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Medicare at 50: Hassles lead to doctor opt-outs, new business models
After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.
“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”
Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.
“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.
Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.
Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.
However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.
Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.
But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.
“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”
For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.
“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”
The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.
“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”
Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”
Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.
“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”
The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.
When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.
Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.
“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”
On Twitter @legal_med
After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.
“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”
Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.
“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.
Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.
Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.
However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.
Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.
But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.
“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”
For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.
“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”
The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.
“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”
Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”
Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.
“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”
The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.
When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.
Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.
“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”
On Twitter @legal_med
After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.
“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”
Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.
“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.
Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.
Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.
However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.
Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.
But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.
“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”
For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.
“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”
The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.
“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”
Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”
Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.
“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”
The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.
When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.
Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.
“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”
On Twitter @legal_med
Pain control with ketorolac appears safe after pediatric heart surgery
PHOENIX – The NSAID ketorolac is safe to use in very young children after cardiac surgery, and dramatically decreases the length of intubation and ICU stay as well as the use of opioids, according to a retrospective cohort study from the Cohen Children’s Medical Center in New Hyde Park, N.Y.
Ketorolac is catching on in some places for postoperative pain control, but there are still significant concerns about nephrotoxicity and bleeding, especially in children, said Dr. Tracie Lin, a pediatrics resident at the medical center.
Those potential side effects didn’t turn out to be problems when her team compared outcomes in 26 children who received ketorolac – 0.5 mg/kg to a maximum of 30 mg/day – to 34 who did not receive it following congenital heart surgery.
“Think twice before holding back on ketorolac. There seems to be a lot of benefit, and less harm than someone might expect,” Dr. Lin said at the meeting sponsored by the Society for Critical Care Medicine.
Patients who received ketorolac, a mean of 35.5 months old, received less than 0.5 mg/kg per day of morphine IV equivalents in the first day after surgery, even less on day 2, and virtually none on day 3. They were, on average, intubated less than a day, in the ICU for 110 hours, and in the hospital for 5 days.
Patients in the no-ketorolac group, a mean of 2 months old, received almost 4 mg/kg per day of morphine IV equivalents in the first and second postop day, and about 2 mg/kg per day on day 3. They were intubated for an average of 3 days, in the ICU for 188 hours, and in the hospital for 17 days.
The age difference between the two groups probably reflects the hesitancy to use ketorolac in children under 6 months old. Only a couple children under 6 months old received ketorolac in the study; it didn’t cause them any kidney problems, Dr. Lin said.
Pain control was statistically equal in both groups, with pain-free assessments over 75% of the time during the first 3 postop days in both groups, and there were no statistically significant differences in the rates of breakthrough pain.
Meanwhile, “we found no additional nephrotoxicity” in the children taking ketorolac, Dr. Lin said.
At ICU arrival and after cardiac surgery, about 60% of those taking ketorolac had some degree of acute kidney injury, mostly stage 1 or 2; the finding was the same at 2 weeks post op. About 40% of children in the no-ketorolac group arrived at the ICU with some degree of acute kidney injury, again the majority stage 1 and 2; at 2 weeks assessment, that number had increased to almost 60%.
The investigators did not directly assess postoperative bleeding, but children taking ketorolac had their chest tubes pulled at about 3 days, while those in the no-ketorolac group retained their chest tubes for about 5 days. The finding suggests that ketorolac didn’t cause bleeding problems that prevented chest tube removal, Dr. Lin said.
There were other differences between the groups; ketorolac patients had RACH-1 [Risk Adjustment for Congenital Heart Surgery] scores of 3 or less, and almost all had sternotomies.
Children in the no-ketorolac group had RACH-1 scores ranging from 1 to 5, and although the majority had sternotomies, about a quarter had thoracotomies. The differences in incision types were most likely related to age-specific indications for surgery.
Dr. Lin and her team adjusted for all those differences on multivariate analysis, and found that the benefits of ketorolac remained; they “were not due to confounders,” she said.
The investigators have no relevant disclosures, and there was no external funding for the project.
PHOENIX – The NSAID ketorolac is safe to use in very young children after cardiac surgery, and dramatically decreases the length of intubation and ICU stay as well as the use of opioids, according to a retrospective cohort study from the Cohen Children’s Medical Center in New Hyde Park, N.Y.
Ketorolac is catching on in some places for postoperative pain control, but there are still significant concerns about nephrotoxicity and bleeding, especially in children, said Dr. Tracie Lin, a pediatrics resident at the medical center.
Those potential side effects didn’t turn out to be problems when her team compared outcomes in 26 children who received ketorolac – 0.5 mg/kg to a maximum of 30 mg/day – to 34 who did not receive it following congenital heart surgery.
“Think twice before holding back on ketorolac. There seems to be a lot of benefit, and less harm than someone might expect,” Dr. Lin said at the meeting sponsored by the Society for Critical Care Medicine.
Patients who received ketorolac, a mean of 35.5 months old, received less than 0.5 mg/kg per day of morphine IV equivalents in the first day after surgery, even less on day 2, and virtually none on day 3. They were, on average, intubated less than a day, in the ICU for 110 hours, and in the hospital for 5 days.
Patients in the no-ketorolac group, a mean of 2 months old, received almost 4 mg/kg per day of morphine IV equivalents in the first and second postop day, and about 2 mg/kg per day on day 3. They were intubated for an average of 3 days, in the ICU for 188 hours, and in the hospital for 17 days.
The age difference between the two groups probably reflects the hesitancy to use ketorolac in children under 6 months old. Only a couple children under 6 months old received ketorolac in the study; it didn’t cause them any kidney problems, Dr. Lin said.
Pain control was statistically equal in both groups, with pain-free assessments over 75% of the time during the first 3 postop days in both groups, and there were no statistically significant differences in the rates of breakthrough pain.
Meanwhile, “we found no additional nephrotoxicity” in the children taking ketorolac, Dr. Lin said.
At ICU arrival and after cardiac surgery, about 60% of those taking ketorolac had some degree of acute kidney injury, mostly stage 1 or 2; the finding was the same at 2 weeks post op. About 40% of children in the no-ketorolac group arrived at the ICU with some degree of acute kidney injury, again the majority stage 1 and 2; at 2 weeks assessment, that number had increased to almost 60%.
The investigators did not directly assess postoperative bleeding, but children taking ketorolac had their chest tubes pulled at about 3 days, while those in the no-ketorolac group retained their chest tubes for about 5 days. The finding suggests that ketorolac didn’t cause bleeding problems that prevented chest tube removal, Dr. Lin said.
There were other differences between the groups; ketorolac patients had RACH-1 [Risk Adjustment for Congenital Heart Surgery] scores of 3 or less, and almost all had sternotomies.
Children in the no-ketorolac group had RACH-1 scores ranging from 1 to 5, and although the majority had sternotomies, about a quarter had thoracotomies. The differences in incision types were most likely related to age-specific indications for surgery.
Dr. Lin and her team adjusted for all those differences on multivariate analysis, and found that the benefits of ketorolac remained; they “were not due to confounders,” she said.
The investigators have no relevant disclosures, and there was no external funding for the project.
PHOENIX – The NSAID ketorolac is safe to use in very young children after cardiac surgery, and dramatically decreases the length of intubation and ICU stay as well as the use of opioids, according to a retrospective cohort study from the Cohen Children’s Medical Center in New Hyde Park, N.Y.
Ketorolac is catching on in some places for postoperative pain control, but there are still significant concerns about nephrotoxicity and bleeding, especially in children, said Dr. Tracie Lin, a pediatrics resident at the medical center.
Those potential side effects didn’t turn out to be problems when her team compared outcomes in 26 children who received ketorolac – 0.5 mg/kg to a maximum of 30 mg/day – to 34 who did not receive it following congenital heart surgery.
“Think twice before holding back on ketorolac. There seems to be a lot of benefit, and less harm than someone might expect,” Dr. Lin said at the meeting sponsored by the Society for Critical Care Medicine.
Patients who received ketorolac, a mean of 35.5 months old, received less than 0.5 mg/kg per day of morphine IV equivalents in the first day after surgery, even less on day 2, and virtually none on day 3. They were, on average, intubated less than a day, in the ICU for 110 hours, and in the hospital for 5 days.
Patients in the no-ketorolac group, a mean of 2 months old, received almost 4 mg/kg per day of morphine IV equivalents in the first and second postop day, and about 2 mg/kg per day on day 3. They were intubated for an average of 3 days, in the ICU for 188 hours, and in the hospital for 17 days.
The age difference between the two groups probably reflects the hesitancy to use ketorolac in children under 6 months old. Only a couple children under 6 months old received ketorolac in the study; it didn’t cause them any kidney problems, Dr. Lin said.
