Kerri Wachter

The World Health Organization has launched a major initiative to standardize the way that information on clinical trials is made available to the public.

In an attempt to address growing public concerns about the transparency of medical research involving human participants, WHO is recommending 20 key details that all clinical trial registries should include.

“Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants,” Dr. Timothy Evans, assistant director-general of the WHO, said in a written statement.

WHO's International Clinical Trials Registry Platform is not itself a registry but provides standards for all clinical trial registries. These standards require information about sources of monetary or material support, primary and secondary sponsors, contacts for public and scientific queries, countries of recruitment, health conditions or problems studied, interventions, key inclusion and exclusion criteria, study design, date of first enrollment, target sample size, recruitment status, and primary and secondary outcomes.

The voluntary initiative is part of a growing movement toward greater accessibility to clinical trial information, prompted in part by high-profile cases involving the suppression of data by pharmaceutical companies.

In the European Union, all clinical trials conducted in member states are required to be registered in the EudraCT database, supervised by the European Medicines Agency.

In the United States, www.ClinicalTrials.gov

The WHO has acknowledged the need to balance increased transparency with the protection of competitive advantage. It may come down to a question of the timing of disclosure. In comments submitted to a WHO formal consultation on disclosure timing policy in April, the Pharmaceutical Research and Manufacturers of America noted “there may be infrequent instances where companies may regard certain data elements as sensitive for competitive reasons and wish to delay public disclosure.” In particular, the organization said that companies may wish to delay the disclosure of the official scientific title of the study, specific mechanism or molecular identifiers of the intervention, target sample size, primary outcome, and key secondary outcomes.

The WHO Registry Platform is expected to launch a Web-based search portal later this year that would allow interested individuals to search among participating registries for clinical trials taking place or completed throughout the world.

For more information on the registry platform, visit www.who.int/ictrp/en

The World Health Organization has launched a major initiative to standardize the way that information on clinical trials is made available to the public.

In an attempt to address growing public concerns about the transparency of medical research involving human participants, WHO is recommending 20 key details that all clinical trial registries should include.

“Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants,” Dr. Timothy Evans, assistant director-general of the WHO, said in a written statement.

WHO's International Clinical Trials Registry Platform is not itself a registry but provides standards for all clinical trial registries. These standards require information about sources of monetary or material support, primary and secondary sponsors, contacts for public and scientific queries, countries of recruitment, health conditions or problems studied, interventions, key inclusion and exclusion criteria, study design, date of first enrollment, target sample size, recruitment status, and primary and secondary outcomes.

The voluntary initiative is part of a growing movement toward greater accessibility to clinical trial information, prompted in part by high-profile cases involving the suppression of data by pharmaceutical companies.

In the European Union, all clinical trials conducted in member states are required to be registered in the EudraCT database, supervised by the European Medicines Agency.

In the United States, www.ClinicalTrials.gov

The WHO has acknowledged the need to balance increased transparency with the protection of competitive advantage. It may come down to a question of the timing of disclosure. In comments submitted to a WHO formal consultation on disclosure timing policy in April, the Pharmaceutical Research and Manufacturers of America noted “there may be infrequent instances where companies may regard certain data elements as sensitive for competitive reasons and wish to delay public disclosure.” In particular, the organization said that companies may wish to delay the disclosure of the official scientific title of the study, specific mechanism or molecular identifiers of the intervention, target sample size, primary outcome, and key secondary outcomes.

The WHO Registry Platform is expected to launch a Web-based search portal later this year that would allow interested individuals to search among participating registries for clinical trials taking place or completed throughout the world.

For more information on the registry platform, visit www.who.int/ictrp/en

The World Health Organization has launched a major initiative to standardize the way that information on clinical trials is made available to the public.

In an attempt to address growing public concerns about the transparency of medical research involving human participants, WHO is recommending 20 key details that all clinical trial registries should include.

“Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants,” Dr. Timothy Evans, assistant director-general of the WHO, said in a written statement.

WHO's International Clinical Trials Registry Platform is not itself a registry but provides standards for all clinical trial registries. These standards require information about sources of monetary or material support, primary and secondary sponsors, contacts for public and scientific queries, countries of recruitment, health conditions or problems studied, interventions, key inclusion and exclusion criteria, study design, date of first enrollment, target sample size, recruitment status, and primary and secondary outcomes.

The voluntary initiative is part of a growing movement toward greater accessibility to clinical trial information, prompted in part by high-profile cases involving the suppression of data by pharmaceutical companies.

In the European Union, all clinical trials conducted in member states are required to be registered in the EudraCT database, supervised by the European Medicines Agency.

In the United States, www.ClinicalTrials.gov

The WHO has acknowledged the need to balance increased transparency with the protection of competitive advantage. It may come down to a question of the timing of disclosure. In comments submitted to a WHO formal consultation on disclosure timing policy in April, the Pharmaceutical Research and Manufacturers of America noted “there may be infrequent instances where companies may regard certain data elements as sensitive for competitive reasons and wish to delay public disclosure.” In particular, the organization said that companies may wish to delay the disclosure of the official scientific title of the study, specific mechanism or molecular identifiers of the intervention, target sample size, primary outcome, and key secondary outcomes.

The WHO Registry Platform is expected to launch a Web-based search portal later this year that would allow interested individuals to search among participating registries for clinical trials taking place or completed throughout the world.

For more information on the registry platform, visit www.who.int/ictrp/en

STOCKHOLM — The search continues for sensitive and specific classification criteria for psoriatic arthritis.

At an international conference on psoriasis and psoriatic arthritis, the latest results were presented from the classification criteria for psoriatic arthritis (CASPAR) group, an international team of leading psoriatic arthritis researchers. The group has initiated a prospective study to evaluate existing diagnostic criteria as well as to derive new, more accurate criteria, said Philip S. Helliwell, Ph.D., of the rheumatology and rehabilitation research unit at the University of Leeds (England). The group's efforts are modeled on those of the OMERACT (Outcome Measures in Rheumatology) core set for rheumatoid arthritis.

Although clinical and radiologic evidence supports psoriatic arthritis as a separate disease, there's no consensus on diagnostic criteria. Such standardization would enhance research efforts by making patient comparisons easier. Although there are several sets of classification criteria for diagnosing psoriatic arthritis, only one was derived statistically from patient data, Dr. Helliwell said.

A diagnosis according to CASPAR criteria requires established inflammatory articular disease and a score of at least 3 points from the following features: current psoriasis (2 points), history of psoriasis but no evidence of psoriasis (1 point), family history of psoriasis but no evidence of psoriasis (1 point), dactylitis (1 point), juxtaarticular new bone formation (1 point), negative rheumatoid factor (1 point), and nail dystrophy (1 point). These criteria were specific (0.99) and fairly specific (0.91) for the diagnosis of psoriatic arthritis.

The criteria were derived using data collected prospectively from 588 patients with psoriatic arthritis and from 536 controls with other inflammatory arthritis diagnoses at 30 clinics in 13 countries. Of the controls, 71% had rheumatoid arthritis, 14% had ankylosing spondylitis, 7% had undifferentiated arthritis, 3% had connective tissue disorders, and 5% had other diseases.

The researchers collected data on more than 100 clinical and historical features. They also performed x-rays of the spine, hands, and feet. Samples were analyzed for rheumatoid factor, human leukocyte antigen, and anti-cyclic citrullinated peptide antibody.

For the first iteration of the criteria, the researchers performed a classification and regression tree analysis of existing criteria. The presence of two findings—a history of psoriasis and current psoriasis—was 97% sensitive and 96% specific. “It's very hard to beat that,” Dr. Helliwell noted.

By multivariate logistical regression analysis, the top predictive features were negative rheumatoid arthritis factor, current dactylitis, a history of dactylitis, and a history of psoriasis. The results of those two analyses were combined to produce the CASPAR criteria.

Until now, the diagnosis of psoriatic arthritis has been widely based on the Moll-Wright criteria developed in 1973 (Semin. Arthritis Rheum. 1973;3:55–78). These criteria require an inflammatory arthritis (peripheral arthritis and/or sacroiliitis or spondylitis), the presence of psoriasis, and the absence of serologic tests for rheumatoid factor.

The Moll-Wright criteria are considered simple and sensitive; however, they are not very specific, suggesting that some seronegative rheumatoid arthritis patients with coincidental psoriasis are mistakenly classified with psoriatic arthritis, Dr. Helliwell said.

“Clearly we need criteria to help us to distinguish this group that may be confounding because of the seronegative rheumatoid factor and coincidental psoriasis,” he said. Another group that is hard to diagnose comprises those who meet all other criteria for psoriatic arthritis but who have not yet developed psoriasis.

STOCKHOLM — The search continues for sensitive and specific classification criteria for psoriatic arthritis.

At an international conference on psoriasis and psoriatic arthritis, the latest results were presented from the classification criteria for psoriatic arthritis (CASPAR) group, an international team of leading psoriatic arthritis researchers. The group has initiated a prospective study to evaluate existing diagnostic criteria as well as to derive new, more accurate criteria, said Philip S. Helliwell, Ph.D., of the rheumatology and rehabilitation research unit at the University of Leeds (England). The group's efforts are modeled on those of the OMERACT (Outcome Measures in Rheumatology) core set for rheumatoid arthritis.

Although clinical and radiologic evidence supports psoriatic arthritis as a separate disease, there's no consensus on diagnostic criteria. Such standardization would enhance research efforts by making patient comparisons easier. Although there are several sets of classification criteria for diagnosing psoriatic arthritis, only one was derived statistically from patient data, Dr. Helliwell said.

A diagnosis according to CASPAR criteria requires established inflammatory articular disease and a score of at least 3 points from the following features: current psoriasis (2 points), history of psoriasis but no evidence of psoriasis (1 point), family history of psoriasis but no evidence of psoriasis (1 point), dactylitis (1 point), juxtaarticular new bone formation (1 point), negative rheumatoid factor (1 point), and nail dystrophy (1 point). These criteria were specific (0.99) and fairly specific (0.91) for the diagnosis of psoriatic arthritis.

The criteria were derived using data collected prospectively from 588 patients with psoriatic arthritis and from 536 controls with other inflammatory arthritis diagnoses at 30 clinics in 13 countries. Of the controls, 71% had rheumatoid arthritis, 14% had ankylosing spondylitis, 7% had undifferentiated arthritis, 3% had connective tissue disorders, and 5% had other diseases.

The researchers collected data on more than 100 clinical and historical features. They also performed x-rays of the spine, hands, and feet. Samples were analyzed for rheumatoid factor, human leukocyte antigen, and anti-cyclic citrullinated peptide antibody.

For the first iteration of the criteria, the researchers performed a classification and regression tree analysis of existing criteria. The presence of two findings—a history of psoriasis and current psoriasis—was 97% sensitive and 96% specific. “It's very hard to beat that,” Dr. Helliwell noted.

By multivariate logistical regression analysis, the top predictive features were negative rheumatoid arthritis factor, current dactylitis, a history of dactylitis, and a history of psoriasis. The results of those two analyses were combined to produce the CASPAR criteria.

Until now, the diagnosis of psoriatic arthritis has been widely based on the Moll-Wright criteria developed in 1973 (Semin. Arthritis Rheum. 1973;3:55–78). These criteria require an inflammatory arthritis (peripheral arthritis and/or sacroiliitis or spondylitis), the presence of psoriasis, and the absence of serologic tests for rheumatoid factor.

The Moll-Wright criteria are considered simple and sensitive; however, they are not very specific, suggesting that some seronegative rheumatoid arthritis patients with coincidental psoriasis are mistakenly classified with psoriatic arthritis, Dr. Helliwell said.

“Clearly we need criteria to help us to distinguish this group that may be confounding because of the seronegative rheumatoid factor and coincidental psoriasis,” he said. Another group that is hard to diagnose comprises those who meet all other criteria for psoriatic arthritis but who have not yet developed psoriasis.

STOCKHOLM — The search continues for sensitive and specific classification criteria for psoriatic arthritis.

