad Issam Abu Zaid, MBBS, said in a press briefing at the annual meeting of the American Society of Clinical Oncology. “However, they are at risk of other health problems that may be related to their cancer treatment, including late complications from chemotherapy.”
“Testicular cancer survivors, especially those treated with chemotherapy, are at increased risk for hypogonadism, a problem that can be associated with predisposing factors for heart disease,” summarized Dr. Abu Zaid, of Indiana University in Indianapolis. “Mitigating approaches are the usual weight control, exercise, and monitoring of blood pressure and cholesterol levels.”
Expert perspective
“This is an important study, and it sends a loud message to those of us who take care of testis cancer patients, my area of expertise. ... We need to watch for hypogonadism, and we need to ask survivors about it. We need to examine them thinking about it, and, in patients who we are worried [they] might have hypogonadism, we need to do blood tests for testosterone and other hormone levels,” commented ASCO Expert Timothy D. Gilligan, MD, MSc, of the Cleveland Clinic in Ohio. “These are young patients, they have many years of life, so it’s many decades of suffering from consequences of this if it’s undetected.”
The findings were not surprising based on his personal experience and on evidence from the prostate cancer field showing the adverse metabolic effects of withdrawing testosterone, he said. Although the prevalence of hypogonadism found in the study was higher than that found in other studies, given the large size of the cohort, it should be taken seriously. Additionally, even if the true prevalence is somewhat lower, the absolute number of survivors affected would be substantial.
“We need to be cautious though and make sure people don’t misunderstand and think that this means we should test testosterone levels in all patients, which is a risky thing to do because the definition of normal testosterone is very fuzzy,” Dr. Gilligan stressed. “There is a wide range of normal, and what’s normal for me may not be the same as what’s normal for another man. So, looking for symptoms is really what guides this work, and, when there are symptoms, then testing is important.”
Study details
The Platinum Study is a large, ongoing, multicenter North American–based cohort study of testicular cancer survivors who received cisplatin as part of their chemotherapy.
Dr. Abu Zaid and his colleagues analyzed data from 491 participants who were aged 50 years or younger at diagnosis. All completed questionnaires addressing comorbidities, medications, and health behaviors; underwent physical examination; had measurement of testosterone levels; and had a genetic analysis.
The men were by and large young at the time of evaluation, with a mean age of just 38 years, he reported in the press briefing and a poster session at the meeting.
Overall, 38.5% had hypogonadism, defined in the study as a serum testosterone level of 3 ng/mL or lower or as use of testosterone replacement therapy.
In a multivariate analysis, survivors’ odds of hypogonadism increased with age (odds ratio, 1.41 per 10-year increment; P = .007) and were higher for those having a body mass index of 25 kg/m2 or greater, vs. lower (OR, 2.22; P = .003). On the other hand, there was a trend whereby survivors who engaged in any vigorous-intensity physical activity, vs. none, were less likely to have hypogonadism (OR, 0.64; P = .06).
The odds rose with number of risk alleles in the sex hormone–binding globulin gene, but findings were not significant, Dr. Abu Zaid said. They were also statistically indistinguishable across groups differing with respect to the chemotherapy regimen received and socioeconomic factors.
Compared with counterparts having normal testosterone levels, survivors having hypogonadism were up to four times more likely to be taking medication to treat dyslipidemia (20.1% vs. 6.0%; P less than .001), hypertension (18.5% vs. 10.6%; P = .013), erectile dysfunction (19.6% vs. 11.9%; P = .018), diabetes (5.8% vs. 2.6%; P = .067), and anxiety or depression (14.8% vs. 9.3%; P = .060).
Testicular cancer survivors should not universally have testosterone testing, agreed Dr. Abu Zaid. Such a practice might lead to overtreatment, and, in older men at least, use of testosterone itself has been linked to elevated cardiovascular risk.
“You really want to treat somebody who has symptoms related to hypogonadism: constant fatigue, night sweats, and depressed mood and some other symptoms that are well known to the clinician,” he maintained. “At the moment, we have no studies done looking at testosterone replacement in young men. I would hypothesize that we actually help them by giving them testosterone, and that’s what I tell my patients.”
CHICAGO – Hypogonadism may compromise the long-term health outlook for many younger men who have been successfully treated for testicular cancer, according to an analysis conducted by the Platinum Study Group.