Pain control was statistically equal in both groups, with pain-free assessments over 75% of the time during the first 3 postop days in both groups, and there were no statistically significant differences in the rates of breakthrough pain.
Meanwhile, “we found no additional nephrotoxicity” in the children taking ketorolac, Dr. Lin said.
At ICU arrival and after cardiac surgery, about 60% of those taking ketorolac had some degree of acute kidney injury, mostly stage 1 or 2; the finding was the same at 2 weeks post op. About 40% of children in the no-ketorolac group arrived at the ICU with some degree of acute kidney injury, again the majority stage 1 and 2; at 2 weeks assessment, that number had increased to almost 60%.
The investigators did not directly assess postoperative bleeding, but children taking ketorolac had their chest tubes pulled at about 3 days, while those in the no-ketorolac group retained their chest tubes for about 5 days. The finding suggests that ketorolac didn’t cause bleeding problems that prevented chest tube removal, Dr. Lin said.
There were other differences between the groups; ketorolac patients had RACH-1 [Risk Adjustment for Congenital Heart Surgery] scores of 3 or less, and almost all had sternotomies.
Children in the no-ketorolac group had RACH-1 scores ranging from 1 to 5, and although the majority had sternotomies, about a quarter had thoracotomies. The differences in incision types were most likely related to age-specific indications for surgery.
Dr. Lin and her team adjusted for all those differences on multivariate analysis, and found that the benefits of ketorolac remained; they “were not due to confounders,” she said.
The investigators have no relevant disclosures, and there was no external funding for the project.
AT THE CRITICAL CARE CONGRESS
Key clinical point: The benefits of postoperative ketorolac outweigh the risks, even in very young children.
Major finding: Following heart surgery, children with ketorolac as part of their pain control regimen were intubated for less than a day; children without ketorolac were intubated an average of 3 days.
Data source: Retrospective cohort study of 60 very young children following congenital heart surgery.
Disclosures:The investigators have no relevant disclosures, and there was no external funding for the project.
Transoral fundoplication can be effective against GERD symptoms
Transoral esophagogastric fundoplication can be an effective treatment for patients seeking to alleviate symptoms associated with gastroesophageal reflux disease, particularly in individuals with persistent regurgitation despite prior treatment with proton pump inhibitor therapy, according to the results of a new study published in the February issue of Gastroenterology (doi:10.1053/j.gastro.2014.10.009).
“Gastroesophageal reflux disease (GERD) remains one of the most common conditions for which Americans take daily medication, and PPI use has more than doubled in the last decade,” wrote lead authors Dr. John G. Hunter of Oregon Health & Science University in Portland, and Dr. Peter J. Kahrilas of Northwestern University in Chicago, and their associates. “Despite this, up to 40% of proton pump inhibitor (PPI)–dependent GERD patients have troublesome symptoms of GERD, despite PPI therapy.”
In the Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication (RESPECT) trial, investigators screened 696 patients who were experiencing “troublesome regurgitation” despite daily PPI treatment. These subjects were evaluated via three validated GERD-specific symptom scales, and were either on or off PPI use at the time of trial commencement. Post trial, patients were blinded to therapy and were reassessed at intervals of 2, 12, and 26 weeks. All patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy at 66 months after the trial ended.
Regurgitation severity was based on the Montreal definition, which was used to measure efficacy of treatments given as part of the study. The Montreal definition of reflux is described by the authors as “either mucosal damage or troublesome symptoms attributable to reflux.” Those with “least troublesome” regurgitation while on PPIs “underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses.”
Eighty-seven subjects with GERD and hiatal hernias of at least 2 centimeters were randomly assigned to groups that underwent transoral fundoplication (TF) followed by placebo treatment after 6 months, while 42 subjects, who made up the control group, underwent a “sham surgery” and began regimens of once- or twice-daily omeprazole medication for 6 months.
Results showed that 67% of patients who received TF treatment experienced elimination of adverse regurgitation vs. 45% of those treated with PPI (P = .023). Control of esophageal pH also improved noticeably in patients who received TF treatment versus those who did not (9.3% vs. 6.3% on average, respectively, P < .001), but not in patients who received the “sham surgery” (8.6% preop vs. 8.9% postop on average). Fewer patients who received TF treatment recorded having “no response” after 3 months compared with those in the control group (11% vs. 36%, respectively, P = .004).
“Transoral fundoplication may fill the ‘therapeutic gap’ that exists between PPI and laparoscopic fundoplication,” wrote the authors. “Considering the virtual absence of dysphagia and bloating after TF, which may be problematic with LINX [LINX Reflux Management System], it would appear that TF is an option for patients with troublesome regurgitation, as well as for patients with troublesome GERD symptoms who wish not to take PPI over a protracted period of time.”
Several coauthors disclosed ties with the study sponsor EndoGastric Solutions of Redmond, Wash., as well as individual potential conflicts of interest.
Transoral esophagogastric fundoplication can be an effective treatment for patients seeking to alleviate symptoms associated with gastroesophageal reflux disease, particularly in individuals with persistent regurgitation despite prior treatment with proton pump inhibitor therapy, according to the results of a new study published in the February issue of Gastroenterology (doi:10.1053/j.gastro.2014.10.009).
“Gastroesophageal reflux disease (GERD) remains one of the most common conditions for which Americans take daily medication, and PPI use has more than doubled in the last decade,” wrote lead authors Dr. John G. Hunter of Oregon Health & Science University in Portland, and Dr. Peter J. Kahrilas of Northwestern University in Chicago, and their associates. “Despite this, up to 40% of proton pump inhibitor (PPI)–dependent GERD patients have troublesome symptoms of GERD, despite PPI therapy.”
In the Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication (RESPECT) trial, investigators screened 696 patients who were experiencing “troublesome regurgitation” despite daily PPI treatment. These subjects were evaluated via three validated GERD-specific symptom scales, and were either on or off PPI use at the time of trial commencement. Post trial, patients were blinded to therapy and were reassessed at intervals of 2, 12, and 26 weeks. All patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy at 66 months after the trial ended.
Regurgitation severity was based on the Montreal definition, which was used to measure efficacy of treatments given as part of the study. The Montreal definition of reflux is described by the authors as “either mucosal damage or troublesome symptoms attributable to reflux.” Those with “least troublesome” regurgitation while on PPIs “underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses.”
Eighty-seven subjects with GERD and hiatal hernias of at least 2 centimeters were randomly assigned to groups that underwent transoral fundoplication (TF) followed by placebo treatment after 6 months, while 42 subjects, who made up the control group, underwent a “sham surgery” and began regimens of once- or twice-daily omeprazole medication for 6 months.
Results showed that 67% of patients who received TF treatment experienced elimination of adverse regurgitation vs. 45% of those treated with PPI (P = .023). Control of esophageal pH also improved noticeably in patients who received TF treatment versus those who did not (9.3% vs. 6.3% on average, respectively, P < .001), but not in patients who received the “sham surgery” (8.6% preop vs. 8.9% postop on average). Fewer patients who received TF treatment recorded having “no response” after 3 months compared with those in the control group (11% vs. 36%, respectively, P = .004).
“Transoral fundoplication may fill the ‘therapeutic gap’ that exists between PPI and laparoscopic fundoplication,” wrote the authors. “Considering the virtual absence of dysphagia and bloating after TF, which may be problematic with LINX [LINX Reflux Management System], it would appear that TF is an option for patients with troublesome regurgitation, as well as for patients with troublesome GERD symptoms who wish not to take PPI over a protracted period of time.”
Several coauthors disclosed ties with the study sponsor EndoGastric Solutions of Redmond, Wash., as well as individual potential conflicts of interest.
Transoral esophagogastric fundoplication can be an effective treatment for patients seeking to alleviate symptoms associated with gastroesophageal reflux disease, particularly in individuals with persistent regurgitation despite prior treatment with proton pump inhibitor therapy, according to the results of a new study published in the February issue of Gastroenterology (doi:10.1053/j.gastro.2014.10.009).
“Gastroesophageal reflux disease (GERD) remains one of the most common conditions for which Americans take daily medication, and PPI use has more than doubled in the last decade,” wrote lead authors Dr. John G. Hunter of Oregon Health & Science University in Portland, and Dr. Peter J. Kahrilas of Northwestern University in Chicago, and their associates. “Despite this, up to 40% of proton pump inhibitor (PPI)–dependent GERD patients have troublesome symptoms of GERD, despite PPI therapy.”
