User login
Colonoscopy Without Sedation Deemed Okay
SAN DIEGO — One-third of veterans offered colonoscopy without sedation agreed to the procedure, which was conducted safely and successfully with high levels of patient satisfaction, according to results of a prospective study presented at the annual Digestive Disease Week.
In 2002, the staff at Sepulveda Ambulatory Care Center began offering unsedated colonoscopy because of a nursing shortage in the Los Angeles area, said Dr. Felix Leung, professor of medicine at the University of California, Los Angeles. Sepulveda is part of the VA of Greater Los Angeles health care system.
At Sepulveda, about a third of patients needing colonoscopy have agreed to have it without sedation over the last 5 years, and about a quarter have agreed to this at the VA Palo Alto (Calif.) health care system facility, said Dr. Leung. When a colonoscopy is required, patients are told about the pros and cons, he said. On the plus side, they are told that they can talk during the exam, that they can drive themselves home, and that there is no recovery time. However, they are told “that they would feel every little thing that we do to them, including pain and discomfort.”
Physicians explain that they will do everything possible to minimize the discomfort, but patients are not given any pharmaceutical agents, such as diazepam (Valium), said Dr. Leung in an interview.
Dr. Leung and his colleagues prospectively tracked patients who underwent colonoscopy without sedation during a period of about 2 years and 4 months (July 2005 to June 2006 and July 2006 to November 2007). In 2006, colonoscopies were performed with air insufflation, but in 2007, a new water method was used.
Sixty-two patients were in the air cohort, and 66 were in the water group. Among the 62 in the first group, 54 (87%) had satisfactory bowel prep; 8 (13%) could not complete because of poor bowel prep, and 7 (11%) could not complete because of discomfort. Forty-seven of the 54 who completed (87%), had a successful cecal intubation. Forty-one (76%) said they had a good experience, and 42 (78%) were willing to repeat it without sedation.
Two patients could not complete the study because of discomfort. Sixty-three (97%) had successful cecal intubation. Fifty-five (85%) had a good experience and 60 (92%) said they would repeat the procedure without sedation. Dr. Leung disclosed no conflicts of interest.
SAN DIEGO — One-third of veterans offered colonoscopy without sedation agreed to the procedure, which was conducted safely and successfully with high levels of patient satisfaction, according to results of a prospective study presented at the annual Digestive Disease Week.
In 2002, the staff at Sepulveda Ambulatory Care Center began offering unsedated colonoscopy because of a nursing shortage in the Los Angeles area, said Dr. Felix Leung, professor of medicine at the University of California, Los Angeles. Sepulveda is part of the VA of Greater Los Angeles health care system.
At Sepulveda, about a third of patients needing colonoscopy have agreed to have it without sedation over the last 5 years, and about a quarter have agreed to this at the VA Palo Alto (Calif.) health care system facility, said Dr. Leung. When a colonoscopy is required, patients are told about the pros and cons, he said. On the plus side, they are told that they can talk during the exam, that they can drive themselves home, and that there is no recovery time. However, they are told “that they would feel every little thing that we do to them, including pain and discomfort.”
Physicians explain that they will do everything possible to minimize the discomfort, but patients are not given any pharmaceutical agents, such as diazepam (Valium), said Dr. Leung in an interview.
Dr. Leung and his colleagues prospectively tracked patients who underwent colonoscopy without sedation during a period of about 2 years and 4 months (July 2005 to June 2006 and July 2006 to November 2007). In 2006, colonoscopies were performed with air insufflation, but in 2007, a new water method was used.
Sixty-two patients were in the air cohort, and 66 were in the water group. Among the 62 in the first group, 54 (87%) had satisfactory bowel prep; 8 (13%) could not complete because of poor bowel prep, and 7 (11%) could not complete because of discomfort. Forty-seven of the 54 who completed (87%), had a successful cecal intubation. Forty-one (76%) said they had a good experience, and 42 (78%) were willing to repeat it without sedation.
Two patients could not complete the study because of discomfort. Sixty-three (97%) had successful cecal intubation. Fifty-five (85%) had a good experience and 60 (92%) said they would repeat the procedure without sedation. Dr. Leung disclosed no conflicts of interest.
SAN DIEGO — One-third of veterans offered colonoscopy without sedation agreed to the procedure, which was conducted safely and successfully with high levels of patient satisfaction, according to results of a prospective study presented at the annual Digestive Disease Week.
In 2002, the staff at Sepulveda Ambulatory Care Center began offering unsedated colonoscopy because of a nursing shortage in the Los Angeles area, said Dr. Felix Leung, professor of medicine at the University of California, Los Angeles. Sepulveda is part of the VA of Greater Los Angeles health care system.
At Sepulveda, about a third of patients needing colonoscopy have agreed to have it without sedation over the last 5 years, and about a quarter have agreed to this at the VA Palo Alto (Calif.) health care system facility, said Dr. Leung. When a colonoscopy is required, patients are told about the pros and cons, he said. On the plus side, they are told that they can talk during the exam, that they can drive themselves home, and that there is no recovery time. However, they are told “that they would feel every little thing that we do to them, including pain and discomfort.”
Physicians explain that they will do everything possible to minimize the discomfort, but patients are not given any pharmaceutical agents, such as diazepam (Valium), said Dr. Leung in an interview.
Dr. Leung and his colleagues prospectively tracked patients who underwent colonoscopy without sedation during a period of about 2 years and 4 months (July 2005 to June 2006 and July 2006 to November 2007). In 2006, colonoscopies were performed with air insufflation, but in 2007, a new water method was used.
Sixty-two patients were in the air cohort, and 66 were in the water group. Among the 62 in the first group, 54 (87%) had satisfactory bowel prep; 8 (13%) could not complete because of poor bowel prep, and 7 (11%) could not complete because of discomfort. Forty-seven of the 54 who completed (87%), had a successful cecal intubation. Forty-one (76%) said they had a good experience, and 42 (78%) were willing to repeat it without sedation.
Two patients could not complete the study because of discomfort. Sixty-three (97%) had successful cecal intubation. Fifty-five (85%) had a good experience and 60 (92%) said they would repeat the procedure without sedation. Dr. Leung disclosed no conflicts of interest.
Insurer Ranking Systems Challenged in Mass.
The Massachusetts Medical Society has filed suit against a state agency and two insurers to “correct the wrongs” in programs that charge patients copayments based on physicians' performance ratings.
The suit is the latest in a series of broadsides against systems that purport to rank physicians, usually based on cost data extracted from claims. Physician groups have called that method flawed, and complained that often physicians have not been privy to how the ratings are calculated.
The Massachusetts physicians said that the program developed by the Massachusetts Group Insurance Commission (GIC) is seriously flawed. For example, the medical society cites a neurologist who took on multiple sclerosis patients and used a team approach to care, having all of the providers' costs assigned to her, making it appear that she was a very-high-cost provider, the suit alleges.
The commission buys health insurance for about 300,000 state employees through six plans. Tufts Health Plan and the UniCare Life and Health Insurance Co., both of which were also named in the suit, had the most egregious practices, said Frank Fortin, a spokesman for the Massachusetts Medical Society, in an interview. UniCare began using tiers in 2006 and Tufts in 2007.
The suit was filed now because starting this month there will be three tiers instead of just two and more specialists will be subject to tiering, Mr. Fortin said. Primary care has not yet been included.
Mr. Fortin alleged that the distribution among the tiers was partly set by quota. The expansion will affect more patients, and, with the new rankings, “more physicians are in lower tiers because they were assigned costs from patients they did not treat and for procedures they did not perform,” said Dr. Bruce S. Auerbach, president of the Massachusetts Medical Society, in a statement. The society does not oppose rankings, but said that the data are not accurate enough to be used to rate individual physicians.
Tufts wouldn't comment on the litigation. However, in a statement, spokeswoman Patti Embry-Tautenhan said that Tufts “developed physician tiering methodology with guidance from the Massachusetts Medical Society and other interested and affected parties in the health care community.” She added, “Transparency of information regarding cost and quality is in the best interest of our members and health care consumers in general.”
It's not the first time physicians have resorted to litigation. Rating systems instituted by UnitedHealthcare and Cigna Healthcare came under fire in Connecticut; a lawsuit filed in 2007 by the Fairfield County Medical Association is still pending. And, after filing suit in 2006 to block a Regence Blue Shield network, the Washington State Medical Association accepted a settlement last August in which Regence will continue to measure performance, but will engage physicians more directly in the process and make the programs more transparent.
The American Medical Association wants a settlement won in late 2007 by New York Attorney General Andrew Cuomo to serve as a national model. Cigna was the first to enter into the agreement. Aetna followed and said it would apply the agreement nationally. Empire Blue Cross and Blue Shield (a division of WellPoint), United Health, Group Health, and the Health Insurance Plan of Greater New York also agreed to the terms, within New York state.
