Jennie Smith

The newly approved 52-mg levonorgestrel intrauterine contraceptive (LNG20) system demonstrated safety and efficacy for 3 years for a range of women, regardless of weight or parity, according to a study of 1,750 women recently published in Contraception.

In February, the Food and Drug Administration approved the new hormonal intrauterine contraceptive system, which is now being marketed in the United States as Liletta (LNG20) by the Dublin-based pharmaceutical company Actavis and the nonprofit women’s health pharmaceutical company Medicines360. The LNG20 is a flexible, plastic T-frame measuring 32 mm × 32 mm with a release rate–controlling membrane over a reservoir containing 52 mg levonorgestrel. The system is indicated to prevent pregnancy for up to 3 years.

©EduardoLuzzatti/iStockphoto.com

The newly published data include 3 years of results from the ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS). The multicenter study is ongoing and will evaluate the safety and effectiveness of the system for up to 7 years of use.

Dr. Mitchell Creinin of the University of California, Davis, and colleagues recruited 1,600 U.S. women aged 16-35 years and 151 women aged 36-45 years.

Overall, the pregnancy rate (as measured by the Pearl Index) was 0.15 (95% confidence interval, 0.02-0.55) per 100 women-years through the first year of the study. Through year 2, the Pearl Index was 0.26 (95% CI, 0.10-0.57), and 0.22 (95% CI, 0.08-0.49) through year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI, 0.24-1.23) through 3 years (Contraception 2015 [doi:10.1016/j.contraception.2015.04.006]).

The researchers reported a total of six pregnancies in the study cohort, four of which were ectopic. Four of the six pregnancies occurred in parous women.

Expulsion of the device leading to discontinuation occurred in 3.5% of women (n = 62), mostly in the first year of use and more frequently among subjects who had previously given birth. Other adverse effects leading to discontinuation of use included bleeding, acne, and mood swings.

Symptomatic ovarian cysts developed in 3.4% of the cohort, though only five patients discontinued for this reason. Pelvic infection (including endometriosis) occurred in 10 women, with seven cases of pelvic inflammatory disease and three cases of endometritis.

Of the 68 women followed for fertility outcomes after discontinuing the device, 70.6% conceived spontaneously within 6 months and 86.8% within a year, with a median time to conception of 4 months.

Based on the safety and effectiveness findings, the researchers concluded that the LNG20 system meets the criteria defined by the Centers for Disease Control and Prevention and the World Health Organization for highly effective contraceptive methods.

The study, conducted exclusively in the United States, is notable because a quarter of the cohort had a body mass index of 30 or greater, with 5% of study participants having a BMI of 40 or greater; nearly 60% of the study participants were nulliparous.

It was conducted at 29 sites including public, private, and university clinics and enrolled 13.3% African American, 14.7% Hispanic, and 78.4% white subjects, in keeping with the expected racial, age, and weight characteristics of women likely to use this method of contraception, the researchers noted.

The study enrolled “a substantial number of nulliparous participants, representing 57.7% of the study efficacy population,” the researchers wrote. “This number was not a result of targeted recruitment and thus may represent the interest of nulliparous U.S. women in using highly effective contraceptives such as an IUS.”

Despite the high number of nulliparous subjects, 98.7% of placement attempts were successful.

Although IUDs have been available in the United States for decades, adoption remains low, with less than 8% of U.S. women using them as their preferred method of contraception. The new contraceptive system “will address some of the barriers that have previously limited full access to intrauterine contraceptives,” the researchers wrote.

The study was sponsored by Medicines360. The researchers reported having no financial disclosures.

The newly approved 52-mg levonorgestrel intrauterine contraceptive (LNG20) system demonstrated safety and efficacy for 3 years for a range of women, regardless of weight or parity, according to a study of 1,750 women recently published in Contraception.

In February, the Food and Drug Administration approved the new hormonal intrauterine contraceptive system, which is now being marketed in the United States as Liletta (LNG20) by the Dublin-based pharmaceutical company Actavis and the nonprofit women’s health pharmaceutical company Medicines360. The LNG20 is a flexible, plastic T-frame measuring 32 mm × 32 mm with a release rate–controlling membrane over a reservoir containing 52 mg levonorgestrel. The system is indicated to prevent pregnancy for up to 3 years.

©EduardoLuzzatti/iStockphoto.com

The newly published data include 3 years of results from the ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS). The multicenter study is ongoing and will evaluate the safety and effectiveness of the system for up to 7 years of use.

Dr. Mitchell Creinin of the University of California, Davis, and colleagues recruited 1,600 U.S. women aged 16-35 years and 151 women aged 36-45 years.

Overall, the pregnancy rate (as measured by the Pearl Index) was 0.15 (95% confidence interval, 0.02-0.55) per 100 women-years through the first year of the study. Through year 2, the Pearl Index was 0.26 (95% CI, 0.10-0.57), and 0.22 (95% CI, 0.08-0.49) through year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI, 0.24-1.23) through 3 years (Contraception 2015 [doi:10.1016/j.contraception.2015.04.006]).

The researchers reported a total of six pregnancies in the study cohort, four of which were ectopic. Four of the six pregnancies occurred in parous women.

Expulsion of the device leading to discontinuation occurred in 3.5% of women (n = 62), mostly in the first year of use and more frequently among subjects who had previously given birth. Other adverse effects leading to discontinuation of use included bleeding, acne, and mood swings.

Symptomatic ovarian cysts developed in 3.4% of the cohort, though only five patients discontinued for this reason. Pelvic infection (including endometriosis) occurred in 10 women, with seven cases of pelvic inflammatory disease and three cases of endometritis.

Of the 68 women followed for fertility outcomes after discontinuing the device, 70.6% conceived spontaneously within 6 months and 86.8% within a year, with a median time to conception of 4 months.

Based on the safety and effectiveness findings, the researchers concluded that the LNG20 system meets the criteria defined by the Centers for Disease Control and Prevention and the World Health Organization for highly effective contraceptive methods.

The study, conducted exclusively in the United States, is notable because a quarter of the cohort had a body mass index of 30 or greater, with 5% of study participants having a BMI of 40 or greater; nearly 60% of the study participants were nulliparous.

It was conducted at 29 sites including public, private, and university clinics and enrolled 13.3% African American, 14.7% Hispanic, and 78.4% white subjects, in keeping with the expected racial, age, and weight characteristics of women likely to use this method of contraception, the researchers noted.

The study enrolled “a substantial number of nulliparous participants, representing 57.7% of the study efficacy population,” the researchers wrote. “This number was not a result of targeted recruitment and thus may represent the interest of nulliparous U.S. women in using highly effective contraceptives such as an IUS.”

Despite the high number of nulliparous subjects, 98.7% of placement attempts were successful.

Although IUDs have been available in the United States for decades, adoption remains low, with less than 8% of U.S. women using them as their preferred method of contraception. The new contraceptive system “will address some of the barriers that have previously limited full access to intrauterine contraceptives,” the researchers wrote.

The study was sponsored by Medicines360. The researchers reported having no financial disclosures.

The newly approved 52-mg levonorgestrel intrauterine contraceptive (LNG20) system demonstrated safety and efficacy for 3 years for a range of women, regardless of weight or parity, according to a study of 1,750 women recently published in Contraception.

In February, the Food and Drug Administration approved the new hormonal intrauterine contraceptive system, which is now being marketed in the United States as Liletta (LNG20) by the Dublin-based pharmaceutical company Actavis and the nonprofit women’s health pharmaceutical company Medicines360. The LNG20 is a flexible, plastic T-frame measuring 32 mm × 32 mm with a release rate–controlling membrane over a reservoir containing 52 mg levonorgestrel. The system is indicated to prevent pregnancy for up to 3 years.

©EduardoLuzzatti/iStockphoto.com

The newly published data include 3 years of results from the ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS). The multicenter study is ongoing and will evaluate the safety and effectiveness of the system for up to 7 years of use.

Dr. Mitchell Creinin of the University of California, Davis, and colleagues recruited 1,600 U.S. women aged 16-35 years and 151 women aged 36-45 years.

Overall, the pregnancy rate (as measured by the Pearl Index) was 0.15 (95% confidence interval, 0.02-0.55) per 100 women-years through the first year of the study. Through year 2, the Pearl Index was 0.26 (95% CI, 0.10-0.57), and 0.22 (95% CI, 0.08-0.49) through year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI, 0.24-1.23) through 3 years (Contraception 2015 [doi:10.1016/j.contraception.2015.04.006]).

The researchers reported a total of six pregnancies in the study cohort, four of which were ectopic. Four of the six pregnancies occurred in parous women.

Expulsion of the device leading to discontinuation occurred in 3.5% of women (n = 62), mostly in the first year of use and more frequently among subjects who had previously given birth. Other adverse effects leading to discontinuation of use included bleeding, acne, and mood swings.

Symptomatic ovarian cysts developed in 3.4% of the cohort, though only five patients discontinued for this reason. Pelvic infection (including endometriosis) occurred in 10 women, with seven cases of pelvic inflammatory disease and three cases of endometritis.

Of the 68 women followed for fertility outcomes after discontinuing the device, 70.6% conceived spontaneously within 6 months and 86.8% within a year, with a median time to conception of 4 months.

Based on the safety and effectiveness findings, the researchers concluded that the LNG20 system meets the criteria defined by the Centers for Disease Control and Prevention and the World Health Organization for highly effective contraceptive methods.

The study, conducted exclusively in the United States, is notable because a quarter of the cohort had a body mass index of 30 or greater, with 5% of study participants having a BMI of 40 or greater; nearly 60% of the study participants were nulliparous.

It was conducted at 29 sites including public, private, and university clinics and enrolled 13.3% African American, 14.7% Hispanic, and 78.4% white subjects, in keeping with the expected racial, age, and weight characteristics of women likely to use this method of contraception, the researchers noted.

The study enrolled “a substantial number of nulliparous participants, representing 57.7% of the study efficacy population,” the researchers wrote. “This number was not a result of targeted recruitment and thus may represent the interest of nulliparous U.S. women in using highly effective contraceptives such as an IUS.”

Despite the high number of nulliparous subjects, 98.7% of placement attempts were successful.

Although IUDs have been available in the United States for decades, adoption remains low, with less than 8% of U.S. women using them as their preferred method of contraception. The new contraceptive system “will address some of the barriers that have previously limited full access to intrauterine contraceptives,” the researchers wrote.

The study was sponsored by Medicines360. The researchers reported having no financial disclosures.

Cost increases at Medicare’s Pioneer accountable care organizations were $385 million less than those of traditional fee-for-service Medicare in their first 2 years, without compromising patient satisfaction, a new study showed.

The Centers for Medicare & Medicaid Services launched the Pioneer ACOs in 2012 to control cost increases associated with a standard fee-for-service system that tends to favor better-compensated services.

Pioneer ACOs – which comprise established health care organizations opting to participate – also receive fee-for-service (FFS) payments, but they are encouraged to keep costs within limits by sharing both savings and risk if actual costs are lower or higher than projected. The goal is to encourage providers to direct more resources to services that may be less lucrative but are associated with better patient outcomes and patient experiences.

Research published online May 4 in JAMA (doi:10.1001/jama.2015.4930) compared spending for two populations of Medicare beneficiaries in 2012 and 2013: one associated with one of 32 Pioneer ACOs, and a larger group under standard FFS Medicare in the same markets, according to David J. Nyweide, Ph.D., of the Centers for Medicare & Medicaid Services, Baltimore, and his associates.

For 2012, the investigators found that cost increases were $35.62 lower per beneficiary per month for the Pioneer ACO patients, compared with patients living in the same markets but not affiliated with a Pioneer ACO – a total difference in 2012 of about $280 million overall.

In the second year of the study, 2013, the difference in costs increases dropped by two-thirds, to $11.18 per ACO beneficiary per month – about $105 million less in cost increases incurred by the Pioneer ACOs.

About half of the savings, Dr. Nyweide and his associates reported, came from smaller increases in inpatient care spending among the Pioneer-aligned Medicare patients ($14.40 less per patient per month in 2012 and $6.46 less in 2013), compared with FFS patients. There were, however, also differences in physician services ($8.29 less per ACO patient per month in 2012 and $2.69 less in 2013), along with smaller savings in tests, procedures, and imaging, compared with non–Pioneer-aligned Medicare beneficiaries.

Performance for Pioneer ACO populations was shown to be better in terms of patient-reported timely care and clinician communication, the investigators found. ACO performance was comparable to traditional fee-for-service and Medicare Advantage programs in ease of getting care and access to specialists.

Dr. Nyweide and his colleagues surmised that decreases in spending growth may have been greater in the first year as the ACOs focused first on management of high-cost patients, savings that may have been harder to sustain the following year. Physician turnover may have contributed to the lower savings seen in 2013, they acknowledged.

