Mark S. Lesney

Depression is a clinically significant risk factor for developing coronary heart disease, especially in men and women aged 25–50, according to an analysis of a national family database at the Karolinska Institute, Stockholm.

Data from the family coronary heart disease database at the institute were used to identify all people in Sweden aged 25–64 at the onset of depression, and aged 25–79 at the onset of nonfatal coronary heart disease (CHD) from 1987 to 2001. Onset of depression and onset of CHD were defined by the first recorded hospitalization. To prevent confounding reaction to CHD with depression, depression hospitalization had to occur before CHD hospitalization.

The analysis, performed in 2005, compared the standardized incidence ratios (SIRs) of CHD in patients with and without hospitalization for depression. Complete data on all hospital discharges in Sweden have been recorded since 1986 and formed part of the database, reported Jan Sunquist, Ph.D., and colleagues from the Center for Family and Community Medicine, Huddinge, Sweden (Am. J. Prev. Med. 2005;29:428–33).

Significant SIR for CHD hospitalization in depressive patients was greatest in the 25–39 age group in both men (SIR = 2.97) and women (SIR = 3.04) and remained significant after adjustment for socioeconomic status of all age groups for both men and women—except for those in the 70–79 age group. In fact, the risk of developing CHD after hospitalization for depression decreased with increasing age at diagnosis of CHD, the investigators reported.

Two groups of patients were compared from the larger database. The first group studied had hospitalization for depression, followed by CHD hospitalization (n = 1,916). The second group had been hospitalized only for nonfatal CHD (n = 425,495). Both depression and CHD had to be diagnosed based on World Health Organization ICD criteria. Gender, age at diagnosis of CHD, socioeconomic status, and geographic region were included as variables.

The researchers believe that their results have important clinical implications for preventive care. “Primary health care teams meet patients with depression, and it is important that they treat depression as an individual and independent CHD risk factor,” the researchers wrote.

“The risk associated with clinically significant depression probably cannot be overcome by short-term interventions alone. Patients with clinical depression should be given not only short-term treatment, but also maintenance therapy to prevent relapses and recurrences.”

Previous studies have shown that patients with depression have higher rates of CHD than nonaffected individuals. But this research is the first, large-scale population-based study of the incidence of CHD in patients with depression.

Depression is a clinically significant risk factor for developing coronary heart disease, especially in men and women aged 25–50, according to an analysis of a national family database at the Karolinska Institute, Stockholm.

Data from the family coronary heart disease database at the institute were used to identify all people in Sweden aged 25–64 at the onset of depression, and aged 25–79 at the onset of nonfatal coronary heart disease (CHD) from 1987 to 2001. Onset of depression and onset of CHD were defined by the first recorded hospitalization. To prevent confounding reaction to CHD with depression, depression hospitalization had to occur before CHD hospitalization.

The analysis, performed in 2005, compared the standardized incidence ratios (SIRs) of CHD in patients with and without hospitalization for depression. Complete data on all hospital discharges in Sweden have been recorded since 1986 and formed part of the database, reported Jan Sunquist, Ph.D., and colleagues from the Center for Family and Community Medicine, Huddinge, Sweden (Am. J. Prev. Med. 2005;29:428–33).

Significant SIR for CHD hospitalization in depressive patients was greatest in the 25–39 age group in both men (SIR = 2.97) and women (SIR = 3.04) and remained significant after adjustment for socioeconomic status of all age groups for both men and women—except for those in the 70–79 age group. In fact, the risk of developing CHD after hospitalization for depression decreased with increasing age at diagnosis of CHD, the investigators reported.

Two groups of patients were compared from the larger database. The first group studied had hospitalization for depression, followed by CHD hospitalization (n = 1,916). The second group had been hospitalized only for nonfatal CHD (n = 425,495). Both depression and CHD had to be diagnosed based on World Health Organization ICD criteria. Gender, age at diagnosis of CHD, socioeconomic status, and geographic region were included as variables.

The researchers believe that their results have important clinical implications for preventive care. “Primary health care teams meet patients with depression, and it is important that they treat depression as an individual and independent CHD risk factor,” the researchers wrote.

“The risk associated with clinically significant depression probably cannot be overcome by short-term interventions alone. Patients with clinical depression should be given not only short-term treatment, but also maintenance therapy to prevent relapses and recurrences.”

Previous studies have shown that patients with depression have higher rates of CHD than nonaffected individuals. But this research is the first, large-scale population-based study of the incidence of CHD in patients with depression.

Depression is a clinically significant risk factor for developing coronary heart disease, especially in men and women aged 25–50, according to an analysis of a national family database at the Karolinska Institute, Stockholm.

Data from the family coronary heart disease database at the institute were used to identify all people in Sweden aged 25–64 at the onset of depression, and aged 25–79 at the onset of nonfatal coronary heart disease (CHD) from 1987 to 2001. Onset of depression and onset of CHD were defined by the first recorded hospitalization. To prevent confounding reaction to CHD with depression, depression hospitalization had to occur before CHD hospitalization.

The analysis, performed in 2005, compared the standardized incidence ratios (SIRs) of CHD in patients with and without hospitalization for depression. Complete data on all hospital discharges in Sweden have been recorded since 1986 and formed part of the database, reported Jan Sunquist, Ph.D., and colleagues from the Center for Family and Community Medicine, Huddinge, Sweden (Am. J. Prev. Med. 2005;29:428–33).

Significant SIR for CHD hospitalization in depressive patients was greatest in the 25–39 age group in both men (SIR = 2.97) and women (SIR = 3.04) and remained significant after adjustment for socioeconomic status of all age groups for both men and women—except for those in the 70–79 age group. In fact, the risk of developing CHD after hospitalization for depression decreased with increasing age at diagnosis of CHD, the investigators reported.

Two groups of patients were compared from the larger database. The first group studied had hospitalization for depression, followed by CHD hospitalization (n = 1,916). The second group had been hospitalized only for nonfatal CHD (n = 425,495). Both depression and CHD had to be diagnosed based on World Health Organization ICD criteria. Gender, age at diagnosis of CHD, socioeconomic status, and geographic region were included as variables.

The researchers believe that their results have important clinical implications for preventive care. “Primary health care teams meet patients with depression, and it is important that they treat depression as an individual and independent CHD risk factor,” the researchers wrote.

“The risk associated with clinically significant depression probably cannot be overcome by short-term interventions alone. Patients with clinical depression should be given not only short-term treatment, but also maintenance therapy to prevent relapses and recurrences.”

Previous studies have shown that patients with depression have higher rates of CHD than nonaffected individuals. But this research is the first, large-scale population-based study of the incidence of CHD in patients with depression.

SILVER SPRING, MD. — Several decades' worth of clinical data on antibacterial additives in home-use soaps and detergents has shown no benefit over plain soap and water in reducing infection, the Food and Drug Administration's advisory panel on nonprescription drugs found at its recent meeting.

Lacking such clear benefits, compounds such as triclosan and triclocarban pose unacceptable risks of environmental contamination and contribution to the evolution of antibiotic resistance, the panel unanimously concluded.

Evidence on the efficacy of alcohol-based gels and wipes was found to be similar (no more effective in reducing infection than soap and water). However, their utility in situations where water was not available, safe, or convenient—combined with their low risk of contributing to the development of resistant bacteria—was recognized by the panel, which recommended the products' continued use in defined circumstances.

A 1994 FDA decision said that antibacterial consumer products were deemed effective if they could meet the surrogate end point of decreasing bacterial load on the skin. Such a decrease was assumed to be clinically significant, according to the 1994 monograph.

However, subsequent, real-world clinical trials, though imperfect in design, have been unable to demonstrate a corresponding decrease in disease incidence or severity, compared with soap and water, for either respiratory or GI infections.

It was this question of efficacy of consumer antiseptic products that the FDA asked its advisory panel to address.

The panel heard presentations of clinical evidence regarding the benefits of consumer antiseptics from Steven Osborne, M.D., medical officer at FDA's Office of Nonprescription Products, and Allison E. Aiello, Ph.D., of the University of Michigan School of Public Health, Ann Arbor.

In eight studies from the literature, use of plain or unidentified soap and water reduced cases of diarrhea from 30% to 89% (median reduction 53%). In three studies comparing antiseptic soap with no soap in control groups, reductions in diarrhea with antiseptic soap ranged from 29% to 50%.

Furthermore, in five studies comparing antiseptic soaps with plain soap, there was no statistically significant difference shown for all infectious symptoms, the presenters said.

Stuart B. Levy, M.D., a professor at Tufts University, Boston, spoke on the products' contribution to bacterial resistance.

“What are we worried about?” he asked, “We are worried that an antibiotic can select this kind of mutant and make it resistant to biocides…. Or we could be using the biocides and select a mutant which now is resistant to antibiotics. We're not talking about just one [antibiotic]. We're talking about tetracycline, penicillin, fluoroquinalone, chloramphenicol.”

Such resistance can also develop to the biocides themselves, he added. “I'm not saying I don't see the need for biocides—I don't see that they are needed in consumer products.”

The impact of triclosan and triclocarban accumulation in the environment was discussed by Rolf U. Halden, Ph.D., of Johns Hopkins University, Baltimore.

In Baltimore area surface water samples, Dr. Halden and colleagues found triclocarban concentrations of 6,750 ng/L (Environ. Sci. Technol. 2005;39:1420–6).

According to Dr. Halden, his results suggest triclocarban is a previously unrecognized contaminant of U.S. water resources nationwide, probably in the top 10 in occurrence rates and in the top 20 in maximum concentration.

The amount of triclocarban contamination was markedly higher than the non-peer-reviewed numbers (240 ng/L) used by the Environmental Protection Agency to evaluate ecological and human health risks, he said. The predicted half-life of triclocarban ranged from less than a day in air to 540 days in sediment. Cooccurrence of triclosan was observed at all sites.

Dr. Halden questioned why manufacturers were still using vast quantities of chlorinated compounds that could migrate into the environment, given the dubious nature of chlorine chemistry in the previous history of pollutants.

Several presenters highlighted the importance of hand hygiene in preventing the transmission of infectious diseases and the effectiveness of antibacterial products in reducing or eliminating bacteria.

“Every 3 minutes, a child brings his/her hand to nose or mouth; every 60 seconds, a working adult touches as many as 30 objects…. Washing fomites with soap and water is not enough to prevent the spread of pathogens,” said Charles P. Gerba, Ph.D., of the University of Arizona, Tucson.

Handwashing after risk exposure is needed for home infection control, he said, adding that the data show that antiseptic products “decrease bacteria on the skin.”

The utility of antibacterial consumer products was stressed by the Cosmetic, Toiletry, and Fragrance Association (CTFA), which said “the benefits of topical OTC antimicrobial drug products clearly support the current proposed labeling indication (i.e., 'to decrease bacteria on skin') and provide consumers an effective means of controlling the risks of infection.”

CTFA had previously asked the FDA to lower the threshold for approval of consumer antibacterial products. That request was not recommended by the panel at a meeting in March 2005. At that meeting, the panel voted unanimously to recommend retention of the standards for bacteria reduction in antibacterial and antiseptic products for nonconsumer products.

