Miriam E. Tucker

WASHINGTON — The probiotic Lactobacillus GG failed to prevent Clostridium difficile infection when given at the same time as systemic antibiotics to hospitalized adults in two prospective, randomized, double-blind, placebo-controlled trials.

Lactobacillus GG (LGG) is an L. rhamnosus isolate named after the initials of the two scientists—Sherwood Gorbach and Barry Goldin—from whom the strain was derived and who hold the patents for it. The strain is marketed as a dietary supplement under the name Culturelle by the ConAgra Foods Co., which funded the two studies.

The organism is acid- and bile-stable and has high affinity to mucosal cells of the gastrointestinal tract, thus rendering it a potential gut probiotic that could prevent disruptions in normal flora that occur with antibiotic use, Dr. Mark Miller said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Virtually all cases of Clostridium difficile infection (CDI) are preceded by antibiotic consumption in the previous 60 days, and perturbation of normal flora is almost certainly responsible for the mechanism that “turns on” CD spore germination and toxin production. Yet no study has demonstrated the effectiveness of a probiotic to prevent CDI, said Dr. Miller, head of the division of infectious diseases and chief of the department of microbiology at SMBD-Jewish General Hospital, McGill University, Montreal.

In the first study, 95 hospitalized patients who were receiving oral or parenteral antibiotics for 14 days or less were randomized to receive LGG in an oral dose of 2 × 1010 bacteria twice daily for 14 days; 94 patients received placebo. No patient was severely immunocompromised, and all were able to take medications by mouth.

Over the subsequent 30 days, four of the LGG patients (4.2%) and seven of the placebo patients (7.4%) developed documented CDI (diarrhea plus positive toxin B assay), but this difference was not significant.

Two of the LGG patients (2.1%) and four placebo patients (4.3%) died; none of the deaths were deemed to be related to the study drug.

The larger, second study employed a higher dose of LGG (6 × 1010) twice daily for 14 days. Again there was no significant difference between groups, with CDI developing in 2 (1.3%) of 157 the LGG patients and in 0 of the 159 placebo patients.

Four (2.6%) of the LGG patients died—none deemed related to the study drug—while none of the placebo patients died. Watery diarrhea was reported by 5.1% of the LGG patients and 2.5% of the placebo group, also not a significant difference.

Study medication compliance was similar for the two groups.

It's possible that the low rate of CDI in the study population may have obscured an effect of LGG, or that monitoring the effects of “lesser” diarrhea than “watery” may have shown an effect, Dr. Miller commented.

In general, probiotic prophylaxis studies are hampered by the large number of study subjects needed to show an effect. Also, whether the failure of LGG is a product-specific effect or is representative of all probiotics is an open question.

Dr. Miller received research support from ConAgra Inc.

WASHINGTON — The probiotic Lactobacillus GG failed to prevent Clostridium difficile infection when given at the same time as systemic antibiotics to hospitalized adults in two prospective, randomized, double-blind, placebo-controlled trials.

Lactobacillus GG (LGG) is an L. rhamnosus isolate named after the initials of the two scientists—Sherwood Gorbach and Barry Goldin—from whom the strain was derived and who hold the patents for it. The strain is marketed as a dietary supplement under the name Culturelle by the ConAgra Foods Co., which funded the two studies.

The organism is acid- and bile-stable and has high affinity to mucosal cells of the gastrointestinal tract, thus rendering it a potential gut probiotic that could prevent disruptions in normal flora that occur with antibiotic use, Dr. Mark Miller said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Virtually all cases of Clostridium difficile infection (CDI) are preceded by antibiotic consumption in the previous 60 days, and perturbation of normal flora is almost certainly responsible for the mechanism that “turns on” CD spore germination and toxin production. Yet no study has demonstrated the effectiveness of a probiotic to prevent CDI, said Dr. Miller, head of the division of infectious diseases and chief of the department of microbiology at SMBD-Jewish General Hospital, McGill University, Montreal.

In the first study, 95 hospitalized patients who were receiving oral or parenteral antibiotics for 14 days or less were randomized to receive LGG in an oral dose of 2 × 1010 bacteria twice daily for 14 days; 94 patients received placebo. No patient was severely immunocompromised, and all were able to take medications by mouth.

Over the subsequent 30 days, four of the LGG patients (4.2%) and seven of the placebo patients (7.4%) developed documented CDI (diarrhea plus positive toxin B assay), but this difference was not significant.

Two of the LGG patients (2.1%) and four placebo patients (4.3%) died; none of the deaths were deemed to be related to the study drug.

The larger, second study employed a higher dose of LGG (6 × 1010) twice daily for 14 days. Again there was no significant difference between groups, with CDI developing in 2 (1.3%) of 157 the LGG patients and in 0 of the 159 placebo patients.

Four (2.6%) of the LGG patients died—none deemed related to the study drug—while none of the placebo patients died. Watery diarrhea was reported by 5.1% of the LGG patients and 2.5% of the placebo group, also not a significant difference.

Study medication compliance was similar for the two groups.

It's possible that the low rate of CDI in the study population may have obscured an effect of LGG, or that monitoring the effects of “lesser” diarrhea than “watery” may have shown an effect, Dr. Miller commented.

In general, probiotic prophylaxis studies are hampered by the large number of study subjects needed to show an effect. Also, whether the failure of LGG is a product-specific effect or is representative of all probiotics is an open question.

Dr. Miller received research support from ConAgra Inc.

WASHINGTON — The probiotic Lactobacillus GG failed to prevent Clostridium difficile infection when given at the same time as systemic antibiotics to hospitalized adults in two prospective, randomized, double-blind, placebo-controlled trials.

Lactobacillus GG (LGG) is an L. rhamnosus isolate named after the initials of the two scientists—Sherwood Gorbach and Barry Goldin—from whom the strain was derived and who hold the patents for it. The strain is marketed as a dietary supplement under the name Culturelle by the ConAgra Foods Co., which funded the two studies.

The organism is acid- and bile-stable and has high affinity to mucosal cells of the gastrointestinal tract, thus rendering it a potential gut probiotic that could prevent disruptions in normal flora that occur with antibiotic use, Dr. Mark Miller said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Virtually all cases of Clostridium difficile infection (CDI) are preceded by antibiotic consumption in the previous 60 days, and perturbation of normal flora is almost certainly responsible for the mechanism that “turns on” CD spore germination and toxin production. Yet no study has demonstrated the effectiveness of a probiotic to prevent CDI, said Dr. Miller, head of the division of infectious diseases and chief of the department of microbiology at SMBD-Jewish General Hospital, McGill University, Montreal.

In the first study, 95 hospitalized patients who were receiving oral or parenteral antibiotics for 14 days or less were randomized to receive LGG in an oral dose of 2 × 1010 bacteria twice daily for 14 days; 94 patients received placebo. No patient was severely immunocompromised, and all were able to take medications by mouth.

Over the subsequent 30 days, four of the LGG patients (4.2%) and seven of the placebo patients (7.4%) developed documented CDI (diarrhea plus positive toxin B assay), but this difference was not significant.

Two of the LGG patients (2.1%) and four placebo patients (4.3%) died; none of the deaths were deemed to be related to the study drug.

The larger, second study employed a higher dose of LGG (6 × 1010) twice daily for 14 days. Again there was no significant difference between groups, with CDI developing in 2 (1.3%) of 157 the LGG patients and in 0 of the 159 placebo patients.

Four (2.6%) of the LGG patients died—none deemed related to the study drug—while none of the placebo patients died. Watery diarrhea was reported by 5.1% of the LGG patients and 2.5% of the placebo group, also not a significant difference.

Study medication compliance was similar for the two groups.

It's possible that the low rate of CDI in the study population may have obscured an effect of LGG, or that monitoring the effects of “lesser” diarrhea than “watery” may have shown an effect, Dr. Miller commented.

In general, probiotic prophylaxis studies are hampered by the large number of study subjects needed to show an effect. Also, whether the failure of LGG is a product-specific effect or is representative of all probiotics is an open question.

Dr. Miller received research support from ConAgra Inc.

WASHINGTON — Nosocomial Clostridium difficile infection was associated with 85% higher costs per hospital stay and 99% longer lengths of stay in the first-ever nationwide multihospital analysis of these infections.

The study included 10,857 cases of C. difficile infection (CDI) and 19,214 controls; all were adult inpatients. Data were collected from teaching hospitals in the University HealthSystem Consortium for the period 2002-2007. The number of hospitals participating in the UHC's clinical resource manager database varied from 25 to 45, depending on the year.

Cases of health care-acquired CDI were defined as instances where patients had the appropriate ICD-9 code listed as a secondary diagnosis, and metronidazole or oral vancomycin was administered for 4 or more days starting on day 5 of the hospitalization or later.

This case definition has been validated, Amy L. Pakyz, Pharm.D., said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Each case was matched with at least one control who did not have an ICD-9 code for CDI but who had another in the same diagnosis-related group (DRG), was within 5 years of the case patient's age, and was from the same hospital and year quarter.

Both groups had a mean age of 61 years and were 48% female. The CDI group was more likely to be white (68% vs. 65%) and less likely to be black (19% vs. 21%); both were significant differences. The All-Patient Refined DRG severity of illness rating (APR-DRG SOI) for the CDI patients was significantly more likely to be “extreme” (56% vs. 21%) and less likely to be “minor” (2.0% vs. 11%), compared with controls.

Unadjusted mean total hospital costs were $56,407 for the CDI cases vs. $29,237 for controls. Mean length of stay was 21.2 days vs. 10.1 days, respectively. Both differences were highly statistically significant. After adjustment for sex, age, race, and APR-DRG SOI, health care-acquired CDI was associated with 85% higher costs and 99% longer inpatient stays, vs. controls, said Dr. Pakyz of Virginia Commonwealth University, Richmond.

CDI had a greater effect on costs in patients with the “minor” APR-DRG SOI classification, in whom CDI was associated with 65% greater total hospital costs and 46% longer stays, compared with controls.

These results are consistent with those of previous studies done in single hospitals and one multihospital study conducted in Massachusetts, she noted.

Dr. Pakyz received investigator-initiated funding for this study from ViroPharma Inc.

WASHINGTON — Nosocomial Clostridium difficile infection was associated with 85% higher costs per hospital stay and 99% longer lengths of stay in the first-ever nationwide multihospital analysis of these infections.

The study included 10,857 cases of C. difficile infection (CDI) and 19,214 controls; all were adult inpatients. Data were collected from teaching hospitals in the University HealthSystem Consortium for the period 2002-2007. The number of hospitals participating in the UHC's clinical resource manager database varied from 25 to 45, depending on the year.

Cases of health care-acquired CDI were defined as instances where patients had the appropriate ICD-9 code listed as a secondary diagnosis, and metronidazole or oral vancomycin was administered for 4 or more days starting on day 5 of the hospitalization or later.

This case definition has been validated, Amy L. Pakyz, Pharm.D., said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Each case was matched with at least one control who did not have an ICD-9 code for CDI but who had another in the same diagnosis-related group (DRG), was within 5 years of the case patient's age, and was from the same hospital and year quarter.

Both groups had a mean age of 61 years and were 48% female. The CDI group was more likely to be white (68% vs. 65%) and less likely to be black (19% vs. 21%); both were significant differences. The All-Patient Refined DRG severity of illness rating (APR-DRG SOI) for the CDI patients was significantly more likely to be “extreme” (56% vs. 21%) and less likely to be “minor” (2.0% vs. 11%), compared with controls.

Unadjusted mean total hospital costs were $56,407 for the CDI cases vs. $29,237 for controls. Mean length of stay was 21.2 days vs. 10.1 days, respectively. Both differences were highly statistically significant. After adjustment for sex, age, race, and APR-DRG SOI, health care-acquired CDI was associated with 85% higher costs and 99% longer inpatient stays, vs. controls, said Dr. Pakyz of Virginia Commonwealth University, Richmond.

CDI had a greater effect on costs in patients with the “minor” APR-DRG SOI classification, in whom CDI was associated with 65% greater total hospital costs and 46% longer stays, compared with controls.

These results are consistent with those of previous studies done in single hospitals and one multihospital study conducted in Massachusetts, she noted.

Dr. Pakyz received investigator-initiated funding for this study from ViroPharma Inc.

WASHINGTON — Nosocomial Clostridium difficile infection was associated with 85% higher costs per hospital stay and 99% longer lengths of stay in the first-ever nationwide multihospital analysis of these infections.

The study included 10,857 cases of C. difficile infection (CDI) and 19,214 controls; all were adult inpatients. Data were collected from teaching hospitals in the University HealthSystem Consortium for the period 2002-2007. The number of hospitals participating in the UHC's clinical resource manager database varied from 25 to 45, depending on the year.

Cases of health care-acquired CDI were defined as instances where patients had the appropriate ICD-9 code listed as a secondary diagnosis, and metronidazole or oral vancomycin was administered for 4 or more days starting on day 5 of the hospitalization or later.

This case definition has been validated, Amy L. Pakyz, Pharm.D., said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Each case was matched with at least one control who did not have an ICD-9 code for CDI but who had another in the same diagnosis-related group (DRG), was within 5 years of the case patient's age, and was from the same hospital and year quarter.