At an international conference on psoriasis and psoriatic arthritis, the latest results were presented from the classification criteria for psoriatic arthritis (CASPAR) group, an international team of leading psoriatic arthritis researchers. The group has initiated a prospective study to evaluate existing diagnostic criteria as well as to derive new, more accurate criteria, said Philip S. Helliwell, Ph.D., of the rheumatology and rehabilitation research unit at the University of Leeds (England). The group's efforts are modeled on those of the OMERACT (Outcome Measures in Rheumatology) core set for rheumatoid arthritis.

Although clinical and radiologic evidence supports psoriatic arthritis as a separate disease, there's no consensus on diagnostic criteria. Such standardization would enhance research efforts by making patient comparisons easier. Although there are several sets of classification criteria for diagnosing psoriatic arthritis, only one was derived statistically from patient data, Dr. Helliwell said.

A diagnosis according to CASPAR criteria requires established inflammatory articular disease and a score of at least 3 points from the following features: current psoriasis (2 points), history of psoriasis but no evidence of psoriasis (1 point), family history of psoriasis but no evidence of psoriasis (1 point), dactylitis (1 point), juxtaarticular new bone formation (1 point), negative rheumatoid factor (1 point), and nail dystrophy (1 point). These criteria were specific (0.99) and fairly specific (0.91) for the diagnosis of psoriatic arthritis.

The criteria were derived using data collected prospectively from 588 patients with psoriatic arthritis and from 536 controls with other inflammatory arthritis diagnoses at 30 clinics in 13 countries. Of the controls, 71% had rheumatoid arthritis, 14% had ankylosing spondylitis, 7% had undifferentiated arthritis, 3% had connective tissue disorders, and 5% had other diseases.

The researchers collected data on more than 100 clinical and historical features. They also performed x-rays of the spine, hands, and feet. Samples were analyzed for rheumatoid factor, human leukocyte antigen, and anti-cyclic citrullinated peptide antibody.

For the first iteration of the criteria, the researchers performed a classification and regression tree analysis of existing criteria. The presence of two findings—a history of psoriasis and current psoriasis—was 97% sensitive and 96% specific. “It's very hard to beat that,” Dr. Helliwell noted.

By multivariate logistical regression analysis, the top predictive features were negative rheumatoid arthritis factor, current dactylitis, a history of dactylitis, and a history of psoriasis. The results of those two analyses were combined to produce the CASPAR criteria.

Until now, the diagnosis of psoriatic arthritis has been widely based on the Moll-Wright criteria developed in 1973 (Semin. Arthritis Rheum. 1973;3:55–78). These criteria require an inflammatory arthritis (peripheral arthritis and/or sacroiliitis or spondylitis), the presence of psoriasis, and the absence of serologic tests for rheumatoid factor.

The Moll-Wright criteria are considered simple and sensitive; however, they are not very specific, suggesting that some seronegative rheumatoid arthritis patients with coincidental psoriasis are mistakenly classified with psoriatic arthritis, Dr. Helliwell said.

“Clearly we need criteria to help us to distinguish this group that may be confounding because of the seronegative rheumatoid factor and coincidental psoriasis,” he said. Another group that is hard to diagnose comprises those who meet all other criteria for psoriatic arthritis but who have not yet developed psoriasis.

ARLINGTON, VA. — The approach to treating bifurcated lesions—using one stent or two—should depend on the size of the side branch, recommended Dr. Samin K. Sharma at a meeting sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

About 15% of coronary interventions involve some type of bifurcation. These lesions are often complex and are associated with greater lumen loss and longer stents, said Dr. Sharma, director of the cardiac catheterization laboratory at Mount Sinai Medical Center in New York.

He offered a treatment algorithm for bifurcations, based on side branch size:

▸ Large. If the side branch is greater than 2.5 mm, “we all believe that we should use two stents,” said Dr. Sharma. He noted that there are no data from randomized trials showing that this approach is better in terms of restenosis.

▸ Medium. With side branches of 2.25–2.5 mm diameter, stent the main vessel but avoid putting a stent in the side branch.

Opening the side branch is important. “Leave the wire in the side branch. We learned in bifurcation lesions that if we leave the wire in the side branch, it's better,” in terms of decreased compromise and loss of lumen. The branch can be stented if there is restenosis at some point.

▸ Small. If the side branch is smaller than 2.25 mm, stent only the main branch and leave the wire in the side branch.

A number of stent techniques have been developed to deal with the special challenges of bifurcated lesions, Dr. Sharma said. The conventional technique for bifurcations—developed during the bare-metal stent era—is to stent the main vessel, with plaque modification of the side branch and provisional stenting of the side branch as necessary. “Even with a drug-eluting stent [this technique] seems to be the optimal treatment in the majority of bifurcation lesions,” said Dr. Sharma. If the result in the side branch is suboptimal, a stent will be required. However, if there is a dissection in the side branch prior to stenting the main vessel, then the side branch should be stented first, followed by the main vessel.

The crush technique involves advancing a stent into the side branch (without expansion) and advancing another stent into the main vessel (without expansion), fully covering the bifurcation. The side branch stent is retracted into the main vessel, then expanded. The main vessel stent is then expanded. The side branch stent is crushed against the main branch stent.

“The data have shown that you need to do a follow-up kissing balloon dilation. If you don't, there is a high incidence in the event rate, in terms of restenosis and the major adverse cardiac events,” said Dr. Sharma, who is also codirector of the Cardiovascular Institute at Mount Sinai Medical Center.

The kissing balloon dilation is more important for the side branch than for the main vessel. The thrombosis rate with the crush technique is about 2%–3%.

The simultaneous kissing stent technique involves advancing a stent to the side branch, followed by one to the main vessel. The two stents are then simultaneously pulled back to the bifurcation and then into the proximal part of the main vessel, configuring a Y (with the stem of the Y in the main vessel, completely covering the proximal end of the lesion, one arm in the distal main vessel, and one arm in the side branch). “This is very suitable for the distal left main bifurcation but also for left anterior descending coronary artery diagonals,” said Dr. Sharma. He recommends initial inflation of about 8–10 atmospheres (atm), then deflation, then expansion up to 18–20 atm and deflation. This should be followed up with simultaneous balloon inflation at 8–10 atm. The researchers compared the simultaneous kissing stent and the conventional technique; target lesion revascularization was 18% for the conventional technique and 5% for the kissing stent technique. There was no late thrombosis (Am. J. Cardiol. 2004;94:913–7).

Emily Brannan, Illustration

Here, the kissing technique is used to place stents at a bifurcated lesion of the left main, left anterior descending, and left circumflex coronary arteries. Courtesy Dr. Samin K. Sharma

ARLINGTON, VA. — The approach to treating bifurcated lesions—using one stent or two—should depend on the size of the side branch, recommended Dr. Samin K. Sharma at a meeting sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

About 15% of coronary interventions involve some type of bifurcation. These lesions are often complex and are associated with greater lumen loss and longer stents, said Dr. Sharma, director of the cardiac catheterization laboratory at Mount Sinai Medical Center in New York.

He offered a treatment algorithm for bifurcations, based on side branch size:

▸ Large. If the side branch is greater than 2.5 mm, “we all believe that we should use two stents,” said Dr. Sharma. He noted that there are no data from randomized trials showing that this approach is better in terms of restenosis.

▸ Medium. With side branches of 2.25–2.5 mm diameter, stent the main vessel but avoid putting a stent in the side branch.

Opening the side branch is important. “Leave the wire in the side branch. We learned in bifurcation lesions that if we leave the wire in the side branch, it's better,” in terms of decreased compromise and loss of lumen. The branch can be stented if there is restenosis at some point.

▸ Small. If the side branch is smaller than 2.25 mm, stent only the main branch and leave the wire in the side branch.

A number of stent techniques have been developed to deal with the special challenges of bifurcated lesions, Dr. Sharma said. The conventional technique for bifurcations—developed during the bare-metal stent era—is to stent the main vessel, with plaque modification of the side branch and provisional stenting of the side branch as necessary. “Even with a drug-eluting stent [this technique] seems to be the optimal treatment in the majority of bifurcation lesions,” said Dr. Sharma. If the result in the side branch is suboptimal, a stent will be required. However, if there is a dissection in the side branch prior to stenting the main vessel, then the side branch should be stented first, followed by the main vessel.

The crush technique involves advancing a stent into the side branch (without expansion) and advancing another stent into the main vessel (without expansion), fully covering the bifurcation. The side branch stent is retracted into the main vessel, then expanded. The main vessel stent is then expanded. The side branch stent is crushed against the main branch stent.

“The data have shown that you need to do a follow-up kissing balloon dilation. If you don't, there is a high incidence in the event rate, in terms of restenosis and the major adverse cardiac events,” said Dr. Sharma, who is also codirector of the Cardiovascular Institute at Mount Sinai Medical Center.

The kissing balloon dilation is more important for the side branch than for the main vessel. The thrombosis rate with the crush technique is about 2%–3%.

The simultaneous kissing stent technique involves advancing a stent to the side branch, followed by one to the main vessel. The two stents are then simultaneously pulled back to the bifurcation and then into the proximal part of the main vessel, configuring a Y (with the stem of the Y in the main vessel, completely covering the proximal end of the lesion, one arm in the distal main vessel, and one arm in the side branch). “This is very suitable for the distal left main bifurcation but also for left anterior descending coronary artery diagonals,” said Dr. Sharma. He recommends initial inflation of about 8–10 atmospheres (atm), then deflation, then expansion up to 18–20 atm and deflation. This should be followed up with simultaneous balloon inflation at 8–10 atm. The researchers compared the simultaneous kissing stent and the conventional technique; target lesion revascularization was 18% for the conventional technique and 5% for the kissing stent technique. There was no late thrombosis (Am. J. Cardiol. 2004;94:913–7).

Emily Brannan, Illustration

Here, the kissing technique is used to place stents at a bifurcated lesion of the left main, left anterior descending, and left circumflex coronary arteries. Courtesy Dr. Samin K. Sharma

ARLINGTON, VA. — The approach to treating bifurcated lesions—using one stent or two—should depend on the size of the side branch, recommended Dr. Samin K. Sharma at a meeting sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

About 15% of coronary interventions involve some type of bifurcation. These lesions are often complex and are associated with greater lumen loss and longer stents, said Dr. Sharma, director of the cardiac catheterization laboratory at Mount Sinai Medical Center in New York.

He offered a treatment algorithm for bifurcations, based on side branch size:

▸ Large. If the side branch is greater than 2.5 mm, “we all believe that we should use two stents,” said Dr. Sharma. He noted that there are no data from randomized trials showing that this approach is better in terms of restenosis.

▸ Medium. With side branches of 2.25–2.5 mm diameter, stent the main vessel but avoid putting a stent in the side branch.

Opening the side branch is important. “Leave the wire in the side branch. We learned in bifurcation lesions that if we leave the wire in the side branch, it's better,” in terms of decreased compromise and loss of lumen. The branch can be stented if there is restenosis at some point.

▸ Small. If the side branch is smaller than 2.25 mm, stent only the main branch and leave the wire in the side branch.

A number of stent techniques have been developed to deal with the special challenges of bifurcated lesions, Dr. Sharma said. The conventional technique for bifurcations—developed during the bare-metal stent era—is to stent the main vessel, with plaque modification of the side branch and provisional stenting of the side branch as necessary. “Even with a drug-eluting stent [this technique] seems to be the optimal treatment in the majority of bifurcation lesions,” said Dr. Sharma. If the result in the side branch is suboptimal, a stent will be required. However, if there is a dissection in the side branch prior to stenting the main vessel, then the side branch should be stented first, followed by the main vessel.

The crush technique involves advancing a stent into the side branch (without expansion) and advancing another stent into the main vessel (without expansion), fully covering the bifurcation. The side branch stent is retracted into the main vessel, then expanded. The main vessel stent is then expanded. The side branch stent is crushed against the main branch stent.

“The data have shown that you need to do a follow-up kissing balloon dilation. If you don't, there is a high incidence in the event rate, in terms of restenosis and the major adverse cardiac events,” said Dr. Sharma, who is also codirector of the Cardiovascular Institute at Mount Sinai Medical Center.