The FDA usually follows the recommendations of its advisory panels but is not obligated to do so. Final review of these products is to be concluded by 2007.

When antibacterial soap is compared with soap and water, no decrease in disease incidence or severity has been found.

SILVER SPRING, MD. — Several decades' worth of clinical data on antibacterial additives in home-use soaps and detergents has shown no benefit over plain soap and water in reducing infection, the Food and Drug Administration's advisory panel on nonprescription drugs found at its recent meeting.

Lacking such clear benefits, compounds such as triclosan and triclocarban pose unacceptable risks of environmental contamination and contribution to the evolution of antibiotic resistance, the panel unanimously concluded.

Evidence on the efficacy of alcohol-based gels and wipes was found to be similar (no more effective in reducing infection than soap and water). However, their utility in situations where water was not available, safe, or convenient—combined with their low risk of contributing to the development of resistant bacteria—was recognized by the panel, which recommended the products' continued use in defined circumstances.

A 1994 FDA decision said that antibacterial consumer products were deemed effective if they could meet the surrogate end point of decreasing bacterial load on the skin. Such a decrease was assumed to be clinically significant, according to the 1994 monograph.

However, subsequent, real-world clinical trials, though imperfect in design, have been unable to demonstrate a corresponding decrease in disease incidence or severity, compared with soap and water, for either respiratory or GI infections.

It was this question of efficacy of consumer antiseptic products that the FDA asked its advisory panel to address.

The panel heard presentations of clinical evidence regarding the benefits of consumer antiseptics from Steven Osborne, M.D., medical officer at FDA's Office of Nonprescription Products, and Allison E. Aiello, Ph.D., of the University of Michigan School of Public Health, Ann Arbor.

In eight studies from the literature, use of plain or unidentified soap and water reduced cases of diarrhea from 30% to 89% (median reduction 53%). In three studies comparing antiseptic soap with no soap in control groups, reductions in diarrhea with antiseptic soap ranged from 29% to 50%.

Furthermore, in five studies comparing antiseptic soaps with plain soap, there was no statistically significant difference shown for all infectious symptoms, the presenters said.

Stuart B. Levy, M.D., a professor at Tufts University, Boston, spoke on the products' contribution to bacterial resistance.

“What are we worried about?” he asked, “We are worried that an antibiotic can select this kind of mutant and make it resistant to biocides…. Or we could be using the biocides and select a mutant which now is resistant to antibiotics. We're not talking about just one [antibiotic]. We're talking about tetracycline, penicillin, fluoroquinalone, chloramphenicol.”

Such resistance can also develop to the biocides themselves, he added. “I'm not saying I don't see the need for biocides—I don't see that they are needed in consumer products.”

The impact of triclosan and triclocarban accumulation in the environment was discussed by Rolf U. Halden, Ph.D., of Johns Hopkins University, Baltimore.

In Baltimore area surface water samples, Dr. Halden and colleagues found triclocarban concentrations of 6,750 ng/L (Environ. Sci. Technol. 2005;39:1420–6).

According to Dr. Halden, his results suggest triclocarban is a previously unrecognized contaminant of U.S. water resources nationwide, probably in the top 10 in occurrence rates and in the top 20 in maximum concentration.

The amount of triclocarban contamination was markedly higher than the non-peer-reviewed numbers (240 ng/L) used by the Environmental Protection Agency to evaluate ecological and human health risks, he said. The predicted half-life of triclocarban ranged from less than a day in air to 540 days in sediment. Cooccurrence of triclosan was observed at all sites.

Dr. Halden questioned why manufacturers were still using vast quantities of chlorinated compounds that could migrate into the environment, given the dubious nature of chlorine chemistry in the previous history of pollutants.

Several presenters highlighted the importance of hand hygiene in preventing the transmission of infectious diseases and the effectiveness of antibacterial products in reducing or eliminating bacteria.

“Every 3 minutes, a child brings his/her hand to nose or mouth; every 60 seconds, a working adult touches as many as 30 objects…. Washing fomites with soap and water is not enough to prevent the spread of pathogens,” said Charles P. Gerba, Ph.D., of the University of Arizona, Tucson.

Handwashing after risk exposure is needed for home infection control, he said, adding that the data show that antiseptic products “decrease bacteria on the skin.”

The utility of antibacterial consumer products was stressed by the Cosmetic, Toiletry, and Fragrance Association (CTFA), which said “the benefits of topical OTC antimicrobial drug products clearly support the current proposed labeling indication (i.e., 'to decrease bacteria on skin') and provide consumers an effective means of controlling the risks of infection.”

CTFA had previously asked the FDA to lower the threshold for approval of consumer antibacterial products. That request was not recommended by the panel at a meeting in March 2005. At that meeting, the panel voted unanimously to recommend retention of the standards for bacteria reduction in antibacterial and antiseptic products for nonconsumer products.

The FDA usually follows the recommendations of its advisory panels but is not obligated to do so. Final review of these products is to be concluded by 2007.

When antibacterial soap is compared with soap and water, no decrease in disease incidence or severity has been found.

SILVER SPRING, MD. — Several decades' worth of clinical data on antibacterial additives in home-use soaps and detergents has shown no benefit over plain soap and water in reducing infection, the Food and Drug Administration's advisory panel on nonprescription drugs found at its recent meeting.

Lacking such clear benefits, compounds such as triclosan and triclocarban pose unacceptable risks of environmental contamination and contribution to the evolution of antibiotic resistance, the panel unanimously concluded.

Evidence on the efficacy of alcohol-based gels and wipes was found to be similar (no more effective in reducing infection than soap and water). However, their utility in situations where water was not available, safe, or convenient—combined with their low risk of contributing to the development of resistant bacteria—was recognized by the panel, which recommended the products' continued use in defined circumstances.

A 1994 FDA decision said that antibacterial consumer products were deemed effective if they could meet the surrogate end point of decreasing bacterial load on the skin. Such a decrease was assumed to be clinically significant, according to the 1994 monograph.

However, subsequent, real-world clinical trials, though imperfect in design, have been unable to demonstrate a corresponding decrease in disease incidence or severity, compared with soap and water, for either respiratory or GI infections.

It was this question of efficacy of consumer antiseptic products that the FDA asked its advisory panel to address.

The panel heard presentations of clinical evidence regarding the benefits of consumer antiseptics from Steven Osborne, M.D., medical officer at FDA's Office of Nonprescription Products, and Allison E. Aiello, Ph.D., of the University of Michigan School of Public Health, Ann Arbor.

In eight studies from the literature, use of plain or unidentified soap and water reduced cases of diarrhea from 30% to 89% (median reduction 53%). In three studies comparing antiseptic soap with no soap in control groups, reductions in diarrhea with antiseptic soap ranged from 29% to 50%.

Furthermore, in five studies comparing antiseptic soaps with plain soap, there was no statistically significant difference shown for all infectious symptoms, the presenters said.

Stuart B. Levy, M.D., a professor at Tufts University, Boston, spoke on the products' contribution to bacterial resistance.

“What are we worried about?” he asked, “We are worried that an antibiotic can select this kind of mutant and make it resistant to biocides…. Or we could be using the biocides and select a mutant which now is resistant to antibiotics. We're not talking about just one [antibiotic]. We're talking about tetracycline, penicillin, fluoroquinalone, chloramphenicol.”

Such resistance can also develop to the biocides themselves, he added. “I'm not saying I don't see the need for biocides—I don't see that they are needed in consumer products.”

The impact of triclosan and triclocarban accumulation in the environment was discussed by Rolf U. Halden, Ph.D., of Johns Hopkins University, Baltimore.

In Baltimore area surface water samples, Dr. Halden and colleagues found triclocarban concentrations of 6,750 ng/L (Environ. Sci. Technol. 2005;39:1420–6).

According to Dr. Halden, his results suggest triclocarban is a previously unrecognized contaminant of U.S. water resources nationwide, probably in the top 10 in occurrence rates and in the top 20 in maximum concentration.

The amount of triclocarban contamination was markedly higher than the non-peer-reviewed numbers (240 ng/L) used by the Environmental Protection Agency to evaluate ecological and human health risks, he said. The predicted half-life of triclocarban ranged from less than a day in air to 540 days in sediment. Cooccurrence of triclosan was observed at all sites.

Dr. Halden questioned why manufacturers were still using vast quantities of chlorinated compounds that could migrate into the environment, given the dubious nature of chlorine chemistry in the previous history of pollutants.

Several presenters highlighted the importance of hand hygiene in preventing the transmission of infectious diseases and the effectiveness of antibacterial products in reducing or eliminating bacteria.

“Every 3 minutes, a child brings his/her hand to nose or mouth; every 60 seconds, a working adult touches as many as 30 objects…. Washing fomites with soap and water is not enough to prevent the spread of pathogens,” said Charles P. Gerba, Ph.D., of the University of Arizona, Tucson.

Handwashing after risk exposure is needed for home infection control, he said, adding that the data show that antiseptic products “decrease bacteria on the skin.”

The utility of antibacterial consumer products was stressed by the Cosmetic, Toiletry, and Fragrance Association (CTFA), which said “the benefits of topical OTC antimicrobial drug products clearly support the current proposed labeling indication (i.e., 'to decrease bacteria on skin') and provide consumers an effective means of controlling the risks of infection.”

CTFA had previously asked the FDA to lower the threshold for approval of consumer antibacterial products. That request was not recommended by the panel at a meeting in March 2005. At that meeting, the panel voted unanimously to recommend retention of the standards for bacteria reduction in antibacterial and antiseptic products for nonconsumer products.

The FDA usually follows the recommendations of its advisory panels but is not obligated to do so. Final review of these products is to be concluded by 2007.

When antibacterial soap is compared with soap and water, no decrease in disease incidence or severity has been found.

SILVER SPRING, MD. — Several decades' worth of clinical data on antibacterial additives in home-use soaps and detergents has shown no benefit over plain soap and water in reducing infection, the Food and Drug Administration's advisory panel on nonprescription drugs found at its recent meeting.

Lacking such clear benefits, compounds such as triclosan and triclocarban pose unacceptable risks of environmental contamination and contribution to the evolution of antibiotic resistance, the panel unanimously concluded.

Evidence on the efficacy of alcohol-based gels and wipes was found to be similar (no more effective in reducing infection than soap and water). However, their utility in situations where water was not available, safe, or convenient—combined with their low risk of contributing to the development of resistant bacteria—was recognized by the panel, which recommended the products' continued use in defined circumstances.

A 1994 FDA decision said that antibacterial consumer products were deemed effective if they could meet the surrogate end point of decreasing bacterial load on the skin. Such a decrease was assumed to be clinically significant, according to the 1994 monograph.

However, subsequent, real-world clinical trials, though imperfect in design, have been unable to demonstrate a corresponding decrease in disease incidence or severity, compared with soap and water, either for respiratory or GI infections.

It was this question of efficacy of consumer antiseptic products that the FDA asked its advisory panel to address.