In the Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication (RESPECT) trial, investigators screened 696 patients who were experiencing “troublesome regurgitation” despite daily PPI treatment. These subjects were evaluated via three validated GERD-specific symptom scales, and were either on or off PPI use at the time of trial commencement. Post trial, patients were blinded to therapy and were reassessed at intervals of 2, 12, and 26 weeks. All patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy at 66 months after the trial ended.
Regurgitation severity was based on the Montreal definition, which was used to measure efficacy of treatments given as part of the study. The Montreal definition of reflux is described by the authors as “either mucosal damage or troublesome symptoms attributable to reflux.” Those with “least troublesome” regurgitation while on PPIs “underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses.”
Eighty-seven subjects with GERD and hiatal hernias of at least 2 centimeters were randomly assigned to groups that underwent transoral fundoplication (TF) followed by placebo treatment after 6 months, while 42 subjects, who made up the control group, underwent a “sham surgery” and began regimens of once- or twice-daily omeprazole medication for 6 months.
Results showed that 67% of patients who received TF treatment experienced elimination of adverse regurgitation vs. 45% of those treated with PPI (P = .023). Control of esophageal pH also improved noticeably in patients who received TF treatment versus those who did not (9.3% vs. 6.3% on average, respectively, P < .001), but not in patients who received the “sham surgery” (8.6% preop vs. 8.9% postop on average). Fewer patients who received TF treatment recorded having “no response” after 3 months compared with those in the control group (11% vs. 36%, respectively, P = .004).
“Transoral fundoplication may fill the ‘therapeutic gap’ that exists between PPI and laparoscopic fundoplication,” wrote the authors. “Considering the virtual absence of dysphagia and bloating after TF, which may be problematic with LINX [LINX Reflux Management System], it would appear that TF is an option for patients with troublesome regurgitation, as well as for patients with troublesome GERD symptoms who wish not to take PPI over a protracted period of time.”
Several coauthors disclosed ties with the study sponsor EndoGastric Solutions of Redmond, Wash., as well as individual potential conflicts of interest.
FROM GASTROENTEROLOGY
Key clinical point: Transoral esophagogastric fundoplication (TF) is an effective treatment for gastroesophageal reflux disease symptoms, particularly in patients with persistent regurgitation despite proton pump inhibitor therapy (PPI).
Major finding: Of patients who received TF, 67% experienced elimination of adverse regurgitation, compared with 45% of those treated with PPI (P = .023).
Data source: Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication (RESPECT) trial.
Disclosures: Several coauthors disclosed ties with the study sponsor EndoGastric Solutions of Redmond, Wash., as well as individual potential conflicts of interest.
Postop NSAIDs may raise anastomotic complications
Postoperative NSAIDs appear to raise the risk for anastomotic complications among patients undergoing nonelective colorectal resection, according to a report in JAMA Surgery.
“Given that other analgesic regimens are effective and well tolerated, these data may be enough from some surgeons to alter practice patterns,” said Dr. Timo W. Hakkarainen of the department of surgery at the University of Washington, Seattle, and his associates.
The recent development of intravenous formulations of NSAIDs has expanded their use in postoperative patients, chiefly because the drugs don’t carry the adverse effects of opioid analgesia, which include impaired GI motility. However, several small and single-institution studies have suggested that NSAIDs used in this setting may impair anastomotic healing and may raise the rates of leakage.
Dr. Hakkarainen and his associates examined this issue using data from a statewide surveillance system for surgical quality. They analyzed 90-day complications among 13,082 adults (mean age, 58 years) who underwent surgery of the GI tract with anastomosis at 47 participating hospitals throughout Washington State during a 5-year period. The investigators tracked the use of ibuprofen, naproxen, ketorolac tromethamine, Caldolor, celecoxib, and diclofenac during the first 24 hours after surgery; they assumed that in most cases, this involved IV NSAIDs because such patients don’t take oral medications within that time period.
Postoperative NSAIDs were given to 24% of the study population. This use was associated with a significantly increased risk for anastomotic leakage during the next 90 days, with an OR of 1.24. Further analysis showed that this association was largely restricted to the subgroup of patients who had nonelective colorectal surgery, in whom the relationship was even stronger, with an OR of 1.70. Among patients who had nonelective colorectal surgery, those who received postoperative NSAIDs had a 12.3% rate of anastomotic leakage, compared with an 8.3% rate among those who did not receive NSAIDs, the investigators said (JAMA Surg. 2015 Jan. 21 [doi:10.1001/jamasurg.2014.2239]).
This study was limited in that the records didn’t specify the dose or duration of NSAID use, didn’t take into account preoperative NSAID use, and didn’t include the timing of anastomotic leakage (immediately following surgery vs. weeks or months later). “We believe that [these] results are sufficient to suggest caution in the use of NSAIDs in the postoperative treatment of patients undergoing nonelective colorectal surgery, and highlight the importance of further evaluation of this association,” the investigators added.
Postoperative NSAIDs appear to raise the risk for anastomotic complications among patients undergoing nonelective colorectal resection, according to a report in JAMA Surgery.
“Given that other analgesic regimens are effective and well tolerated, these data may be enough from some surgeons to alter practice patterns,” said Dr. Timo W. Hakkarainen of the department of surgery at the University of Washington, Seattle, and his associates.
The recent development of intravenous formulations of NSAIDs has expanded their use in postoperative patients, chiefly because the drugs don’t carry the adverse effects of opioid analgesia, which include impaired GI motility. However, several small and single-institution studies have suggested that NSAIDs used in this setting may impair anastomotic healing and may raise the rates of leakage.
Dr. Hakkarainen and his associates examined this issue using data from a statewide surveillance system for surgical quality. They analyzed 90-day complications among 13,082 adults (mean age, 58 years) who underwent surgery of the GI tract with anastomosis at 47 participating hospitals throughout Washington State during a 5-year period. The investigators tracked the use of ibuprofen, naproxen, ketorolac tromethamine, Caldolor, celecoxib, and diclofenac during the first 24 hours after surgery; they assumed that in most cases, this involved IV NSAIDs because such patients don’t take oral medications within that time period.
Postoperative NSAIDs were given to 24% of the study population. This use was associated with a significantly increased risk for anastomotic leakage during the next 90 days, with an OR of 1.24. Further analysis showed that this association was largely restricted to the subgroup of patients who had nonelective colorectal surgery, in whom the relationship was even stronger, with an OR of 1.70. Among patients who had nonelective colorectal surgery, those who received postoperative NSAIDs had a 12.3% rate of anastomotic leakage, compared with an 8.3% rate among those who did not receive NSAIDs, the investigators said (JAMA Surg. 2015 Jan. 21 [doi:10.1001/jamasurg.2014.2239]).
This study was limited in that the records didn’t specify the dose or duration of NSAID use, didn’t take into account preoperative NSAID use, and didn’t include the timing of anastomotic leakage (immediately following surgery vs. weeks or months later). “We believe that [these] results are sufficient to suggest caution in the use of NSAIDs in the postoperative treatment of patients undergoing nonelective colorectal surgery, and highlight the importance of further evaluation of this association,” the investigators added.
Postoperative NSAIDs appear to raise the risk for anastomotic complications among patients undergoing nonelective colorectal resection, according to a report in JAMA Surgery.
“Given that other analgesic regimens are effective and well tolerated, these data may be enough from some surgeons to alter practice patterns,” said Dr. Timo W. Hakkarainen of the department of surgery at the University of Washington, Seattle, and his associates.
The recent development of intravenous formulations of NSAIDs has expanded their use in postoperative patients, chiefly because the drugs don’t carry the adverse effects of opioid analgesia, which include impaired GI motility. However, several small and single-institution studies have suggested that NSAIDs used in this setting may impair anastomotic healing and may raise the rates of leakage.
Dr. Hakkarainen and his associates examined this issue using data from a statewide surveillance system for surgical quality. They analyzed 90-day complications among 13,082 adults (mean age, 58 years) who underwent surgery of the GI tract with anastomosis at 47 participating hospitals throughout Washington State during a 5-year period. The investigators tracked the use of ibuprofen, naproxen, ketorolac tromethamine, Caldolor, celecoxib, and diclofenac during the first 24 hours after surgery; they assumed that in most cases, this involved IV NSAIDs because such patients don’t take oral medications within that time period.
Postoperative NSAIDs were given to 24% of the study population. This use was associated with a significantly increased risk for anastomotic leakage during the next 90 days, with an OR of 1.24. Further analysis showed that this association was largely restricted to the subgroup of patients who had nonelective colorectal surgery, in whom the relationship was even stronger, with an OR of 1.70. Among patients who had nonelective colorectal surgery, those who received postoperative NSAIDs had a 12.3% rate of anastomotic leakage, compared with an 8.3% rate among those who did not receive NSAIDs, the investigators said (JAMA Surg. 2015 Jan. 21 [doi:10.1001/jamasurg.2014.2239]).