The kissing balloon dilation is more important for the side branch than for the main vessel. The thrombosis rate with the crush technique is about 2%–3%.

The simultaneous kissing stent technique involves advancing a stent to the side branch, followed by one to the main vessel. The two stents are then simultaneously pulled back to the bifurcation and then into the proximal part of the main vessel, configuring a Y (with the stem of the Y in the main vessel, completely covering the proximal end of the lesion, one arm in the distal main vessel, and one arm in the side branch). “This is very suitable for the distal left main bifurcation but also for left anterior descending coronary artery diagonals,” said Dr. Sharma. He recommends initial inflation of about 8–10 atmospheres (atm), then deflation, then expansion up to 18–20 atm and deflation. This should be followed up with simultaneous balloon inflation at 8–10 atm. The researchers compared the simultaneous kissing stent and the conventional technique; target lesion revascularization was 18% for the conventional technique and 5% for the kissing stent technique. There was no late thrombosis (Am. J. Cardiol. 2004;94:913–7).

Emily Brannan, Illustration

Here, the kissing technique is used to place stents at a bifurcated lesion of the left main, left anterior descending, and left circumflex coronary arteries. Courtesy Dr. Samin K. Sharma

The Food and Drug Administration has announced the recall of Closercare insulin syringes and the extension of an earlier recall of Ultilet insulin syringes due to bacterial contamination with Paenibacillus.

The recall includes Closercare insulin syringe 29g 1cc with lot number 5JCZ1 as displayed on the inner case.

The recall also includes Ultilet insulin syringe 30g 1/2 cc with product lot number 5KEO1.

Patients with products from these lots should stop use and return the syringes to the manufacturer.

This bacterial contamination presents a risk of local infection, as well as a risk of the introduction of contaminating organisms into a previously sterile vial.

Moreover, the introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels.

For more information, contact Boca Medical Products Inc. by calling 800–354–8460.

The Food and Drug Administration has announced the recall of Closercare insulin syringes and the extension of an earlier recall of Ultilet insulin syringes due to bacterial contamination with Paenibacillus.

The recall includes Closercare insulin syringe 29g 1cc with lot number 5JCZ1 as displayed on the inner case.

The recall also includes Ultilet insulin syringe 30g 1/2 cc with product lot number 5KEO1.

Patients with products from these lots should stop use and return the syringes to the manufacturer.

This bacterial contamination presents a risk of local infection, as well as a risk of the introduction of contaminating organisms into a previously sterile vial.

Moreover, the introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels.

For more information, contact Boca Medical Products Inc. by calling 800–354–8460.

The Food and Drug Administration has announced the recall of Closercare insulin syringes and the extension of an earlier recall of Ultilet insulin syringes due to bacterial contamination with Paenibacillus.

The recall includes Closercare insulin syringe 29g 1cc with lot number 5JCZ1 as displayed on the inner case.

The recall also includes Ultilet insulin syringe 30g 1/2 cc with product lot number 5KEO1.

Patients with products from these lots should stop use and return the syringes to the manufacturer.

This bacterial contamination presents a risk of local infection, as well as a risk of the introduction of contaminating organisms into a previously sterile vial.

Moreover, the introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels.

For more information, contact Boca Medical Products Inc. by calling 800–354–8460.

SAN JUAN, P.R. – Consulting psychiatrists can help improve the lives of nursing home residents by establishing psychiatric diagnoses, coordinating medications, and educating staff, Dr. Olivera Bogunovic said at the annual meeting of the American Association for Geriatric Psychiatry.

An estimated 91%–94% of nursing home residents have some form of psychiatric disorder, said Dr. Bogunovic, professor of psychiatry at the State University of New York at Buffalo. Despite that high prevalence, though, only 2.3% of nursing home residents receive psychiatric consultations.

Consulting psychiatrists, therefore, play an important role in caring for nursing home residents–who are usually managed by internal medicine physicians. Most important, psychiatrists establish a diagnosis, said Dr. Bogunovic, who has also worked as a psychiatric consultant in nursing homes for several years.

Psychiatrists also can assess the interaction between patients with psychiatric disorders and nursing home staff. By educating staff about a patient's condition, psychiatrists can improve general patient care.

In addition, nursing home patients are often taking several medications. “The role of the psychiatrist is to optimize medications and simplify drug routines,” Dr. Bogunovic said. Make sure to discuss the rationale for medications with staff and provide some information about possible drug-drug interactions.

Consulting psychiatrists should also arrange for brief psychiatric hospitalization when necessary. Psychiatrists are often called upon to make competency assessments.

Consulting psychiatrists also have an important role to play in helping nursing homes conform to requirements of the Omnibus Budget Reconciliation Act (OBRA). These regulations require that individuals admitted for the first time to a nursing home be prescreened for major psychiatric disorders.

In addition, every 3 months, nursing homes are required to complete a minimum data set. This tool addresses patient mood, cognition, communication and behavioral patterns, psychosocial well-being, comorbid conditions, and medications.

The OBRA regulations also require clear documentation of the need for psychotropic medication use.

Once a patient is prescribed psychotropic medication, psychiatrists should attempt to reduce the dosage at regular intervals.

“The requirement is that nursing home residents should be maintained on minimal effective dosages,” Dr. Bogunovic said.

Sometimes nursing home residents must be hospitalized in a psychiatric ward, especially if they are assaultive or suicidal. “But the patient should be initially screened, because a lot of medical conditions may present with psychiatric symptoms,” Dr. Bogunovic said.

Psychiatrists can be instrumental in arranging the acceptance of temporarily hospitalized patients back into the nursing home.

Educating nursing home staff is one of the key roles for a psychiatrist. Nursing home staff are often poorly trained, and turnover rates are high. “I personally have experienced that these staff were really not aware and were not educated about psychiatric symptoms of dementia,” Dr. Bogunovic said.

Psychiatrists should consider giving in-service training on signs and symptoms of psychiatric disorders, stages of dementia, drug-drug interactions, pharmacologic and nonpharmacologic management, injury prevention, and minimizing restraint use, he suggested.

It might also be worthwhile to train staff in the administration of assessment tools, such as the Mini Mental State Examination or the Global Deterioration Scale, Dr. Bogunovic said.

SAN JUAN, P.R. – Consulting psychiatrists can help improve the lives of nursing home residents by establishing psychiatric diagnoses, coordinating medications, and educating staff, Dr. Olivera Bogunovic said at the annual meeting of the American Association for Geriatric Psychiatry.

An estimated 91%–94% of nursing home residents have some form of psychiatric disorder, said Dr. Bogunovic, professor of psychiatry at the State University of New York at Buffalo. Despite that high prevalence, though, only 2.3% of nursing home residents receive psychiatric consultations.

Consulting psychiatrists, therefore, play an important role in caring for nursing home residents–who are usually managed by internal medicine physicians. Most important, psychiatrists establish a diagnosis, said Dr. Bogunovic, who has also worked as a psychiatric consultant in nursing homes for several years.

Psychiatrists also can assess the interaction between patients with psychiatric disorders and nursing home staff. By educating staff about a patient's condition, psychiatrists can improve general patient care.

In addition, nursing home patients are often taking several medications. “The role of the psychiatrist is to optimize medications and simplify drug routines,” Dr. Bogunovic said. Make sure to discuss the rationale for medications with staff and provide some information about possible drug-drug interactions.

Consulting psychiatrists should also arrange for brief psychiatric hospitalization when necessary. Psychiatrists are often called upon to make competency assessments.

Consulting psychiatrists also have an important role to play in helping nursing homes conform to requirements of the Omnibus Budget Reconciliation Act (OBRA). These regulations require that individuals admitted for the first time to a nursing home be prescreened for major psychiatric disorders.

In addition, every 3 months, nursing homes are required to complete a minimum data set. This tool addresses patient mood, cognition, communication and behavioral patterns, psychosocial well-being, comorbid conditions, and medications.

The OBRA regulations also require clear documentation of the need for psychotropic medication use.

Once a patient is prescribed psychotropic medication, psychiatrists should attempt to reduce the dosage at regular intervals.

“The requirement is that nursing home residents should be maintained on minimal effective dosages,” Dr. Bogunovic said.

Sometimes nursing home residents must be hospitalized in a psychiatric ward, especially if they are assaultive or suicidal. “But the patient should be initially screened, because a lot of medical conditions may present with psychiatric symptoms,” Dr. Bogunovic said.

Psychiatrists can be instrumental in arranging the acceptance of temporarily hospitalized patients back into the nursing home.

Educating nursing home staff is one of the key roles for a psychiatrist. Nursing home staff are often poorly trained, and turnover rates are high. “I personally have experienced that these staff were really not aware and were not educated about psychiatric symptoms of dementia,” Dr. Bogunovic said.

Psychiatrists should consider giving in-service training on signs and symptoms of psychiatric disorders, stages of dementia, drug-drug interactions, pharmacologic and nonpharmacologic management, injury prevention, and minimizing restraint use, he suggested.

It might also be worthwhile to train staff in the administration of assessment tools, such as the Mini Mental State Examination or the Global Deterioration Scale, Dr. Bogunovic said.

SAN JUAN, P.R. – Consulting psychiatrists can help improve the lives of nursing home residents by establishing psychiatric diagnoses, coordinating medications, and educating staff, Dr. Olivera Bogunovic said at the annual meeting of the American Association for Geriatric Psychiatry.

An estimated 91%–94% of nursing home residents have some form of psychiatric disorder, said Dr. Bogunovic, professor of psychiatry at the State University of New York at Buffalo. Despite that high prevalence, though, only 2.3% of nursing home residents receive psychiatric consultations.

Consulting psychiatrists, therefore, play an important role in caring for nursing home residents–who are usually managed by internal medicine physicians. Most important, psychiatrists establish a diagnosis, said Dr. Bogunovic, who has also worked as a psychiatric consultant in nursing homes for several years.

Psychiatrists also can assess the interaction between patients with psychiatric disorders and nursing home staff. By educating staff about a patient's condition, psychiatrists can improve general patient care.

In addition, nursing home patients are often taking several medications. “The role of the psychiatrist is to optimize medications and simplify drug routines,” Dr. Bogunovic said. Make sure to discuss the rationale for medications with staff and provide some information about possible drug-drug interactions.

Consulting psychiatrists should also arrange for brief psychiatric hospitalization when necessary. Psychiatrists are often called upon to make competency assessments.

Consulting psychiatrists also have an important role to play in helping nursing homes conform to requirements of the Omnibus Budget Reconciliation Act (OBRA). These regulations require that individuals admitted for the first time to a nursing home be prescreened for major psychiatric disorders.

In addition, every 3 months, nursing homes are required to complete a minimum data set. This tool addresses patient mood, cognition, communication and behavioral patterns, psychosocial well-being, comorbid conditions, and medications.

The OBRA regulations also require clear documentation of the need for psychotropic medication use.

Once a patient is prescribed psychotropic medication, psychiatrists should attempt to reduce the dosage at regular intervals.

“The requirement is that nursing home residents should be maintained on minimal effective dosages,” Dr. Bogunovic said.

Sometimes nursing home residents must be hospitalized in a psychiatric ward, especially if they are assaultive or suicidal. “But the patient should be initially screened, because a lot of medical conditions may present with psychiatric symptoms,” Dr. Bogunovic said.

Psychiatrists can be instrumental in arranging the acceptance of temporarily hospitalized patients back into the nursing home.

Educating nursing home staff is one of the key roles for a psychiatrist. Nursing home staff are often poorly trained, and turnover rates are high. “I personally have experienced that these staff were really not aware and were not educated about psychiatric symptoms of dementia,” Dr. Bogunovic said.

Psychiatrists should consider giving in-service training on signs and symptoms of psychiatric disorders, stages of dementia, drug-drug interactions, pharmacologic and nonpharmacologic management, injury prevention, and minimizing restraint use, he suggested.

It might also be worthwhile to train staff in the administration of assessment tools, such as the Mini Mental State Examination or the Global Deterioration Scale, Dr. Bogunovic said.