The panel heard presentations of clinical evidence regarding the benefits of consumer antiseptics from Steven Osborne, M.D., medical officer at FDA's Office of Nonprescription Products, and Allison E. Aiello, Ph.D., of the University of Michigan School of Public Health, Ann Arbor.

In eight studies from the literature, use of plain or unidentified soap and water reduced cases of diarrhea from 30% to 89% (median reduction 53%). In three studies comparing antiseptic soap with no soap in control groups, reductions in diarrhea with antiseptic soap ranged from 29% to 50%.

Furthermore, five studies comparing antiseptic soaps with plain soap found no statistically significant difference for all infectious symptoms, the presenters said.

Stuart B. Levy, M.D., a professor at Tufts University, Boston, spoke on the products' contribution to bacterial resistance.

“What are we worried about?” he asked, “We are worried that an antibiotic can select this kind of mutant and make it resistant to biocides …. Or we could be using the biocides and select a mutant which now is resistant to antibiotics. We're not talking about just one [antibiotic]. We're talking about tetracycline, penicillin, fluoroquinalone, chloramphenicol.”

Such resistance can also develop to the biocides themselves, he added. “I'm not saying I don't see the need for biocides—I don't see that they are needed in consumer products.”

The impact of triclosan and triclocarban accumulation in the environment was discussed by Rolf U. Halden, Ph.D., of Johns Hopkins University, Baltimore.

In samples of surface water from the Baltimore area, Dr. Halden and colleagues found triclocarban concentrations of 6,750 ng/L (Environ. Sci. Technol. 2005;39:1420–6). According to Dr. Halden, his results suggest triclocarban is a previously unrecognized contaminant of U.S. water resources nationwide, probably in the top 10 in occurrence rates and in the top 20 in maximum concentration.

The amount of triclocarban contamination was markedly higher than the non-peer-reviewed numbers (240 ng/L) used by the Environmental Protection Agency to evaluate ecological and human health risks, he said. The predicted half-life of triclocarban ranged from less than a day in air to 540 days in sediment. Cooccurrence of triclosan was observed at all sites.

Dr. Halden questioned why manufacturers were still using vast quantities of chlorinated compounds that could migrate into the environment, given the dubious nature of chlorine chemistry in the previous history of pollutants.

Several presenters highlighted the importance of hand hygiene in preventing the transmission of infectious diseases and the effectiveness of antibacterial products in reducing or eliminating bacteria from the skin.

“Every 3 minutes, a child brings his/her hand to nose or mouth. Every 60 seconds, a working adult touches as many as 30 objects,” said Charles P. Gerba, Ph.D., of the University of Arizona, Tucson. “Washing fomites with soap and water is not enough to prevent the spread of pathogens.”

Targeted hygiene by handwashing after risk exposure (bathrooms, food preparation, contact with potentially infected people) is needed for home infection control, he said, adding that the data clearly show that antiseptic products “decrease bacteria on the skin” and follow the log reduction requirements after a single wash.

The utility of antibacterial consumer products was stressed by the Cosmetic, Toiletry, and Fragrance Association (CTFA), which said “the benefits of topical OTC antimicrobial drug products clearly support the current proposed labeling indication (i.e., 'to decrease bacteria on skin') and provide consumers an effective means of controlling the risks of infection.”

CTFA had previously asked the FDA to lower the threshold for approval of consumer antibacterial products. That request was not recommended by the panel at a meeting in March 2005. At that meeting, the panel voted unanimously to recommend retention of the standards for bacteria reduction in antibacterial and antiseptic products for nonconsumer products.

The FDA usually follows the recommendations of its advisory panels but is not obligated to do so.

Final review of these products is to be concluded by 2007.

SILVER SPRING, MD. — Several decades' worth of clinical data on antibacterial additives in home-use soaps and detergents has shown no benefit over plain soap and water in reducing infection, the Food and Drug Administration's advisory panel on nonprescription drugs found at its recent meeting.

Lacking such clear benefits, compounds such as triclosan and triclocarban pose unacceptable risks of environmental contamination and contribution to the evolution of antibiotic resistance, the panel unanimously concluded.

Evidence on the efficacy of alcohol-based gels and wipes was found to be similar (no more effective in reducing infection than soap and water). However, their utility in situations where water was not available, safe, or convenient—combined with their low risk of contributing to the development of resistant bacteria—was recognized by the panel, which recommended the products' continued use in defined circumstances.

A 1994 FDA decision said that antibacterial consumer products were deemed effective if they could meet the surrogate end point of decreasing bacterial load on the skin. Such a decrease was assumed to be clinically significant, according to the 1994 monograph.

However, subsequent, real-world clinical trials, though imperfect in design, have been unable to demonstrate a corresponding decrease in disease incidence or severity, compared with soap and water, either for respiratory or GI infections.

It was this question of efficacy of consumer antiseptic products that the FDA asked its advisory panel to address.

The panel heard presentations of clinical evidence regarding the benefits of consumer antiseptics from Steven Osborne, M.D., medical officer at FDA's Office of Nonprescription Products, and Allison E. Aiello, Ph.D., of the University of Michigan School of Public Health, Ann Arbor.

In eight studies from the literature, use of plain or unidentified soap and water reduced cases of diarrhea from 30% to 89% (median reduction 53%). In three studies comparing antiseptic soap with no soap in control groups, reductions in diarrhea with antiseptic soap ranged from 29% to 50%.

Furthermore, five studies comparing antiseptic soaps with plain soap found no statistically significant difference for all infectious symptoms, the presenters said.

Stuart B. Levy, M.D., a professor at Tufts University, Boston, spoke on the products' contribution to bacterial resistance.

“What are we worried about?” he asked, “We are worried that an antibiotic can select this kind of mutant and make it resistant to biocides …. Or we could be using the biocides and select a mutant which now is resistant to antibiotics. We're not talking about just one [antibiotic]. We're talking about tetracycline, penicillin, fluoroquinalone, chloramphenicol.”

Such resistance can also develop to the biocides themselves, he added. “I'm not saying I don't see the need for biocides—I don't see that they are needed in consumer products.”

The impact of triclosan and triclocarban accumulation in the environment was discussed by Rolf U. Halden, Ph.D., of Johns Hopkins University, Baltimore.

In samples of surface water from the Baltimore area, Dr. Halden and colleagues found triclocarban concentrations of 6,750 ng/L (Environ. Sci. Technol. 2005;39:1420–6). According to Dr. Halden, his results suggest triclocarban is a previously unrecognized contaminant of U.S. water resources nationwide, probably in the top 10 in occurrence rates and in the top 20 in maximum concentration.

The amount of triclocarban contamination was markedly higher than the non-peer-reviewed numbers (240 ng/L) used by the Environmental Protection Agency to evaluate ecological and human health risks, he said. The predicted half-life of triclocarban ranged from less than a day in air to 540 days in sediment. Cooccurrence of triclosan was observed at all sites.

Dr. Halden questioned why manufacturers were still using vast quantities of chlorinated compounds that could migrate into the environment, given the dubious nature of chlorine chemistry in the previous history of pollutants.

Several presenters highlighted the importance of hand hygiene in preventing the transmission of infectious diseases and the effectiveness of antibacterial products in reducing or eliminating bacteria from the skin.

“Every 3 minutes, a child brings his/her hand to nose or mouth. Every 60 seconds, a working adult touches as many as 30 objects,” said Charles P. Gerba, Ph.D., of the University of Arizona, Tucson. “Washing fomites with soap and water is not enough to prevent the spread of pathogens.”

Targeted hygiene by handwashing after risk exposure (bathrooms, food preparation, contact with potentially infected people) is needed for home infection control, he said, adding that the data clearly show that antiseptic products “decrease bacteria on the skin” and follow the log reduction requirements after a single wash.

The utility of antibacterial consumer products was stressed by the Cosmetic, Toiletry, and Fragrance Association (CTFA), which said “the benefits of topical OTC antimicrobial drug products clearly support the current proposed labeling indication (i.e., 'to decrease bacteria on skin') and provide consumers an effective means of controlling the risks of infection.”

CTFA had previously asked the FDA to lower the threshold for approval of consumer antibacterial products. That request was not recommended by the panel at a meeting in March 2005. At that meeting, the panel voted unanimously to recommend retention of the standards for bacteria reduction in antibacterial and antiseptic products for nonconsumer products.

The FDA usually follows the recommendations of its advisory panels but is not obligated to do so.

Final review of these products is to be concluded by 2007.

SILVER SPRING, MD. — Several decades' worth of clinical data on antibacterial additives in home-use soaps and detergents has shown no benefit over plain soap and water in reducing infection, the Food and Drug Administration's advisory panel on nonprescription drugs found at its recent meeting.

Lacking such clear benefits, compounds such as triclosan and triclocarban pose unacceptable risks of environmental contamination and contribution to the evolution of antibiotic resistance, the panel unanimously concluded.

Evidence on the efficacy of alcohol-based gels and wipes was found to be similar (no more effective in reducing infection than soap and water). However, their utility in situations where water was not available, safe, or convenient—combined with their low risk of contributing to the development of resistant bacteria—was recognized by the panel, which recommended the products' continued use in defined circumstances.

A 1994 FDA decision said that antibacterial consumer products were deemed effective if they could meet the surrogate end point of decreasing bacterial load on the skin. Such a decrease was assumed to be clinically significant, according to the 1994 monograph.

However, subsequent, real-world clinical trials, though imperfect in design, have been unable to demonstrate a corresponding decrease in disease incidence or severity, compared with soap and water, either for respiratory or GI infections.

It was this question of efficacy of consumer antiseptic products that the FDA asked its advisory panel to address.

The panel heard presentations of clinical evidence regarding the benefits of consumer antiseptics from Steven Osborne, M.D., medical officer at FDA's Office of Nonprescription Products, and Allison E. Aiello, Ph.D., of the University of Michigan School of Public Health, Ann Arbor.

In eight studies from the literature, use of plain or unidentified soap and water reduced cases of diarrhea from 30% to 89% (median reduction 53%). In three studies comparing antiseptic soap with no soap in control groups, reductions in diarrhea with antiseptic soap ranged from 29% to 50%.

Furthermore, five studies comparing antiseptic soaps with plain soap found no statistically significant difference for all infectious symptoms, the presenters said.

Stuart B. Levy, M.D., a professor at Tufts University, Boston, spoke on the products' contribution to bacterial resistance.

“What are we worried about?” he asked, “We are worried that an antibiotic can select this kind of mutant and make it resistant to biocides …. Or we could be using the biocides and select a mutant which now is resistant to antibiotics. We're not talking about just one [antibiotic]. We're talking about tetracycline, penicillin, fluoroquinalone, chloramphenicol.”

Such resistance can also develop to the biocides themselves, he added. “I'm not saying I don't see the need for biocides—I don't see that they are needed in consumer products.”

The impact of triclosan and triclocarban accumulation in the environment was discussed by Rolf U. Halden, Ph.D., of Johns Hopkins University, Baltimore.