This study was limited in that the records didn’t specify the dose or duration of NSAID use, didn’t take into account preoperative NSAID use, and didn’t include the timing of anastomotic leakage (immediately following surgery vs. weeks or months later). “We believe that [these] results are sufficient to suggest caution in the use of NSAIDs in the postoperative treatment of patients undergoing nonelective colorectal surgery, and highlight the importance of further evaluation of this association,” the investigators added.
Key clinical point: Postoperative NSAIDs appear to raise the risk of anastomotic complications in patients undergoing nonelective colorectal resection.
Major finding: Among patients who had nonelective colorectal surgery, those who received postoperative NSAIDs had a 12.3% rate of anastomotic leakage, compared with an 8.3% rate among those who did not receive NSAIDs.
Data source: A secondary analysis of a cohort study involving 13,082 patients who had GI-tract surgery with anastomosis at 47 hospitals in Washington State during a 5-year period.
Disclosures: The Comparative Effective Research Translation Network of the Agency for Healthcare Research and Quality, the Washington State Life Science Discovery Fund, and the National Institutes of Health supported the study. Dr. Hakkarainen and his associates reported having no financial disclosures.
President unveils details of precision medicine initiative
President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.
The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.
“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”
The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.
The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.
Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.
“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).
“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.
The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.
“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”
In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.
“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”
On Twitter @legal_med
President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.
The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.
“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”
The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.
The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.
Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.
“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).
“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.
The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.
“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”
In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.
“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”
On Twitter @legal_med
President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.
The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.
“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”
The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.
The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.
Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.
“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).
“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.
The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.
“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”
In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.
“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”
On Twitter @legal_med
Postop pancreatectomy complications most deadly in elderly
Although rates of complications following pancreatectomy are relatively similar in patients both above and below the age of 80 years, significantly higher mortality rates occur in the older age group, according to the findings of a new study published online in the Annals of Surgery
“Previous studies have focused solely on mortality after pancreatectomy in older patients or failure to rescue for all patients undergoing pancreatectomy,” wrote lead author Dr. Nina P. Tamirisa of the University of Texas Medical Branch in Galveston, and her associates. “For older patients, it is not clear whether the observed increase in mortality rate is attributed to higher rates of postsurgical complications, higher failure to rescue from these postsurgical complications, or both” (Ann. Surg. 2015 [doi:10.1097/SLA.0000000000001093]).
In this study, “failure to rescue” was calculated as the number of patients who died from complications divided by total number of patients with complications and was understood to measure of a hospital’s ability to recognize and manage postoperative complications.
In a retrospective cohort study, Dr. Tamirisa and her coinvestigators looked at data on 2,805 patients in the American College of Surgeons’ National Surgical Quality Improvement Pancreatectomy Demonstration Project (ACS NSQIP) at 43 high-volume centers around the United States between November 2011 and December 2012. Institutions with fewer than 10 cases were excluded, leaving 2,694 subjects from 37 centers for the study.
Following this, patients were divided into cohorts of those younger than 80 years of age, and those aged 80 years or older, which contained 2,496 and 198 subjects, respectively. Overall and individual cohorts were split roughly evenly between males and females. Postoperative morbidity and in-hospital mortality rates were measured along with rate of “failure to rescue.”
Results indicated that there were no significant differences in the rates of complications between the cohorts: 41.4% in patients under 80 years and 39.4% in patients aged 80 years or older (P = .58). However, in-hospital mortality rates were significant higher in the 80 and older cohort (3.0%) than in the younger group (1.1%) (P = .01).
Overall, unadjusted complication rates in the 37 centers included in the study varied widely from 25.0% to as high as 72.2%, while failure to rescue rates at ranged from 0.0% to 25.0%.
Major complications were seen in 29.3% of patients aged 80 years or older and in 28.5% of patients under 80 years old (P = .79), with perioperative bleeding being the most prevalent. Among patients with postoperative complications, ascites, chronic obstructive pulmonary disease, and diabetes were the comorbidities most highly associated with failure to rescue, along with acute renal failure, septic shock, and postoperative pulmonary complications.
“It is always true that avoiding complications will decrease mortality for all patients undergoing pancreatectomy,” concluded the investigators, adding that it’s crucial for there to be more interventions to facilitate identification and aggressive treatment of complications to decrease mortality in vulnerable older patients.
“Several factors, such as individual surgeon volume, impact patient outcomes and failure to rescue rates are a significant but not the sole contributor to increased mortality rates in older patients undergoing pancreatectomy,” wrote Dr. Tamirisa and her coauthors.
This study was funded by grants from the Cancer Prevention Research Institute of Texas, UTMB Clinical and Translational Science Award, the National Institutes of Health, and the Agency for Healthcare Research & Quality. Coauthor Dr. Bruce L. Hall disclosed being a paid consulting director of the American College of Surgeons’ National Surgical Quality Improvement Program.
Although rates of complications following pancreatectomy are relatively similar in patients both above and below the age of 80 years, significantly higher mortality rates occur in the older age group, according to the findings of a new study published online in the Annals of Surgery
“Previous studies have focused solely on mortality after pancreatectomy in older patients or failure to rescue for all patients undergoing pancreatectomy,” wrote lead author Dr. Nina P. Tamirisa of the University of Texas Medical Branch in Galveston, and her associates. “For older patients, it is not clear whether the observed increase in mortality rate is attributed to higher rates of postsurgical complications, higher failure to rescue from these postsurgical complications, or both” (Ann. Surg. 2015 [doi:10.1097/SLA.0000000000001093]).
In this study, “failure to rescue” was calculated as the number of patients who died from complications divided by total number of patients with complications and was understood to measure of a hospital’s ability to recognize and manage postoperative complications.
In a retrospective cohort study, Dr. Tamirisa and her coinvestigators looked at data on 2,805 patients in the American College of Surgeons’ National Surgical Quality Improvement Pancreatectomy Demonstration Project (ACS NSQIP) at 43 high-volume centers around the United States between November 2011 and December 2012. Institutions with fewer than 10 cases were excluded, leaving 2,694 subjects from 37 centers for the study.
Following this, patients were divided into cohorts of those younger than 80 years of age, and those aged 80 years or older, which contained 2,496 and 198 subjects, respectively. Overall and individual cohorts were split roughly evenly between males and females. Postoperative morbidity and in-hospital mortality rates were measured along with rate of “failure to rescue.”
Results indicated that there were no significant differences in the rates of complications between the cohorts: 41.4% in patients under 80 years and 39.4% in patients aged 80 years or older (P = .58). However, in-hospital mortality rates were significant higher in the 80 and older cohort (3.0%) than in the younger group (1.1%) (P = .01).
Overall, unadjusted complication rates in the 37 centers included in the study varied widely from 25.0% to as high as 72.2%, while failure to rescue rates at ranged from 0.0% to 25.0%.
Major complications were seen in 29.3% of patients aged 80 years or older and in 28.5% of patients under 80 years old (P = .79), with perioperative bleeding being the most prevalent. Among patients with postoperative complications, ascites, chronic obstructive pulmonary disease, and diabetes were the comorbidities most highly associated with failure to rescue, along with acute renal failure, septic shock, and postoperative pulmonary complications.
“It is always true that avoiding complications will decrease mortality for all patients undergoing pancreatectomy,” concluded the investigators, adding that it’s crucial for there to be more interventions to facilitate identification and aggressive treatment of complications to decrease mortality in vulnerable older patients.
“Several factors, such as individual surgeon volume, impact patient outcomes and failure to rescue rates are a significant but not the sole contributor to increased mortality rates in older patients undergoing pancreatectomy,” wrote Dr. Tamirisa and her coauthors.
This study was funded by grants from the Cancer Prevention Research Institute of Texas, UTMB Clinical and Translational Science Award, the National Institutes of Health, and the Agency for Healthcare Research & Quality. Coauthor Dr. Bruce L. Hall disclosed being a paid consulting director of the American College of Surgeons’ National Surgical Quality Improvement Program.