WASHINGTON – Many patients with Parkinson's disease turn to complementary and alternative medicine therapies for the relief of symptoms. Keeping an open mind can help these patients get nontraditional treatments that actually may help them and at the very least won't harm them, said one expert speaking at the World Parkinson Congress.

“People are already using these therapies whether we doctors want them to or not,” said Dr. Melanie M. Brandabur, medical director of the Parkinson's Disease and Movement Disorders Center at Alexian Neurosciences Institute in Chicago.

According to a 2001 study, 40% of Parkinson's disease (PD) patients use some form of alternative therapy, compared with 33% of adults without the disease. Vitamins, herbs, massage, and acupuncture were the most popular therapies among these patients (Neurology 2001;57:790–4).

Dr. Brandabur, also a professor of clinical neurology at the University of Illinois at Chicago, offered her thoughts on several popular CAM therapies:

▸ Traditional Chinese medicine. Traditional Chinese medicine seeks to maintain a balance between an organ (yin) and its activity (yang). Diseases are believed to result from disturbances in this balance, and treatment aims to restore balance. Modalities may include acupuncture, tai chi, and herbal medicines.

If patients want to explore traditional Chinese medicine, have them find a practitioner with the appropriate credentials. In general, encourage patients to seek out treatment from practitioners credentialed through the National Certification Commission for Acupuncture and Oriental Medicine. Alternatively, refer patients to conventionally trained physicians who are also trained in CAM.

▸ Acupuncture. Many patients who have experienced acupuncture report improvements in pain, stiffness, and dyskinesias. But the effect tends to wear off after a few days. A few small clinical trials of acupuncture for PD have been conducted, but so far, it has not been shown to offer any measurable benefit to affected patients.

▸ Tai chi. Tai chi is part of the Chinese qigong system of healing and is considered both a martial art and a medication technique. “Tai chi has been shown in study after study to help with various types of balance problems,” Dr. Brandabur said. The slow side-to-side movements of tai chi–the sustained transfer of weight–“really seems to be invaluable for balance.” Dr. Brandabur encourages her PD patients to practice tai chi if at all possible.

Recommend a well-trained instructor to patients or have them look for classes with words such as “senior” or “arthritis” in the title. Discuss health issues with patients prior to starting a class, so that they can talk with their instructor to explain physical limitations and any areas/functions that they would like to improve.

▸ Ayurveda. Ayurveda is an ancient Indian medicine that focuses on maintaining a mind-body balance. Ayurvedic practitioners determine a person's metabolic type and assess various pulse points and their relation to internal organs. Detoxification is accomplished through cleansing techniques; balance is restored with yoga and meditation.

One agent used in ayurvedic medicine is particularly interesting in the context of PD. Mucuna pruriens is a legume containing a levodopa-like substance. A few recent studies suggest that there may be an advantage of this substance over synthetic levodopa, in terms of decreased toxicity to the brain and neuroprotection.

There is no licensing board for ayurvedic practitioners. Ask local CAM practitioners if they can recommend a reputable ayurvedic medicine practitioner.

▸ Yoga. There have been no studies assessing the efficacy of yoga for improving PD symptoms. Many Parkinson's patients have trouble with full inhalation and exhalation, and the the practice helps with breathing, Dr. Brandabur said.

Interested patients should enroll in beginning-level classes or classes aimed at those with physical limitations, taught by instructors who stress listening to one's body. Patients should discuss their limitations with the instructor before class.

▸ Coenzyme Q10. The antioxidant coenzyme Q10 was shown to slow the decline of mental and motor function in PD at a dose of 1,200 mg/day in a small study (Arch. Neurol. 2002;59:1541–50). For patients who want to try coenzyme Q10, discuss the study limitations. Point out that no blanket recommendation exists for PD patients to take coenzyme Q10 but that if they are going to take it, go with a bigger dose (at least 1,200 mg/day).

▸ Massage. Neuromuscular therapy has shown some benefit to PD patients (J. Am. Osteopath. Assoc. 2005;105:26). Many types of massage exist; Dr. Brandabur advises her patients to try several.

“The tricky issue is getting it paid for,” she said. An alternative medicine specialist might have a massage therapist in the office. In addition, some physical therapists are trained in massage. In these situations, massage therapy may be eligible for Medicare reimbursement. Another alternative is to look for a local, reputable school of massage therapy, which may offer reduced rates.

▸ Herbal therapy. Herbal therapies all have potential side effects. Encourage patients to keep you informed of everything they are taking–herbal therapies, over-the-counter supplements, and vitamins and minerals. “I try to keep an open mind. When a patient comes in with three agents, if I haven't heard of any one of them, I send to an alternative medicine practitioner to go over what they're taking and make sure it's safe,” she said.

Dr. Brandabur recommended visiting www.integrativemedicine.arizona.edu/alum/index.html

WASHINGTON – Many patients with Parkinson's disease turn to complementary and alternative medicine therapies for the relief of symptoms. Keeping an open mind can help these patients get nontraditional treatments that actually may help them and at the very least won't harm them, said one expert speaking at the World Parkinson Congress.

“People are already using these therapies whether we doctors want them to or not,” said Dr. Melanie M. Brandabur, medical director of the Parkinson's Disease and Movement Disorders Center at Alexian Neurosciences Institute in Chicago.

According to a 2001 study, 40% of Parkinson's disease (PD) patients use some form of alternative therapy, compared with 33% of adults without the disease. Vitamins, herbs, massage, and acupuncture were the most popular therapies among these patients (Neurology 2001;57:790–4).

Dr. Brandabur, also a professor of clinical neurology at the University of Illinois at Chicago, offered her thoughts on several popular CAM therapies:

▸ Traditional Chinese medicine. Traditional Chinese medicine seeks to maintain a balance between an organ (yin) and its activity (yang). Diseases are believed to result from disturbances in this balance, and treatment aims to restore balance. Modalities may include acupuncture, tai chi, and herbal medicines.

If patients want to explore traditional Chinese medicine, have them find a practitioner with the appropriate credentials. In general, encourage patients to seek out treatment from practitioners credentialed through the National Certification Commission for Acupuncture and Oriental Medicine. Alternatively, refer patients to conventionally trained physicians who are also trained in CAM.

▸ Acupuncture. Many patients who have experienced acupuncture report improvements in pain, stiffness, and dyskinesias. But the effect tends to wear off after a few days. A few small clinical trials of acupuncture for PD have been conducted, but so far, it has not been shown to offer any measurable benefit to affected patients.

▸ Tai chi. Tai chi is part of the Chinese qigong system of healing and is considered both a martial art and a medication technique. “Tai chi has been shown in study after study to help with various types of balance problems,” Dr. Brandabur said. The slow side-to-side movements of tai chi–the sustained transfer of weight–“really seems to be invaluable for balance.” Dr. Brandabur encourages her PD patients to practice tai chi if at all possible.

Recommend a well-trained instructor to patients or have them look for classes with words such as “senior” or “arthritis” in the title. Discuss health issues with patients prior to starting a class, so that they can talk with their instructor to explain physical limitations and any areas/functions that they would like to improve.

▸ Ayurveda. Ayurveda is an ancient Indian medicine that focuses on maintaining a mind-body balance. Ayurvedic practitioners determine a person's metabolic type and assess various pulse points and their relation to internal organs. Detoxification is accomplished through cleansing techniques; balance is restored with yoga and meditation.

One agent used in ayurvedic medicine is particularly interesting in the context of PD. Mucuna pruriens is a legume containing a levodopa-like substance. A few recent studies suggest that there may be an advantage of this substance over synthetic levodopa, in terms of decreased toxicity to the brain and neuroprotection.

There is no licensing board for ayurvedic practitioners. Ask local CAM practitioners if they can recommend a reputable ayurvedic medicine practitioner.

▸ Yoga. There have been no studies assessing the efficacy of yoga for improving PD symptoms. Many Parkinson's patients have trouble with full inhalation and exhalation, and the the practice helps with breathing, Dr. Brandabur said.

Interested patients should enroll in beginning-level classes or classes aimed at those with physical limitations, taught by instructors who stress listening to one's body. Patients should discuss their limitations with the instructor before class.

▸ Coenzyme Q10. The antioxidant coenzyme Q10 was shown to slow the decline of mental and motor function in PD at a dose of 1,200 mg/day in a small study (Arch. Neurol. 2002;59:1541–50). For patients who want to try coenzyme Q10, discuss the study limitations. Point out that no blanket recommendation exists for PD patients to take coenzyme Q10 but that if they are going to take it, go with a bigger dose (at least 1,200 mg/day).

▸ Massage. Neuromuscular therapy has shown some benefit to PD patients (J. Am. Osteopath. Assoc. 2005;105:26). Many types of massage exist; Dr. Brandabur advises her patients to try several.

“The tricky issue is getting it paid for,” she said. An alternative medicine specialist might have a massage therapist in the office. In addition, some physical therapists are trained in massage. In these situations, massage therapy may be eligible for Medicare reimbursement. Another alternative is to look for a local, reputable school of massage therapy, which may offer reduced rates.

▸ Herbal therapy. Herbal therapies all have potential side effects. Encourage patients to keep you informed of everything they are taking–herbal therapies, over-the-counter supplements, and vitamins and minerals. “I try to keep an open mind. When a patient comes in with three agents, if I haven't heard of any one of them, I send to an alternative medicine practitioner to go over what they're taking and make sure it's safe,” she said.

Dr. Brandabur recommended visiting www.integrativemedicine.arizona.edu/alum/index.html

WASHINGTON – Many patients with Parkinson's disease turn to complementary and alternative medicine therapies for the relief of symptoms. Keeping an open mind can help these patients get nontraditional treatments that actually may help them and at the very least won't harm them, said one expert speaking at the World Parkinson Congress.

“People are already using these therapies whether we doctors want them to or not,” said Dr. Melanie M. Brandabur, medical director of the Parkinson's Disease and Movement Disorders Center at Alexian Neurosciences Institute in Chicago.

According to a 2001 study, 40% of Parkinson's disease (PD) patients use some form of alternative therapy, compared with 33% of adults without the disease. Vitamins, herbs, massage, and acupuncture were the most popular therapies among these patients (Neurology 2001;57:790–4).

Dr. Brandabur, also a professor of clinical neurology at the University of Illinois at Chicago, offered her thoughts on several popular CAM therapies:

▸ Traditional Chinese medicine. Traditional Chinese medicine seeks to maintain a balance between an organ (yin) and its activity (yang). Diseases are believed to result from disturbances in this balance, and treatment aims to restore balance. Modalities may include acupuncture, tai chi, and herbal medicines.

If patients want to explore traditional Chinese medicine, have them find a practitioner with the appropriate credentials. In general, encourage patients to seek out treatment from practitioners credentialed through the National Certification Commission for Acupuncture and Oriental Medicine. Alternatively, refer patients to conventionally trained physicians who are also trained in CAM.

▸ Acupuncture. Many patients who have experienced acupuncture report improvements in pain, stiffness, and dyskinesias. But the effect tends to wear off after a few days. A few small clinical trials of acupuncture for PD have been conducted, but so far, it has not been shown to offer any measurable benefit to affected patients.

▸ Tai chi. Tai chi is part of the Chinese qigong system of healing and is considered both a martial art and a medication technique. “Tai chi has been shown in study after study to help with various types of balance problems,” Dr. Brandabur said. The slow side-to-side movements of tai chi–the sustained transfer of weight–“really seems to be invaluable for balance.” Dr. Brandabur encourages her PD patients to practice tai chi if at all possible.

Recommend a well-trained instructor to patients or have them look for classes with words such as “senior” or “arthritis” in the title. Discuss health issues with patients prior to starting a class, so that they can talk with their instructor to explain physical limitations and any areas/functions that they would like to improve.

▸ Ayurveda. Ayurveda is an ancient Indian medicine that focuses on maintaining a mind-body balance. Ayurvedic practitioners determine a person's metabolic type and assess various pulse points and their relation to internal organs. Detoxification is accomplished through cleansing techniques; balance is restored with yoga and meditation.