Both groups had a mean age of 61 years and were 48% female. The CDI group was more likely to be white (68% vs. 65%) and less likely to be black (19% vs. 21%); both were significant differences. The All-Patient Refined DRG severity of illness rating (APR-DRG SOI) for the CDI patients was significantly more likely to be “extreme” (56% vs. 21%) and less likely to be “minor” (2.0% vs. 11%), compared with controls.

Unadjusted mean total hospital costs were $56,407 for the CDI cases vs. $29,237 for controls. Mean length of stay was 21.2 days vs. 10.1 days, respectively. Both differences were highly statistically significant. After adjustment for sex, age, race, and APR-DRG SOI, health care-acquired CDI was associated with 85% higher costs and 99% longer inpatient stays, vs. controls, said Dr. Pakyz of Virginia Commonwealth University, Richmond.

CDI had a greater effect on costs in patients with the “minor” APR-DRG SOI classification, in whom CDI was associated with 65% greater total hospital costs and 46% longer stays, compared with controls.

These results are consistent with those of previous studies done in single hospitals and one multihospital study conducted in Massachusetts, she noted.

Dr. Pakyz received investigator-initiated funding for this study from ViroPharma Inc.

NATIONAL HARBOR, MD. — Fears about liability appear to be one of several factors undercutting the ability and desire of physicians to provide care in nursing homes.

That conclusion comes from a study funded jointly by the Southern Illinois University School of Law, the California HealthCare Foundation, and the Commonwealth Fund. The findings suggest that legal reforms, as well as changes in practice conditions, could make nursing homes more appealing settings for physicians, said Marshall B. Kapp, J.D., M.P.H., a professor at the law school's Center for Health Policy and Law, Carbondale, Ill.

“Many facilities have difficulty attracting and retaining high-quality, conscientious medical directors and attending physicians in part because of physicians' legal anxieties,” said Mr. Kapp, who did the study's survey and reported its results at the annual meeting of the Gerontological Society of America.

He conducted 44 structured telephone interviews with 20 physicians, 6 advocacy organization representatives, 5 trade association officials, 4 nursing home administrators, 4 health services researchers, 2 attorneys, 2 insurance industry representatives, and 1 nurse.

The aim was to elicit in-depth information about physicians' apprehensions regarding their own personal legal exposure, the reasons for those fears and whether they're justified, and the consequences of such fears for both physicians and nursing home residents.

Overall, study participants agreed that nursing home residents today are sicker, older, more disabled, and more in need of medical care than in the past. On the other hand, Mr. Kapp said, wide geographic variation emerged in both the degree of liability anxiety felt by physicians and in the accuracy of their concerns. Attitudes ranged from “almost paranoia” in California to “not worried enough” about liability in New York, he said.

Physicians' anxieties were often influenced by factors such as attorney advertising, media coverage of nursing homes, and residents' and families' threats to sue.

Whether or not nursing homes have “deep pockets” to pay liability claims also contributes to physicians' concerns about their own liability. Some nursing homes have made themselves unlikely defendants in malpractice lawsuits by purchasing less insurance or in some cases even “going bare,” Mr. Kapp said. He contrasted this financial tactic for reducing facilities' legal vulnerability to the improvements in quality and safety that are now being made at many nursing homes.

Some state laws have further limited nursing home liability, thereby leaving physicians as the primary targets for lawsuits, Mr. Kapp said. For example, tort reform in Florida increased legal protection for nursing homes but resulted in almost a doubling since 2001 in the proportion of nursing home-related lawsuits in which individuals, including physicians, were named as defendants, from 13.5% to 26.5%.

In some states, physicians have had problems obtaining liability insurance for their actions as medical directors or attendings because insurance companies have increasingly pulled out of the nursing home market. Affordability of coverage for nursing home care also was cited as a problem, Mr. Kapp reported.

In addition, physicians complained that insufficient nursing home staffing and training often yield unreliable information about residents' health status and poor follow-through on the doctors' orders. Physicians practicing in nursing homes whose workforce includes trained physician extenders, especially geriatric nurse practitioners, were less apprehensive than others about their legal liability.

“The overwhelming sentiment was that while we do need physicians, we can greatly improve quality of care and reduce liability with the use of physician extenders,” Mr. Kapp said.

Physicians' legal anxieties can result in positive consequences for nursing home residents, such as improvements in safety, patient rights, and documentation of care, Mr. Kapp said. However, negative consequences are also common. Some physicians have curtailed nursing home work or abandoned it because of legal anxieties, he noted. This problem is particularly acute in California.

Physicians' legal anxieties also can result in overtreatment of residents, including unnecessary transfers to hospitals, or undertreatment, especially with pain medication. Nursing home “overprotectiveness” may result in a loss of autonomy for residents, Mr. Kapp said.

The survey also showed that legal anxieties aren't the only reason physicians limit or avoid nursing home involvement. Other factors cited include low prestige for the work, less control over care than in hospital or office settings, professional isolation, poor compensation, administrative and regulatory burdens on medical directors, and patient populations prone to bad outcomes, no matter the quality of care.

These issues, as well as liability, require attention, Mr. Kapp said. He cited the nursing home-physician reimbursement mechanisms of Medicare, Medicaid, and private insurers as problematic.

In fact, Mr. Kapp said he was surprised by the strength of the issues, beyond liability concerns, that prompt physicians to avoid nursing home care. “I thought that if we could change [liability laws], it would solve the problem. But really, that's only one small piece of a larger puzzle.”

A full report of the study is available at www.chcf.org/documents/chronicdisease/PhysicianLiability.pdf

NATIONAL HARBOR, MD. — Fears about liability appear to be one of several factors undercutting the ability and desire of physicians to provide care in nursing homes.

That conclusion comes from a study funded jointly by the Southern Illinois University School of Law, the California HealthCare Foundation, and the Commonwealth Fund. The findings suggest that legal reforms, as well as changes in practice conditions, could make nursing homes more appealing settings for physicians, said Marshall B. Kapp, J.D., M.P.H., a professor at the law school's Center for Health Policy and Law, Carbondale, Ill.

“Many facilities have difficulty attracting and retaining high-quality, conscientious medical directors and attending physicians in part because of physicians' legal anxieties,” said Mr. Kapp, who did the study's survey and reported its results at the annual meeting of the Gerontological Society of America.

He conducted 44 structured telephone interviews with 20 physicians, 6 advocacy organization representatives, 5 trade association officials, 4 nursing home administrators, 4 health services researchers, 2 attorneys, 2 insurance industry representatives, and 1 nurse.

The aim was to elicit in-depth information about physicians' apprehensions regarding their own personal legal exposure, the reasons for those fears and whether they're justified, and the consequences of such fears for both physicians and nursing home residents.

Overall, study participants agreed that nursing home residents today are sicker, older, more disabled, and more in need of medical care than in the past. On the other hand, Mr. Kapp said, wide geographic variation emerged in both the degree of liability anxiety felt by physicians and in the accuracy of their concerns. Attitudes ranged from “almost paranoia” in California to “not worried enough” about liability in New York, he said.

Physicians' anxieties were often influenced by factors such as attorney advertising, media coverage of nursing homes, and residents' and families' threats to sue.

Whether or not nursing homes have “deep pockets” to pay liability claims also contributes to physicians' concerns about their own liability. Some nursing homes have made themselves unlikely defendants in malpractice lawsuits by purchasing less insurance or in some cases even “going bare,” Mr. Kapp said. He contrasted this financial tactic for reducing facilities' legal vulnerability to the improvements in quality and safety that are now being made at many nursing homes.

Some state laws have further limited nursing home liability, thereby leaving physicians as the primary targets for lawsuits, Mr. Kapp said. For example, tort reform in Florida increased legal protection for nursing homes but resulted in almost a doubling since 2001 in the proportion of nursing home-related lawsuits in which individuals, including physicians, were named as defendants, from 13.5% to 26.5%.

In some states, physicians have had problems obtaining liability insurance for their actions as medical directors or attendings because insurance companies have increasingly pulled out of the nursing home market. Affordability of coverage for nursing home care also was cited as a problem, Mr. Kapp reported.

In addition, physicians complained that insufficient nursing home staffing and training often yield unreliable information about residents' health status and poor follow-through on the doctors' orders. Physicians practicing in nursing homes whose workforce includes trained physician extenders, especially geriatric nurse practitioners, were less apprehensive than others about their legal liability.

“The overwhelming sentiment was that while we do need physicians, we can greatly improve quality of care and reduce liability with the use of physician extenders,” Mr. Kapp said.

Physicians' legal anxieties can result in positive consequences for nursing home residents, such as improvements in safety, patient rights, and documentation of care, Mr. Kapp said. However, negative consequences are also common. Some physicians have curtailed nursing home work or abandoned it because of legal anxieties, he noted. This problem is particularly acute in California.

Physicians' legal anxieties also can result in overtreatment of residents, including unnecessary transfers to hospitals, or undertreatment, especially with pain medication. Nursing home “overprotectiveness” may result in a loss of autonomy for residents, Mr. Kapp said.

The survey also showed that legal anxieties aren't the only reason physicians limit or avoid nursing home involvement. Other factors cited include low prestige for the work, less control over care than in hospital or office settings, professional isolation, poor compensation, administrative and regulatory burdens on medical directors, and patient populations prone to bad outcomes, no matter the quality of care.

These issues, as well as liability, require attention, Mr. Kapp said. He cited the nursing home-physician reimbursement mechanisms of Medicare, Medicaid, and private insurers as problematic.

In fact, Mr. Kapp said he was surprised by the strength of the issues, beyond liability concerns, that prompt physicians to avoid nursing home care. “I thought that if we could change [liability laws], it would solve the problem. But really, that's only one small piece of a larger puzzle.”

A full report of the study is available at www.chcf.org/documents/chronicdisease/PhysicianLiability.pdf

NATIONAL HARBOR, MD. — Fears about liability appear to be one of several factors undercutting the ability and desire of physicians to provide care in nursing homes.

That conclusion comes from a study funded jointly by the Southern Illinois University School of Law, the California HealthCare Foundation, and the Commonwealth Fund. The findings suggest that legal reforms, as well as changes in practice conditions, could make nursing homes more appealing settings for physicians, said Marshall B. Kapp, J.D., M.P.H., a professor at the law school's Center for Health Policy and Law, Carbondale, Ill.

“Many facilities have difficulty attracting and retaining high-quality, conscientious medical directors and attending physicians in part because of physicians' legal anxieties,” said Mr. Kapp, who did the study's survey and reported its results at the annual meeting of the Gerontological Society of America.

He conducted 44 structured telephone interviews with 20 physicians, 6 advocacy organization representatives, 5 trade association officials, 4 nursing home administrators, 4 health services researchers, 2 attorneys, 2 insurance industry representatives, and 1 nurse.

The aim was to elicit in-depth information about physicians' apprehensions regarding their own personal legal exposure, the reasons for those fears and whether they're justified, and the consequences of such fears for both physicians and nursing home residents.

Overall, study participants agreed that nursing home residents today are sicker, older, more disabled, and more in need of medical care than in the past. On the other hand, Mr. Kapp said, wide geographic variation emerged in both the degree of liability anxiety felt by physicians and in the accuracy of their concerns. Attitudes ranged from “almost paranoia” in California to “not worried enough” about liability in New York, he said.

Physicians' anxieties were often influenced by factors such as attorney advertising, media coverage of nursing homes, and residents' and families' threats to sue.

Whether or not nursing homes have “deep pockets” to pay liability claims also contributes to physicians' concerns about their own liability. Some nursing homes have made themselves unlikely defendants in malpractice lawsuits by purchasing less insurance or in some cases even “going bare,” Mr. Kapp said. He contrasted this financial tactic for reducing facilities' legal vulnerability to the improvements in quality and safety that are now being made at many nursing homes.

Some state laws have further limited nursing home liability, thereby leaving physicians as the primary targets for lawsuits, Mr. Kapp said. For example, tort reform in Florida increased legal protection for nursing homes but resulted in almost a doubling since 2001 in the proportion of nursing home-related lawsuits in which individuals, including physicians, were named as defendants, from 13.5% to 26.5%.

In some states, physicians have had problems obtaining liability insurance for their actions as medical directors or attendings because insurance companies have increasingly pulled out of the nursing home market. Affordability of coverage for nursing home care also was cited as a problem, Mr. Kapp reported.

In addition, physicians complained that insufficient nursing home staffing and training often yield unreliable information about residents' health status and poor follow-through on the doctors' orders. Physicians practicing in nursing homes whose workforce includes trained physician extenders, especially geriatric nurse practitioners, were less apprehensive than others about their legal liability.

“The overwhelming sentiment was that while we do need physicians, we can greatly improve quality of care and reduce liability with the use of physician extenders,” Mr. Kapp said.

Physicians' legal anxieties can result in positive consequences for nursing home residents, such as improvements in safety, patient rights, and documentation of care, Mr. Kapp said. However, negative consequences are also common. Some physicians have curtailed nursing home work or abandoned it because of legal anxieties, he noted. This problem is particularly acute in California.