Although rates of complications following pancreatectomy are relatively similar in patients both above and below the age of 80 years, significantly higher mortality rates occur in the older age group, according to the findings of a new study published online in the Annals of Surgery
“Previous studies have focused solely on mortality after pancreatectomy in older patients or failure to rescue for all patients undergoing pancreatectomy,” wrote lead author Dr. Nina P. Tamirisa of the University of Texas Medical Branch in Galveston, and her associates. “For older patients, it is not clear whether the observed increase in mortality rate is attributed to higher rates of postsurgical complications, higher failure to rescue from these postsurgical complications, or both” (Ann. Surg. 2015 [doi:10.1097/SLA.0000000000001093]).
In this study, “failure to rescue” was calculated as the number of patients who died from complications divided by total number of patients with complications and was understood to measure of a hospital’s ability to recognize and manage postoperative complications.
In a retrospective cohort study, Dr. Tamirisa and her coinvestigators looked at data on 2,805 patients in the American College of Surgeons’ National Surgical Quality Improvement Pancreatectomy Demonstration Project (ACS NSQIP) at 43 high-volume centers around the United States between November 2011 and December 2012. Institutions with fewer than 10 cases were excluded, leaving 2,694 subjects from 37 centers for the study.
Following this, patients were divided into cohorts of those younger than 80 years of age, and those aged 80 years or older, which contained 2,496 and 198 subjects, respectively. Overall and individual cohorts were split roughly evenly between males and females. Postoperative morbidity and in-hospital mortality rates were measured along with rate of “failure to rescue.”
Results indicated that there were no significant differences in the rates of complications between the cohorts: 41.4% in patients under 80 years and 39.4% in patients aged 80 years or older (P = .58). However, in-hospital mortality rates were significant higher in the 80 and older cohort (3.0%) than in the younger group (1.1%) (P = .01).
Overall, unadjusted complication rates in the 37 centers included in the study varied widely from 25.0% to as high as 72.2%, while failure to rescue rates at ranged from 0.0% to 25.0%.
Major complications were seen in 29.3% of patients aged 80 years or older and in 28.5% of patients under 80 years old (P = .79), with perioperative bleeding being the most prevalent. Among patients with postoperative complications, ascites, chronic obstructive pulmonary disease, and diabetes were the comorbidities most highly associated with failure to rescue, along with acute renal failure, septic shock, and postoperative pulmonary complications.
“It is always true that avoiding complications will decrease mortality for all patients undergoing pancreatectomy,” concluded the investigators, adding that it’s crucial for there to be more interventions to facilitate identification and aggressive treatment of complications to decrease mortality in vulnerable older patients.
“Several factors, such as individual surgeon volume, impact patient outcomes and failure to rescue rates are a significant but not the sole contributor to increased mortality rates in older patients undergoing pancreatectomy,” wrote Dr. Tamirisa and her coauthors.
This study was funded by grants from the Cancer Prevention Research Institute of Texas, UTMB Clinical and Translational Science Award, the National Institutes of Health, and the Agency for Healthcare Research & Quality. Coauthor Dr. Bruce L. Hall disclosed being a paid consulting director of the American College of Surgeons’ National Surgical Quality Improvement Program.
FROM THE ANNALS OF SURGERY
Key clinical point: Significantly higher rates of mortality are experienced in pancreatectomy patients aged 80 years or older, requiring urgent attention toward minimizing postoperative complications.
Major finding: In-hospital mortality rates were significant higher in the cohort aged 80 years and older (3.0%) than in the younger group (1.1%) (P = .01) even though rates of complications between the two groups were relatively similar.
Data source: Retrospective cohort study of 2,694 patients in the American College of Surgeons’ National Surgical Quality Improvement Pancreatectomy Demonstration Project at 37 high-volume U.S. centers.
Disclosures: Study was funded by grants from the Cancer Prevention Research Institute of Texas, UTMB Clinical and Translational Science Award, the National Institutes of Health, and the Agency for Healthcare Research & Quality. Coauthor Dr. Bruce L. Hall disclosed being a paid consulting director of the American College of Surgeons’ National Surgical Quality Improvement Program.
CMS to shorten 2015 MU attestation to 90 days
Physicians will have to attest to meeting Stage 2 meaningful use criteria for 90 days in 2015, officials at the Centers for Medicare and Medicaid Services announced Jan. 29.
Currently under the meaningful use program, physicians must attest that they met requirements for the entire year or be subject to a Medicare payment reduction. Low attestation numbers for 2015 suggested that many doctors would not be able to meet the full year requirement. Additionally, Congress has been looking at forcing the change by a legislative mandate.
The change, along with a few other program modifications, will be detailed in a proposed rule.
“The new rule, expected this spring, would be intended to be responsive to provider concerns about software implementation, information exchange readiness, and other related concerns in 2015,” Dr. Patrick Conway, CMS Chief Medical Officer, said in a Jan. 29 blog post. The changes “would help to reduce the reporting burden on providers, while supporting the long term goals of the program.”
Physicians’ organizations applauded the proposed change.
The American Medical Association welcomes the Centers for Medicare and Medicaid Services’ (CMS) announcement of plans to address some of the issues we have raised with the Meaningful Use program through rulemaking aimed at requirements for meeting Meaningful Use in 2015.
The American Medical Association is “eager to see the proposed rule as we have been working with CMS and the Office of the National Coordinator for Health IT, offering solutions to improve the incentive program for quite some time,” Dr. Steven J. Stack, AMA president-elect, said in a statement. “EHRs are intended to help physicians improve care for their patients, but unfortunately, today’s EHR certification standards and the stringent requirements of the Meaningful Use program do not support that goal and decrease efficiency.”
Dr. Patrick T. O’Gara, president of the American College of Cardilogy said, “We are pleased that CMS responded to feedback from the ACC and other health organizations and is considering shortening the 2015 reporting period to 90 days for electronic health records. He added that CMS should move quickly to disseminate information regarding the reporting timeline, so that physicians could successfully attest to Stage 2.
A separate rule on Stage 3 of meaningful use also will be published this year.
Read the full post on the CMS Blog.
Physicians will have to attest to meeting Stage 2 meaningful use criteria for 90 days in 2015, officials at the Centers for Medicare and Medicaid Services announced Jan. 29.
Currently under the meaningful use program, physicians must attest that they met requirements for the entire year or be subject to a Medicare payment reduction. Low attestation numbers for 2015 suggested that many doctors would not be able to meet the full year requirement. Additionally, Congress has been looking at forcing the change by a legislative mandate.
The change, along with a few other program modifications, will be detailed in a proposed rule.
“The new rule, expected this spring, would be intended to be responsive to provider concerns about software implementation, information exchange readiness, and other related concerns in 2015,” Dr. Patrick Conway, CMS Chief Medical Officer, said in a Jan. 29 blog post. The changes “would help to reduce the reporting burden on providers, while supporting the long term goals of the program.”
Physicians’ organizations applauded the proposed change.
The American Medical Association welcomes the Centers for Medicare and Medicaid Services’ (CMS) announcement of plans to address some of the issues we have raised with the Meaningful Use program through rulemaking aimed at requirements for meeting Meaningful Use in 2015.
The American Medical Association is “eager to see the proposed rule as we have been working with CMS and the Office of the National Coordinator for Health IT, offering solutions to improve the incentive program for quite some time,” Dr. Steven J. Stack, AMA president-elect, said in a statement. “EHRs are intended to help physicians improve care for their patients, but unfortunately, today’s EHR certification standards and the stringent requirements of the Meaningful Use program do not support that goal and decrease efficiency.”
Dr. Patrick T. O’Gara, president of the American College of Cardilogy said, “We are pleased that CMS responded to feedback from the ACC and other health organizations and is considering shortening the 2015 reporting period to 90 days for electronic health records. He added that CMS should move quickly to disseminate information regarding the reporting timeline, so that physicians could successfully attest to Stage 2.
A separate rule on Stage 3 of meaningful use also will be published this year.
Read the full post on the CMS Blog.
Physicians will have to attest to meeting Stage 2 meaningful use criteria for 90 days in 2015, officials at the Centers for Medicare and Medicaid Services announced Jan. 29.
Currently under the meaningful use program, physicians must attest that they met requirements for the entire year or be subject to a Medicare payment reduction. Low attestation numbers for 2015 suggested that many doctors would not be able to meet the full year requirement. Additionally, Congress has been looking at forcing the change by a legislative mandate.
The change, along with a few other program modifications, will be detailed in a proposed rule.
“The new rule, expected this spring, would be intended to be responsive to provider concerns about software implementation, information exchange readiness, and other related concerns in 2015,” Dr. Patrick Conway, CMS Chief Medical Officer, said in a Jan. 29 blog post. The changes “would help to reduce the reporting burden on providers, while supporting the long term goals of the program.”
Physicians’ organizations applauded the proposed change.