One agent used in ayurvedic medicine is particularly interesting in the context of PD. Mucuna pruriens is a legume containing a levodopa-like substance. A few recent studies suggest that there may be an advantage of this substance over synthetic levodopa, in terms of decreased toxicity to the brain and neuroprotection.

There is no licensing board for ayurvedic practitioners. Ask local CAM practitioners if they can recommend a reputable ayurvedic medicine practitioner.

▸ Yoga. There have been no studies assessing the efficacy of yoga for improving PD symptoms. Many Parkinson's patients have trouble with full inhalation and exhalation, and the the practice helps with breathing, Dr. Brandabur said.

Interested patients should enroll in beginning-level classes or classes aimed at those with physical limitations, taught by instructors who stress listening to one's body. Patients should discuss their limitations with the instructor before class.

▸ Coenzyme Q10. The antioxidant coenzyme Q10 was shown to slow the decline of mental and motor function in PD at a dose of 1,200 mg/day in a small study (Arch. Neurol. 2002;59:1541–50). For patients who want to try coenzyme Q10, discuss the study limitations. Point out that no blanket recommendation exists for PD patients to take coenzyme Q10 but that if they are going to take it, go with a bigger dose (at least 1,200 mg/day).

▸ Massage. Neuromuscular therapy has shown some benefit to PD patients (J. Am. Osteopath. Assoc. 2005;105:26). Many types of massage exist; Dr. Brandabur advises her patients to try several.

“The tricky issue is getting it paid for,” she said. An alternative medicine specialist might have a massage therapist in the office. In addition, some physical therapists are trained in massage. In these situations, massage therapy may be eligible for Medicare reimbursement. Another alternative is to look for a local, reputable school of massage therapy, which may offer reduced rates.

▸ Herbal therapy. Herbal therapies all have potential side effects. Encourage patients to keep you informed of everything they are taking–herbal therapies, over-the-counter supplements, and vitamins and minerals. “I try to keep an open mind. When a patient comes in with three agents, if I haven't heard of any one of them, I send to an alternative medicine practitioner to go over what they're taking and make sure it's safe,” she said.

Dr. Brandabur recommended visiting www.integrativemedicine.arizona.edu/alum/index.html

SAN JUAN, P.R. – Dementia and depression appear to be quite common among residents in assisted living facilities, based on two analyses of facilities in Maryland that were presented at the annual meeting of the American Association for Geriatric Psychiatry.

Both analyses looked at data from the Maryland Assisted Living Study that included 22 facilities–10 large facilities (more than 15 beds) and 12 small (15 beds or fewer). Assisted living facilities are regulated at the state level, and the levels of regulation vary widely.

For the Maryland Assisted Living Study, residents of assisted living facilities were evaluated by a geriatric psychiatrist, a nurse (who was experienced with dementia evaluation), and a research assistant specializing in psychometrics.

Comprehensive evaluations of residents included information from caregivers and family members, a clinical exam and history, assessment with quantitative scales (function, behavior, depression, medical comorbidity, quality of life, caregiver activity/burden), and neuropsychological battery.

A consensus conference specialist determined diagnoses for residents and assessed whether residents had been worked up and whether they were being treated appropriately.

In particular, participants were assessed using the Cornell Scale for Depression in Dementia (CSDD), a 19-item clinician-administered instrument that uses information from interviews with both the patient and a nursing staff member. Those with scores greater than 7 were considered clinically depressed. The General Medical Health Rating was used to describe comorbidity and health status.

In the first analysis, researchers looked at levels of depression among 196 residents of assisted living facilities. “This is an important study for several reasons, but it is the first comprehensive assessment of psychiatric disease in the assisted living industry,” said Dr. Lea C. Watson, professor of psychiatry at the University of North Carolina at Chapel Hill. Subjects were an average of 86 years old, and were primarily women (79%) and white (84%).

Overall, 24% (47 subjects) met the criteria for clinical depression and 8% (15 subjects) met the criteria for severe depression (CSDD score greater than 12). Roughly two-thirds (67%) of participants had dementia. The third of the participants who did not have dementia–those with Mini- Mental State Examination scores greater than 22–were evaluated with the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID IV). Of those, 13 met the criteria for depression.

Bivariate analysis revealed no differences between depressed and nondepressed individuals based on age, gender, number of social visits, or facility size. However, depressed individuals did have a greater number of comorbid conditions, required more assistance with activities of daily living, spent a greater number of days in bed per month, and participated in organized activities less frequently than did nondepressed individuals.

After the investigators controlled for several pertinent factors, (global health, supervision of activities of daily living, and social interaction), assistance with activities of daily living alone remained significantly associated with depression (odds ratio 3.8), while medical comorbidity showed a trend toward significance (odds ratio 1.9).

Only 43% of those who were currently depressed were being treated with antidepressants. Likewise, only 40% of those who were severely depressed were being treated with antidepressants. Those with depression were more likely to be treated with antidepressants if they lived in a larger facility (51% vs. 17%).

“Interestingly, 60% of those in these facilities with depression had no source of psychiatric care,” Dr. Watson said.

In the second analysis, researchers looked for any differences between large and small facilities for dementia frequency, detection, and management.

“Large facilities have most commonly arisen out of the hospitality industry and are more likely to be part of a chain,” said Quincy M. Samus, a graduate student at Johns Hopkins University in Baltimore, who presented a paper for Dr. Iracema Leroi of the University of Manchester (England), who could not attend the meeting. “Small facilities have evolved from the traditional board-and-care homes or group homes” for mentally ill individuals, Ms. Samus said.

This analysis included 198 residents (150 from large facilities and 48 from small facilities). Residents in smaller facilities were somewhat younger than were those in larger facilities–average age 82 years vs. 87 years.

Residents in both types of facilities were admitted primarily because of functional limitations. Those in large facilities were significantly more likely to be admitted for medical reasons than were those in small facilities.

Significantly more residents in small facilities had dementia than those in large facilities. Residents in small facilities also were slightly more likely to be diagnosed with Alzheimer's disease, though not significantly so, Ms. Samus said.

Almost all residents (98%) in small facilities had either dementia or some other psychiatric diagnosis. In comparison, 74% of those in large facilities had dementia or some other psychiatric diagnosis. Likewise, residents in small facilities had more cognitive difficulties as measured by the Mini-Mental State Examination, with an average score of 13 compared with 20 for those in large facilities.

Residents in small facilities also had a greater number of behavioral symptoms, as measured by the Neuropsychiatric Inventory (17 vs. 10). More residents living in small facilities had psychotic disorders as well (10% vs. 1%). There were no differences in mood or anxiety disorders between the two facility sizes.

Of the 39 residents with dementia in small facilities, the caregiver was slightly more likely to recognize dementia symptoms than were family members. The opposite was true for the 95 residents with dementia in large facilities.

In terms of treatment, small and large facilities were comparable in the percentage of patients considered completely treated (around 50%). However, smaller facilities had a greater percentage of residents (41%) receiving at least partial treatment for dementia than those at large facilities (29%). These results were not statistically significant.

“Residents who are living in large facilities actually were more likely to have a private duty [caregiver] stay with them,” Ms. Samus said. Residents in large facilities also were more likely to undergo physical therapy. Large facilities offered more activities for residents. Small facilities were more likely to use restraints and bedrails.

“Small care providers were actually spending more than 400 minutes a day caring, supervising, or doing activities of daily living with their residents compared with a little over 100 minutes for the large facilities,” Ms. Samus said. The difference may be partly explained by the higher likelihood of having a private-duty caregiver at large facilities.

Residents at small facilities had fewer falls per month (0.13, compared with 0.33). No difference was found in emergency department visits in the last month. Also in the last month, residents of small facilities spent slightly more time in the hospital (0.65 days, compared with 0.5 days).

ELSEVIER GLOBAL MEDICAL NEWS

SAN JUAN, P.R. – Dementia and depression appear to be quite common among residents in assisted living facilities, based on two analyses of facilities in Maryland that were presented at the annual meeting of the American Association for Geriatric Psychiatry.

Both analyses looked at data from the Maryland Assisted Living Study that included 22 facilities–10 large facilities (more than 15 beds) and 12 small (15 beds or fewer). Assisted living facilities are regulated at the state level, and the levels of regulation vary widely.

For the Maryland Assisted Living Study, residents of assisted living facilities were evaluated by a geriatric psychiatrist, a nurse (who was experienced with dementia evaluation), and a research assistant specializing in psychometrics.

Comprehensive evaluations of residents included information from caregivers and family members, a clinical exam and history, assessment with quantitative scales (function, behavior, depression, medical comorbidity, quality of life, caregiver activity/burden), and neuropsychological battery.

A consensus conference specialist determined diagnoses for residents and assessed whether residents had been worked up and whether they were being treated appropriately.

In particular, participants were assessed using the Cornell Scale for Depression in Dementia (CSDD), a 19-item clinician-administered instrument that uses information from interviews with both the patient and a nursing staff member. Those with scores greater than 7 were considered clinically depressed. The General Medical Health Rating was used to describe comorbidity and health status.

In the first analysis, researchers looked at levels of depression among 196 residents of assisted living facilities. “This is an important study for several reasons, but it is the first comprehensive assessment of psychiatric disease in the assisted living industry,” said Dr. Lea C. Watson, professor of psychiatry at the University of North Carolina at Chapel Hill. Subjects were an average of 86 years old, and were primarily women (79%) and white (84%).

Overall, 24% (47 subjects) met the criteria for clinical depression and 8% (15 subjects) met the criteria for severe depression (CSDD score greater than 12). Roughly two-thirds (67%) of participants had dementia. The third of the participants who did not have dementia–those with Mini- Mental State Examination scores greater than 22–were evaluated with the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID IV). Of those, 13 met the criteria for depression.

Bivariate analysis revealed no differences between depressed and nondepressed individuals based on age, gender, number of social visits, or facility size. However, depressed individuals did have a greater number of comorbid conditions, required more assistance with activities of daily living, spent a greater number of days in bed per month, and participated in organized activities less frequently than did nondepressed individuals.

After the investigators controlled for several pertinent factors, (global health, supervision of activities of daily living, and social interaction), assistance with activities of daily living alone remained significantly associated with depression (odds ratio 3.8), while medical comorbidity showed a trend toward significance (odds ratio 1.9).

Only 43% of those who were currently depressed were being treated with antidepressants. Likewise, only 40% of those who were severely depressed were being treated with antidepressants. Those with depression were more likely to be treated with antidepressants if they lived in a larger facility (51% vs. 17%).

“Interestingly, 60% of those in these facilities with depression had no source of psychiatric care,” Dr. Watson said.

In the second analysis, researchers looked for any differences between large and small facilities for dementia frequency, detection, and management.

“Large facilities have most commonly arisen out of the hospitality industry and are more likely to be part of a chain,” said Quincy M. Samus, a graduate student at Johns Hopkins University in Baltimore, who presented a paper for Dr. Iracema Leroi of the University of Manchester (England), who could not attend the meeting. “Small facilities have evolved from the traditional board-and-care homes or group homes” for mentally ill individuals, Ms. Samus said.

This analysis included 198 residents (150 from large facilities and 48 from small facilities). Residents in smaller facilities were somewhat younger than were those in larger facilities–average age 82 years vs. 87 years.

Residents in both types of facilities were admitted primarily because of functional limitations. Those in large facilities were significantly more likely to be admitted for medical reasons than were those in small facilities.

Significantly more residents in small facilities had dementia than those in large facilities. Residents in small facilities also were slightly more likely to be diagnosed with Alzheimer's disease, though not significantly so, Ms. Samus said.

Almost all residents (98%) in small facilities had either dementia or some other psychiatric diagnosis. In comparison, 74% of those in large facilities had dementia or some other psychiatric diagnosis. Likewise, residents in small facilities had more cognitive difficulties as measured by the Mini-Mental State Examination, with an average score of 13 compared with 20 for those in large facilities.

Residents in small facilities also had a greater number of behavioral symptoms, as measured by the Neuropsychiatric Inventory (17 vs. 10). More residents living in small facilities had psychotic disorders as well (10% vs. 1%). There were no differences in mood or anxiety disorders between the two facility sizes.