The agreement was crafted by the attorney general, with the AMA, the Medical Society of the State of New York, and consumer groups such as Consumers Union and the National Partnership for Women and Families. It included a requirement that insurers publicly disclose rating methods and how much of the ratings is based on cost, and retain an independent monitoring board to report on compliance.
In early April, a group of physicians, consumers, employers, and insurers agreed to a voluntary program similar to the New York settlement. The Patient Charter was forged by the Consumer-Purchaser Disclosure Project.
Dr. Nancy Nielsen, AMA incoming president, said in an interview that the Massachusetts suit could have been avoided if the Patient Charter was in place. Rating systems are here to stay, however, she acknowledged, adding that the AMA does not oppose the programs on principle.
She said legislation codifying the voluntary standards would not likely pass Congress, because of insurance industry opposition. But when insurers don't follow the principles backed by physicians and consumers, “we'll go to the attorney general of that state,” Dr. Nielsen said.
The Massachusetts Medical Society has filed suit against a state agency and two insurers to “correct the wrongs” in programs that charge patients copayments based on physicians' performance ratings.
The suit is the latest in a series of broadsides against systems that purport to rank physicians, usually based on cost data extracted from claims. Physician groups have called that method flawed, and complained that often physicians have not been privy to how the ratings are calculated.
The Massachusetts physicians said that the program developed by the Massachusetts Group Insurance Commission (GIC) is seriously flawed. For example, the medical society cites a neurologist who took on multiple sclerosis patients and used a team approach to care, having all of the providers' costs assigned to her, making it appear that she was a very-high-cost provider, the suit alleges.
The commission buys health insurance for about 300,000 state employees through six plans. Tufts Health Plan and the UniCare Life and Health Insurance Co., both of which were also named in the suit, had the most egregious practices, said Frank Fortin, a spokesman for the Massachusetts Medical Society, in an interview. UniCare began using tiers in 2006 and Tufts in 2007.
The suit was filed now because starting this month there will be three tiers instead of just two and more specialists will be subject to tiering, Mr. Fortin said. Primary care has not yet been included.
Mr. Fortin alleged that the distribution among the tiers was partly set by quota. The expansion will affect more patients, and, with the new rankings, “more physicians are in lower tiers because they were assigned costs from patients they did not treat and for procedures they did not perform,” said Dr. Bruce S. Auerbach, president of the Massachusetts Medical Society, in a statement. The society does not oppose rankings, but said that the data are not accurate enough to be used to rate individual physicians.
Tufts wouldn't comment on the litigation. However, in a statement, spokeswoman Patti Embry-Tautenhan said that Tufts “developed physician tiering methodology with guidance from the Massachusetts Medical Society and other interested and affected parties in the health care community.” She added, “Transparency of information regarding cost and quality is in the best interest of our members and health care consumers in general.”
It's not the first time physicians have resorted to litigation. Rating systems instituted by UnitedHealthcare and Cigna Healthcare came under fire in Connecticut; a lawsuit filed in 2007 by the Fairfield County Medical Association is still pending. And, after filing suit in 2006 to block a Regence Blue Shield network, the Washington State Medical Association accepted a settlement last August in which Regence will continue to measure performance, but will engage physicians more directly in the process and make the programs more transparent.
The American Medical Association wants a settlement won in late 2007 by New York Attorney General Andrew Cuomo to serve as a national model. Cigna was the first to enter into the agreement. Aetna followed and said it would apply the agreement nationally. Empire Blue Cross and Blue Shield (a division of WellPoint), United Health, Group Health, and the Health Insurance Plan of Greater New York also agreed to the terms, within New York state.
The agreement was crafted by the attorney general, with the AMA, the Medical Society of the State of New York, and consumer groups such as Consumers Union and the National Partnership for Women and Families. It included a requirement that insurers publicly disclose rating methods and how much of the ratings is based on cost, and retain an independent monitoring board to report on compliance.
In early April, a group of physicians, consumers, employers, and insurers agreed to a voluntary program similar to the New York settlement. The Patient Charter was forged by the Consumer-Purchaser Disclosure Project.
Dr. Nancy Nielsen, AMA incoming president, said in an interview that the Massachusetts suit could have been avoided if the Patient Charter was in place. Rating systems are here to stay, however, she acknowledged, adding that the AMA does not oppose the programs on principle.
She said legislation codifying the voluntary standards would not likely pass Congress, because of insurance industry opposition. But when insurers don't follow the principles backed by physicians and consumers, “we'll go to the attorney general of that state,” Dr. Nielsen said.
The Massachusetts Medical Society has filed suit against a state agency and two insurers to “correct the wrongs” in programs that charge patients copayments based on physicians' performance ratings.
The suit is the latest in a series of broadsides against systems that purport to rank physicians, usually based on cost data extracted from claims. Physician groups have called that method flawed, and complained that often physicians have not been privy to how the ratings are calculated.
The Massachusetts physicians said that the program developed by the Massachusetts Group Insurance Commission (GIC) is seriously flawed. For example, the medical society cites a neurologist who took on multiple sclerosis patients and used a team approach to care, having all of the providers' costs assigned to her, making it appear that she was a very-high-cost provider, the suit alleges.
The commission buys health insurance for about 300,000 state employees through six plans. Tufts Health Plan and the UniCare Life and Health Insurance Co., both of which were also named in the suit, had the most egregious practices, said Frank Fortin, a spokesman for the Massachusetts Medical Society, in an interview. UniCare began using tiers in 2006 and Tufts in 2007.
The suit was filed now because starting this month there will be three tiers instead of just two and more specialists will be subject to tiering, Mr. Fortin said. Primary care has not yet been included.
Mr. Fortin alleged that the distribution among the tiers was partly set by quota. The expansion will affect more patients, and, with the new rankings, “more physicians are in lower tiers because they were assigned costs from patients they did not treat and for procedures they did not perform,” said Dr. Bruce S. Auerbach, president of the Massachusetts Medical Society, in a statement. The society does not oppose rankings, but said that the data are not accurate enough to be used to rate individual physicians.
Tufts wouldn't comment on the litigation. However, in a statement, spokeswoman Patti Embry-Tautenhan said that Tufts “developed physician tiering methodology with guidance from the Massachusetts Medical Society and other interested and affected parties in the health care community.” She added, “Transparency of information regarding cost and quality is in the best interest of our members and health care consumers in general.”
It's not the first time physicians have resorted to litigation. Rating systems instituted by UnitedHealthcare and Cigna Healthcare came under fire in Connecticut; a lawsuit filed in 2007 by the Fairfield County Medical Association is still pending. And, after filing suit in 2006 to block a Regence Blue Shield network, the Washington State Medical Association accepted a settlement last August in which Regence will continue to measure performance, but will engage physicians more directly in the process and make the programs more transparent.
The American Medical Association wants a settlement won in late 2007 by New York Attorney General Andrew Cuomo to serve as a national model. Cigna was the first to enter into the agreement. Aetna followed and said it would apply the agreement nationally. Empire Blue Cross and Blue Shield (a division of WellPoint), United Health, Group Health, and the Health Insurance Plan of Greater New York also agreed to the terms, within New York state.
The agreement was crafted by the attorney general, with the AMA, the Medical Society of the State of New York, and consumer groups such as Consumers Union and the National Partnership for Women and Families. It included a requirement that insurers publicly disclose rating methods and how much of the ratings is based on cost, and retain an independent monitoring board to report on compliance.
In early April, a group of physicians, consumers, employers, and insurers agreed to a voluntary program similar to the New York settlement. The Patient Charter was forged by the Consumer-Purchaser Disclosure Project.
Dr. Nancy Nielsen, AMA incoming president, said in an interview that the Massachusetts suit could have been avoided if the Patient Charter was in place. Rating systems are here to stay, however, she acknowledged, adding that the AMA does not oppose the programs on principle.
She said legislation codifying the voluntary standards would not likely pass Congress, because of insurance industry opposition. But when insurers don't follow the principles backed by physicians and consumers, “we'll go to the attorney general of that state,” Dr. Nielsen said.
Amenorrheic Athletes Have Higher Ghrelin Levels
SAN FRANCISCO — Athletic teenage girls who are amenorrheic have higher ghrelin and lower leptin levels than athletic girls who are eumenorrheic or girls who are nonathletic, according to a small study.
The findings could help tease out which girls are more likely to stop menstruating, study investigator Madhusmita Misra of Harvard Medical School, and a pediatric endocrinologist at MassGeneral Hospital for Children, Boston, reported at the annual meeting of the Endocrine Society.