In addition, “since beneficiaries in the comparison group could still receive care from ACO-affiliated physicians, the practice patterns of those physicians may have affected the care of other Medicare patients,” more closely aligning costs between the study arms, the investigators wrote.

Although the results were encouraging, savings generated by ACOs “will have little effect on U.S. health care” unless a large number of ACOs enter the program, Dr. Lawrence P. Casalino of Cornell University, New York, noted in an editorial accompanying the study (JAMA 2015 May 4 [doi:10.1001/jama.2015.5086]).

Of the 32 original Pioneer ACOs, however, 13 have left the program, he noted, adding that many have opted to participate instead in the Medicare Shared Savings Program, which does not come with either the higher level of reward for keeping costs down or the risk of the Pioneer ACOs.

Medicare will have to create stronger incentives for ACOs, Dr. Casalino argued, which should be rewarded “not only for improving their own performance – a difficult task, year after year, for ACOs that already perform well – but also for improving compared with their region and with the nation as a whole.” And Medicare patients will require stronger incentives, such as waived copays, to keep their care within the ACO.

The new evidence “moves the effects of ACOs from speculation to reality and highlights the importance of further evaluation as alternative payment models are refined,” wrote Dr. Mark McClellan of the Brookings Institution, Washington, in a separate editorial (JAMA 2015 May 4 [doi:10.1001/jama.2015.5087]). “Payment reform moving away from FFS is now part of the policy landscape, but the exact form it will take is less clear. Evaluations like this, derived from actual payment reforms, can provide more clarity.”

Nonetheless, “these early results may be viewed as modest,” cautioned Dr. McClellan, former administrator of the Centers for Medicare & Medicaid Services. “The smaller increase in spending amounted to 4% in year 1 and less than 1.5% in year 2. The estimates do not account for the shared-savings payments to the ACOs, which totaled $77 million in 2012. Nor do they account for the investments of time and money made by the health care organizations.”

The Centers for Medicare & Medicaid Services funded the study. Dr. Nyweide and his colleagues reported no conflicts of interest related to the study. Dr. Casalino reported receiving advisory fees on health care delivery and payment from the American Medical Association, part-time employment as an advisor to the Agency for Healthcare Research and Quality, and serving as coinvestigator and coauthor on articles with Dr. Nyweide not related to ACOs. Dr. McClellan disclosed no conflicts of interest.

Cost increases at Medicare’s Pioneer accountable care organizations were $385 million less than those of traditional fee-for-service Medicare in their first 2 years, without compromising patient satisfaction, a new study showed.

The Centers for Medicare & Medicaid Services launched the Pioneer ACOs in 2012 to control cost increases associated with a standard fee-for-service system that tends to favor better-compensated services.

Pioneer ACOs – which comprise established health care organizations opting to participate – also receive fee-for-service (FFS) payments, but they are encouraged to keep costs within limits by sharing both savings and risk if actual costs are lower or higher than projected. The goal is to encourage providers to direct more resources to services that may be less lucrative but are associated with better patient outcomes and patient experiences.

Research published online May 4 in JAMA (doi:10.1001/jama.2015.4930) compared spending for two populations of Medicare beneficiaries in 2012 and 2013: one associated with one of 32 Pioneer ACOs, and a larger group under standard FFS Medicare in the same markets, according to David J. Nyweide, Ph.D., of the Centers for Medicare & Medicaid Services, Baltimore, and his associates.

For 2012, the investigators found that cost increases were $35.62 lower per beneficiary per month for the Pioneer ACO patients, compared with patients living in the same markets but not affiliated with a Pioneer ACO – a total difference in 2012 of about $280 million overall.

In the second year of the study, 2013, the difference in costs increases dropped by two-thirds, to $11.18 per ACO beneficiary per month – about $105 million less in cost increases incurred by the Pioneer ACOs.

About half of the savings, Dr. Nyweide and his associates reported, came from smaller increases in inpatient care spending among the Pioneer-aligned Medicare patients ($14.40 less per patient per month in 2012 and $6.46 less in 2013), compared with FFS patients. There were, however, also differences in physician services ($8.29 less per ACO patient per month in 2012 and $2.69 less in 2013), along with smaller savings in tests, procedures, and imaging, compared with non–Pioneer-aligned Medicare beneficiaries.

Performance for Pioneer ACO populations was shown to be better in terms of patient-reported timely care and clinician communication, the investigators found. ACO performance was comparable to traditional fee-for-service and Medicare Advantage programs in ease of getting care and access to specialists.

Dr. Nyweide and his colleagues surmised that decreases in spending growth may have been greater in the first year as the ACOs focused first on management of high-cost patients, savings that may have been harder to sustain the following year. Physician turnover may have contributed to the lower savings seen in 2013, they acknowledged.

In addition, “since beneficiaries in the comparison group could still receive care from ACO-affiliated physicians, the practice patterns of those physicians may have affected the care of other Medicare patients,” more closely aligning costs between the study arms, the investigators wrote.

Although the results were encouraging, savings generated by ACOs “will have little effect on U.S. health care” unless a large number of ACOs enter the program, Dr. Lawrence P. Casalino of Cornell University, New York, noted in an editorial accompanying the study (JAMA 2015 May 4 [doi:10.1001/jama.2015.5086]).

Of the 32 original Pioneer ACOs, however, 13 have left the program, he noted, adding that many have opted to participate instead in the Medicare Shared Savings Program, which does not come with either the higher level of reward for keeping costs down or the risk of the Pioneer ACOs.

Medicare will have to create stronger incentives for ACOs, Dr. Casalino argued, which should be rewarded “not only for improving their own performance – a difficult task, year after year, for ACOs that already perform well – but also for improving compared with their region and with the nation as a whole.” And Medicare patients will require stronger incentives, such as waived copays, to keep their care within the ACO.

The new evidence “moves the effects of ACOs from speculation to reality and highlights the importance of further evaluation as alternative payment models are refined,” wrote Dr. Mark McClellan of the Brookings Institution, Washington, in a separate editorial (JAMA 2015 May 4 [doi:10.1001/jama.2015.5087]). “Payment reform moving away from FFS is now part of the policy landscape, but the exact form it will take is less clear. Evaluations like this, derived from actual payment reforms, can provide more clarity.”

Nonetheless, “these early results may be viewed as modest,” cautioned Dr. McClellan, former administrator of the Centers for Medicare & Medicaid Services. “The smaller increase in spending amounted to 4% in year 1 and less than 1.5% in year 2. The estimates do not account for the shared-savings payments to the ACOs, which totaled $77 million in 2012. Nor do they account for the investments of time and money made by the health care organizations.”

The Centers for Medicare & Medicaid Services funded the study. Dr. Nyweide and his colleagues reported no conflicts of interest related to the study. Dr. Casalino reported receiving advisory fees on health care delivery and payment from the American Medical Association, part-time employment as an advisor to the Agency for Healthcare Research and Quality, and serving as coinvestigator and coauthor on articles with Dr. Nyweide not related to ACOs. Dr. McClellan disclosed no conflicts of interest.

Cost increases at Medicare’s Pioneer accountable care organizations were $385 million less than those of traditional fee-for-service Medicare in their first 2 years, without compromising patient satisfaction, a new study showed.

The Centers for Medicare & Medicaid Services launched the Pioneer ACOs in 2012 to control cost increases associated with a standard fee-for-service system that tends to favor better-compensated services.

Pioneer ACOs – which comprise established health care organizations opting to participate – also receive fee-for-service (FFS) payments, but they are encouraged to keep costs within limits by sharing both savings and risk if actual costs are lower or higher than projected. The goal is to encourage providers to direct more resources to services that may be less lucrative but are associated with better patient outcomes and patient experiences.

Research published online May 4 in JAMA (doi:10.1001/jama.2015.4930) compared spending for two populations of Medicare beneficiaries in 2012 and 2013: one associated with one of 32 Pioneer ACOs, and a larger group under standard FFS Medicare in the same markets, according to David J. Nyweide, Ph.D., of the Centers for Medicare & Medicaid Services, Baltimore, and his associates.

For 2012, the investigators found that cost increases were $35.62 lower per beneficiary per month for the Pioneer ACO patients, compared with patients living in the same markets but not affiliated with a Pioneer ACO – a total difference in 2012 of about $280 million overall.

In the second year of the study, 2013, the difference in costs increases dropped by two-thirds, to $11.18 per ACO beneficiary per month – about $105 million less in cost increases incurred by the Pioneer ACOs.

About half of the savings, Dr. Nyweide and his associates reported, came from smaller increases in inpatient care spending among the Pioneer-aligned Medicare patients ($14.40 less per patient per month in 2012 and $6.46 less in 2013), compared with FFS patients. There were, however, also differences in physician services ($8.29 less per ACO patient per month in 2012 and $2.69 less in 2013), along with smaller savings in tests, procedures, and imaging, compared with non–Pioneer-aligned Medicare beneficiaries.

Performance for Pioneer ACO populations was shown to be better in terms of patient-reported timely care and clinician communication, the investigators found. ACO performance was comparable to traditional fee-for-service and Medicare Advantage programs in ease of getting care and access to specialists.

Dr. Nyweide and his colleagues surmised that decreases in spending growth may have been greater in the first year as the ACOs focused first on management of high-cost patients, savings that may have been harder to sustain the following year. Physician turnover may have contributed to the lower savings seen in 2013, they acknowledged.

In addition, “since beneficiaries in the comparison group could still receive care from ACO-affiliated physicians, the practice patterns of those physicians may have affected the care of other Medicare patients,” more closely aligning costs between the study arms, the investigators wrote.

Although the results were encouraging, savings generated by ACOs “will have little effect on U.S. health care” unless a large number of ACOs enter the program, Dr. Lawrence P. Casalino of Cornell University, New York, noted in an editorial accompanying the study (JAMA 2015 May 4 [doi:10.1001/jama.2015.5086]).

Of the 32 original Pioneer ACOs, however, 13 have left the program, he noted, adding that many have opted to participate instead in the Medicare Shared Savings Program, which does not come with either the higher level of reward for keeping costs down or the risk of the Pioneer ACOs.

Medicare will have to create stronger incentives for ACOs, Dr. Casalino argued, which should be rewarded “not only for improving their own performance – a difficult task, year after year, for ACOs that already perform well – but also for improving compared with their region and with the nation as a whole.” And Medicare patients will require stronger incentives, such as waived copays, to keep their care within the ACO.

The new evidence “moves the effects of ACOs from speculation to reality and highlights the importance of further evaluation as alternative payment models are refined,” wrote Dr. Mark McClellan of the Brookings Institution, Washington, in a separate editorial (JAMA 2015 May 4 [doi:10.1001/jama.2015.5087]). “Payment reform moving away from FFS is now part of the policy landscape, but the exact form it will take is less clear. Evaluations like this, derived from actual payment reforms, can provide more clarity.”

Nonetheless, “these early results may be viewed as modest,” cautioned Dr. McClellan, former administrator of the Centers for Medicare & Medicaid Services. “The smaller increase in spending amounted to 4% in year 1 and less than 1.5% in year 2. The estimates do not account for the shared-savings payments to the ACOs, which totaled $77 million in 2012. Nor do they account for the investments of time and money made by the health care organizations.”

The Centers for Medicare & Medicaid Services funded the study. Dr. Nyweide and his colleagues reported no conflicts of interest related to the study. Dr. Casalino reported receiving advisory fees on health care delivery and payment from the American Medical Association, part-time employment as an advisor to the Agency for Healthcare Research and Quality, and serving as coinvestigator and coauthor on articles with Dr. Nyweide not related to ACOs. Dr. McClellan disclosed no conflicts of interest.

The coapplication of two topical creams, one containing 6% sodium nitrite and another containing 9% citric acid, together producing nitric oxide, was effective in treating genital warts in close to one-third of patients, in a study published online April 29 in JAMA Dermatology.

In a randomized, placebo-controlled trial, 31% of patients treated with the nitric oxide topical treatment had complete clinical clearance within 12 weeks, compared to 14% of those assigned to placebo (P = .01), Dr. Anthony D. Ormerod of the University of Aberdeen, Scotland, and associates reported (JAMA Derm. 2015 April 29 [doi:10.1001/jamadermatol.2015.0381]).

Researchers randomized 299 patients (64% men) from 40 treatment centers across Europe to one of three dose regimens of sodium nitrite and citric acid, or placebo. Sodium nitrite reacts with citric acid to produce nitric oxide, which acts as an antiviral and antimicrobial; for the study, patients applied two separately prepared creams, allowing the agents to combine at the treatment site. Only the highest-dose combination studied, sodium nitrite 6% and citric acid 9% applied twice daily, was shown to be significantly more effective than placebo.