“Today, 95% of all testicular cancer patients are cured of their disease thanks to cisplatin-based chemotherapy. Nowadays, testicular cancer survivors can expect to live for over 40 years from the time of their diagnosis,” lead investigator Mohammad Issam Abu Zaid, MBBS, said in a press briefing at the annual meeting of the American Society of Clinical Oncology. “However, they are at risk of other health problems that may be related to their cancer treatment, including late complications from chemotherapy.”
“Testicular cancer survivors, especially those treated with chemotherapy, are at increased risk for hypogonadism, a problem that can be associated with predisposing factors for heart disease,” summarized Dr. Abu Zaid, of Indiana University in Indianapolis. “Mitigating approaches are the usual weight control, exercise, and monitoring of blood pressure and cholesterol levels.”
Expert perspective
“This is an important study, and it sends a loud message to those of us who take care of testis cancer patients, my area of expertise. ... We need to watch for hypogonadism, and we need to ask survivors about it. We need to examine them thinking about it, and, in patients who we are worried [they] might have hypogonadism, we need to do blood tests for testosterone and other hormone levels,” commented ASCO Expert Timothy D. Gilligan, MD, MSc, of the Cleveland Clinic in Ohio. “These are young patients, they have many years of life, so it’s many decades of suffering from consequences of this if it’s undetected.”
The findings were not surprising based on his personal experience and on evidence from the prostate cancer field showing the adverse metabolic effects of withdrawing testosterone, he said. Although the prevalence of hypogonadism found in the study was higher than that found in other studies, given the large size of the cohort, it should be taken seriously. Additionally, even if the true prevalence is somewhat lower, the absolute number of survivors affected would be substantial.
“We need to be cautious though and make sure people don’t misunderstand and think that this means we should test testosterone levels in all patients, which is a risky thing to do because the definition of normal testosterone is very fuzzy,” Dr. Gilligan stressed. “There is a wide range of normal, and what’s normal for me may not be the same as what’s normal for another man. So, looking for symptoms is really what guides this work, and, when there are symptoms, then testing is important.”
Study details
The Platinum Study is a large, ongoing, multicenter North American–based cohort study of testicular cancer survivors who received cisplatin as part of their chemotherapy.
Dr. Abu Zaid and his colleagues analyzed data from 491 participants who were aged 50 years or younger at diagnosis. All completed questionnaires addressing comorbidities, medications, and health behaviors; underwent physical examination; had measurement of testosterone levels; and had a genetic analysis.
The men were by and large young at the time of evaluation, with a mean age of just 38 years, he reported in the press briefing and a poster session at the meeting.
Overall, 38.5% had hypogonadism, defined in the study as a serum testosterone level of 3 ng/mL or lower or as use of testosterone replacement therapy.
In a multivariate analysis, survivors’ odds of hypogonadism increased with age (odds ratio, 1.41 per 10-year increment; P = .007) and were higher for those having a body mass index of 25 kg/m2 or greater, vs. lower (OR, 2.22; P = .003). On the other hand, there was a trend whereby survivors who engaged in any vigorous-intensity physical activity, vs. none, were less likely to have hypogonadism (OR, 0.64; P = .06).
The odds rose with number of risk alleles in the sex hormone–binding globulin gene, but findings were not significant, Dr. Abu Zaid said. They were also statistically indistinguishable across groups differing with respect to the chemotherapy regimen received and socioeconomic factors.
Compared with counterparts having normal testosterone levels, survivors having hypogonadism were up to four times more likely to be taking medication to treat dyslipidemia (20.1% vs. 6.0%; P less than .001), hypertension (18.5% vs. 10.6%; P = .013), erectile dysfunction (19.6% vs. 11.9%; P = .018), diabetes (5.8% vs. 2.6%; P = .067), and anxiety or depression (14.8% vs. 9.3%; P = .060).
Testicular cancer survivors should not universally have testosterone testing, agreed Dr. Abu Zaid. Such a practice might lead to overtreatment, and, in older men at least, use of testosterone itself has been linked to elevated cardiovascular risk.