Physicians' legal anxieties also can result in overtreatment of residents, including unnecessary transfers to hospitals, or undertreatment, especially with pain medication. Nursing home “overprotectiveness” may result in a loss of autonomy for residents, Mr. Kapp said.

The survey also showed that legal anxieties aren't the only reason physicians limit or avoid nursing home involvement. Other factors cited include low prestige for the work, less control over care than in hospital or office settings, professional isolation, poor compensation, administrative and regulatory burdens on medical directors, and patient populations prone to bad outcomes, no matter the quality of care.

These issues, as well as liability, require attention, Mr. Kapp said. He cited the nursing home-physician reimbursement mechanisms of Medicare, Medicaid, and private insurers as problematic.

In fact, Mr. Kapp said he was surprised by the strength of the issues, beyond liability concerns, that prompt physicians to avoid nursing home care. “I thought that if we could change [liability laws], it would solve the problem. But really, that's only one small piece of a larger puzzle.”

A full report of the study is available at www.chcf.org/documents/chronicdisease/PhysicianLiability.pdf

NATIONAL HARBOR, MD. — Long-term care residents aged 85 and older are less likely than younger residents to have a serious mental illness, more likely to have dementia, and equally likely to have depression or anxiety.

Up to 80% of long-term care (LTC) residents have diagnosable neuropsychiatric disorders, including dementia, according to an analysis of data from the 2004 National Nursing Home Survey. The new findings are among the first detailing the rates of these disorders among the “oldest old” population now making up the fastest-growing segment of the over-65 age group and disproportionately represented in nursing homes.

“As a rapidly growing subpopulation, the oldest old in LTC have what appears to be distinct characteristics relative to other age groups, and these no doubt affect their care,” Catherine A. Yeager, Ph.D., and her associates said in a poster presented at the annual meeting of the Gerontological Society of America.

The 2004 National Nursing Home Survey, conducted between August and December 2004, is one in a series of nationally representative sample surveys of U.S. nursing homes conducted by the Centers for Disease Control and Prevention. A total of 1,174 nursing home facilities participated, producing data for 1,317,300 residents.

The population included 674,500 persons aged 85 and older. That group's average stay in those facilities was longer than that of their younger peers: 862 vs. 766 days. The survey data show “a few notable exceptions” to expected patterns of frailty and disability with age, said Dr. Yeager, of Robert Wood Johnson Medical School, Piscataway, N.J., and her associates.

The 85-plus group was made up of more women (82%) and more whites (90%), and was more likely to be widowed (72%) than were either the aged 75–84 or 65–74 groups. Of the 674,500 oldest old population, 17,300 had lived 100 years or more.

Only small proportions of all residents had neuropsychiatric diagnoses at the time they were admitted to LTC: 10% with dementia, 2% with schizophrenia spectrum, 0.3% with bipolar disorder, 0.2% with depressive disorder, and 0.2% with anxiety. However, neuropsychiatric diagnoses increased in all groups. At the time of the survey, depressive disorders were present in 35% of the oldest old, a percentage not significantly different from the 36% among the 75- to 84-year-old group and 32% of the 65- to 74-year-old individuals. Neither did rates of anxiety disorders differ by age, occurring in 12% of both the 85-plus and 75- to 84-year-old groups, and 11% of the 65- to 74-year-old group.

However, the oldest old were less likely than the two younger groups to have been diagnosed with a serious mental illness, including schizophrenia spectrum disorder (8.5% in 85-plus group, 13% in 75–84 group, and 17% in 65–74 group) and bipolar spectrum (1.2%, 2.3%, and 3.2%, respectively). Conversely, both the 85-plus and 75–84 groups were more likely than the 65- to 74-year-olds to have dementia (22% in the older groups vs. 13% in the youngest group).

In all three age groups—and especially among the oldest old—the survey found more clinical indicators of dementia and depression than formal diagnoses had indicated. The researchers reported moderate to severe impairment in decision making, an indicator of dementia, in 55% of the oldest old, 34% of the 75- to 84-year-olds, and 11% of the youngest group. Likewise, the proportions with “low mood not easily altered,” a proxy for depressive disorder, were 49%, 37.5%, and 14%, respectively.

“Older residents are not admitted to LTC with neuropsychiatric diagnoses to any degree,” perhaps because of preadmission screening, reported the group led by Dr. Yeager, who works in the Essex County Hospital Medical Center, Cedar Grove, N.J. “Once in the LTC, all groups show an increased prevalence of formal neuropsychiatric conditions.”

Residents with dementia diagnoses were more functionally impaired than their peers without dementia at all ages, the investigators reported.

NATIONAL HARBOR, MD. — Long-term care residents aged 85 and older are less likely than younger residents to have a serious mental illness, more likely to have dementia, and equally likely to have depression or anxiety.

Up to 80% of long-term care (LTC) residents have diagnosable neuropsychiatric disorders, including dementia, according to an analysis of data from the 2004 National Nursing Home Survey. The new findings are among the first detailing the rates of these disorders among the “oldest old” population now making up the fastest-growing segment of the over-65 age group and disproportionately represented in nursing homes.

“As a rapidly growing subpopulation, the oldest old in LTC have what appears to be distinct characteristics relative to other age groups, and these no doubt affect their care,” Catherine A. Yeager, Ph.D., and her associates said in a poster presented at the annual meeting of the Gerontological Society of America.

The 2004 National Nursing Home Survey, conducted between August and December 2004, is one in a series of nationally representative sample surveys of U.S. nursing homes conducted by the Centers for Disease Control and Prevention. A total of 1,174 nursing home facilities participated, producing data for 1,317,300 residents.

The population included 674,500 persons aged 85 and older. That group's average stay in those facilities was longer than that of their younger peers: 862 vs. 766 days. The survey data show “a few notable exceptions” to expected patterns of frailty and disability with age, said Dr. Yeager, of Robert Wood Johnson Medical School, Piscataway, N.J., and her associates.

The 85-plus group was made up of more women (82%) and more whites (90%), and was more likely to be widowed (72%) than were either the aged 75–84 or 65–74 groups. Of the 674,500 oldest old population, 17,300 had lived 100 years or more.

Only small proportions of all residents had neuropsychiatric diagnoses at the time they were admitted to LTC: 10% with dementia, 2% with schizophrenia spectrum, 0.3% with bipolar disorder, 0.2% with depressive disorder, and 0.2% with anxiety. However, neuropsychiatric diagnoses increased in all groups. At the time of the survey, depressive disorders were present in 35% of the oldest old, a percentage not significantly different from the 36% among the 75- to 84-year-old group and 32% of the 65- to 74-year-old individuals. Neither did rates of anxiety disorders differ by age, occurring in 12% of both the 85-plus and 75- to 84-year-old groups, and 11% of the 65- to 74-year-old group.

However, the oldest old were less likely than the two younger groups to have been diagnosed with a serious mental illness, including schizophrenia spectrum disorder (8.5% in 85-plus group, 13% in 75–84 group, and 17% in 65–74 group) and bipolar spectrum (1.2%, 2.3%, and 3.2%, respectively). Conversely, both the 85-plus and 75–84 groups were more likely than the 65- to 74-year-olds to have dementia (22% in the older groups vs. 13% in the youngest group).

In all three age groups—and especially among the oldest old—the survey found more clinical indicators of dementia and depression than formal diagnoses had indicated. The researchers reported moderate to severe impairment in decision making, an indicator of dementia, in 55% of the oldest old, 34% of the 75- to 84-year-olds, and 11% of the youngest group. Likewise, the proportions with “low mood not easily altered,” a proxy for depressive disorder, were 49%, 37.5%, and 14%, respectively.

“Older residents are not admitted to LTC with neuropsychiatric diagnoses to any degree,” perhaps because of preadmission screening, reported the group led by Dr. Yeager, who works in the Essex County Hospital Medical Center, Cedar Grove, N.J. “Once in the LTC, all groups show an increased prevalence of formal neuropsychiatric conditions.”

Residents with dementia diagnoses were more functionally impaired than their peers without dementia at all ages, the investigators reported.

NATIONAL HARBOR, MD. — Long-term care residents aged 85 and older are less likely than younger residents to have a serious mental illness, more likely to have dementia, and equally likely to have depression or anxiety.

Up to 80% of long-term care (LTC) residents have diagnosable neuropsychiatric disorders, including dementia, according to an analysis of data from the 2004 National Nursing Home Survey. The new findings are among the first detailing the rates of these disorders among the “oldest old” population now making up the fastest-growing segment of the over-65 age group and disproportionately represented in nursing homes.

“As a rapidly growing subpopulation, the oldest old in LTC have what appears to be distinct characteristics relative to other age groups, and these no doubt affect their care,” Catherine A. Yeager, Ph.D., and her associates said in a poster presented at the annual meeting of the Gerontological Society of America.

The 2004 National Nursing Home Survey, conducted between August and December 2004, is one in a series of nationally representative sample surveys of U.S. nursing homes conducted by the Centers for Disease Control and Prevention. A total of 1,174 nursing home facilities participated, producing data for 1,317,300 residents.

The population included 674,500 persons aged 85 and older. That group's average stay in those facilities was longer than that of their younger peers: 862 vs. 766 days. The survey data show “a few notable exceptions” to expected patterns of frailty and disability with age, said Dr. Yeager, of Robert Wood Johnson Medical School, Piscataway, N.J., and her associates.

The 85-plus group was made up of more women (82%) and more whites (90%), and was more likely to be widowed (72%) than were either the aged 75–84 or 65–74 groups. Of the 674,500 oldest old population, 17,300 had lived 100 years or more.

Only small proportions of all residents had neuropsychiatric diagnoses at the time they were admitted to LTC: 10% with dementia, 2% with schizophrenia spectrum, 0.3% with bipolar disorder, 0.2% with depressive disorder, and 0.2% with anxiety. However, neuropsychiatric diagnoses increased in all groups. At the time of the survey, depressive disorders were present in 35% of the oldest old, a percentage not significantly different from the 36% among the 75- to 84-year-old group and 32% of the 65- to 74-year-old individuals. Neither did rates of anxiety disorders differ by age, occurring in 12% of both the 85-plus and 75- to 84-year-old groups, and 11% of the 65- to 74-year-old group.

However, the oldest old were less likely than the two younger groups to have been diagnosed with a serious mental illness, including schizophrenia spectrum disorder (8.5% in 85-plus group, 13% in 75–84 group, and 17% in 65–74 group) and bipolar spectrum (1.2%, 2.3%, and 3.2%, respectively). Conversely, both the 85-plus and 75–84 groups were more likely than the 65- to 74-year-olds to have dementia (22% in the older groups vs. 13% in the youngest group).

In all three age groups—and especially among the oldest old—the survey found more clinical indicators of dementia and depression than formal diagnoses had indicated. The researchers reported moderate to severe impairment in decision making, an indicator of dementia, in 55% of the oldest old, 34% of the 75- to 84-year-olds, and 11% of the youngest group. Likewise, the proportions with “low mood not easily altered,” a proxy for depressive disorder, were 49%, 37.5%, and 14%, respectively.

“Older residents are not admitted to LTC with neuropsychiatric diagnoses to any degree,” perhaps because of preadmission screening, reported the group led by Dr. Yeager, who works in the Essex County Hospital Medical Center, Cedar Grove, N.J. “Once in the LTC, all groups show an increased prevalence of formal neuropsychiatric conditions.”

Residents with dementia diagnoses were more functionally impaired than their peers without dementia at all ages, the investigators reported.

NATIONAL HARBOR, MD. — Weight loss, verbally abusive behavior, and moderate pain were all significant predictors of a new diagnosis of depression among established nursing home residents in a longitudinal analysis.

Although studies have shown that depression affects 20%–55% of nursing home residents, the condition frequently goes unrecognized because of factors such as limited availability of formal psychiatric services, attribution of symptoms to physical ailments, and the tendency to see depressive symptoms as normal in residents. Development of a set of observable indicators of depression may facilitate earlier diagnosis and treatment by nursing home staffs, said Dr. Lorraine J. Phillips and her associates in a poster at the annual meeting of the Gerontological Society of America.

The data were taken from a sample of 13,588 nursing home residents who were among the 127,587 included in the Missouri Minimum Data Set (MDS) from Jan. 1, 2003, to March 31, 2005. The MDS is the federal system of periodic assessments of all nursing home residents' health and functional status, reported state by state and in a national database.

Among the study's inclusion criteria were two sequential assessments 90 days apart (excluding admission and discharge assessments), age 65 years and older, no prior diagnosis of depression or use of antidepressant medications, and no severe cognitive impairment.

Mean age of the study population was 85 years, 74% were women, and 88% were white. More than 66% of residents were widowed, 19.5% were married, and 12% had never married. About 49% had less than a high school education, 37% had finished high school, and 14% had a college education.

Documentation of weight loss at the study's first assessment was associated with a significantly increased chance of being diagnosed with depression between the first and second assessments (odds ratio 1.68, P less than .0001). Verbally abusive behaviors, such as threatening, screaming, or cursing at others, also predicted a depression diagnosis between the two study assessments (OR 1.44, P = .0004).