In samples of surface water from the Baltimore area, Dr. Halden and colleagues found triclocarban concentrations of 6,750 ng/L (Environ. Sci. Technol. 2005;39:1420–6). According to Dr. Halden, his results suggest triclocarban is a previously unrecognized contaminant of U.S. water resources nationwide, probably in the top 10 in occurrence rates and in the top 20 in maximum concentration.

The amount of triclocarban contamination was markedly higher than the non-peer-reviewed numbers (240 ng/L) used by the Environmental Protection Agency to evaluate ecological and human health risks, he said. The predicted half-life of triclocarban ranged from less than a day in air to 540 days in sediment. Cooccurrence of triclosan was observed at all sites.

Dr. Halden questioned why manufacturers were still using vast quantities of chlorinated compounds that could migrate into the environment, given the dubious nature of chlorine chemistry in the previous history of pollutants.

Several presenters highlighted the importance of hand hygiene in preventing the transmission of infectious diseases and the effectiveness of antibacterial products in reducing or eliminating bacteria from the skin.

“Every 3 minutes, a child brings his/her hand to nose or mouth. Every 60 seconds, a working adult touches as many as 30 objects,” said Charles P. Gerba, Ph.D., of the University of Arizona, Tucson. “Washing fomites with soap and water is not enough to prevent the spread of pathogens.”

Targeted hygiene by handwashing after risk exposure (bathrooms, food preparation, contact with potentially infected people) is needed for home infection control, he said, adding that the data clearly show that antiseptic products “decrease bacteria on the skin” and follow the log reduction requirements after a single wash.

The utility of antibacterial consumer products was stressed by the Cosmetic, Toiletry, and Fragrance Association (CTFA), which said “the benefits of topical OTC antimicrobial drug products clearly support the current proposed labeling indication (i.e., 'to decrease bacteria on skin') and provide consumers an effective means of controlling the risks of infection.”

CTFA had previously asked the FDA to lower the threshold for approval of consumer antibacterial products. That request was not recommended by the panel at a meeting in March 2005. At that meeting, the panel voted unanimously to recommend retention of the standards for bacteria reduction in antibacterial and antiseptic products for nonconsumer products.

The FDA usually follows the recommendations of its advisory panels but is not obligated to do so.

Final review of these products is to be concluded by 2007.

Prophylactic use of calcitonin prevents the rapid initial bone loss commonly associated with high-dose steroids early after heart transplant surgery in adults, although bone mass eventually reaches normal levels after 7 years even without treatment, according to Emmanouil I. Kapetanakis, M.D., and colleagues.

Triple-drug immunosuppression treatment after cardiac transplantation usually combines cyclosporine, azathioprine, and prednisone. The long-term administration of the steroid is generally blamed for the associated bone loss and fractures seen as a complication after transplant.

In a small study of 23 patients, age-adjusted bone mineral density (BMD) values 1 year after cardiac transplant were significantly different for the 11 control group patients (BMD 61%), compared with the 12 calcitonin-treated patients (BMD 89%).

During the first 3 years of follow-up, these values reached 69% for the no-calcitonin group, compared with 90% in the treated group—also a significant difference. The calcitonin group maintained BMD within normal ranges during the entire time of follow-up.

Calcitonin is a salmon-derived polypeptide hormone approved for the treatment of osteoporosis.

However, “the BMD decline in the no-calcitonin group stabilized and was reversed during subsequent follow-up so that BMD values during the intermediate (4–6 years) and late (7+ years) follow-up periods were not statistically different,” according to Dr. Kapetanakis of Washington Hospital Center and colleagues (J. Heart Lung Transplant. 2005;24:526–32).

The researchers believe their work indicates the benefits of using intranasal salmon calcitonin to prevent rapid bone loss associated with high-dose steroids early after heart transplantation. But they also said that long-term use does not seem warranted, given the natural reestablishment of BMD over lengthier periods of time.

A related small study examined the rate and etiology of osteoporosis in nine adult transplant survivors who received their new heart in adolescence. These patients were compared with an equal number of control subjects matched for age (21–32 years), sex (seven men, two women), and race (six white, one black, one Hispanic, one other), reported Adi Cohen, M.D., and colleagues (J. Heart Lung Transplant. 2005;24:696–702).

Hyperparathyroidism, mild renal insufficiency, and increased bone turnover appeared to be the key factors involved in the high rate of long-term osteoporosis seen in the transplant subjects, according to Dr. Cohen of Columbia University, New York, and associates.

BMD was measured in the lumbar spine, femoral neck, and the forearm one-third radius (DR).

Osteoporosis was present in 56% of the transplant subjects at the lumbar spine, in 33% at the femoral neck, and in 100% at the DR. Only two control subjects showed osteoporosis, and only in the lumbar spine.

Biochemically, serum parathyroid hormone (PTH) levels were threefold higher in transplant subjects than in controls.

All serum markers for bone turnover were higher in subjects than in controls, with statistically significant differences for bone-specific alkaline phosphatase and N-telopeptide. Serum calcium levels, although in the normal range, were significantly lower in the subjects than in the controls.

“Although the precise etiology of the osteoporosis remains unclear … biochemical studies suggest slightly impaired renal function and documented secondary hyperparathyroidism and increased bone turnover,” Dr. Cohen and associates reported.

“This is the first study of pediatric transplant recipients to evaluate the forearm … [that is] sensitive to the catabolic effects of PTH,” they added. Because the radius was also the most severely affected site, “these findings suggest a role for PTH in the pathogenesis of osteoporosis in this population.”

Because survival rates after pediatric cardiac transplantation have increased dramatically, long-term consequences, such as osteoporosis, will become more evident and must be properly managed, according to the researchers. Understanding the etiology of these complications is the first step to developing treatments, Dr. Cohen and his associates said.

Prophylactic use of calcitonin prevents the rapid initial bone loss commonly associated with high-dose steroids early after heart transplant surgery in adults, although bone mass eventually reaches normal levels after 7 years even without treatment, according to Emmanouil I. Kapetanakis, M.D., and colleagues.

Triple-drug immunosuppression treatment after cardiac transplantation usually combines cyclosporine, azathioprine, and prednisone. The long-term administration of the steroid is generally blamed for the associated bone loss and fractures seen as a complication after transplant.

In a small study of 23 patients, age-adjusted bone mineral density (BMD) values 1 year after cardiac transplant were significantly different for the 11 control group patients (BMD 61%), compared with the 12 calcitonin-treated patients (BMD 89%).

During the first 3 years of follow-up, these values reached 69% for the no-calcitonin group, compared with 90% in the treated group—also a significant difference. The calcitonin group maintained BMD within normal ranges during the entire time of follow-up.

Calcitonin is a salmon-derived polypeptide hormone approved for the treatment of osteoporosis.

However, “the BMD decline in the no-calcitonin group stabilized and was reversed during subsequent follow-up so that BMD values during the intermediate (4–6 years) and late (7+ years) follow-up periods were not statistically different,” according to Dr. Kapetanakis of Washington Hospital Center and colleagues (J. Heart Lung Transplant. 2005;24:526–32).

The researchers believe their work indicates the benefits of using intranasal salmon calcitonin to prevent rapid bone loss associated with high-dose steroids early after heart transplantation. But they also said that long-term use does not seem warranted, given the natural reestablishment of BMD over lengthier periods of time.

A related small study examined the rate and etiology of osteoporosis in nine adult transplant survivors who received their new heart in adolescence. These patients were compared with an equal number of control subjects matched for age (21–32 years), sex (seven men, two women), and race (six white, one black, one Hispanic, one other), reported Adi Cohen, M.D., and colleagues (J. Heart Lung Transplant. 2005;24:696–702).

Hyperparathyroidism, mild renal insufficiency, and increased bone turnover appeared to be the key factors involved in the high rate of long-term osteoporosis seen in the transplant subjects, according to Dr. Cohen of Columbia University, New York, and associates.

BMD was measured in the lumbar spine, femoral neck, and the forearm one-third radius (DR).

Osteoporosis was present in 56% of the transplant subjects at the lumbar spine, in 33% at the femoral neck, and in 100% at the DR. Only two control subjects showed osteoporosis, and only in the lumbar spine.

Biochemically, serum parathyroid hormone (PTH) levels were threefold higher in transplant subjects than in controls.

All serum markers for bone turnover were higher in subjects than in controls, with statistically significant differences for bone-specific alkaline phosphatase and N-telopeptide. Serum calcium levels, although in the normal range, were significantly lower in the subjects than in the controls.

“Although the precise etiology of the osteoporosis remains unclear … biochemical studies suggest slightly impaired renal function and documented secondary hyperparathyroidism and increased bone turnover,” Dr. Cohen and associates reported.

“This is the first study of pediatric transplant recipients to evaluate the forearm … [that is] sensitive to the catabolic effects of PTH,” they added. Because the radius was also the most severely affected site, “these findings suggest a role for PTH in the pathogenesis of osteoporosis in this population.”

Because survival rates after pediatric cardiac transplantation have increased dramatically, long-term consequences, such as osteoporosis, will become more evident and must be properly managed, according to the researchers. Understanding the etiology of these complications is the first step to developing treatments, Dr. Cohen and his associates said.

Prophylactic use of calcitonin prevents the rapid initial bone loss commonly associated with high-dose steroids early after heart transplant surgery in adults, although bone mass eventually reaches normal levels after 7 years even without treatment, according to Emmanouil I. Kapetanakis, M.D., and colleagues.

Triple-drug immunosuppression treatment after cardiac transplantation usually combines cyclosporine, azathioprine, and prednisone. The long-term administration of the steroid is generally blamed for the associated bone loss and fractures seen as a complication after transplant.

In a small study of 23 patients, age-adjusted bone mineral density (BMD) values 1 year after cardiac transplant were significantly different for the 11 control group patients (BMD 61%), compared with the 12 calcitonin-treated patients (BMD 89%).

During the first 3 years of follow-up, these values reached 69% for the no-calcitonin group, compared with 90% in the treated group—also a significant difference. The calcitonin group maintained BMD within normal ranges during the entire time of follow-up.

Calcitonin is a salmon-derived polypeptide hormone approved for the treatment of osteoporosis.

However, “the BMD decline in the no-calcitonin group stabilized and was reversed during subsequent follow-up so that BMD values during the intermediate (4–6 years) and late (7+ years) follow-up periods were not statistically different,” according to Dr. Kapetanakis of Washington Hospital Center and colleagues (J. Heart Lung Transplant. 2005;24:526–32).

The researchers believe their work indicates the benefits of using intranasal salmon calcitonin to prevent rapid bone loss associated with high-dose steroids early after heart transplantation. But they also said that long-term use does not seem warranted, given the natural reestablishment of BMD over lengthier periods of time.

A related small study examined the rate and etiology of osteoporosis in nine adult transplant survivors who received their new heart in adolescence. These patients were compared with an equal number of control subjects matched for age (21–32 years), sex (seven men, two women), and race (six white, one black, one Hispanic, one other), reported Adi Cohen, M.D., and colleagues (J. Heart Lung Transplant. 2005;24:696–702).