“You really want to treat somebody who has symptoms related to hypogonadism: constant fatigue, night sweats, and depressed mood and some other symptoms that are well known to the clinician,” he maintained. “At the moment, we have no studies done looking at testosterone replacement in young men. I would hypothesize that we actually help them by giving them testosterone, and that’s what I tell my patients.”
AT ASCO 2017
Key clinical point:
Major finding: Fully 38.5% of survivors had low testosterone levels, and men in this group were more likely to be taking medications for dyslipidemia, hypertension, diabetes, erectile dysfunction, and anxiety or depression.
Data source: A cohort study of 491 testicular cancer survivors who had been treated with cisplatin-based chemotherapy (Platinum Study).
Disclosures: Dr. Abu Zaid reported that he had no relevant disclosures.
Consistent weight benefits seen in empagliflozin use
SAN DIEGO – In a follow-up to the blockbuster trial results linking the type 2 diabetes drug empagliflozin (Jardiance) to a dramatically lower risk of cardiac death, researchers report that the drug improved weight-related measures in multiple groups.
Two daily doses of empagliflozin, 10 mg and 25 mg, “had consistent and robust effects on lowering weight, waist circumference, and other markers of body fat across most patients regardless of their age, sex, or degree of abdominal obesity,” study lead author Ian J. Neeland, MD, of the department of medicine at UT Southwestern Medical Center, Dallas, said in an interview. “Our next step is to determine if these effects may contribute to the improvement in cardiovascular risk seen with the drug.”
“In the EMPA-REG OUTCOME study, empagliflozin treatment significantly reduced the risk of cardiovascular death by 38%,” Dr. Neeland said. “We also observed that patients treated with empagliflozin had improvements in markers of body fatness such as weight, waist circumference, and estimated total body fat. Since we know that obesity is a major risk factor for cardiovascular disease, we were interested in finding out if the improvements in weight and other markers of body fatness may have contributed to the observed cardiovascular benefits of empagliflozin in the study. One part of this was to examine whether the drug had consistent effects on body fat according to other important cardiovascular risk factors.”
The researchers analyzed changes in body weight, waist circumference, index of central obesity, and estimated total body fat from baseline to week 164 in a study that randomly assigned participants with type 2 diabetes and cardiovascular disease to placebo or 10 mg or 25 mg of empagliflozin. The number of patients in the groups were 2,333, 2,345 and 2,342, respectively, and their mean baseline weight was around 86.0 kg.
In general, researchers found that across groups, weight measures improved more in drug-treated patients than those treated with placebo. The higher dose (25 mg) often had a greater effect; the two available doses of the drug are 10 mg and 20 mg.
For example, the placebo-adjusted mean reduction in weight was –1.70 kg in men (95% confidence interval, –2.14 to –1.27) in the 10-mg group and 2.18 kg (95% CI, –2.61 to –1.75) in the 25-mg group. For women, the reduction was –1.32 kg (95% CI, –2.02 to –0.62) in the 10-mg group and –1.44 kg (95% CI, –2.15 to –0.73) in the 25-mg group.
“Patients lost on average 1.5-2 kg of weight – about 4 pounds – with empagliflozin, compared with placebo,” Dr. Neeland said. “Although quality of life and other metrics of better health were not systematically collected, we do know that people who lose weight and waist circumference tend to feel better, have fewer health problems, and live longer, compared with people who remain obese.”
Dr. Neeland said researchers still need to understand whether the improvements in obesity markers contribute to the drug’s positive cardiac effects.
Study funding was not reported. The original EMPA-REG OUTCOME trial was funded by Boehringer Ingelheim and Eli Lilly. Dr. Neeland disclosed consultant/speakers bureau support from Boehringer Ingelheim. He is a scientific advisory board member for Advanced MR Analytics AB.
SAN DIEGO – In a follow-up to the blockbuster trial results linking the type 2 diabetes drug empagliflozin (Jardiance) to a dramatically lower risk of cardiac death, researchers report that the drug improved weight-related measures in multiple groups.
Two daily doses of empagliflozin, 10 mg and 25 mg, “had consistent and robust effects on lowering weight, waist circumference, and other markers of body fat across most patients regardless of their age, sex, or degree of abdominal obesity,” study lead author Ian J. Neeland, MD, of the department of medicine at UT Southwestern Medical Center, Dallas, said in an interview. “Our next step is to determine if these effects may contribute to the improvement in cardiovascular risk seen with the drug.”