Moderate pain was a third significant predictor (OR 1.43, P less than .0001), reported Dr. Phillips of the Sinclair School of Nursing at the University of Missouri-Columbia and her associates.

Conversely, frequent urinary incontinence was significantly associated with a lower incidence of depression (OR 0.70, P less than .0001). Post hoc analysis showed a correlation between incontinence and cognitive impairment, suggesting that the lower incidence of depression being diagnosed in nursing home residents can be explained by cognitive impairment that impedes the recognition of depression, the investigators said.

Never being married also predicted a lower incidence of depression (OR 0.66, P = .0004), as did age 95 and above (OR 0.70, P = .0006).

Among the residents with depression, only 12 had “excruciating” pain, a number too small for statistically significant analysis, the researchers noted.

This research was funded by the University of Missouri MDS and Quality Research Team (www.nursinghomehelp.org

NATIONAL HARBOR, MD. — Weight loss, verbally abusive behavior, and moderate pain were all significant predictors of a new diagnosis of depression among established nursing home residents in a longitudinal analysis.

Although studies have shown that depression affects 20%–55% of nursing home residents, the condition frequently goes unrecognized because of factors such as limited availability of formal psychiatric services, attribution of symptoms to physical ailments, and the tendency to see depressive symptoms as normal in residents. Development of a set of observable indicators of depression may facilitate earlier diagnosis and treatment by nursing home staffs, said Dr. Lorraine J. Phillips and her associates in a poster at the annual meeting of the Gerontological Society of America.

The data were taken from a sample of 13,588 nursing home residents who were among the 127,587 included in the Missouri Minimum Data Set (MDS) from Jan. 1, 2003, to March 31, 2005. The MDS is the federal system of periodic assessments of all nursing home residents' health and functional status, reported state by state and in a national database.

Among the study's inclusion criteria were two sequential assessments 90 days apart (excluding admission and discharge assessments), age 65 years and older, no prior diagnosis of depression or use of antidepressant medications, and no severe cognitive impairment.

Mean age of the study population was 85 years, 74% were women, and 88% were white. More than 66% of residents were widowed, 19.5% were married, and 12% had never married. About 49% had less than a high school education, 37% had finished high school, and 14% had a college education.

Documentation of weight loss at the study's first assessment was associated with a significantly increased chance of being diagnosed with depression between the first and second assessments (odds ratio 1.68, P less than .0001). Verbally abusive behaviors, such as threatening, screaming, or cursing at others, also predicted a depression diagnosis between the two study assessments (OR 1.44, P = .0004).

Moderate pain was a third significant predictor (OR 1.43, P less than .0001), reported Dr. Phillips of the Sinclair School of Nursing at the University of Missouri-Columbia and her associates.

Conversely, frequent urinary incontinence was significantly associated with a lower incidence of depression (OR 0.70, P less than .0001). Post hoc analysis showed a correlation between incontinence and cognitive impairment, suggesting that the lower incidence of depression being diagnosed in nursing home residents can be explained by cognitive impairment that impedes the recognition of depression, the investigators said.

Never being married also predicted a lower incidence of depression (OR 0.66, P = .0004), as did age 95 and above (OR 0.70, P = .0006).

Among the residents with depression, only 12 had “excruciating” pain, a number too small for statistically significant analysis, the researchers noted.

This research was funded by the University of Missouri MDS and Quality Research Team (www.nursinghomehelp.org

NATIONAL HARBOR, MD. — Weight loss, verbally abusive behavior, and moderate pain were all significant predictors of a new diagnosis of depression among established nursing home residents in a longitudinal analysis.

Although studies have shown that depression affects 20%–55% of nursing home residents, the condition frequently goes unrecognized because of factors such as limited availability of formal psychiatric services, attribution of symptoms to physical ailments, and the tendency to see depressive symptoms as normal in residents. Development of a set of observable indicators of depression may facilitate earlier diagnosis and treatment by nursing home staffs, said Dr. Lorraine J. Phillips and her associates in a poster at the annual meeting of the Gerontological Society of America.

The data were taken from a sample of 13,588 nursing home residents who were among the 127,587 included in the Missouri Minimum Data Set (MDS) from Jan. 1, 2003, to March 31, 2005. The MDS is the federal system of periodic assessments of all nursing home residents' health and functional status, reported state by state and in a national database.

Among the study's inclusion criteria were two sequential assessments 90 days apart (excluding admission and discharge assessments), age 65 years and older, no prior diagnosis of depression or use of antidepressant medications, and no severe cognitive impairment.

Mean age of the study population was 85 years, 74% were women, and 88% were white. More than 66% of residents were widowed, 19.5% were married, and 12% had never married. About 49% had less than a high school education, 37% had finished high school, and 14% had a college education.

Documentation of weight loss at the study's first assessment was associated with a significantly increased chance of being diagnosed with depression between the first and second assessments (odds ratio 1.68, P less than .0001). Verbally abusive behaviors, such as threatening, screaming, or cursing at others, also predicted a depression diagnosis between the two study assessments (OR 1.44, P = .0004).

Moderate pain was a third significant predictor (OR 1.43, P less than .0001), reported Dr. Phillips of the Sinclair School of Nursing at the University of Missouri-Columbia and her associates.

Conversely, frequent urinary incontinence was significantly associated with a lower incidence of depression (OR 0.70, P less than .0001). Post hoc analysis showed a correlation between incontinence and cognitive impairment, suggesting that the lower incidence of depression being diagnosed in nursing home residents can be explained by cognitive impairment that impedes the recognition of depression, the investigators said.

Never being married also predicted a lower incidence of depression (OR 0.66, P = .0004), as did age 95 and above (OR 0.70, P = .0006).

Among the residents with depression, only 12 had “excruciating” pain, a number too small for statistically significant analysis, the researchers noted.

This research was funded by the University of Missouri MDS and Quality Research Team (www.nursinghomehelp.org

Patients who revert from impaired to normal glucose tolerance, especially those who do so via intensive lifestyle modification, can significantly reduce their cardiovascular risk factors, according to an analysis of data from the Diabetes Prevention Program.

The Diabetes Prevention Program (DPP) was a landmark study that showed that intervention with intensive lifestyle (ILS) modification and, to a lesser degree, metformin could reduce or delay the progression to diabetes over a mean 3.2 years follow-up in patients who had impaired glucose tolerance (IGT) at baseline (N. Engl. J. Med. 2002;346:393–403).

The new analysis in those 3,234 DPP patients also showed a lesser improvement with metformin (Diabetes Care 2009 Jan. 26; doi:10.2337/dc08–0494). “Importantly, improvement of glucose tolerance is associated with a more favorable risk factor profile, with intensive lifestyle accompanied by larger improvements than metformin,” said DPP writing group chair Dr. Ronald B. Goldberg, of the University of Miami, and his associates.

Overall, deterioration of glucose tolerance was associated with a worsening of risk factor levels, whereas improvement in status was associated with a beneficial risk factor change. The relationship between changes from normal glucose tolerance (NGT) to IGT to diabetes and changes in risk factors for cardiovascular disease (CVD) were significant for all risk factors except LDL peak particle density (LDL-PPD) in the intensive lifestyle group and for HDL cholesterol in the placebo group, they reported.

The biggest changes in CVD risk factor profile occurred among the patients in the intensive lifestyle group who transitioned from IGT to NGT. Their systolic blood pressure and triglyceride levels fell by about 25% over the study period, whereas HDL cholesterol and LDL-PPD increased by about 8% and 17%, respectively, from baseline.

Among those whose glucose tolerance status didn't change throughout the study, risk factors also didn't change among those with IGT. For those who achieved NGT during the study, risk factor profiles improved slightly in the intensive lifestyle group: Systolic blood pressure fell by 7%, diastolic blood pressure by 9%, and triglycerides by 7% from baseline, while HDL cholesterol and LDL-PPD increased by 5% and 6%, respectively.

Among the patients who progressed from IGT to diabetes, there were small—but mostly insignificant—deteriorations in their cardiovascular risk factor profiles. In the ILS group, progression from IGT to diabetes was not associated with any significant change in risk factors.

“There is no unique effect of conversion to diabetes but rather a linear relationship between glycemic measures and risk factor levels,” the researchers said.

'Improvement of glucose tolerance is associated with a more favorable [CV] risk factor profile.' DR. GOLDBERG

Patients who revert from impaired to normal glucose tolerance, especially those who do so via intensive lifestyle modification, can significantly reduce their cardiovascular risk factors, according to an analysis of data from the Diabetes Prevention Program.

The Diabetes Prevention Program (DPP) was a landmark study that showed that intervention with intensive lifestyle (ILS) modification and, to a lesser degree, metformin could reduce or delay the progression to diabetes over a mean 3.2 years follow-up in patients who had impaired glucose tolerance (IGT) at baseline (N. Engl. J. Med. 2002;346:393–403).

The new analysis in those 3,234 DPP patients also showed a lesser improvement with metformin (Diabetes Care 2009 Jan. 26; doi:10.2337/dc08–0494). “Importantly, improvement of glucose tolerance is associated with a more favorable risk factor profile, with intensive lifestyle accompanied by larger improvements than metformin,” said DPP writing group chair Dr. Ronald B. Goldberg, of the University of Miami, and his associates.

Overall, deterioration of glucose tolerance was associated with a worsening of risk factor levels, whereas improvement in status was associated with a beneficial risk factor change. The relationship between changes from normal glucose tolerance (NGT) to IGT to diabetes and changes in risk factors for cardiovascular disease (CVD) were significant for all risk factors except LDL peak particle density (LDL-PPD) in the intensive lifestyle group and for HDL cholesterol in the placebo group, they reported.

The biggest changes in CVD risk factor profile occurred among the patients in the intensive lifestyle group who transitioned from IGT to NGT. Their systolic blood pressure and triglyceride levels fell by about 25% over the study period, whereas HDL cholesterol and LDL-PPD increased by about 8% and 17%, respectively, from baseline.

Among those whose glucose tolerance status didn't change throughout the study, risk factors also didn't change among those with IGT. For those who achieved NGT during the study, risk factor profiles improved slightly in the intensive lifestyle group: Systolic blood pressure fell by 7%, diastolic blood pressure by 9%, and triglycerides by 7% from baseline, while HDL cholesterol and LDL-PPD increased by 5% and 6%, respectively.

Among the patients who progressed from IGT to diabetes, there were small—but mostly insignificant—deteriorations in their cardiovascular risk factor profiles. In the ILS group, progression from IGT to diabetes was not associated with any significant change in risk factors.

“There is no unique effect of conversion to diabetes but rather a linear relationship between glycemic measures and risk factor levels,” the researchers said.

'Improvement of glucose tolerance is associated with a more favorable [CV] risk factor profile.' DR. GOLDBERG

Patients who revert from impaired to normal glucose tolerance, especially those who do so via intensive lifestyle modification, can significantly reduce their cardiovascular risk factors, according to an analysis of data from the Diabetes Prevention Program.

The Diabetes Prevention Program (DPP) was a landmark study that showed that intervention with intensive lifestyle (ILS) modification and, to a lesser degree, metformin could reduce or delay the progression to diabetes over a mean 3.2 years follow-up in patients who had impaired glucose tolerance (IGT) at baseline (N. Engl. J. Med. 2002;346:393–403).

The new analysis in those 3,234 DPP patients also showed a lesser improvement with metformin (Diabetes Care 2009 Jan. 26; doi:10.2337/dc08–0494). “Importantly, improvement of glucose tolerance is associated with a more favorable risk factor profile, with intensive lifestyle accompanied by larger improvements than metformin,” said DPP writing group chair Dr. Ronald B. Goldberg, of the University of Miami, and his associates.

Overall, deterioration of glucose tolerance was associated with a worsening of risk factor levels, whereas improvement in status was associated with a beneficial risk factor change. The relationship between changes from normal glucose tolerance (NGT) to IGT to diabetes and changes in risk factors for cardiovascular disease (CVD) were significant for all risk factors except LDL peak particle density (LDL-PPD) in the intensive lifestyle group and for HDL cholesterol in the placebo group, they reported.

The biggest changes in CVD risk factor profile occurred among the patients in the intensive lifestyle group who transitioned from IGT to NGT. Their systolic blood pressure and triglyceride levels fell by about 25% over the study period, whereas HDL cholesterol and LDL-PPD increased by about 8% and 17%, respectively, from baseline.

Among those whose glucose tolerance status didn't change throughout the study, risk factors also didn't change among those with IGT. For those who achieved NGT during the study, risk factor profiles improved slightly in the intensive lifestyle group: Systolic blood pressure fell by 7%, diastolic blood pressure by 9%, and triglycerides by 7% from baseline, while HDL cholesterol and LDL-PPD increased by 5% and 6%, respectively.

Among the patients who progressed from IGT to diabetes, there were small—but mostly insignificant—deteriorations in their cardiovascular risk factor profiles. In the ILS group, progression from IGT to diabetes was not associated with any significant change in risk factors.

“There is no unique effect of conversion to diabetes but rather a linear relationship between glycemic measures and risk factor levels,” the researchers said.