Hyperparathyroidism, mild renal insufficiency, and increased bone turnover appeared to be the key factors involved in the high rate of long-term osteoporosis seen in the transplant subjects, according to Dr. Cohen of Columbia University, New York, and associates.

BMD was measured in the lumbar spine, femoral neck, and the forearm one-third radius (DR).

Osteoporosis was present in 56% of the transplant subjects at the lumbar spine, in 33% at the femoral neck, and in 100% at the DR. Only two control subjects showed osteoporosis, and only in the lumbar spine.

Biochemically, serum parathyroid hormone (PTH) levels were threefold higher in transplant subjects than in controls.

All serum markers for bone turnover were higher in subjects than in controls, with statistically significant differences for bone-specific alkaline phosphatase and N-telopeptide. Serum calcium levels, although in the normal range, were significantly lower in the subjects than in the controls.

“Although the precise etiology of the osteoporosis remains unclear … biochemical studies suggest slightly impaired renal function and documented secondary hyperparathyroidism and increased bone turnover,” Dr. Cohen and associates reported.

“This is the first study of pediatric transplant recipients to evaluate the forearm … [that is] sensitive to the catabolic effects of PTH,” they added. Because the radius was also the most severely affected site, “these findings suggest a role for PTH in the pathogenesis of osteoporosis in this population.”

Because survival rates after pediatric cardiac transplantation have increased dramatically, long-term consequences, such as osteoporosis, will become more evident and must be properly managed, according to the researchers. Understanding the etiology of these complications is the first step to developing treatments, Dr. Cohen and his associates said.

Elderly patients with mild to moderate hypertension and lowered cognitive function show greater cognitive decline, compared with equivalent hypertensive individuals with high cognitive function, a posthoc analysis shows.

The first Study on Cognition and Prognosis in the Elderly (SCOPE) analysis showed inconclusive results in demonstrating that antihypertensive treatment, primarily with candesartan, may preserve cognitive function and reduce the incidence of dementia, according to Ingmar Skoog, M.D., of Sahlgrenska University Hospital, Göteborg, Sweden, and colleagues in the international SCOPE study group.

The post hoc analysis was performed to compare cognitive and cardiovascular outcomes between 2,070 patients with slightly lower baseline cognitive function (LCF) as defined by Mini-Mental State Examination (MMSE) scores of 24–28, and 2,867 patients with higher cognitive function (HCF), defined by MMSE scores of 29–30 (Am. J. Hypertens. 2005;18:1052–9).

Additionally, the analysis separately compared cognitive and cardiovascular outcomes in the candesartan with the control groups for LCF and HCF patients.

Significant cognitive decline was nearly twice as common in patients with LCF (6.6%), compared with patients with HCF (3.6%). Cognitive decline did not differ significantly between candesartan and control groups. (For ethical reasons in the SCOPE trial, control patients also were given off-label active hypertensive therapy when deemed necessary, primarily with hydrochlorothiazide, significantly lowering blood pressure in both treatment groups).

Dementia onset during the study was found to be over four times as common in patients with LCF (4.4%) as in patients with HCF (1.0%). Here, too, no difference was seen between the candesartan and control groups, Dr. Skoog and colleagues reported.

Contrary to perceived fears by many physicians that lowering blood pressure in the elderly would cause cognitive decline because of reduction in cerebral blood flow, cognitive function changed very little, even in patients with LCF, the authors reported. In addition, dementia incidence in the study was found to be in the lower range of expectation for this age group. Thus, there appeared to be no negative effect of blood pressure control, according to the report.

Such evidence, coupled with the observation that mild to moderate hypertension and slightly impaired cognitive function in the elderly at baseline were associated with increased risk of significant cognitive decline and dementia, indicate that effective antihypertensive therapy may reduce cognitive decline in these patients, Dr. Skoog and colleagues concluded.

Elderly patients with mild to moderate hypertension and lowered cognitive function show greater cognitive decline, compared with equivalent hypertensive individuals with high cognitive function, a posthoc analysis shows.

The first Study on Cognition and Prognosis in the Elderly (SCOPE) analysis showed inconclusive results in demonstrating that antihypertensive treatment, primarily with candesartan, may preserve cognitive function and reduce the incidence of dementia, according to Ingmar Skoog, M.D., of Sahlgrenska University Hospital, Göteborg, Sweden, and colleagues in the international SCOPE study group.

The post hoc analysis was performed to compare cognitive and cardiovascular outcomes between 2,070 patients with slightly lower baseline cognitive function (LCF) as defined by Mini-Mental State Examination (MMSE) scores of 24–28, and 2,867 patients with higher cognitive function (HCF), defined by MMSE scores of 29–30 (Am. J. Hypertens. 2005;18:1052–9).

Additionally, the analysis separately compared cognitive and cardiovascular outcomes in the candesartan with the control groups for LCF and HCF patients.

Significant cognitive decline was nearly twice as common in patients with LCF (6.6%), compared with patients with HCF (3.6%). Cognitive decline did not differ significantly between candesartan and control groups. (For ethical reasons in the SCOPE trial, control patients also were given off-label active hypertensive therapy when deemed necessary, primarily with hydrochlorothiazide, significantly lowering blood pressure in both treatment groups).

Dementia onset during the study was found to be over four times as common in patients with LCF (4.4%) as in patients with HCF (1.0%). Here, too, no difference was seen between the candesartan and control groups, Dr. Skoog and colleagues reported.

Contrary to perceived fears by many physicians that lowering blood pressure in the elderly would cause cognitive decline because of reduction in cerebral blood flow, cognitive function changed very little, even in patients with LCF, the authors reported. In addition, dementia incidence in the study was found to be in the lower range of expectation for this age group. Thus, there appeared to be no negative effect of blood pressure control, according to the report.

Such evidence, coupled with the observation that mild to moderate hypertension and slightly impaired cognitive function in the elderly at baseline were associated with increased risk of significant cognitive decline and dementia, indicate that effective antihypertensive therapy may reduce cognitive decline in these patients, Dr. Skoog and colleagues concluded.

Elderly patients with mild to moderate hypertension and lowered cognitive function show greater cognitive decline, compared with equivalent hypertensive individuals with high cognitive function, a posthoc analysis shows.

The first Study on Cognition and Prognosis in the Elderly (SCOPE) analysis showed inconclusive results in demonstrating that antihypertensive treatment, primarily with candesartan, may preserve cognitive function and reduce the incidence of dementia, according to Ingmar Skoog, M.D., of Sahlgrenska University Hospital, Göteborg, Sweden, and colleagues in the international SCOPE study group.

The post hoc analysis was performed to compare cognitive and cardiovascular outcomes between 2,070 patients with slightly lower baseline cognitive function (LCF) as defined by Mini-Mental State Examination (MMSE) scores of 24–28, and 2,867 patients with higher cognitive function (HCF), defined by MMSE scores of 29–30 (Am. J. Hypertens. 2005;18:1052–9).

Additionally, the analysis separately compared cognitive and cardiovascular outcomes in the candesartan with the control groups for LCF and HCF patients.

Significant cognitive decline was nearly twice as common in patients with LCF (6.6%), compared with patients with HCF (3.6%). Cognitive decline did not differ significantly between candesartan and control groups. (For ethical reasons in the SCOPE trial, control patients also were given off-label active hypertensive therapy when deemed necessary, primarily with hydrochlorothiazide, significantly lowering blood pressure in both treatment groups).

Dementia onset during the study was found to be over four times as common in patients with LCF (4.4%) as in patients with HCF (1.0%). Here, too, no difference was seen between the candesartan and control groups, Dr. Skoog and colleagues reported.

Contrary to perceived fears by many physicians that lowering blood pressure in the elderly would cause cognitive decline because of reduction in cerebral blood flow, cognitive function changed very little, even in patients with LCF, the authors reported. In addition, dementia incidence in the study was found to be in the lower range of expectation for this age group. Thus, there appeared to be no negative effect of blood pressure control, according to the report.

Such evidence, coupled with the observation that mild to moderate hypertension and slightly impaired cognitive function in the elderly at baseline were associated with increased risk of significant cognitive decline and dementia, indicate that effective antihypertensive therapy may reduce cognitive decline in these patients, Dr. Skoog and colleagues concluded.

Persons suffering from dementia rate their distinct self-identity roles in the past and present differently from the way their family or staff caregivers rate those roles, according to Jiska Cohen-Mansfield, Ph.D.

Researchers studied 46 people attending six adult day care centers and 56 residents in two nursing homes in the Washington metropolitan area. A previously developed self-identity in dementia questionnaire was used to interview the participants, their families, and staff caregivers, reported Dr. Cohen-Mansfield, research director of the Research Institute on Aging of the Hebrew Home of Greater Washington, Rockville, Md., and colleagues (Soc. Sci. Med. [Epub ahead of print] 2005. Article DOI number: 10.1016/j.socscimed.2005.06.031

The four self-identity domains investigated were professional, family/social, hobbies/leisure-time activities, and personal attributes/achievements/traits.

Of these self-identity categories, family roles ratings were the most likely to be maintained over time, with almost half of the participants (48%) identifying their parental role as the most important of these. In contrast, family members rated the spousal relationship as the most important (31%) with parental role a close second (29%).

The study showed a significant time effect, with a decline in the importance of role identity from past to present, and the family role being the most important throughout. The importance of professional identity declined most over time.

The greatest discrepancy between family and participant reports on professional roles involved the category of homemaker. Of the 24 participants categorized by the family as homemakers, only 21% (5) of those participants agreed. The differential was largely attributable to reports of family members who were children of the participants and described their mothers as homemakers, while the mothers described themselves as having other professions. More than a third (38%) of responses from staff members indicating ignorance of the participant's occupation were for those whose family members described them as homemakers, Dr. Cohen-Mansfield reported.

In addition, although no significant gender differences were seen in role importance as assigned by participants and staff caregivers for each role group over time, family members reported significantly higher importance ranking for professional identity for males than for females in the past as well as present. “Family members generally estimated the importance of role identities in the past to be higher, and that in the present as lower, than did the participants,” Dr. Cohen-Mansfield reported.

“Our results show that while general trends of a decline in importance of role-identity domains are the same between family informants and participants, the absolute ratings were significantly influenced by [which group were] informants.” Understanding the changing self-identities of these people with dementia is a crucial first step toward providing tailored care and enhancing their life experience.

Persons suffering from dementia rate their distinct self-identity roles in the past and present differently from the way their family or staff caregivers rate those roles, according to Jiska Cohen-Mansfield, Ph.D.

Researchers studied 46 people attending six adult day care centers and 56 residents in two nursing homes in the Washington metropolitan area. A previously developed self-identity in dementia questionnaire was used to interview the participants, their families, and staff caregivers, reported Dr. Cohen-Mansfield, research director of the Research Institute on Aging of the Hebrew Home of Greater Washington, Rockville, Md., and colleagues (Soc. Sci. Med. [Epub ahead of print] 2005. Article DOI number: 10.1016/j.socscimed.2005.06.031

The four self-identity domains investigated were professional, family/social, hobbies/leisure-time activities, and personal attributes/achievements/traits.