Of the 39 residents with dementia in small facilities, the caregiver was slightly more likely to recognize dementia symptoms than were family members. The opposite was true for the 95 residents with dementia in large facilities.

In terms of treatment, small and large facilities were comparable in the percentage of patients considered completely treated (around 50%). However, smaller facilities had a greater percentage of residents (41%) receiving at least partial treatment for dementia than those at large facilities (29%). These results were not statistically significant.

“Residents who are living in large facilities actually were more likely to have a private duty [caregiver] stay with them,” Ms. Samus said. Residents in large facilities also were more likely to undergo physical therapy. Large facilities offered more activities for residents. Small facilities were more likely to use restraints and bedrails.

“Small care providers were actually spending more than 400 minutes a day caring, supervising, or doing activities of daily living with their residents compared with a little over 100 minutes for the large facilities,” Ms. Samus said. The difference may be partly explained by the higher likelihood of having a private-duty caregiver at large facilities.

Residents at small facilities had fewer falls per month (0.13, compared with 0.33). No difference was found in emergency department visits in the last month. Also in the last month, residents of small facilities spent slightly more time in the hospital (0.65 days, compared with 0.5 days).

ELSEVIER GLOBAL MEDICAL NEWS

SAN JUAN, P.R. – Dementia and depression appear to be quite common among residents in assisted living facilities, based on two analyses of facilities in Maryland that were presented at the annual meeting of the American Association for Geriatric Psychiatry.

Both analyses looked at data from the Maryland Assisted Living Study that included 22 facilities–10 large facilities (more than 15 beds) and 12 small (15 beds or fewer). Assisted living facilities are regulated at the state level, and the levels of regulation vary widely.

For the Maryland Assisted Living Study, residents of assisted living facilities were evaluated by a geriatric psychiatrist, a nurse (who was experienced with dementia evaluation), and a research assistant specializing in psychometrics.

Comprehensive evaluations of residents included information from caregivers and family members, a clinical exam and history, assessment with quantitative scales (function, behavior, depression, medical comorbidity, quality of life, caregiver activity/burden), and neuropsychological battery.

A consensus conference specialist determined diagnoses for residents and assessed whether residents had been worked up and whether they were being treated appropriately.

In particular, participants were assessed using the Cornell Scale for Depression in Dementia (CSDD), a 19-item clinician-administered instrument that uses information from interviews with both the patient and a nursing staff member. Those with scores greater than 7 were considered clinically depressed. The General Medical Health Rating was used to describe comorbidity and health status.

In the first analysis, researchers looked at levels of depression among 196 residents of assisted living facilities. “This is an important study for several reasons, but it is the first comprehensive assessment of psychiatric disease in the assisted living industry,” said Dr. Lea C. Watson, professor of psychiatry at the University of North Carolina at Chapel Hill. Subjects were an average of 86 years old, and were primarily women (79%) and white (84%).

Overall, 24% (47 subjects) met the criteria for clinical depression and 8% (15 subjects) met the criteria for severe depression (CSDD score greater than 12). Roughly two-thirds (67%) of participants had dementia. The third of the participants who did not have dementia–those with Mini- Mental State Examination scores greater than 22–were evaluated with the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID IV). Of those, 13 met the criteria for depression.

Bivariate analysis revealed no differences between depressed and nondepressed individuals based on age, gender, number of social visits, or facility size. However, depressed individuals did have a greater number of comorbid conditions, required more assistance with activities of daily living, spent a greater number of days in bed per month, and participated in organized activities less frequently than did nondepressed individuals.

After the investigators controlled for several pertinent factors, (global health, supervision of activities of daily living, and social interaction), assistance with activities of daily living alone remained significantly associated with depression (odds ratio 3.8), while medical comorbidity showed a trend toward significance (odds ratio 1.9).

Only 43% of those who were currently depressed were being treated with antidepressants. Likewise, only 40% of those who were severely depressed were being treated with antidepressants. Those with depression were more likely to be treated with antidepressants if they lived in a larger facility (51% vs. 17%).

“Interestingly, 60% of those in these facilities with depression had no source of psychiatric care,” Dr. Watson said.

In the second analysis, researchers looked for any differences between large and small facilities for dementia frequency, detection, and management.

“Large facilities have most commonly arisen out of the hospitality industry and are more likely to be part of a chain,” said Quincy M. Samus, a graduate student at Johns Hopkins University in Baltimore, who presented a paper for Dr. Iracema Leroi of the University of Manchester (England), who could not attend the meeting. “Small facilities have evolved from the traditional board-and-care homes or group homes” for mentally ill individuals, Ms. Samus said.

This analysis included 198 residents (150 from large facilities and 48 from small facilities). Residents in smaller facilities were somewhat younger than were those in larger facilities–average age 82 years vs. 87 years.

Residents in both types of facilities were admitted primarily because of functional limitations. Those in large facilities were significantly more likely to be admitted for medical reasons than were those in small facilities.

Significantly more residents in small facilities had dementia than those in large facilities. Residents in small facilities also were slightly more likely to be diagnosed with Alzheimer's disease, though not significantly so, Ms. Samus said.

Almost all residents (98%) in small facilities had either dementia or some other psychiatric diagnosis. In comparison, 74% of those in large facilities had dementia or some other psychiatric diagnosis. Likewise, residents in small facilities had more cognitive difficulties as measured by the Mini-Mental State Examination, with an average score of 13 compared with 20 for those in large facilities.

Residents in small facilities also had a greater number of behavioral symptoms, as measured by the Neuropsychiatric Inventory (17 vs. 10). More residents living in small facilities had psychotic disorders as well (10% vs. 1%). There were no differences in mood or anxiety disorders between the two facility sizes.

Of the 39 residents with dementia in small facilities, the caregiver was slightly more likely to recognize dementia symptoms than were family members. The opposite was true for the 95 residents with dementia in large facilities.

In terms of treatment, small and large facilities were comparable in the percentage of patients considered completely treated (around 50%). However, smaller facilities had a greater percentage of residents (41%) receiving at least partial treatment for dementia than those at large facilities (29%). These results were not statistically significant.

“Residents who are living in large facilities actually were more likely to have a private duty [caregiver] stay with them,” Ms. Samus said. Residents in large facilities also were more likely to undergo physical therapy. Large facilities offered more activities for residents. Small facilities were more likely to use restraints and bedrails.

“Small care providers were actually spending more than 400 minutes a day caring, supervising, or doing activities of daily living with their residents compared with a little over 100 minutes for the large facilities,” Ms. Samus said. The difference may be partly explained by the higher likelihood of having a private-duty caregiver at large facilities.

Residents at small facilities had fewer falls per month (0.13, compared with 0.33). No difference was found in emergency department visits in the last month. Also in the last month, residents of small facilities spent slightly more time in the hospital (0.65 days, compared with 0.5 days).

ELSEVIER GLOBAL MEDICAL NEWS

Updated secondary prevention guidelines pull together the latest data from clinical trials to advocate more aggressive management of patients with coronary heart disease.

The American Heart Association/American College of Cardiology Guidelines for Secondary Prevention for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2006 Update assembles evolving evidence from trials involving the management of key risk factors.

“Physicians may have followed the low-density lipid story but they may not be aware of the recommendations for waist circumference or have a good idea about what to do about ACE inhibitors. This puts it all together, hopefully in a usable manner,” said Dr. Sidney C. Smith Jr., chairman of the ACC/AHA writing group.

The new guidelines—an update of the 2001 guidelines—recommend more stringent management of six risk factors in patients with coronary heart disease, along with changes to pharmacologic management. Many of these recommendations may seem familiar to cardiologists.

“If you closely read the literature, you probably already know these things,” said Dr. James A. De Lemos, a cardiologist at the University of Texas Southwestern Medical Center in Dallas.

Despite this, the updated changes to lipid management and aspirin therapy in this patient group are worth drawing attention to, he said.

Here's a look at the new guidelines, which advise the following changes to pharmacologic management:

▸ Lipid management. The goal of less than 100 mg/dL for LDL cholesterol is unchanged, but the guideline adds that further reduction to levels less than 70 mg/dL is reasonable. If triglyceride levels are 200–499 mg/dL, non-HDL cholesterol should be less than 130 mg/dL; further reduction below 100 mg/dL is reasonable.

The lipid management guidelines reflect recommendations made in 2004 by the National Cholesterol Education Program (NCEP) Adult Treatment Panel, which advised a target LDL level of less than 100 mg/dL and offered an optional target of 70 mg/dL in patients at very high risk. More recent study results, such as those from the Treating to New Targets (TNT) and the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) studies, show that aggressive lipid-lowering therapy provides significant clinical benefit in patients who have stable coronary heart disease.

“These guidelines reinforce that all patients [with coronary heart disease] should have LDL of less than 100 mg/dL and provide a reasonable target of 70 mg/dL,” said Dr. Smith, a professor of medicine and director of the center for cardiovascular science and medicine at the University of North Carolina at Chapel Hill.

▸ Antiplatelet and anticoagulant therapy. Aspirin therapy has been reduced to 75–162 mg/day, down from 75–325 mg/day in all patients, unless contraindicated. The lowering of the aspirin dose for chronic therapy was based largely on antiplatelet trials, which showed that the benefits of aspirin therapy are the same for lower dose regimens (75–80 mg) as for the adult dose (325 mg) but that the risk of bleeding was considerably less for the lower dose, Dr. Smith said.

Following acute coronary syndrome or percutaneous coronary intervention with stent placement, start and continue 75 mg/day of clopidogrel in combination with aspirin for up to 12 months. Therapy for stent recipients, for which the aspirin dosage is 325 mg/day, should last at least 1 month in patients who have received bare-metal stents, at least 3 months in those who have received sirolimus-eluting stents, and at least 6 months in those who have received paclitaxel-eluting stents.

▸ Renin-angiotensin-aldosterone system blockers. The guidance for these agents has expanded considerably. ACE inhibitors are recommended for indefinite use in all patients with a left ventricular ejection fraction (LVEF) of 40% or less and in those with hypertension, diabetes, or chronic kidney disease unless contraindicated. The use of ACE inhibitors should be considered in all patients.

Angiotensin receptor blockers (ARBs) should be used in patients who are intolerant of ACE inhibitors and have heart failure or have had an MI with a LVEF of 40% or less. The use of ARBs should be considered in other patients who are intolerant of ACE inhibitors. In patients with systolic heart failure, ARB use in combination with ACE inhibitors should be considered.

Aldosterone blockade should be used for post-MI patients—without significant renal dysfunction or hyperkalemia—who are already receiving therapeutic doses of an ACE inhibitor and β-blocker and who have left ventricular ejection fractions of 40% or less, and have either diabetes or heart failure.

Clinical trials have shown the effectiveness of ACE inhibitors in treating patients with LVEF of 40% or less and in those with hypertension, diabetes, or chronic kidney disease. However, the trial results on the effectiveness of ACE inhibitors in lower-risk patients with normal LV function—who had higher usage of other therapies (statins, β-blockers) and who had a greater level of revascularization— is less clear.

“That's why the committee has said that in patients with normal left ventricular function, all patients should be considered as candidates but among those who have undergone revascularization therapy or who have a high use of other therapies known to reduce risk, it's reasonable not to place them on ACE inhibitors,” Dr. Smith said.

▸ β-Blockers. β-Blockers should be started and indefinitely continued in all patients who have had MI, acute coronary syndrome, or left ventricular dysfunction with or without heart failure symptoms unless contraindicated.

Other updated recommendations include the more stringent management of the following risk factors:

▸ Blood pressure control. The aim is to keep patients' blood pressure under 140/90 mm Hg or less than 130/80 mm Hg in patients with diabetes or chronic kidney disease through lifestyle modification. In patients who do not meet this goal, blood pressure medication should be added as tolerated. Initially treatment should be with β-blockers and/or ACE inhibitors, adding other drugs such as thiazides as needed to achieve target blood pressure.

▸ Physical activity. The goal is 30–60 minutes of moderate-intensity aerobic activity 5–7 days per week, up from 3–4 days per week, supplemented by an increase in daily lifestyle activities, such as housework and gardening, and resistance training 2 days per week.