'Improvement of glucose tolerance is associated with a more favorable [CV] risk factor profile.' DR. GOLDBERG

Concern about harm from antihyperglycemic and antihypertensive medications is associated with their underuse among patients with diabetes, even after controlling for economic factors.

The finding, from a survey of 803 adults with diabetes in Flint, Mich., suggests that “Because medication concerns may directly influence cost-related underuse, improved illness outcome may be achievable by simultaneously addressing attitudinal and economic issues,” wrote Dr. James E. Aikens and Dr. John D. Piette (Diabetes Care 2009;32:19–24).

The survey included 803 diabetes patients using antihyperglycemic agents, of whom 573 also used antihypertensive medications. Slightly more than half of the total group was black, and slightly more than half was female. More than a third had low functional health literacy (FHL) as measured by validated scales. The patients had a mean hemoglobin A_1c (HbA_1c) of 7.8% and mean blood pressure of 139/83 mm Hg.

Patients' treatment beliefs were measured with the well-validated Beliefs About Medicines Questionnaire (BMQ), with separate versions for the two types of medications. Five items are designed to elicit perceived medication necessity—such as “My health, at present, depends on my [diabetes or blood pressure] medication.” Six items pertain to concern, such as “I sometimes worry about the long-term effects of my … medicine.” For each item, patients choose from a 5-point response scale, ranging from “strongly agree” to “strongly disagree.”

Overall, perceived necessity was stronger than concern for both types of medication. Patients taking both types rated the antihyperglycemics as being both more necessary and more concerning than the antihypertensive medication, although the effect sizes were relatively small, said Dr. Aikens and Dr. Piette of the University of Michigan, Ann Arbor.

Perceived necessity for one or both types of medication was stronger among participants who were younger, female, had more comorbid conditions, were prescribed more medications, and were prescribed insulin. Perceived harmfulness of one or both types of medications was stronger among those who were younger, were black, were of low income, were diagnosed with more comorbid conditions, were dissatisfied with medication information, and were of low FHL.

“Given that perceived discrimination and distrust in health care have been documented in African Americans with diabetes, the most culturally sensitive interventions will be those that deal directly and skillfully with medication fears,” they said.

After adjustment for age, sex, ethnicity, and income, perceived need for antihyperglycemic medications was independently associated with having a greater number of prescriptions and being prescribed insulin. In contrast, concern about antihyperglycemic medications was associated with dissatisfaction with medication information, low FHL, and high out-of-pocket prescription costs.

Perceived need for antihypertensives—after adjustment for age, sex, ethnicity, and income—was associated with more comorbid conditions and satisfaction with medication information. As with antihyperglycemics, concern about antihypertensives also was associated with dissatisfaction with medication information and low FHL.

Medication underuse was measured by two questions: “In the past 12 months, have you ever taken less of your [diabetes/hypertension] medication than prescribed by your doctor because of the cost?” and “Many people do not take their prescription medication exactly as prescribed by their doctor. In the past year, have you ever taken less of your … medication for any reason other than the cost?”

Almost half (47%) of participants reported antihyperglycemic underuse, of whom about a third (16.5% of the total) reported cost-related underuse. However, concern about the medications was associated with both cost-related and non-cost-related underuse. Neither perception of medical necessity nor concern regarding antihyperglycemics was significantly related to HbA_1c, although the relationship with concern nearly reached significance.

Of those prescribed antihypertensives, 31% reported underuse, with cost being a reason for about half (15%) of the group.

The study was funded by the American Diabetes Association and the Michigan Diabetes Research and Training Center, with a grant from the National Institutes of Health. The investigators reported no potential conflicts of interest.

Concern about harm from antihyperglycemic and antihypertensive medications is associated with their underuse among patients with diabetes, even after controlling for economic factors.

The finding, from a survey of 803 adults with diabetes in Flint, Mich., suggests that “Because medication concerns may directly influence cost-related underuse, improved illness outcome may be achievable by simultaneously addressing attitudinal and economic issues,” wrote Dr. James E. Aikens and Dr. John D. Piette (Diabetes Care 2009;32:19–24).

The survey included 803 diabetes patients using antihyperglycemic agents, of whom 573 also used antihypertensive medications. Slightly more than half of the total group was black, and slightly more than half was female. More than a third had low functional health literacy (FHL) as measured by validated scales. The patients had a mean hemoglobin A_1c (HbA_1c) of 7.8% and mean blood pressure of 139/83 mm Hg.

Patients' treatment beliefs were measured with the well-validated Beliefs About Medicines Questionnaire (BMQ), with separate versions for the two types of medications. Five items are designed to elicit perceived medication necessity—such as “My health, at present, depends on my [diabetes or blood pressure] medication.” Six items pertain to concern, such as “I sometimes worry about the long-term effects of my … medicine.” For each item, patients choose from a 5-point response scale, ranging from “strongly agree” to “strongly disagree.”

Overall, perceived necessity was stronger than concern for both types of medication. Patients taking both types rated the antihyperglycemics as being both more necessary and more concerning than the antihypertensive medication, although the effect sizes were relatively small, said Dr. Aikens and Dr. Piette of the University of Michigan, Ann Arbor.

Perceived necessity for one or both types of medication was stronger among participants who were younger, female, had more comorbid conditions, were prescribed more medications, and were prescribed insulin. Perceived harmfulness of one or both types of medications was stronger among those who were younger, were black, were of low income, were diagnosed with more comorbid conditions, were dissatisfied with medication information, and were of low FHL.

“Given that perceived discrimination and distrust in health care have been documented in African Americans with diabetes, the most culturally sensitive interventions will be those that deal directly and skillfully with medication fears,” they said.

After adjustment for age, sex, ethnicity, and income, perceived need for antihyperglycemic medications was independently associated with having a greater number of prescriptions and being prescribed insulin. In contrast, concern about antihyperglycemic medications was associated with dissatisfaction with medication information, low FHL, and high out-of-pocket prescription costs.

Perceived need for antihypertensives—after adjustment for age, sex, ethnicity, and income—was associated with more comorbid conditions and satisfaction with medication information. As with antihyperglycemics, concern about antihypertensives also was associated with dissatisfaction with medication information and low FHL.

Medication underuse was measured by two questions: “In the past 12 months, have you ever taken less of your [diabetes/hypertension] medication than prescribed by your doctor because of the cost?” and “Many people do not take their prescription medication exactly as prescribed by their doctor. In the past year, have you ever taken less of your … medication for any reason other than the cost?”

Almost half (47%) of participants reported antihyperglycemic underuse, of whom about a third (16.5% of the total) reported cost-related underuse. However, concern about the medications was associated with both cost-related and non-cost-related underuse. Neither perception of medical necessity nor concern regarding antihyperglycemics was significantly related to HbA_1c, although the relationship with concern nearly reached significance.

Of those prescribed antihypertensives, 31% reported underuse, with cost being a reason for about half (15%) of the group.

The study was funded by the American Diabetes Association and the Michigan Diabetes Research and Training Center, with a grant from the National Institutes of Health. The investigators reported no potential conflicts of interest.

Concern about harm from antihyperglycemic and antihypertensive medications is associated with their underuse among patients with diabetes, even after controlling for economic factors.

The finding, from a survey of 803 adults with diabetes in Flint, Mich., suggests that “Because medication concerns may directly influence cost-related underuse, improved illness outcome may be achievable by simultaneously addressing attitudinal and economic issues,” wrote Dr. James E. Aikens and Dr. John D. Piette (Diabetes Care 2009;32:19–24).

The survey included 803 diabetes patients using antihyperglycemic agents, of whom 573 also used antihypertensive medications. Slightly more than half of the total group was black, and slightly more than half was female. More than a third had low functional health literacy (FHL) as measured by validated scales. The patients had a mean hemoglobin A_1c (HbA_1c) of 7.8% and mean blood pressure of 139/83 mm Hg.

Patients' treatment beliefs were measured with the well-validated Beliefs About Medicines Questionnaire (BMQ), with separate versions for the two types of medications. Five items are designed to elicit perceived medication necessity—such as “My health, at present, depends on my [diabetes or blood pressure] medication.” Six items pertain to concern, such as “I sometimes worry about the long-term effects of my … medicine.” For each item, patients choose from a 5-point response scale, ranging from “strongly agree” to “strongly disagree.”

Overall, perceived necessity was stronger than concern for both types of medication. Patients taking both types rated the antihyperglycemics as being both more necessary and more concerning than the antihypertensive medication, although the effect sizes were relatively small, said Dr. Aikens and Dr. Piette of the University of Michigan, Ann Arbor.

Perceived necessity for one or both types of medication was stronger among participants who were younger, female, had more comorbid conditions, were prescribed more medications, and were prescribed insulin. Perceived harmfulness of one or both types of medications was stronger among those who were younger, were black, were of low income, were diagnosed with more comorbid conditions, were dissatisfied with medication information, and were of low FHL.

“Given that perceived discrimination and distrust in health care have been documented in African Americans with diabetes, the most culturally sensitive interventions will be those that deal directly and skillfully with medication fears,” they said.

After adjustment for age, sex, ethnicity, and income, perceived need for antihyperglycemic medications was independently associated with having a greater number of prescriptions and being prescribed insulin. In contrast, concern about antihyperglycemic medications was associated with dissatisfaction with medication information, low FHL, and high out-of-pocket prescription costs.

Perceived need for antihypertensives—after adjustment for age, sex, ethnicity, and income—was associated with more comorbid conditions and satisfaction with medication information. As with antihyperglycemics, concern about antihypertensives also was associated with dissatisfaction with medication information and low FHL.

Medication underuse was measured by two questions: “In the past 12 months, have you ever taken less of your [diabetes/hypertension] medication than prescribed by your doctor because of the cost?” and “Many people do not take their prescription medication exactly as prescribed by their doctor. In the past year, have you ever taken less of your … medication for any reason other than the cost?”

Almost half (47%) of participants reported antihyperglycemic underuse, of whom about a third (16.5% of the total) reported cost-related underuse. However, concern about the medications was associated with both cost-related and non-cost-related underuse. Neither perception of medical necessity nor concern regarding antihyperglycemics was significantly related to HbA_1c, although the relationship with concern nearly reached significance.

Of those prescribed antihypertensives, 31% reported underuse, with cost being a reason for about half (15%) of the group.

The study was funded by the American Diabetes Association and the Michigan Diabetes Research and Training Center, with a grant from the National Institutes of Health. The investigators reported no potential conflicts of interest.

WASHINGTON — Single-day famciclovir therapy was similar in safety and efficacy to a 3-day course of valacyclovir in the first head-to-head comparison of the two oral medications for the treatment of recurrent genital herpes.

Previous data showed that, when taken within 6 hours of symptom onset, single-day famciclovir (Famvir, 1,000 mg b.i.d.) increased the proportion of patients with aborted episodes from 13% to 23%, and reduced healing time and duration of symptoms by 2 days, vs. placebo (Clin. Infect. Dis. 2006;42:8-13).

Now, the findings of a multicenter, randomized, double-blind study of 751 adults with recurrent genital herpes suggest that single-day famciclovir is as safe and effective as 3-day valacyclovir (Valtrex, 500 mg b.i.d.), Dr. Stephen Tyring said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Patients had at least four outbreaks in the preceding 12 months, with positive herpes simplex virus serology. About two-thirds were female, and most had used suppressive therapy in the previous 12 months. Of 1,179 randomized patients, 751 started the study medication within 6 hours of their next recurrence and were included in the analysis.

The proportion of patients with aborted lesions in the intent-to-treat population was 32.7% among 370 famciclovir patients and 33.6% among 381 valacyclovir patients. Time to healing of nonaborted lesions was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir, an insignificant difference, said Dr. Tyring of the Center for Clinical Studies at Texas Medical Center, Houston.

About one-fifth of each group reported adverse events, including drug-related events in 11% with famciclovir and 9% with valacyclovir. Headache was the most common adverse event (8% with famciclovir and 4% with valacyclovir).

Dr. Tyring receives research funding and is on the speakers bureau for Novartis, which makes Famvir, and GlaxoSmithKline, which makes Valtrex.

WASHINGTON — Single-day famciclovir therapy was similar in safety and efficacy to a 3-day course of valacyclovir in the first head-to-head comparison of the two oral medications for the treatment of recurrent genital herpes.

Previous data showed that, when taken within 6 hours of symptom onset, single-day famciclovir (Famvir, 1,000 mg b.i.d.) increased the proportion of patients with aborted episodes from 13% to 23%, and reduced healing time and duration of symptoms by 2 days, vs. placebo (Clin. Infect. Dis. 2006;42:8-13).

Now, the findings of a multicenter, randomized, double-blind study of 751 adults with recurrent genital herpes suggest that single-day famciclovir is as safe and effective as 3-day valacyclovir (Valtrex, 500 mg b.i.d.), Dr. Stephen Tyring said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Patients had at least four outbreaks in the preceding 12 months, with positive herpes simplex virus serology. About two-thirds were female, and most had used suppressive therapy in the previous 12 months. Of 1,179 randomized patients, 751 started the study medication within 6 hours of their next recurrence and were included in the analysis.