Patients receiving the highest dose also saw the highest rate of adverse effects in the study: Of the 73 patients in that arm, 92% reported treatment site adverse events, including itching, pain, edema and skin staining. “This study proves the concept that acidified nitrite is effective in treating anogenital warts and has identified the dose required for efficacy,” Dr. Ormerod and associates wrote. “For the sensitive anogenital application site, this dose probably represents the optimal one for further evaluation. For future research, extending the duration of treatment might improve the efficacy,” they said.

The researchers noted that studies of another agent used to treat genital warts, imiquimod, demonstrated clearance rates of between 37% and 52%.

The study was funded by the pharmaceutical manufacturer ProStrakan, with additional support from Origin Pharmaceuticals. Dr. Ormerod reported honoraria and royalties from ProStrakan and disclosed patents filed on acidified nitrite for treatment of skin infections. Four other co-authors reported support from ProStrakan.

The coapplication of two topical creams, one containing 6% sodium nitrite and another containing 9% citric acid, together producing nitric oxide, was effective in treating genital warts in close to one-third of patients, in a study published online April 29 in JAMA Dermatology.

In a randomized, placebo-controlled trial, 31% of patients treated with the nitric oxide topical treatment had complete clinical clearance within 12 weeks, compared to 14% of those assigned to placebo (P = .01), Dr. Anthony D. Ormerod of the University of Aberdeen, Scotland, and associates reported (JAMA Derm. 2015 April 29 [doi:10.1001/jamadermatol.2015.0381]).

Researchers randomized 299 patients (64% men) from 40 treatment centers across Europe to one of three dose regimens of sodium nitrite and citric acid, or placebo. Sodium nitrite reacts with citric acid to produce nitric oxide, which acts as an antiviral and antimicrobial; for the study, patients applied two separately prepared creams, allowing the agents to combine at the treatment site. Only the highest-dose combination studied, sodium nitrite 6% and citric acid 9% applied twice daily, was shown to be significantly more effective than placebo.

Patients receiving the highest dose also saw the highest rate of adverse effects in the study: Of the 73 patients in that arm, 92% reported treatment site adverse events, including itching, pain, edema and skin staining. “This study proves the concept that acidified nitrite is effective in treating anogenital warts and has identified the dose required for efficacy,” Dr. Ormerod and associates wrote. “For the sensitive anogenital application site, this dose probably represents the optimal one for further evaluation. For future research, extending the duration of treatment might improve the efficacy,” they said.

The researchers noted that studies of another agent used to treat genital warts, imiquimod, demonstrated clearance rates of between 37% and 52%.

The study was funded by the pharmaceutical manufacturer ProStrakan, with additional support from Origin Pharmaceuticals. Dr. Ormerod reported honoraria and royalties from ProStrakan and disclosed patents filed on acidified nitrite for treatment of skin infections. Four other co-authors reported support from ProStrakan.

The coapplication of two topical creams, one containing 6% sodium nitrite and another containing 9% citric acid, together producing nitric oxide, was effective in treating genital warts in close to one-third of patients, in a study published online April 29 in JAMA Dermatology.

In a randomized, placebo-controlled trial, 31% of patients treated with the nitric oxide topical treatment had complete clinical clearance within 12 weeks, compared to 14% of those assigned to placebo (P = .01), Dr. Anthony D. Ormerod of the University of Aberdeen, Scotland, and associates reported (JAMA Derm. 2015 April 29 [doi:10.1001/jamadermatol.2015.0381]).

Researchers randomized 299 patients (64% men) from 40 treatment centers across Europe to one of three dose regimens of sodium nitrite and citric acid, or placebo. Sodium nitrite reacts with citric acid to produce nitric oxide, which acts as an antiviral and antimicrobial; for the study, patients applied two separately prepared creams, allowing the agents to combine at the treatment site. Only the highest-dose combination studied, sodium nitrite 6% and citric acid 9% applied twice daily, was shown to be significantly more effective than placebo.

Patients receiving the highest dose also saw the highest rate of adverse effects in the study: Of the 73 patients in that arm, 92% reported treatment site adverse events, including itching, pain, edema and skin staining. “This study proves the concept that acidified nitrite is effective in treating anogenital warts and has identified the dose required for efficacy,” Dr. Ormerod and associates wrote. “For the sensitive anogenital application site, this dose probably represents the optimal one for further evaluation. For future research, extending the duration of treatment might improve the efficacy,” they said.

The researchers noted that studies of another agent used to treat genital warts, imiquimod, demonstrated clearance rates of between 37% and 52%.

The study was funded by the pharmaceutical manufacturer ProStrakan, with additional support from Origin Pharmaceuticals. Dr. Ormerod reported honoraria and royalties from ProStrakan and disclosed patents filed on acidified nitrite for treatment of skin infections. Four other co-authors reported support from ProStrakan.

The coapplication of two topical creams, one containing 6% sodium nitrite and another containing 9% citric acid, together producing nitric oxide, was effective in treating genital warts in close to one-third of patients, in a study published online April 29 in JAMA Dermatology.

In a randomized, placebo-controlled trial, 31% of patients treated with the nitric oxide topical treatment had complete clinical clearance within 12 weeks, compared to 14% of those assigned to placebo (P = .01), Dr. Anthony D. Ormerod of the University of Aberdeen, Scotland, and associates reported (JAMA Derm. 2015 April 29 [doi:10.1001/jamadermatol.2015.0381]).

Researchers randomized 299 patients (64% men) from 40 treatment centers across Europe to one of three dose regimens of sodium nitrite and citric acid, or placebo. Sodium nitrite reacts with citric acid to produce nitric oxide, which acts as an antiviral and antimicrobial; for the study, patients applied two separately prepared creams, allowing the agents to combine at the treatment site. Only the highest-dose combination studied, sodium nitrite 6% and citric acid 9% applied twice daily, was shown to be significantly more effective than placebo.

Patients receiving the highest dose also saw the highest rate of adverse effects in the study: Of the 73 patients in that arm, 92% reported treatment site adverse events, including itching, pain, edema and skin staining. “This study proves the concept that acidified nitrite is effective in treating anogenital warts and has identified the dose required for efficacy,” Dr. Ormerod and associates wrote. “For the sensitive anogenital application site, this dose probably represents the optimal one for further evaluation. For future research, extending the duration of treatment might improve the efficacy,” they said.

The researchers noted that studies of another agent used to treat genital warts, imiquimod, demonstrated clearance rates of between 37% and 52%.

The study was funded by the pharmaceutical manufacturer ProStrakan, with additional support from Origin Pharmaceuticals. Dr. Ormerod reported honoraria and royalties from ProStrakan and disclosed patents filed on acidified nitrite for treatment of skin infections. Four other co-authors reported support from ProStrakan.

The coapplication of two topical creams, one containing 6% sodium nitrite and another containing 9% citric acid, together producing nitric oxide, was effective in treating genital warts in close to one-third of patients, in a study published online April 29 in JAMA Dermatology.

In a randomized, placebo-controlled trial, 31% of patients treated with the nitric oxide topical treatment had complete clinical clearance within 12 weeks, compared to 14% of those assigned to placebo (P = .01), Dr. Anthony D. Ormerod of the University of Aberdeen, Scotland, and associates reported (JAMA Derm. 2015 April 29 [doi:10.1001/jamadermatol.2015.0381]).

Researchers randomized 299 patients (64% men) from 40 treatment centers across Europe to one of three dose regimens of sodium nitrite and citric acid, or placebo. Sodium nitrite reacts with citric acid to produce nitric oxide, which acts as an antiviral and antimicrobial; for the study, patients applied two separately prepared creams, allowing the agents to combine at the treatment site. Only the highest-dose combination studied, sodium nitrite 6% and citric acid 9% applied twice daily, was shown to be significantly more effective than placebo.

Patients receiving the highest dose also saw the highest rate of adverse effects in the study: Of the 73 patients in that arm, 92% reported treatment site adverse events, including itching, pain, edema and skin staining. “This study proves the concept that acidified nitrite is effective in treating anogenital warts and has identified the dose required for efficacy,” Dr. Ormerod and associates wrote. “For the sensitive anogenital application site, this dose probably represents the optimal one for further evaluation. For future research, extending the duration of treatment might improve the efficacy,” they said.

The researchers noted that studies of another agent used to treat genital warts, imiquimod, demonstrated clearance rates of between 37% and 52%.

The study was funded by the pharmaceutical manufacturer ProStrakan, with additional support from Origin Pharmaceuticals. Dr. Ormerod reported honoraria and royalties from ProStrakan and disclosed patents filed on acidified nitrite for treatment of skin infections. Four other co-authors reported support from ProStrakan.

The coapplication of two topical creams, one containing 6% sodium nitrite and another containing 9% citric acid, together producing nitric oxide, was effective in treating genital warts in close to one-third of patients, in a study published online April 29 in JAMA Dermatology.

In a randomized, placebo-controlled trial, 31% of patients treated with the nitric oxide topical treatment had complete clinical clearance within 12 weeks, compared to 14% of those assigned to placebo (P = .01), Dr. Anthony D. Ormerod of the University of Aberdeen, Scotland, and associates reported (JAMA Derm. 2015 April 29 [doi:10.1001/jamadermatol.2015.0381]).

Researchers randomized 299 patients (64% men) from 40 treatment centers across Europe to one of three dose regimens of sodium nitrite and citric acid, or placebo. Sodium nitrite reacts with citric acid to produce nitric oxide, which acts as an antiviral and antimicrobial; for the study, patients applied two separately prepared creams, allowing the agents to combine at the treatment site. Only the highest-dose combination studied, sodium nitrite 6% and citric acid 9% applied twice daily, was shown to be significantly more effective than placebo.

Patients receiving the highest dose also saw the highest rate of adverse effects in the study: Of the 73 patients in that arm, 92% reported treatment site adverse events, including itching, pain, edema and skin staining. “This study proves the concept that acidified nitrite is effective in treating anogenital warts and has identified the dose required for efficacy,” Dr. Ormerod and associates wrote. “For the sensitive anogenital application site, this dose probably represents the optimal one for further evaluation. For future research, extending the duration of treatment might improve the efficacy,” they said.

The researchers noted that studies of another agent used to treat genital warts, imiquimod, demonstrated clearance rates of between 37% and 52%.

The study was funded by the pharmaceutical manufacturer ProStrakan, with additional support from Origin Pharmaceuticals. Dr. Ormerod reported honoraria and royalties from ProStrakan and disclosed patents filed on acidified nitrite for treatment of skin infections. Four other co-authors reported support from ProStrakan.

Psychiatrists in direct-pay practices, in which patients must seek their own reimbursement if it is available, say the high quality of care they offer continues to bring patients through their doors from all ends of the economic spectrum.

Just 55% of U.S. psychiatrists accepted any form of insurance during 2009-2010, while nearly 90% of physicians in other specialties did during that period (JAMA Psychiatry 2014;71:176-81). Psychiatrists in cash practices say this is in part because the field is not as good a fit for managed care as other specialties are.

It is also, they say, because certain subspecialties such as addiction treatment are locked into reimbursement models that are rigid and dated; and because clinicians would rather spend time with their patients than on coding and paperwork, even if it means collecting less money or having to offer discounts to patients who find themselves in a tough spot.

“This is about value. And people will pay the money if they feel the value,” said Dr. Mark L. Willenbring of Alltyr clinic in St. Paul, Minn., a cash practice he founded.

Patient advocates are concerned that cash practices create further impediments to access in a mental health care system, that – parity laws and sweeping insurance reforms aside – still suffers from a shortage of providers and high rates of insurance denials for mental health and substance use treatment.

“We can certainly empathize with the rationale for providers doing only direct pay; we just wish it were not so,” said Sita Diehl, director of state policy and advocacy for the Arlington, Va.–based National Alliance on Mental Illness. NAMI’s recent report on parity in mental health care, titled “A Long Road Ahead,” found the dearth of providers accepting insurance to be among the persistent obstacles to access.

A novel addiction model

Dr. Willenbring, a former director of addiction and recovery research at the National Institutes of Health, said his move to a direct-pay clinic came about as a result of what he considered a lack of science-based addiction medicine.

“Research in addictions is astonishing, and there’s lots more we know about the disorders than 50 years ago, but a lot of it sits on the shelf because we don’t have the vehicle to get it to the public,” he said. His Alltyr clinic, now in its third year, began as a demonstration model combining outpatient medical management and psychotherapy to people with alcohol and substance use disorders at varying stages of severity.

“Insurance companies have boxes they want to put you in. They have a box for substance use treatment that says ‘rehab.’ And they have a box for a mental health clinic. But what I’m doing is neither. And I’m a subspecialist; I don’t want to be paid the same as they guy down the street doing 5-minute med checks. Finally, with insurance, I couldn’t do what I want to do. I couldn’t experiment.”