Of these self-identity categories, family roles ratings were the most likely to be maintained over time, with almost half of the participants (48%) identifying their parental role as the most important of these. In contrast, family members rated the spousal relationship as the most important (31%) with parental role a close second (29%).

The study showed a significant time effect, with a decline in the importance of role identity from past to present, and the family role being the most important throughout. The importance of professional identity declined most over time.

The greatest discrepancy between family and participant reports on professional roles involved the category of homemaker. Of the 24 participants categorized by the family as homemakers, only 21% (5) of those participants agreed. The differential was largely attributable to reports of family members who were children of the participants and described their mothers as homemakers, while the mothers described themselves as having other professions. More than a third (38%) of responses from staff members indicating ignorance of the participant's occupation were for those whose family members described them as homemakers, Dr. Cohen-Mansfield reported.

In addition, although no significant gender differences were seen in role importance as assigned by participants and staff caregivers for each role group over time, family members reported significantly higher importance ranking for professional identity for males than for females in the past as well as present. “Family members generally estimated the importance of role identities in the past to be higher, and that in the present as lower, than did the participants,” Dr. Cohen-Mansfield reported.

“Our results show that while general trends of a decline in importance of role-identity domains are the same between family informants and participants, the absolute ratings were significantly influenced by [which group were] informants.” Understanding the changing self-identities of these people with dementia is a crucial first step toward providing tailored care and enhancing their life experience.

Persons suffering from dementia rate their distinct self-identity roles in the past and present differently from the way their family or staff caregivers rate those roles, according to Jiska Cohen-Mansfield, Ph.D.

Researchers studied 46 people attending six adult day care centers and 56 residents in two nursing homes in the Washington metropolitan area. A previously developed self-identity in dementia questionnaire was used to interview the participants, their families, and staff caregivers, reported Dr. Cohen-Mansfield, research director of the Research Institute on Aging of the Hebrew Home of Greater Washington, Rockville, Md., and colleagues (Soc. Sci. Med. [Epub ahead of print] 2005. Article DOI number: 10.1016/j.socscimed.2005.06.031

The four self-identity domains investigated were professional, family/social, hobbies/leisure-time activities, and personal attributes/achievements/traits.

Of these self-identity categories, family roles ratings were the most likely to be maintained over time, with almost half of the participants (48%) identifying their parental role as the most important of these. In contrast, family members rated the spousal relationship as the most important (31%) with parental role a close second (29%).

The study showed a significant time effect, with a decline in the importance of role identity from past to present, and the family role being the most important throughout. The importance of professional identity declined most over time.

The greatest discrepancy between family and participant reports on professional roles involved the category of homemaker. Of the 24 participants categorized by the family as homemakers, only 21% (5) of those participants agreed. The differential was largely attributable to reports of family members who were children of the participants and described their mothers as homemakers, while the mothers described themselves as having other professions. More than a third (38%) of responses from staff members indicating ignorance of the participant's occupation were for those whose family members described them as homemakers, Dr. Cohen-Mansfield reported.

In addition, although no significant gender differences were seen in role importance as assigned by participants and staff caregivers for each role group over time, family members reported significantly higher importance ranking for professional identity for males than for females in the past as well as present. “Family members generally estimated the importance of role identities in the past to be higher, and that in the present as lower, than did the participants,” Dr. Cohen-Mansfield reported.

“Our results show that while general trends of a decline in importance of role-identity domains are the same between family informants and participants, the absolute ratings were significantly influenced by [which group were] informants.” Understanding the changing self-identities of these people with dementia is a crucial first step toward providing tailored care and enhancing their life experience.

A common perception, based on relatively few published studies, is that most psychiatric disorders other than depression occur much less frequently among the elderly. Community samples, however, suggest that many older adults who experience clinically significant pathologies are overlooked or misdiagnosed, according to Dilip V. Jeste, M.D., and colleagues.

This discrepancy points out the need to develop age-appropriate diagnostic criteria that can assess elderly psychiatric patients, according to Dr. Jeste of the department of psychology at the University of California, San Diego, and associates (Biol. Psychiatry 2005;58:265–71).

Five potential causes of diagnostic confusion in the elderly were detailed:

▸ True age-related differences, in which symptoms of the disorder vary according to age. In such cases, application of DSM-IV criteria sets based on the disorder at a younger age results in under-, over-, or misdiagnosis in the elderly.

▸ Physical and psychiatric comorbidities, which tend to occur more frequently in the elderly, including general medical conditions such as congestive heart failure or cognitive deficiencies such as dementia.

▸ Underreporting of symptoms, which occurs more frequently in the elderly, biasing both epidemiologic and clinical-based studies toward underdiagnosis.

▸ Variation through time of onset, such as in major depression, which can show different symptoms in late, compared with early onset, the investigators said.

▸ Subthreshold presentations, in which older patients might experience clinically significant symptoms that fall below standard DSM-IV criteria sets. “For example 'minor generalized anxiety disorder' might have a different significance and outcome in elderly than in younger adults,” Dr. Jeste and associates reported.

Several categories of disorder can be subject to these various difficulties in diagnosis. For example, schizophrenia, though typically of early onset, also occurs in a sizeable minority of patients in middle or old age, and is often misdiagnosed as due to “organic” factors. According to the literature, 13% of all schizophrenia had onset between the ages of 41 and 50 years, 7% in patients aged 51–60 years, and 3% after age 60, they reported. Distinctiveness of symptoms in the “very late onset” indicates the illness may belong in a different category.

Anxiety disorders may be particularly difficult to pin down, according to the authors. For example, new-onset agoraphobic disorder would be less obvious, and thus underdiagnosed, in elderly patients who are less mobile and leave their houses less frequently.

Further research is needed to clarify the classification and incidence of late-life psychiatric disorders. “Most of the gaps in the current knowledge outlined … can be filled by systematic research and better attention to the potential presence of these disorders in elderly patients,” Dr. Jeste and associates said.

A common perception, based on relatively few published studies, is that most psychiatric disorders other than depression occur much less frequently among the elderly. Community samples, however, suggest that many older adults who experience clinically significant pathologies are overlooked or misdiagnosed, according to Dilip V. Jeste, M.D., and colleagues.

This discrepancy points out the need to develop age-appropriate diagnostic criteria that can assess elderly psychiatric patients, according to Dr. Jeste of the department of psychology at the University of California, San Diego, and associates (Biol. Psychiatry 2005;58:265–71).

Five potential causes of diagnostic confusion in the elderly were detailed:

▸ True age-related differences, in which symptoms of the disorder vary according to age. In such cases, application of DSM-IV criteria sets based on the disorder at a younger age results in under-, over-, or misdiagnosis in the elderly.

▸ Physical and psychiatric comorbidities, which tend to occur more frequently in the elderly, including general medical conditions such as congestive heart failure or cognitive deficiencies such as dementia.

▸ Underreporting of symptoms, which occurs more frequently in the elderly, biasing both epidemiologic and clinical-based studies toward underdiagnosis.

▸ Variation through time of onset, such as in major depression, which can show different symptoms in late, compared with early onset, the investigators said.

▸ Subthreshold presentations, in which older patients might experience clinically significant symptoms that fall below standard DSM-IV criteria sets. “For example 'minor generalized anxiety disorder' might have a different significance and outcome in elderly than in younger adults,” Dr. Jeste and associates reported.

Several categories of disorder can be subject to these various difficulties in diagnosis. For example, schizophrenia, though typically of early onset, also occurs in a sizeable minority of patients in middle or old age, and is often misdiagnosed as due to “organic” factors. According to the literature, 13% of all schizophrenia had onset between the ages of 41 and 50 years, 7% in patients aged 51–60 years, and 3% after age 60, they reported. Distinctiveness of symptoms in the “very late onset” indicates the illness may belong in a different category.

Anxiety disorders may be particularly difficult to pin down, according to the authors. For example, new-onset agoraphobic disorder would be less obvious, and thus underdiagnosed, in elderly patients who are less mobile and leave their houses less frequently.

Further research is needed to clarify the classification and incidence of late-life psychiatric disorders. “Most of the gaps in the current knowledge outlined … can be filled by systematic research and better attention to the potential presence of these disorders in elderly patients,” Dr. Jeste and associates said.

A common perception, based on relatively few published studies, is that most psychiatric disorders other than depression occur much less frequently among the elderly. Community samples, however, suggest that many older adults who experience clinically significant pathologies are overlooked or misdiagnosed, according to Dilip V. Jeste, M.D., and colleagues.

This discrepancy points out the need to develop age-appropriate diagnostic criteria that can assess elderly psychiatric patients, according to Dr. Jeste of the department of psychology at the University of California, San Diego, and associates (Biol. Psychiatry 2005;58:265–71).

Five potential causes of diagnostic confusion in the elderly were detailed:

▸ True age-related differences, in which symptoms of the disorder vary according to age. In such cases, application of DSM-IV criteria sets based on the disorder at a younger age results in under-, over-, or misdiagnosis in the elderly.

▸ Physical and psychiatric comorbidities, which tend to occur more frequently in the elderly, including general medical conditions such as congestive heart failure or cognitive deficiencies such as dementia.

▸ Underreporting of symptoms, which occurs more frequently in the elderly, biasing both epidemiologic and clinical-based studies toward underdiagnosis.

▸ Variation through time of onset, such as in major depression, which can show different symptoms in late, compared with early onset, the investigators said.

▸ Subthreshold presentations, in which older patients might experience clinically significant symptoms that fall below standard DSM-IV criteria sets. “For example 'minor generalized anxiety disorder' might have a different significance and outcome in elderly than in younger adults,” Dr. Jeste and associates reported.

Several categories of disorder can be subject to these various difficulties in diagnosis. For example, schizophrenia, though typically of early onset, also occurs in a sizeable minority of patients in middle or old age, and is often misdiagnosed as due to “organic” factors. According to the literature, 13% of all schizophrenia had onset between the ages of 41 and 50 years, 7% in patients aged 51–60 years, and 3% after age 60, they reported. Distinctiveness of symptoms in the “very late onset” indicates the illness may belong in a different category.

Anxiety disorders may be particularly difficult to pin down, according to the authors. For example, new-onset agoraphobic disorder would be less obvious, and thus underdiagnosed, in elderly patients who are less mobile and leave their houses less frequently.

Further research is needed to clarify the classification and incidence of late-life psychiatric disorders. “Most of the gaps in the current knowledge outlined … can be filled by systematic research and better attention to the potential presence of these disorders in elderly patients,” Dr. Jeste and associates said.

CHICAGO — Open surgery bypass graft for repairing the diabetic foot is still the most commonly used therapy for revascularization, and is considered by most to be the preferred method. However, it is part of a complex algorithm of treatment that grows in complexity as more and more considerations come into play, Gary Gibbons, M.D., said at the Vascular Annual Meeting.