The proportion of patients with aborted lesions in the intent-to-treat population was 32.7% among 370 famciclovir patients and 33.6% among 381 valacyclovir patients. Time to healing of nonaborted lesions was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir, an insignificant difference, said Dr. Tyring of the Center for Clinical Studies at Texas Medical Center, Houston.

About one-fifth of each group reported adverse events, including drug-related events in 11% with famciclovir and 9% with valacyclovir. Headache was the most common adverse event (8% with famciclovir and 4% with valacyclovir).

Dr. Tyring receives research funding and is on the speakers bureau for Novartis, which makes Famvir, and GlaxoSmithKline, which makes Valtrex.

WASHINGTON — Single-day famciclovir therapy was similar in safety and efficacy to a 3-day course of valacyclovir in the first head-to-head comparison of the two oral medications for the treatment of recurrent genital herpes.

Previous data showed that, when taken within 6 hours of symptom onset, single-day famciclovir (Famvir, 1,000 mg b.i.d.) increased the proportion of patients with aborted episodes from 13% to 23%, and reduced healing time and duration of symptoms by 2 days, vs. placebo (Clin. Infect. Dis. 2006;42:8-13).

Now, the findings of a multicenter, randomized, double-blind study of 751 adults with recurrent genital herpes suggest that single-day famciclovir is as safe and effective as 3-day valacyclovir (Valtrex, 500 mg b.i.d.), Dr. Stephen Tyring said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Patients had at least four outbreaks in the preceding 12 months, with positive herpes simplex virus serology. About two-thirds were female, and most had used suppressive therapy in the previous 12 months. Of 1,179 randomized patients, 751 started the study medication within 6 hours of their next recurrence and were included in the analysis.

The proportion of patients with aborted lesions in the intent-to-treat population was 32.7% among 370 famciclovir patients and 33.6% among 381 valacyclovir patients. Time to healing of nonaborted lesions was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir, an insignificant difference, said Dr. Tyring of the Center for Clinical Studies at Texas Medical Center, Houston.

About one-fifth of each group reported adverse events, including drug-related events in 11% with famciclovir and 9% with valacyclovir. Headache was the most common adverse event (8% with famciclovir and 4% with valacyclovir).

Dr. Tyring receives research funding and is on the speakers bureau for Novartis, which makes Famvir, and GlaxoSmithKline, which makes Valtrex.

New York City's diabetes prevalence and control numbers paint a dismal picture, but public health officials hope that the now 3-year-old hemoglobin A_1c registry will help brighten the future for the city's nearly 700,000 adult residents living with the condition.

Newly published data from the New York City Department of Health and Mental Hygiene suggest that one in every eight adult residents in the city has diabetes, more than a third don't know it, and even among those who are aware they have the condition, few achieve adequate control of glucose, blood pressure and cholesterol levels (Diabetes Care 2009;32:57–62).

“Adult New Yorkers are at least as overweight or obese as has been reported recently in [United States] national data, and the prevalence of diabetes and impaired fasting glucose causes great concern. The Big Apple is sugarcoated, and improvements in obesity and lifestyle will be needed to improve this situation in the future,” Dr. Peter W.F. Wilson and Dr. K.M. Venkat Narayan, both of Emory University, Atlanta, said in an editorial accompanying the report (Diabetes Care 2009;32:204–5).

Indeed, improving the prospects for people with diabetes—and those at risk for it—has been deemed a high priority for the city's health department, under the leadership of Dr. Thomas Frieden. As part of that effort, on Jan. 15, 2006, the city implemented a rule requiring clinical laboratories to report all hemoglobin A_1c (HbA_1c) testing results electronically to the health department. Since then, more than 3 million results have been collected from more than 1 million individuals, Dr. Shadi Chamany, director of the department's diabetes prevention and control program, said in an interview.

“The original goal of the registry was to use public health tools to support the clinical community and the patient community in improving diabetes outcomes. … This is a starting point, a building block. It's the foundation,” Dr. Chamany said.

Beyond merely collecting the data, the health department offers quarterly reports of HbA_1c results to providers and patients who opt to receive them and is also working in person with practices and providers to support diabetes management. “One thing I think has been really great about this project is that we're learning so much as we go out to all the practices and people are telling us what's going on and what they really need. … I think that as we're going out and reaching so many people, we're also raising awareness,” Dr. Chamany said. “I think this mobilizing of resources and efforts is really going to make a change.”

Clearly, improvement is needed. The newly released prevalence and control data come from another New York City health department project, the first-ever community-level Health and Nutrition Examination Survey (NYC HANES), a cross-sectional examination survey modeled after the National Health and Nutrition Examination Survey (NHANES) conducted annually by the Centers for Disease Control and Prevention. The NYC HANES data were obtained from face-to-face surveys and physical examinations conducted during June-December 2004 with 1,999 randomly selected adults aged 20 years and older (out of a total 3,047 eligible).

Based on the NYC HANES data, the estimated prevalence of diabetes for all New Yorkers aged 20 years and older was 12.5%, representing a population of approximately 696,000. This prevalence is significantly higher than the published NHANES estimate of 9.3% from 1999–2002. This difference is not likely to be caused by an increase in the national number; rather, there was a 17% increase in self-reported diabetes among New Yorkers between 2002 and 2004, whereas national rates did not increase significantly. The high concentration of poverty and racial/ethnic diversity most likely contributes to New York City's increasing diabetes prevalence, Dr. Lorna E. Thorpe and her associates said. (See sidebar for specific numbers.)

Given that these data are now 5 years old, the health department would like to conduct a follow-up, but it won't be easy because of current financial constraints, said Dr. Thorpe, deputy commissioner in charge of the division of epidemiology at the New York City health department. “We didn't get federal support for the first NYC HANES. It was done with New York City tax dollars only. We can't pull off a second one yet. We're exploring ways for how to do it,” she noted.

But funding for the HbA_1c registry is ongoing thus far, Dr. Chamany said. More than 90% of clinical laboratories in the city that conduct HbA_1c testing and that already do electronic reporting for other diseases currently are reporting HbA_1c results. Inclusion in the registry is mandatory for all patients with diabetes in the city, but receipt of the quarterly reports is voluntary for providers and patients. Initially, the reports were offered to just seven health care facilities serving the south Bronx, an area of the city with exceptionally high rates of diabetes. The offer now has been extended to 60 facilities around the city, and more than 1,000 individual providers are currently receiving the reports.

Patients of those providers also are receiving letters from the health department—imprinted with the name of the practice—indicating their HbA_1c level, stratified by green (less than 7%), yellow (7%–9%), and red (above 9%). Patients can elect not to receive the letters, but fewer than 20 individuals have done so in the 3 years since the program began, Dr. Chamany said.

Indeed, while there was a great deal of concern voiced about privacy when the registry was launched, this doesn't appear to be a big problem now. “Whenever you have mandatory reporting, there is concern. We do get occasional questions about how the information is protected, but we're not getting a huge flood of opt-outs,” she noted.

The health department is planning to conduct interviews with medical directors of health care facilities around the city to find out how the reports are being received and aims to publish that information—along with the first 3 years' worth of registry data—later this year, she said.

In the meantime, the agency is moving forward with a pilot project designed to bring diabetes self-management to local communities. The 16-week course will focus on goal-setting skills for patients with diabetes relating to lifestyle modification. It initially will be piloted in Harlem, then expanded if all goes well. “One thing physicians have told us is they need services to refer patients to, Dr. Chamany commented. “There are … just not enough [providers] to do education,” Dr. Chamany commented.

And, with regard to the less-than-optimal data indicated by the NYC HANES, “We need more creative ways to get self-management support out there. Otherwise, those numbers aren't going to move.”

'The Big Apple is sugarcoated, and improvements in … lifestyle will be needed to improve this situation.' DR. WILSON

NYC's Diabetes Numbers Show Room for Improvement

The NYC HANES data revealed some telling facts about New York City's diabetic population.

Diabetes prevalence in NYC HANES increased with age, from 2.5% among those aged 20–39 years to 28.3% among adults aged 60 years and older, but did not differ significantly by sex, race/ethnicity, or nativity. Diabetes prevalence was significantly higher among those with incomes less than $20,000 versus those above that figure (17.0% vs. 9.1%).

The prevalence of diagnosed diabetes was 8.7% and undiagnosed diabetes, 3.8%, indicating that nearly one-third (30.4%) of adults with diabetes were undiagnosed. Blacks and Asians had the highest prevalence of diagnosed diabetes (12.1% and 11.4%, respectively), while the rate of diagnosed diabetes was significantly lower among whites (6.2%), compared with blacks.

Nearly one-fourth (23.5%) of the adults had impaired fasting glucose (defined as a fasting glucose level of 100–125 mg/dL). This also increased with age, reaching more than one-third of the population aged 60 years and older. Men had higher levels of IFG than did women (29.6% vs. 18.4%), and Asians had the highest rate of IFG of all racial and ethnic groups, at 32.4%.

After adjustment for other risk factors, Asians and blacks with normal weight (body mass index of less than 25 kg/m

Indeed, other published studies also have pointed to the fact that Asians—particularly those from south Asia, including India, Pakistan, and Bangladesh—tend to have higher levels of glucose impairment than do other races/ethnicities at lower BMIs. “It's very difficult to tease out, but there is probably a sufficient accumulation of literature suggesting that screening of these individuals should happen at lower weights, although the exact cutoff is not known,” said Dr. Lorna E. Thorpe.

Looking beyond prevalence to risk factor control, NYC HANES revealed that more than half of the adults with diagnosed diabetes (55.1%) had an HbA_1c value of 7% or higher, and 17.1% had an HbA_1c greater than 9%. A total of 12.3% were on insulin (with or without oral agents), 71.5% were on oral agents only, and 16.1% were not taking diabetes medications. Only 15.8% of those with HbA_1c levels above 9% were taking insulin. “Our findings suggest that providers in New York City should consider insulin therapy earlier in the course of their patients' disease,” the investigators wrote.

More than two-thirds (69.7%) the adults with diagnosed diabetes were identified as hypertensive, and half (50%) had elevated blood pressures at the time of the interview. Of those with diabetes and elevated blood pressure, 43.1% were not on antihypertensive medications and 35.4% had not been diagnosed with hypertension. Similarly, nearly two-thirds with diagnosed diabetes had elevated LDL cholesterol levels, of whom three-fourths were not taking cholesterol-lowering medications and 42.8% were undiagnosed for hypercholesterolemia.

“All in all, the 2004 NYC HANES picture does not look so nice,” Dr. Peter W. F. Wilson and Dr. K.M. Venkat Narayan said in their editorial.

New York City's diabetes prevalence and control numbers paint a dismal picture, but public health officials hope that the now 3-year-old hemoglobin A_1c registry will help brighten the future for the city's nearly 700,000 adult residents living with the condition.

Newly published data from the New York City Department of Health and Mental Hygiene suggest that one in every eight adult residents in the city has diabetes, more than a third don't know it, and even among those who are aware they have the condition, few achieve adequate control of glucose, blood pressure and cholesterol levels (Diabetes Care 2009;32:57–62).

“Adult New Yorkers are at least as overweight or obese as has been reported recently in [United States] national data, and the prevalence of diabetes and impaired fasting glucose causes great concern. The Big Apple is sugarcoated, and improvements in obesity and lifestyle will be needed to improve this situation in the future,” Dr. Peter W.F. Wilson and Dr. K.M. Venkat Narayan, both of Emory University, Atlanta, said in an editorial accompanying the report (Diabetes Care 2009;32:204–5).

Indeed, improving the prospects for people with diabetes—and those at risk for it—has been deemed a high priority for the city's health department, under the leadership of Dr. Thomas Frieden. As part of that effort, on Jan. 15, 2006, the city implemented a rule requiring clinical laboratories to report all hemoglobin A_1c (HbA_1c) testing results electronically to the health department. Since then, more than 3 million results have been collected from more than 1 million individuals, Dr. Shadi Chamany, director of the department's diabetes prevention and control program, said in an interview.

“The original goal of the registry was to use public health tools to support the clinical community and the patient community in improving diabetes outcomes. … This is a starting point, a building block. It's the foundation,” Dr. Chamany said.

Beyond merely collecting the data, the health department offers quarterly reports of HbA_1c results to providers and patients who opt to receive them and is also working in person with practices and providers to support diabetes management. “One thing I think has been really great about this project is that we're learning so much as we go out to all the practices and people are telling us what's going on and what they really need. … I think that as we're going out and reaching so many people, we're also raising awareness,” Dr. Chamany said. “I think this mobilizing of resources and efforts is really going to make a change.”

Clearly, improvement is needed. The newly released prevalence and control data come from another New York City health department project, the first-ever community-level Health and Nutrition Examination Survey (NYC HANES), a cross-sectional examination survey modeled after the National Health and Nutrition Examination Survey (NHANES) conducted annually by the Centers for Disease Control and Prevention. The NYC HANES data were obtained from face-to-face surveys and physical examinations conducted during June-December 2004 with 1,999 randomly selected adults aged 20 years and older (out of a total 3,047 eligible).