Dr. Willenbring said direct pay has allowed him to build an addiction treatment model that is an alternative to traditional rehabilitation. “What’s the treatment for bipolar disorder? You put the patient through ‘the program’? No, you try one thing, and if it doesn’t work you try something else. And you don’t blame the patient if it doesn’t work.”

Direct pay helps keep his costs to patients and bureaucracy to a minimum, he said. He charges $495 for a 90-minute initial evaluation, with fees between $95 for 45 minutes with a licensed addiction counselor to $300 with a psychiatrist. “You have to remember: Many of our patients have spent tens of thousands of dollars before coming here,” usually on rehab, he said. Most spend between $2,000 and $3,000 a year at the clinic, less than the $5,000 annual cash outlay required by many high-deductible insurance plans.

Also, he said, “I negotiate with patients. I ask what they can afford. I’m seeing one patient for $50 a visit because that’s what they can pay.”

The Alltyr clinic collects outcome data that helps him to better understand which approaches are working, he said. “My goal is to demonstrate that we can have better outcomes and far better patient satisfaction at substantially less cost than current treatment,” and direct pay is making the effort possible, for now, Dr. Willenbring said.

On an absolute level, his practice is not more costly than under a managed-care model, he added. “I also work part time for one of the large health organizations in a half-day clinic. They take all insurance, but if patients have to pay cash they pay more there than in my clinic.”

Dr. Willenbring said he hopes that some version of his treatment approach will be adopted by health care organizations, allowing it to reach more patients. Treatment for alcohol and substance use disorders can be started in primary care, and patients can be referred to specialists as needed, as is the case with treatment for asthma or depression, he said. This will be particularly important for patients with public insurance, he added.

Ms. Diehl of NAMI agreed that current managed care models do not leave much room for innovation. “There needs to be some kind of acknowledgment that psychiatry is an evolving practice. For acknowledgment of innovation and validation you have to scale up from one practitioner doing something that works, to a small exploratory study, and eventually you get something like cognitive-behavioral therapy where you say, ‘OK, this is robust.’ ”

Trust and continuity

Direct-pay psychiatrists strongly defend their model as placing patient confidentiality, trust, and continuity of care at its center.

The European psychoanalysts who found refuge in the United States around the time of World War II were the first to institute private, office-based practices – a model that psychiatrists, who formerly worked mainly in hospitals, soon adopted, said Dr. Rodrigo A. Muñoz, who has been in private practice in San Diego since 1977 and is a former president of the American Psychiatric Association.

“These were patient-oriented people who truly believed in their practice and expected that this would be their life,” Dr. Muñoz said. But within decades, “all sorts of people came to intervene in psychiatry – government, insurance companies, employers, and the big physicians’ groups. A lot of money came to intermediaries who gained control over large chunks of the practice.”

Although Dr. Muñoz accepted insurance, including Medicaid, for decades, he no longer does. “The HMO people have tried to reduce office practice to 15 minutes for medication. I cannot practice that way,” he said. “My sessions are between 30 minutes and an hour,” he said, and include medication checks, psychotherapy, and detailed progress notes. “I am very interested in many areas of the patient’s life – family, work, plans, many other things, and I take my time. If my decision is between accepting insurance and seeing the patient for less money, I will take less.”

Dr. Muñoz says he does not have a waiting list and sees as many as 30 new patients a month. Direct pay allows him to keep overhead and fees as low as possible, and to maintain a level of discretion that his patients appreciate. He once clashed with Medicaid auditors on recording patients’ cultural backgrounds, because his mostly-Latino patients felt sensitive about what the information was being used for.

“I now have the practice I want to have. I believe I’ve got what every psychiatrist wants – a good relationship with my patients. Because you have to recall that many people come against their will. You’re treating them because you believe they have symptoms, and they may not agree. Sometimes I’m the fellow who tries to put them in the hospital.” Trust of patients, and their families, he said, is key.

Most patients on public insurance, meanwhile, “are destined to go to a clinic where the costs are much lower and supported by state subsidies,” Dr. Muñoz said. “They may see several practitioners – whoever is available that day at the clinic.”

Bridging the gap

“When psychiatrists go into psychiatry they are not simply going in to manage medications. You have to find out what’s going on with the patient’s life to make the best use of the medication. It’s not like primary care where there’s a clear path forward. You have to have a conversation. And health plans have not worked that into their actuarial and financial models,” said Ms. Diehl.

“Effective psychiatric practice includes psychotherapy and medication management,” Ms. Diehl continued. “On the other hand, this costs a lot to the system. We found that the average 45-minute treatment visit costs $250 out of pocket, and an initial evaluation can be upwards of $600. Not many people can pay that,” she said.

Dr. Lee H. Beecher, a psychiatrist recently retired from a direct-pay practice in St. Louis Park, Minn., said the private-pay model, done correctly and transparently, is accessible to most patients.

“I’m not talking about this as a model for the rich or celebrities. My clientele consisted of people from all backgrounds,” he said, and his fees – about $250 for a 50-minute session that included medication checks and psychotherapy – were always posted online. “I would tell patients what my costs were and why I do what I do, and they were satisfied with that,” he said. With a roster of 3,000 patients, Dr. Beecher managed his practice with only one support staff member.

Dr. Beecher, like Dr. Muñoz, said he felt the main advantage of direct pay to be the patient relationship. “Psychotherapy is developing a personal narrative. Who am I in the world? What am I doing? What is the plan gonna be? Good psychotherapy helps the patient rationalize his or her own position,” he said. “Meanwhile, so many of my colleagues in psychiatry are struggling with this question of, what am I doing? Who am I working for, the patient, or the CEO of a health care organization?”

Dr. Beecher said many of his colleagues stopped taking insurance “because we were becoming slaves to coding, trying to coordinate everything so that we could get paid, then we wouldn’t, and we were arguing with the insurers – it was just awful,” he said. Switching to direct pay “re-established psychiatry as a legitimate and valuable service with the patient as the center of the doctor’s attention.”

For her part, Ms. Diehl said NAMI’s report “shows that consumers face huge barriers to psychiatric care and scrimp on necessities in order to pay for it. Direct pay resolves some problems but creates others. We need a middle ground,” she said.

Dr. Beecher acknowledged that the poorest patients are denied the level of care that even the most reasonable and accessible direct-pay practice can offer. With his patients who had Medicaid, he did what he could to bridge the gap. Medicaid does not reimburse direct-pay appointment fees, but prescriptions written by direct-pay providers are paid for, and Dr. Beecher would intervene to make sure patients received the right medications. He also connected with their primary care physicians, explaining drug choices, and provided patients with copies of their notes to allow them to share them with other providers.

A more lasting and innovative solution to help low-income patients access direct-pay quality care would be to “support waivers and experiments in the states that would give patients access – maybe even with a debit card” to funds that can be used for direct pay, Dr. Beecher said.

Enormous sums of public money are going into health care organizations, he said, but “the way it’s now designed is a top-down system deciding what the benefits should be, how they’re administered, who’s getting the money. None of that allows the patient to be the driver of the system.”

Waivers for direct pay “could get the power in the hands of the patient,” he said. “There’s a lot of resistance to doing it. But it works.”

Psychiatrists in direct-pay practices, in which patients must seek their own reimbursement if it is available, say the high quality of care they offer continues to bring patients through their doors from all ends of the economic spectrum.

Just 55% of U.S. psychiatrists accepted any form of insurance during 2009-2010, while nearly 90% of physicians in other specialties did during that period (JAMA Psychiatry 2014;71:176-81). Psychiatrists in cash practices say this is in part because the field is not as good a fit for managed care as other specialties are.

It is also, they say, because certain subspecialties such as addiction treatment are locked into reimbursement models that are rigid and dated; and because clinicians would rather spend time with their patients than on coding and paperwork, even if it means collecting less money or having to offer discounts to patients who find themselves in a tough spot.

“This is about value. And people will pay the money if they feel the value,” said Dr. Mark L. Willenbring of Alltyr clinic in St. Paul, Minn., a cash practice he founded.

Patient advocates are concerned that cash practices create further impediments to access in a mental health care system, that – parity laws and sweeping insurance reforms aside – still suffers from a shortage of providers and high rates of insurance denials for mental health and substance use treatment.

“We can certainly empathize with the rationale for providers doing only direct pay; we just wish it were not so,” said Sita Diehl, director of state policy and advocacy for the Arlington, Va.–based National Alliance on Mental Illness. NAMI’s recent report on parity in mental health care, titled “A Long Road Ahead,” found the dearth of providers accepting insurance to be among the persistent obstacles to access.

A novel addiction model

Dr. Willenbring, a former director of addiction and recovery research at the National Institutes of Health, said his move to a direct-pay clinic came about as a result of what he considered a lack of science-based addiction medicine.

“Research in addictions is astonishing, and there’s lots more we know about the disorders than 50 years ago, but a lot of it sits on the shelf because we don’t have the vehicle to get it to the public,” he said. His Alltyr clinic, now in its third year, began as a demonstration model combining outpatient medical management and psychotherapy to people with alcohol and substance use disorders at varying stages of severity.

“Insurance companies have boxes they want to put you in. They have a box for substance use treatment that says ‘rehab.’ And they have a box for a mental health clinic. But what I’m doing is neither. And I’m a subspecialist; I don’t want to be paid the same as they guy down the street doing 5-minute med checks. Finally, with insurance, I couldn’t do what I want to do. I couldn’t experiment.”

Dr. Willenbring said direct pay has allowed him to build an addiction treatment model that is an alternative to traditional rehabilitation. “What’s the treatment for bipolar disorder? You put the patient through ‘the program’? No, you try one thing, and if it doesn’t work you try something else. And you don’t blame the patient if it doesn’t work.”

Direct pay helps keep his costs to patients and bureaucracy to a minimum, he said. He charges $495 for a 90-minute initial evaluation, with fees between $95 for 45 minutes with a licensed addiction counselor to $300 with a psychiatrist. “You have to remember: Many of our patients have spent tens of thousands of dollars before coming here,” usually on rehab, he said. Most spend between $2,000 and $3,000 a year at the clinic, less than the $5,000 annual cash outlay required by many high-deductible insurance plans.

Also, he said, “I negotiate with patients. I ask what they can afford. I’m seeing one patient for $50 a visit because that’s what they can pay.”

The Alltyr clinic collects outcome data that helps him to better understand which approaches are working, he said. “My goal is to demonstrate that we can have better outcomes and far better patient satisfaction at substantially less cost than current treatment,” and direct pay is making the effort possible, for now, Dr. Willenbring said.

On an absolute level, his practice is not more costly than under a managed-care model, he added. “I also work part time for one of the large health organizations in a half-day clinic. They take all insurance, but if patients have to pay cash they pay more there than in my clinic.”

Dr. Willenbring said he hopes that some version of his treatment approach will be adopted by health care organizations, allowing it to reach more patients. Treatment for alcohol and substance use disorders can be started in primary care, and patients can be referred to specialists as needed, as is the case with treatment for asthma or depression, he said. This will be particularly important for patients with public insurance, he added.

Ms. Diehl of NAMI agreed that current managed care models do not leave much room for innovation. “There needs to be some kind of acknowledgment that psychiatry is an evolving practice. For acknowledgment of innovation and validation you have to scale up from one practitioner doing something that works, to a small exploratory study, and eventually you get something like cognitive-behavioral therapy where you say, ‘OK, this is robust.’ ”

Trust and continuity

Direct-pay psychiatrists strongly defend their model as placing patient confidentiality, trust, and continuity of care at its center.

The European psychoanalysts who found refuge in the United States around the time of World War II were the first to institute private, office-based practices – a model that psychiatrists, who formerly worked mainly in hospitals, soon adopted, said Dr. Rodrigo A. Muñoz, who has been in private practice in San Diego since 1977 and is a former president of the American Psychiatric Association.

“These were patient-oriented people who truly believed in their practice and expected that this would be their life,” Dr. Muñoz said. But within decades, “all sorts of people came to intervene in psychiatry – government, insurance companies, employers, and the big physicians’ groups. A lot of money came to intermediaries who gained control over large chunks of the practice.”

Although Dr. Muñoz accepted insurance, including Medicaid, for decades, he no longer does. “The HMO people have tried to reduce office practice to 15 minutes for medication. I cannot practice that way,” he said. “My sessions are between 30 minutes and an hour,” he said, and include medication checks, psychotherapy, and detailed progress notes. “I am very interested in many areas of the patient’s life – family, work, plans, many other things, and I take my time. If my decision is between accepting insurance and seeing the patient for less money, I will take less.”

Dr. Muñoz says he does not have a waiting list and sees as many as 30 new patients a month. Direct pay allows him to keep overhead and fees as low as possible, and to maintain a level of discretion that his patients appreciate. He once clashed with Medicaid auditors on recording patients’ cultural backgrounds, because his mostly-Latino patients felt sensitive about what the information was being used for.