She and her colleagues aimed to determine whether ghrelin, which stimulates appetite, and leptin, which suppresses appetite, might be related to amenorrhea in young women, especially those with intense energy expenditures and a heightened need for caloric intake. Ghrelin levels have been shown to be increased in people with anorexia nervosa, and higher levels also have been linked to impaired secretion of hormones that regulate menstrual and ovarian function.
Dr. Misra and colleagues enrolled 21 girls who were amenorrheic athletes, 19 eumenorrheic athletes, and 18 nonathletic controls. All were aged 12–18 years. Fasting blood was drawn to measure ghrelin, leptin, estradiol, testosterone, and follicle-stimulating hormone levels.
The two athletic groups had similar activity levels, which were higher than that for the control group of nonathletes. The athletes were 85% of ideal body weight for their age.
As predicted, the amenorrheic girls had lower leptin levels, and their ghrelin levels were twice those of the other two arms. The girls with the highest ghrelin levels and lowest leptin levels also had the lowest levels of estrogen, she said.
The study was funded by the National Institutes of Health. Dr. Misra reported no conflicts related to the study.
SAN FRANCISCO — Athletic teenage girls who are amenorrheic have higher ghrelin and lower leptin levels than athletic girls who are eumenorrheic or girls who are nonathletic, according to a small study.
The findings could help tease out which girls are more likely to stop menstruating, study investigator Madhusmita Misra of Harvard Medical School, and a pediatric endocrinologist at MassGeneral Hospital for Children, Boston, reported at the annual meeting of the Endocrine Society.
She and her colleagues aimed to determine whether ghrelin, which stimulates appetite, and leptin, which suppresses appetite, might be related to amenorrhea in young women, especially those with intense energy expenditures and a heightened need for caloric intake. Ghrelin levels have been shown to be increased in people with anorexia nervosa, and higher levels also have been linked to impaired secretion of hormones that regulate menstrual and ovarian function.
Dr. Misra and colleagues enrolled 21 girls who were amenorrheic athletes, 19 eumenorrheic athletes, and 18 nonathletic controls. All were aged 12–18 years. Fasting blood was drawn to measure ghrelin, leptin, estradiol, testosterone, and follicle-stimulating hormone levels.
The two athletic groups had similar activity levels, which were higher than that for the control group of nonathletes. The athletes were 85% of ideal body weight for their age.
As predicted, the amenorrheic girls had lower leptin levels, and their ghrelin levels were twice those of the other two arms. The girls with the highest ghrelin levels and lowest leptin levels also had the lowest levels of estrogen, she said.
The study was funded by the National Institutes of Health. Dr. Misra reported no conflicts related to the study.
SAN FRANCISCO — Athletic teenage girls who are amenorrheic have higher ghrelin and lower leptin levels than athletic girls who are eumenorrheic or girls who are nonathletic, according to a small study.
The findings could help tease out which girls are more likely to stop menstruating, study investigator Madhusmita Misra of Harvard Medical School, and a pediatric endocrinologist at MassGeneral Hospital for Children, Boston, reported at the annual meeting of the Endocrine Society.
She and her colleagues aimed to determine whether ghrelin, which stimulates appetite, and leptin, which suppresses appetite, might be related to amenorrhea in young women, especially those with intense energy expenditures and a heightened need for caloric intake. Ghrelin levels have been shown to be increased in people with anorexia nervosa, and higher levels also have been linked to impaired secretion of hormones that regulate menstrual and ovarian function.
Dr. Misra and colleagues enrolled 21 girls who were amenorrheic athletes, 19 eumenorrheic athletes, and 18 nonathletic controls. All were aged 12–18 years. Fasting blood was drawn to measure ghrelin, leptin, estradiol, testosterone, and follicle-stimulating hormone levels.
The two athletic groups had similar activity levels, which were higher than that for the control group of nonathletes. The athletes were 85% of ideal body weight for their age.
As predicted, the amenorrheic girls had lower leptin levels, and their ghrelin levels were twice those of the other two arms. The girls with the highest ghrelin levels and lowest leptin levels also had the lowest levels of estrogen, she said.
The study was funded by the National Institutes of Health. Dr. Misra reported no conflicts related to the study.
Roux-En-Y Bypass Helps Obese Meet Type 2 Treatment Goals
SAN FRANCISCO — Roux-en-Y gastric bypass surgery is effective in helping people with type 2 diabetes meet the American Diabetes Association goals for hemoglobin A1c, systolic blood pressure, and LDL cholesterol, according to a retrospective study presented June 16 at the annual meeting of the Endocrine Society.
Dr. Daniel Leslie of the University of Minnesota, Minneapolis, said that his study was the first to report on the effectiveness of Roux-en-Y in meeting treatment goals set by the American Diabetes Association (ADA) in 2004 for the management of type 2 diabetes.
Dr. Leslie and colleagues reviewed all Roux-en-Y gastric bypass procedures conducted at the University of Minnesota between 2001 and 2007. Eighty-five percent of the procedures were done laparoscopically. There were a total of 2,210 consecutive surgeries, and of those patients, 564 had type 2 diabetes.
But only 338 patients had all three measures—HbA1c, systolic blood pressure, and LDL cholesterol—available at baseline. Only 169 patients had all three measures available both pre- and postoperatively, Dr. Leslie said.
The average age of the patients was 51 years; 79% (133) were women and 85% (143) were white. The average duration of diabetes was 9 years, although 39% (66) of the group had diabetes for more than 10 years. Patients were followed for an average of 26 months.
Dr. Leslie estimated that 32% (54) of the patients met the ADA goals after surgery. Only 9.5% (16) of patients had met those goals before gastric bypass. The duration of diabetes was not associated with meeting the goals.
The ADA goals included an HbA1c of 7% or less, LDL cholesterol of 100 mg/dL or less, and systolic blood pressure of 130 mm Hg or less.
The HbA1c value improved from 7.7% on average to 6.2% after the procedure. Systolic blood pressure dropped from an average of 136 mm Hg to 128 mm Hg. The use of oral antidiabetic medications and insulin dropped dramatically, Dr. Leslie noted. Use of cholesterol-lowering and blood pressure-lowering drugs also fell, but the need for antihypertensives increased after about 24 months, Dr. Leslie said.
The mean body mass index dropped from 49 to 33 kg/m
“Gastric bypass is a useful tool for improving diabetes treatment goals,” said Dr. Leslie, although he noted that the study was not controlled. He also said that surgery improved glycemic control the most out of all the parameters measured, but that the procedure should not be used to replace any other modalities aimed at cardiovascular risk factors.
Dr. Leslie disclosed that his surgery division receives grant support from Covidien AG and Ethicon Endo-Surgery Inc., but said that he does not personally receive any industry grants.
SAN FRANCISCO — Roux-en-Y gastric bypass surgery is effective in helping people with type 2 diabetes meet the American Diabetes Association goals for hemoglobin A1c, systolic blood pressure, and LDL cholesterol, according to a retrospective study presented June 16 at the annual meeting of the Endocrine Society.
Dr. Daniel Leslie of the University of Minnesota, Minneapolis, said that his study was the first to report on the effectiveness of Roux-en-Y in meeting treatment goals set by the American Diabetes Association (ADA) in 2004 for the management of type 2 diabetes.
Dr. Leslie and colleagues reviewed all Roux-en-Y gastric bypass procedures conducted at the University of Minnesota between 2001 and 2007. Eighty-five percent of the procedures were done laparoscopically. There were a total of 2,210 consecutive surgeries, and of those patients, 564 had type 2 diabetes.
But only 338 patients had all three measures—HbA1c, systolic blood pressure, and LDL cholesterol—available at baseline. Only 169 patients had all three measures available both pre- and postoperatively, Dr. Leslie said.
The average age of the patients was 51 years; 79% (133) were women and 85% (143) were white. The average duration of diabetes was 9 years, although 39% (66) of the group had diabetes for more than 10 years. Patients were followed for an average of 26 months.
Dr. Leslie estimated that 32% (54) of the patients met the ADA goals after surgery. Only 9.5% (16) of patients had met those goals before gastric bypass. The duration of diabetes was not associated with meeting the goals.
The ADA goals included an HbA1c of 7% or less, LDL cholesterol of 100 mg/dL or less, and systolic blood pressure of 130 mm Hg or less.
The HbA1c value improved from 7.7% on average to 6.2% after the procedure. Systolic blood pressure dropped from an average of 136 mm Hg to 128 mm Hg. The use of oral antidiabetic medications and insulin dropped dramatically, Dr. Leslie noted. Use of cholesterol-lowering and blood pressure-lowering drugs also fell, but the need for antihypertensives increased after about 24 months, Dr. Leslie said.