"To achieve the most rapid and durable healing, what you want to do is restore a pulse to the foot by whatever means you can," he explained. Typically, this is still through an open bypass, according to Dr. Gibbons, professor of surgery at Boston University and executive director, Foot Care Specialists of Boston Medical Center.

But the open bypass procedures—which are dictated by the status of the patient's vascular anatomy and wound morphology—can be quite complex.

In order to be prepared for the almost inevitable surprises upon exploring the foot, "I tell my residents every time they're with me that I want three approaches to do this operation, because it is the nature of diabetic vascular disease [that] oftentimes approach No. 1 isn't going to work," he said.

The most critical consideration, outside of the surgery itself, is the overall control of sepsis before and after the operation. "We used to think, just get the blood sugar down to maybe 200 [mg/dL], but now we really, really like to have very low blood sugars in the postoperative course. It's the greatest way to determine how well you drain sepsis, because the blood sugar will not fall until you have adequately debrided and controlled sepsis," Dr. Gibbons said.

After surgery, the effects of revascularization on infection can become quickly evident. "Don't be surprised if you have to take the patient immediately back into the operating room 24 hours later to further control sepsis because you have woken the bacteria up," he said.

Although these bypasses are durable, limb salvage is ultimately more important than patency, he added. "The thing to remember is that a third of these patients are going to be dead in 5 years. But the thing is, they want to die intact."

Additionally, Dr. Gibbons said, "I am on a mission for protecting the other leg and foot. Anywhere from 24% to 48% [of these patients] will have a contralateral extremity problem within the next 3 years," and therefore they must be monitored carefully long after surgery on the currently affected foot.

Dr. Gibbons said that his center is doing more and more endovascular treatment of diabetic foot patients. For many of the more complex wounds with damaged vasculature, a bypass can salvage a foot in the only way possible.

CHICAGO — Open surgery bypass graft for repairing the diabetic foot is still the most commonly used therapy for revascularization, and is considered by most to be the preferred method. However, it is part of a complex algorithm of treatment that grows in complexity as more and more considerations come into play, Gary Gibbons, M.D., said at the Vascular Annual Meeting.

"To achieve the most rapid and durable healing, what you want to do is restore a pulse to the foot by whatever means you can," he explained. Typically, this is still through an open bypass, according to Dr. Gibbons, professor of surgery at Boston University and executive director, Foot Care Specialists of Boston Medical Center.

But the open bypass procedures—which are dictated by the status of the patient's vascular anatomy and wound morphology—can be quite complex.

In order to be prepared for the almost inevitable surprises upon exploring the foot, "I tell my residents every time they're with me that I want three approaches to do this operation, because it is the nature of diabetic vascular disease [that] oftentimes approach No. 1 isn't going to work," he said.

The most critical consideration, outside of the surgery itself, is the overall control of sepsis before and after the operation. "We used to think, just get the blood sugar down to maybe 200 [mg/dL], but now we really, really like to have very low blood sugars in the postoperative course. It's the greatest way to determine how well you drain sepsis, because the blood sugar will not fall until you have adequately debrided and controlled sepsis," Dr. Gibbons said.

After surgery, the effects of revascularization on infection can become quickly evident. "Don't be surprised if you have to take the patient immediately back into the operating room 24 hours later to further control sepsis because you have woken the bacteria up," he said.

Although these bypasses are durable, limb salvage is ultimately more important than patency, he added. "The thing to remember is that a third of these patients are going to be dead in 5 years. But the thing is, they want to die intact."

Additionally, Dr. Gibbons said, "I am on a mission for protecting the other leg and foot. Anywhere from 24% to 48% [of these patients] will have a contralateral extremity problem within the next 3 years," and therefore they must be monitored carefully long after surgery on the currently affected foot.

Dr. Gibbons said that his center is doing more and more endovascular treatment of diabetic foot patients. For many of the more complex wounds with damaged vasculature, a bypass can salvage a foot in the only way possible.

CHICAGO — Open surgery bypass graft for repairing the diabetic foot is still the most commonly used therapy for revascularization, and is considered by most to be the preferred method. However, it is part of a complex algorithm of treatment that grows in complexity as more and more considerations come into play, Gary Gibbons, M.D., said at the Vascular Annual Meeting.

"To achieve the most rapid and durable healing, what you want to do is restore a pulse to the foot by whatever means you can," he explained. Typically, this is still through an open bypass, according to Dr. Gibbons, professor of surgery at Boston University and executive director, Foot Care Specialists of Boston Medical Center.

But the open bypass procedures—which are dictated by the status of the patient's vascular anatomy and wound morphology—can be quite complex.

In order to be prepared for the almost inevitable surprises upon exploring the foot, "I tell my residents every time they're with me that I want three approaches to do this operation, because it is the nature of diabetic vascular disease [that] oftentimes approach No. 1 isn't going to work," he said.

The most critical consideration, outside of the surgery itself, is the overall control of sepsis before and after the operation. "We used to think, just get the blood sugar down to maybe 200 [mg/dL], but now we really, really like to have very low blood sugars in the postoperative course. It's the greatest way to determine how well you drain sepsis, because the blood sugar will not fall until you have adequately debrided and controlled sepsis," Dr. Gibbons said.

After surgery, the effects of revascularization on infection can become quickly evident. "Don't be surprised if you have to take the patient immediately back into the operating room 24 hours later to further control sepsis because you have woken the bacteria up," he said.

Although these bypasses are durable, limb salvage is ultimately more important than patency, he added. "The thing to remember is that a third of these patients are going to be dead in 5 years. But the thing is, they want to die intact."

Additionally, Dr. Gibbons said, "I am on a mission for protecting the other leg and foot. Anywhere from 24% to 48% [of these patients] will have a contralateral extremity problem within the next 3 years," and therefore they must be monitored carefully long after surgery on the currently affected foot.

Dr. Gibbons said that his center is doing more and more endovascular treatment of diabetic foot patients. For many of the more complex wounds with damaged vasculature, a bypass can salvage a foot in the only way possible.

Persons suffering from dementia rate their distinct self-identity roles in the past and present differently from the way their family or staff caregivers rate those roles, according to Jiska Cohen-Mansfield, Ph.D.

Researchers studied 46 people attending six adult day care centers and 56 residents in two nursing homes in the Washington metropolitan area. A previously developed self-identity in dementia questionnaire was used to interview the participants, their families, and staff caregivers, reported Dr. Cohen-Mansfield, research director of the Research Institute on Aging of the Hebrew Home of Greater Washington, Rockville, Md., and colleagues (Soc. Sci. Med. [Epub ahead of print] 2005. Article DOI number: doi.10.1016/j.socscimed.2005.06.031).

The four self-identity domains investigated were professional, family/social, hobbies/leisuretime activities, and personal attributes/achievements/traits. Of these self-identity categories, family roles ratings were the most likely to be maintained over time, with almost half of the participants (48%) identifying their parental role as the most important of these. In contrast, family members rated the spousal relationship as the most important (31%) with parental role a close second (29%).

The study showed a significant time effect, with a decline in the importance of role identity from past to present, and the family role being the most important throughout. The importance of professional identity declined most.

The greatest discrepancy between family and participant reports on professional roles involved the category of homemaker. Of the 24 participants categorized by the family as homemakers, only 21% (5) of those participants agreed. The differential was largely attributable to reports of family members who were children of the participants and described their mothers as homemakers, while the mothers described themselves as having other professions. More than a third (38%) of responses from staff members indicating ignorance of the participant's occupation were for those whose family members described them as homemakers, Dr. Cohen-Mansfield reported.

In addition, although no significant gender differences were seen in role importance as assigned by participants and staff caregivers for each role group over time, family members reported significantly higher importance ranking for professional identity for males than for females in the past as well as present.

“Family members generally estimated the importance of role identities in the past to be higher, and that in the present as lower, than did the participants,” Dr. Cohen-Mansfield reported.

“Our results show that while general trends of a decline in importance of role-identity domains are the same between family informants and participants, the absolute ratings were significantly influenced by [which group were] informants.” This finding indicates a need to obtain as much information as possible from the participants in order to identify their role perceptions. Understanding the changing self-identities of these people with dementia is a crucial first step toward providing tailored care and enhancing their life experience, Dr. Cohen-Mansfield and colleagues reported.

Persons suffering from dementia rate their distinct self-identity roles in the past and present differently from the way their family or staff caregivers rate those roles, according to Jiska Cohen-Mansfield, Ph.D.

Researchers studied 46 people attending six adult day care centers and 56 residents in two nursing homes in the Washington metropolitan area. A previously developed self-identity in dementia questionnaire was used to interview the participants, their families, and staff caregivers, reported Dr. Cohen-Mansfield, research director of the Research Institute on Aging of the Hebrew Home of Greater Washington, Rockville, Md., and colleagues (Soc. Sci. Med. [Epub ahead of print] 2005. Article DOI number: doi.10.1016/j.socscimed.2005.06.031).

The four self-identity domains investigated were professional, family/social, hobbies/leisuretime activities, and personal attributes/achievements/traits. Of these self-identity categories, family roles ratings were the most likely to be maintained over time, with almost half of the participants (48%) identifying their parental role as the most important of these. In contrast, family members rated the spousal relationship as the most important (31%) with parental role a close second (29%).

The study showed a significant time effect, with a decline in the importance of role identity from past to present, and the family role being the most important throughout. The importance of professional identity declined most.

The greatest discrepancy between family and participant reports on professional roles involved the category of homemaker. Of the 24 participants categorized by the family as homemakers, only 21% (5) of those participants agreed. The differential was largely attributable to reports of family members who were children of the participants and described their mothers as homemakers, while the mothers described themselves as having other professions. More than a third (38%) of responses from staff members indicating ignorance of the participant's occupation were for those whose family members described them as homemakers, Dr. Cohen-Mansfield reported.

In addition, although no significant gender differences were seen in role importance as assigned by participants and staff caregivers for each role group over time, family members reported significantly higher importance ranking for professional identity for males than for females in the past as well as present.

“Family members generally estimated the importance of role identities in the past to be higher, and that in the present as lower, than did the participants,” Dr. Cohen-Mansfield reported.

“Our results show that while general trends of a decline in importance of role-identity domains are the same between family informants and participants, the absolute ratings were significantly influenced by [which group were] informants.” This finding indicates a need to obtain as much information as possible from the participants in order to identify their role perceptions. Understanding the changing self-identities of these people with dementia is a crucial first step toward providing tailored care and enhancing their life experience, Dr. Cohen-Mansfield and colleagues reported.

Persons suffering from dementia rate their distinct self-identity roles in the past and present differently from the way their family or staff caregivers rate those roles, according to Jiska Cohen-Mansfield, Ph.D.

Researchers studied 46 people attending six adult day care centers and 56 residents in two nursing homes in the Washington metropolitan area. A previously developed self-identity in dementia questionnaire was used to interview the participants, their families, and staff caregivers, reported Dr. Cohen-Mansfield, research director of the Research Institute on Aging of the Hebrew Home of Greater Washington, Rockville, Md., and colleagues (Soc. Sci. Med. [Epub ahead of print] 2005. Article DOI number: doi.10.1016/j.socscimed.2005.06.031).