“I now have the practice I want to have. I believe I’ve got what every psychiatrist wants – a good relationship with my patients. Because you have to recall that many people come against their will. You’re treating them because you believe they have symptoms, and they may not agree. Sometimes I’m the fellow who tries to put them in the hospital.” Trust of patients, and their families, he said, is key.

Most patients on public insurance, meanwhile, “are destined to go to a clinic where the costs are much lower and supported by state subsidies,” Dr. Muñoz said. “They may see several practitioners – whoever is available that day at the clinic.”

Bridging the gap

“When psychiatrists go into psychiatry they are not simply going in to manage medications. You have to find out what’s going on with the patient’s life to make the best use of the medication. It’s not like primary care where there’s a clear path forward. You have to have a conversation. And health plans have not worked that into their actuarial and financial models,” said Ms. Diehl.

“Effective psychiatric practice includes psychotherapy and medication management,” Ms. Diehl continued. “On the other hand, this costs a lot to the system. We found that the average 45-minute treatment visit costs $250 out of pocket, and an initial evaluation can be upwards of $600. Not many people can pay that,” she said.

Dr. Lee H. Beecher, a psychiatrist recently retired from a direct-pay practice in St. Louis Park, Minn., said the private-pay model, done correctly and transparently, is accessible to most patients.

“I’m not talking about this as a model for the rich or celebrities. My clientele consisted of people from all backgrounds,” he said, and his fees – about $250 for a 50-minute session that included medication checks and psychotherapy – were always posted online. “I would tell patients what my costs were and why I do what I do, and they were satisfied with that,” he said. With a roster of 3,000 patients, Dr. Beecher managed his practice with only one support staff member.

Dr. Beecher, like Dr. Muñoz, said he felt the main advantage of direct pay to be the patient relationship. “Psychotherapy is developing a personal narrative. Who am I in the world? What am I doing? What is the plan gonna be? Good psychotherapy helps the patient rationalize his or her own position,” he said. “Meanwhile, so many of my colleagues in psychiatry are struggling with this question of, what am I doing? Who am I working for, the patient, or the CEO of a health care organization?”

Dr. Beecher said many of his colleagues stopped taking insurance “because we were becoming slaves to coding, trying to coordinate everything so that we could get paid, then we wouldn’t, and we were arguing with the insurers – it was just awful,” he said. Switching to direct pay “re-established psychiatry as a legitimate and valuable service with the patient as the center of the doctor’s attention.”

For her part, Ms. Diehl said NAMI’s report “shows that consumers face huge barriers to psychiatric care and scrimp on necessities in order to pay for it. Direct pay resolves some problems but creates others. We need a middle ground,” she said.

Dr. Beecher acknowledged that the poorest patients are denied the level of care that even the most reasonable and accessible direct-pay practice can offer. With his patients who had Medicaid, he did what he could to bridge the gap. Medicaid does not reimburse direct-pay appointment fees, but prescriptions written by direct-pay providers are paid for, and Dr. Beecher would intervene to make sure patients received the right medications. He also connected with their primary care physicians, explaining drug choices, and provided patients with copies of their notes to allow them to share them with other providers.

A more lasting and innovative solution to help low-income patients access direct-pay quality care would be to “support waivers and experiments in the states that would give patients access – maybe even with a debit card” to funds that can be used for direct pay, Dr. Beecher said.

Enormous sums of public money are going into health care organizations, he said, but “the way it’s now designed is a top-down system deciding what the benefits should be, how they’re administered, who’s getting the money. None of that allows the patient to be the driver of the system.”

Waivers for direct pay “could get the power in the hands of the patient,” he said. “There’s a lot of resistance to doing it. But it works.”

Psychiatrists in direct-pay practices, in which patients must seek their own reimbursement if it is available, say the high quality of care they offer continues to bring patients through their doors from all ends of the economic spectrum.

Just 55% of U.S. psychiatrists accepted any form of insurance during 2009-2010, while nearly 90% of physicians in other specialties did during that period (JAMA Psychiatry 2014;71:176-81). Psychiatrists in cash practices say this is in part because the field is not as good a fit for managed care as other specialties are.

It is also, they say, because certain subspecialties such as addiction treatment are locked into reimbursement models that are rigid and dated; and because clinicians would rather spend time with their patients than on coding and paperwork, even if it means collecting less money or having to offer discounts to patients who find themselves in a tough spot.

“This is about value. And people will pay the money if they feel the value,” said Dr. Mark L. Willenbring of Alltyr clinic in St. Paul, Minn., a cash practice he founded.

Patient advocates are concerned that cash practices create further impediments to access in a mental health care system, that – parity laws and sweeping insurance reforms aside – still suffers from a shortage of providers and high rates of insurance denials for mental health and substance use treatment.

“We can certainly empathize with the rationale for providers doing only direct pay; we just wish it were not so,” said Sita Diehl, director of state policy and advocacy for the Arlington, Va.–based National Alliance on Mental Illness. NAMI’s recent report on parity in mental health care, titled “A Long Road Ahead,” found the dearth of providers accepting insurance to be among the persistent obstacles to access.

A novel addiction model

Dr. Willenbring, a former director of addiction and recovery research at the National Institutes of Health, said his move to a direct-pay clinic came about as a result of what he considered a lack of science-based addiction medicine.

“Research in addictions is astonishing, and there’s lots more we know about the disorders than 50 years ago, but a lot of it sits on the shelf because we don’t have the vehicle to get it to the public,” he said. His Alltyr clinic, now in its third year, began as a demonstration model combining outpatient medical management and psychotherapy to people with alcohol and substance use disorders at varying stages of severity.

“Insurance companies have boxes they want to put you in. They have a box for substance use treatment that says ‘rehab.’ And they have a box for a mental health clinic. But what I’m doing is neither. And I’m a subspecialist; I don’t want to be paid the same as they guy down the street doing 5-minute med checks. Finally, with insurance, I couldn’t do what I want to do. I couldn’t experiment.”

Dr. Willenbring said direct pay has allowed him to build an addiction treatment model that is an alternative to traditional rehabilitation. “What’s the treatment for bipolar disorder? You put the patient through ‘the program’? No, you try one thing, and if it doesn’t work you try something else. And you don’t blame the patient if it doesn’t work.”

Direct pay helps keep his costs to patients and bureaucracy to a minimum, he said. He charges $495 for a 90-minute initial evaluation, with fees between $95 for 45 minutes with a licensed addiction counselor to $300 with a psychiatrist. “You have to remember: Many of our patients have spent tens of thousands of dollars before coming here,” usually on rehab, he said. Most spend between $2,000 and $3,000 a year at the clinic, less than the $5,000 annual cash outlay required by many high-deductible insurance plans.

Also, he said, “I negotiate with patients. I ask what they can afford. I’m seeing one patient for $50 a visit because that’s what they can pay.”

The Alltyr clinic collects outcome data that helps him to better understand which approaches are working, he said. “My goal is to demonstrate that we can have better outcomes and far better patient satisfaction at substantially less cost than current treatment,” and direct pay is making the effort possible, for now, Dr. Willenbring said.

On an absolute level, his practice is not more costly than under a managed-care model, he added. “I also work part time for one of the large health organizations in a half-day clinic. They take all insurance, but if patients have to pay cash they pay more there than in my clinic.”

Dr. Willenbring said he hopes that some version of his treatment approach will be adopted by health care organizations, allowing it to reach more patients. Treatment for alcohol and substance use disorders can be started in primary care, and patients can be referred to specialists as needed, as is the case with treatment for asthma or depression, he said. This will be particularly important for patients with public insurance, he added.

Ms. Diehl of NAMI agreed that current managed care models do not leave much room for innovation. “There needs to be some kind of acknowledgment that psychiatry is an evolving practice. For acknowledgment of innovation and validation you have to scale up from one practitioner doing something that works, to a small exploratory study, and eventually you get something like cognitive-behavioral therapy where you say, ‘OK, this is robust.’ ”

Trust and continuity

Direct-pay psychiatrists strongly defend their model as placing patient confidentiality, trust, and continuity of care at its center.

The European psychoanalysts who found refuge in the United States around the time of World War II were the first to institute private, office-based practices – a model that psychiatrists, who formerly worked mainly in hospitals, soon adopted, said Dr. Rodrigo A. Muñoz, who has been in private practice in San Diego since 1977 and is a former president of the American Psychiatric Association.

“These were patient-oriented people who truly believed in their practice and expected that this would be their life,” Dr. Muñoz said. But within decades, “all sorts of people came to intervene in psychiatry – government, insurance companies, employers, and the big physicians’ groups. A lot of money came to intermediaries who gained control over large chunks of the practice.”

Although Dr. Muñoz accepted insurance, including Medicaid, for decades, he no longer does. “The HMO people have tried to reduce office practice to 15 minutes for medication. I cannot practice that way,” he said. “My sessions are between 30 minutes and an hour,” he said, and include medication checks, psychotherapy, and detailed progress notes. “I am very interested in many areas of the patient’s life – family, work, plans, many other things, and I take my time. If my decision is between accepting insurance and seeing the patient for less money, I will take less.”

Dr. Muñoz says he does not have a waiting list and sees as many as 30 new patients a month. Direct pay allows him to keep overhead and fees as low as possible, and to maintain a level of discretion that his patients appreciate. He once clashed with Medicaid auditors on recording patients’ cultural backgrounds, because his mostly-Latino patients felt sensitive about what the information was being used for.

“I now have the practice I want to have. I believe I’ve got what every psychiatrist wants – a good relationship with my patients. Because you have to recall that many people come against their will. You’re treating them because you believe they have symptoms, and they may not agree. Sometimes I’m the fellow who tries to put them in the hospital.” Trust of patients, and their families, he said, is key.

Most patients on public insurance, meanwhile, “are destined to go to a clinic where the costs are much lower and supported by state subsidies,” Dr. Muñoz said. “They may see several practitioners – whoever is available that day at the clinic.”

Bridging the gap

“When psychiatrists go into psychiatry they are not simply going in to manage medications. You have to find out what’s going on with the patient’s life to make the best use of the medication. It’s not like primary care where there’s a clear path forward. You have to have a conversation. And health plans have not worked that into their actuarial and financial models,” said Ms. Diehl.

“Effective psychiatric practice includes psychotherapy and medication management,” Ms. Diehl continued. “On the other hand, this costs a lot to the system. We found that the average 45-minute treatment visit costs $250 out of pocket, and an initial evaluation can be upwards of $600. Not many people can pay that,” she said.

Dr. Lee H. Beecher, a psychiatrist recently retired from a direct-pay practice in St. Louis Park, Minn., said the private-pay model, done correctly and transparently, is accessible to most patients.

“I’m not talking about this as a model for the rich or celebrities. My clientele consisted of people from all backgrounds,” he said, and his fees – about $250 for a 50-minute session that included medication checks and psychotherapy – were always posted online. “I would tell patients what my costs were and why I do what I do, and they were satisfied with that,” he said. With a roster of 3,000 patients, Dr. Beecher managed his practice with only one support staff member.

Dr. Beecher, like Dr. Muñoz, said he felt the main advantage of direct pay to be the patient relationship. “Psychotherapy is developing a personal narrative. Who am I in the world? What am I doing? What is the plan gonna be? Good psychotherapy helps the patient rationalize his or her own position,” he said. “Meanwhile, so many of my colleagues in psychiatry are struggling with this question of, what am I doing? Who am I working for, the patient, or the CEO of a health care organization?”

Dr. Beecher said many of his colleagues stopped taking insurance “because we were becoming slaves to coding, trying to coordinate everything so that we could get paid, then we wouldn’t, and we were arguing with the insurers – it was just awful,” he said. Switching to direct pay “re-established psychiatry as a legitimate and valuable service with the patient as the center of the doctor’s attention.”

For her part, Ms. Diehl said NAMI’s report “shows that consumers face huge barriers to psychiatric care and scrimp on necessities in order to pay for it. Direct pay resolves some problems but creates others. We need a middle ground,” she said.

Dr. Beecher acknowledged that the poorest patients are denied the level of care that even the most reasonable and accessible direct-pay practice can offer. With his patients who had Medicaid, he did what he could to bridge the gap. Medicaid does not reimburse direct-pay appointment fees, but prescriptions written by direct-pay providers are paid for, and Dr. Beecher would intervene to make sure patients received the right medications. He also connected with their primary care physicians, explaining drug choices, and provided patients with copies of their notes to allow them to share them with other providers.

A more lasting and innovative solution to help low-income patients access direct-pay quality care would be to “support waivers and experiments in the states that would give patients access – maybe even with a debit card” to funds that can be used for direct pay, Dr. Beecher said.

Enormous sums of public money are going into health care organizations, he said, but “the way it’s now designed is a top-down system deciding what the benefits should be, how they’re administered, who’s getting the money. None of that allows the patient to be the driver of the system.”