The mean body mass index dropped from 49 to 33 kg/m
“Gastric bypass is a useful tool for improving diabetes treatment goals,” said Dr. Leslie, although he noted that the study was not controlled. He also said that surgery improved glycemic control the most out of all the parameters measured, but that the procedure should not be used to replace any other modalities aimed at cardiovascular risk factors.
Dr. Leslie disclosed that his surgery division receives grant support from Covidien AG and Ethicon Endo-Surgery Inc., but said that he does not personally receive any industry grants.
SAN FRANCISCO — Roux-en-Y gastric bypass surgery is effective in helping people with type 2 diabetes meet the American Diabetes Association goals for hemoglobin A1c, systolic blood pressure, and LDL cholesterol, according to a retrospective study presented June 16 at the annual meeting of the Endocrine Society.
Dr. Daniel Leslie of the University of Minnesota, Minneapolis, said that his study was the first to report on the effectiveness of Roux-en-Y in meeting treatment goals set by the American Diabetes Association (ADA) in 2004 for the management of type 2 diabetes.
Dr. Leslie and colleagues reviewed all Roux-en-Y gastric bypass procedures conducted at the University of Minnesota between 2001 and 2007. Eighty-five percent of the procedures were done laparoscopically. There were a total of 2,210 consecutive surgeries, and of those patients, 564 had type 2 diabetes.
But only 338 patients had all three measures—HbA1c, systolic blood pressure, and LDL cholesterol—available at baseline. Only 169 patients had all three measures available both pre- and postoperatively, Dr. Leslie said.
The average age of the patients was 51 years; 79% (133) were women and 85% (143) were white. The average duration of diabetes was 9 years, although 39% (66) of the group had diabetes for more than 10 years. Patients were followed for an average of 26 months.
Dr. Leslie estimated that 32% (54) of the patients met the ADA goals after surgery. Only 9.5% (16) of patients had met those goals before gastric bypass. The duration of diabetes was not associated with meeting the goals.
The ADA goals included an HbA1c of 7% or less, LDL cholesterol of 100 mg/dL or less, and systolic blood pressure of 130 mm Hg or less.
The HbA1c value improved from 7.7% on average to 6.2% after the procedure. Systolic blood pressure dropped from an average of 136 mm Hg to 128 mm Hg. The use of oral antidiabetic medications and insulin dropped dramatically, Dr. Leslie noted. Use of cholesterol-lowering and blood pressure-lowering drugs also fell, but the need for antihypertensives increased after about 24 months, Dr. Leslie said.
The mean body mass index dropped from 49 to 33 kg/m
“Gastric bypass is a useful tool for improving diabetes treatment goals,” said Dr. Leslie, although he noted that the study was not controlled. He also said that surgery improved glycemic control the most out of all the parameters measured, but that the procedure should not be used to replace any other modalities aimed at cardiovascular risk factors.
Dr. Leslie disclosed that his surgery division receives grant support from Covidien AG and Ethicon Endo-Surgery Inc., but said that he does not personally receive any industry grants.
Obesity Does Not Complicate Medical Abortion
NEW ORLEANS — Obesity was not found to increase the risk of adverse events in women undergoing medical abortion in a retrospective chart review of 1,193 procedures.
Medical abortion might be considered before surgical abortion in obese patients because of the additional risk obesity confers during surgical abortions, Dr. Melissa Strafford said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Strafford and her colleagues reviewed charts for women who had medical abortions from 2005 to 2007 at Boston Medical Center. The investigators compared extremes of body mass index to detect any difference in complication rates. Overall, 1,398 charts were reviewed; the researchers excluded women with a body mass index between 30 and 35 and those who had repeat abortions, leaving 1,193 procedures performed using mifepristone and misoprostol.
A total of 918 of those women (77%) had a BMI of less than 30 and 131 (11%) had a BMI of greater than 35.
Overall, 743 women (81%) with a BMI of less than 30 had a documented complete abortion, compared with 106 (81%) of those with a BMI of greater than 35. An equal number required surgical intervention—about 5% of each group. And the numbers requiring additional visits and treatment also were similar—at 64 (7%) for those with a BMI under 30 and 6 (5%) of those with a BMI over 35.
While there was some difference in the composition of the two groups, multiple regression analyses did not change the results, said Dr. Strafford.
Medical abortion should be considered for obese patients because surgical abortion presents an increased risk. That makes early counseling and referral even more important for obese patients, she said.
NEW ORLEANS — Obesity was not found to increase the risk of adverse events in women undergoing medical abortion in a retrospective chart review of 1,193 procedures.
Medical abortion might be considered before surgical abortion in obese patients because of the additional risk obesity confers during surgical abortions, Dr. Melissa Strafford said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Strafford and her colleagues reviewed charts for women who had medical abortions from 2005 to 2007 at Boston Medical Center. The investigators compared extremes of body mass index to detect any difference in complication rates. Overall, 1,398 charts were reviewed; the researchers excluded women with a body mass index between 30 and 35 and those who had repeat abortions, leaving 1,193 procedures performed using mifepristone and misoprostol.
A total of 918 of those women (77%) had a BMI of less than 30 and 131 (11%) had a BMI of greater than 35.
Overall, 743 women (81%) with a BMI of less than 30 had a documented complete abortion, compared with 106 (81%) of those with a BMI of greater than 35. An equal number required surgical intervention—about 5% of each group. And the numbers requiring additional visits and treatment also were similar—at 64 (7%) for those with a BMI under 30 and 6 (5%) of those with a BMI over 35.
While there was some difference in the composition of the two groups, multiple regression analyses did not change the results, said Dr. Strafford.
Medical abortion should be considered for obese patients because surgical abortion presents an increased risk. That makes early counseling and referral even more important for obese patients, she said.
NEW ORLEANS — Obesity was not found to increase the risk of adverse events in women undergoing medical abortion in a retrospective chart review of 1,193 procedures.
Medical abortion might be considered before surgical abortion in obese patients because of the additional risk obesity confers during surgical abortions, Dr. Melissa Strafford said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Strafford and her colleagues reviewed charts for women who had medical abortions from 2005 to 2007 at Boston Medical Center. The investigators compared extremes of body mass index to detect any difference in complication rates. Overall, 1,398 charts were reviewed; the researchers excluded women with a body mass index between 30 and 35 and those who had repeat abortions, leaving 1,193 procedures performed using mifepristone and misoprostol.
A total of 918 of those women (77%) had a BMI of less than 30 and 131 (11%) had a BMI of greater than 35.
Overall, 743 women (81%) with a BMI of less than 30 had a documented complete abortion, compared with 106 (81%) of those with a BMI of greater than 35. An equal number required surgical intervention—about 5% of each group. And the numbers requiring additional visits and treatment also were similar—at 64 (7%) for those with a BMI under 30 and 6 (5%) of those with a BMI over 35.
While there was some difference in the composition of the two groups, multiple regression analyses did not change the results, said Dr. Strafford.
Medical abortion should be considered for obese patients because surgical abortion presents an increased risk. That makes early counseling and referral even more important for obese patients, she said.
Rapid GBS Assay Is Equal to Standard Cultures : The polymerase chain reaction-based diagnostic costs more, but cuts turnaround time from days to hours.
NEW ORLEANS — A rapid polymerase chain reaction-based diagnostic to detect group B streptococcus infection during pregnancy is as specific and sensitive as are standard cultures and delivers results in a matter of a few hours, according to a small comparative study.
Dr. Lori Goranson, a resident at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., presented data from 99 women who came to the center's outpatient clinic.
The Centers for Disease Control and Prevention has issued a call for a rapid assay for group B strep that is available 24 hours a day, 7 days a week, and that can be easily performed without a sophisticated lab or highly trained personnel, Dr. Goranson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The agency recommends that all women be tested for GBS by 35–37 weeks' gestational age, she said. Laboring women who present with unknown GBS status, however, are empirically given antibiotics as a precaution. As a result, thousands of women are likely being treated unnecessarily, Dr. Goranson said.
There are a little more than 4 million live births a year in the United States, she said.
Given that 10%–30% of women are colonized with GBS, that 13% of women present preterm, and that 8% are without prenatal care, as many as 600,000 may inappropriately receive antibiotics, according to Dr. Goranson.
She and her colleagues at Dartmouth aimed to determine whether the Xpert GBS test could fulfill the CDC's parameters. The Xpert was approved by the Food and Drug Administration in 2006. Two vaginal/rectal swabs were taken from 99 women; one swab was tested using standard culture and the other with the Xpert device.
The swab is placed into a cartridge with reagents. It takes 2 minutes from sampling to the start of analysis, said Dr. Goranson. Results generally are available within 75 minutes, although the average in the Dartmouth study was 83 minutes. That compares with an average of 2.3 days to receive a culture result, she said.