Based on the NYC HANES data, the estimated prevalence of diabetes for all New Yorkers aged 20 years and older was 12.5%, representing a population of approximately 696,000. This prevalence is significantly higher than the published NHANES estimate of 9.3% from 1999–2002. This difference is not likely to be caused by an increase in the national number; rather, there was a 17% increase in self-reported diabetes among New Yorkers between 2002 and 2004, whereas national rates did not increase significantly. The high concentration of poverty and racial/ethnic diversity most likely contributes to New York City's increasing diabetes prevalence, Dr. Lorna E. Thorpe and her associates said. (See sidebar for specific numbers.)

Given that these data are now 5 years old, the health department would like to conduct a follow-up, but it won't be easy because of current financial constraints, said Dr. Thorpe, deputy commissioner in charge of the division of epidemiology at the New York City health department. “We didn't get federal support for the first NYC HANES. It was done with New York City tax dollars only. We can't pull off a second one yet. We're exploring ways for how to do it,” she noted.

But funding for the HbA_1c registry is ongoing thus far, Dr. Chamany said. More than 90% of clinical laboratories in the city that conduct HbA_1c testing and that already do electronic reporting for other diseases currently are reporting HbA_1c results. Inclusion in the registry is mandatory for all patients with diabetes in the city, but receipt of the quarterly reports is voluntary for providers and patients. Initially, the reports were offered to just seven health care facilities serving the south Bronx, an area of the city with exceptionally high rates of diabetes. The offer now has been extended to 60 facilities around the city, and more than 1,000 individual providers are currently receiving the reports.

Patients of those providers also are receiving letters from the health department—imprinted with the name of the practice—indicating their HbA_1c level, stratified by green (less than 7%), yellow (7%–9%), and red (above 9%). Patients can elect not to receive the letters, but fewer than 20 individuals have done so in the 3 years since the program began, Dr. Chamany said.

Indeed, while there was a great deal of concern voiced about privacy when the registry was launched, this doesn't appear to be a big problem now. “Whenever you have mandatory reporting, there is concern. We do get occasional questions about how the information is protected, but we're not getting a huge flood of opt-outs,” she noted.

The health department is planning to conduct interviews with medical directors of health care facilities around the city to find out how the reports are being received and aims to publish that information—along with the first 3 years' worth of registry data—later this year, she said.

In the meantime, the agency is moving forward with a pilot project designed to bring diabetes self-management to local communities. The 16-week course will focus on goal-setting skills for patients with diabetes relating to lifestyle modification. It initially will be piloted in Harlem, then expanded if all goes well. “One thing physicians have told us is they need services to refer patients to, Dr. Chamany commented. “There are … just not enough [providers] to do education,” Dr. Chamany commented.

And, with regard to the less-than-optimal data indicated by the NYC HANES, “We need more creative ways to get self-management support out there. Otherwise, those numbers aren't going to move.”

'The Big Apple is sugarcoated, and improvements in … lifestyle will be needed to improve this situation.' DR. WILSON

NYC's Diabetes Numbers Show Room for Improvement

The NYC HANES data revealed some telling facts about New York City's diabetic population.

Diabetes prevalence in NYC HANES increased with age, from 2.5% among those aged 20–39 years to 28.3% among adults aged 60 years and older, but did not differ significantly by sex, race/ethnicity, or nativity. Diabetes prevalence was significantly higher among those with incomes less than $20,000 versus those above that figure (17.0% vs. 9.1%).

The prevalence of diagnosed diabetes was 8.7% and undiagnosed diabetes, 3.8%, indicating that nearly one-third (30.4%) of adults with diabetes were undiagnosed. Blacks and Asians had the highest prevalence of diagnosed diabetes (12.1% and 11.4%, respectively), while the rate of diagnosed diabetes was significantly lower among whites (6.2%), compared with blacks.

Nearly one-fourth (23.5%) of the adults had impaired fasting glucose (defined as a fasting glucose level of 100–125 mg/dL). This also increased with age, reaching more than one-third of the population aged 60 years and older. Men had higher levels of IFG than did women (29.6% vs. 18.4%), and Asians had the highest rate of IFG of all racial and ethnic groups, at 32.4%.

After adjustment for other risk factors, Asians and blacks with normal weight (body mass index of less than 25 kg/m

Indeed, other published studies also have pointed to the fact that Asians—particularly those from south Asia, including India, Pakistan, and Bangladesh—tend to have higher levels of glucose impairment than do other races/ethnicities at lower BMIs. “It's very difficult to tease out, but there is probably a sufficient accumulation of literature suggesting that screening of these individuals should happen at lower weights, although the exact cutoff is not known,” said Dr. Lorna E. Thorpe.

Looking beyond prevalence to risk factor control, NYC HANES revealed that more than half of the adults with diagnosed diabetes (55.1%) had an HbA_1c value of 7% or higher, and 17.1% had an HbA_1c greater than 9%. A total of 12.3% were on insulin (with or without oral agents), 71.5% were on oral agents only, and 16.1% were not taking diabetes medications. Only 15.8% of those with HbA_1c levels above 9% were taking insulin. “Our findings suggest that providers in New York City should consider insulin therapy earlier in the course of their patients' disease,” the investigators wrote.

More than two-thirds (69.7%) the adults with diagnosed diabetes were identified as hypertensive, and half (50%) had elevated blood pressures at the time of the interview. Of those with diabetes and elevated blood pressure, 43.1% were not on antihypertensive medications and 35.4% had not been diagnosed with hypertension. Similarly, nearly two-thirds with diagnosed diabetes had elevated LDL cholesterol levels, of whom three-fourths were not taking cholesterol-lowering medications and 42.8% were undiagnosed for hypercholesterolemia.

“All in all, the 2004 NYC HANES picture does not look so nice,” Dr. Peter W. F. Wilson and Dr. K.M. Venkat Narayan said in their editorial.

New York City's diabetes prevalence and control numbers paint a dismal picture, but public health officials hope that the now 3-year-old hemoglobin A_1c registry will help brighten the future for the city's nearly 700,000 adult residents living with the condition.

Newly published data from the New York City Department of Health and Mental Hygiene suggest that one in every eight adult residents in the city has diabetes, more than a third don't know it, and even among those who are aware they have the condition, few achieve adequate control of glucose, blood pressure and cholesterol levels (Diabetes Care 2009;32:57–62).

“Adult New Yorkers are at least as overweight or obese as has been reported recently in [United States] national data, and the prevalence of diabetes and impaired fasting glucose causes great concern. The Big Apple is sugarcoated, and improvements in obesity and lifestyle will be needed to improve this situation in the future,” Dr. Peter W.F. Wilson and Dr. K.M. Venkat Narayan, both of Emory University, Atlanta, said in an editorial accompanying the report (Diabetes Care 2009;32:204–5).

Indeed, improving the prospects for people with diabetes—and those at risk for it—has been deemed a high priority for the city's health department, under the leadership of Dr. Thomas Frieden. As part of that effort, on Jan. 15, 2006, the city implemented a rule requiring clinical laboratories to report all hemoglobin A_1c (HbA_1c) testing results electronically to the health department. Since then, more than 3 million results have been collected from more than 1 million individuals, Dr. Shadi Chamany, director of the department's diabetes prevention and control program, said in an interview.

“The original goal of the registry was to use public health tools to support the clinical community and the patient community in improving diabetes outcomes. … This is a starting point, a building block. It's the foundation,” Dr. Chamany said.

Beyond merely collecting the data, the health department offers quarterly reports of HbA_1c results to providers and patients who opt to receive them and is also working in person with practices and providers to support diabetes management. “One thing I think has been really great about this project is that we're learning so much as we go out to all the practices and people are telling us what's going on and what they really need. … I think that as we're going out and reaching so many people, we're also raising awareness,” Dr. Chamany said. “I think this mobilizing of resources and efforts is really going to make a change.”

Clearly, improvement is needed. The newly released prevalence and control data come from another New York City health department project, the first-ever community-level Health and Nutrition Examination Survey (NYC HANES), a cross-sectional examination survey modeled after the National Health and Nutrition Examination Survey (NHANES) conducted annually by the Centers for Disease Control and Prevention. The NYC HANES data were obtained from face-to-face surveys and physical examinations conducted during June-December 2004 with 1,999 randomly selected adults aged 20 years and older (out of a total 3,047 eligible).

Based on the NYC HANES data, the estimated prevalence of diabetes for all New Yorkers aged 20 years and older was 12.5%, representing a population of approximately 696,000. This prevalence is significantly higher than the published NHANES estimate of 9.3% from 1999–2002. This difference is not likely to be caused by an increase in the national number; rather, there was a 17% increase in self-reported diabetes among New Yorkers between 2002 and 2004, whereas national rates did not increase significantly. The high concentration of poverty and racial/ethnic diversity most likely contributes to New York City's increasing diabetes prevalence, Dr. Lorna E. Thorpe and her associates said. (See sidebar for specific numbers.)

Given that these data are now 5 years old, the health department would like to conduct a follow-up, but it won't be easy because of current financial constraints, said Dr. Thorpe, deputy commissioner in charge of the division of epidemiology at the New York City health department. “We didn't get federal support for the first NYC HANES. It was done with New York City tax dollars only. We can't pull off a second one yet. We're exploring ways for how to do it,” she noted.

But funding for the HbA_1c registry is ongoing thus far, Dr. Chamany said. More than 90% of clinical laboratories in the city that conduct HbA_1c testing and that already do electronic reporting for other diseases currently are reporting HbA_1c results. Inclusion in the registry is mandatory for all patients with diabetes in the city, but receipt of the quarterly reports is voluntary for providers and patients. Initially, the reports were offered to just seven health care facilities serving the south Bronx, an area of the city with exceptionally high rates of diabetes. The offer now has been extended to 60 facilities around the city, and more than 1,000 individual providers are currently receiving the reports.

Patients of those providers also are receiving letters from the health department—imprinted with the name of the practice—indicating their HbA_1c level, stratified by green (less than 7%), yellow (7%–9%), and red (above 9%). Patients can elect not to receive the letters, but fewer than 20 individuals have done so in the 3 years since the program began, Dr. Chamany said.

Indeed, while there was a great deal of concern voiced about privacy when the registry was launched, this doesn't appear to be a big problem now. “Whenever you have mandatory reporting, there is concern. We do get occasional questions about how the information is protected, but we're not getting a huge flood of opt-outs,” she noted.

The health department is planning to conduct interviews with medical directors of health care facilities around the city to find out how the reports are being received and aims to publish that information—along with the first 3 years' worth of registry data—later this year, she said.

In the meantime, the agency is moving forward with a pilot project designed to bring diabetes self-management to local communities. The 16-week course will focus on goal-setting skills for patients with diabetes relating to lifestyle modification. It initially will be piloted in Harlem, then expanded if all goes well. “One thing physicians have told us is they need services to refer patients to, Dr. Chamany commented. “There are … just not enough [providers] to do education,” Dr. Chamany commented.

And, with regard to the less-than-optimal data indicated by the NYC HANES, “We need more creative ways to get self-management support out there. Otherwise, those numbers aren't going to move.”

'The Big Apple is sugarcoated, and improvements in … lifestyle will be needed to improve this situation.' DR. WILSON

NYC's Diabetes Numbers Show Room for Improvement

The NYC HANES data revealed some telling facts about New York City's diabetic population.

Diabetes prevalence in NYC HANES increased with age, from 2.5% among those aged 20–39 years to 28.3% among adults aged 60 years and older, but did not differ significantly by sex, race/ethnicity, or nativity. Diabetes prevalence was significantly higher among those with incomes less than $20,000 versus those above that figure (17.0% vs. 9.1%).

The prevalence of diagnosed diabetes was 8.7% and undiagnosed diabetes, 3.8%, indicating that nearly one-third (30.4%) of adults with diabetes were undiagnosed. Blacks and Asians had the highest prevalence of diagnosed diabetes (12.1% and 11.4%, respectively), while the rate of diagnosed diabetes was significantly lower among whites (6.2%), compared with blacks.

Nearly one-fourth (23.5%) of the adults had impaired fasting glucose (defined as a fasting glucose level of 100–125 mg/dL). This also increased with age, reaching more than one-third of the population aged 60 years and older. Men had higher levels of IFG than did women (29.6% vs. 18.4%), and Asians had the highest rate of IFG of all racial and ethnic groups, at 32.4%.

After adjustment for other risk factors, Asians and blacks with normal weight (body mass index of less than 25 kg/m

Indeed, other published studies also have pointed to the fact that Asians—particularly those from south Asia, including India, Pakistan, and Bangladesh—tend to have higher levels of glucose impairment than do other races/ethnicities at lower BMIs. “It's very difficult to tease out, but there is probably a sufficient accumulation of literature suggesting that screening of these individuals should happen at lower weights, although the exact cutoff is not known,” said Dr. Lorna E. Thorpe.

Looking beyond prevalence to risk factor control, NYC HANES revealed that more than half of the adults with diagnosed diabetes (55.1%) had an HbA_1c value of 7% or higher, and 17.1% had an HbA_1c greater than 9%. A total of 12.3% were on insulin (with or without oral agents), 71.5% were on oral agents only, and 16.1% were not taking diabetes medications. Only 15.8% of those with HbA_1c levels above 9% were taking insulin. “Our findings suggest that providers in New York City should consider insulin therapy earlier in the course of their patients' disease,” the investigators wrote.