Waivers for direct pay “could get the power in the hands of the patient,” he said. “There’s a lot of resistance to doing it. But it works.”

New diabetes mellitus practice guidelines from the American Association of Clinical Endocrinologists introduce recommendations on evaluating cancer risk, vaccinations, and special populations such as long-distance truck drivers who represent a high-risk occupational group in need of special attention in the diabetes population.

The guidelines, published in the April issue of Endocrine Practice (2015;21:1-87), expand on previous AACE recommendations on sleep disorders, breathing disorders, and depression in type 2 diabetes, and introduce more flexible and individualized targets not just for glucose and lipids but blood pressure and coagulation.

©Tashatuvango/Thinkstockphotos.com

The 2015 guidelines replace those issued by AACE in 2011, and come with an updated diabetes management algorithm largely unchanged from the 2013 version. The new algorithm, like its predecessor, is not intended to substitute for a guideline but rather serves as a quick reference for management – “a sort of cookbook” – for clinicians, said Dr. Yehuda Handelsman, director of the Metabolic Institute of America in Tarzana, Calif., and a cochair of the guidelines writing committee of the AACE task force.

The main changes to the algorithm were intended to reflect current Food and Drug Administration advice and a change in the warnings for the medications rosiglitazone and pioglitazone, and the two sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors.

The guideline, meanwhile, was significantly expanded. Among AACE’s new recommendations is that all patients with type 2 diabetes be vaccinated with influenza pneumococcal, and hepatitis B virus vaccine, tetanus-diphtheria boosters every 10 years, and other vaccines as recommended by their physicians.

The guidelines also recommend that people with diabetes be screened more rigorously for common cancers and cancers associated with obesity and metabolic disorders. Moreover, the guidelines recommend that while no specific antihyperglycemic agent has been definitively linked to cancer, “when a patient with DM has a history of a particular cancer, the physician may consider avoiding a medication that was initially considered disadvantageous to that cancer.”

Commercial drivers are identified as a group at high risk for developing obesity and diabetes. Moreover, “persons with DM engaged in various occupations including commercial drivers and pilots, anesthesiologists, and commercial or recreational divers have special management requirements, namely avoiding hypoglycemia. Treatment efforts for such patients should be focused on agents with reduced likelihood of hypoglycemia,” according to the guideline.

Dr. Handelsman said the recommendations on truck drivers came about “as we started to recognize that there are about 15 million commercial drivers in the United States, about 6 million of them transcontinental drivers. They are at huge risk for gaining weight and developing diabetes and cardiovascular disease. And a lot of states will not allow them to drive if they get insulin because they are considered at risk for hypoglycemia.” The guidelines recommend long-distance commercial drivers “would particularly benefit from improved healthcare access with a focus on measures to reduce obesity.”

The guidelines also promote individualizing hemoglobin A_1ctargets to below 6.5% for most and above 6.5% for less-healthy individuals. Dr. Handelsman explained that “for people who are very sick with a lot of complications, very high hypoglycemia risk, and maybe short longevity, we might relax control on this group – maybe not even follow hemoglobin A_1c but make sure the glucose is within a reasonable limit,” he said.

The guidelines apply the same principle to cardiovascular and weight targets, and aspirin. Lipid targets are also adjustable: “People in a very-high-risk group ought to have an appropriate goal. Those at lesser risk for complications can have a more intensive target, and if they have a lot of complications you may want to be more lax,” Dr. Handelsman said. For example, blood pressure, though ideally at less than 130/80 mm Hg for people with diabetes and kidney disease, should also be individualized on the basis of age, comorbidities, and duration of disease, the guidelines say.

“Recently, there were so many new guidelines and different targets were proposed for blood pressure and glucose yet many if not most had no relevance: The one-size-fits all approach is dead,” Dr. Handelsman said. “The concept of individualized care not only for the glucose but for the CV parameters is new this year and this is perhaps the only guideline on the market that to focus on comprehensive personalized management for people with diabetes and related cardiometabolic conditions.” 

Dr. Handelsman reported fees, honoraria, or other forms of support from Boehringer Ingelheim, GlaxoSmithKline, Novo Nordisk, Amgen, Gilead, Merck, Sanofi-Aventis, Intarcia, Lexicon, Takeda, Halozyme, Amarin, Amylin, Janssen, and Vivus. Of the guideline’s 34 authors, all but 5 disclosed industry relationships.

New diabetes mellitus practice guidelines from the American Association of Clinical Endocrinologists introduce recommendations on evaluating cancer risk, vaccinations, and special populations such as long-distance truck drivers who represent a high-risk occupational group in need of special attention in the diabetes population.

The guidelines, published in the April issue of Endocrine Practice (2015;21:1-87), expand on previous AACE recommendations on sleep disorders, breathing disorders, and depression in type 2 diabetes, and introduce more flexible and individualized targets not just for glucose and lipids but blood pressure and coagulation.

©Tashatuvango/Thinkstockphotos.com

The 2015 guidelines replace those issued by AACE in 2011, and come with an updated diabetes management algorithm largely unchanged from the 2013 version. The new algorithm, like its predecessor, is not intended to substitute for a guideline but rather serves as a quick reference for management – “a sort of cookbook” – for clinicians, said Dr. Yehuda Handelsman, director of the Metabolic Institute of America in Tarzana, Calif., and a cochair of the guidelines writing committee of the AACE task force.

The main changes to the algorithm were intended to reflect current Food and Drug Administration advice and a change in the warnings for the medications rosiglitazone and pioglitazone, and the two sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors.

The guideline, meanwhile, was significantly expanded. Among AACE’s new recommendations is that all patients with type 2 diabetes be vaccinated with influenza pneumococcal, and hepatitis B virus vaccine, tetanus-diphtheria boosters every 10 years, and other vaccines as recommended by their physicians.

The guidelines also recommend that people with diabetes be screened more rigorously for common cancers and cancers associated with obesity and metabolic disorders. Moreover, the guidelines recommend that while no specific antihyperglycemic agent has been definitively linked to cancer, “when a patient with DM has a history of a particular cancer, the physician may consider avoiding a medication that was initially considered disadvantageous to that cancer.”

Commercial drivers are identified as a group at high risk for developing obesity and diabetes. Moreover, “persons with DM engaged in various occupations including commercial drivers and pilots, anesthesiologists, and commercial or recreational divers have special management requirements, namely avoiding hypoglycemia. Treatment efforts for such patients should be focused on agents with reduced likelihood of hypoglycemia,” according to the guideline.

Dr. Handelsman said the recommendations on truck drivers came about “as we started to recognize that there are about 15 million commercial drivers in the United States, about 6 million of them transcontinental drivers. They are at huge risk for gaining weight and developing diabetes and cardiovascular disease. And a lot of states will not allow them to drive if they get insulin because they are considered at risk for hypoglycemia.” The guidelines recommend long-distance commercial drivers “would particularly benefit from improved healthcare access with a focus on measures to reduce obesity.”

The guidelines also promote individualizing hemoglobin A_1ctargets to below 6.5% for most and above 6.5% for less-healthy individuals. Dr. Handelsman explained that “for people who are very sick with a lot of complications, very high hypoglycemia risk, and maybe short longevity, we might relax control on this group – maybe not even follow hemoglobin A_1c but make sure the glucose is within a reasonable limit,” he said.

The guidelines apply the same principle to cardiovascular and weight targets, and aspirin. Lipid targets are also adjustable: “People in a very-high-risk group ought to have an appropriate goal. Those at lesser risk for complications can have a more intensive target, and if they have a lot of complications you may want to be more lax,” Dr. Handelsman said. For example, blood pressure, though ideally at less than 130/80 mm Hg for people with diabetes and kidney disease, should also be individualized on the basis of age, comorbidities, and duration of disease, the guidelines say.

“Recently, there were so many new guidelines and different targets were proposed for blood pressure and glucose yet many if not most had no relevance: The one-size-fits all approach is dead,” Dr. Handelsman said. “The concept of individualized care not only for the glucose but for the CV parameters is new this year and this is perhaps the only guideline on the market that to focus on comprehensive personalized management for people with diabetes and related cardiometabolic conditions.” 

Dr. Handelsman reported fees, honoraria, or other forms of support from Boehringer Ingelheim, GlaxoSmithKline, Novo Nordisk, Amgen, Gilead, Merck, Sanofi-Aventis, Intarcia, Lexicon, Takeda, Halozyme, Amarin, Amylin, Janssen, and Vivus. Of the guideline’s 34 authors, all but 5 disclosed industry relationships.

New diabetes mellitus practice guidelines from the American Association of Clinical Endocrinologists introduce recommendations on evaluating cancer risk, vaccinations, and special populations such as long-distance truck drivers who represent a high-risk occupational group in need of special attention in the diabetes population.

The guidelines, published in the April issue of Endocrine Practice (2015;21:1-87), expand on previous AACE recommendations on sleep disorders, breathing disorders, and depression in type 2 diabetes, and introduce more flexible and individualized targets not just for glucose and lipids but blood pressure and coagulation.

©Tashatuvango/Thinkstockphotos.com

The 2015 guidelines replace those issued by AACE in 2011, and come with an updated diabetes management algorithm largely unchanged from the 2013 version. The new algorithm, like its predecessor, is not intended to substitute for a guideline but rather serves as a quick reference for management – “a sort of cookbook” – for clinicians, said Dr. Yehuda Handelsman, director of the Metabolic Institute of America in Tarzana, Calif., and a cochair of the guidelines writing committee of the AACE task force.

The main changes to the algorithm were intended to reflect current Food and Drug Administration advice and a change in the warnings for the medications rosiglitazone and pioglitazone, and the two sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors.

The guideline, meanwhile, was significantly expanded. Among AACE’s new recommendations is that all patients with type 2 diabetes be vaccinated with influenza pneumococcal, and hepatitis B virus vaccine, tetanus-diphtheria boosters every 10 years, and other vaccines as recommended by their physicians.

The guidelines also recommend that people with diabetes be screened more rigorously for common cancers and cancers associated with obesity and metabolic disorders. Moreover, the guidelines recommend that while no specific antihyperglycemic agent has been definitively linked to cancer, “when a patient with DM has a history of a particular cancer, the physician may consider avoiding a medication that was initially considered disadvantageous to that cancer.”

Commercial drivers are identified as a group at high risk for developing obesity and diabetes. Moreover, “persons with DM engaged in various occupations including commercial drivers and pilots, anesthesiologists, and commercial or recreational divers have special management requirements, namely avoiding hypoglycemia. Treatment efforts for such patients should be focused on agents with reduced likelihood of hypoglycemia,” according to the guideline.

Dr. Handelsman said the recommendations on truck drivers came about “as we started to recognize that there are about 15 million commercial drivers in the United States, about 6 million of them transcontinental drivers. They are at huge risk for gaining weight and developing diabetes and cardiovascular disease. And a lot of states will not allow them to drive if they get insulin because they are considered at risk for hypoglycemia.” The guidelines recommend long-distance commercial drivers “would particularly benefit from improved healthcare access with a focus on measures to reduce obesity.”

The guidelines also promote individualizing hemoglobin A_1ctargets to below 6.5% for most and above 6.5% for less-healthy individuals. Dr. Handelsman explained that “for people who are very sick with a lot of complications, very high hypoglycemia risk, and maybe short longevity, we might relax control on this group – maybe not even follow hemoglobin A_1c but make sure the glucose is within a reasonable limit,” he said.

The guidelines apply the same principle to cardiovascular and weight targets, and aspirin. Lipid targets are also adjustable: “People in a very-high-risk group ought to have an appropriate goal. Those at lesser risk for complications can have a more intensive target, and if they have a lot of complications you may want to be more lax,” Dr. Handelsman said. For example, blood pressure, though ideally at less than 130/80 mm Hg for people with diabetes and kidney disease, should also be individualized on the basis of age, comorbidities, and duration of disease, the guidelines say.

“Recently, there were so many new guidelines and different targets were proposed for blood pressure and glucose yet many if not most had no relevance: The one-size-fits all approach is dead,” Dr. Handelsman said. “The concept of individualized care not only for the glucose but for the CV parameters is new this year and this is perhaps the only guideline on the market that to focus on comprehensive personalized management for people with diabetes and related cardiometabolic conditions.” 

Dr. Handelsman reported fees, honoraria, or other forms of support from Boehringer Ingelheim, GlaxoSmithKline, Novo Nordisk, Amgen, Gilead, Merck, Sanofi-Aventis, Intarcia, Lexicon, Takeda, Halozyme, Amarin, Amylin, Janssen, and Vivus. Of the guideline’s 34 authors, all but 5 disclosed industry relationships.

Metformin and glyburide are both as effective as insulin in the management of gestational diabetes, a meta-analysis of randomized clinical trials has found, though their risk profiles differ.