The average maternal age was 29.7 years and the average gestational age at collection was 36 weeks.
Twenty-five of 99 specimens cultured positive, for a prevalence rate of 25%, which was consistent with the literature, noted Dr. Goranson.
Seventy-four of 99 (75%) cultured negative. With the PCR-based Xpert system, 27 of 99 specimens were positive, and 72 of 99 were negative. The overall agreement rate between the two tests was 96%. There were discordant results. Three of the four PCR-positive results cultured negative. One PCR-negative swab cultured positive.
The Xpert test had 96% sensitivity and 96% specificity, with a negative predictive value of 99%, and a positive predictive value of 88%.
The test is highly sensitive and specific, easy to use, and produces rapid results, concluded Dr. Goranson. Though they are not yet using the Xpert system clinically at Dartmouth, it could eventually be used to support standard culture or as a substitute for women presenting preterm with an unknown GBS status, she said.
It is more expensive than standard culture—probably about 1.5 times as much, said Dr. Goranson. The device costs about $65,000 and cartridges cost about $45 each, she said. But the Xpert system can also be used to conduct rapid enterovirus, methicillin-resistant Streptococcus aureus, and other diagnostics, she said.
Dr. Goranson stated that she had no financial conflicts of interest to report.
NEW ORLEANS — A rapid polymerase chain reaction-based diagnostic to detect group B streptococcus infection during pregnancy is as specific and sensitive as are standard cultures and delivers results in a matter of a few hours, according to a small comparative study.
Dr. Lori Goranson, a resident at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., presented data from 99 women who came to the center's outpatient clinic.
The Centers for Disease Control and Prevention has issued a call for a rapid assay for group B strep that is available 24 hours a day, 7 days a week, and that can be easily performed without a sophisticated lab or highly trained personnel, Dr. Goranson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The agency recommends that all women be tested for GBS by 35–37 weeks' gestational age, she said. Laboring women who present with unknown GBS status, however, are empirically given antibiotics as a precaution. As a result, thousands of women are likely being treated unnecessarily, Dr. Goranson said.
There are a little more than 4 million live births a year in the United States, she said.
Given that 10%–30% of women are colonized with GBS, that 13% of women present preterm, and that 8% are without prenatal care, as many as 600,000 may inappropriately receive antibiotics, according to Dr. Goranson.
She and her colleagues at Dartmouth aimed to determine whether the Xpert GBS test could fulfill the CDC's parameters. The Xpert was approved by the Food and Drug Administration in 2006. Two vaginal/rectal swabs were taken from 99 women; one swab was tested using standard culture and the other with the Xpert device.
The swab is placed into a cartridge with reagents. It takes 2 minutes from sampling to the start of analysis, said Dr. Goranson. Results generally are available within 75 minutes, although the average in the Dartmouth study was 83 minutes. That compares with an average of 2.3 days to receive a culture result, she said.
The average maternal age was 29.7 years and the average gestational age at collection was 36 weeks.
Twenty-five of 99 specimens cultured positive, for a prevalence rate of 25%, which was consistent with the literature, noted Dr. Goranson.
Seventy-four of 99 (75%) cultured negative. With the PCR-based Xpert system, 27 of 99 specimens were positive, and 72 of 99 were negative. The overall agreement rate between the two tests was 96%. There were discordant results. Three of the four PCR-positive results cultured negative. One PCR-negative swab cultured positive.
The Xpert test had 96% sensitivity and 96% specificity, with a negative predictive value of 99%, and a positive predictive value of 88%.
The test is highly sensitive and specific, easy to use, and produces rapid results, concluded Dr. Goranson. Though they are not yet using the Xpert system clinically at Dartmouth, it could eventually be used to support standard culture or as a substitute for women presenting preterm with an unknown GBS status, she said.
It is more expensive than standard culture—probably about 1.5 times as much, said Dr. Goranson. The device costs about $65,000 and cartridges cost about $45 each, she said. But the Xpert system can also be used to conduct rapid enterovirus, methicillin-resistant Streptococcus aureus, and other diagnostics, she said.
Dr. Goranson stated that she had no financial conflicts of interest to report.
NEW ORLEANS — A rapid polymerase chain reaction-based diagnostic to detect group B streptococcus infection during pregnancy is as specific and sensitive as are standard cultures and delivers results in a matter of a few hours, according to a small comparative study.
Dr. Lori Goranson, a resident at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., presented data from 99 women who came to the center's outpatient clinic.
The Centers for Disease Control and Prevention has issued a call for a rapid assay for group B strep that is available 24 hours a day, 7 days a week, and that can be easily performed without a sophisticated lab or highly trained personnel, Dr. Goranson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The agency recommends that all women be tested for GBS by 35–37 weeks' gestational age, she said. Laboring women who present with unknown GBS status, however, are empirically given antibiotics as a precaution. As a result, thousands of women are likely being treated unnecessarily, Dr. Goranson said.
There are a little more than 4 million live births a year in the United States, she said.
Given that 10%–30% of women are colonized with GBS, that 13% of women present preterm, and that 8% are without prenatal care, as many as 600,000 may inappropriately receive antibiotics, according to Dr. Goranson.
She and her colleagues at Dartmouth aimed to determine whether the Xpert GBS test could fulfill the CDC's parameters. The Xpert was approved by the Food and Drug Administration in 2006. Two vaginal/rectal swabs were taken from 99 women; one swab was tested using standard culture and the other with the Xpert device.
The swab is placed into a cartridge with reagents. It takes 2 minutes from sampling to the start of analysis, said Dr. Goranson. Results generally are available within 75 minutes, although the average in the Dartmouth study was 83 minutes. That compares with an average of 2.3 days to receive a culture result, she said.
The average maternal age was 29.7 years and the average gestational age at collection was 36 weeks.
Twenty-five of 99 specimens cultured positive, for a prevalence rate of 25%, which was consistent with the literature, noted Dr. Goranson.
Seventy-four of 99 (75%) cultured negative. With the PCR-based Xpert system, 27 of 99 specimens were positive, and 72 of 99 were negative. The overall agreement rate between the two tests was 96%. There were discordant results. Three of the four PCR-positive results cultured negative. One PCR-negative swab cultured positive.
The Xpert test had 96% sensitivity and 96% specificity, with a negative predictive value of 99%, and a positive predictive value of 88%.
The test is highly sensitive and specific, easy to use, and produces rapid results, concluded Dr. Goranson. Though they are not yet using the Xpert system clinically at Dartmouth, it could eventually be used to support standard culture or as a substitute for women presenting preterm with an unknown GBS status, she said.
It is more expensive than standard culture—probably about 1.5 times as much, said Dr. Goranson. The device costs about $65,000 and cartridges cost about $45 each, she said. But the Xpert system can also be used to conduct rapid enterovirus, methicillin-resistant Streptococcus aureus, and other diagnostics, she said.
Dr. Goranson stated that she had no financial conflicts of interest to report.
Both Candidates' Health Plans Murky on Cost-Cutting Details
WASHINGTON — While health care has been a key issue in this year's presidential campaign, plans from both Barack Obama (D-Ill.) and John McCain (R.-Ariz.) are light on details about the most important aspects of the health system, like controlling costs, and improving efficiency and productivity.
The candidates have presented a wish list with very little detail on how they would accomplish the “fundamental change needed for our delivery system,” said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, at a briefing sponsored by the Alliance for Health Reform. “They could have a debate over how best to do that,” he said, adding, “We aren't hearing that.”
Economists have estimated that over the next decade, U.S. health spending will double from $2.2 trillion to $4.3 trillion. Dr. Ginsburg, with Princeton (N.J.) University economist Uwe Reinhardt and former Centers for Medicare and Medicaid Services Administrator Mark McClellan, said that rising costs are being driven by variations in practice, growth in volume, and intensity of services.
Sen. Obama has said that he favors health information technology, transparency of price, promotion of quality care, chronic-care coordination, payment reforms for value, malpractice reform, and promotion of generics.
Most of these are old, but not worthless, ideas, said Dr. Reinhardt, James Madison Professor of Political Economy at Princeton. “These are not to be laughed off, but they won't get us out of the box,” he said.
Dr. Reinhardt called Sen. McCain a “true radical” for his proposal to eliminate the tax exemption for employer-provided health insurance. Individuals who purchase insurance on their own would instead receive a $2,500 tax credit; families would receive $5,000.
“This is almost un-American—to take away a tax preference,” said Dr. Reinhardt, adding that it is “a shocking idea and not easy to get through Congress.”