More than two-thirds (69.7%) the adults with diagnosed diabetes were identified as hypertensive, and half (50%) had elevated blood pressures at the time of the interview. Of those with diabetes and elevated blood pressure, 43.1% were not on antihypertensive medications and 35.4% had not been diagnosed with hypertension. Similarly, nearly two-thirds with diagnosed diabetes had elevated LDL cholesterol levels, of whom three-fourths were not taking cholesterol-lowering medications and 42.8% were undiagnosed for hypercholesterolemia.

“All in all, the 2004 NYC HANES picture does not look so nice,” Dr. Peter W. F. Wilson and Dr. K.M. Venkat Narayan said in their editorial.

Concern about harm from antihyperglycemic and antihypertensive medications is associated with their underuse among patients with diabetes, even after controlling for economic factors.

The finding, from a survey of 803 adults with diabetes in Flint, Mich., suggests that “Because medication concerns may directly influence cost-related underuse, improved illness outcome may be achievable by simultaneously addressing attitudinal and economic issues,” Dr. James E. Aikens and Dr. John D. Piette said in an article published in Diabetes Care (2009;32:19–24).

The survey included 803 diabetes patients using antihyperglycemic agents, of whom 573 also used antihypertensive medications. Slightly more than half of the total group was black, and slightly more than half was female. More than a third had low functional health literacy (FHL) as measured by validated scales. The patients had a mean hemoglobin A_1c (HbA_1c) of 7.8% and mean blood pressure of 139/83 mm Hg.

Patients' treatment beliefs were measured with the well-validated Beliefs About Medicines Questionnaire (BMQ), with separate versions for the two types of medications. Five items are designed to elicit perceived medication necessity—such as “My health, at present, depends on my [diabetes or blood pressure] medication.” Six items pertain to concern, such as “I sometimes worry about the long-term effects of my … medicine.” For each item, patients choose from a 5-point response scale, ranging from “strongly agree” to “strongly disagree.”

Overall, perceived necessity was stronger than concern for both types of medication. Patients taking both types rated the antihyperglycemics as being both more necessary and more concerning than the antihypertensive medication, although the effect sizes were relatively small, said Dr. Aikens and Dr. Piette of the University of Michigan, Ann Arbor.

Perceived necessity for one or both types of medication was stronger among participants who were younger, female, had more comorbid conditions, were prescribed more medications, and were prescribed insulin. Perceived harmfulness of one or both types of medications was stronger among those who were younger, were black, were of low income, were diagnosed with more comorbid conditions, were dissatisfied with medication information, and were of low FHL.

“Given that perceived discrimination and distrust in health care have been documented in African Americans with diabetes, the most culturally sensitive interventions will be those that deal directly and skillfully with medication fears,” the investigators commented.

After adjustment for age, sex, ethnicity, and income, perceived need for antihyperglycemic medications was independently associated with having a greater number of prescriptions and being prescribed insulin. In contrast, concern about antihyperglycemic medications was associated with dissatisfaction with medication information, low FHL, and high out-of-pocket prescription costs.

Perceived need for antihypertensives—after adjustment for age, sex, ethnicity, and income—was associated with more comorbid conditions and satisfaction with medication information. As with antihyperglycemics, concern about antihypertensives also was associated with dissatisfaction with medication information and low FHL.

Medication underuse was measured by two questions: “In the past 12 months, have you ever taken less of your [diabetes/hypertension] medication than prescribed by your doctor because of the cost?” and “Many people do not take their prescription medication exactly as prescribed by their doctor. In the past year, have you ever taken less of your … medication for any reason other than the cost?”

Almost half (47%) of participants reported antihyperglycemic underuse, of whom about a third (16.5% of the total) reported cost-related underuse. However, concern about the medications was associated with both cost-related and non-cost-related underuse. Neither perception of medical necessity nor concern regarding antihyperglycemics was significantly related to HbA_1c, although the relationship with concern nearly reached significance, they noted.

Of those prescribed antihypertensives, 31% reported underuse, with cost being a reason for about half (15%) of the total group. As with the antihyperglycemics, concern was significantly associated with both types of underuse, but perceived necessity was not. Concern about potential harm from antihypertensive medications was significantly related to higher blood pressure.

Interestingly, perceived necessity was associated primarily with medical factors—such as number of comorbidities and insulin use—while perceived harmfulness was more strongly associated with psychosocial factors such as FHL and dissatisfaction with the information the patients had received. “Because only the latter belief relates to adherence and outcomes, it seems far more important to address key psychosocial factors in nonadherent patients, rather than assume that they fail to grasp the medical necessity or treatment,” Dr. Aikens and Dr. Piette concluded.

This study was funded by the American Diabetes Association and the Michigan Diabetes Research and Training Center, with a grant from the National Institutes of Health. Neither investigator reported potential conflicts of interest.

Concern about harm from antihyperglycemic and antihypertensive medications is associated with their underuse among patients with diabetes, even after controlling for economic factors.

The finding, from a survey of 803 adults with diabetes in Flint, Mich., suggests that “Because medication concerns may directly influence cost-related underuse, improved illness outcome may be achievable by simultaneously addressing attitudinal and economic issues,” Dr. James E. Aikens and Dr. John D. Piette said in an article published in Diabetes Care (2009;32:19–24).

The survey included 803 diabetes patients using antihyperglycemic agents, of whom 573 also used antihypertensive medications. Slightly more than half of the total group was black, and slightly more than half was female. More than a third had low functional health literacy (FHL) as measured by validated scales. The patients had a mean hemoglobin A_1c (HbA_1c) of 7.8% and mean blood pressure of 139/83 mm Hg.

Patients' treatment beliefs were measured with the well-validated Beliefs About Medicines Questionnaire (BMQ), with separate versions for the two types of medications. Five items are designed to elicit perceived medication necessity—such as “My health, at present, depends on my [diabetes or blood pressure] medication.” Six items pertain to concern, such as “I sometimes worry about the long-term effects of my … medicine.” For each item, patients choose from a 5-point response scale, ranging from “strongly agree” to “strongly disagree.”

Overall, perceived necessity was stronger than concern for both types of medication. Patients taking both types rated the antihyperglycemics as being both more necessary and more concerning than the antihypertensive medication, although the effect sizes were relatively small, said Dr. Aikens and Dr. Piette of the University of Michigan, Ann Arbor.

Perceived necessity for one or both types of medication was stronger among participants who were younger, female, had more comorbid conditions, were prescribed more medications, and were prescribed insulin. Perceived harmfulness of one or both types of medications was stronger among those who were younger, were black, were of low income, were diagnosed with more comorbid conditions, were dissatisfied with medication information, and were of low FHL.

“Given that perceived discrimination and distrust in health care have been documented in African Americans with diabetes, the most culturally sensitive interventions will be those that deal directly and skillfully with medication fears,” the investigators commented.

After adjustment for age, sex, ethnicity, and income, perceived need for antihyperglycemic medications was independently associated with having a greater number of prescriptions and being prescribed insulin. In contrast, concern about antihyperglycemic medications was associated with dissatisfaction with medication information, low FHL, and high out-of-pocket prescription costs.

Perceived need for antihypertensives—after adjustment for age, sex, ethnicity, and income—was associated with more comorbid conditions and satisfaction with medication information. As with antihyperglycemics, concern about antihypertensives also was associated with dissatisfaction with medication information and low FHL.

Medication underuse was measured by two questions: “In the past 12 months, have you ever taken less of your [diabetes/hypertension] medication than prescribed by your doctor because of the cost?” and “Many people do not take their prescription medication exactly as prescribed by their doctor. In the past year, have you ever taken less of your … medication for any reason other than the cost?”

Almost half (47%) of participants reported antihyperglycemic underuse, of whom about a third (16.5% of the total) reported cost-related underuse. However, concern about the medications was associated with both cost-related and non-cost-related underuse. Neither perception of medical necessity nor concern regarding antihyperglycemics was significantly related to HbA_1c, although the relationship with concern nearly reached significance, they noted.

Of those prescribed antihypertensives, 31% reported underuse, with cost being a reason for about half (15%) of the total group. As with the antihyperglycemics, concern was significantly associated with both types of underuse, but perceived necessity was not. Concern about potential harm from antihypertensive medications was significantly related to higher blood pressure.

Interestingly, perceived necessity was associated primarily with medical factors—such as number of comorbidities and insulin use—while perceived harmfulness was more strongly associated with psychosocial factors such as FHL and dissatisfaction with the information the patients had received. “Because only the latter belief relates to adherence and outcomes, it seems far more important to address key psychosocial factors in nonadherent patients, rather than assume that they fail to grasp the medical necessity or treatment,” Dr. Aikens and Dr. Piette concluded.

This study was funded by the American Diabetes Association and the Michigan Diabetes Research and Training Center, with a grant from the National Institutes of Health. Neither investigator reported potential conflicts of interest.

Concern about harm from antihyperglycemic and antihypertensive medications is associated with their underuse among patients with diabetes, even after controlling for economic factors.

The finding, from a survey of 803 adults with diabetes in Flint, Mich., suggests that “Because medication concerns may directly influence cost-related underuse, improved illness outcome may be achievable by simultaneously addressing attitudinal and economic issues,” Dr. James E. Aikens and Dr. John D. Piette said in an article published in Diabetes Care (2009;32:19–24).

The survey included 803 diabetes patients using antihyperglycemic agents, of whom 573 also used antihypertensive medications. Slightly more than half of the total group was black, and slightly more than half was female. More than a third had low functional health literacy (FHL) as measured by validated scales. The patients had a mean hemoglobin A_1c (HbA_1c) of 7.8% and mean blood pressure of 139/83 mm Hg.

Patients' treatment beliefs were measured with the well-validated Beliefs About Medicines Questionnaire (BMQ), with separate versions for the two types of medications. Five items are designed to elicit perceived medication necessity—such as “My health, at present, depends on my [diabetes or blood pressure] medication.” Six items pertain to concern, such as “I sometimes worry about the long-term effects of my … medicine.” For each item, patients choose from a 5-point response scale, ranging from “strongly agree” to “strongly disagree.”

Overall, perceived necessity was stronger than concern for both types of medication. Patients taking both types rated the antihyperglycemics as being both more necessary and more concerning than the antihypertensive medication, although the effect sizes were relatively small, said Dr. Aikens and Dr. Piette of the University of Michigan, Ann Arbor.

Perceived necessity for one or both types of medication was stronger among participants who were younger, female, had more comorbid conditions, were prescribed more medications, and were prescribed insulin. Perceived harmfulness of one or both types of medications was stronger among those who were younger, were black, were of low income, were diagnosed with more comorbid conditions, were dissatisfied with medication information, and were of low FHL.

“Given that perceived discrimination and distrust in health care have been documented in African Americans with diabetes, the most culturally sensitive interventions will be those that deal directly and skillfully with medication fears,” the investigators commented.

After adjustment for age, sex, ethnicity, and income, perceived need for antihyperglycemic medications was independently associated with having a greater number of prescriptions and being prescribed insulin. In contrast, concern about antihyperglycemic medications was associated with dissatisfaction with medication information, low FHL, and high out-of-pocket prescription costs.

Perceived need for antihypertensives—after adjustment for age, sex, ethnicity, and income—was associated with more comorbid conditions and satisfaction with medication information. As with antihyperglycemics, concern about antihypertensives also was associated with dissatisfaction with medication information and low FHL.

Medication underuse was measured by two questions: “In the past 12 months, have you ever taken less of your [diabetes/hypertension] medication than prescribed by your doctor because of the cost?” and “Many people do not take their prescription medication exactly as prescribed by their doctor. In the past year, have you ever taken less of your … medication for any reason other than the cost?”

Almost half (47%) of participants reported antihyperglycemic underuse, of whom about a third (16.5% of the total) reported cost-related underuse. However, concern about the medications was associated with both cost-related and non-cost-related underuse. Neither perception of medical necessity nor concern regarding antihyperglycemics was significantly related to HbA_1c, although the relationship with concern nearly reached significance, they noted.

Of those prescribed antihypertensives, 31% reported underuse, with cost being a reason for about half (15%) of the total group. As with the antihyperglycemics, concern was significantly associated with both types of underuse, but perceived necessity was not. Concern about potential harm from antihypertensive medications was significantly related to higher blood pressure.

Interestingly, perceived necessity was associated primarily with medical factors—such as number of comorbidities and insulin use—while perceived harmfulness was more strongly associated with psychosocial factors such as FHL and dissatisfaction with the information the patients had received. “Because only the latter belief relates to adherence and outcomes, it seems far more important to address key psychosocial factors in nonadherent patients, rather than assume that they fail to grasp the medical necessity or treatment,” Dr. Aikens and Dr. Piette concluded.

This study was funded by the American Diabetes Association and the Michigan Diabetes Research and Training Center, with a grant from the National Institutes of Health. Neither investigator reported potential conflicts of interest.