“In the EMPA-REG OUTCOME study, empagliflozin treatment significantly reduced the risk of cardiovascular death by 38%,” Dr. Neeland said. “We also observed that patients treated with empagliflozin had improvements in markers of body fatness such as weight, waist circumference, and estimated total body fat. Since we know that obesity is a major risk factor for cardiovascular disease, we were interested in finding out if the improvements in weight and other markers of body fatness may have contributed to the observed cardiovascular benefits of empagliflozin in the study. One part of this was to examine whether the drug had consistent effects on body fat according to other important cardiovascular risk factors.”
The researchers analyzed changes in body weight, waist circumference, index of central obesity, and estimated total body fat from baseline to week 164 in a study that randomly assigned participants with type 2 diabetes and cardiovascular disease to placebo or 10 mg or 25 mg of empagliflozin. The number of patients in the groups were 2,333, 2,345 and 2,342, respectively, and their mean baseline weight was around 86.0 kg.
In general, researchers found that across groups, weight measures improved more in drug-treated patients than those treated with placebo. The higher dose (25 mg) often had a greater effect; the two available doses of the drug are 10 mg and 20 mg.
For example, the placebo-adjusted mean reduction in weight was –1.70 kg in men (95% confidence interval, –2.14 to –1.27) in the 10-mg group and 2.18 kg (95% CI, –2.61 to –1.75) in the 25-mg group. For women, the reduction was –1.32 kg (95% CI, –2.02 to –0.62) in the 10-mg group and –1.44 kg (95% CI, –2.15 to –0.73) in the 25-mg group.
“Patients lost on average 1.5-2 kg of weight – about 4 pounds – with empagliflozin, compared with placebo,” Dr. Neeland said. “Although quality of life and other metrics of better health were not systematically collected, we do know that people who lose weight and waist circumference tend to feel better, have fewer health problems, and live longer, compared with people who remain obese.”
Dr. Neeland said researchers still need to understand whether the improvements in obesity markers contribute to the drug’s positive cardiac effects.
Study funding was not reported. The original EMPA-REG OUTCOME trial was funded by Boehringer Ingelheim and Eli Lilly. Dr. Neeland disclosed consultant/speakers bureau support from Boehringer Ingelheim. He is a scientific advisory board member for Advanced MR Analytics AB.
SAN DIEGO – In a follow-up to the blockbuster trial results linking the type 2 diabetes drug empagliflozin (Jardiance) to a dramatically lower risk of cardiac death, researchers report that the drug improved weight-related measures in multiple groups.
Two daily doses of empagliflozin, 10 mg and 25 mg, “had consistent and robust effects on lowering weight, waist circumference, and other markers of body fat across most patients regardless of their age, sex, or degree of abdominal obesity,” study lead author Ian J. Neeland, MD, of the department of medicine at UT Southwestern Medical Center, Dallas, said in an interview. “Our next step is to determine if these effects may contribute to the improvement in cardiovascular risk seen with the drug.”
“In the EMPA-REG OUTCOME study, empagliflozin treatment significantly reduced the risk of cardiovascular death by 38%,” Dr. Neeland said. “We also observed that patients treated with empagliflozin had improvements in markers of body fatness such as weight, waist circumference, and estimated total body fat. Since we know that obesity is a major risk factor for cardiovascular disease, we were interested in finding out if the improvements in weight and other markers of body fatness may have contributed to the observed cardiovascular benefits of empagliflozin in the study. One part of this was to examine whether the drug had consistent effects on body fat according to other important cardiovascular risk factors.”
The researchers analyzed changes in body weight, waist circumference, index of central obesity, and estimated total body fat from baseline to week 164 in a study that randomly assigned participants with type 2 diabetes and cardiovascular disease to placebo or 10 mg or 25 mg of empagliflozin. The number of patients in the groups were 2,333, 2,345 and 2,342, respectively, and their mean baseline weight was around 86.0 kg.
In general, researchers found that across groups, weight measures improved more in drug-treated patients than those treated with placebo. The higher dose (25 mg) often had a greater effect; the two available doses of the drug are 10 mg and 20 mg.