Dr. Ginsburg called the proposal “a potentially powerful idea,” saying that it could make consumers more sensitive to the cost side of insurance, and thus make them a more potent demand force.
Cost control is important because there will be no new federal money available to increase access to insurance or initiatives aimed at improving quality or productivity, said Dr. McClellan. “Next year is going to be a very tight year fiscally,” he said. In fact, tax reform, the Iraq war, and the economy are likely to be higher up on the campaign agenda than health during the general election run-up this fall, said Dr. McClellan and his fellow panelists.
“I'm not personally persuaded that health care, in fact, will drive the campaign in the fall,” said Dr. Reinhardt.
But Dr. McClellan said, “My hope is it doesn't get pushed to the back burner,” noting that “it will be a major missed opportunity if we don't have health reform next year.”
WASHINGTON — While health care has been a key issue in this year's presidential campaign, plans from both Barack Obama (D-Ill.) and John McCain (R.-Ariz.) are light on details about the most important aspects of the health system, like controlling costs, and improving efficiency and productivity.
The candidates have presented a wish list with very little detail on how they would accomplish the “fundamental change needed for our delivery system,” said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, at a briefing sponsored by the Alliance for Health Reform. “They could have a debate over how best to do that,” he said, adding, “We aren't hearing that.”
Economists have estimated that over the next decade, U.S. health spending will double from $2.2 trillion to $4.3 trillion. Dr. Ginsburg, with Princeton (N.J.) University economist Uwe Reinhardt and former Centers for Medicare and Medicaid Services Administrator Mark McClellan, said that rising costs are being driven by variations in practice, growth in volume, and intensity of services.
Sen. Obama has said that he favors health information technology, transparency of price, promotion of quality care, chronic-care coordination, payment reforms for value, malpractice reform, and promotion of generics.
Most of these are old, but not worthless, ideas, said Dr. Reinhardt, James Madison Professor of Political Economy at Princeton. “These are not to be laughed off, but they won't get us out of the box,” he said.
Dr. Reinhardt called Sen. McCain a “true radical” for his proposal to eliminate the tax exemption for employer-provided health insurance. Individuals who purchase insurance on their own would instead receive a $2,500 tax credit; families would receive $5,000.
“This is almost un-American—to take away a tax preference,” said Dr. Reinhardt, adding that it is “a shocking idea and not easy to get through Congress.”
Dr. Ginsburg called the proposal “a potentially powerful idea,” saying that it could make consumers more sensitive to the cost side of insurance, and thus make them a more potent demand force.
Cost control is important because there will be no new federal money available to increase access to insurance or initiatives aimed at improving quality or productivity, said Dr. McClellan. “Next year is going to be a very tight year fiscally,” he said. In fact, tax reform, the Iraq war, and the economy are likely to be higher up on the campaign agenda than health during the general election run-up this fall, said Dr. McClellan and his fellow panelists.
“I'm not personally persuaded that health care, in fact, will drive the campaign in the fall,” said Dr. Reinhardt.
But Dr. McClellan said, “My hope is it doesn't get pushed to the back burner,” noting that “it will be a major missed opportunity if we don't have health reform next year.”
WASHINGTON — While health care has been a key issue in this year's presidential campaign, plans from both Barack Obama (D-Ill.) and John McCain (R.-Ariz.) are light on details about the most important aspects of the health system, like controlling costs, and improving efficiency and productivity.
The candidates have presented a wish list with very little detail on how they would accomplish the “fundamental change needed for our delivery system,” said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, at a briefing sponsored by the Alliance for Health Reform. “They could have a debate over how best to do that,” he said, adding, “We aren't hearing that.”
Economists have estimated that over the next decade, U.S. health spending will double from $2.2 trillion to $4.3 trillion. Dr. Ginsburg, with Princeton (N.J.) University economist Uwe Reinhardt and former Centers for Medicare and Medicaid Services Administrator Mark McClellan, said that rising costs are being driven by variations in practice, growth in volume, and intensity of services.
Sen. Obama has said that he favors health information technology, transparency of price, promotion of quality care, chronic-care coordination, payment reforms for value, malpractice reform, and promotion of generics.
Most of these are old, but not worthless, ideas, said Dr. Reinhardt, James Madison Professor of Political Economy at Princeton. “These are not to be laughed off, but they won't get us out of the box,” he said.
Dr. Reinhardt called Sen. McCain a “true radical” for his proposal to eliminate the tax exemption for employer-provided health insurance. Individuals who purchase insurance on their own would instead receive a $2,500 tax credit; families would receive $5,000.
“This is almost un-American—to take away a tax preference,” said Dr. Reinhardt, adding that it is “a shocking idea and not easy to get through Congress.”
Dr. Ginsburg called the proposal “a potentially powerful idea,” saying that it could make consumers more sensitive to the cost side of insurance, and thus make them a more potent demand force.
Cost control is important because there will be no new federal money available to increase access to insurance or initiatives aimed at improving quality or productivity, said Dr. McClellan. “Next year is going to be a very tight year fiscally,” he said. In fact, tax reform, the Iraq war, and the economy are likely to be higher up on the campaign agenda than health during the general election run-up this fall, said Dr. McClellan and his fellow panelists.
“I'm not personally persuaded that health care, in fact, will drive the campaign in the fall,” said Dr. Reinhardt.
But Dr. McClellan said, “My hope is it doesn't get pushed to the back burner,” noting that “it will be a major missed opportunity if we don't have health reform next year.”
Bisphosphonates Tied to High Jaw Necrosis Risk
SAN FRANCISCO — The prevalence of osteonecrosis of the jaw appears to be about 1 in 1,700 for adults taking long-term oral bisphosphonate therapy, according to an initial analysis of a group of Kaiser Permanente Northern California members.
Dr. Joan Lo surveyed 13,946 members who'd been taking oral bisphosphonates for at least 1 year and had no known exposure to intravenous bisphosphonate. The researchers received 8,568 responses to the mailed survey, which included questions about dental symptoms, said Dr. Lo, an endocrinologist at the Kaiser Permanente Division of Research, at the annual meeting of the Endocrine Society. Respondents who reported a diagnosis of osteonecrosis, or who reported exposed bone, periodontal disease, delayed bone healing, complications after invasive dental procedures, or persistent symptoms of concern were offered a dental exam by dentists on the PROBE study team. Cases of suspected osteonecrosis of the jaw (ONJ)—defined as exposed bone for greater than 8 weeks in the maxillofacial region, absent prior radiation—were referred for further examination by an oral surgeon. Dental records were reviewed in cases where patients declined a dental exam. Pharmacy records were also reviewed for all patients.
Of those who responded, about 6,402 patients did not have any symptoms of concern. A little more than 2,000 had symptoms of concern; 1,000 of those patients were examined by a dentist.
Dr. Lo said the team had identified eight cases of ONJ so far, for a prevalence of 0.09%, or 1 in 1,100. Three were localized to the palatal torus, and one in the mandible. The remaining four had bone exposure in the mandible following extraction. The confirmed cases had variable areas of bone exposure, variable locations, and various predisposing factors, she said.
In addition, the researchers identified an additional nine patients who had ONJ-like features but did not meet the classic definition of bisphosphonate-related ONJ. Three patients had signs of osteomyelitis of the mandible; an additional four had transient exposure, and another had a small area of bone exposure that persisted up to 1 year but eventually healed after a tooth extraction. The ninth patient had spontaneous tooth loss. Five had evidence of radiographic abnormalities, said Dr. Lo.
With these additional ONJ-like cases, the prevalence increased to 0.2%. Extrapolated to the entire cohort of patients taking bisphosphonates, the prevalence was 1 in 1,729, said Dr. Lo.
The current definition of bisphosphonate-related ONJ may not cover the spectrum of jaw complications seen in patients with long-term exposure, and may underestimate ONJ's prevalence, said Dr. Lo.
Such complications include nonhealing extraction sites and osteomyelitis or osteoporosis without exposed bone. The Kaiser researchers will continue to compile dental records to come up with a more accurate estimate of prevalence, she said.
Dr. Lo disclosed no conflicts of interest related to the study.
SAN FRANCISCO — The prevalence of osteonecrosis of the jaw appears to be about 1 in 1,700 for adults taking long-term oral bisphosphonate therapy, according to an initial analysis of a group of Kaiser Permanente Northern California members.