The four self-identity domains investigated were professional, family/social, hobbies/leisuretime activities, and personal attributes/achievements/traits. Of these self-identity categories, family roles ratings were the most likely to be maintained over time, with almost half of the participants (48%) identifying their parental role as the most important of these. In contrast, family members rated the spousal relationship as the most important (31%) with parental role a close second (29%).

The study showed a significant time effect, with a decline in the importance of role identity from past to present, and the family role being the most important throughout. The importance of professional identity declined most.

The greatest discrepancy between family and participant reports on professional roles involved the category of homemaker. Of the 24 participants categorized by the family as homemakers, only 21% (5) of those participants agreed. The differential was largely attributable to reports of family members who were children of the participants and described their mothers as homemakers, while the mothers described themselves as having other professions. More than a third (38%) of responses from staff members indicating ignorance of the participant's occupation were for those whose family members described them as homemakers, Dr. Cohen-Mansfield reported.

In addition, although no significant gender differences were seen in role importance as assigned by participants and staff caregivers for each role group over time, family members reported significantly higher importance ranking for professional identity for males than for females in the past as well as present.

“Family members generally estimated the importance of role identities in the past to be higher, and that in the present as lower, than did the participants,” Dr. Cohen-Mansfield reported.

“Our results show that while general trends of a decline in importance of role-identity domains are the same between family informants and participants, the absolute ratings were significantly influenced by [which group were] informants.” This finding indicates a need to obtain as much information as possible from the participants in order to identify their role perceptions. Understanding the changing self-identities of these people with dementia is a crucial first step toward providing tailored care and enhancing their life experience, Dr. Cohen-Mansfield and colleagues reported.

CHICAGO — Clinical symptoms are critical in distinguishing between uninfected and mildly infected diabetic foot lesions, Warren S. Joseph, D.P.M., reported at the Vascular Annual Meeting.

For instance, lack of cellulitis indicates lack of infection, as does good granulation. If the wound is purulent, it is infected.

Surprisingly, culturing the wound for microorganisms is not the best way to diagnose infection. This is because even noninfected diabetic foot lesions are “wound toilets” or, less bluntly, they have a significant “bioburden or bioload” of microorganisms that are simply colonizing the lesion, said Dr. Joseph of the Veterans Affairs Medical Center in Coatesville, Pa.

Just because an ulcer is colonized does not mean it is infected, he explained. However, in patients whose diabetic foot lesions are colonized but not infected, physicians may feel uncomfortable about doing nothing, Dr. Joseph said. They know the microbes are there, and they feel compelled to provide treatment, he said.

In this situation, topical treatments such as those with broad-spectrum activated silver are better than systemic antibiotics. And yet there is little evidence that topical antibiotics have any benefit for healing wounds, he said. In addition, they have little effect on preventing infection.

“Antibiotics do not heal wounds, antibiotics treat infection,” Dr. Joseph said, adding that he could not overemphasize the point that systemic antibiotics do not have a place in treating noninfected wounds.

Why? Because the first strain of vancomycin-resistant Staphylococcus aureus was found in a diabetic foot wound; it showed up in a swab culture of a clinically noninfected wound.

According to Dr. Joseph, the Infectious Diseases Society of America classification system developed last year defines mild infection as that extending less than 2 cm (www.idsociety.org

It is a misconception, Dr. Joseph pointed out, that all diabetic foot infections are polymicrobial. Virtually all diabetic foot infections have been shown to be caused by just two microorganism types—Staphylococcus aureus and group B streptococci. “This is great news, because when you think about what antibiotics you need for staph and strep—just about anything,” he said. “Those broad-spectrum drugs we have been using all these years we probably do not need, with one small caveat—there has been an incredible increase in prevalence of methicillin-resistant staph in [the] diabetic foot.” The bottom line is that 40% or more of all diabetic foot staph infections are methicillin resistant.

The number of diabetic foot patients who presented with methicillin-resistant Staphylococcus aureus doubled between 1999 and 2002, he said.

Given the variety of alternatives available—anything you would use for staph or strep throat—Dr. Joseph said: “Do not use ciprofloxacin in the infected diabetic foot.”

The reasoning is that it has poor activity against staph and strep, and it is a single-step mutation to getting staph or strep resistant to ciprofloxacin.

“You might have a nice big S sitting next to the cipro line, but give that patient the drug, [and] within a week it's going to turn to an R.”

Dr. Joseph said that he believes ultimately it will be shown that severe infections will respond to antibiotics directed against staph and strep, even if there are corresponding anaerobic microbes present.

He used the analogy of a snake: Remove the head (staph and strep), and the rest dies.

However, he stated that the clinical data are not there just yet to support advising against the use of broad-spectrum antibiotics for such infections, and so he could not recommend it.

Dr. Joseph disclosed financial relationships with Merck and Pfizer.

CHICAGO — Clinical symptoms are critical in distinguishing between uninfected and mildly infected diabetic foot lesions, Warren S. Joseph, D.P.M., reported at the Vascular Annual Meeting.

For instance, lack of cellulitis indicates lack of infection, as does good granulation. If the wound is purulent, it is infected.

Surprisingly, culturing the wound for microorganisms is not the best way to diagnose infection. This is because even noninfected diabetic foot lesions are “wound toilets” or, less bluntly, they have a significant “bioburden or bioload” of microorganisms that are simply colonizing the lesion, said Dr. Joseph of the Veterans Affairs Medical Center in Coatesville, Pa.

Just because an ulcer is colonized does not mean it is infected, he explained. However, in patients whose diabetic foot lesions are colonized but not infected, physicians may feel uncomfortable about doing nothing, Dr. Joseph said. They know the microbes are there, and they feel compelled to provide treatment, he said.

In this situation, topical treatments such as those with broad-spectrum activated silver are better than systemic antibiotics. And yet there is little evidence that topical antibiotics have any benefit for healing wounds, he said. In addition, they have little effect on preventing infection.

“Antibiotics do not heal wounds, antibiotics treat infection,” Dr. Joseph said, adding that he could not overemphasize the point that systemic antibiotics do not have a place in treating noninfected wounds.

Why? Because the first strain of vancomycin-resistant Staphylococcus aureus was found in a diabetic foot wound; it showed up in a swab culture of a clinically noninfected wound.

According to Dr. Joseph, the Infectious Diseases Society of America classification system developed last year defines mild infection as that extending less than 2 cm (www.idsociety.org

It is a misconception, Dr. Joseph pointed out, that all diabetic foot infections are polymicrobial. Virtually all diabetic foot infections have been shown to be caused by just two microorganism types—Staphylococcus aureus and group B streptococci. “This is great news, because when you think about what antibiotics you need for staph and strep—just about anything,” he said. “Those broad-spectrum drugs we have been using all these years we probably do not need, with one small caveat—there has been an incredible increase in prevalence of methicillin-resistant staph in [the] diabetic foot.” The bottom line is that 40% or more of all diabetic foot staph infections are methicillin resistant.

The number of diabetic foot patients who presented with methicillin-resistant Staphylococcus aureus doubled between 1999 and 2002, he said.

Given the variety of alternatives available—anything you would use for staph or strep throat—Dr. Joseph said: “Do not use ciprofloxacin in the infected diabetic foot.”

The reasoning is that it has poor activity against staph and strep, and it is a single-step mutation to getting staph or strep resistant to ciprofloxacin.

“You might have a nice big S sitting next to the cipro line, but give that patient the drug, [and] within a week it's going to turn to an R.”

Dr. Joseph said that he believes ultimately it will be shown that severe infections will respond to antibiotics directed against staph and strep, even if there are corresponding anaerobic microbes present.

He used the analogy of a snake: Remove the head (staph and strep), and the rest dies.

However, he stated that the clinical data are not there just yet to support advising against the use of broad-spectrum antibiotics for such infections, and so he could not recommend it.

Dr. Joseph disclosed financial relationships with Merck and Pfizer.

CHICAGO — Clinical symptoms are critical in distinguishing between uninfected and mildly infected diabetic foot lesions, Warren S. Joseph, D.P.M., reported at the Vascular Annual Meeting.

For instance, lack of cellulitis indicates lack of infection, as does good granulation. If the wound is purulent, it is infected.

Surprisingly, culturing the wound for microorganisms is not the best way to diagnose infection. This is because even noninfected diabetic foot lesions are “wound toilets” or, less bluntly, they have a significant “bioburden or bioload” of microorganisms that are simply colonizing the lesion, said Dr. Joseph of the Veterans Affairs Medical Center in Coatesville, Pa.

Just because an ulcer is colonized does not mean it is infected, he explained. However, in patients whose diabetic foot lesions are colonized but not infected, physicians may feel uncomfortable about doing nothing, Dr. Joseph said. They know the microbes are there, and they feel compelled to provide treatment, he said.

In this situation, topical treatments such as those with broad-spectrum activated silver are better than systemic antibiotics. And yet there is little evidence that topical antibiotics have any benefit for healing wounds, he said. In addition, they have little effect on preventing infection.

“Antibiotics do not heal wounds, antibiotics treat infection,” Dr. Joseph said, adding that he could not overemphasize the point that systemic antibiotics do not have a place in treating noninfected wounds.

Why? Because the first strain of vancomycin-resistant Staphylococcus aureus was found in a diabetic foot wound; it showed up in a swab culture of a clinically noninfected wound.

According to Dr. Joseph, the Infectious Diseases Society of America classification system developed last year defines mild infection as that extending less than 2 cm (www.idsociety.org

It is a misconception, Dr. Joseph pointed out, that all diabetic foot infections are polymicrobial. Virtually all diabetic foot infections have been shown to be caused by just two microorganism types—Staphylococcus aureus and group B streptococci. “This is great news, because when you think about what antibiotics you need for staph and strep—just about anything,” he said. “Those broad-spectrum drugs we have been using all these years we probably do not need, with one small caveat—there has been an incredible increase in prevalence of methicillin-resistant staph in [the] diabetic foot.” The bottom line is that 40% or more of all diabetic foot staph infections are methicillin resistant.

The number of diabetic foot patients who presented with methicillin-resistant Staphylococcus aureus doubled between 1999 and 2002, he said.

Given the variety of alternatives available—anything you would use for staph or strep throat—Dr. Joseph said: “Do not use ciprofloxacin in the infected diabetic foot.”

The reasoning is that it has poor activity against staph and strep, and it is a single-step mutation to getting staph or strep resistant to ciprofloxacin.

“You might have a nice big S sitting next to the cipro line, but give that patient the drug, [and] within a week it's going to turn to an R.”

Dr. Joseph said that he believes ultimately it will be shown that severe infections will respond to antibiotics directed against staph and strep, even if there are corresponding anaerobic microbes present.

He used the analogy of a snake: Remove the head (staph and strep), and the rest dies.

However, he stated that the clinical data are not there just yet to support advising against the use of broad-spectrum antibiotics for such infections, and so he could not recommend it.

Dr. Joseph disclosed financial relationships with Merck and Pfizer.