The investigators looked at 18 trials comparing the two oral agents with insulin, and in some cases with each other, in about 2,800 women with gestational diabetes.

The study showed significant differences among the oral drugs and insulin in maternal fasting blood glucose or glycosylated hemoglobin levels, suggesting that all are effective in controlling GDM, according to Dr. Yun-fa Jiang of Hebei Medical University in Shijiazhuang, China, and associates (J. Clin. Endocrinol. Metab. [doi:10.1210/jc.2014-4403]).

However, compared with insulin, metformin was associated with lower maternal weight gain (weighted mean difference: –1.49 kg; 95% confidence interval, –2.26 to 0.31), and shorter gestational age (WMD, –0.16 kg/week; 95% CI, –0.30 to –0.03). Glyburide was associated with higher neonatal birth weight (130.68 g; 95% CI, 55.98 to 205.38), neonatal hypoglycemia (odds ratio, 2.64; 95% CI, 1.59 to 4.38), and increased incidence of macrosomia (OR, 3.09; 95% CI, 1.59 to 6.04) compared with insulin. In a network meta-analysis, metformin was seen associated with significantly less maternal weight gain, compared with glyburide (WMD, –1.34; 95% CI, –3.05 to 0.38; P = .009).

The differences might be attributable to different mechanisms of action in the two oral drugs, according to the investigators, who noted that this was the first network meta-analysis comparing efficacy and safety of oral antidiabetics in management of gestational diabetes. “There exists some apprehension regarding the use of oral antidiabetic drugs during pregnancy,” they wrote. “While no long-term harms to the exposed offspring from either of these drugs have been demonstrated, no long-term studies have been performed with appropriate controls, either in humans or animal models.”

Dr. Jiang and colleagues noted among the weaknesses of their study the relatively few trials included, and that blinding was not possible in trials that compared oral agents with insulin therapy.

The study was funded by China’s National Science Foundation and none of its authors declared conflicts of interest.

Metformin and glyburide are both as effective as insulin in the management of gestational diabetes, a meta-analysis of randomized clinical trials has found, though their risk profiles differ.

The investigators looked at 18 trials comparing the two oral agents with insulin, and in some cases with each other, in about 2,800 women with gestational diabetes.

The study showed significant differences among the oral drugs and insulin in maternal fasting blood glucose or glycosylated hemoglobin levels, suggesting that all are effective in controlling GDM, according to Dr. Yun-fa Jiang of Hebei Medical University in Shijiazhuang, China, and associates (J. Clin. Endocrinol. Metab. [doi:10.1210/jc.2014-4403]).

However, compared with insulin, metformin was associated with lower maternal weight gain (weighted mean difference: –1.49 kg; 95% confidence interval, –2.26 to 0.31), and shorter gestational age (WMD, –0.16 kg/week; 95% CI, –0.30 to –0.03). Glyburide was associated with higher neonatal birth weight (130.68 g; 95% CI, 55.98 to 205.38), neonatal hypoglycemia (odds ratio, 2.64; 95% CI, 1.59 to 4.38), and increased incidence of macrosomia (OR, 3.09; 95% CI, 1.59 to 6.04) compared with insulin. In a network meta-analysis, metformin was seen associated with significantly less maternal weight gain, compared with glyburide (WMD, –1.34; 95% CI, –3.05 to 0.38; P = .009).

The differences might be attributable to different mechanisms of action in the two oral drugs, according to the investigators, who noted that this was the first network meta-analysis comparing efficacy and safety of oral antidiabetics in management of gestational diabetes. “There exists some apprehension regarding the use of oral antidiabetic drugs during pregnancy,” they wrote. “While no long-term harms to the exposed offspring from either of these drugs have been demonstrated, no long-term studies have been performed with appropriate controls, either in humans or animal models.”

Dr. Jiang and colleagues noted among the weaknesses of their study the relatively few trials included, and that blinding was not possible in trials that compared oral agents with insulin therapy.

The study was funded by China’s National Science Foundation and none of its authors declared conflicts of interest.

Metformin and glyburide are both as effective as insulin in the management of gestational diabetes, a meta-analysis of randomized clinical trials has found, though their risk profiles differ.

The investigators looked at 18 trials comparing the two oral agents with insulin, and in some cases with each other, in about 2,800 women with gestational diabetes.

The study showed significant differences among the oral drugs and insulin in maternal fasting blood glucose or glycosylated hemoglobin levels, suggesting that all are effective in controlling GDM, according to Dr. Yun-fa Jiang of Hebei Medical University in Shijiazhuang, China, and associates (J. Clin. Endocrinol. Metab. [doi:10.1210/jc.2014-4403]).

However, compared with insulin, metformin was associated with lower maternal weight gain (weighted mean difference: –1.49 kg; 95% confidence interval, –2.26 to 0.31), and shorter gestational age (WMD, –0.16 kg/week; 95% CI, –0.30 to –0.03). Glyburide was associated with higher neonatal birth weight (130.68 g; 95% CI, 55.98 to 205.38), neonatal hypoglycemia (odds ratio, 2.64; 95% CI, 1.59 to 4.38), and increased incidence of macrosomia (OR, 3.09; 95% CI, 1.59 to 6.04) compared with insulin. In a network meta-analysis, metformin was seen associated with significantly less maternal weight gain, compared with glyburide (WMD, –1.34; 95% CI, –3.05 to 0.38; P = .009).

The differences might be attributable to different mechanisms of action in the two oral drugs, according to the investigators, who noted that this was the first network meta-analysis comparing efficacy and safety of oral antidiabetics in management of gestational diabetes. “There exists some apprehension regarding the use of oral antidiabetic drugs during pregnancy,” they wrote. “While no long-term harms to the exposed offspring from either of these drugs have been demonstrated, no long-term studies have been performed with appropriate controls, either in humans or animal models.”

Dr. Jiang and colleagues noted among the weaknesses of their study the relatively few trials included, and that blinding was not possible in trials that compared oral agents with insulin therapy.

The study was funded by China’s National Science Foundation and none of its authors declared conflicts of interest.

High resting heart rate and low heart rate variability – both indicators of autonomic imbalance – can predict some elements of metabolic syndrome, according to findings derived from the Framingham Heart Study offspring cohort.

In that cohort (n = 1,882), both high resting heart rate (RHR) and low heart rate variability (HRV) at baseline were significant predictors of high blood pressure, hyperglycemia, and a diagnosis of diabetes within 12 years. The research points to the potential usefulness of autonomic imbalance measures in interventional and epidemiologic studies, according to Dr. Lawson R. Wulsin of Cincinnati Veterans Affairs Medical Center and University of Cincinnati and his associates (J. Clin. Endocrinol. Metab. 2015 [doi:10.1210/jc.2014-4123]).

The investigators sought to determine any links between RHR, HRV, and any of five key measures of metabolic syndrome: elevated triglycerides, low high-density lipoprotein cholesterol (HDL-C), elevated blood pressure, elevated fasting glucose, and body mass index. Low HRV, along with age, sex, and smoking status, predicted high blood pressure (P= .0002) and hyperglycemia (P= .0015), while elevated RHR was significantly predictive of high blood pressure (P< .0001) and hyperglycemia (P= .0013) along with the other risk factors. HRV also predicted incident diabetes along with smoking, age, and sex (odds ratio, 0.549; 95% confidence interval, 0.429-0.701; P < .0001) as did RHR (OR, 1.638; 95% CI, 1.364-1.966; P < .0001).

Dr. Wulsin and his colleagues noted in their analysis that they could not explain why the two indicators of autonomic imbalance were better predictors of high blood pressure and hyperglycemia than were the three other outcome measures used in the study. “It is possible that in our sample, lipids were more influenced by insulin resistance or some other factor than by autonomic activity,” they wrote. Dr. Wulsin and his colleagues noted as the weaknesses of their study its use of a mostly white and middle-class cohort, and that the duration of autonomic imbalance was not captured, nor were other potential variables including physical activity, inflammation, and insulin resistance.

The study was funded by the Department of Veterans Affairs; none of its authors reported conflicts of interest.

High resting heart rate and low heart rate variability – both indicators of autonomic imbalance – can predict some elements of metabolic syndrome, according to findings derived from the Framingham Heart Study offspring cohort.

In that cohort (n = 1,882), both high resting heart rate (RHR) and low heart rate variability (HRV) at baseline were significant predictors of high blood pressure, hyperglycemia, and a diagnosis of diabetes within 12 years. The research points to the potential usefulness of autonomic imbalance measures in interventional and epidemiologic studies, according to Dr. Lawson R. Wulsin of Cincinnati Veterans Affairs Medical Center and University of Cincinnati and his associates (J. Clin. Endocrinol. Metab. 2015 [doi:10.1210/jc.2014-4123]).

The investigators sought to determine any links between RHR, HRV, and any of five key measures of metabolic syndrome: elevated triglycerides, low high-density lipoprotein cholesterol (HDL-C), elevated blood pressure, elevated fasting glucose, and body mass index. Low HRV, along with age, sex, and smoking status, predicted high blood pressure (P= .0002) and hyperglycemia (P= .0015), while elevated RHR was significantly predictive of high blood pressure (P< .0001) and hyperglycemia (P= .0013) along with the other risk factors. HRV also predicted incident diabetes along with smoking, age, and sex (odds ratio, 0.549; 95% confidence interval, 0.429-0.701; P < .0001) as did RHR (OR, 1.638; 95% CI, 1.364-1.966; P < .0001).

Dr. Wulsin and his colleagues noted in their analysis that they could not explain why the two indicators of autonomic imbalance were better predictors of high blood pressure and hyperglycemia than were the three other outcome measures used in the study. “It is possible that in our sample, lipids were more influenced by insulin resistance or some other factor than by autonomic activity,” they wrote. Dr. Wulsin and his colleagues noted as the weaknesses of their study its use of a mostly white and middle-class cohort, and that the duration of autonomic imbalance was not captured, nor were other potential variables including physical activity, inflammation, and insulin resistance.

The study was funded by the Department of Veterans Affairs; none of its authors reported conflicts of interest.

High resting heart rate and low heart rate variability – both indicators of autonomic imbalance – can predict some elements of metabolic syndrome, according to findings derived from the Framingham Heart Study offspring cohort.

In that cohort (n = 1,882), both high resting heart rate (RHR) and low heart rate variability (HRV) at baseline were significant predictors of high blood pressure, hyperglycemia, and a diagnosis of diabetes within 12 years. The research points to the potential usefulness of autonomic imbalance measures in interventional and epidemiologic studies, according to Dr. Lawson R. Wulsin of Cincinnati Veterans Affairs Medical Center and University of Cincinnati and his associates (J. Clin. Endocrinol. Metab. 2015 [doi:10.1210/jc.2014-4123]).

The investigators sought to determine any links between RHR, HRV, and any of five key measures of metabolic syndrome: elevated triglycerides, low high-density lipoprotein cholesterol (HDL-C), elevated blood pressure, elevated fasting glucose, and body mass index. Low HRV, along with age, sex, and smoking status, predicted high blood pressure (P= .0002) and hyperglycemia (P= .0015), while elevated RHR was significantly predictive of high blood pressure (P< .0001) and hyperglycemia (P= .0013) along with the other risk factors. HRV also predicted incident diabetes along with smoking, age, and sex (odds ratio, 0.549; 95% confidence interval, 0.429-0.701; P < .0001) as did RHR (OR, 1.638; 95% CI, 1.364-1.966; P < .0001).

Dr. Wulsin and his colleagues noted in their analysis that they could not explain why the two indicators of autonomic imbalance were better predictors of high blood pressure and hyperglycemia than were the three other outcome measures used in the study. “It is possible that in our sample, lipids were more influenced by insulin resistance or some other factor than by autonomic activity,” they wrote. Dr. Wulsin and his colleagues noted as the weaknesses of their study its use of a mostly white and middle-class cohort, and that the duration of autonomic imbalance was not captured, nor were other potential variables including physical activity, inflammation, and insulin resistance.

The study was funded by the Department of Veterans Affairs; none of its authors reported conflicts of interest.

Some 29 million private patient health records were compromised between 2010 and the end of 2013 – mostly as a result of criminal activity, say researchers, who described their findings as a likely underestimate of the magnitude of the problem.

In a research letter published April 14 in JAMA (doi:10.1001/jama.2015.2252), Dr. Vincent Liu of Kaiser Permanente in Oakland, Calif., and his colleagues at Stanford (Calif.) University, evaluated U.S. Department of Health & Human Services reports of data breaches involving 500 or more patient records covered under the Health Insurance Portability and Accountability Act (HIPAA). Of the 949 reported breach events during the 4-year study period, 67% involved electronic media while about 20% were attributed to paper records. Laptop or portable device theft accounted for 33% of all breaches reported.