The American Medical Association welcomes the Centers for Medicare and Medicaid Services’ (CMS) announcement of plans to address some of the issues we have raised with the Meaningful Use program through rulemaking aimed at requirements for meeting Meaningful Use in 2015.
The American Medical Association is “eager to see the proposed rule as we have been working with CMS and the Office of the National Coordinator for Health IT, offering solutions to improve the incentive program for quite some time,” Dr. Steven J. Stack, AMA president-elect, said in a statement. “EHRs are intended to help physicians improve care for their patients, but unfortunately, today’s EHR certification standards and the stringent requirements of the Meaningful Use program do not support that goal and decrease efficiency.”
Dr. Patrick T. O’Gara, president of the American College of Cardilogy said, “We are pleased that CMS responded to feedback from the ACC and other health organizations and is considering shortening the 2015 reporting period to 90 days for electronic health records. He added that CMS should move quickly to disseminate information regarding the reporting timeline, so that physicians could successfully attest to Stage 2.
A separate rule on Stage 3 of meaningful use also will be published this year.
Read the full post on the CMS Blog.
Statins found to have a survival benefit in colorectal cancer
SAN FRANCISCO – Statin use confers a survival benefit in patients with colorectal cancer, suggests a systematic review and meta-analysis presented at the annual Gastrointestinal Cancers Symposium.
Investigators analyzed data from seven observational studies having a total of 64,773 patients with this cancer, a fifth of whom were using statins. Results showed that statin users had a nearly 30% reduction in the adjusted risk of all-cause mortality relative to nonusers, Dr. Arjun Gupta, the lead investigator, reported in a poster session at the meeting cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology.
“There is a lot of interest in non–cytotoxic chemotherapy drugs that can be used to treat cancer,” he said in an interview. “Thirty percent is a very, very significant number – we use chemotherapy drugs even if they have just a 10% survival benefit. So I am hopeful that this will help people.”
Accumulating preclinical data suggest that statins have anticancer actions, inhibiting cell proliferation and angiogenesis, and inducing apoptosis, according to Dr. Gupta, who is a resident in internal medicine at the University of Texas Southwestern Medical Center, Dallas. Previous studies have shown use to be associated with a decreased risk of developing colorectal cancer, but its impact on established disease has not been well assessed on a large scale.
“This is all observational data. There is no randomized controlled trial that’s been done,” he acknowledged. “But these data certainly seem to point out that this is something we can do. It’s a cheap and easy, safe drug which people take for years on end without any complications.”
At present, statins are approved by the Food and Drug Administration only for lipid-lowering indications, he noted. However, patients with colorectal cancer often have cardiovascular risk factors that make them candidates for statins.
“No one really gets a statin right now for colon cancer. We are just sort of lucky, maybe, that so many people with colon cancer have high cholesterol and are getting these drugs,” Dr. Gupta said. “But hopefully, my dream is 5 years down the line, it will be prescribed to people for this indication.”
Study results showed that in multivariate analyses, patients using statins were 26% less likely to die of any cause (hazard ratio, 0.74). Findings were similar whether they had colon cancer (hazard ratio, 0.79) or rectal cancer (hazard ratio, 0.63).
When analyses were restricted to studies that adjusted for concomitant use of aspirin and nonsteroidal anti-inflammatory drugs, statin users had significantly reduced risks of both all-cause mortality (hazard ratio, 0.74) and colorectal cancer–specific mortality (HR, 0.76), reported Dr. Gupta.
Patients who started using the medications after their cancer diagnosis had a significantly reduced risk of colorectal cancer-specific mortality (HR, 0.70) but not all-cause mortality.
Dr. Gupta disclosed that he had no relevant conflicts of interest.
SAN FRANCISCO – Statin use confers a survival benefit in patients with colorectal cancer, suggests a systematic review and meta-analysis presented at the annual Gastrointestinal Cancers Symposium.
Investigators analyzed data from seven observational studies having a total of 64,773 patients with this cancer, a fifth of whom were using statins. Results showed that statin users had a nearly 30% reduction in the adjusted risk of all-cause mortality relative to nonusers, Dr. Arjun Gupta, the lead investigator, reported in a poster session at the meeting cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology.
“There is a lot of interest in non–cytotoxic chemotherapy drugs that can be used to treat cancer,” he said in an interview. “Thirty percent is a very, very significant number – we use chemotherapy drugs even if they have just a 10% survival benefit. So I am hopeful that this will help people.”
Accumulating preclinical data suggest that statins have anticancer actions, inhibiting cell proliferation and angiogenesis, and inducing apoptosis, according to Dr. Gupta, who is a resident in internal medicine at the University of Texas Southwestern Medical Center, Dallas. Previous studies have shown use to be associated with a decreased risk of developing colorectal cancer, but its impact on established disease has not been well assessed on a large scale.
“This is all observational data. There is no randomized controlled trial that’s been done,” he acknowledged. “But these data certainly seem to point out that this is something we can do. It’s a cheap and easy, safe drug which people take for years on end without any complications.”
At present, statins are approved by the Food and Drug Administration only for lipid-lowering indications, he noted. However, patients with colorectal cancer often have cardiovascular risk factors that make them candidates for statins.
“No one really gets a statin right now for colon cancer. We are just sort of lucky, maybe, that so many people with colon cancer have high cholesterol and are getting these drugs,” Dr. Gupta said. “But hopefully, my dream is 5 years down the line, it will be prescribed to people for this indication.”
Study results showed that in multivariate analyses, patients using statins were 26% less likely to die of any cause (hazard ratio, 0.74). Findings were similar whether they had colon cancer (hazard ratio, 0.79) or rectal cancer (hazard ratio, 0.63).
When analyses were restricted to studies that adjusted for concomitant use of aspirin and nonsteroidal anti-inflammatory drugs, statin users had significantly reduced risks of both all-cause mortality (hazard ratio, 0.74) and colorectal cancer–specific mortality (HR, 0.76), reported Dr. Gupta.
Patients who started using the medications after their cancer diagnosis had a significantly reduced risk of colorectal cancer-specific mortality (HR, 0.70) but not all-cause mortality.
Dr. Gupta disclosed that he had no relevant conflicts of interest.
SAN FRANCISCO – Statin use confers a survival benefit in patients with colorectal cancer, suggests a systematic review and meta-analysis presented at the annual Gastrointestinal Cancers Symposium.
Investigators analyzed data from seven observational studies having a total of 64,773 patients with this cancer, a fifth of whom were using statins. Results showed that statin users had a nearly 30% reduction in the adjusted risk of all-cause mortality relative to nonusers, Dr. Arjun Gupta, the lead investigator, reported in a poster session at the meeting cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology.
“There is a lot of interest in non–cytotoxic chemotherapy drugs that can be used to treat cancer,” he said in an interview. “Thirty percent is a very, very significant number – we use chemotherapy drugs even if they have just a 10% survival benefit. So I am hopeful that this will help people.”
Accumulating preclinical data suggest that statins have anticancer actions, inhibiting cell proliferation and angiogenesis, and inducing apoptosis, according to Dr. Gupta, who is a resident in internal medicine at the University of Texas Southwestern Medical Center, Dallas. Previous studies have shown use to be associated with a decreased risk of developing colorectal cancer, but its impact on established disease has not been well assessed on a large scale.
“This is all observational data. There is no randomized controlled trial that’s been done,” he acknowledged. “But these data certainly seem to point out that this is something we can do. It’s a cheap and easy, safe drug which people take for years on end without any complications.”
At present, statins are approved by the Food and Drug Administration only for lipid-lowering indications, he noted. However, patients with colorectal cancer often have cardiovascular risk factors that make them candidates for statins.
“No one really gets a statin right now for colon cancer. We are just sort of lucky, maybe, that so many people with colon cancer have high cholesterol and are getting these drugs,” Dr. Gupta said. “But hopefully, my dream is 5 years down the line, it will be prescribed to people for this indication.”
Study results showed that in multivariate analyses, patients using statins were 26% less likely to die of any cause (hazard ratio, 0.74). Findings were similar whether they had colon cancer (hazard ratio, 0.79) or rectal cancer (hazard ratio, 0.63).
When analyses were restricted to studies that adjusted for concomitant use of aspirin and nonsteroidal anti-inflammatory drugs, statin users had significantly reduced risks of both all-cause mortality (hazard ratio, 0.74) and colorectal cancer–specific mortality (HR, 0.76), reported Dr. Gupta.
Patients who started using the medications after their cancer diagnosis had a significantly reduced risk of colorectal cancer-specific mortality (HR, 0.70) but not all-cause mortality.
Dr. Gupta disclosed that he had no relevant conflicts of interest.