Dr. Joan Lo surveyed 13,946 members who'd been taking oral bisphosphonates for at least 1 year and had no known exposure to intravenous bisphosphonate. The researchers received 8,568 responses to the mailed survey, which included questions about dental symptoms, said Dr. Lo, an endocrinologist at the Kaiser Permanente Division of Research, at the annual meeting of the Endocrine Society. Respondents who reported a diagnosis of osteonecrosis, or who reported exposed bone, periodontal disease, delayed bone healing, complications after invasive dental procedures, or persistent symptoms of concern were offered a dental exam by dentists on the PROBE study team. Cases of suspected osteonecrosis of the jaw (ONJ)—defined as exposed bone for greater than 8 weeks in the maxillofacial region, absent prior radiation—were referred for further examination by an oral surgeon. Dental records were reviewed in cases where patients declined a dental exam. Pharmacy records were also reviewed for all patients.
Of those who responded, about 6,402 patients did not have any symptoms of concern. A little more than 2,000 had symptoms of concern; 1,000 of those patients were examined by a dentist.
Dr. Lo said the team had identified eight cases of ONJ so far, for a prevalence of 0.09%, or 1 in 1,100. Three were localized to the palatal torus, and one in the mandible. The remaining four had bone exposure in the mandible following extraction. The confirmed cases had variable areas of bone exposure, variable locations, and various predisposing factors, she said.
In addition, the researchers identified an additional nine patients who had ONJ-like features but did not meet the classic definition of bisphosphonate-related ONJ. Three patients had signs of osteomyelitis of the mandible; an additional four had transient exposure, and another had a small area of bone exposure that persisted up to 1 year but eventually healed after a tooth extraction. The ninth patient had spontaneous tooth loss. Five had evidence of radiographic abnormalities, said Dr. Lo.
With these additional ONJ-like cases, the prevalence increased to 0.2%. Extrapolated to the entire cohort of patients taking bisphosphonates, the prevalence was 1 in 1,729, said Dr. Lo.
The current definition of bisphosphonate-related ONJ may not cover the spectrum of jaw complications seen in patients with long-term exposure, and may underestimate ONJ's prevalence, said Dr. Lo.
Such complications include nonhealing extraction sites and osteomyelitis or osteoporosis without exposed bone. The Kaiser researchers will continue to compile dental records to come up with a more accurate estimate of prevalence, she said.
Dr. Lo disclosed no conflicts of interest related to the study.
SAN FRANCISCO — The prevalence of osteonecrosis of the jaw appears to be about 1 in 1,700 for adults taking long-term oral bisphosphonate therapy, according to an initial analysis of a group of Kaiser Permanente Northern California members.
Dr. Joan Lo surveyed 13,946 members who'd been taking oral bisphosphonates for at least 1 year and had no known exposure to intravenous bisphosphonate. The researchers received 8,568 responses to the mailed survey, which included questions about dental symptoms, said Dr. Lo, an endocrinologist at the Kaiser Permanente Division of Research, at the annual meeting of the Endocrine Society. Respondents who reported a diagnosis of osteonecrosis, or who reported exposed bone, periodontal disease, delayed bone healing, complications after invasive dental procedures, or persistent symptoms of concern were offered a dental exam by dentists on the PROBE study team. Cases of suspected osteonecrosis of the jaw (ONJ)—defined as exposed bone for greater than 8 weeks in the maxillofacial region, absent prior radiation—were referred for further examination by an oral surgeon. Dental records were reviewed in cases where patients declined a dental exam. Pharmacy records were also reviewed for all patients.
Of those who responded, about 6,402 patients did not have any symptoms of concern. A little more than 2,000 had symptoms of concern; 1,000 of those patients were examined by a dentist.
Dr. Lo said the team had identified eight cases of ONJ so far, for a prevalence of 0.09%, or 1 in 1,100. Three were localized to the palatal torus, and one in the mandible. The remaining four had bone exposure in the mandible following extraction. The confirmed cases had variable areas of bone exposure, variable locations, and various predisposing factors, she said.
In addition, the researchers identified an additional nine patients who had ONJ-like features but did not meet the classic definition of bisphosphonate-related ONJ. Three patients had signs of osteomyelitis of the mandible; an additional four had transient exposure, and another had a small area of bone exposure that persisted up to 1 year but eventually healed after a tooth extraction. The ninth patient had spontaneous tooth loss. Five had evidence of radiographic abnormalities, said Dr. Lo.
With these additional ONJ-like cases, the prevalence increased to 0.2%. Extrapolated to the entire cohort of patients taking bisphosphonates, the prevalence was 1 in 1,729, said Dr. Lo.
The current definition of bisphosphonate-related ONJ may not cover the spectrum of jaw complications seen in patients with long-term exposure, and may underestimate ONJ's prevalence, said Dr. Lo.
Such complications include nonhealing extraction sites and osteomyelitis or osteoporosis without exposed bone. The Kaiser researchers will continue to compile dental records to come up with a more accurate estimate of prevalence, she said.
Dr. Lo disclosed no conflicts of interest related to the study.
Policy & Practice
Registry Urged for CAS Reporting
Use of specialty-society-developed registries to track carotid stent procedures should be considered if Medicare expands its coverage of them, according to comments submitted to the Centers for Medicare and Medicaid Services by the Society for Vascular Surgery in June. The comments were in response to CMS' February announcement that it is considering reinstating coverage of stenting for patients who are at high risk for carotid endarterectomy because of defined anatomic factors, and who have symptomatic carotid artery stenosis of 50%-90% or greater or asymptomatic carotid artery stenosis of at least 80%. If there is national coverage, specialty society registries could be used to serve as the carotid artery stenting (CAS) outcomes reporting mechanism, said SVS. The organization also requested that the reporting requirements be extended beyond the initial hospitalization, as has been proposed. It should be extended “to at least 30 days and potentially to 12 months [because] CAS procedures have event rates documented to occur after hospital discharge,” said the SVS letter.
Ischemic Stroke Admissions Drop
Ischemic stroke hospitalizations dropped by one-third from 1997 to 2005, according to the Agency for Healthcare Research and Quality's latest “News and Numbers.” In 1997, 54 of every 10,000 Americans over age 45 years were hospitalized for ischemic stroke, but by 2005 that had dropped to 36 of every 10,000. Hemorrhagic stroke hospitalizations remained unchanged at 11 for every 10,000 Americans over age 45 years. Death rates were also higher for hemorrhagic stroke, at 25% for those hospitalized, compared with 6% for hospitalized ischemic stroke patients. The data are taken from Hospital Stays for Strokes and Other Cerebral Vascular Diseases, 2005, which uses statistics from the Nationwide Inpatient Sample.
Half of America on Drugs
Medco Health Solutions has determined that 51% of insured Americans—children and adults—were taking prescription medications for at least one chronic condition in 2007. The pharmacy benefit management company analyzed a representative sample of 2.5 million people from its database. There was a surprise: 48% of women aged 20–44 years are being treated for a chronic condition, compared with 33% of men. Antidepressants were the most common prescription for this age group, while the top therapies overall were antihypertensives and cholesterol cutters. Hormone therapy use by women aged 45–64 years declined from 30% in 2001 to 15% in 2007. The data “paint a pretty unhealthy picture of America,” Dr. Robert Epstein, Medco's chief medical officer, said in a statement. “But there is a silver lining: It does show that people are receiving treatment which can prevent more serious health problems down the road.”
MDs Don't Promote Research
Nearly 95% of Americans in a recent survey said that their physicians have never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that fewer than 10% of respondents had ever participated in such a study. Further, women were less likely than were men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. “Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them,” Sherry Marts, Ph.D., vice president of scientific affairs for the Society for Women's Health Research, said in a statement. The telephone survey included responses from 2,028 U.S. adults.
CBO Casts Doubt on IT Savings
Health information technology, when combined with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings. For example, institutions that have successfully used health IT to lower costs are generally integrated health care systems such as Kaiser Permanente. “Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm,” the CBO report said. The full report is available online at
Registry Urged for CAS Reporting
Use of specialty-society-developed registries to track carotid stent procedures should be considered if Medicare expands its coverage of them, according to comments submitted to the Centers for Medicare and Medicaid Services by the Society for Vascular Surgery in June. The comments were in response to CMS' February announcement that it is considering reinstating coverage of stenting for patients who are at high risk for carotid endarterectomy because of defined anatomic factors, and who have symptomatic carotid artery stenosis of 50%-90% or greater or asymptomatic carotid artery stenosis of at least 80%. If there is national coverage, specialty society registries could be used to serve as the carotid artery stenting (CAS) outcomes reporting mechanism, said SVS. The organization also requested that the reporting requirements be extended beyond the initial hospitalization, as has been proposed. It should be extended “to at least 30 days and potentially to 12 months [because] CAS procedures have event rates documented to occur after hospital discharge,” said the SVS letter.