For example, the placebo-adjusted mean reduction in weight was –1.70 kg in men (95% confidence interval, –2.14 to –1.27) in the 10-mg group and 2.18 kg (95% CI, –2.61 to –1.75) in the 25-mg group. For women, the reduction was –1.32 kg (95% CI, –2.02 to –0.62) in the 10-mg group and –1.44 kg (95% CI, –2.15 to –0.73) in the 25-mg group.
“Patients lost on average 1.5-2 kg of weight – about 4 pounds – with empagliflozin, compared with placebo,” Dr. Neeland said. “Although quality of life and other metrics of better health were not systematically collected, we do know that people who lose weight and waist circumference tend to feel better, have fewer health problems, and live longer, compared with people who remain obese.”
Dr. Neeland said researchers still need to understand whether the improvements in obesity markers contribute to the drug’s positive cardiac effects.
Study funding was not reported. The original EMPA-REG OUTCOME trial was funded by Boehringer Ingelheim and Eli Lilly. Dr. Neeland disclosed consultant/speakers bureau support from Boehringer Ingelheim. He is a scientific advisory board member for Advanced MR Analytics AB.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Placebo-adjusted mean reduction in weight was –1.70 kg in men for daily 10-mg dose group and –2.18 kg in daily 25-mg group. For women, the losses were –1.32 kg in the 10-mg group and –1.44 kg in the 25-mg group.
Data source: Secondary analysis of 164-week randomized, double-blind, placebo-controlled study of patients with type 2 diabetes and cardiovascular disease assigned to placebo or 10-mg or 25-mg doses of empagliflozin.
Disclosures: Study funding was not reported. The original EMPA-REG OUTCOME trial was funded by Boehringer Ingelheim and Eli Lilly.
HFrEF mortality halved when treatment matches guidelines
PARIS – Heart failure patients who received guideline-directed pharmacotherapy, at dosages that approached guideline-directed levels, had roughly half the 6-month mortality as did similar patients who did not receive this level of treatment in a real-world, observational study with more than 6,000 patients.
Adherence to pharmacologic treatment guidelines for patients with heart failure with reduced ejection fraction (HFrEF) “was strongly associated with clinical outcomes during 6-month follow-up,” Michel Komajda, MD, said at a meeting held by the Heart Failure Association of the European Society of Cardiology. The findings highlight the importance of closely following guideline recommendations in routine practice.
[polldaddy:9772629]
The analysis used data collected in the QUALIFY (Quality of Adherence to Guideline Recommendations for Life-Saving Treatment in Heart Failure: an International Survey) registry, which enrolled 7,127 HFrEF patients during September 2013–December 2014 at 547 centers in 36 countries, mostly in Europe, Asia, and Africa but also in Canada, Ecuador, and Australia. All enrolled patients had to have been hospitalized for worsening heart failure at least once during the 1-15 months before they entered QUALIFY.
Dr. Komajda and his associates assessed each enrolled patient at baseline by their treatment with each of four guideline-recommended drug classes: an ACE inhibitor or angiotensin receptor blocker; a beta-blocker; an aldosterone receptor antagonist (ARA) if the patient’s functional status was rated as New York Heart Association class II, III, or IV; and ivabradine (Corlanor) if the patient was in NYHA class II, III, or IV, in sinus rhythm, had a heart rate of at least 70 beats per minute, and if the patient was in a country where ivabradine was available. Because patient enrollment occurred in 2013 and 2014, the study couldn’t include the new formulation of sacubitril plus valsartan (Entresto) in its analysis.
For each eligible drug class a patient received 1 point if their daily prescribed dosage was at least 50% of the recommended dosage (or 100% for an ARA), 0.5 points if the patient received the recommended drug but at a lower dosage, and no points if the drug wasn’t given. A patient also received 1 point if they were appropriately not given a drug because of a documented contraindication or intolerance. The researchers then calculated each patient’s “adherence score” by dividing their point total by the potentially maximum number of points that each patient could have received (a number that ranged from 2 to 4). They defined a score of 1 (which meant the patients received at least half the recommended dosage of all recommended drugs) as good adherence, a score of 0.51-0.99 as moderate adherence, and a score of 0.5 or less as poor adherence.
Because patient enrollment occurred during 2013 and 2014, the benchmark heart failure treatment guidelines were those issued by the European Society of Cardiology in 2012 (Eur Heart J. 2012 July;33[14]:1787-1847).