Key clinical point: Patients with colorectal cancer who take statins are less likely to die.
Major finding: Relative to nonusers, statin users had a 26% reduction in the adjusted risk of all-cause mortality.
Data source: A systematic review and meta-analysis of seven observational studies having a total of 64,773 patients.
Disclosures: Dr. Gupta disclosed that he had no relevant conflicts of interest.
Poll: Congress should act if subsidies struck down by high court
Most Americans believe Congress should make health insurance subsidies available in all states should the Supreme Court restrict the use of federal tax credits to help purchase coverage.
The findings come from a poll released Jan. 28 by the Kaiser Family Foundation. The results show that few people are paying attention to the pending King v. Burwell, but that nearly two-thirds of patients think Congress should take action if the high court eliminates use of the tax credits. A majority of people in states that use the federal marketplace want their state to create its own marketplace if the Supreme Court limits federal subsidies.
The Supreme Court is set to hear arguments March 4 in the high profile case of King v. Burwell. Justices will weigh whether residents in states that rely on the federal marketplace are eligible for tax credits to purchase insurance, or whether such assistance can only go to residents with state-run marketplaces.
Estimates vary on how many Americans could lose subsidies in 2016 if the high court strikes down the financial assistance. An Urban Institute analysis estimated that just over 6 million people would lose coverage – 61% would be non-Hispanic white, 81% would work full- or part-time, and 82% would have modest incomes, but not be considered poor.
According to a study by the Rand. Corp., individual-market enrollment would decline by an estimated 70%, or 10 million people, if subsidies are eliminated.
As the Supreme Court prepares to hear the case, 34% of adults in states with the federal or partnership marketplaces are aware their state uses the federal marketplace, while 39% believe their state operates its own exchange (28% don’t know), according to the Kaiser Health Tracking Poll. In contrast, most people (63%) in states operating their own exchange are aware that theirs is a state-run marketplace, while about 17% think their state uses the federal marketplace (19% don’t know). More than half of those surveyed said they’ve never heard about the Burwell case.
The Kaiser survey analyzed the responses of 1,503 adults from Jan. 15 through Jan. 21 among a nationally representative random digit dial telephone sample. The combined landline and cell phone sample was weighted to match estimates for the national population using data from the Census Bureau’s 2013 American Community Survey and data from the 2010 Census on population density.
Overall views of the ACA haven’t changed much in the past few months, the survey found. Forty-six percent of people have an unfavorable opinion of the law, while 40% have a favorable opinion. Among uninsured respondents, 60% were unaware that the deadline to enroll in health insurance under the ACA is Feb. 15.
A large number of those surveyed said that they oppose legislation that would change the ACA’s employer coverage threshold for a full-time worker from 30 hours to 40 hours per week: 40% opposed the change while 26% supported it, and 34% said they did not know enough to comment.
On Twitter @legal_med
Most Americans believe Congress should make health insurance subsidies available in all states should the Supreme Court restrict the use of federal tax credits to help purchase coverage.
The findings come from a poll released Jan. 28 by the Kaiser Family Foundation. The results show that few people are paying attention to the pending King v. Burwell, but that nearly two-thirds of patients think Congress should take action if the high court eliminates use of the tax credits. A majority of people in states that use the federal marketplace want their state to create its own marketplace if the Supreme Court limits federal subsidies.
The Supreme Court is set to hear arguments March 4 in the high profile case of King v. Burwell. Justices will weigh whether residents in states that rely on the federal marketplace are eligible for tax credits to purchase insurance, or whether such assistance can only go to residents with state-run marketplaces.
Estimates vary on how many Americans could lose subsidies in 2016 if the high court strikes down the financial assistance. An Urban Institute analysis estimated that just over 6 million people would lose coverage – 61% would be non-Hispanic white, 81% would work full- or part-time, and 82% would have modest incomes, but not be considered poor.
According to a study by the Rand. Corp., individual-market enrollment would decline by an estimated 70%, or 10 million people, if subsidies are eliminated.
As the Supreme Court prepares to hear the case, 34% of adults in states with the federal or partnership marketplaces are aware their state uses the federal marketplace, while 39% believe their state operates its own exchange (28% don’t know), according to the Kaiser Health Tracking Poll. In contrast, most people (63%) in states operating their own exchange are aware that theirs is a state-run marketplace, while about 17% think their state uses the federal marketplace (19% don’t know). More than half of those surveyed said they’ve never heard about the Burwell case.
The Kaiser survey analyzed the responses of 1,503 adults from Jan. 15 through Jan. 21 among a nationally representative random digit dial telephone sample. The combined landline and cell phone sample was weighted to match estimates for the national population using data from the Census Bureau’s 2013 American Community Survey and data from the 2010 Census on population density.
Overall views of the ACA haven’t changed much in the past few months, the survey found. Forty-six percent of people have an unfavorable opinion of the law, while 40% have a favorable opinion. Among uninsured respondents, 60% were unaware that the deadline to enroll in health insurance under the ACA is Feb. 15.
A large number of those surveyed said that they oppose legislation that would change the ACA’s employer coverage threshold for a full-time worker from 30 hours to 40 hours per week: 40% opposed the change while 26% supported it, and 34% said they did not know enough to comment.
On Twitter @legal_med
Most Americans believe Congress should make health insurance subsidies available in all states should the Supreme Court restrict the use of federal tax credits to help purchase coverage.
The findings come from a poll released Jan. 28 by the Kaiser Family Foundation. The results show that few people are paying attention to the pending King v. Burwell, but that nearly two-thirds of patients think Congress should take action if the high court eliminates use of the tax credits. A majority of people in states that use the federal marketplace want their state to create its own marketplace if the Supreme Court limits federal subsidies.
The Supreme Court is set to hear arguments March 4 in the high profile case of King v. Burwell. Justices will weigh whether residents in states that rely on the federal marketplace are eligible for tax credits to purchase insurance, or whether such assistance can only go to residents with state-run marketplaces.
Estimates vary on how many Americans could lose subsidies in 2016 if the high court strikes down the financial assistance. An Urban Institute analysis estimated that just over 6 million people would lose coverage – 61% would be non-Hispanic white, 81% would work full- or part-time, and 82% would have modest incomes, but not be considered poor.
According to a study by the Rand. Corp., individual-market enrollment would decline by an estimated 70%, or 10 million people, if subsidies are eliminated.
As the Supreme Court prepares to hear the case, 34% of adults in states with the federal or partnership marketplaces are aware their state uses the federal marketplace, while 39% believe their state operates its own exchange (28% don’t know), according to the Kaiser Health Tracking Poll. In contrast, most people (63%) in states operating their own exchange are aware that theirs is a state-run marketplace, while about 17% think their state uses the federal marketplace (19% don’t know). More than half of those surveyed said they’ve never heard about the Burwell case.
The Kaiser survey analyzed the responses of 1,503 adults from Jan. 15 through Jan. 21 among a nationally representative random digit dial telephone sample. The combined landline and cell phone sample was weighted to match estimates for the national population using data from the Census Bureau’s 2013 American Community Survey and data from the 2010 Census on population density.
Overall views of the ACA haven’t changed much in the past few months, the survey found. Forty-six percent of people have an unfavorable opinion of the law, while 40% have a favorable opinion. Among uninsured respondents, 60% were unaware that the deadline to enroll in health insurance under the ACA is Feb. 15.
A large number of those surveyed said that they oppose legislation that would change the ACA’s employer coverage threshold for a full-time worker from 30 hours to 40 hours per week: 40% opposed the change while 26% supported it, and 34% said they did not know enough to comment.
On Twitter @legal_med
Targeted fusion biopsy superior for suspected prostate cancer
Targeted biopsy using magnetic resonance/ultrasound fusion imaging increased the detection of high-risk prostate cancer by 30% and decreased the detection of low-risk prostate cancer by 17%, compared with standard biopsy, according to a report published online Jan. 27 in JAMA.
Researchers compared the two approaches in a prospective cohort study involving 1,003 men referred to the National Cancer Institute during a 7-year period for evaluation of suspected prostate cancer. All the study participants had an elevated PSA or abnormal findings on digital rectal exam plus a multiparametric MRI showing at least 1 lesion in the prostate, said Dr. M. Minhaj Siddiqui of the urologic oncology branch, National Cancer Institute, Bethesda, Md., and his associates.
All the patients underwent both standard extended-sextant ultrasound-guided biopsy and targeted magnetic resonance/ultrasound fusion biopsy at the same visit. The latter technique involves electronically superimposing multiparametric MR images in real time onto transrectal ultrasound images, which improves spatial localization and capture of location in three planes. The lesions were separately categorized as low-risk, intermediate-risk, or high-risk by highly experienced genitourinary radiologists.