©Sebastian Duda/Thinkstock

Importantly, the frequency of breaches from hacking and unauthorized access increased significantly during the study period (from 12% in 2010 to 27% in 2013), and breaches involving external vendors represented 29% of all incidents.

“Given the rapid expansion in electronic health record deployment since 2012, as well as the expected increase in cloud-based services provided by vendors supporting predictive analytics, personal health records, health-related sensors, and gene-sequencing technology, the frequency and scope of electronic health care data breaches are likely to increase,” Dr. Liu and colleagues wrote.

“Our study was limited to breaches that were already recognized, reported, and affecting at least 500 individuals [as required by the HITECH Act of 2009],” Dr. Liu and colleagues wrote. “Therefore, our study likely underestimated the true number of health care data breaches occurring each year.” The study was funded by Permanente Medical Group and the National Institutes of Health. None of its authors reported any relevant conflicts of interest.

Some 29 million private patient health records were compromised between 2010 and the end of 2013 – mostly as a result of criminal activity, say researchers, who described their findings as a likely underestimate of the magnitude of the problem.

In a research letter published April 14 in JAMA (doi:10.1001/jama.2015.2252), Dr. Vincent Liu of Kaiser Permanente in Oakland, Calif., and his colleagues at Stanford (Calif.) University, evaluated U.S. Department of Health & Human Services reports of data breaches involving 500 or more patient records covered under the Health Insurance Portability and Accountability Act (HIPAA). Of the 949 reported breach events during the 4-year study period, 67% involved electronic media while about 20% were attributed to paper records. Laptop or portable device theft accounted for 33% of all breaches reported.

©Sebastian Duda/Thinkstock

Importantly, the frequency of breaches from hacking and unauthorized access increased significantly during the study period (from 12% in 2010 to 27% in 2013), and breaches involving external vendors represented 29% of all incidents.

“Given the rapid expansion in electronic health record deployment since 2012, as well as the expected increase in cloud-based services provided by vendors supporting predictive analytics, personal health records, health-related sensors, and gene-sequencing technology, the frequency and scope of electronic health care data breaches are likely to increase,” Dr. Liu and colleagues wrote.

“Our study was limited to breaches that were already recognized, reported, and affecting at least 500 individuals [as required by the HITECH Act of 2009],” Dr. Liu and colleagues wrote. “Therefore, our study likely underestimated the true number of health care data breaches occurring each year.” The study was funded by Permanente Medical Group and the National Institutes of Health. None of its authors reported any relevant conflicts of interest.

Some 29 million private patient health records were compromised between 2010 and the end of 2013 – mostly as a result of criminal activity, say researchers, who described their findings as a likely underestimate of the magnitude of the problem.

In a research letter published April 14 in JAMA (doi:10.1001/jama.2015.2252), Dr. Vincent Liu of Kaiser Permanente in Oakland, Calif., and his colleagues at Stanford (Calif.) University, evaluated U.S. Department of Health & Human Services reports of data breaches involving 500 or more patient records covered under the Health Insurance Portability and Accountability Act (HIPAA). Of the 949 reported breach events during the 4-year study period, 67% involved electronic media while about 20% were attributed to paper records. Laptop or portable device theft accounted for 33% of all breaches reported.

©Sebastian Duda/Thinkstock

Importantly, the frequency of breaches from hacking and unauthorized access increased significantly during the study period (from 12% in 2010 to 27% in 2013), and breaches involving external vendors represented 29% of all incidents.

“Given the rapid expansion in electronic health record deployment since 2012, as well as the expected increase in cloud-based services provided by vendors supporting predictive analytics, personal health records, health-related sensors, and gene-sequencing technology, the frequency and scope of electronic health care data breaches are likely to increase,” Dr. Liu and colleagues wrote.

“Our study was limited to breaches that were already recognized, reported, and affecting at least 500 individuals [as required by the HITECH Act of 2009],” Dr. Liu and colleagues wrote. “Therefore, our study likely underestimated the true number of health care data breaches occurring each year.” The study was funded by Permanente Medical Group and the National Institutes of Health. None of its authors reported any relevant conflicts of interest.

Optimal control of glucose, blood pressure, LDL cholesterol, and smoking in adults with diabetes could result in substantial reductions of cardiovascular risk, according to results from a large cohort study of diabetes patients with and without underlying cardiovascular disease.

CV events and deaths associated with inadequate control of any of these four modifiable risk factors were about 11% and 3%, respectively, for subjects with baseline CVD, and 34% and 7%, respectively, for those without it.

Though risk was much higher for those with CVD, as expected, more attention to these traditional CVD risk factors in all diabetic patients – with or without CVD – would significantly reduce CVD-related morbidity and mortality, investigators concluded.

For their research, published online in Diabetes Care, epidemiologist Gabriela Vasquez-Benitez, Ph.D., of the Health Partners Institute for Education and Research in Minneapolis and her associates identified 859,617 patients with diabetes (31% with CVD) receiving treatment at a network of 11 U.S. health centers for 6 months or more, with mean follow-up of 5 years. About half of patients were female, and 45% were white. Risk factors were defined as LDL-C ≥100 mg/dL, glycosylated hemoglobin (HbA_1c) ≥7%, blood pressure ≥140/90 mm Hg, or smoking.

Dr. Vasquez-Benitez and associates used a regression analysis to quantify the contributions each risk factor made to CVD risk and type of CV event in both patient groups.

In patients without CVD (n = 593,167), the vast majority had HbA_1c, BP, and LDL-C not at goal or were current smokers. Inadequately controlled LDL cholesterol was associated with 19.6% of myocardial infarction or acute coronary syndrome (95% confidence interval, 18.7-20.5), and 13.7% of strokes. Smoking was associated with 3.8% of all CV events, while inadequately controlled blood pressure was associated with 11.6% of strokes. Dr. Vasquez-Benitez and colleagues found an increased CV risk for HbA_1c above 9%, but no increased risk for HbA_1c of 7%-7.9%, compared with 6.5%-6.9%. This finding supports current guidelines recommending HbA_1c targets below 7% or 8% for patients with diabetes, according to the investigators (Diab. Care 2015 Feb. 20 [doi:10.2337/dc14-1877]).

In subjects with diabetes and CVD, 7% of stroke was found attributable to inadequate blood pressure control and 5.9% to poor glycemic control. Smoking was the only factor seen associated with an increase in all-cause mortality in this patient group, with 2.6% of deaths seen linked to smoking.

Dr. Vasquez-Benitez and her colleagues noted in their analysis that a substantial share of risk could not be attributed to the modifiable factors investigated in their study, raising the possibility that “unidentified genetic, metabolic, or psychosocial risk factors may affect risk.”

The investigators noted as limitations of their study the fact that risk factors and comorbidities were assessed at baseline and may have changed during follow-up, and that data were obtained from routine care settings with varying time intervals. Patients with type I diabetes may have been included in the cohort due to difficulties distinguishing diabetes types in patient records, they said.

The study was funded by the Agency for Healthcare Research & Quality. None of its authors reported conflicts of interest.

Optimal control of glucose, blood pressure, LDL cholesterol, and smoking in adults with diabetes could result in substantial reductions of cardiovascular risk, according to results from a large cohort study of diabetes patients with and without underlying cardiovascular disease.

CV events and deaths associated with inadequate control of any of these four modifiable risk factors were about 11% and 3%, respectively, for subjects with baseline CVD, and 34% and 7%, respectively, for those without it.

Though risk was much higher for those with CVD, as expected, more attention to these traditional CVD risk factors in all diabetic patients – with or without CVD – would significantly reduce CVD-related morbidity and mortality, investigators concluded.

For their research, published online in Diabetes Care, epidemiologist Gabriela Vasquez-Benitez, Ph.D., of the Health Partners Institute for Education and Research in Minneapolis and her associates identified 859,617 patients with diabetes (31% with CVD) receiving treatment at a network of 11 U.S. health centers for 6 months or more, with mean follow-up of 5 years. About half of patients were female, and 45% were white. Risk factors were defined as LDL-C ≥100 mg/dL, glycosylated hemoglobin (HbA_1c) ≥7%, blood pressure ≥140/90 mm Hg, or smoking.

Dr. Vasquez-Benitez and associates used a regression analysis to quantify the contributions each risk factor made to CVD risk and type of CV event in both patient groups.

In patients without CVD (n = 593,167), the vast majority had HbA_1c, BP, and LDL-C not at goal or were current smokers. Inadequately controlled LDL cholesterol was associated with 19.6% of myocardial infarction or acute coronary syndrome (95% confidence interval, 18.7-20.5), and 13.7% of strokes. Smoking was associated with 3.8% of all CV events, while inadequately controlled blood pressure was associated with 11.6% of strokes. Dr. Vasquez-Benitez and colleagues found an increased CV risk for HbA_1c above 9%, but no increased risk for HbA_1c of 7%-7.9%, compared with 6.5%-6.9%. This finding supports current guidelines recommending HbA_1c targets below 7% or 8% for patients with diabetes, according to the investigators (Diab. Care 2015 Feb. 20 [doi:10.2337/dc14-1877]).

In subjects with diabetes and CVD, 7% of stroke was found attributable to inadequate blood pressure control and 5.9% to poor glycemic control. Smoking was the only factor seen associated with an increase in all-cause mortality in this patient group, with 2.6% of deaths seen linked to smoking.

Dr. Vasquez-Benitez and her colleagues noted in their analysis that a substantial share of risk could not be attributed to the modifiable factors investigated in their study, raising the possibility that “unidentified genetic, metabolic, or psychosocial risk factors may affect risk.”

The investigators noted as limitations of their study the fact that risk factors and comorbidities were assessed at baseline and may have changed during follow-up, and that data were obtained from routine care settings with varying time intervals. Patients with type I diabetes may have been included in the cohort due to difficulties distinguishing diabetes types in patient records, they said.

The study was funded by the Agency for Healthcare Research & Quality. None of its authors reported conflicts of interest.

Optimal control of glucose, blood pressure, LDL cholesterol, and smoking in adults with diabetes could result in substantial reductions of cardiovascular risk, according to results from a large cohort study of diabetes patients with and without underlying cardiovascular disease.

CV events and deaths associated with inadequate control of any of these four modifiable risk factors were about 11% and 3%, respectively, for subjects with baseline CVD, and 34% and 7%, respectively, for those without it.

Though risk was much higher for those with CVD, as expected, more attention to these traditional CVD risk factors in all diabetic patients – with or without CVD – would significantly reduce CVD-related morbidity and mortality, investigators concluded.

For their research, published online in Diabetes Care, epidemiologist Gabriela Vasquez-Benitez, Ph.D., of the Health Partners Institute for Education and Research in Minneapolis and her associates identified 859,617 patients with diabetes (31% with CVD) receiving treatment at a network of 11 U.S. health centers for 6 months or more, with mean follow-up of 5 years. About half of patients were female, and 45% were white. Risk factors were defined as LDL-C ≥100 mg/dL, glycosylated hemoglobin (HbA_1c) ≥7%, blood pressure ≥140/90 mm Hg, or smoking.

Dr. Vasquez-Benitez and associates used a regression analysis to quantify the contributions each risk factor made to CVD risk and type of CV event in both patient groups.

In patients without CVD (n = 593,167), the vast majority had HbA_1c, BP, and LDL-C not at goal or were current smokers. Inadequately controlled LDL cholesterol was associated with 19.6% of myocardial infarction or acute coronary syndrome (95% confidence interval, 18.7-20.5), and 13.7% of strokes. Smoking was associated with 3.8% of all CV events, while inadequately controlled blood pressure was associated with 11.6% of strokes. Dr. Vasquez-Benitez and colleagues found an increased CV risk for HbA_1c above 9%, but no increased risk for HbA_1c of 7%-7.9%, compared with 6.5%-6.9%. This finding supports current guidelines recommending HbA_1c targets below 7% or 8% for patients with diabetes, according to the investigators (Diab. Care 2015 Feb. 20 [doi:10.2337/dc14-1877]).

In subjects with diabetes and CVD, 7% of stroke was found attributable to inadequate blood pressure control and 5.9% to poor glycemic control. Smoking was the only factor seen associated with an increase in all-cause mortality in this patient group, with 2.6% of deaths seen linked to smoking.

Dr. Vasquez-Benitez and her colleagues noted in their analysis that a substantial share of risk could not be attributed to the modifiable factors investigated in their study, raising the possibility that “unidentified genetic, metabolic, or psychosocial risk factors may affect risk.”

The investigators noted as limitations of their study the fact that risk factors and comorbidities were assessed at baseline and may have changed during follow-up, and that data were obtained from routine care settings with varying time intervals. Patients with type I diabetes may have been included in the cohort due to difficulties distinguishing diabetes types in patient records, they said.

The study was funded by the Agency for Healthcare Research & Quality. None of its authors reported conflicts of interest.