Concurrently with Dr. Komajda’s report at the meeting the results appeared in an article online (Eur J Heart Failure. 2017. doi: 10.1002/ejhf.887).
QUANTIFY was sponsored by Servier. Dr. Komajda has received honoraria from Servier and from Amgen, AstraZeneca, Bristol-Myers Squibb, Menarini, MSD, Novartis, Novo Nordisk, and Sanofi.
[email protected]
On Twitter @mitchelzoler
This was a wonderful and useful study. It was large, prospective, covered a wide geographic area, and showed that drug dosage matters when treating heart failure with reduced ejection fraction.
The geographic diversity was a strength, but also a potential weakness because of the resulting differences among the enrolled patients in financial resources, ethnic and genetic makeup, and their tolerance to various drugs. I hope that further research can dissect the role that each of these factors played in the results.
Another limitation is the relatively simplistic approach used for assessing drug dosages to calculate the adherence scores. While it is a very useful step forward to classify patients by the drug dosages they received, there could be some very legitimate variations in dosages based on parameters such as blood pressure. An important question to address in the future is whether it is better to use all the recommended drugs at reduced dosages if necessary, or to use fewer agents at higher dosages.
But these are just quibbles about what is a very important study.
Andrew J.S. Coats, MD , is a cardiologist, professor of medicine, and academic vice-president for the Monash Warwick Alliance of Warwick University in Coventry, England, and Monash University in Melbourne. He has received honoraria from Impulse Dynamics, Menarini, PsiOxus, ResMed, Respicardia, and Servier. He made these comments as designated discussant for Dr. Komajda’s report.
This was a wonderful and useful study. It was large, prospective, covered a wide geographic area, and showed that drug dosage matters when treating heart failure with reduced ejection fraction.
The geographic diversity was a strength, but also a potential weakness because of the resulting differences among the enrolled patients in financial resources, ethnic and genetic makeup, and their tolerance to various drugs. I hope that further research can dissect the role that each of these factors played in the results.
Another limitation is the relatively simplistic approach used for assessing drug dosages to calculate the adherence scores. While it is a very useful step forward to classify patients by the drug dosages they received, there could be some very legitimate variations in dosages based on parameters such as blood pressure. An important question to address in the future is whether it is better to use all the recommended drugs at reduced dosages if necessary, or to use fewer agents at higher dosages.
But these are just quibbles about what is a very important study.
Andrew J.S. Coats, MD , is a cardiologist, professor of medicine, and academic vice-president for the Monash Warwick Alliance of Warwick University in Coventry, England, and Monash University in Melbourne. He has received honoraria from Impulse Dynamics, Menarini, PsiOxus, ResMed, Respicardia, and Servier. He made these comments as designated discussant for Dr. Komajda’s report.
This was a wonderful and useful study. It was large, prospective, covered a wide geographic area, and showed that drug dosage matters when treating heart failure with reduced ejection fraction.
The geographic diversity was a strength, but also a potential weakness because of the resulting differences among the enrolled patients in financial resources, ethnic and genetic makeup, and their tolerance to various drugs. I hope that further research can dissect the role that each of these factors played in the results.
Another limitation is the relatively simplistic approach used for assessing drug dosages to calculate the adherence scores. While it is a very useful step forward to classify patients by the drug dosages they received, there could be some very legitimate variations in dosages based on parameters such as blood pressure. An important question to address in the future is whether it is better to use all the recommended drugs at reduced dosages if necessary, or to use fewer agents at higher dosages.
But these are just quibbles about what is a very important study.
Andrew J.S. Coats, MD , is a cardiologist, professor of medicine, and academic vice-president for the Monash Warwick Alliance of Warwick University in Coventry, England, and Monash University in Melbourne. He has received honoraria from Impulse Dynamics, Menarini, PsiOxus, ResMed, Respicardia, and Servier. He made these comments as designated discussant for Dr. Komajda’s report.
PARIS – Heart failure patients who received guideline-directed pharmacotherapy, at dosages that approached guideline-directed levels, had roughly half the 6-month mortality as did similar patients who did not receive this level of treatment in a real-world, observational study with more than 6,000 patients.