▸ Smoking. Not only should patients completely stop smoking but they also should not be exposed to any environmental tobacco smoke.

▸ Weight management. Not only should patients aim for a BMI between 18.5 and 24.9, but also a waist circumference of less than 40 inches for men and less than 35 inches for women. If waist circumference exceeds these values, patients should initiate lifestyle changes and physicians should consider treatment strategies for metabolic syndrome. The initial goal of weight loss should be to reduce body weight by roughly 10% from baseline. Once this goal has been met, further weight loss can be attempted if indicated.

▸ Flu vaccine. All patients with cardiovascular disease should receive inactivated influenza vaccinations because these individuals are at increased risk for complications from influenza.

The guidelines make a point of noting that ethnic minorities, women, and the elderly are underrepresented in many trials and urge greater participation by these populations in clinical trials to provide additional evidence about the best therapeutic strategies for these groups.

“Having worked in this area for 15 years … I think that it is very important that trials include older patients, that the trials include a high percentage of women … and that they recruit ethnic minorities, because I think that even though it seems logical to assume that the therapies may work, we need the evidence to really strengthen the basis for these recommendations,” Dr. Smith said.

The complete guidelines are available in the Journal of the American College of Cardiology (J. Am. Coll. Cardiol. 2006; 47:2130–2139).

Updated secondary prevention guidelines pull together the latest data from clinical trials to advocate more aggressive management of patients with coronary heart disease.

The American Heart Association/American College of Cardiology Guidelines for Secondary Prevention for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2006 Update assembles evolving evidence from trials involving the management of key risk factors.

“Physicians may have followed the low-density lipid story but they may not be aware of the recommendations for waist circumference or have a good idea about what to do about ACE inhibitors. This puts it all together, hopefully in a usable manner,” said Dr. Sidney C. Smith Jr., chairman of the ACC/AHA writing group.

The new guidelines—an update of the 2001 guidelines—recommend more stringent management of six risk factors in patients with coronary heart disease, along with changes to pharmacologic management. Many of these recommendations may seem familiar to cardiologists.

“If you closely read the literature, you probably already know these things,” said Dr. James A. De Lemos, a cardiologist at the University of Texas Southwestern Medical Center in Dallas.

Despite this, the updated changes to lipid management and aspirin therapy in this patient group are worth drawing attention to, he said.

Here's a look at the new guidelines, which advise the following changes to pharmacologic management:

▸ Lipid management. The goal of less than 100 mg/dL for LDL cholesterol is unchanged, but the guideline adds that further reduction to levels less than 70 mg/dL is reasonable. If triglyceride levels are 200–499 mg/dL, non-HDL cholesterol should be less than 130 mg/dL; further reduction below 100 mg/dL is reasonable.

The lipid management guidelines reflect recommendations made in 2004 by the National Cholesterol Education Program (NCEP) Adult Treatment Panel, which advised a target LDL level of less than 100 mg/dL and offered an optional target of 70 mg/dL in patients at very high risk. More recent study results, such as those from the Treating to New Targets (TNT) and the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) studies, show that aggressive lipid-lowering therapy provides significant clinical benefit in patients who have stable coronary heart disease.

“These guidelines reinforce that all patients [with coronary heart disease] should have LDL of less than 100 mg/dL and provide a reasonable target of 70 mg/dL,” said Dr. Smith, a professor of medicine and director of the center for cardiovascular science and medicine at the University of North Carolina at Chapel Hill.

▸ Antiplatelet and anticoagulant therapy. Aspirin therapy has been reduced to 75–162 mg/day, down from 75–325 mg/day in all patients, unless contraindicated. The lowering of the aspirin dose for chronic therapy was based largely on antiplatelet trials, which showed that the benefits of aspirin therapy are the same for lower dose regimens (75–80 mg) as for the adult dose (325 mg) but that the risk of bleeding was considerably less for the lower dose, Dr. Smith said.

Following acute coronary syndrome or percutaneous coronary intervention with stent placement, start and continue 75 mg/day of clopidogrel in combination with aspirin for up to 12 months. Therapy for stent recipients, for which the aspirin dosage is 325 mg/day, should last at least 1 month in patients who have received bare-metal stents, at least 3 months in those who have received sirolimus-eluting stents, and at least 6 months in those who have received paclitaxel-eluting stents.

▸ Renin-angiotensin-aldosterone system blockers. The guidance for these agents has expanded considerably. ACE inhibitors are recommended for indefinite use in all patients with a left ventricular ejection fraction (LVEF) of 40% or less and in those with hypertension, diabetes, or chronic kidney disease unless contraindicated. The use of ACE inhibitors should be considered in all patients.

Angiotensin receptor blockers (ARBs) should be used in patients who are intolerant of ACE inhibitors and have heart failure or have had an MI with a LVEF of 40% or less. The use of ARBs should be considered in other patients who are intolerant of ACE inhibitors. In patients with systolic heart failure, ARB use in combination with ACE inhibitors should be considered.

Aldosterone blockade should be used for post-MI patients—without significant renal dysfunction or hyperkalemia—who are already receiving therapeutic doses of an ACE inhibitor and β-blocker and who have left ventricular ejection fractions of 40% or less, and have either diabetes or heart failure.

Clinical trials have shown the effectiveness of ACE inhibitors in treating patients with LVEF of 40% or less and in those with hypertension, diabetes, or chronic kidney disease. However, the trial results on the effectiveness of ACE inhibitors in lower-risk patients with normal LV function—who had higher usage of other therapies (statins, β-blockers) and who had a greater level of revascularization— is less clear.

“That's why the committee has said that in patients with normal left ventricular function, all patients should be considered as candidates but among those who have undergone revascularization therapy or who have a high use of other therapies known to reduce risk, it's reasonable not to place them on ACE inhibitors,” Dr. Smith said.

▸ β-Blockers. β-Blockers should be started and indefinitely continued in all patients who have had MI, acute coronary syndrome, or left ventricular dysfunction with or without heart failure symptoms unless contraindicated.

Other updated recommendations include the more stringent management of the following risk factors:

▸ Blood pressure control. The aim is to keep patients' blood pressure under 140/90 mm Hg or less than 130/80 mm Hg in patients with diabetes or chronic kidney disease through lifestyle modification. In patients who do not meet this goal, blood pressure medication should be added as tolerated. Initially treatment should be with β-blockers and/or ACE inhibitors, adding other drugs such as thiazides as needed to achieve target blood pressure.

▸ Physical activity. The goal is 30–60 minutes of moderate-intensity aerobic activity 5–7 days per week, up from 3–4 days per week, supplemented by an increase in daily lifestyle activities, such as housework and gardening, and resistance training 2 days per week.

▸ Smoking. Not only should patients completely stop smoking but they also should not be exposed to any environmental tobacco smoke.

▸ Weight management. Not only should patients aim for a BMI between 18.5 and 24.9, but also a waist circumference of less than 40 inches for men and less than 35 inches for women. If waist circumference exceeds these values, patients should initiate lifestyle changes and physicians should consider treatment strategies for metabolic syndrome. The initial goal of weight loss should be to reduce body weight by roughly 10% from baseline. Once this goal has been met, further weight loss can be attempted if indicated.

▸ Flu vaccine. All patients with cardiovascular disease should receive inactivated influenza vaccinations because these individuals are at increased risk for complications from influenza.

The guidelines make a point of noting that ethnic minorities, women, and the elderly are underrepresented in many trials and urge greater participation by these populations in clinical trials to provide additional evidence about the best therapeutic strategies for these groups.

“Having worked in this area for 15 years … I think that it is very important that trials include older patients, that the trials include a high percentage of women … and that they recruit ethnic minorities, because I think that even though it seems logical to assume that the therapies may work, we need the evidence to really strengthen the basis for these recommendations,” Dr. Smith said.

The complete guidelines are available in the Journal of the American College of Cardiology (J. Am. Coll. Cardiol. 2006; 47:2130–2139).

Updated secondary prevention guidelines pull together the latest data from clinical trials to advocate more aggressive management of patients with coronary heart disease.

The American Heart Association/American College of Cardiology Guidelines for Secondary Prevention for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2006 Update assembles evolving evidence from trials involving the management of key risk factors.

“Physicians may have followed the low-density lipid story but they may not be aware of the recommendations for waist circumference or have a good idea about what to do about ACE inhibitors. This puts it all together, hopefully in a usable manner,” said Dr. Sidney C. Smith Jr., chairman of the ACC/AHA writing group.

The new guidelines—an update of the 2001 guidelines—recommend more stringent management of six risk factors in patients with coronary heart disease, along with changes to pharmacologic management. Many of these recommendations may seem familiar to cardiologists.

“If you closely read the literature, you probably already know these things,” said Dr. James A. De Lemos, a cardiologist at the University of Texas Southwestern Medical Center in Dallas.

Despite this, the updated changes to lipid management and aspirin therapy in this patient group are worth drawing attention to, he said.

Here's a look at the new guidelines, which advise the following changes to pharmacologic management:

▸ Lipid management. The goal of less than 100 mg/dL for LDL cholesterol is unchanged, but the guideline adds that further reduction to levels less than 70 mg/dL is reasonable. If triglyceride levels are 200–499 mg/dL, non-HDL cholesterol should be less than 130 mg/dL; further reduction below 100 mg/dL is reasonable.

The lipid management guidelines reflect recommendations made in 2004 by the National Cholesterol Education Program (NCEP) Adult Treatment Panel, which advised a target LDL level of less than 100 mg/dL and offered an optional target of 70 mg/dL in patients at very high risk. More recent study results, such as those from the Treating to New Targets (TNT) and the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) studies, show that aggressive lipid-lowering therapy provides significant clinical benefit in patients who have stable coronary heart disease.

“These guidelines reinforce that all patients [with coronary heart disease] should have LDL of less than 100 mg/dL and provide a reasonable target of 70 mg/dL,” said Dr. Smith, a professor of medicine and director of the center for cardiovascular science and medicine at the University of North Carolina at Chapel Hill.

▸ Antiplatelet and anticoagulant therapy. Aspirin therapy has been reduced to 75–162 mg/day, down from 75–325 mg/day in all patients, unless contraindicated. The lowering of the aspirin dose for chronic therapy was based largely on antiplatelet trials, which showed that the benefits of aspirin therapy are the same for lower dose regimens (75–80 mg) as for the adult dose (325 mg) but that the risk of bleeding was considerably less for the lower dose, Dr. Smith said.

Following acute coronary syndrome or percutaneous coronary intervention with stent placement, start and continue 75 mg/day of clopidogrel in combination with aspirin for up to 12 months. Therapy for stent recipients, for which the aspirin dosage is 325 mg/day, should last at least 1 month in patients who have received bare-metal stents, at least 3 months in those who have received sirolimus-eluting stents, and at least 6 months in those who have received paclitaxel-eluting stents.

▸ Renin-angiotensin-aldosterone system blockers. The guidance for these agents has expanded considerably. ACE inhibitors are recommended for indefinite use in all patients with a left ventricular ejection fraction (LVEF) of 40% or less and in those with hypertension, diabetes, or chronic kidney disease unless contraindicated. The use of ACE inhibitors should be considered in all patients.

Angiotensin receptor blockers (ARBs) should be used in patients who are intolerant of ACE inhibitors and have heart failure or have had an MI with a LVEF of 40% or less. The use of ARBs should be considered in other patients who are intolerant of ACE inhibitors. In patients with systolic heart failure, ARB use in combination with ACE inhibitors should be considered.

Aldosterone blockade should be used for post-MI patients—without significant renal dysfunction or hyperkalemia—who are already receiving therapeutic doses of an ACE inhibitor and β-blocker and who have left ventricular ejection fractions of 40% or less, and have either diabetes or heart failure.

Clinical trials have shown the effectiveness of ACE inhibitors in treating patients with LVEF of 40% or less and in those with hypertension, diabetes, or chronic kidney disease. However, the trial results on the effectiveness of ACE inhibitors in lower-risk patients with normal LV function—who had higher usage of other therapies (statins, β-blockers) and who had a greater level of revascularization— is less clear.