Ischemic Stroke Admissions Drop
Ischemic stroke hospitalizations dropped by one-third from 1997 to 2005, according to the Agency for Healthcare Research and Quality's latest “News and Numbers.” In 1997, 54 of every 10,000 Americans over age 45 years were hospitalized for ischemic stroke, but by 2005 that had dropped to 36 of every 10,000. Hemorrhagic stroke hospitalizations remained unchanged at 11 for every 10,000 Americans over age 45 years. Death rates were also higher for hemorrhagic stroke, at 25% for those hospitalized, compared with 6% for hospitalized ischemic stroke patients. The data are taken from Hospital Stays for Strokes and Other Cerebral Vascular Diseases, 2005, which uses statistics from the Nationwide Inpatient Sample.
Half of America on Drugs
Medco Health Solutions has determined that 51% of insured Americans—children and adults—were taking prescription medications for at least one chronic condition in 2007. The pharmacy benefit management company analyzed a representative sample of 2.5 million people from its database. There was a surprise: 48% of women aged 20–44 years are being treated for a chronic condition, compared with 33% of men. Antidepressants were the most common prescription for this age group, while the top therapies overall were antihypertensives and cholesterol cutters. Hormone therapy use by women aged 45–64 years declined from 30% in 2001 to 15% in 2007. The data “paint a pretty unhealthy picture of America,” Dr. Robert Epstein, Medco's chief medical officer, said in a statement. “But there is a silver lining: It does show that people are receiving treatment which can prevent more serious health problems down the road.”
MDs Don't Promote Research
Nearly 95% of Americans in a recent survey said that their physicians have never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that fewer than 10% of respondents had ever participated in such a study. Further, women were less likely than were men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. “Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them,” Sherry Marts, Ph.D., vice president of scientific affairs for the Society for Women's Health Research, said in a statement. The telephone survey included responses from 2,028 U.S. adults.
CBO Casts Doubt on IT Savings
Health information technology, when combined with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings. For example, institutions that have successfully used health IT to lower costs are generally integrated health care systems such as Kaiser Permanente. “Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm,” the CBO report said. The full report is available online at
Registry Urged for CAS Reporting
Use of specialty-society-developed registries to track carotid stent procedures should be considered if Medicare expands its coverage of them, according to comments submitted to the Centers for Medicare and Medicaid Services by the Society for Vascular Surgery in June. The comments were in response to CMS' February announcement that it is considering reinstating coverage of stenting for patients who are at high risk for carotid endarterectomy because of defined anatomic factors, and who have symptomatic carotid artery stenosis of 50%-90% or greater or asymptomatic carotid artery stenosis of at least 80%. If there is national coverage, specialty society registries could be used to serve as the carotid artery stenting (CAS) outcomes reporting mechanism, said SVS. The organization also requested that the reporting requirements be extended beyond the initial hospitalization, as has been proposed. It should be extended “to at least 30 days and potentially to 12 months [because] CAS procedures have event rates documented to occur after hospital discharge,” said the SVS letter.
Ischemic Stroke Admissions Drop
Ischemic stroke hospitalizations dropped by one-third from 1997 to 2005, according to the Agency for Healthcare Research and Quality's latest “News and Numbers.” In 1997, 54 of every 10,000 Americans over age 45 years were hospitalized for ischemic stroke, but by 2005 that had dropped to 36 of every 10,000. Hemorrhagic stroke hospitalizations remained unchanged at 11 for every 10,000 Americans over age 45 years. Death rates were also higher for hemorrhagic stroke, at 25% for those hospitalized, compared with 6% for hospitalized ischemic stroke patients. The data are taken from Hospital Stays for Strokes and Other Cerebral Vascular Diseases, 2005, which uses statistics from the Nationwide Inpatient Sample.
Half of America on Drugs
Medco Health Solutions has determined that 51% of insured Americans—children and adults—were taking prescription medications for at least one chronic condition in 2007. The pharmacy benefit management company analyzed a representative sample of 2.5 million people from its database. There was a surprise: 48% of women aged 20–44 years are being treated for a chronic condition, compared with 33% of men. Antidepressants were the most common prescription for this age group, while the top therapies overall were antihypertensives and cholesterol cutters. Hormone therapy use by women aged 45–64 years declined from 30% in 2001 to 15% in 2007. The data “paint a pretty unhealthy picture of America,” Dr. Robert Epstein, Medco's chief medical officer, said in a statement. “But there is a silver lining: It does show that people are receiving treatment which can prevent more serious health problems down the road.”
MDs Don't Promote Research
Nearly 95% of Americans in a recent survey said that their physicians have never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that fewer than 10% of respondents had ever participated in such a study. Further, women were less likely than were men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. “Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them,” Sherry Marts, Ph.D., vice president of scientific affairs for the Society for Women's Health Research, said in a statement. The telephone survey included responses from 2,028 U.S. adults.
CBO Casts Doubt on IT Savings
Health information technology, when combined with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings. For example, institutions that have successfully used health IT to lower costs are generally integrated health care systems such as Kaiser Permanente. “Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm,” the CBO report said. The full report is available online at
Candidates' Health Plans Murky on Cost-Cutting Details
WASHINGTON — While health care has been a key issue in this year's presidential campaign, plans from both Barack Obama and John McCain are light on details when it comes to the most important aspects of the health system, including controlling costs, and improving efficiency and productivity.
The candidates have presented a wish list with very little detail on how they would accomplish the “fundamental change needed for our delivery system,” said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, at a briefing sponsored by the Alliance for Health Reform.
Economists have estimated that over the next decade, U.S. health spending will double from $2.2 trillion to $4.3 trillion. Dr. Ginsburg, along with Princeton University economist Uwe Reinhardt and former Centers for Medicare and Medicaid Services Administrator Dr. Mark McClellan, said that rising costs are largely being driven by variations in practice, growth in volume, and intensity of services.
Senator Obama has said that he favors health information technology, transparency of price, promotion of quality care, chronic care coordination, payment reforms for value, malpractice reform, and promotion of generics.
Most of these are old, but not worthless, ideas, said Dr. Reinhardt, James Madison Professor of Political Economy at Princeton.
He called Senator McCain a “true radical” for his proposal to eliminate the tax exemption for employer-provided health insurance. Individuals who purchase insurance on their own would instead receive a $2,500 tax credit; families would receive $5,000. “This is almost un-American—to take away a tax preference,” said Dr. Reinhardt.
WASHINGTON — While health care has been a key issue in this year's presidential campaign, plans from both Barack Obama and John McCain are light on details when it comes to the most important aspects of the health system, including controlling costs, and improving efficiency and productivity.
The candidates have presented a wish list with very little detail on how they would accomplish the “fundamental change needed for our delivery system,” said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, at a briefing sponsored by the Alliance for Health Reform.
Economists have estimated that over the next decade, U.S. health spending will double from $2.2 trillion to $4.3 trillion. Dr. Ginsburg, along with Princeton University economist Uwe Reinhardt and former Centers for Medicare and Medicaid Services Administrator Dr. Mark McClellan, said that rising costs are largely being driven by variations in practice, growth in volume, and intensity of services.
Senator Obama has said that he favors health information technology, transparency of price, promotion of quality care, chronic care coordination, payment reforms for value, malpractice reform, and promotion of generics.
Most of these are old, but not worthless, ideas, said Dr. Reinhardt, James Madison Professor of Political Economy at Princeton.
He called Senator McCain a “true radical” for his proposal to eliminate the tax exemption for employer-provided health insurance. Individuals who purchase insurance on their own would instead receive a $2,500 tax credit; families would receive $5,000. “This is almost un-American—to take away a tax preference,” said Dr. Reinhardt.
WASHINGTON — While health care has been a key issue in this year's presidential campaign, plans from both Barack Obama and John McCain are light on details when it comes to the most important aspects of the health system, including controlling costs, and improving efficiency and productivity.
The candidates have presented a wish list with very little detail on how they would accomplish the “fundamental change needed for our delivery system,” said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, at a briefing sponsored by the Alliance for Health Reform.
Economists have estimated that over the next decade, U.S. health spending will double from $2.2 trillion to $4.3 trillion. Dr. Ginsburg, along with Princeton University economist Uwe Reinhardt and former Centers for Medicare and Medicaid Services Administrator Dr. Mark McClellan, said that rising costs are largely being driven by variations in practice, growth in volume, and intensity of services.
Senator Obama has said that he favors health information technology, transparency of price, promotion of quality care, chronic care coordination, payment reforms for value, malpractice reform, and promotion of generics.
Most of these are old, but not worthless, ideas, said Dr. Reinhardt, James Madison Professor of Political Economy at Princeton.
He called Senator McCain a “true radical” for his proposal to eliminate the tax exemption for employer-provided health insurance. Individuals who purchase insurance on their own would instead receive a $2,500 tax credit; families would receive $5,000. “This is almost un-American—to take away a tax preference,” said Dr. Reinhardt.