Adherence to pharmacologic treatment guidelines for patients with heart failure with reduced ejection fraction (HFrEF) “was strongly associated with clinical outcomes during 6-month follow-up,” Michel Komajda, MD, said at a meeting held by the Heart Failure Association of the European Society of Cardiology. The findings highlight the importance of closely following guideline recommendations in routine practice.
[polldaddy:9772629]
The analysis used data collected in the QUALIFY (Quality of Adherence to Guideline Recommendations for Life-Saving Treatment in Heart Failure: an International Survey) registry, which enrolled 7,127 HFrEF patients during September 2013–December 2014 at 547 centers in 36 countries, mostly in Europe, Asia, and Africa but also in Canada, Ecuador, and Australia. All enrolled patients had to have been hospitalized for worsening heart failure at least once during the 1-15 months before they entered QUALIFY.
Dr. Komajda and his associates assessed each enrolled patient at baseline by their treatment with each of four guideline-recommended drug classes: an ACE inhibitor or angiotensin receptor blocker; a beta-blocker; an aldosterone receptor antagonist (ARA) if the patient’s functional status was rated as New York Heart Association class II, III, or IV; and ivabradine (Corlanor) if the patient was in NYHA class II, III, or IV, in sinus rhythm, had a heart rate of at least 70 beats per minute, and if the patient was in a country where ivabradine was available. Because patient enrollment occurred in 2013 and 2014, the study couldn’t include the new formulation of sacubitril plus valsartan (Entresto) in its analysis.
For each eligible drug class a patient received 1 point if their daily prescribed dosage was at least 50% of the recommended dosage (or 100% for an ARA), 0.5 points if the patient received the recommended drug but at a lower dosage, and no points if the drug wasn’t given. A patient also received 1 point if they were appropriately not given a drug because of a documented contraindication or intolerance. The researchers then calculated each patient’s “adherence score” by dividing their point total by the potentially maximum number of points that each patient could have received (a number that ranged from 2 to 4). They defined a score of 1 (which meant the patients received at least half the recommended dosage of all recommended drugs) as good adherence, a score of 0.51-0.99 as moderate adherence, and a score of 0.5 or less as poor adherence.
Because patient enrollment occurred during 2013 and 2014, the benchmark heart failure treatment guidelines were those issued by the European Society of Cardiology in 2012 (Eur Heart J. 2012 July;33[14]:1787-1847).
Concurrently with Dr. Komajda’s report at the meeting the results appeared in an article online (Eur J Heart Failure. 2017. doi: 10.1002/ejhf.887).
QUANTIFY was sponsored by Servier. Dr. Komajda has received honoraria from Servier and from Amgen, AstraZeneca, Bristol-Myers Squibb, Menarini, MSD, Novartis, Novo Nordisk, and Sanofi.
[email protected]
On Twitter @mitchelzoler
PARIS – Heart failure patients who received guideline-directed pharmacotherapy, at dosages that approached guideline-directed levels, had roughly half the 6-month mortality as did similar patients who did not receive this level of treatment in a real-world, observational study with more than 6,000 patients.
Adherence to pharmacologic treatment guidelines for patients with heart failure with reduced ejection fraction (HFrEF) “was strongly associated with clinical outcomes during 6-month follow-up,” Michel Komajda, MD, said at a meeting held by the Heart Failure Association of the European Society of Cardiology. The findings highlight the importance of closely following guideline recommendations in routine practice.
[polldaddy:9772629]
The analysis used data collected in the QUALIFY (Quality of Adherence to Guideline Recommendations for Life-Saving Treatment in Heart Failure: an International Survey) registry, which enrolled 7,127 HFrEF patients during September 2013–December 2014 at 547 centers in 36 countries, mostly in Europe, Asia, and Africa but also in Canada, Ecuador, and Australia. All enrolled patients had to have been hospitalized for worsening heart failure at least once during the 1-15 months before they entered QUALIFY.
Dr. Komajda and his associates assessed each enrolled patient at baseline by their treatment with each of four guideline-recommended drug classes: an ACE inhibitor or angiotensin receptor blocker; a beta-blocker; an aldosterone receptor antagonist (ARA) if the patient’s functional status was rated as New York Heart Association class II, III, or IV; and ivabradine (Corlanor) if the patient was in NYHA class II, III, or IV, in sinus rhythm, had a heart rate of at least 70 beats per minute, and if the patient was in a country where ivabradine was available. Because patient enrollment occurred in 2013 and 2014, the study couldn’t include the new formulation of sacubitril plus valsartan (Entresto) in its analysis.