The two image-guided biopsy techniques agreed on these classifications in 69% of cases and identified a similar number of cancers. However, targeted biopsy detected 173 high-risk tumors, compared with only 122 identified on standard biopsy, and targeted biopsy detected 213 low-risk tumors, compared with 258 identified on standard biopsy. In a subset of 170 cases, these biopsy results could be compared against pathology found at whole-gland prostatectomy. Targeted biopsy proved to be much more accurate than standard biopsy, with sensitivities of 77% and 53%, respectively, the investigators said (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17942]).
These findings show that targeted biopsy “could significantly change the distribution of risk in men newly diagnosed with prostate cancer toward diagnosis of more high-risk disease. Although these improvements in risk stratification could translate into substantial clinical benefits, it is important to recognize that this study is preliminary” and didn’t include clinical end points such as cancer recurrence or prostate cancer–specific mortality, Dr. Siddiqui and his associates said.
Despite these promising results, it remains unknown whether improved risk stratification with targeted biopsy will translate into clinically meaningful outcomes such as better functional status or higher survival rates.
Improved classification of tumor grades should lead to more appropriate treatment recommendations – more intense therapy for men with higher-risk disease and active surveillance for those with lower-risk disease. But further study is needed to assess this technique’s impact on quality of life, disease progression, and life expectancy.
Dr. Lawrence H. Schwartz is in the department of radiology at Columbia University, New York, and at New York Presbyterian Hospital. Dr. Ethan Basch is at Lineberger Comprehensive Cancer Center and the University of North Carolina, Chapel Hill, as well as an associate editor at JAMA. Dr. Schwartz reported ties to Pfizer, Celgene, Novartis, Icon, and BioImaging, and Dr. Basch reported having no financial conflicts of interest. They made these remarks in an editorial accompanying Dr. Siddiqui’s report (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17943]).
Despite these promising results, it remains unknown whether improved risk stratification with targeted biopsy will translate into clinically meaningful outcomes such as better functional status or higher survival rates.
Improved classification of tumor grades should lead to more appropriate treatment recommendations – more intense therapy for men with higher-risk disease and active surveillance for those with lower-risk disease. But further study is needed to assess this technique’s impact on quality of life, disease progression, and life expectancy.
Dr. Lawrence H. Schwartz is in the department of radiology at Columbia University, New York, and at New York Presbyterian Hospital. Dr. Ethan Basch is at Lineberger Comprehensive Cancer Center and the University of North Carolina, Chapel Hill, as well as an associate editor at JAMA. Dr. Schwartz reported ties to Pfizer, Celgene, Novartis, Icon, and BioImaging, and Dr. Basch reported having no financial conflicts of interest. They made these remarks in an editorial accompanying Dr. Siddiqui’s report (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17943]).
Despite these promising results, it remains unknown whether improved risk stratification with targeted biopsy will translate into clinically meaningful outcomes such as better functional status or higher survival rates.
Improved classification of tumor grades should lead to more appropriate treatment recommendations – more intense therapy for men with higher-risk disease and active surveillance for those with lower-risk disease. But further study is needed to assess this technique’s impact on quality of life, disease progression, and life expectancy.
Dr. Lawrence H. Schwartz is in the department of radiology at Columbia University, New York, and at New York Presbyterian Hospital. Dr. Ethan Basch is at Lineberger Comprehensive Cancer Center and the University of North Carolina, Chapel Hill, as well as an associate editor at JAMA. Dr. Schwartz reported ties to Pfizer, Celgene, Novartis, Icon, and BioImaging, and Dr. Basch reported having no financial conflicts of interest. They made these remarks in an editorial accompanying Dr. Siddiqui’s report (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17943]).
Targeted biopsy using magnetic resonance/ultrasound fusion imaging increased the detection of high-risk prostate cancer by 30% and decreased the detection of low-risk prostate cancer by 17%, compared with standard biopsy, according to a report published online Jan. 27 in JAMA.
Researchers compared the two approaches in a prospective cohort study involving 1,003 men referred to the National Cancer Institute during a 7-year period for evaluation of suspected prostate cancer. All the study participants had an elevated PSA or abnormal findings on digital rectal exam plus a multiparametric MRI showing at least 1 lesion in the prostate, said Dr. M. Minhaj Siddiqui of the urologic oncology branch, National Cancer Institute, Bethesda, Md., and his associates.
All the patients underwent both standard extended-sextant ultrasound-guided biopsy and targeted magnetic resonance/ultrasound fusion biopsy at the same visit. The latter technique involves electronically superimposing multiparametric MR images in real time onto transrectal ultrasound images, which improves spatial localization and capture of location in three planes. The lesions were separately categorized as low-risk, intermediate-risk, or high-risk by highly experienced genitourinary radiologists.
The two image-guided biopsy techniques agreed on these classifications in 69% of cases and identified a similar number of cancers. However, targeted biopsy detected 173 high-risk tumors, compared with only 122 identified on standard biopsy, and targeted biopsy detected 213 low-risk tumors, compared with 258 identified on standard biopsy. In a subset of 170 cases, these biopsy results could be compared against pathology found at whole-gland prostatectomy. Targeted biopsy proved to be much more accurate than standard biopsy, with sensitivities of 77% and 53%, respectively, the investigators said (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17942]).
These findings show that targeted biopsy “could significantly change the distribution of risk in men newly diagnosed with prostate cancer toward diagnosis of more high-risk disease. Although these improvements in risk stratification could translate into substantial clinical benefits, it is important to recognize that this study is preliminary” and didn’t include clinical end points such as cancer recurrence or prostate cancer–specific mortality, Dr. Siddiqui and his associates said.
Targeted biopsy using magnetic resonance/ultrasound fusion imaging increased the detection of high-risk prostate cancer by 30% and decreased the detection of low-risk prostate cancer by 17%, compared with standard biopsy, according to a report published online Jan. 27 in JAMA.
Researchers compared the two approaches in a prospective cohort study involving 1,003 men referred to the National Cancer Institute during a 7-year period for evaluation of suspected prostate cancer. All the study participants had an elevated PSA or abnormal findings on digital rectal exam plus a multiparametric MRI showing at least 1 lesion in the prostate, said Dr. M. Minhaj Siddiqui of the urologic oncology branch, National Cancer Institute, Bethesda, Md., and his associates.
All the patients underwent both standard extended-sextant ultrasound-guided biopsy and targeted magnetic resonance/ultrasound fusion biopsy at the same visit. The latter technique involves electronically superimposing multiparametric MR images in real time onto transrectal ultrasound images, which improves spatial localization and capture of location in three planes. The lesions were separately categorized as low-risk, intermediate-risk, or high-risk by highly experienced genitourinary radiologists.
The two image-guided biopsy techniques agreed on these classifications in 69% of cases and identified a similar number of cancers. However, targeted biopsy detected 173 high-risk tumors, compared with only 122 identified on standard biopsy, and targeted biopsy detected 213 low-risk tumors, compared with 258 identified on standard biopsy. In a subset of 170 cases, these biopsy results could be compared against pathology found at whole-gland prostatectomy. Targeted biopsy proved to be much more accurate than standard biopsy, with sensitivities of 77% and 53%, respectively, the investigators said (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17942]).
These findings show that targeted biopsy “could significantly change the distribution of risk in men newly diagnosed with prostate cancer toward diagnosis of more high-risk disease. Although these improvements in risk stratification could translate into substantial clinical benefits, it is important to recognize that this study is preliminary” and didn’t include clinical end points such as cancer recurrence or prostate cancer–specific mortality, Dr. Siddiqui and his associates said.
Key clinical point: Targeted magnetic resonance/ultrasound fusion biopsy detected more high-risk and fewer low-risk prostate cancers than standard ultrasound-guided biopsy.
Major finding: Targeted biopsy detected 173 high-risk tumors, compared with only 122 identified on standard biopsy (30% more), and targeted biopsy detected 213 low-risk tumors, compared with 258 identified on standard biopsy (17% fewer).
Data source: A prospective cohort study involving 1,003 men undergoing both standard ultrasound-guided biopsy and targeted magnetic resonance/ultrasound fusion biopsy of the prostate during a 7-year period at a single medical center.
Disclosures: This study was supported by the National Cancer Institute, the National Institutes of Health, the Center for Cancer Research, and the Center for Interventional Oncology. Dr. Siddiqui reported having no financial disclosures; his associates reported holding multiple patents related to biopsies and imaging,