“That's why the committee has said that in patients with normal left ventricular function, all patients should be considered as candidates but among those who have undergone revascularization therapy or who have a high use of other therapies known to reduce risk, it's reasonable not to place them on ACE inhibitors,” Dr. Smith said.

▸ β-Blockers. β-Blockers should be started and indefinitely continued in all patients who have had MI, acute coronary syndrome, or left ventricular dysfunction with or without heart failure symptoms unless contraindicated.

Other updated recommendations include the more stringent management of the following risk factors:

▸ Blood pressure control. The aim is to keep patients' blood pressure under 140/90 mm Hg or less than 130/80 mm Hg in patients with diabetes or chronic kidney disease through lifestyle modification. In patients who do not meet this goal, blood pressure medication should be added as tolerated. Initially treatment should be with β-blockers and/or ACE inhibitors, adding other drugs such as thiazides as needed to achieve target blood pressure.

▸ Physical activity. The goal is 30–60 minutes of moderate-intensity aerobic activity 5–7 days per week, up from 3–4 days per week, supplemented by an increase in daily lifestyle activities, such as housework and gardening, and resistance training 2 days per week.

▸ Smoking. Not only should patients completely stop smoking but they also should not be exposed to any environmental tobacco smoke.

▸ Weight management. Not only should patients aim for a BMI between 18.5 and 24.9, but also a waist circumference of less than 40 inches for men and less than 35 inches for women. If waist circumference exceeds these values, patients should initiate lifestyle changes and physicians should consider treatment strategies for metabolic syndrome. The initial goal of weight loss should be to reduce body weight by roughly 10% from baseline. Once this goal has been met, further weight loss can be attempted if indicated.

▸ Flu vaccine. All patients with cardiovascular disease should receive inactivated influenza vaccinations because these individuals are at increased risk for complications from influenza.

The guidelines make a point of noting that ethnic minorities, women, and the elderly are underrepresented in many trials and urge greater participation by these populations in clinical trials to provide additional evidence about the best therapeutic strategies for these groups.

“Having worked in this area for 15 years … I think that it is very important that trials include older patients, that the trials include a high percentage of women … and that they recruit ethnic minorities, because I think that even though it seems logical to assume that the therapies may work, we need the evidence to really strengthen the basis for these recommendations,” Dr. Smith said.

The complete guidelines are available in the Journal of the American College of Cardiology (J. Am. Coll. Cardiol. 2006; 47:2130–2139).

The World Health Organization has launched a major initiative to standardize the way that information on clinical trials is made available to the public.

In an attempt to address growing public concerns about the transparency of medical research involving human participants, WHO is recommending 20 key details that all clinical trial registries should include.

"Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants," Dr. Timothy Evans, assistant director-general of the WHO, said in a written statement.

WHO's International Clinical Trials Registry Platform is not itself a registry but provides standards for all clinical trial registries. These standards require information about sources of monetary or material support, primary and secondary sponsors, contacts for public and scientific queries, countries of recruitment, health conditions or problems studied, interventions, key inclusion and exclusion criteria, study design, date of first enrollment, target sample size, recruitment status, and primary and secondary outcomes. The voluntary initiative is part of a growing movement toward greater accessibility to clinical trial information, prompted in part by high-profile cases involving the suppression of data by pharmaceutical companies.

In the European Union, all clinical trials conducted in member states are required to be registered in the EudraCT database, supervised by the European Medicines Agency. In the United States, www.ClinicalTrials.gov

The WHO has acknowledged the need to balance increased transparency with the protection of competitive advantage. It may come down to a question of the timing of disclosure. In comments submitted to a WHO formal consultation on disclosure timing policy in April, the Pharmaceutical Research and Manufacturers of America noted "there may be infrequent instances where companies may regard certain data elements as sensitive for competitive reasons and wish to delay public disclosure." In particular, the organization said that companies may wish to delay the disclosure of the official scientific title of the study, specific mechanism or molecular identifiers of the intervention, target sample size, primary outcome, and key secondary outcomes.

The WHO Registry Platform is expected to launch a web-based search portal later this year that would allow interested individuals to search among participating registries for clinical trials taking place or completed throughout the world.

For more information on the registry platform, visit www.who.int/ictrp/en

The World Health Organization has launched a major initiative to standardize the way that information on clinical trials is made available to the public.

In an attempt to address growing public concerns about the transparency of medical research involving human participants, WHO is recommending 20 key details that all clinical trial registries should include.

"Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants," Dr. Timothy Evans, assistant director-general of the WHO, said in a written statement.

WHO's International Clinical Trials Registry Platform is not itself a registry but provides standards for all clinical trial registries. These standards require information about sources of monetary or material support, primary and secondary sponsors, contacts for public and scientific queries, countries of recruitment, health conditions or problems studied, interventions, key inclusion and exclusion criteria, study design, date of first enrollment, target sample size, recruitment status, and primary and secondary outcomes. The voluntary initiative is part of a growing movement toward greater accessibility to clinical trial information, prompted in part by high-profile cases involving the suppression of data by pharmaceutical companies.

In the European Union, all clinical trials conducted in member states are required to be registered in the EudraCT database, supervised by the European Medicines Agency. In the United States, www.ClinicalTrials.gov

The WHO has acknowledged the need to balance increased transparency with the protection of competitive advantage. It may come down to a question of the timing of disclosure. In comments submitted to a WHO formal consultation on disclosure timing policy in April, the Pharmaceutical Research and Manufacturers of America noted "there may be infrequent instances where companies may regard certain data elements as sensitive for competitive reasons and wish to delay public disclosure." In particular, the organization said that companies may wish to delay the disclosure of the official scientific title of the study, specific mechanism or molecular identifiers of the intervention, target sample size, primary outcome, and key secondary outcomes.

The WHO Registry Platform is expected to launch a web-based search portal later this year that would allow interested individuals to search among participating registries for clinical trials taking place or completed throughout the world.

For more information on the registry platform, visit www.who.int/ictrp/en

The World Health Organization has launched a major initiative to standardize the way that information on clinical trials is made available to the public.

In an attempt to address growing public concerns about the transparency of medical research involving human participants, WHO is recommending 20 key details that all clinical trial registries should include.

"Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants," Dr. Timothy Evans, assistant director-general of the WHO, said in a written statement.

WHO's International Clinical Trials Registry Platform is not itself a registry but provides standards for all clinical trial registries. These standards require information about sources of monetary or material support, primary and secondary sponsors, contacts for public and scientific queries, countries of recruitment, health conditions or problems studied, interventions, key inclusion and exclusion criteria, study design, date of first enrollment, target sample size, recruitment status, and primary and secondary outcomes. The voluntary initiative is part of a growing movement toward greater accessibility to clinical trial information, prompted in part by high-profile cases involving the suppression of data by pharmaceutical companies.

In the European Union, all clinical trials conducted in member states are required to be registered in the EudraCT database, supervised by the European Medicines Agency. In the United States, www.ClinicalTrials.gov

The WHO has acknowledged the need to balance increased transparency with the protection of competitive advantage. It may come down to a question of the timing of disclosure. In comments submitted to a WHO formal consultation on disclosure timing policy in April, the Pharmaceutical Research and Manufacturers of America noted "there may be infrequent instances where companies may regard certain data elements as sensitive for competitive reasons and wish to delay public disclosure." In particular, the organization said that companies may wish to delay the disclosure of the official scientific title of the study, specific mechanism or molecular identifiers of the intervention, target sample size, primary outcome, and key secondary outcomes.

The WHO Registry Platform is expected to launch a web-based search portal later this year that would allow interested individuals to search among participating registries for clinical trials taking place or completed throughout the world.

For more information on the registry platform, visit www.who.int/ictrp/en

College freshman living in dorms and adolescents entering high school are moving to the head of the line to receive Menactra, following an announcement from the manufacturer that the company won't be able to meet demand for the meningococcal vaccine at least through this summer.

The Centers for Disease Control and Prevention announced in May that Sanofi Pasteur Inc., maker of the tetravalent meningococcal polysaccharide-protein conjugate vaccine (MCV4), expects demand for the vaccine to exceed supply (MMWR May 19, 2006;55[Dispatch]:1).

In response, the CDC—in conjunction with the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, the American College Health Association, and the Society for Adolescent Medicine—recommends that providers continue to vaccinate adolescents entering high school (if they have not been previously vaccinated) and college freshman living in dorms. The company anticipates that enough MCV4 will be available to meet demand for these two groups, based on current supply projections.

Vaccination of children aged 11–12 years should be deferred until further notice. If possible, physicians should track any children in this age group, for whom MCV4 vaccination has been deferred, and recall them when the supply improves.

Other high-risk groups that should be vaccinated include: military recruits, travelers to areas where meningococcal disease is hyperendemic or epidemic, microbiologists who are routinely exposed to isolates of Neisseria meningitidis, individuals with anatomic or functional asplenia, and individuals with terminal complement deficiency.

For periodic updates of vaccine supply, visit www.cdc.gov/nip/news/shortages/default.htm

Physicians with questions about their orders should contact Sanofi Pasteur by calling 800-822-2436 or by visiting www.vaccineshoppe.com

College freshman living in dorms and adolescents entering high school are moving to the head of the line to receive Menactra, following an announcement from the manufacturer that the company won't be able to meet demand for the meningococcal vaccine at least through this summer.

The Centers for Disease Control and Prevention announced in May that Sanofi Pasteur Inc., maker of the tetravalent meningococcal polysaccharide-protein conjugate vaccine (MCV4), expects demand for the vaccine to exceed supply (MMWR May 19, 2006;55[Dispatch]:1).

In response, the CDC—in conjunction with the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, the American College Health Association, and the Society for Adolescent Medicine—recommends that providers continue to vaccinate adolescents entering high school (if they have not been previously vaccinated) and college freshman living in dorms. The company anticipates that enough MCV4 will be available to meet demand for these two groups, based on current supply projections.

Vaccination of children aged 11–12 years should be deferred until further notice. If possible, physicians should track any children in this age group, for whom MCV4 vaccination has been deferred, and recall them when the supply improves.

Other high-risk groups that should be vaccinated include: military recruits, travelers to areas where meningococcal disease is hyperendemic or epidemic, microbiologists who are routinely exposed to isolates of Neisseria meningitidis, individuals with anatomic or functional asplenia, and individuals with terminal complement deficiency.

For periodic updates of vaccine supply, visit www.cdc.gov/nip/news/shortages/default.htm

Physicians with questions about their orders should contact Sanofi Pasteur by calling 800-822-2436 or by visiting www.vaccineshoppe.com

College freshman living in dorms and adolescents entering high school are moving to the head of the line to receive Menactra, following an announcement from the manufacturer that the company won't be able to meet demand for the meningococcal vaccine at least through this summer.

The Centers for Disease Control and Prevention announced in May that Sanofi Pasteur Inc., maker of the tetravalent meningococcal polysaccharide-protein conjugate vaccine (MCV4), expects demand for the vaccine to exceed supply (MMWR May 19, 2006;55[Dispatch]:1).

In response, the CDC—in conjunction with the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, the American College Health Association, and the Society for Adolescent Medicine—recommends that providers continue to vaccinate adolescents entering high school (if they have not been previously vaccinated) and college freshman living in dorms. The company anticipates that enough MCV4 will be available to meet demand for these two groups, based on current supply projections.

Vaccination of children aged 11–12 years should be deferred until further notice. If possible, physicians should track any children in this age group, for whom MCV4 vaccination has been deferred, and recall them when the supply improves.

Other high-risk groups that should be vaccinated include: military recruits, travelers to areas where meningococcal disease is hyperendemic or epidemic, microbiologists who are routinely exposed to isolates of Neisseria meningitidis, individuals with anatomic or functional asplenia, and individuals with terminal complement deficiency.

For periodic updates of vaccine supply, visit www.cdc.gov/nip/news/shortages/default.htm

Physicians with questions about their orders should contact Sanofi Pasteur by calling 800-822-2436 or by visiting www.vaccineshoppe.com