For each eligible drug class a patient received 1 point if their daily prescribed dosage was at least 50% of the recommended dosage (or 100% for an ARA), 0.5 points if the patient received the recommended drug but at a lower dosage, and no points if the drug wasn’t given. A patient also received 1 point if they were appropriately not given a drug because of a documented contraindication or intolerance. The researchers then calculated each patient’s “adherence score” by dividing their point total by the potentially maximum number of points that each patient could have received (a number that ranged from 2 to 4). They defined a score of 1 (which meant the patients received at least half the recommended dosage of all recommended drugs) as good adherence, a score of 0.51-0.99 as moderate adherence, and a score of 0.5 or less as poor adherence.
Because patient enrollment occurred during 2013 and 2014, the benchmark heart failure treatment guidelines were those issued by the European Society of Cardiology in 2012 (Eur Heart J. 2012 July;33[14]:1787-1847).
Concurrently with Dr. Komajda’s report at the meeting the results appeared in an article online (Eur J Heart Failure. 2017. doi: 10.1002/ejhf.887).
QUANTIFY was sponsored by Servier. Dr. Komajda has received honoraria from Servier and from Amgen, AstraZeneca, Bristol-Myers Squibb, Menarini, MSD, Novartis, Novo Nordisk, and Sanofi.
[email protected]
On Twitter @mitchelzoler
AT HEART FAILURE 2017
Key clinical point:
Major finding: Six-month all-cause, cardiovascular, and heart failure mortalities were doubled in patients not on guideline-adherent therapy and dosages.
Data source: QUANTIFY, an international registry with 6,669 HFrEF patients followed for 6 months.
Disclosures: QUANTIFY was sponsored by Servier. Dr. Komajda has received honoraria from Servier and from Amgen, AstraZeneca, Bristol-Myers Squibb, Menarini, MSD, Novartis, Novo Nordisk, and Sanofi.
Rural patients less likely to have bariatric surgery
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
FROM SURGERY FOR OBESITY AND RELATED DISEASES
Key clinical point: Obese patients living in rural areas of West Virginia are substantially less likely than are their urban and suburban counterparts to have bariatric surgery.
Major finding: Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference.
Data source: A retrospective single-center cohort study involving 122 obese West Virginians seeking bariatric surgery in 2012-2014.
Disclosures: No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
VIDEO: Metastatic Trial Search links MBC patients to relevant trials
CHICAGO – Metastatic Trial Search was launched in 2015 by ClinicalTrials.org to make it easier for patients with metastatic breast cancer to consider clinical trials as a routine option as they are making treatment decisions with their physicians.
In a video interview, Shirley A. Mertz, JD, president of the Metastatic Breast Cancer Network, describes the tool, the mixed response from physicians, the barriers to trial participation still faced by patients, and the tweaked version 2.0 of the search tool, expected to launch by the end of this year.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @nikolaideslaura
CHICAGO – Metastatic Trial Search was launched in 2015 by ClinicalTrials.org to make it easier for patients with metastatic breast cancer to consider clinical trials as a routine option as they are making treatment decisions with their physicians.
In a video interview, Shirley A. Mertz, JD, president of the Metastatic Breast Cancer Network, describes the tool, the mixed response from physicians, the barriers to trial participation still faced by patients, and the tweaked version 2.0 of the search tool, expected to launch by the end of this year.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @nikolaideslaura
CHICAGO – Metastatic Trial Search was launched in 2015 by ClinicalTrials.org to make it easier for patients with metastatic breast cancer to consider clinical trials as a routine option as they are making treatment decisions with their physicians.
In a video interview, Shirley A. Mertz, JD, president of the Metastatic Breast Cancer Network, describes the tool, the mixed response from physicians, the barriers to trial participation still faced by patients, and the tweaked version 2.0 of the search tool, expected to launch by the end of this year.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @nikolaideslaura
AT ASCO 2017
Waiving screening copayments could cut colorectal cancer deaths
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
AT DDW